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Article Title:
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Product Mislabeling Makes Recalls Likely

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

What happens when drug or medical device manufacturers mislabel
their products? The Food and Drug Administration (FDA) regularly
monitors labels for false claims and errors, often pulling whole
lots of product for which it finds a problem. Case in point: a
recent nationwide recall of Encore Tablets, a dietary supplement
sold in health food stores, via the internet and by mail order
nationwide and in Canada.


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

612 Words; formatted to 65 Characters per Line
Distribution Date and Time: 2008-01-07 11:00:00

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



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Product Mislabeling Makes Recalls Likely
Copyright (c) 2008 Norm Howe
Validation and Compliance Institute
http://www.vcillc.com



The Food and Drug Administration (FDA) regularly monitors labels
for false claims and errors, often pulling whole lots of product
for which it finds a problem. Case in point: a recent nationwide
recall of Encore Tablets, a dietary supplement sold in health
food stores, via the internet and by mail order nationwide and in
Canada.

The product was recalled because it contains potentially harmful,
undeclared ingredients. According to FDA, the undeclared
chemicals poses a threat to consumers because they may interact
with nitrates found in some prescription drugs (such as
nitroglycerin) and may lower blood pressure to dangerous levels.

In a similar vein, approximately $2 Million of a potentially
harmful "cosmetic" eye product was recently seized by FDA. The
product, a batch of 12,682 applicator tubes of Age Intervention
Eyelash, may lead to decreased vision. Age Intervention Eyelash
is sold and distributed by Jan Marini Skin Research, Inc., of San
Jose, Calif.

FDA considers Age Intervention Eyelash to be an unapproved and
misbranded drug because Jan Marini Skin Research has promoted the
product to increase eyelash growth. Before any new drug product
may be legally marketed, it must be shown to be safe and
effective, and approved by FDA.

FDA also considers the seized Age Intervention Eyelash to be an
adulterated cosmetic. The product contains bimatoprost, an active
ingredient in an FDA-approved drug to treat elevated intraocular
pressure (elevated pressure inside the eye).

Also in recent months, the labeling has been revised for the
diabetes drug Avandia. FDA announced that the manufacturer of
Avandia (rosiglitazone) has agreed to add new information about
potential increased risk for heart attacks to the existing boxed
warning. Avandia, which is used to treat type 2 diabetes, is
manufactured by GlaxoSmithKline.

FDA is allowing Avandia to stay on the market while a new
long-term study to evaluate the potential cardiovascular risk of
Avandia, compared to an active control agent, is conducted by
GSK. The company agreed to add new information to the drug's
labeling, warning of the potential for increased risk of heart
attacks.

Mislabeling has also hit the dietary supplement industry, when
approximately $71,000 of dietary supplements was recently seized
at FDA's request. U.S. Marshals seized the goods from FulLife
Natural Options, Inc., of Boca Raton, Fla., which marketed and
distributed Charantea Ampalaya Capsules and Charantea Ampalaya
Tea.

Although these products were labeled as dietary supplements, they
were being promoted by FulLife for use in treating serious
conditions, such as diabetes, anemia, and hypertension. These
claims were evident in the products' labeling, including
promotional literature and FulLife's Internet Web site.

FDA considers these products to be unapproved new drugs because
they make claims related to the prevention or treatment of
diseases in the products' labeling.

Following an investigation of the firm's marketing practices,
FDA officials advised FulLife that the claims related to
prevention or treatment of diseases made these products subject
to regulation as drugs. Despite FDA's warnings, the firm failed
to bring its marketing into compliance with the law. During
subsequent inspections, FDA inspectors found that the offending
claims were still being made.

The seizure at FulLife is the second such enforcement action in
two months taken by FDA against dietary supplements being
promoted with drug claims to cure or treat diabetes and other
diseases or conditions.

They also seized an estimated $41,000 worth of inventory of
Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex,
MSM-1000, and Atri-E-400 capsules being promoted and distributed
by Charron Nutrition of Tallahassee, Fla., for use in treating
diabetes, arthritis, and other serious health conditions.

Whether products are cosmetic, medical or herbal, the best way to
avoid having product seized and losing money is to get labels and
marketing materials right the first time.




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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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