$71,000 Worth Of Dietary Supplements Seized For Allegedly Violating New Act, Says FDA

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Main Category: Litigation / Medical Malpractice
Also Included In: Complementary Medicine / Alternative Medicine;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 13 Oct 2007 - 0:00 PDT

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US Marshals seized about $71,000 of FulLife Natural Options Inc. goods last Tuesday for violating new drug and misbranding provisions of Federal Food, Drug and Cosmetic Act. The company marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.

These products are being marketed by the company for the treatment of diabetes, anemia and hypertension, even though they are labeled as just dietary supplements, informs the FDA (Food and Drug Administration). The Agency explains that the claims are clearly stated in the labeling of the products, which contains promotional literature and FulLife's URL (web site address).

These products are not approved new drugs, says the FDA, as they make claims related to the prevention or treatment of chronic diseases mentioned in the labeling of the products. A drug has to be shown to be effective and safe, and approved by the FDA, before it can be legally marketed in the USA.

The FDA explains that it is its duty to protect consumers who make important decisions about their health from reading unsubstantiated claims about unapproved products.

A Complaint was filed by the US Attorney's Office for the Southern District of Florida. It charges that the products are in violation of the drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.

By making claims that the products can prevent and treat chronic diseases, the FDA told FulLife's marketing department that the said products must be subject to the same regulations as drugs, not dietary supplements. The FDA warnings were ignored by the company.

This is the second seizure of products whose marketers/distributors make claims to treat and/or cure chronic conditions. In August US Marshals seized approximately $41,000 worth of Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400 capsules from Charron Nutrition of Tallahassee, Fla., which claimed to treat diabetes, arthritis, and other chronic conditions.

http://www.fda.gov

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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