ROCKVILLE, Md. At the request of the Food and Drug Administration, U.S. Marshals last week seized approximately $71,000 of goods from FulLife Natural Options, 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, the FDA stated. These claims were evident in the products’ labeling, including promotional literature and FulLife’s internet web site.
The U.S. Attorney’s Office for the Southern District of Florida charged the company for distributing products that 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 last week 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. The FDA 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 in August.