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Senior Citizen Alerts
FDA Has More Dietary Supplements Seized in Florida:
Charantea Targeted
Products said to violate new drug and misbranding
provisions of Federal Food, Drug and Cosmetic Act
 Oct. 13, 2007 - At the request of the U.S. Food and
Drug Administration (FDA), U.S. Marshals seized on Tuesday approximately
$71,000 of goods from FulLife Natural Options, Inc., of Boca Raton,
Fla., which marketed and distributed Charantea Ampalaya Capsules and
Charantea Ampalaya Tea. This follows a seizure in August of capsules by Charron Nutrition of Tallahassee, Fla., promoted for use in
treating diabetes, arthritis, and other serious health conditions.
Although the products in the latest raid are labeled as dietary
supplements, they are also being promoted by FulLife for use in treating
serious conditions, such as diabetes, anemia, and hypertension.
These
claims are evident in the products' labeling, including promotional
literature and FulLife's Internet Web site, according to the FDA.
"The agency takes seriously its responsibility to
protect Americans from unapproved drugs," the agency said in announcing
the seizure. "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."
Before a new drug product may be legally marketed,
it must be shown to be safe and effective, and approved by FDA.
Tuesday's action protects consumers who may rely on unapproved products
and unsubstantiated claims associated with these products when making
important decisions about their health.
The Complaint, filed by the U.S. Attorney's Office
for the Southern District of Florida, charges the products are in
violation of the drug and misbranding provisions of the Federal Food,
Drug and Cosmetic Act.
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 Tuesday 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.
On August 23, 2007, at the request of FDA, U.S.
Marshals in the Northern District of Florida 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.
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