FDA files permanent injunction against ATF Fitness Products
SILVER SPRING, Md. — The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.
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. Brands include Sci-Fit, Nature's Science and For Store Only.
"Dietary supplements have a significant role in the public's health," stated Dara Corrigan, FDA associate commissioner for regulatory affairs. "[Last week's] injunction reinforces our commitment to ensuring that these supplements meet the [current Good Manufacturing Practices] requirements the law establishes."
The government's complaint, filed Nov. 23 in the U.S. District Court for the Western District of Pennsylvania, alleged 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.
This is the first time the 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 regulations, the agency stated.