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|"Stop Fluoridation in New York City" on Change.org |
Top Fluoride News Stories of 2011
TOP 20 FLUORIDE NEWS STORIES OF 2011
Misinformed fluoridation promoters falsely assure unquestioning and confused legislators that fluoride-laced water is safe for everyone and no credible evidence proves otherwise. However, hundreds of studies and an abundance of evidence prove them wrong, reports the New York State Coalition Opposed to Fluoridation, Inc. (NYSCOF).
Here's what happened in 2011
1) U.S. Department of Health and Human Services (HHS) recommends lowering water fluoride levels due to fluoride's harmful dental effects
For over 6 decades, HHS assured Americans that artificially fluoridated water was safe for everyone to drink. But they were wrong. About 50% of U.S. adolescents have fluoride-ruined teeth or dental fluorosis – white spotted, yellow, brown and/or pitted teeth. So HHS' recommends lowering "optimal" water fluoride levels.
2) HHS recommends avoiding fluoridated water when making infant formula to prevent dental fluorosis (discolored teeth)
Many government, health and dental agencies report that babies who consume fluoridated water are more apt to have fluoride-discolored/damaged teeth without benefit of less tooth decay. (References: http://www.FormulaFluoride.Webs.com)
3) The Environmental Protection Agency (EPA) will lower safe water fluoride levels to protect bones and teeth
The prestigious National Research Council found EPA's current safe water fluoride levels can adversely affect bones and teeth. EPA's Office of Water will lower safe water fluoride levels
4) U.S. Centers for Disease Control (CDC) reports growing numbers of U.S. children have fluoride-damaged teeth, arguably at epidemic proportions.
Due to fluoride over-exposure, the CDC reports that over 41% of 12-15 years olds are afflicted with dental fluorosis. However, no research was conducted to discover what fluoride over-exposure has done to children's bones.
5) Fumigant sulfuryl fluoride found to leave health-damaging levels of fluoride residues on food
EPA's Office of Pesticides proposes to ban fumigant sulfuryl fluoride because harmful fluoride levels remain on many foods e.g. cocoa beans and dried eggs.
6) Even fluoride-seller, Colgate, reports that studies confirm "the association between infant formula consumption and permanent dentition fluorosis."
Colgate joins many government, health and dental organizations in advising that infant formula should not be mixed with fluoridated water to lower babies' risk of developing dental fluorosis (http://www.FormulaFluoride.Webs.com), but this is little publicized.
7) Infant juices contain non-labeled tooth-damaging fluoride levels
Commonly-consumed infant fruit juices contain fluoride, some at levels higher than recommended for pubic water supplies, according to research presented at the International Association for Dental Research annual meeting.
8) More studies published linking fluoride to human brain damage and lower IQ
A review of studies published in Neurologia reports, "The prolonged ingestion of fluoride may cause significant damage to health and particularly to the nervous system." The research team reports, "It is important to be aware of this serious problem and avoid the use of toothpaste and items that contain fluoride, particularly in children as they are more susceptible to the toxic effects of fluoride."
9) New Study Fails to Refute Fluoride-Osteosarcoma Link
A paper in the Journal of Dental Research by dentist Chester Douglass and colleagues, "An Assessment of Bone Fluoride and Osteosarcoma," claims to show no association between fluoride bone levels and osteosarcoma, a form of bone cancer. However, Douglass' study has serious scientific flaws and is incapable of disproving a previous study (Bassin et al., 2006) which linked water fluoridation to osteosarcoma.
10) Prominent Hispanic Civil Rights Group Opposes Fluoridation
The League of United Latin American Citizens (LULAC) opposes fluoridation as a civil rights violation and because "the National Research Council in 2006 established that there are large gaps in the research on fluoride's effects on the whole body; a fact that contradicts previous assurances made by public health officials and by elected officials, that fluorides and fluoridation have been exhaustively researched."
11) Prominent Civil Rights Leaders Oppose Fluoridation
Because fluoride can disproportionately harm poor citizens and black families, Atlanta civil rights leaders, former UN Ambassador Andrew Young, Reverend Gerald Durley, PhD, Martin Luther King's daughters, Bernice and Alveda. asked Georgia legislators to repeal the state's mandatory water fluoridation law.
12) Tennessee House Speaker, Other Legislators Call for Halt to State Promotion of Fluoridation
Bipartisan group cites risks for citizens and water utilities. Tennessee, once 99% fluoridated, is now down in the low 90's according to the American Dental Association News.
13) Water Fluoridation Injury Lawsuit Filed in Federal Court
A 13-year-old's fluoride-discolored teeth were allegedly caused by drinking fluoridated bottled water since infancy. Her mom is suing the bottlers for the cost to cover up the unsightly teeth.
14) Review of Fluoride Supplement Studies Show No Evidence of Safety - No Benefit Either
According to the Cochrane Oral Health Group, fluoride supplements fail to reduce tooth decay in primary teeth, permanent teeth cavity-reduction is dubious and health risks are little studied -- The Pennsylvania Chapter of the American Academy of Pediatrics recommends NO fluoride supplementation because "Too much fluoride causes streaks in the teeth" and it's impossible to determine a child's individual daily fluoride intake from all sources. Sodium fluoride supplements "have not been found by FDA to be safe or effective," according to the U.S. National Library of Medicine.
15) Dental hygienist's Master's thesis and experience shows no Benefit from fluoridation
In a Master's thesis, a dental hygienist, with 20 years experience in a clinic for low-income children, noticed these children had significant tooth decay in spite of fluoridation. When people were educated about fluoride's risks and benefits, they stopped drinking fluoridated water, she reported.
16) CDC Reveals Fluoridation Fails Alaskans
The CDC reports that 91% of rural Alaskan Native adolescents have cavities whether their water is fluoridated or not. The CDC acknowledges that poor diets and lack of dental care are the probable culprits.
17) Pew Charitable Trust uses propaganda, PR and political clout to force more fluoride into people who don't want it.
The Pew Charitable Trust paid for lobbyists to misinform Arkansas state legislators into mandating fluoridation statewide which nullified local referendums where residents said NO to fluoridation. Pew continues to contaminate local fluoridation politics in New Hampshire, Iowa, Austin and elsewhere.
18) The Council of Canadians, Canadian Association of Physicians for the Environment and Great Lakes United demand an end to fluoridation
Council of Canadians' Unfluoridate It! campaign. Great Lakes United statement against the 'practice of artificial drinking water fluoridation.'
19) Dr. Joe Mercola, owner of the world's most visited natural health website conducted Fluoride Awareness Week
Dr. Mercola reveals the science behind fluoride's adverse health effects to the brain, bones, the thyroid and pineal glands.
20) New York City Council Members introduce legislation (Int 0463-2011) to stop fluoridation
City Council Member Peter Vallone, Jr. says, "There is a growing body of evidence that fluoride does more harm than good."
"Those who claim fluoridation is harmless for everyone and that fluoride's health effects have been exhaustively studied cannot be trusted because that's simply not true," says Beeber.
Click the link below to view the message and reply.
Gov't Agencies, Health Dept's and Dental Groups
Advise to Avoid Fluoride Discolored Teeth (Dental Fluorosis):
Don't Feed Fluoridated Water to Infants
Dr. Howard Koh, Assistant Secretary for Health, US Department of Health and Human Services (HHS) in a video commentary published on Medscape.com, March 8, 2011.
Koh says, "…tooth enamel formation occurs from birth until about 8 years old. This is also the time when dental fluorosis may occur with excess fluoride consumption."
Koh advises low-fluoride bottled water be used for routinely reconstituting infant formula.
Reference: Government Perspectives on Healthcare;HHS: Proposed Guidelines on Fluoride in Drinking Water,A Commentary By Howard K. Koh, MD, MPH
From the Centers for Disease Control
"Recent evidence suggests that mixing powdered or liquid infant formula concentrate with fluoridated water on a regular basis may increase the chance of a child developing the faint, white markings of very mild or mild enamel fluorosis."
Academy of General Dentistry
"If you add fluoridated water to your infant's baby formula, you may be putting your child at risk of developing dental fluorosis..."
"Regularly mixing a baby's formula with fluoridated tap water can provide enough fluoride to cause fluorosis — mild white streaks on the teeth or more severe pitting or staining of tooth enamel. Fluorosis can affect both baby teeth and permanent teeth."
Vermont Department of Health
"The Vermont Department of Health recommends mixing powdered or concentrated baby formula with water that is fluoride-free, or contains very low levels of fluoride, for feeding infants under 12 months of age. Recent studies have discovered the possibility that infants in this age group may be consuming more fluoride than necessary."
New York State Department of Health
Parents who are concerned about the risk of enamel fluorosis, can mix liquid concentrate or powdered infant formula with water that is fluoride free or contains low levels of fluoride. Examples are water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water.
California Dental Association
"...mixing powdered or liquid infant formula concentrate with
fluoridated water on a regular basis for infants primarily fed in this
way may increase the chance of a child's developing enamel fluorosis,"
according to the CDA's Feb 2010 Report, Oral Health During Pregnancy
and Early Childhood: Evidence-Based Guidelines for Health
Professionals. ( http://www.cdafoundation.org/library/docs/poh_guidelines.pdf
National Research Council In March 2006, the National Research Council (NRC) cautioned that infants can fluoride-overdose via reconstituted baby formula. (2) The
American Dental Association (ADA) passed this information on to its
members in a November 2006 e-gram .
American Dental Association_Evidence-based_Infant_Formula_Chairside_Guide.
Recommendations for infants who consume reconstituted infant formula as the main source of nutrition: • Continue use of liquid or powdered concentrate infant formulas reconstituted with optimally fluoridated drinking water while being cognizant of the potential risk for enamel fluorosis. • Use ready-to-feed formula or liquid or powdered concentrate formula reconstituted with water that is either fluoride-free or has low concentrations of fluoride when the potential risk for enamel fluorosis is a concern. http://ebd.ada.org/contentdocs/ADA_Evidence-based_Infant_Formula_Chairside_Guide.pdf
The American Dental Association expert panel concluded that for infants from birth to age 12 months who consume reconstituted infant formula as the main source of nutrition, the continued use of powdered or liquid concentrate formulas reconstituted with optimally fluoridated drinking water is appropriate, as long as the parent or caregiver is cognizant of the potential risk for enamel fluorosis. If parents and caregivers are concerned about the potential for increasing a child's risk of developing enamel fluorosis, breast feeding, ready-to-feed formula or powdered or liquid concentrate formula reconstituted with water that either is fluoride free or contains low concentrations of fluoride are an alternative. This type of water is often labeled "purified," "demineralized," "deionized," "distilled" or "produced through reverse-osmosis."
Minnesota Dental Association
If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be mixed with water that is fluoride free, or contains low levels of fluoride to reduce the risk of fluorosis. Examples are water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water. Many grocery stores sell these types of drinking water for less than $1 per gallon.
Maryland Government Agency
Regularly mixing powdered or liquid infant formula concentrate with fluoridated water may increase your child's risk of developing faint white markings or streaks on the teeth -- a sign of mild enamel fluorosis.If you're concerned about fluorosis, you can minimize your baby's exposure to fluoride by using ready-to-feed formula. You can also alternate using tap water and nonfluoridated water for formula preparation, or mix powdered or liquid infant formula concentrate with low-fluoride water most or all of the time. CDC also recommends that parents can use low-fluoride bottled water some of the time to mix infant formula; these bottled waters are labeled as de-ionized, purified, demineralized, or distilled. http://fha.maryland.gov/oralhealth/community-water.cfm#formula
Chester Water Authority (Chester, Pennsylvania)
Parents should consider preparing powdered or liquid concentrate formulas for infants using water that contains no or low levels of fluoride, if reconstituted formula is the primary source of nutrition for the infant. Other sources of infant nutrition could include breast milk or ready to feed (no-mix) formula, both of which are low in fluoride.Some fluoride is beneficial, but dental fluorosis or mottling of the teeth can occur if an infant receives too much fluoride. Infants are susceptible to receiving too much fluoride due to their low body weight and high fluid intake
Wisconsin WIC If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be mixed with water that is fluoride free or contains low levels of fluoride to reduce the risk of fluorosis. http://www.dhs.wisconsin.gov/wic/WICPRO/training/fluoride.pdf
American Public Health Association: Policy Statement Database
Recent evidence suggests that mixing powdered or liquid infant formula concentrate with fluoridated water on a regular basis for infants primarily fed in this way may increase the chance of a child's developing the faint white markings of very mild or mild enamel fluorosis. Occasional use of water containing optimal levels of fluoride should not appreciably increase a child's risk for fluorosis. Studies have not shown that teeth are likely to develop more esthetically noticeable forms of fluorosis, even with regular mixing of formula with fluoridated water. http://www.apha.org/advocacy/policy/policysearch/default.htm?id=1373
Des Moines Water Works
Powdered or liquid concentrate infant formula can be mixed with water that is fluoride free or contains low levels of fluoride. These types of water are labeled as purified, demineralized, deionized, distilled or reverse osmosis filtered water http://www.dmww.com/upl/documents/water-quality/lab-reports/fact-sheets/fluoride.pdf
Smile Florida SmileFlorida.org is a product of the Florida Dental Association, Inc.,
Some infant formulas may already contain beneficial fluoride levels from water used during the manufacture of the product. If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be mixed with water that is fluoride-free or contains low levels of fluoride to reduce the risk of fluorosis.
These include water labeled as purified, demineralized, deionized or distilled, as well as reverse-osmosis filtered water.
The American Dental Association has recommended that for infants being fed primarily reconstituted infant formula, a fluoride-free water source such as demineralized or distilled water be used to reduce fluoride intake. For http://www.broomfield.org/environment/FactSheets/Fact%20Sheet%208.pdf
Ormond Beach, Florida puts infant warning advisory on Annual Water Quality Report
Dental Associations Advise Against Fluoride in Baby Formula
Although the American Dental Association and the Florida Dental Association both endorse fluoridated water as an effective way to prevent tooth decay, they have issued an advisory recommending that non-fluoridated bottled water be used in powdered or liquid-concentrate baby formula for infants.The advisories note that too much fluoride can cause fluorosis, resulting in a discoloration or streaks on teeth.
However, recent studies revealed infants might receive greater than optimal amounts of fluoride when fed formula mixed with water containing fluoride. The ADA recommends ways to reduce fluoride intake from reconstituted infant formula: • Breast milk is widely acknowledged as the most complete form of nutrition for infants. • Ready-to-feed formula is preferred to help ensure fluoride intake does not exceed optimal amounts. • Liquid concentrate or powdered infant formula mixed with bottled water that is fluoride free or contains low levels of fluoride can reduce the risk of fluorosis. • Occasional use of water containing optimal levels of fluoride should not appreciably increase a child's risk for fluorosis.
Infant Formula & Fluoridated Water Advice
Wisconsin Division of Public Health
Statement in Response to the American Dental Association's
Infant Formula Recommendation
In November 2006, the American Dental Association (ADA) released an "Interim Guidance on
Fluoride Intake for Infants and Young Children." The ADA guidance was based on a report from the
National Research Council (NRC) that raised the possibility that infants could receive a greater than
optimal amount of fluoride from liquid concentrate or from powdered baby formula that was mixed
with water containing fluoride during a time that their developing teeth may be susceptible to enamel
The ADA Interim Guidance recommends:
• Breast milk is widely acknowledged as the most complete form of nutrition for infants.
• For infants who get most of their nutrition from formula during the first 12 months, ready-tofeed
formula is preferred to help ensure that infants do not exceed the optimal amount of
• If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be
mixed with water that is fluoride free or contains low levels of fluoride to reduce the risk of
• The occasional use of water containing optimal levels of fluoride should not appreciably
increase a child's risk for fluorosis.
The Wisconsin Division of Public Health recommends that the proper amount of fluoride be ingested
from infancy through old age to prevent and control tooth decay. However, in a small number of
children, excess fluoride exposure during the ages when teeth are forming (from birth through age 8)
can result in a range of changes within the outer surface of the tooth called enamel fluorosis. In the
vast majority of cases, fluorosis appears as barely noticeable faint white lines or streaks on tooth
enamel and does not affect the function of the teeth. Studies have shown that teeth are unlikely to
develop more esthetically noticeable forms of fluorosis, even with regular mixing of formula with
Since fluoride exposure to developing teeth plays a very important long-term role in preventing tooth
decay, parents and healthcare providers should weigh the small risk of the mild cosmetic effect from
enamel fluorosis against the benefit of fluoride in preventing tooth decay and the need for dental
fillings. This includes consideration of higher decay prevalence and low dental care access
experienced by low income populations. Such populations are usually seen in Women, Infant and
Child (WIC) clinics and other public health programs.
