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FDA Takes Actions Against Dietary Supplement Manufacturers Due to GMP Violations and Misbranding
FDA has taken actions against two manufacturers of dietary supplements due to violations of current Good Manufacturing Practice (cGMP) regulations and for misbranding their products. The agency filed a permanent injunction that stops a Pennsylvania dietary supplement producer from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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. FDA indicates in a news release that the injunction, filed November 23, 2011, marks the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement cGMP. The complaint filed 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. 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 US “Today’s injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes,” stated Dara Corrigan, FDA associate commissioner for regulatory affairs.
In addition, at the request of FDA, US Marshals seized dietary supplements manufactured at Syntec, Inc, Hillsboro, WI, due to false claims made about their safety and effectiveness in treating a number of diseases. A complaint filed by FDA alleges that several products made by Syntec Inc are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the FD&C Act. Specifically, the complaint alleges that the company made claims in videos and promotional materials that some of its products could be used to prevent, treat, or cure diseases such as asthma, cardiovascular disease, cataracts, glaucoma, and infections. However, the products are not FDA-approved as safe and effective for treating any diseases. In addition, the complaint alleges that the company failed to follow the cGMP requirements for dietary supplements. FDA advises that Syntec products are sold under several brand names including SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare, and SynOmega. Additional details are available in an FDA news release.
