The U.S. Department of Justice has entered a consent decree against ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence Inc. (MADE), and James G. Vercellotti (the president and owner of both companies), preventing these parties from continuing to make, package and sell over 400 dietary supplements. The products manufactured by MADE include vitamins and minerals sold under the brand names "Sci-Fit", "Nature's Science", and "For Store Only". ATF Fitness Products Inc. purchases and distributes these supplements.
The decree will be in effect until the U.S. Food and Drug Administration (FDA) re-inspects the facilities and determines that Food, Drug and Cosmetic Act (FDCA) regulations are no longer being violated by the manufacturer and distributer. In addition, the two companies and their owner are required to hire an independent expert who can ensure that the future production and distribution of supplements by these companies continues to follow FDCA regulations.
The consent decree was first filed in November 2011 after the FDA learned that the companies and their owner were substituting ingredients and products in dietary supplements without making appropriate changes to the labels of the final products. For instance, in 2004, Scientific Fitness was issued a warning letter that its product Androstenedione contained androstenedione, which was not considered to be a dietary ingredient in the United States. Consequently, according to 21 U.S.C. 350(b)(a)(2) and 21 CFR 190.6, Scientific Fitness would have needed to submit information to the FDA notifying the administration that the product contained a new dietary ingredient. This information would have needed to show that the new dietary ingredient was reasonably expected to be safe. Because the company did not follow this regulation, the product was considered to be adulterated.
Later that same year, Mr. Vercellotti was issued a warning letter from the FDA after the administration determined that certain products sold under the brand name "Sci-Fit" had mahuang extract listed as an ingredient. Mahuang extract is a source of ephedrine alkaloids, which at the time were prohibited to be included in any dietary supplements according to section 402(f)(l)(A) of the FDCA, since such ingredient may have an unreasonable risk of causing illness or injury. Two years later, in 2006, the U.S. Marshals had to confiscate over $16,000 worth of the dietary supplement Lipodrene from ATF Fitness Product, Inc. because these supplements still contained 50 milligrams of ephedrine alkaloids per dose and were being distributed in the United States.
Although the products could have been manufactured if they were going to be exported out of the United States, the companies or Mr. Vercellotti would have needed to provide documentation that followed section 801(e)(l) of the act, which requires that the manufacturer proves that the product to be exported meets the purchaser's specifications, that the product does not violate laws of the purchasing company, that the product is labeled for international shipping, and that the product is not sold or offered in the United States. These requirements were not met during FDA inspection of the facilities.
In addition, the two companies were not reporting adverse effects experienced by customers who consumed their products. For instance, one individual required hospitalization after suffering a significant increase in blood pressure and eventual heart attack.
According to statements made by Stuart F. Delery, Acting Assistant Attorney General for the Civil Division, the Department of Justice needed to enter this consent decree to help ensure the safety of dietary supplement consumers. Because people purchase dietary supplements to improve their health, they need to be certain that the products they buy are safe and contain the ingredients stated on the label.
For more information about the effects of ephedra, androstenedione and other chemicals found in natural herbal sources that may be harmful, please visit Natural Standard's Foods, Herbs & Supplements Database.