Community water fluoridation is safe and is beneficial for the dental health of children and adults.
The Centers for Disease Control and Prevention (CDC) and the Wisconsin Division of Public Health
promotes its use for people of all ages. Parents and caregivers of infants fed primarily with
powdered or liquid concentrate formula mixed with fluoridated water, who are concerned about
enamel fluorosis, can lessen this exposure by mixing formula with low fluoride water most of the
time or by using ready-to-feed formula. (Note: per Federal WIC regulations, the WIC program
cannot provide ready-to-feed formula for this purpose.) However, for many infants the use of
fluoridated water in formula is appropriate and can reduce the risk of tooth decay.
For further information on infant formula and the risk for enamel fluorosis, see the CDC web site at:
I donâ€™t know what the solution is. But I do know that when we put the merely miseducated in with the truly malevolent, we drive potential allies further away from the neutral ground where we might be able to connect and enlighten. Not saying I am any good at it! And of course, public health professionals are even more prejudiced against us as a group. But in my experience with the Council of Canadians and Green Party over three years, it was the ability of Elizabeth May and Maude Barlow to deliver a soft answer to my wrath and invite me to step into the middle ground for further discussion that has resulted in their two powerful national resolutions calling for an end to fluoridation in Canada. Council of Canadians has been a staunch supporter of water fluoridation in the past.
All I can suggest is that you keep politely pressing them for evidence that fluoride supplement of 700 micrograms per day provided by on quart of fluoridated water used to make formula for an infant under six months is safe (as they claim on this â€˜warningâ€™) when fluoride supplement of 250 micrograms Â per day should not be given at all to any infant under six months, breastfed or bottle fed, because it is not protective of systemic overdose known to cause dental fluorosis.
From: FluoridePoisoning@yahoogroups.com [mailto:FluoridePoisoning@yahoogroups.com] On Behalf Of MRN Olenick
Sent: March-09-12 10:30 AM
Subject: RE: [FluoridePoisoning] Re: The first posted infant formula advisory for pare...
There's a good deal of truth in what you say, Aliss - I can see that True Believer light in their eyes .. but there are plenty of real sociopaths, too, and they tend to rise to the top.
--- On Fri, 3/9/12, Aliss <aliss@...> wrote:
From: Aliss <aliss@...>
Subject: RE: [FluoridePoisoning] Re: The first posted infant formula advisory for pare...
Date: Friday, March 9, 2012, 7:51 AM
Nita, there may be a person every so often among them (e.g. Michael Easeley) who does lack the ability to feel empathy for otherâ€™s suffering (that the research lit indicates can be caused by pharmaceuticals, toxins, congenital brain abnormality or is learned behaviour usually as a result of abuse or early emotional neglect), but virtually all of the public health people Iâ€™ve met are just mis-educated and unconsciously biased due to having a basic loyalty to their peer group in their profession. The loyalty to their profession and peers makes it impossible to accept the idea that fluoridation is harmful and what theyâ€™ve been promoting all their professional lives is harming not only their communityâ€™s children â€“ but their own. So they are True Believers that fluoridation is always The Right Thing To Do. They are not evil and not sociopathic. But like all of us, they will seek to avoid being caught in a serious mistake that shows them up as foolish or incompetent even if the mistake is genuinely not their fault. The drive to avoid humiliation, maintain power/status and save face is even more powerful than the drive to avoid starvation.
I do think that in order to allow them to back down with dignity, we must find a way to end fluoridation on neutral information and impartial rule of law.
Augie is feeling the effects of challenging their integrity firsthand. My, my, how times donâ€™t change since good ole Mr. Bull started helping fluoridation get established and deal with objectors. John Yiamouiyannis was reprimanded, demoted and then fired. Dr. Waldbott and Dr. Spira encountered the same closing of ranks and hostility from governing bodies. Bryson, Limeback, Bassin, Mullenix â€“ all suffered serious career setbacks as a result of breaking from the ranks.
Dougâ€™s experience with WIC is one I should learn from too. I confess I am not exactly gentle in my scathing reprimands of people who, but for capricious circumstance, are mostly just like me.
From: FluoridePoisoning@yahoogroups.com [mailto:FluoridePoisoning@yahoogroups.com] On Behalf Of mommy2baron@...
Sent: March-09-12 4:11 AM
Subject: Re: [FluoridePoisoning] Re: The first posted infant formula advisory for pare...
In a message dated 3/8/2012 10:10:25 P.M. Pacific Standard Time, cragoe@... writes:
In California the WIC advisors were told to not to tell the parents anything unless the parents had asked specifically about the risk of fluorosis. And since very few parents know about this very few were being told.
How truly evil to know about something that will hurt people--especially babies-- and purposefully keep quiet about it. A sin of omission is as serious and can cause as much harm as a sin of commission. And how doubly revolting to order others that they have power over to hush up too. I hate to think of the awful mental anguish some of those WIC advisors who know how bad fluoride is are going through as a result of the hush up orders from their superiors.
If those at the top who are giving the hush up orders do not care about doing the right thing then so be it--basic human decency cannot be forced upon someone--either they are truthful and moral and live their lives doing the right thing or they are not--and there are some very bad names for this sort of person. This sort of person has absolutely no business working for a public health agency. In my opinion such a person is corrupt. I'm sure some of this type of person is reading this right now since this board is monitored.
However they are being incredibly stupid if they are too boneheaded to realize that the day is coming when they will end up being deposed for lawsuits and sued silly for failure to warn. Oh and just think of all the WIC advisors being deposed and telling how their bosses told them not to warn and to keep quiet unless specifically asked. Oh my just imagine what juries will do when they hear about that !!! And to add to their upcoming legal woes a sizeable percentage of WIC families are minorities which opens up a whole new world of Civil Rights Violations lawsuits where these health officials PERSONAL ASSETS CAN BE GONE AFTER.
Sure hope the "monitors" spread this post across the country to the public health community !!!
Mailbag: Fluoride down the drain
Did anybody ever think about fluoridating water being the most inefficient means of preventive dentistry?
Almost everyone drinking the water is over- or underdosing. They say a person needs eight glasses of water a day. (That assumes they don't drink milk, soda, fruit or vegetable juice or eat moist food like spaghetti.) Eight glasses of water is about half a gallon a day per person.
When you flush a toilet you use a week's dosage of fluoride. A shower uses three to four weeks, and a bath six or seven weeks' worth.
I won't guess how much for laundry or dish washing. And don't forget we water our lawns with it in summer and the city parks department buys it for watering the many acres of parks we have.
Most of it goes into things that don't even have teeth. I am not a chemist and don't know how cumulative it is in the ground, but over the years there must have been some change in the chemical make-up of soil and plants watered with fluoride.
Forty years ago I bought a water distiller and still use it to avoid chlorine and fluoride. And I asked at my favorite restaurant if they were giving me city water and I was told they have an efficient filter on their water. It may be (and should be) required by state health inspectors.
Think of it like this. Fluoride is available in prescription doses in pills. The city buys you one of these pills every day and you take it and have great teeth. But for each pill they buy an undetermined number of the same pills (hundreds at least and some days thousands) which they dump on the ground or flush down the sewer every single day.
Ward Mackey, Albany (March 4)
Read more: http://democratherald.com/news/opinion/mailbag/mailbag-fluoride-down-the-drain/article_8339ef8c-6a1f-11e1-b55a-0019bb2963f4.html#ixzz1op6Oj6Jw
The International Bottled Water Association (IBWA) issued the following statement regarding a March 6, 2012, New York Times article concerning recent increases in children's cavity rates.
The International Bottled Water Association (IBWA) issued the following statement regarding a March 6, 2012, New York Times article concerning recent increases in children's cavity rates:
"The New York Times article, Preschoolers in Surgery for a Mouthful of Cavities, (March 6, 2012), notes that the causes of increased dental problems in young children vary, from a simple lack of brushing to too many sugary foods and beverages. Unfortunately, the article also incorrectly states that drinking bottled water instead of `fluoridated tap water' can contribute to tooth decay. This statement is both inaccurate and misleading. There is absolutely no correlation between consumption of bottled water and an increase in cavities. In fact, bottled water does not contain ingredients that cause cavities, such as sugar.
For consumers who want fluoride in their drinking water and wish to choose bottled water, approximately 20 IBWA member companies make clearly-labeled fluoridated bottled water products under stringent FDA guidelines. For a complete list of these brands, which are available in many markets across the country, please visit IBWA's Website, http://www.bottledwater.org/fluoride.
There are many sources of fluoride, and the amount of fluoride exposure varies greatly by community and individual. Approximately two-thirds of communities in the Unites States fluoridate their public drinking water supplies. Those who live in communities that do not fluoridate public drinking water, who get their drinking water from wells, or who filter their fluoridated tap water will not be getting fluoride in their drinking water. Fluoride is present in many foods and beverages and almost all toothpaste contains fluoride. Too much exposure to fluoride can lead to a condition called fluorosis, which results in stains to the teeth. Consumers should therefore look at how much fluoride they are receiving as part of an overall diet and should contact their health-care provider or dental-care provider for their recommendation.
As a packaged food product, comprehensively regulated by the U.S. Food and Drug Administration (FDA), bottled water labels must contain the name and place of business of the bottler, packer or distributor, and virtually all bottled water products provide a telephone number. With this information, consumers may contact the bottled water company directly to obtain information about the product. Bottled water companies must also follow fluoride labeling guidelines should fluoride be added to the product or be present at a naturally occurring level as set for the by FDA regulation (21C.F.R. §165.110(b)
Former U.N. ambassador Andrew Young and Dr. Gerald Durley were civil rights
leaders in south in the 1960's. Along with Bernice King, daughter of Martin
Luther King, they are now opposed to water fluoridation and are calling for a
repeal of the Georgia mandatory fluoridation law.
One thing we can do is thank these people for their support. They have come
under a lot of pressure since they took this stand. After they wrote the
letters they had a meeting with some powerful high level people in federal
public health. However, they have not withdrawn their letters.
If you go to http://spotsonmyteeth.com/ you will find the letters written by
Young and Durley in the "endorsements/letters" section.
I posted a message on Andrew Young's facebook page, which is here:
I also wrote a letter of support to Dr. Gerald Durley, his address is on his
letter found on the "spots on my teeth" website. I wrote a letter for former
President Jimmy Carter, who signed the mandatory bill when he was governor of
Dan Stockin was the person who informed these leaders. He asks that any letters
of support be respectful, and please don't ask them to do anything else
regarding fluoride or another issue. They are very busy with many things on
City cuts fluoride levels in water supply
by Curtis Wackerle, Aspen Daily News Staff Writer
Tuesday, March 13, 2012
Aspen's drinking water will contain less fluoride, City Council decided at Monday's meeting.
Effective immediately, the city will adapt the amount of fluoride it adds to the water supply to new federal standards recommending levels be set at 0.7 parts per million. The chemical is added to drinking water because of its ability to stem cavities in children, but is controversial because it is also a toxin with adverse health effects in high enough doses.
The city for decades has added enough fluoride, which is naturally occurring in lower levels in area streams, to bring the level up to 1.0 parts per million.
The official action by council comes after years of debate on the issue. Removing fluoride from public water supplies has become a cause for some, and officials within the city's water department have become concerned over the years about adding the substance.
"We have the best water in the world," said water treatment supervisor Charles Bailey, a 20-year veteran of the water department. "We cringe when we load" the fluoride bags into the water supply, he said, noting the chemical's industrial Chinese origin. There are no domestically available sources of fluoride additive, he said.
Bailey likened the practice of adding fluoride to polluting the water.
Councilman Torre was in favor of eliminating fluoride altogether, saying the practice is like medicating "nine out of 10 people because one out of 10 needs it."
Jake DeWolfe, treatment operator for the city of Aspen's water department, pours fluoride into a hopper that dispenses the chemical into the water system in this photo taken in 2011. When handling fluoride, one must wear a full-body protective suit, gloves and a respirator mask.
Councilman Steve Skadron, recognizing the issue's ability to stir passions on both sides, said there are "significant trade-offs and competing benefits and risks." He felt that lowering the amount of fluoride added, as opposed to eliminating it, best addressed all concerns.
Councilman Derek Johnson said he is concerned by reports from some local dentists, who claim that children in Basalt and Carbondale have higher incidents of cavities than their counterparts in Aspen. Basalt and Carbondale do not add fluoride to their water supplies.
However, he said the city should stay on top of the issue and continually monitor the fluoride added to the water supply to see what's really in it and keep up with federal recommendations.
The plan approved instructs the water department to "create a more extensive testing protocol" on fluoride levels, and report back annually to council on fluoride.
C.J. Oliver, the city's director of the environmental health department, wrote in a memo on the issue that the government must rely on "peer-reviewed" studies in deciding which way to go. While too much fluoride has been shown to degrade tooth enamel and lead to more bone fractures, the jury is still out on whether the levels of fluoride in Aspen's water are truly dangerous, the memo says. Other claims, including concerns that fluoride causes cancer and lowers IQ levels, are unsubstantiated at this time, Oliver wrote.
City will continue adding fluoride to water
Council says it was swamped with info on controversial issue
Ireland said the council will review the fluoridation issue annually and asked the city's Water Department to test the substance in the bag, before it's added, on a regular basis. Fluoride is not manufactured in the United States — China is a leading producer — and part of the council discussion centered on ensuring its quality so that there is no outside health risk to the public.
Testing the "product" that is coming from China needs to be done to each batch. I guess that will also change the the "$1 spent gives $38 in savings" , which is not accurate to begin with. Exactly what method will be used to test it? Ion-chromatography with chemical suppression of eluent conductivity would be the best and what is the cost to do it? Even better would be to require testing of individuals serum fluoride, thyroid function, kidney function, IQ, dental fluorosis, etc. and correlating it to other health conditions such as chronic fatigue syndrome, fibromyalgia, kidney disease, diabetes, and especially heart disease. I guess this would again cause the "for every $1 spent" to be diminished. If you truely want to get the big picture all this and MORE is needed.
I've been informed that all the members of the New Jersey senate health
committee were issued literature proving that NJ dental records are the same if
not better than more fluoridated states.
I'd like to get that literature if possible. Does anybody know who gave them
Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. The FDA's evidence-based system of drug approval and the OTC monograph system play essential roles in ensuring that drugs are both safe and effective. For instance, during the drug approval process the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. Furthermore, FDA's review of the applicant's labeling insures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.
The Agency has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Physicians and other healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the U.S. without required FDA approval. The manufacturers of unapproved drug products have not received FDA approval and do not conform to a monograph for making over-the-counter (OTC) drugs. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern.
Unapproved Drugs Initiative
In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)," outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process. The FDA uses a risk-based enforcement program in order to concentrate its resources on those products that pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market. For all unapproved drugs, the CPG gives highest enforcement priority to the following:
- Drugs with potential safety risks
- Drugs that lack evidence of effectiveness
- Health fraud drugs
- Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
- Unapproved new drugs that are also violative of the Act in other ways
- Drugs that are reformulated to evade an FDA enforcement action
Summary of Compliance Policy Guide
The Marketed Unapproved Drugs—Compliance Policy Guide (CPG):
- provides official notice that any illegally marketed product is subject to FDA enforcement at any time
- clarifies that the FDA intends to use a risk-based approach to enforcement
- once the risk-based assessment has been made, the FDA can and will take any number of enforcement actions, including but not limited to:
- requesting voluntary compliance
- providing notice of action in a Federal register notice
- issuing an untitled letter
- issuing a warning letter, or
- initiating a seizure, injunction, or other proceeding
What are unapproved drugs and why are they on the market?
The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety. In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness. To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.
Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval. In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs. This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug. Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.
Guidance for FDA Staff and Industry
Marketed Unapproved Drugs – Compliance Policy Guide
Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
September 19, 2011 Compliance
Guidance for FDA Staff and
Marketed Unapproved Drugs Compliance Policy Guide
Sec. 440.100 Marketed New Drugs Without Approved NDAS or ANDAs
Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@...
