On November 23, 2011, the U.S. FDA took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The agency seeks a permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), which makes “Sci-Fit,” “Nature’s Science” and “For Store Only.” products. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.
This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations. The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size. This company's compliance date came into effect in 2010, and they did not meet the relevant cGMP requirements after that date.
The FDA requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies. The cGMP regulations require manufacturers to ensure quality in their dietary supplements by controlling all aspects of their processes and procedures. MADE makes more than 400 dietary supplements, including vitamins and minerals, under the brands “Sci-Fit,” “Nature’s Science” and “For Store Only.” ATF purchases dietary supplements exclusively from MADE and distributes them throughout the United States.
“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for regulatory affairs. “Today’s injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes.”
The government's complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, alleges that in addition to “adulterating” and “misbranding” their final products, the manufacturer and its owner failed to report serious adverse events associated with their products. In one case an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.
Among the products found during the inspection, which would be affected by the injunction, Sci-Fit Procuts, which is labeled to contain MaHuang Extract, a source of ephedrine alkaloids. Under section 402(f)(1)(A) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 342(f)(1)(A)], the presence of these ephedrine alkaloids would make the product "adulterated". Apparently, this product was meant to be exported to a foreign buyer but the guidelines for exporting a product which cannot be legally sold inside the US to a foreign market have not been met by the company. These guidelines are found under section 801(e)(1) Federal Food, Drug and Cosmetic Act.
Also, U.S. Marshals seized five unlabeled boxes containing various quantities of Lipodrene bottles from ATF Fitness Products, Inc. Each bottle of Lipodrene contains 100 tablets and is labeled with the recommended daily dose of 50 mg of ephedrine alkaloids. The seized products are valued at approximately $16,000.
Scientific Fitness (SciFit) Androstenedione Product
The FDA sent a warning letter to Scientific Fitness concerning its Androstenedione Product, which purportedly contains 4-androstenedione or 4-androstene-3,17-dione, which was unlawfully marketed as a "dietary supplement."