FDA Sends U.S. Marshals to Seize Syntec Dietary Supplements
November 5, 2011 — The FDA sent U.S. federal marshals to seize all products manufactured by Syntec, Inc. (Syntec Nutraceuticals) because the company has continued to make false claims about their products’ safety and effectiveness at treating several diseases, and violates Good Manufacturing Practices.
Drugs manufactured by Syntec Inc. include: SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare, and SynOmega.
The products are not FDA-approved, and they contain unapproved drugs that are not allowed in interstate commerce in the U.S.
The product manufacturers claim that they can cure diseases such as asthma, cardiovascular disease, cataracts, glaucoma, and infections. The FDA sent Syntec a warning letter in 2009 regarding the disease claims, but Syntec refused to comply, and continued to sell the products.
Furthermore, on Syntec’s website, the company claims: “As a food manufacturer, Syntec is subject to and consistently passes audits by FDA and USDA inspectors.” They also claim that “Syntec manufactures all supplements according to current Good Manufacturing Practices established by the FDA.”
The FDA safety warnings argue these claims are false. FDA inspections of the Wisconsin-based manufacturing facilities in October and November 2010, June 2011, and September 2011, found numerous, serious violations of the current Good Manufacturing Practices (cGMP). The cGMP are federal requirements for dietary supplements, intended to regulate the products so that they are safe for interstate commerce.
According to the FDA: “Marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA is committed to protecting consumers from unapproved new drugs.”
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