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
September 19, 2011 Compliance
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 2
II. BACKGROUND ............................................................................................................... 2
A. Reason for This Guidance.......................................................................................................2
B. Historical Enforcement Approach..........................................................................................3
III. FDA'S ENFORCEMENT POLICY................................................................................ 4
A. Enforcement Priorities............................................................................................................4
B. Notice of Enforcement Action and Continued Marketing of Unapproved Drugs..............5
C. Special Circumstances — Newly Approved Product............................................................7
D. Regulatory Action Guidance...................................................................................................8
APPENDIX.................................................................................................................................... 9 Contains Nonbinding Recommendations
Guidance for FDA Staff and Industry1 Marketed Unapproved Drugs — Compliance Policy Guide Chapter 4 Subchapter 440
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This Compliance Policy Guide (CPG) describes how we intend to exercise our enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. This is a revision of a guidance of the same name that was issued in June 2006. The guidance has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the guidance apply only to unapproved new drugs (including new drugs covered by the Over-the-Counter (OTC) Drug Review), except for licensed biologics and veterinary drugs, that are commercially used or sold2 prior to September 19, 2011.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
A. Reason for This Guidance
For historical reasons, some drugs are available in the United States that lack required FDA approval for marketing. A brief, informal summary description of the various
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2 For the purposes of this guidance, the term "commercially used or sold" means that the product has been used in a business or activity involving retail or wholesale marketing and/or sale.
2 Contains Nonbinding Recommendations
categories of these drugs and their regulatory status is provided in Appendix A as general background for this document. The manufacturers of these drugs have not received FDA approval to legally market their drugs, nor are the drugs being marketed in accordance with the OTC drug review. The new drug approval and OTC drug monograph processes play an essential role in ensuring that all drugs are both safe and effective for their intended uses. Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided FDA with evidence demonstrating that their products are safe and effective, and so we have an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or remove the products from the market. We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market.
The goals of this guidance are to (1) clarify for FDA personnel and the regulated industry how we intend to exercise our enforcement discretion regarding unapproved drugs and
(2) emphasize that illegally marketed drugs must obtain FDA approval.
B. Historical Enforcement Approach
FDA estimates that in the United States today perhaps as many as several thousand drug products are marketed illegally without required FDA approval.3 Because we do not have complete data on illegally marketed products, and because the universe of such products is constantly changing as products enter and leave the market, we first have to identify illegally marketed products before we can contemplate enforcement action. Once an illegally marketed product is identified, taking enforcement action against the product would typically involve one or more of the following: requesting voluntary compliance; providing notice of action in a Federal Register notice; issuing an untitled letter; issuing a Warning Letter; or initiating a seizure, injunction, or other proceeding. Each of these actions is time-consuming and resource intensive. Recognizing that we are unable to take action immediately against all of these illegally marketed products and that we need to make the best use of scarce Agency resources, we have had to prioritize our enforcement efforts and exercise enforcement discretion with regard to products that remain on the market.
In general, in recent years, FDA has employed a risk-based enforcement approach with respect to marketed unapproved drugs. This approach includes efforts to identify illegally marketed drugs, prioritization of those drugs according to potential public health concerns or other impacts on the public health, and subsequent regulatory follow-up. Some of the specific actions the Agency has taken have been precipitated by evidence of safety or effectiveness problems that has either come to our attention during inspections or been brought to our attention by outside sources.
3 This rough estimate comprises several hundred drugs (different active ingredients) in various strengths, combinations, and dosage forms from multiple distributors and repackagers.
3 Contains Nonbinding Recommendations
III. FDA'S ENFORCEMENT POLICY
In the discussion that follows, we intend to clarify our approach to prioritizing our enforcement actions and exercising our enforcement discretion with regard to unapproved, illegally marketed drug products.
The enforcement priorities and potential exercise of enforcement discretion discussed in this guidance apply only to unapproved drug products that are being commercially used or sold as of September 19, 2011. All unapproved drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth below. In light of the notice provided by this guidance, we believe it is inappropriate to exercise enforcement discretion with respect to unapproved drugs that a company (including a manufacturer or distributor) begins marketing after September 19, 2011.
For unapproved drugs commercially used or sold as of September 19, 2011, FDA's enforcement priorities are described below.
A. Enforcement Priorities
Consistent with our risk-based approach to the regulation of pharmaceuticals, FDA intends to continue its current policy of giving higher priority to enforcement actions involving unapproved drug products in the following categories:
Drugs with potential safety risks. Removing potentially unsafe drugs protects the public from direct and indirect health threats.
Drugs that lack evidence of effectiveness. Removing ineffective drugs protects the public from using these products in lieu of effective treatments. Depending on the indication, some ineffective products would, of course, pose safety risks as well.
Health fraud drugs. FDA defines health fraud as "[t]he deceptive promotion, advertisement, distribution or sale of articles . . . that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate or done without adequate knowledge or understanding of the article" (CPG Sec. 120.500). Of highest priority in this area are drugs that present a direct risk to health. Indirect health hazards exist if, as a result of reliance on the product, the consumer is likely to delay or discontinue appropriate medical treatment. Indirect health hazards will be evaluated for enforcement action based on section 120.500, Health Fraud - Factors in Considering Regulatory Action (CPG Sec. 120.500). FDA's health fraud CPG outlines priorities for evaluating regulatory actions against indirect health hazard products, such as whether the therapeutic claims are significant, whether there are any scientific data to support the safety and
4 Contains Nonbinding Recommendations
effectiveness of the product, and the degree of vulnerability of the prospective user group (CPG Sec. 120.500).
Drugs that present direct challenges to the new drug approval and OTC drug monograph systems. The drug approval and OTC drug monograph systems are designed to avoid the risks associated with potentially unsafe, ineffective, and fraudulent drugs. The drugs described in the preceding three categories present direct challenges to these systems, as do unapproved drugs that directly compete with an approved drug, such as when a company obtains approval of a new drug application (NDA) for a product that other companies are marketing without approval (see section III.C, Special Circumstances – Newly Approved Product). Also included are drugs marketed in violation of a final and effective OTC drug monograph. Targeting drugs that challenge the drug approval or OTC drug monograph systems buttresses the integrity of these systems and makes it more likely that firms will comply with the new drug approval and monograph requirements, which benefits the public health.
Unapproved new drugs that are also violative of the Act in other ways. The Agency also intends, in circumstances that it considers appropriate, to continue its policy of enforcing the preapproval requirements of the FD&C Act against a drug or firm that also violates another provision of the FD&C Act, even if there are other unapproved versions of the drug made by other firms on the market. For instance, if a firm that sells an unapproved new drug also violates current good manufacturing practice (CGMP) regulations, the Agency is not inclined to limit an enforcement action in that instance to the CGMP violations. Rather, the Agency may initiate a regulatory action that targets both the CGMP violation and the violation of section 505 of the FD&C Act (21 U.S.C. 355). This policy efficiently preserves scarce Agency resources by allowing the Agency to pursue all applicable charges against a drug and/or a firm and avoiding duplicative action. See United States v. Sage Pharmaceuticals, Inc., 210 F.3d 475, 479-80 (5th Cir. 2000).
Drugs that are reformulated to evade an FDA enforcement action. The Agency is also aware of instances in which companies that anticipate an FDA enforcement action against a specific type or formulation of an unapproved product have made formulation changes to evade that action, but have not brought the product into compliance with the law. Companies should be aware that the Agency is not inclined to exercise its enforcement discretion with regard to such products. Factors that the Agency may consider in determining whether to bring action against the reformulated products include, but are not limited to, the timing of the change, the addition of an ingredient without adequate scientific justification (see, for example, 21 CFR 300.50 and 330.10(a)(4)(iv)), the creation of a new combination that has not previously been marketed, and the claims made for the new product.
B. Notice of Enforcement Action and Continued Marketing of Unapproved Drugs
FDA is not required to, and generally does not intend to, give special notice that a drug product may be subject to enforcement action, unless FDA determines that
5 Contains Nonbinding Recommendations
notice is necessary or appropriate to protect the public health.4 The issuance of this guidance is intended to provide notice that any product that is being marketed illegally is subject to FDA enforcement action at any time.5 The only exception to this policy is, as set forth elsewhere, that generally products subject to an ongoing DESI6 proceeding or ongoing OTC drug monograph proceeding (i.e., an OTC product that is part of the OTC drug review for which an effective final monograph is not yet in place) may remain on the market during the pendency of that proceeding7 and any additional period specifically provided in the proceeding (such as a delay in the effective date of a final OTC drug monograph).8 However, once the relevant DESI or OTC drug monograph proceeding is completed and any additional grace period specifically provided in the proceeding has expired, all products that are not in compliance with the conditions for marketing determined in that proceeding are subject to enforcement action at any time without further notice (see, for example, 21 CFR 310.6).
FDA intends to evaluate on a case-by-case basis whether justification exists to exercise enforcement discretion to allow continued marketing for some period of time after FDA determines that a product is being marketed illegally. In deciding whether to allow such a grace period,9 we may consider the following factors: (1) the effects on the public health of proceeding immediately to remove the illegal products from the market (including whether the product is medically necessary and, if so, the ability of legally marketed products to meet the needs of patients taking the drug); (2) the difficulty associated with conducting any required studies, preparing and submitting applications, and obtaining approval of an application; (3) the burden on affected parties of
4 For example, in 1997, FDA issued a Federal Register notice declaring all orally administered levothyroxine sodium products to be new drugs and requiring manufacturers to obtain approved new drug applications (62 FR 43535, August 14, 1997). Nevertheless, FDA gave manufacturers 3 years (later extended to 4 (65 FR 24488, April 26, 2000)) to obtain approved applications and allowed continued marketing without approved new drug applications because FDA found that levothyroxine sodium products were medically necessary to treat hypothyroidism and no alternative drug provided an adequate substitute.
5 For example, FDA may take action at any time against a product that was originally marketed before 1938, but that has been changed since 1938 in such a way as to lose its grandfather status (21 U.S.C. 321(p)).
6 The Drug Efficacy Study Implementation (DESI) was the process used by FDA to evaluate for effectiveness for their labeled indications over 3,400 products that were approved only for safety between 1938 and 1962. DESI is explained more fully in the appendix to this document.
7 OTC drugs covered by ongoing OTC drug monograph proceedings may remain on the market as provided in current enforcement policies. See, for example, CPG sections 450.200 and 450.300 and 21 CFR part 330. This document does not affect the current enforcement policies for such drugs.
8 Sometimes, a final OTC drug monograph may have a delayed effective date or provide for a specific period of time for marketed drugs to come into compliance with the monograph. At the end of that period, drugs that are not marketed in accordance with the monograph are subject to enforcement action and the exercise of enforcement discretion in the same way as any other drug discussed in this CPG.
9 For purposes of this guidance, the terms grace period and allow a grace period refer to an exercise of enforcement discretion by the Agency (i.e., a period of time during which FDA, as a matter of discretion, elects not to initiate a regulatory action on the ground that an article is an unapproved new drug).
6 Contains Nonbinding Recommendations
immediately removing the products from the market; (4) the Agency's available enforcement resources; and (5) any special circumstances relevant to the particular case under consideration. However, as stated above, FDA does not intend to apply any such grace period to an unapproved drug that was introduced onto the market after September 19, 2011.
C. Special Circumstances — Newly Approved Product
Sometimes, a company may obtain approval of an NDA for a product that other companies are marketing without approval.10 We want to encourage this type of voluntary compliance with the new drug requirements because it benefits the public health by increasing the assurance that marketed drug products are safe and effective — it also reduces the resources that FDA must expend on enforcement. Thus, because they present a direct challenge to the drug approval system, FDA is more likely to take enforcement action against remaining unapproved drugs in this kind of situation. However, we intend to take into account the circumstances once the product is approved in determining how to exercise our enforcement discretion with regard to the unapproved products. In exercising enforcement discretion, we intend to balance the need to provide incentives for voluntary compliance against the implications of enforcement actions on the marketplace and on consumers who are accustomed to using the marketed products.
When a company obtains approval to market a product that other companies are marketing without approval, FDA normally intends to allow a grace period of roughly 1 year from the date of approval of the product before it will initiate enforcement action (e.g., seizure or injunction) against marketed unapproved products of the same type. However, the grace period provided is expected to vary from this baseline based upon the following factors: (1) the effects on the public health of proceeding immediately to remove the illegal products from the market (including whether the product is medically necessary and, if so, the ability of the holder of the approved application to meet the needs of patients taking the drug); (2) whether the effort to obtain approval was publicly disclosed;11 (3) the difficulty associated with conducting any required studies, preparing and submitting applications, and obtaining approval of an application; (4) the burden on affected parties of removing the products from the market; (5) the Agency's available enforcement resources; and (6) any other special circumstances relevant to the particular case under consideration. To assist in an orderly transition to the approved product(s), in implementing a grace period, FDA may identify interim dates by which firms should first
10 These may be products that are the same as the approved product or somewhat different, such as products of different strength.
11 For example, at the Agency's discretion, we may provide for a shorter grace period if an applicant seeking approval of a product that other companies are marketing without approval agrees to publication, around the time it submits the approval application, of a Federal Register notice informing the public that the applicant has submitted that application. A shortened grace period may also be warranted if the fact of the application is widely known publicly because of applicant press releases or other public statements. Such a grace period may run from the time of approval or from the time the applicant has made the public aware of the submission, as the Agency deems appropriate.
7 Contains Nonbinding Recommendations
cease manufacturing unapproved forms of the drug product, and later cease distributing the unapproved product.
The length of any grace period and the nature of any enforcement action taken by FDA will be decided on a case-by-case basis. Companies should be aware that a Warning Letter may not be sent before initiation of enforcement action and should not expect any grace period that is granted to protect them from the need to leave the market for some period of time while obtaining approval. Companies marketing unapproved new drugs should also recognize that, while FDA normally intends to allow a grace period of roughly 1 year from the date of approval of an unapproved product before it will initiate enforcement action (e.g., seizure or injunction) against others who are marketing that unapproved product, it is possible that a substantially shorter grace period would be provided, depending on the individual facts and circumstances.12
The shorter the grace period, the more likely it is that the first company to obtain an approval will have a period of de facto market exclusivity before other products obtain approval. For example, if FDA provides a 1-year grace period before it takes action to remove unapproved competitors from the market, and it takes 2 years for a second application to be approved, the first approved product could have 1 year of market exclusivity before the onset of competition. If FDA provides for a shorter grace period, the period of effective exclusivity could be longer. FDA hopes that this period of market exclusivity will provide an incentive to firms to be the first to obtain approval to market a previously unapproved drug.13
D. Regulatory Action Guidance
District offices are encouraged to refer to CDER for review (with copies of labeling) any unapproved drugs that appear to fall within the enforcement priorities in section III.A. Charges that may be brought against unapproved drugs include, but are not limited to, violations of 21 U.S.C. 355(a) and 352(f)(1) of the FD&C Act. Other charges may also apply based on, among others, violations of 21 U.S.C. 351(a)(2)(B) (CGMP), 352(a) (misbranding), or 352(o) (failure to register or list).
12 Firms are reminded that this CPG does not create any right to a grace period; the length of the grace period, if any, is solely at the discretion of the Agency. For instance, firms should not expect any grace period when the public health requires immediate removal of a product from the market, or when the Agency has given specific prior notice in the Federal Register or otherwise that a drug product requires FDA approval.
13 The Agency understands that, under the Act, holders of NDAs must list patents claiming the approved drug product and that newly approved drug products may, in certain circumstances, be eligible for marketing exclusivity. Listed patents and marketing exclusivity may delay the approval of competitor products. If FDA believes that an NDA holder is manipulating these statutory protections to inappropriately delay competition, the Agency will provide relevant information on the matter to the Federal Trade Commission (FTC). In the past, FDA has provided information to the FTC regarding patent infringement lawsuits related to pending abbreviated new drug applications (ANDAs), citizen petitions, and scientific challenges to the approval of competitor drug products.
8 Contains Nonbinding Recommendations
BRIEF HISTORY OF FDA MARKETING APPROVAL REQUIREMENTS AND CATEGORIES OF DRUGS THAT LACK REQUIRED FDA APPROVAL14
Key events in the history of FDA's drug approval regulation and the categories of drugs affected by these events are described below.
