Marketing director Billy Yeh told NutraIngredients-USA: “Syntec is in the process of reviewing all allegations filed by the FDA.
"We look forward to fully cooperating with all governmental authorities and will take any necessary steps to address the issues and concerns cited by the FDA.
"Syntec is a small minority-owned and run start up business with the mission of producing the highest quality nutritional supplements possible. While small, we try our best to sell our products in overseas markets to bring jobs and dollars back to our local communities and the US economy."
He added: "We hope to come to a swift resolution with the FDA so that we can return our focus to the company’s long-time goal of providing the highest caliber dietary supplements to our customers."
Unauthorized drug claims
His comments came after 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 alleging 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.”