Controversy over the proper authority for supplementals has been in existence for generations. However, the heat has really been turned up in the past few years, as consumer awareness of drug interactions with supplements has surfaced. Additionally, findings of a prescription drug being used extensively in a common supplement for cholesterol occurred only a few months ago. Safety, Safety, Safety!!!!
The FDA has been in the center of the debate. Some emphasizing the need for FDA to take more control of supplements to increase public safety. Others, advocating the decentralization of authority and more accountability placed on the manufacturer's of supplements.
The FDA has taken a low profile stance. Therefore, it was surprising that approximately $71,000 of dietary supplements were seized at FDA Request. Products were alleged to violate new drug and misbranding provisions of Federal Food, Drug and Cosmetic Act.
U.S. Marshals seized 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.
Although these products are labeled as dietary supplements, they are 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.
The agency takes seriously its responsibility to protect Americans from unapproved drugs. 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.
Perhaps, the controversy is coming to a head, and we will see increasing authority for supplements come under the control of the FDA. Additionally, consumers can expect a price increase when that transition occurs.
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