A. 1938 and 1962 Legislation
The original Federal Food and Drugs Act of June 30, 1906, first brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which required that new drugs be approved for safety. As discussed below, the active ingredients of many drugs currently on the market were first introduced, at least in some form, before 1938. Between 1938 and 1962, if a drug obtained approval, FDA considered drugs that were identical, related, or similar (IRS) to the approved drug to be covered by that approval, and allowed those IRS drugs to be marketed without independent approval. Many manufacturers also introduced drugs onto the market between 1938 and 1962 based on their own conclusion that the products were generally recognized as safe (GRAS) or based on an opinion from FDA that the products were not new drugs. Between 1938 and 1962, the Agency issued many such opinions, although all were formally revoked in 1968 (see 21 CFR 310.100).
In 1962, Congress amended the Act to require that a new drug also be proven effective, as well as safe, to obtain FDA approval. This amendment also required FDA to conduct a retrospective evaluation of the effectiveness of the drug products that FDA had approved as safe between 1938 and 1962 through the new drug approval process.
FDA contracted with the National Academy of Science/National Research Council (NAS/NRC) to make an initial evaluation of the effectiveness of over 3,400 products that were approved only for safety between 1938 and 1962. The NAS/NRC created 30 panels of 6 professionals each to conduct the review, which was broken down into specific drug categories. The NAS/NRC reports for these drug products were submitted to FDA in the late 1960s and early 1970s. The Agency reviewed and re-evaluated the findings of each panel and published its findings in Federal Register notices. FDA's administrative implementation of the NAS/NRC reports was called the Drug Efficacy Study Implementation (DESI). DESI covered the 3,400 products specifically reviewed by the NAS/NRCs as well as the even larger number of IRS products that entered the market without FDA approval.
14 This brief history document should be viewed as a secondary source. To determine the regulatory status of a particular drug or category of drugs, the original source documents cited should be consulted.
9 Contains Nonbinding Recommendations
Because DESI products were covered by approved (pre-1962) applications, the Agency concluded that, prior to removing products not found effective from the market, it would follow procedures in the FD&C Act and regulations that apply when an approved new drug application is withdrawn:
Federal Register and, if the drug is found to be less than fully effective, there is an opportunity for a hearing.
The Agency considers the basis of any hearing request and either grants the hearing or denies the hearing on summary judgment and publishes its final determination in the Federal Register.
If FDA's final determination classifies the drug as effective for its labeled indications, as required by the FD&C Act, FDA still requires approved applications for continued marketing of the drug and all drugs IRS to it – NDA supplements for those drugs with NDAs approved for safety, or new ANDAs or NDAs, as appropriate, for IRS drugs. DESI-effective drugs that do not obtain approval of the required supplement, ANDA, or NDA are subject to enforcement action.
If FDA's final determination classifies the drug as ineffective, the drug and those IRS to it can no longer be marketed and are subject to enforcement action.
- All initial DESI determinations are published in the
1. Products Subject to Ongoing DESI Proceedings
Some unapproved marketed products are undergoing DESI reviews in which a final determination regarding efficacy has not yet been made. In addition to the products specifically reviewed by the NAS/NRC (i.e., those products approved for safety only between 1938 and 1962), this group includes unapproved products identical, related, or similar to those products specifically reviewed (see 21 CFR 310.6). In virtually all these proceedings, FDA has made an initial determination that the products lack substantial evidence of effectiveness, and the manufacturers have requested a hearing on that finding. It is the Agency's longstanding policy that products subject to an ongoing DESI proceeding may remain on the market during the pendency of the proceeding. See, e.g., Upjohn Co. v. Finch, 303 F. Supp. 241, 256-61 (W.D. Mich. 1969).15
2. Products Subject to Completed DESI Proceedings
15 Products first marketed after a hearing notice is issued with a different formulation than those covered by the notice are not considered subject to the DESI proceeding. Rather, they need approval prior to marketing. Under longstanding Agency policies, a firm holding an NDA on a product for which a DESI hearing is pending must submit a supplement prior to reformulating that product. The changed formulation may not be marketed as a related product under the pending DESI proceeding; it is a new drug, and it must be approved for safety and efficacy before it can be legally marketed. See, e.g., "Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy" (DESI 6514), 49 FR 153 (January 3, 1984) (Dimetane and Actifed); "Certain Drugs Containing Antibiotic, Corticosteroid, and Antifungal Components" (DESI 10826), 50 FR 15227 (April 17, 1985) (Mycolog). See also 21
U.S.C. 356a(c)(2)(A). Similarly, firms without NDAs cannot market new formulations of a drug without first getting approval of an NDA.
10 Contains Nonbinding Recommendations
Some unapproved marketed products are subject to already-completed DESI proceedings and lack required approved applications. This includes a number of products IRS to DESI products for which approval was withdrawn due to a lack of substantial evidence of effectiveness. This group also includes a number of products IRS to those DESI products for which FDA made a final determination that the product is effective, but applications for the IRS products have not been both submitted and approved as required under the statute and longstanding enforcement policy (see 21 CFR 310.6). FDA considers all products described in this paragraph to be marketed illegally.
C. Prescription Drug Wrap-Up
As mentioned above, many drugs came onto the market before 1962 without FDA approvals. Of these, many claimed to have been marketed prior to 1938 or to be IRS to such a drug. Drugs that did not have pre-1962 approvals and were not IRS to drugs with pre-1962 approvals were not subject to DESI. For a period of time, FDA did not take action against these drugs and did not take action against new unapproved drugs that were IRS to these pre-1962 drugs that entered the market without approval.
Beginning in 1983, it was discovered that one drug that was IRS to a pre-1962 drug, a high potency Vitamin E intravenous injection named E-Ferol, was associated with adverse reactions in about 100 premature infants, 40 of whom died. In November of 1984, in response to this, a congressional oversight committee issued a report to FDA expressing the committee's concern regarding the thousands of unapproved drug products in the marketplace.
In response to the E-Ferol tragedy, CDER assessed the number of pre-1962 non-DESI marketed drug products. To address those drug products, the Agency significantly revised and expanded CPG section 440.100 to cover all marketed unapproved prescription drugs, not just DESI products. The program for addressing these marketed unapproved drugs and certain others like them became known as the Prescription Drug Wrap-Up. Most of the Prescription Drug Wrap-Up drugs first entered the market before 1938, at least in some form. For the most part, the Agency had evaluated neither the safety nor the effectiveness of the drugs in the Prescription Drug Wrap-Up.
A drug that was subject to the Prescription Drug Wrap-Up is marketed illegally, unless the manufacturer of such a drug can establish that its drug is grandfathered or otherwise not a new drug.
Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.
Under the 1962 grandfather clause, the FD&C Act exempts a drug from the effectiveness requirements if its composition and labeling has not changed since 1962 and if, on the day before the 1962 Amendments became effective, it was (a) used or sold commercially in the United
11 Contains Nonbinding Recommendations
States, (b) not a new drug as defined by the FD&C Act at that time, and (c) not covered by an effective application. See Public Law 87-781, section 107 (reprinted following 21 U.S.C.A. 321); see also USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 662-66 (1973).
The two grandfather clauses in the FD&C Act have been construed very narrowly by the courts. FDA believes that there are very few drugs on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population. If a firm claims that its product is grandfathered, it is that firm's burden to prove that assertion. See 21 CFR 314.200(e)(5); see also United States v. An Article of Drug (Bentex Ulcerine), 469 F.2d 875, 878 (5th Cir. 1972); United States v. Articles of Drug Consisting of the Following: 5,906 Boxes, 745 F.2d 105, 113 (1st Cir 1984).
Finally, a product would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time. See 21
U.S.C. 321(p)(1) and (2). As with the grandfather clauses, this has been construed very narrowly by the courts. See, e.g., Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973); United States v. 50 Boxes More or Less Etc., 909 F.2d 24, 27-28 (1st Cir. 1990); United States v. 225 Cartons . . . Fiorinal, 871 F.2d 409 (3rd Cir. 1989). See also Letter from Dennis E. Baker, Associate Commissioner for Regulatory Affairs, FDA, to Gary D. Dolch, Melvin Spigelman, and Jeffrey A. Staffa, Knoll Pharmaceutical Co. (April 26, 2001) (on file in FDA Docket No. 97N0314/CP2) (finding that Synthroid, a levothyroxine sodium product, was not GRAS/GRAE).
As mentioned above, the Agency believes it is not likely that any currently marketed prescription drug product is grandfathered or is otherwise not a new drug. However, the Agency recognizes that it is at least theoretically possible. No part of this guidance, including the Appendix, is a finding as to the legal status of any particular drug product. In light of the strict standards governing exceptions to the approval process, it would be prudent for firms marketing unapproved products to carefully assess whether their products meet these standards.
D. New Unapproved Drugs
Some unapproved drugs were first marketed (or changed) after 1962. These drugs are on the market illegally. Some also may have already been the subject of a formal Agency finding that they are new drugs. See, e.g., 21 CFR 310.502 (discussing, among other things, controlled/timed release dosage forms).
E. Over-the-Counter (OTC) Drug Review
Although OTC drugs were originally included in DESI, FDA eventually concluded that this was not an efficient use of resources. The Agency also was faced with resource challenges because it was receiving many applications for different OTC drugs for the same indications. Therefore, in 1972, the Agency implemented a process of reviewing OTC drugs through rulemaking by therapeutic classes (e.g., antacids, antiperspirants, cold remedies). This process involves convening an advisory panel for each therapeutic class to review data relating to claims and active ingredients. These panel reports are then published in the Federal Register, and after
12 Contains Nonbinding Recommendations
FDA review, tentative final monographs for the classes of drugs are published. The final step is the publication of a final monograph for each class, which sets forth the allowable claims, labeling, and active ingredients for OTC drugs in each class (see, e.g., 21 CFR part 333). Drugs marketed in accordance with a final monograph are considered to be generally recognized as safe and effective (GRAS/GRAE) and do not require FDA approval of a marketing application.
Final monographs have been published for the majority of OTC drugs. Tentative final monographs are in place for virtually all categories of OTC drugs. FDA has also finalized a number of negative monographs that list therapeutic categories (e.g., OTC daytime sedatives, 21 CFR 310.519) in which no OTC drugs can be marketed without approval. Finally, the Agency has promulgated a list of active ingredients that cannot be used in OTC drugs without approved applications because there are inadequate data to establish that they are GRAS/GRAE (e.g., phenolphthalein in stimulant laxative products, 21 CFR 310.545(a)(12)(iv)(B)).
OTC drugs covered by ongoing OTC drug monograph proceedings may remain on the market as provided in current enforcement policies (see, e.g., CPG sections 450.200 and 450.300, and 21 CFR part 330). This document does not affect the current enforcement policies for such drugs.
OTC drugs that need approval, either because their ingredients or claims are not within the scope of the OTC drug review or because they are not allowed under a final monograph or another final rule, are illegally marketed. For example, this group would include a product containing an ingredient determined to be ineffective for a particular indication or one that exceeds the dosage limit established in the monograph. Such products are new drugs that must be approved by FDA to be legally marketed.
I was almost killed today. This is what happened--
My health has taken a nosedive since the artificial fluoridation of our water supply. The chemical used has never been tested for safety. It is an unrefined highly contaminated toxic industrial hazardous waste product which contains hydrofluorosilicic acid (not natural calcium fluoride) and a whole slew of other contaminants including arsenic, mercury, lead, radioactive particles etc. It is not good for anyone but in my case I am deathly allergic/sensitive to it.
Even with our whole house and yard water fluoridation filter system there are water hazards everywhere. It is like living in a war zone filled with snipers, tossed grenades without warning and land mines everywhere I turn. I can't even take a walk safely in case sprinklers go off or a street sweeper truck goes past. I'm so severely allergic/sensitive to the fluoridation solution I even react to fluoridated water mist in the air--my sister (who suffers from the same problem) and I call the produce aisle in the supermarket "The Aisle of Death" because of the water misters : (
I was told by one doctor that I needed a colonoscopy so I was referred to the appropriate specialist. He was a doctor I had never seen before but he took my concerns and severely adverse medical history concerning fluoride seriously. Most general anesthesia drugs and several sedatives (e.g. Versed) are fluorinated drugs. He seemed to be unaware that Versed for example was fluorinated until I told him.
Researching colonoscopies in advance of my consultation appointment I learned that even some drugs used for it that aren't fluorinated are sometimes dissolved in a fluorinated solution so BEWARE!!! Because so many drugs--especially fluorinated drugs are dangerous to me it was deemed--and I agreed--needlessly risky to have a colonoscopsy because of the drugs used and risk of medication error when we could try a barium enema with air first since it is done without drugs. Then we could see if everything was okay and if it wasn't then I would need to have the colonoscopsy.
I asked the doctor if there was fluoride in the barium enema or if there was any tap water involved in the procedure and he said no there wasn't. I asked if he was sure there wasn't and he said he was sure. I was offered my choice between the colonoscopsy and the barium enema with air and opted for the barium since I had previously had an upper GI with barium and didn't have a problem with barium.
Before I left home this morning for the test my sister and I had prayed for my safety--good thing we did.
At the hospital there is a big water fountain near the front door so I had to take a longer way in since I could not walk past the fountain because of the water mist in the air from it. So far so good.
I went in the exam room and the technician was wiping down the table but I saw he was using some sort of commercially prepared wipe from a pop up container and not a tap water dampened sponge. Oh my was I glad to see that since even the slightest dampness from tap water even on my skin causes a serious systemic reaction. Because he was busy cleaning up after the last patient I had time to chat with him instead of my test being done immediately.
I told him I was glad he wasn't using tap water on the table because I was violently and deathly allergic/sensitive to it because it was fluoridated and that I couldn't even be touched with hands that were the slightest bit damp from tap water--I react systemically from even tiny dermal exposures. He said that was okay since he used gloves so no tap water damp hands would touch me and he asked if I was allergic to latex. We both found the irony mildly amusing that I couldn't have tap water even touch me--something he had never heard of before and yet I had no problem with latex which is a dangerous allergen for many people--and we laughed a little about it.
Since my doctor told me no tap water was involved I felt safe but just to be sure I asked if there was tap water in the enema. The technician said no--they used a barium solution instead and that they didn't use tap water. As he started to get the supplies together for my test I told him I was very glad I wouldn't have to worry because I could not be exposed to the tap water.
But then to my horror I saw him reach for the water faucet--It turns out that they mix the barium solution with warm tap water : ( !!! For some reason he did not comprehend that mixing the fluoridated tap water into the barium solution was as dangerous to me as using plain tap water. If I hadn't been so noisy and "paranoid" from previous medical errors that would have literally been the end of me.
You can bet that they would have tried to blame my death on an allergic reaction to the barium or to the latex instead of the tap water but it is in my chart that I tolerate both of those but not fluoridated tap water. There would have been a big legal battle but the truth would have come out.
He said that the barium used for the lower GI is too thick to be used as is and has to be watered down. They mix the tap water and barium solution together in the enema bag. I asked if there was any bottled water he could use but he said no because they always use warm tap water. I said if only I had known I would have brought my own bottled water to use. I had a small bottle of safe water in the car but it wouldn't be enough. He devised a way to thin the lower GI barium with the barium used for upper GI's which is thinner.
I asked if he was positive no tap water had been added to either bottle and he said yes. However I was so scared of another potential error I asked if I could taste some of the barium since I can actually taste the slightest trace of the tap water fluoridation solution due to my severe sensitivity to it. (I am the worst fluoride allergy/sensitivity case my allergist has ever seen and she has seen a lot of them).
Tasting it--even the tiniest amount--was very risky for me in case there was tap water in it but it was safer than what they were going to do to me if it was contaminated with tap water. Thankfully it was okay--I could tell that no tap water had been added to the bottles--so they were able to proceed with the test.
I really dodged a bullet today. If they had put the barium mixed with tap water solution directly inside me that would have been it--and my death would have been a truly terrible one. I really don't care at this point if I do drop dead--there is only so much a person can take--but I am worried about my family so I have tried to take precautions to stay alive for their sake but it is getting to the point where it is useless. You can only struggle so long against odds that keep getting worse and worse.
For those of you with fluoride allergy/sensitivity or allergy/sensitivity to any other drugs or substances heed my cautionary tale. Doctors and technicians are often wrong about substances administered. Even pharmacists can be wrong--one told me the antibiotic Cypro did not contain fluoride but it does as I learned the hard way after taking one. Check out every procedure in advance to the slightest detail including anything the active drug may be mixed with--solid, liquid, powder, gas-- that may not be classified as a drug per say. Do not overlook the fact that often drugs are mixed with carrying agents/solutions etc.
