Syntec supplements seized over unauthorized disease claims and serious cGMP violations

By Elaine Watson

- Last updated on GMT

Related tags: Manufacturing, Federal food drug and cosmetic act, Food and drug administration

Syntec supplements seized over unauthorized disease claims and serious cGMP violations
The Food and Drug Administration (FDA) says it had no choice but to seize supplements manufactured by Syntec Inc (Syntec Nutraceuticals) after the firm committed serious cGMP violations and ignored warning letters accusing it of making unauthorized disease claims.

US marshals – at the request of the FDA –seized supplements made at Syntec’s facility in Hillsboro, Wisconsin, last Thursday.

The firm, which claims on its website ​that it “consistently passes audits by FDA and USDA inspectors” ​and “manufactures all supplements according to current Good Manufacturing Practices established by the FDA” ​was sent a warning letter ​ in 2009.

This alleged it was making unauthorized drug claims about supplements including CardioCare, BoneCare, SynGevity and SynPhyto-K, by claiming they could prevent, treat, or cure diseases.

Serious cGMP violations

Subsequent FDA inspections of its manufacturing facility in October and November 2010, June 2011 and September 2011 also highlighted “serious cGMP violations, in addition to the company's continued use of disease claims for some of its products​”, claimed the FDA.

“A complaint filed in the US District Court for the Western District of Wisconsin alleges that several of Syntec Inc.'s products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the Federal Food, Drug, and Cosmetic Act.”

Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs, said: "The FDA is committed to protecting consumers from unapproved new drugs."

The company was unavailable for comment as this article went to press.

Related topics: Regulation, GMPs, QA & QC, Product claims

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