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FDA Cracks Down on Fake Cures

Article Description:
====================

In an effort to crack down on charlatans who prey on the sick,
the U.S. Food and Drug Administration (FDA) recently issued
warning letters to 23 U.S. companies and two foreign individuals
marketing a wide range of products that fraudulently claim to
prevent and cure cancer.


Additional Article Information:
===============================

406 Words; formatted to 65 Characters per Line
Distribution Date and Time: 2008-08-14 11:36:00

Written By: Norm Howe
Copyright: 2008
Contact Email: mailto:info@...



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FDA Cracks Down on Fake Cures
Copyright (c) 2008 Norm Howe
Validation and Compliance Institute
http://www.vcillc.com



Licensed physicians prescribe drugs that undergo clinical testing
to determine if they are safe and effective for their intended
uses. These drugs have been clinically tested or reviewed by FDA
for safety and effectiveness.

Of course, where there are rules and regulations, there will be
those who try to take shortcuts.

In an effort to crack down on charlatans who prey on the sick,
the U.S. Food and Drug Administration (FDA) recently issued
warning letters to 23 U.S. companies and two foreign individuals
marketing a wide range of products that fraudulently claim to
prevent and cure cancer.

Those companies and/or individuals include Vitasalus, Inc.
(Nu-Gen Nutrition), USA Golden Vision, Richard McPhail (Be
Healed), Ageless Cures, Plantcures.com, Precision Herbs, Burt
Hampton (The Original Cream Company), Coral Calcium, JHS
Naturals, Vitapurity AKA: Vitapurity Corp, Millenium Health,
Herbs for Cancer, Triherba Marketing, Herbal Remission, Nutrition
2000, Superb Herbs AKA: FemHealth, Wallcann-Cura-Care.com, Road
to Healing, Herbtime, New Sun Inc., The Institute for Healthy
Aging, Gemtronics, H and L Worldwide Inc. (Vitasprings),
Generation, and Best on Earth Products.

Because these products claim to cure, treat, mitigate or prevent
disease, and these products have not been shown to be safe and
effective for their labeled conditions of use, they are
unapproved new drugs marketed in violation of the Federal Food,
Drug, and Cosmetic Act.

According to Gary Coody, R.Ph., the National Health Fraud
Coordinator and a Consumer Safety Officer with the FDA Office of
Regulatory Affairs, red flag claims consumers should be on the
lookout for include:

* "Treats all forms of cancer"; * "Skin cancers disappear";
* "Shrinks malignant tumors"; * "Non-toxic"; * "Doesn't
make you sick"; * "Avoid painful surgery, radiotherapy,
chemotherapy, or other conventional treatments"; and/or *
"Treat Non Melanoma Skin Cancers easily and safely".

The FDA urges consumers to avoid products that bear claims of:
being a quick and effective cure-all or a diagnostic tool for a
wide variety of ailments; treating or curing serious or incurable
diseases; being a "scientific breakthrough" or a "miraculous
cure"; containing a "secret ingredient" or "ancient remedy";
possessing a "hunger stimulation point" or "thermogenesis"
(for a weight loss product); safety because it is "natural";
limited availability and advance payment requirements; no-risk,
money-back guarantees; or being an "easy" fix for problems like
excess weight, hair loss or impotency.

Parties that fail to properly resolve violations cited in the
Warning Letters issued will be subject to enforcement action up
to and including seizure of illegal products, injunction and
possible criminal prosecution.




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Norm Howe, Senior Partner at Validation and Compliance Institute,
consultants for the pharmaceutical and medical device industries.
He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.
He has held many management positions in FDA regulated industries,
most at BASF. http://www.vcillc.com


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