Do not take anything for granted. Do not assume that because you have told the doctor and even written it in your patient questioner that you are allergic/sensitive to something that he or she won't give it to you anyway. My father was a doctor and warned us about how common this is with doctors.
My mother was permanently damaged and got Parkinson's from a drug the doctor gave her after I warned him she was severely allergic/sensitive to it and had even told him to write it in big red letters on her chart to avoid any mistakes. Of course he made the mistake of giving it to her anyway.
Or for instance many of you will remember the time I had a simple breast biopsy and warned the doctor about my severe allergies/sensitivities and yet she put a stainless steel clip inside me to mark the lump. She was positive it was a titanium clip--she did not read the package. Unfortunately I am seriously allergic to nickel which is one of the metals in stainless steel. What a disaster that turned out to be : (
These sorts of medical errors are a common everyday occurrence--but tragically the consequences to the unfortunate patient can be serious and even deadly.
Feel free to forward this to others too--it may very well save a life.
Belleville resident, council join debate on fluoride safety
Thursday, March 15, 2012
Long after they were outlawed by the Food and Drug Administration, fluoride tablets may still be making their way onto drug store shelves and pediatricians' offices.
According to documents provided to the Belleville Times by township resident Mike Perrone, fluoride tablets and fluoride drops for infants were introduced to the marketplace in the late 1950s without prior FDA approval. The FDA ultimately sent out regulatory letters in 1975 to no less than 35 fluoride tablet drug manufacturers, which stated that their tablets/drops were in violation of the federal Food and Drug Act, along with a request that they be removed from the marketplace. Some, but not all, of the 35 companies supposedly have complied with the FDA's request.
Clinical trials conducted in the 1950s, 1960s and 1970s were said to have been illegal, because no related toxicology studies had also been conducted. It was also determined that using fluoride tablets did not prevent tooth decay, but rather stained and mottled tooth enamel in a process known as dental fluorosis.
A strong link between osteosarcoma, or bone cancer, and fluoridated water was also determined in the 1990s in studies made by the New Jersey Department of Health through the involvement of Assemblyman John V. Kelly. Perrone said that Kelly assigned him the task of gathering information on the safety and effectiveness of fluoride tablets and drops, and Perrone subsequently consulted with agencies including the American Dental Association, the American Academy of Pediatrics, and the National Institute of Dental Research. It was later found that those agencies and others had not conducted any studies on the safety of fluoride tablets and drops, had no scientific references for any such studies, and that the FDA had never approved any of their drugs.
The issue of fluoride in municipal water was recently brought up at a Belleville Township council meeting last month. As part of its consent agenda on Feb. 14, the council passed a resolution opposing Assembly Bill 3709, which was approved on Feb. 9 and mandates fluoridation of municipal water supplies. According to the council's resolution, fluoride has been identified at both the state and federal levels as a drinking water contaminant.
Longtime Belleville resident David Harris asked why the council was against the bill, and Third Ward Councilman Vincent Cozzarelli replied that he had come across reports that stated that the total amount of fluoride deposited in water could not be measured.
"It's no different than other states," said Cozzarelli, in regards to tooth decay and its prevention, and he didn't see a reason why fluoride should be added to New Jersey municipal water.
Township Manager Victor Canning, who is leaving Belleville after almost six years on the job to take a similar position in Montville, said at that meeting that the fluoride additive would actually be hydrofluorosilicic acid, which was considered hazardous by the Center for Disease Control. The council resolution also stated that hydrofluorosilicic acid was listed as an extremely hazardous chemical by both the United States Environmental Protection Agency and the New Jersey Department of Environmental Protection.
Canning also said that there was no correlation between water fluoridation and healthy teeth, while Deputy Mayor Steven Rovell added that no other country fluoridated its water.
Influence of Fluoride upon Plaque and Gingivitis in the Beagle Dog
Two studies were conducted to explore the effects of twice daily topical applications of NaF, SnF 2, and an amine fluoride at equivalent fluoride concentrations (0.1%) upon plaque and gingivitis in the dog. Although some trends toward modest benefits were noted in certain instances, none of the agents exerted a significant effect upon either parameter
There have been numberous of studies evaluated the effects of various topical fluorides on gingivitis in children. J.J. Murray in 1969 investigate the prevalence of gingivitis in 15 year old children from high fluoride (1.5 to 2 ppm) and low fluoride (0.2 ppm) areas. He reported that up to the level of 2 ppm, fluoride in drinking water has no influence on prevalence of gingivitis, on its extent or on the relative distribution of gingivitis in individual labial papillae and the margins associated with anterior teeth in 15 year old children. This study was in agreement with James et al. in 1960 who reported that there was no significant increase in incidence and severity of gingivitis in children living in the high fluoride areas. On the contrary, Ast and Schlesinger in 1954 measured gingivitis in children aged 6-9 years from the fluoride city of Newburgh (1-1.2 ppm F) and the control city of Kingston (F= .1ppm) and concluded that a slight but significantly more gingivitis was observed amongst Kingston children than among those in Newburgh. Russell in 1957 carried out a similar study involving school children of 7-14 yrs old and found that proportions of children free form overt signs of periodontal disease (including gingivitis) were higher throughout the age range in children of high fluoride city than the low fluoride city. It is rather difficult to assess whether the lower prevalence of gingivitis observed in children from fluoride areas is directly or indirectly associated with the F content of drinking water. One theory would be since application of fluoride involved involved mainly tooth brushing, the effect of gingival inflammation may well be a result of mechanical oral hygiene effort. Fluoride treatment, nevertheless, have not been shown to have significant effect on periodontal surgical healing in animal. Fluoride actually causes healing time to increase (delay wound healing). Another area of application of fluoride is hypersensitivity teeth. The use of sodium fluoride has been reported in many studies as an effective agent in treatment dentinal hypersensitivity (Stout et al. in 1955, Hoyt et al. in 1943).
A large number of studies reported no detrimental effects of fluorides on periodontal tissue. Side effect included staining, mild blanching of the gingiva when high concentration of SnF2 were applied topically (only on 5% of subjects), sloughing of gingival tissue of children within an hour of topical application of APF. This effect was related to the presence of inflammation, the more inflammation, the more sloughing. Crevicular epithelium was more susceptible to sloughing than the papillary gingiva. Branemark studied the effect of commonly used topical fluoride solutions on intact connective tissue, damaged connective tissue, and epithelium in hamster, rabbits, and humans. Changes noted varied with concentration of NaF and went from slight and reversible trauma to definite destruction of tissue cells leading to necrosis and subsequent proliferative reparative phenomena. Prolonged contact with fluoride solution may aggravate the existing chronic inflammation. Finally, titanium does not withstand certain acidic fluoride prophylactic agents. The use of fluoride near the implant restoration should be avoided. Lothar Probster et al. in 1992 examined the use of sodium fluoride gel, amino-fluoride gel, sodium fluoride solution, aminofluoride solution, and sodium fluoride lacquer. Drops of 4mm in diameter were placed on the polished titanium surfaces. Surface roughness was investigated with profilometer and SEM. They also placed and IMZ implant and its transmucosal abutment in Oral B fluor gel for 24 hours. The results showed significant increase of surface roughness in acidulated fluoride agent. Scannic electron microscope illustrated the corrosive effect of the acidic agent. The implant and abutment which was stored for 24 hours in Oral B gel showed massive corrosion and the effect is compatible to the cast titanium used in the study. Acidic fluoride agents should not be used in patients with titanium implants or restoration.
Gingivitis in 15-year-old children from high-fluoride and low-fluoride areas
Evidence concerning the influence of fluoride drinking water on gingivitis is inconsistent. In order to determine whether fluoride in drinking water up to the level of 2 ppm has any effect on the prevalence, extent or pattern of gingivitis in anterior labial units, the gingival health of 386 15-year-old children, continuously resident in West Hartlepool, a high fluoride area (1.5–2.00 ppm F), was compared with that of 38115-year-old children from York, a low fluoride area (0.2 ppm F).
The method of measurement was that described by Jackson (1965).
It was concluded that fluoride in drinking water, at least up to the level of 2 ppm, has no influence of clinical significance on the prevalence of gingivitis, on the extent, or on the pattern of gingivitis in individual papillae and margins associated with incisor and canine teeth in 15-year-old-children.
In both communities prevalence of gingivitis was higher in boys than in girls. However, when only those children with a good standard of oral cleanliness were considered this sex difference disappeared, suggesting that the observed sex difference could be due to differences in the standards of oral cleanliness between boys and girls.
A distinctive pattern of gingivitis in papillae and margins associated with anterior teeth was observed in all four groups studied, and this pattern was essentially the same as that observed independently by Jackson (1965) and Sutcliffe (1968), suggesting that this pattern is universally true.
Gingivitis and gingival recession in adults from high-fluoride and low-fluoride areas
The prevalence of gingivitis and gingival recession in 1884 dentate adults, aged 15–65 yr, continuously resident in the natural fluoride area of Hartlepool (1.5–2.0 ppm F.) was compared with that in 2015 dentate adults from the low-fluoride town of York (0.15–0.28 ppm F.).
The measurement of gingivitis was restricted to the anterior labial gingival sites, after the method described by Jackson (1965). The prevalence of gingivitis did not vary with increasing age. Therefore, data for all age groups were combined. Eighty nine per cent in Hartlepool and 87 per cent in York had one or more gingival sites inflamed. In both communities, the slightly higher prevalence of gingivitis in males than in females disappeared when only those with good oral cleanliness were considered. In Hartlepool, the site prevalence of gingivitis was 37.2 per cent and in York 35.4 per cent. In those with good oral cleanliness, the site prevalence of gingivitis was 21.8 per cent in Hartlepool and 19.8 per cent in York. The maximum divergence between the two communities was 0.4 gingival units.
No sex difference in the prevalence of gingival recession was observed in either community. Therefore, data for males and females were combined. In Hartlepool at 15–19 yr of age, 3.0 per cent were affected by gingival recession; at 60–65 yr, virtually 100 per cent were affected. The trend with age in York followed exactly the same pattern as that observed in Hartlepool. The percentage of teeth with gingival recession also increased steadily with age. In Hartlepool at 15–19 yr of age, 0.2 per cent of teeth had gingival recession. At 60–65 yr, 66.7 per cent of teeth were affected. The corresponding values in York were 0.2 per cent and 63.8 per cent. No significant differences were observed between Hartlepool and York data.
It was concluded that fluoride in drinking water, at least up to the level of 2 ppm, has no effect of clinical significance on the prevalence of gingivitis or gingival recession in adults.
|PFPC NEWSLETTER #9:
, & Oral Cancer"© 2002 PFPC http://220.127.116.11/pfpc/html/newsletter_9.html
stronger than the one for smoking or high cholesterol. As heart disease is the #1 killer in the US, many efforts are undertaken to reduce this alarming figure. In Canada large pictures of a diseased heart are placed on cigarette packs alerting to the fact that smoking causes heart disease. and periodontal disease are the oral diseases requiring most urgent intervention. Over 90% of the U.S. population over 13 is affected. Strong links have been made to heart disease and low birth weight and infant mortality. For heart disease the association with is
It is of great importance that warning labels and pictures of periodontal disease, oral cancer, diseased hearts, pituitary and thyroid glands, as well as Alzheimer's brains - just to name a few - are placed on all oral care products containing .
A patent by the pharmaceutical company Sepracor discloses that concentrations of (CDC, 2001).s from fluoridated toothpastes and mouthwashes activate G proteins in the oral cavity, thereby promoting and periodontitis, as well as oral cancer. Incomprehensibly, this vital information is being withheld from the public by all parties involved, including the company, at least two well-known Universities, and numerous oral disease experts. This includes a much-decorated ADA scientist who was involved in setting the CDC recommendations for intake in children, served as head of a Food and Drug Administration subcommittee that decides which dental products to make available to the public, and who chaired the panel on safe use of for the Centers for Disease Control
An extensive section of this Newsletter deals with biochemical aspects [Part 4].
ORAL CANCER - Statistics
FLUORIDATION AND ORAL CANCER
BRIEF LITERATURE REVIEW - EVIDENCE
BIOCHEMISTRY - G PROTEINS
Oral Cancer - The ras oncogene
G q/11 Diseases
Dentists & Oral Cancer
Richard Gracer, MD
THYROID HORMONES &
Many of our children have experienced oral diseases which miraculously disappeared when intake was curtailed. For example, some had consistent "white spots" on their gums which vanished upon elimination of fluoridated toothpaste, but returned as soon as such toothpaste was used again.
Some of these white spots and patches were diagnosed as pre-cursors to oral cancer (squamous cell carcinomas), while others were deemed to be "allergic reactions" by medical professionals. Yet other doctors identified oral yeast infections (Candidiasis).
When we investigated the scientific literature on [See:Part 3] toxicity we found that such oral conditions have been related to intake countless times. There is extensive evidence of such disease in humans from areas with water fluoridation, from toothpaste and mouthrinse use, as well as in workers exposed to s.
Studies in workers exposed to directly correlated to the levels in systemic fluids (i.e. Domazalska, 1972). The more in the system - the more severe the periodontal disease. The same findings have been made for have shown that the severity of periodontal disease is Asthma.
In 1996 three biochemists (Aberg, Jerussi & McCullough, 1998), working for the pharmaceutical company Sepracor, speculated on (PGE2) and the thromboxane A2 (TXA2) receptor. Both are coupled to G proteins called implications in periodontal disease. Realizing that s activate G proteins, they reasoned that s would also be involved in the activation of those G proteins which regulate the pathways involved in and periodontitis - and they decided to test for the ability of to activate two integral receptors involved in periodontal disease - the prostaglandin E2 receptor G q/11.
The scientists conducted a test with sodium based on a well-established in-vitro protocol model involving HL-60 cells. These are Human Leukemia cells often used in biochemistry investigations, as one can observe fundamental and critical signals involved in the activation of the body's immune system - because of the cells' ability to respond to foreign organisms.
The authors reported:
- "We found that , in the concentration range in which it is used for the prevention of dental caries, stimulates production of prostaglandins and thereby excaberates the inflammatory response in and periodontitis.... Thus, the inclusion of in toothpastes and mouthwashes for the purpose of inhibiting the development of caries may, at the same time, accelerate the process of chronic, destructive periodontitis."
A very important finding as it relates to public health!
In the 1986 National Institute of Health (NIH) survey, 93% of adults indicated that their children used toothpaste with , obviously putting all at risk. and periodontal disease constitute THE major public oral health problems in the US.
The patent findings supply the biochemical explanation for earlier reports by many researchers who had found increased and gum inflammation due to fluoridated water, or other sources of .
Even T. Dean himself - the so-called "Father of Fluoridation", made such observations.[see: Part 3]
However, instead of alerting the public health officials to their findings, those men apparently decided to take another avenue.
They went looking for an agent which would counteract the adverse effects of and therefore could be used together WITH . After all, was/is the "proven caries fighter"!
They chose a non-steroidal anti-inflammatory agent (NSAID) called ketoprofin, conducted more studies to see if ketoprofin was efficient in off-setting the damaging effects, and then filed a patent on their new concoction now containing both and ketoprofin (Aberg et al, 1998).
Subsequently, a study was instigated at the Harvard School of Dental Medicine (funded by Sepracor), documenting the `wonderful' effects of ketoprofin upon . The first study on beagles included one of the three co-inventors (McCullough) together with two Assistant Professors from two separate well-respected Universities, and was subsequently published in the Journal of Clinical Periodontology in 1997 (Paquette et al, 1997).
In the study not one word is mentioned about being a causative/promoting agent of , as stated in the patent claims.
Another study - this time on rats, and again as a direct result of the patent research - was conducted involving yet another of the three co-inventors from Sepracor (Jerussi).
This time the study was done with two professionals from the University of Rochester, one being Prof. Bowen, the much-adorned and decorated ADA scientist involved in setting the 2001 CDC recommendations on intake.
Results of this study were published recently in the Journal of Oral Diseases (Bowen et al, 2000) Full Text
Again, not one single word about promoting and causing appears in the entire text.
According to the National Institute of Dental and Craniofacial Research (NIDCR; Brown et al, 1996), over 90% of persons 13 years or older experience some form of periodontal disease.
74.9 % of all people between 35 and 44 years suffer from periodontal disease (Fig.4.7, Oral Health Report, 2000). 29% of males and 15 % of females between 35 and 44 years old have destructive periodontal disease (Healthy People 2010-Conference Edition).
60% of all people between 18 and 44 suffer from periodontal disease (Figure 4.8, OHR).
Compared to these figures - up to 46% of adults over 18 years old have untreated caries (Figure 4.5, OHR).
Not surprisingly, periodontal disease has recently become the primary focus for dental researchers because of the very strong links which have been made to other conditions such as heart disease (Loesche 1994, 1998; Herzberg and Meyer 1996), as well as infants with low birth weight and premature births. For heart disease the association is stronger than for smoking (Loesche et al, 1998).
The NID(C)R, in their 1999 appeal to the Appropriation Committee for $276,518,000 in funding, stated that gum disease is now also known as a high risk factor for low birth weight babies. Said Crawford in his plea for the big money:
- "Care of low birth weight babies costs the nation approximately $5 billion dollars each year. If we can lower the incidence of low birth weight babies by treating gum disease it will mean that 1:10 babies born in the US have a better chance of a healthy start in life."
Further, he reasoned:
- "As we come to the end of this, century, 50% of heart attacks (the number one cause of death in the Western World) and 25% of low birth weight babies have no aditional risk factors associated with them. We now have strong evidence that gum disease is a risk factor for both these conditions - in fact - as strong a risk factor for heart disease as elevated cholesterol or smoking!"(Crawford, 1999)
This clearly means that s - by promoting - also contribute to heart disease and low birth weight. Heart disease has long been known to be higher in workers exposed to s, or caused by s in medications (PFPC, 2001). Biochemical investigations have identified the pathways.
The patent findings implicating the "topical" activation of G proteins in the oral cavity have many far-reaching and serious implications - not only for periodontal disease, but also for oral cancers - which involve "mutated" G proteins, and which are activated by , often even "preferring" activation.[see Part 4: Biochemistry]
ORAL CANCER - Statistics
Oral cancer is the sixth most frequent cancer in the world (Buffalo Sisters Hospital, 2000).
Oral cancer claims the life of one American every hour. Over thirty thousand Americans are diagnosed with oral or pharyngeal (throat) cancer every year and 8,000 people die annually from these cancers. Only half survive more than five years. This overall 5-year survival rate (52 percent) has not changed in the past five decades - coincident with the appearance of as a `preventive treatment' for caries.
Black people have higher incidence and mortality rates than other subgroups (OHR, 2000; Caplan et al. 1993; NIH Press Release, 1996), as they do with most thyroid hormone-related disorders, including, of course, "dental fluorosis" (PFPC, 2000).
"White Patches" - Cancer
As was mentioned in the INTRO, many of our kids have had these "white patches" in the mouth, often diagnosed as "precursors" for an `oral squamous carcinoma'.
A benign squamous papilloma is the obligate precursor of squamous cell carcinoma, and again, numerous laboratory investigations have shown that these are brought about by . Mere ras oncogene activation is sufficient to produce the papilloma phenotype in skin cancers, and is known to act additively with the ras oncogene in producing this papilloma (Camp & Hoffman, 1993). (-> Cancer promotion).
[see Part 4: Biochemistry]
FLUORIDATION AND ORAL CANCER
In 1981 Dr. John Yiamouyiannis and Dean Burk, chief chemist emeritus of the National Cancer Institute (NCI), first showed very convincingly that there was an increase in oral cancer in fluoridated areas.
An investigation done by the Battelle Institute on behalf of the National Toxicology Program (NTP) (NTP, 1991; also see: Yiamouyiannis, 1993) showed a clear dose-response relationship between oral cancers and intake in the animals tested.
According to the late Yiamouyiannis, the National Cancer Institute (NCI) - in response to the NTP findings - decided to examine the incidence of oral cancer in fluoridated and non-fluoridated areas. The resulting data showed at least a 33% to 50% increase in the incidence of oral cancers in fluoridated areas, indicating at least an additional 5000 - 7500 or more cases or oral and pharyngeal cancer per year as a result of fluoridation alone (Yiamouyiannis, 1993).
An increase in oral carcinomas and their precursors has also been observed in workers exposed to [see next section]s.
BRIEF LITERATURE REVIEW - EVIDENCE
(Compiled by Wendy Small)
and oral diseases due to excess have been reported many times in the world literature.
In 1936 Dean - the "father of fluoridation" himself - wrote in the Journal of the American Medical Association:
- "From observations that I made in areas of relatively high concentration (more than 4 parts per million of fluorine) there is sufficient evidence to suggest that there is an apparent tendency toward a higher incidence of ."
Remember, at that time water with at 4ppm was thought to produce a total intake of 4 mg/day. In 1991 the US PHS estimated that TOTAL intake exceeded 6.5 mg/day in U.S. cities having one part per million (1ppm) of in their water supply!
Similar observations of the link between (Dean & Arnold, 1943; Day, 1940; Spira, 1953; Ramseyer et al, 1957; de Toledo, 1970; Grimbergen et al, 1974; Poulsen & Moller,1974; Waldbott et al, 1978; Olsson, 1979; Reddy et al, 1985; Wei et al, 1986; Yiamouyiannis, 1993). and periodontal disease have been made many times since
In 1953 Leo Spira had identified systemic fluids. and bleeding gums as signs of chronic poisoning. In 1957 Ramseyer observed in older rats drinking water fluoridated at 1 ppm. By 1982 Domazalska observed a direct correlation between the severity of periodontal disease and levels in
From around the world...
"Most children in both urban and rural areas had ...Children who brush their teeth every day were 88.5% in urban and 72.8% in rural areas and most of them used tooth paste."
Suksu-art N, Arkasuwan N - "Survey on the oral health status of primary school children in urban and rural areas, Hat Yai, Songkhla" Research/Government Report, Thailand (2000)
"A significant relationship between the concentration of F- in dental plaque...and the condition of periodontal tissues was established."
Borysewicz-Lewicka M, Kobylanska M - "Periodontal Disease, Oral Hygiene And Content Of Dental Deposits In Aluminum Workers" 16(1):5-10 (1983)
"Fluorosis was endemic...Periodontal disease was moderate at 15 yr of age, but seemed to be a predisposing factor in caries from the late teens onward. ... More than half of persons in the 55-64 yr age group required full maxillary and mandibular dentures while 10% already possessed them."
Speake JD, Malaki T - "Oral health in Tuvalu" Community Dent Oral Epidemiol 10(4):173-177 (1982)
"....We are more prone to caries...The incidence of dental fluorosis is on the rise in Bathinda. Experts reveal that the disease is commonplace due to contamination in the ground water of the region. Studies indicate that nearly 90 per cent of the population ...is suffering from dental caries and chronic , which often leads to pyorrhoea [periodontitis]..."
Rishi, Shella - "We are more prone to caries" Bathinda/India; India Express - Thursday, July 20 (2000)
"There were some controversies in the results of fluoridation studies with one study reporting as high as 47.2% of the children to be afflicted with enamel fluorosis.... 93% of the 12-yr-olds had bleeding, 98% had calculus and 15% had shallow pockets, with 100% of the children needing prophylaxis."
Wei SH, Shi Y, Barmes DE - "Needs and implementation of preventive dentistry in China" Community Dent Oral Epidemiol 4(1):19-23 (1986)
"Teeth with moderate and severe fluorosis more frequently had dental caries than teeth with no or very mild and mild fluorosis.... was seen in 97% of the children..."
Olsson B - "Dental findings in high- areas in Ethiopia" Community Dent Oral Epidemiol 7(1):51-6 (1979)
"The article deals with the problem of relation of the incidence and prevalence of various parodontal diseases in subjects with various degrees of intake to the content of this element in various systemic fluids. ...A correlation was observed between the parodontopathy index of Kotzschke and F levels in the systemic fluids calculated by means of the correlation coefficient of Pearson."
Domazalska W - "Incidence of periodontal diseases in subjects with various degree of exposure to s" Czas Stomatol 25(10):1005-1011 (1972)
"Stomatological and mycological examinations of the workers [exposed to s]at the fusion department of the RZWM "Silesia" showed a considerable intensification of paradontium diseases (about 80% of cases). Leukoplakia [pre-cancerous growth] and candidiasis were the most common changes found on the mucous membrane in the oral cavity. Mycological investigations carried out on the Sabourand culture showed Candida albicans in 73.7% of cases."
Ilewicz L, Chrusciel H, Korycinska-Wronska W, Maniak B, Szlachta R, Mniszkowa M, Waszkiewicz-Golos H, Wrobel J - "Condition of the periodontium and mouth mucosa in workers exposed to s" Med Pr 33(1-3):153-6 (1982)
"...cancers of the oral cavity and pharynx, colon and rectum, hepato-biliary and urinary organs were positively associated with FD" [fluoridated drinking water]
Takahashi K, Akiniwa K, Narita K - "Regression analysis of cancer incidence rates and water in the U.S.A. based on IACR/IARC (WHO) data (1978-1992). International Agency for Research on Cancer" J Epidemiol 11(4):170-9 (2000)
Krook L, Maylin GA, Lillie JH, Wallace RS - "Dental fluorosis in cattle" Cornell Vet 73(4):340-62 (1983)
"Five expressions of dental fluorosis are described in cattle exposed to industrial with recession of bone and gingiva; 4. Oblique eruption of permanent teeth, hypoplasia of teeth with diastemata; and 5. Rapid progression of dental lesions. The five entities are not recognized in the "standard for the classification of dental fluorosis" by the National Academy of Sciences. Since this classification it too limited and superficial, adherence to this standard has left severe cases of intoxication in cattle undetected in field surveys." pollution: 1. Hypercementosis with tooth ankylosis, cementum necrosis and cyst formation; 2. Delayed eruption of permanent incisor teeth; 3 Necrosis of alveolar bone
Chang YC, Chou MY - "Cytotoxicity of
on human pulp cell cultures in vitro" Oral Surg Oral Med Oral Pathol Oral Radiol Endod 91(2):230-4 (2001)http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?uid=11 174602&form=6&db=m&Dopt=r
"OBJECTIVES: Numerous studies have revealed that conventional glass-ionomer cements might release into an aqueous environment. The objective of this study was to examine the effects of on human pulp cells in vitro. STUDY DESIGN: H33258 fluorescence, cell proliferation, protein synthesis, and mitochondrial activity assay were used to investigate the pathobiological effects of on cultured human pulp cells. RESULTS: was found to be a cytotoxic agent to cultured human pulp cells by inhibiting cell growth, proliferation, mitochondrial activity, and protein synthesis. CONCLUSIONS: release has significant potential for pulpal toxicity."
As we have stated many times in the past, all G protein families. The only known receptor which is capable of doing the same, in the human organism, is the receptor for the thyroid-stimulating-hormone (TSH) (Gudermann et al, 1997). is known as the "universal G protein activator" in biochemistry, meaning it can activate
This complex and multifunctional actvity of TSH is the reason why so many different diseases are associated with thyroid hormone dysfunction. It is also the reason why the same associations have been made in poisoning - being a TSH clone.
While for many years it was presumed that the TSH receptor was only expressed in the thyroid gland itself, TSH receptors have now been detected in liver, gastrointestinal tract (Duntas et al, 1998), orbital tissue and dermal fibroblasts (Paschke et al, 1994), peripheral lymphocytes, fat, cardiac muscle (Drvota et al, 1995), thymus, peripheral blood mononuclear cells, osteoblasts and osteosarcoma cells (Inoue et al, 1998), or the brain - where it is overexpressed in patients with Down Syndrome or Alzheimer's Disease (Labudova et al, 1999).
In order for us to understand poisoning better, we have concentrated on the matter of Gq/11, as this is what TSH does - at elevated levels it activates the Gq/11-mediated pathways.
What are G q/11 proteins?
G q/11 proteins are membrane-associated proteins involved in signal transduction - the way cells communicate with each other.
Gq/11 are coupled to receptors which cross the cell membrane seven times ("transmembrane receptors"). Gq/11 proteins are located in the membrane of a cell.
Upon receptor activation, they may send information directly from the membrane to the cell's nucleus. Consider them an essential "relay station" for cell information, the initiators of other cascades of events. One such cascade involves the mitogen-activated-protein-kinase (MAPK). MAPKs are regarded as "switch" kinases in the phosphorylation cascade.
Gq/11 may be released directly from the plasma membrane to an intracellular location in response to activation by alumino(i.e. Arthur et al, 1999). complexes [AlF(x)], directly translocating immunoreactivity
inactive (Utiger, 1995).] not only directly augments the already existing hormonal (TSH) activation of Gq/11, it may activate such proteins even in the absence of TSH. [Without TSH, G proteins involved in thyroid hormone regulation are thought to be
G q/11 Diseases
Gq/11-regulated pathways have profound effects not only on the pathology of gum disease, but of chronic inflammation overall, as well as cancer, heart disease, stroke, diabetes, Alzheimer's Disease, Autism, etc. - in short - all those conditions which represent the most significant health care problems in the developed world today. We have come to describe this as the "G q/11 disease".
For example, in heart disease - which kills 725,192 people a year in the U.S. alone, making it the #1 cause of death (CDC, 2002) - it is G q/11 over-expression which leads to enlargement of the heart, in turn leading to congestive heart failure. Therefore recent pharmacological research has focused on creating so-called "decoys" for G q/11 - non-working versions of Gq to prevent the activation and reception of molecular signals that normally would produce such enlargement of the heart (Akhter et al, 1998; Adams et al, 2001).
It has been shown that on-going ("constitutive") G q/11 activation in heart muscle results in downsignalling of thyroid hormone T3 and inhibition of T3-dependent intra-cellular activities (i.e. Wu et al, 1997).
Needless to say, G q/11 are also involved in dental pulp and enamel formation and are also involved in the condition known as "dental fluorosis" (enamel hypoplasia) (Pozo et al, 2000; Bawden et al, 1996). Gq/11 have been unequivocally established to be the transducing G proteins for all Ca(2+)-mobilizing receptors (i.e. Exton,1993).
In Alzheimer's and Down Syndrome patients Gq/11 is elevated in the brain regions. Virtually all Down Syndrome patients suffer from Alzheimer's in their 40's.
- [NOTE: It is no coincidence that up to 90% of villagers around the NALCO aluminum smelter in Angul, India are experiencing "senility" before the age of 50 (Hindustan Times, Aug. 15, 1999). In fact, Indian parliamentary discussions disclose that, out of 14,000+ -poisoned villagers in the area, 5,000 are suffering from Alzheimer's Disease (Lok Sabha Debates, 1999).]
amplification of the F- signal.s are most-established Gq/11 activators, ensuring a firm and most-important rogue role for s in all of the above diseases. Both inorganic and organic compounds may activate G q/11. It is a matter of degree in the
Diseases linked to the pathways mediated by Gq/11:
- Adenocarcinoma, leukemia, lymphoma, melanoma, myeloma, sarcoma, teratocarcinoma, and cancers of the adrenal gland, bladder, bone, brain, breast, cervix, gall bladder, ganglia, gastrointestinal tract, heart, kidney, liver, lung, bone marrow, muscle, ovary, pancreas, parathyroid, penis, prostate, salivary glands, skin, spleen, testis, thymus, thyroid, and uterus; and immune disorders such as AIDS, Addison's disease, adult respiratory distress syndrome, allergies, Alzheimer's Disease, anemia, ASD, asthma, atherosclerosis, bronchitis, cholecystitus, Crohn's disease, ulcerative colitis, atopic dermatitis, dermatomyositis, diabetes mellitus, emphysema, atrophic gastritis, glomerulonephritis, gout, Graves' disease, hypereosinophilia, irritable bowel syndrome, lupus erythematosus, multiple sclerosis, myasthenia gravis, myocardial or pericardial inflammation, osteoarthritis, osteoporosis, pancreatitis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's syndrome, thyroiditis, etc..
As mimics TSH, we usually check on Down Syndrome first - as all DS patients have shown to have higher TSH levels, they will often show us what (Decoq, 1995;Wilkins, 1994; Ulseth et al, 1991; Barnett et al, 1986). poisoning does. As TSH activates G q/11 - to which PGE2 and TXA 2 are coupled - similar oral conditions should be observable in DS. Needless to say, DS patients also have a high degree of periodontal disease
Gq/11 and the ras oncogene share in mediation of pathways, including MAPK (i.e. LaMorte et al, 1994; Seo et al, 2000).
Oral Cancer - The ras oncogene
Biochemical research in the "search for cancer" conducted during the last few decades has firmly established the involvement of mutated G proteins in the pathogenesis of cancer, including oral cancer (Das et al, 2000; Yoo et al, 2000).
One such well-known mutated G protein is the "ras" oncogene.
These ras oncogenes were first found in human bladder cancer cells, and have now been identified further in pancreas, breast, prostate, thyroid, lung, and uterine cancers, myeloid leukeamias, etc. as well as skin and oral cancers.
Among the cancers which most often include mutated ras genes are adenocarcinomas of the pancreas (90%) (Almoguera et al., 1988), adenocarcinomas of the colon and cancers of the thyroid (50%), as well as carcinomas of the lung and myeloid leukeamias (Bos,1989).
During the last 10 years frantic research has been conducted by the pharmaceutical companies directed at finding agents to counteract ras activity.
In efforts to define the very pathways of ras in cancers - so that treatments can be developed - biochemists have used sodium or aluminum extensively in the past, at many different levels, and under various conditions.
This is because ras oncogene, and at levels even below those seen in the Sepracor patent investigations, especially when combined with aluminum. can substitute directly for the
ras oncogene pathways are readily activated by aluminum- complexes [(AlF(x)] (i.e. Warner et al, 1999; Kleuss et al, 1994; Camp et al, 1993; Matyas et al, 1989; O'Shea etal, 1987; Spina et al, 1987; Haliotis et al, 1988;Lee et al, 1992), as well as beryllium compounds (Diaz et al, 2000, 1997; Kuppens et al, 1999).
The activation of some mutations is more pronounced or "amplified" by aluminum (Warner et al, 1999a,b) while others simply prefer the "false" AlF(x) activation (Natochin et al, 1999; Warner et al, 1999; Clabecq et al, 2000).s
For some, the AlF4--induced activation defect is more pronounced at low magnesium (Mg2+) concentrations (Warner et al, 1999).
Although the "patent" scientists cite a paper by Kawase et al (1991) which documents the potentiating power of the mere trace amounts of aluminum upon sodium activation on prostaglandin receptors - in their own calculation with sodium they fail to account for this important fact. Potentiating effects of aluminum might well exceed 500%, making the concentrations required for prostaglandin activation much lower than those observed in the patent (see: Imai et al., 1996; Turinsky et al, 1992; Kawase et al, 1989).
Already in 1989 Kawase et al had shown in HL-60 cells - the cells used in the patent investigation - that in the presence of mere trace amounts of aluminum, NaF concentrations ranging from 0.01 to 1 mM increased PGE2 synthesis in a dose-dependent manner, whereas NaF alone at lower concentrations (below 0.1 mM) did not show such a significant effect.
Further, when Kawase investigated HL-60 cells treated with sodium (Kawase, 1989). only, he had many more additional findings to report: not only did sodium increase prostaglandin E2 production, but NaF- produced marked changes in cellular morphology, increased cellular adhesion to plastic, reduced the nuclear/cytoplasmic ratio, increased cellular expression of chloroacetate esterase, and stimulated production of interleukin 1 alpha (IL-1 alpha), IL-6, and the tumor necrosis factors
"White Spots" - Candidiasis
As mentioned above, the "white spots" in the mouths of our kids were also frequently attributed to candidiasis (yeast infection) by medical professionals.
Candidiasis is an infection of the moist cutaneous areas of the body, and is generally caused by the fungus Candida albicans. It involves the skin, oral mucous membranes, respiratory tract and vagina.
In workers exposed to Candida albicans was seen in 73.7% of cases. 80% of the cases showed a considerable intensification of periodonatal diseases. Leukoplakia [pre-cancerous growth] and candidiasis were the most common changes found (Ilewicz et al, 1982).s,
Other studies on workers have since confirmed those findings (Borysewicz-Lewicka, 1983; Sroczynski et al, 1991). Case reports on candidiasis caused by mouthrinse are also known (i.e. Axell & Edwarsson, 1978). [see:Part 3]
How much do Dentists know about Oral Cancer?
Excerpts from article by Richard Gracer, MD
Of course many of us who suffer from hypothyroidism and are on replacement thyroid hormone know about and periodontal disease, a quite common concern.
During the last 40 years the strong association between periodontal disease and thyroid disorders, especially hypothyroidism has been documented many times over in the world literature (i.e. Riedel & Ordelheide, 1966; Abate, 1968; Baba et al, 1972; Pencea et al, 1978; Saburova & Isaeva, 1971; Schneider, 1969; Shkoliar et al,1967; Pashaev, 1982; Danilevskii et al, 1988; Kerimov, 1989; Puzin et al, 1996, etc).
Yet it has received little or no attention in the US.
In women with general periodontitis all hormonal systems were shown to be excessively shifted (Puzin et al, 1996).
Wendy Small compiled the following "anecdotal evidence" from past newsgroup/e-mail postings:
1) "The pockets around my gums started getting deeper & the dentist had me coming in every 3 months, instead of the usual 6 months. The pockets got so bad I had to have scaling of one area. On my last visit there was a huge difference. I noticed at this time my TSH was 1.3, so I really think our thyroid level effect this. I go back in May & my TSH has increased slightly, hopefully not enough to increase the pocket size again."
#2) "My own periodontal issues did not begin to resolve until after probably six months of thyroid treatment ...My own periodontist had no clue about the connection between hypothyroid and beginning- or worsening- gum disease, until he saw my own problems stabilize and then begin to heal after a few months of thyroid meds. Prior to my dx of hypo I had been receiving treatment for periodontal disease for a couple of years, and it was just getting worse, little by little - never improved one bit until thyroid supplementation began..."
3) "Monday I went to the dentist for a routine cleaning. I had noticed for about a week or two that my gums were sensitive and bleed some when I brush, but nothing really bad. Or so I thought. The first thing the hygienist did was a periodontal measuring (don't know the official name for what she did) but it consisted of taking a very thin pick with measurement marks on it and inserting between my gums and teeth. She did this at a couple of different places on each tooth and noted the numbers. This is supposed to tell them if I have signs of or periodontal disease. Anyway, the point of all of this is that by the time she had done all my teeth my mouth was bleeding so bad she wouldn't finish the cleaning. All she did was a treatment with some sort of antibacterial solution (felt like she used a water-pik) and sent me home with some medicine to rinse with. I go back in a few weeks for a recheck and a cleaning. I asked my doctor if it was related and he said he didn't think so, but I was just wondering if anyone else has had similar problems."
Bob J, Vishal R, Andreas S, Wendy S, Danielle F,
Trent H, Marshall G
Thanks to: Jack S, Peter M, Jane J, Bob G, and Randy T
Editor: Andreas Schuld
© 2002 PFPC
(Parents of Poisoned Children)
Ronnie from Negaunee
----- Forwarded Message ----
From: Fluoride Action Network <pesticides@...>
Sent: Sun, March 18, 2012 11:22:15 PM
Subject: New Hampshire House Passes Infant Warning Bill
March 18, 2011
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FAN US & CANADIAN LEADERS
If you would like to start or join a local campaign to end fluoridation please first use our State and Regional Coordinator map to locate a FAN coordinator near
you. If one does not exist in your area, then please contact our Campaign Manager.
We have exciting news! This week the largest state legislature in the U.S. passed a bill mandating infant fluoride warnings on all water bills in fluoridated communities.
On Thursday, March 15th, the New Hampshire House of Representatives voted 253-23 in favor of HB-1416 following a 13-2 recommendation from the House Resources, Recreation, and Development committee. While there was a lot of opposition to the bill in committee, there was no debate on the House floor because of the insurmountable 13-2 committee recommendation.
Here is the background on HB1416.
The bill will now go to the Senate, where it will have a public hearing before either the Health or Municipal committee during the next several weeks. While in the Senate, we know that the NH Dental Association, Delta Dental, and the American Water Works Association will continue to oppose this bill. The NH Dental Association has contributed more than $40,000 to NH Senators over the past 5 years, so we expect a battle.
We would like to thank those who contacted NH legislators and committee members. Many legislators told me personally that they received hundreds of emails, dozens of letters, and many personal phone calls, all of which influenced their decision significantly.
We will need this same level of support as this bill heads into the Senate. We need NH Senators to hear from medical and scientific professionals, NH citizens, and from people who have been harmed by water fluoridation. I believe that if we can keep this pressure on NH legislators, then HB-1416 will successfully become law, setting a new precedent in disclosure of the risks associated with water fluoridation.
Be on the lookout for future updates from NH as the bill is referred to a committee and has its public hearing scheduled.
Fluoride Action Network
Fluoride Action Network | 82 Judson St | Canton | NY | 13617
years ago here in california they were doing aerial spraying for the medfly. a few years after they stopped i was talking to a handicapped law compliance officer and he said the reason it finally got stopped had nothing to do with the dreadful health effects it had on people--it was due to the threat it presented to the population of endangered kangaroo rats. so when i ran across the info below it got me to thinking could something like this be used to stop the fluoridation?
"it is generally illegal to deposit in, permit to pass into, or place where it can pass into the waters of this state any substance or material deleterious to fish, plant life or bird life (Fish and Game Code, section 5650"
if hydrofluoriosilicic acid is harmful to fish, plant or birds can it be stopped in california using that law? what about in other states that have similar laws?
Three or four years ago Carole Clinch filed a petition with the Canadian government (Auditor General, who is supposed to be an impartial arbiter, not a politician) using the Canadian Fisheries Act which says much the same thing as that Fish and Game Code.
However, the Canadian Water Quality Guideline for fluoride of 0.12 ppm is not enforceable and the petition was essentially ignored. The Fisheries Department responded that there was no evidence that water fluoridation chemicals diluted in tertiary treated municipal sewage effluent harm the fish in downstream environment. If there is a spill or industrial accident that wipes out a fishery, it’s a prosecutable offence, but they claimed that water fluoridation doesn’t do that so it’s no problem.
I think there is scientific evidence that fish and keystone food chain species are harmed by the amount in effluent, not so much by direct fluoride toxicity, but by fluoride’s well known affinity for taking calcium ions out of solution. It is the loss of calcium, which is essential for forming fish scales and insect exoskeletons, dropping it below a certain critical ratio in soft water with low mineral buffers, that harms aquatic species severely when even a tiny increase in fluoride occurs.
From: FluoridePoisoning@yahoogroups.com [mailto:FluoridePoisoning@yahoogroups.com] On Behalf Of mommy2baron@...
Sent: March-21-12 9:06 PM
Subject: [FluoridePoisoning] Can California Fish and Game regulation be used to stop the fluoridation?
years ago here in california they were doing aerial spraying for the medfly. a few years after they stopped i was talking to a handicapped law compliance officer and he said the reason it finally got stopped had nothing to do with the dreadful health effects it had on people--it was due to the threat it presented to the population of endangered kangaroo rats. so when i ran across the info below it got me to thinking could something like this be used to stop the fluoridation?
"it is generally illegal to deposit in, permit to pass into, or place where it can pass into the waters of this state any substance or material deleterious to fish, plant life or bird life (Fish and Game Code, section 5650"
if hydrofluoriosilicic acid is harmful to fish, plant or birds can it be stopped in california using that law? what about in other states that have similar laws?
West Milford officials opposed to fluoridation mandate
Thursday March 22, 2012, 8:53 AM
A proposal to mandate fluoridation statewide is being opposed by some council members for its affiliated expense. The Township Council is expected to vote this week on a resolution in opposition of New Jersey Senate Bill 959, which would require state entities to enforce the fluoridation of all public community water systems within one year of its effective date. The bill does not apply to systems where the water is naturally laced with sufficient fluorides to conform with the affiliated rules and regulations, which Councilman Joseph Smolinski noted may very well pertain to West Milford as one of the few areas with naturally occurring fluoride.
However, Council President Lou Signorino said he requested the drafting of a resolution since the other 15 Passaic County municipalities do not and will have to abide by rules that he said could be less about safety and more about making people money.
He noted that fluoride can be toxic in large quantities and needs to be highly-regulated in these situations.
Councilwoman CarlLa Horton said she understands the dental health concerns of some state legislators, but does not want the local Municipal Utilities Authority or any other entity to be saddled with another costly requirement from the state. A draft version of municipal resolution 2012-115 reflects the claim that the implementation of the proposal would be an unfunded mandate and "a betrayal of the public trust."
The bill has been opposed for similar reasons by the New Jersey League of Municipalities, which has recommended a careful cost analysis, noting that only a small fraction of water used by public community water systems is actually consumed. Most is used for cleaning, sanitation, and gardening, as noted by a recent memorandum from William Dressel, the league's executive director.
– David M. Zimmer
National fluoride critic would love to attend Athens forum on the issue
To the Editor:
As the lead author of the book "The Case Against Fluoride" (Chelsea Green, 2010), I would be very happy to participate in a public forum on the issue of water fluoridation if one were held in Athens.
In our book, every single argument was carefully documented (80 pages of references). It is now 15 months since our book was published, and proponents have attempted no cogent scientific response. If fluoridation was as good as promoters claim it to be, why are they unable to defend the practice?
I applaud City Council member-at-large Elahu Gosney for pursuing this matter. If proponents cannot defend the matter in open public debate, then local governments should not have the confidence to force this outdated practice on their citizens.
Hopefully, with the help of other communities, Athens can get Ohio's mandatory fluoridation bill overturne; it is an anomaly in the 21st century. We are forcing communities to do to all their citizens what an individual doctor can do to no one – force them to take medicine without their informed consent.
The vast majority of countries do NOT fluoridate their water supply but their teeth are no worse than the few countries that do. Meanwhile, we have 25 studies that have found an association between modest levels of fluoride and lowered IQ in children.
Paul Connett, Ph.D., director of the Fluoride Action Network
Fluoride costs escalate
Wednesday, March 21, 2012
The Carroll Boone Water District (CBWD) board will meet at 10 a.m. April 19 to consider proceeding with fluoridation of public drinking water despite not having sufficient grants to cover startup costs. The board will discuss whether to use district funds to implement fluoridation.
State legislation in 2011 that mandated fluoridation of all water systems with more than 5,000 customers specified that money for fluoridation equipment had to be obtained from outside grants, not tax money or user fees.
Delta Dental, an oral health insurance company, pushed for the mandatory fluoridation law in the legislature, and grants from the Delta Dental Foundation were supposed to be used to pay for the fluoridation equipment. But DDF underestimated what it would cost.
Delta Dental has reportedly offered CBWD about $763,000, while the cost estimated by engineers to institute fluoridation for the
district that serves 25,000 people, including residents of Eureka Springs, Berryville and Harrison, is $1.23 million.
James Yates of Harrison, president of the CBWD board, said he has to follow state law requiring fluoridation.
"My feeling, personal or otherwise, doesn't apply to the board," Yates said. "I have no control over what the health department does. We can't just come up and say, 'Look, this is bad, guys. We aren't going to do it.' They have told us to do it.
"They are the ones who tell us what we have to do. If the state mandates we have to put fluoride in our water and the people managing the grants make a statement that we are only entitled to so much money for startup costs because they won't cover certain things, we are going to do it right.
"We are not going to put any of our employees at risk. If they say we have to do it and the law mandates we do it, we will do it the safest and most effective way for both employees and customers. That is our number one priority."
On Monday, State Rep. Bryan King (R-Green Forest) obtained an opinion from the State of Arkansas Bureau of Legislative Research that said: "You asked whether the Carroll Boone Water District is obligated to pay for fluoride implementation under Act 197 of 2011 even if grant funds fall short. The answer is probably 'No'.
"Under subsection (d)(1) of Act 197 of 2011, codified at Arkansas Code § 20-7-136, water systems are not required to implement the law until funds are available from some source other than taxes or fees regularly collected by the water system. Unless non-tax, no-fee funds are available for capital start up costs, the water system is not required to carry out any of the requirements of the act. That is, unless the capital costs are covered by some outside funds, the water system is not required to maintain the fluoride levels established by the Department of Health under the act."
King said he did not vote for the fluoride mandate in the Public Health Committee or on the House floor, and the majority of constituents who have contacted him oppose fluoridation.
"Concerns have come from all over the political spectrum," King said. "Usually in Carroll County it is liberal versus conservative, or the east side of the river against the west side of river. But this issue has raised a lot of concerns all over the county. A lot of people just don't like the mandate, that they aren't able to decide themselves whether they should fluoridate or not. There have been some people who are supportive of it, but the majority of people who have contacted me have been opposed to it for a wide variety of reasons."
King said he wouldn't be surprised to see an effort in the next legislative session to overturn the mandate. Opponents said it was rushed through in seven days without an opportunity for adequate public comment.
Fluoride added to drinking water is a controversial subject, with the official government position being that it saves money by preventing cavities. Opponents say it can cause health problems such as hypothyroidism, heart disease and learning disabilities in children.
A recent study by the CDC showed 41 percent of children aged 12 to 15 were over-fluoridated, with resulting irreversible damage to their teeth from dental fluorosis.
The Arkansas Department of Health recently set fluoride limits at the level the CDC said could cause fluorosis, rather than at the lower level now recommended by the CDC.
Arkansas allows up to 1.2 milligrams per liter as opposed to the CDC's recommendation of an amount nearly half that level, .7 milligrams per liter.
The health department also denied that lead leaching could be issue in Eureka Springs, which has twice voted against fluoridation.
The city's contract with CBWD forbids the introduction of corrosive water into the city's drinking water supply. Concerns have been raised by the 12 employees at the Carroll Boone Water District (CBWD) that the corrosive nature of fluoride could leach lead from water distribution systems in historic cities like Eureka Springs.
That has happened in other areas of the country, like Washington D.C., leading to excessive levels of lead in children and pregnant women. According to the CDC, lead causes development delays in children, damages kidneys and the nervous system, and interferes with red blood cell chemistry.
The EPA said in 1995 that 69 million people served by 4,167 community water systems in the U.S. exceeded the lead action levels due to corrosive water.
The corrosiveness of fluoride has also been shown to damage water system equipment. Poughkeepsie's Joint Water Board in Dutchess County, N.Y., discontinued use of fluoride after 18 months due to damage to equipment, according to Citizens for Safe Drinking Water.
It is possible that later on grant funds will become available to implement mandatory fluoridation. DDF has announced plans to try to raise an additional $10 million to pay for fluoridation startup costs statewide, but if CBWD accepts the $763,000 grant currently offered, they would not be eligible to receive any more funding from DDF.
"While the benefits of fluoridation may be debatable, the cost factor is certainly not," said CBWD operator René Fonseca. "Those of us who work at the CBWD plant believe there are other more important priorities for infrastructure improvements.
"The West Plant has run 24 hours a day for the past 30 years. It needs money for rehabilitation. Plans for a $1-million-plus parallel pipeline we need for future growth has been put on hold for over a year. These needs are a higher priority than adding fluoridation equipment."
Fonseca said that if the district is forced to proceed with fluoridation, changes will have to be made in its engineering to add chemicals to help with corrosion control.
Currently water leaves the plant at a neutral pH of about 7.2. Adding fluoride would make the water more acidic, and chemicals would have to be added to bring the pH back up. This would involve a new engineering study that would include how to add more chemicals, which would cost money; and adding anti-corrosive chemicals would also raise the yearly costs of fluoridation.
According to a letter explaining terms of the grant, by accepting money from DDF, CBWD has to agree to fluoridate the water for at least ten years, or pay back a pro-rated share if fluoridation is stopped.
Employees of the CBWD are on record as opposed to fluoridation on the grounds that some studies show adverse health effects from drinking fluoridated water; equipment can be damaged by the highly corrosive chemicals; and the chemicals are highly hazardous to workers.
Operators have also raised concerns about recent studies showing the sodium fluorosilicate additive contained 17 trace elements of a toxic nature including lead, arsenic, and thorium, a radionuclide.
"These are extremely dangerous substances," Fonseca said. "The acute lethal toxicity of sodium fluorosilicate for an adult man is 6.2 grams, which is about the weight of an average driver's license. At a water plant the size of CBWD, you would be dumping 150 pounds a day into the water--enough oral doses to poison 9,600 men a day or 297,000 men a month. This is not pharmaceutical grade fluoride, as you would receive in the dental office."
Fonseca said operators, who are well trained and must pass licensing tests, will stand firm about refusing to add this substance to the water unless there is proper disclosure as required by law. He said it appears there are no domestic suppliers of the fluoride additives, so CBWD will start searching for foreign sources.
"Who wouldn't want to know the amount of radionuclides in a product?" Fonseca asked. "If you buy even a candy bar in a store, you get a list of ingredients. Shouldn't we know what we are putting in our drinking water?"
© Copyright 2012 Lovely County Citizen
. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Did the US Centers for Disease Control fudge dental fluorosis statistics?
The CDC officially reports that 41% of 12-15 year olds have fluorosis http://www.cdc.gov/nchs/data/databriefs/...
But a presentation by the EPA reveals CDC's actual statistics show that 60% of 12-15 year-olds are afflicted with dental fluorosis - white spotted, yellow, brown and/or pitted teeth - the outward sign of fluoride's toxicity to the human body http://www.nationaloralhealthconference....
If fluorosis is no big deal, then why the need to downgrade fluorosis levels. And why are dentists telling the national media that children lack fluoride because they drink bottled water when there's no data to support that but loads of data showing American children are fluoride-overdosed and dentist-deficient?
-- Posted by nyscof
on Wed, Mar 21, 2012, at 4:11 PM
Fluoridation is a Waste of Tax Money
As a Civil Engineer, I know how wasteful fluoridation is. People drink only 1/2 % (one half percent) of the water they use, so for every $1000 of fluoride chemical added to water, $995 would be directly wasted down the drain in toilets, showers, dishwashers, etc., $5 would be consumed in water by the people, and less than $0.50 (fifty cents) would be consumed by children, the target group for this outdated practice.
That would be comparable to buying one gallon of milk, using six-and-one-half drops of it, and pouring the rest of the gallon in the sink.
Fluoridation surely is in contention as the most wasteful government program. Giving away fluoride tablets free to anyone who wants them would be far cheaper and certainly more ethical, because then we would have the freedom to choose which prescription drug we take.
It is pure propaganda for the dental groups to claim savings of $38 for each $1 invested in fluoridation.
-- Posted by jwillie6
on Thu, Mar 22, 2012, at 12:23 AM
The cost is said to be $1.23 million. Does that include the costs changes made in its engineering to add chemicals to help with corrosion control,a new engineering study that would cost money; and adding anti-corrosive chemicals would also raise the yearly costs of fluoridation? NO!
So, $1,230,000 divided by 25,000 people =
$49.20 / person
The claim that for every dollar spent that savings of $38 accrue! Is that per year or for life of each person?
Anyway, $1,230,000 times $38 =
Thats 46.74 MILLION DOLLARS !!!!
Holy mackeral - you dentists ought to think about setting up shop somewhere else!
But just think of all the savings each person will have
$46,740,000 / 25,000 =
I guess that money will come in handy when they have to pay for all the health care they might need from drinking an unapproved drug.
-- Posted by FluoridePoisoned
on Thu, Mar 22, 2012, at 10:38 AM
Petrolia's fluoride debate starts
Posted 19 hours ago
The Petrolia Topic
Fluoridation of drinking water has been a contentious debate in communities for
years and the debate has begun in Petrolia — and may continue at Petrolia
council's April 23 meeting.
Councillors have received inquiries about fluoride being added to the town's
drinking water so the town asked for the opinion of Dr. Christopher Greensmith,
Lambton County's Medical Officer of Health.
Greensmith has told the town in a letter that "...community water fluoridation
is beneficial to all residents, especially children, low income families and the
elderly. Over 90 international organizations (such as the World Health
Organization, Public Health Agency of Canada and the U.S. Centers for Disease
Control and Prevention) support the addition of fluoride into community water
Greensmith added it's important that children have access to fluoride "...to
strengthen their teeth enamel and prevent dental disease."
But Petrolian Al Petersen, speaking to council at its March 19 meeting, said
"...the risks (of fluoride) outweigh the limited benefits."
He gave council a report, based on his research, that said "...producing safe
drinking water does not require fluoride to be added to it."
Petersen asked council to take a precautionary approach and discontinue
Fluoride (fluorosilic acid) is added at the town's water treatment plant in
Bright's Grove at a dosage rate between .60 and .70 parts per million, according
to town corporate services director Scott Gawley.
Ontario Clean Water Agency operators contracted by the town to operate the water
treatment plant are responsible for adding fluoride to the drinking water, as
required under the plant's certificate of approval issued by the Environment
Ministry, said Gawley in a report to council.
"The addition of fluoride in the town's drinking water is primarily a municipal
issue in consultation with the public and the medical officer of health, he
said. After the meeting, Gawley explained the ministry doesn't require a
municipality to use fluoride.
Gawley said staff is checking to see how long fluoride has been added to
Petrolia's drinking water.
Petersen's report also said fluoridation is not required under Ontario's Safe
Drinking Water Act; it is a municipality's option.
His report said Petrolia council "...assumes full responsibility for verifying
the safety of the product (fluoride) used, its application to the water supply,
and the health risks which occur; yet take it on faith from other authorities
the product used not only meets the criteria, but is otherwise safe, even though
it's up to the town alone to make that final determination.
"The Ministry of Environment, local medical officer of health, Health Canada,
and the American Water Works Association can state in a general sense the
concept of fluoridation is beneficial because they assume no liability for
responsibility and decisions about Petrolia's drinking water system and chemical
Petersen said fluoride is only potentially effective in protecting teeth as a
topical treatment; not from ingestion. He added because fluoride is also
ingested with mouthwash, food, toothpaste and beverages, "...total fluoride
exposure needs to be limited."
He said by adding fluoride to the water supply, council is accepting unnecessary
liability for potential damages and health impacts.
Petersen said ending the use of fluoride would:
• Eliminate the risk of chronic workplace exposure to hydrofluorosilic acid
chemical emissions for water treatment plant operators;
• Eliminate the potential risk to the health of drinking water consumers; and
• Eliminate exposure to liability for damages and impacts.
Peterson said it's challenging to determine if exposure to low concentrations of
any known hazardous compound over a long period of time causes health impacts.
But he said many municipalities have discontinued using fluoride and added "It's
clear from a simple risk/benefit analysis the benefits of water fluoridation
don't justify the cost and the risk."
Council tentatively tabled discussion about fluoride to its April 23 meeting
after Councillors Mary-Pat Gleeson and Joel Field said Peterson's report and
supplementary information is a "lot of information" to digest.
"There's a lot of information to go through, to make sure we are making the
right decision," said Field.
Mayor John McCharles said a municipal referendum would be needed to take
fluoride out of the town's drinking water
Gawley said after the meeting staff is checking to see if a referendum would
actually be needed; and is also checking to see if a referendum was used to
begin the use of fluoride. If a referendum was used to start it, another would
be needed to end it, he said.
Gawley said April 23 is only a tentative date to continue the fluoride debate
because the town is still trying to secure the attendance of people such as
Greensmith and Petersen.
Council meetings start at 7 p.m.
Fluoride: Safe And Effective?
Terry Wilson takes a look at the history, effectiveness, possible side effects, and large PR campaign that surround the issue of water fluoridation.
Municipal water supplies in North America have been adding hydrofluorosilicic acid to their water supplies sine 1945, in an attempt to lower tooth decay in children and the lower income populations.
In doing so, the basic human right of informed consent to a medical treatment has been completely bypassed in an attempt to achieve the "greater good:.
news from Washington:
put an ad in the Everett Herald: http://fluoride-class-action.com/wp-content/uploads/Everett-press-release-3-18-121.pdf
linked to this page: http://fluoride-class-action.com/press-releases
we had guests show up at the city council meeting, and we made new members who
seem interested in helping organize.
delivered the city council a copy of the press release: http://fluoride-class-action.com/press-releases
explained to the council that the fluoridation materials are not legal. Wash
law says that the materials must comply with NSF 60. NSF 60 says that tox
studies are done and that additives had to be safe at maximum use levels. But
NSF official Stan Hazan has said under oath that tox studies are not being
done. Fluoridation can only be done with materials that comply with NSF. Therefore
there are no legal fluoridation materials and fluoridation itself is illegal.
that the fluoride has been turned off, the tables have turned. They are going to
have to take affirmative action to turn it back on. That will be an illegal
gave them a copy of the 2005 letter the FDA wrote stating that making untrue
medical claims about a product can be a CRIME. http://fluoride-class-action.com/fda-letter-criminal-sanctions-for-making-untrue-claims
are going to hammer on that point.
the local paper published this opinion piece:
additional good news is that the op-ed editor says that he will publish as many
intelligent 300 word letters to the editor as we send him. He has been
listening via the web to all the speeches that Fluoride Class Action and
Washington Safe Water have been giving.
Friday Audrey Adams and I – representing Washington Action for Safe Water
and Fluoride Class Action – attended the Snohomish Health District
seminar on Fluoride.
Pollack, defender of the fluoride faith, cruised along from 8:30 until 10:00
about how great fluoridation was.
the intermission I handed out my broadsheet:
Howard Pollack seemed to be flustered. He asked me if I knew Paul
Connett, and I said “of course”.
and I asked a lot of questions and made our arguments.
present was Mark Weeks, who gave a virtual tour of the water treatment plant. I
asked him if they ever suited up in hazmat gear when working with the fluoride.
He said they did not even have one. He said they didn’t even use
breathers or masks. He said they did not even own any hazmat suits. He said
that the ventilation removed ten volumes of air every hour and that was
Washington Dental Foundation was there too. They are unquestioning supporters
of fluoridation. I think they are funded by the Pew Foundation. The lady said
that if she knew there was anything wrong with fluoridation, they would not
support it. I intend to write them a letter.
will publish more about the conference when I have time. Now back to work.
James Robert Deal , Attorney
PO Box 2276 Lynnwood
Keep hammering on them JRD and all. The success of Everett and San Deigo (if
and when) are going to be the blueprint for me and my town.
If the FDA would truely do their job none of this would be necessary.
--- In FluoridePoisoning@yahoogroups.com, "James Robert Deal"
> The news from Washington:
> I put an ad in the Everett Herald:
> Which linked to this page:
> So we had guests show up at the city council meeting, and we made new
> members who seem interested in helping organize.
> I delivered the city council a copy of the press release:
> I explained to the council that the fluoridation materials are not
> legal. Wash law says that the materials must comply with NSF 60. NSF 60
> says that tox studies are done and that additives had to be safe at
> maximum use levels. But NSF official Stan Hazan has said under oath that
> tox studies are not being done. Fluoridation can only be done with
> materials that comply with NSF. Therefore there are no legal
> fluoridation materials and fluoridation itself is illegal.
> Now that the fluoride has been turned off, the tables have turned. They
> are going to have to take affirmative action to turn it back on. That
> will be an illegal action.
> I gave them a copy of the 2005 letter the FDA wrote stating that making
> untrue medical claims about a product can be a CRIME.
> We are going to hammer on that point.
> And the local paper published this opinion piece:
> The additional good news is that the op-ed editor says that he will
> publish as many intelligent 300 word letters to the editor as we send
> him. He has been listening via the web to all the speeches that Fluoride
> Class Action and Washington Safe Water have been giving.
> On Friday Audrey Adams and I - representing Washington Action for Safe
> Water and Fluoride Class Action - attended the Snohomish Health District
> seminar on Fluoride.
> Howard Pollack, defender of the fluoride faith, cruised along from 8:30
> until 10:00 about how great fluoridation was.
> At the intermission I handed out my broadsheet:
> Thereafter Howard Pollack seemed to be flustered. He asked me if I knew
> Paul Connett, and I said "of course".
> Audrey and I asked a lot of questions and made our arguments.
> Also present was Mark Weeks, who gave a virtual tour of the water
> treatment plant. I asked him if they ever suited up in hazmat gear when
> working with the fluoride. He said they did not even have one. He said
> they didn't even use breathers or masks. He said they did not even own
> any hazmat suits. He said that the ventilation removed ten volumes of
> air every hour and that was protection enough.
> The Washington Dental Foundation was there too. They are unquestioning
> supporters of fluoridation. I think they are funded by the Pew
> Foundation. The lady said that if she knew there was anything wrong with
> fluoridation, they would not support it. I intend to write them a
> I will publish more about the conference when I have time. Now back to
> James Robert Deal , Attorney
> <mailto:James@...> James@...
> PO Box 2276 Lynnwood WA 98036
> Telephone: 425-771-1110
> Fax: 425-776-8081
> www.WashingtonSafeWater.com <http://www.WashingtonSafeWater.com>
> www.Fluoride-Class-Action.com <http://www.fluoride-class-action.com/>
Just address an email to FluoridePoisoning@yahoogroups.com
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