Syntec's Products Seized for Claims, cGMP Violations

HILLSBORO, Wis.U.S. Marshals seized all Syntec Inc.'s dietary supplements for false claims made about their safety and effectiveness in treating a number of diseases. FDA requested the seizure after a complaint filed in the U.S. District Court for the Western District of Wisconsin alleged several of Syntec'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.

The government said company videos and promotional materials claimed some of its products could be used to prevent, treat or cure diseases such as asthma, cardiovascular disease (CVD), cataracts, glaucoma and infections. The products are not FDA-approved as safe and effective for treating any diseases.

According to the complaint, Syntec, Hillsboro, WI, also failed to follow the current good manufacturing practice (cGMP) requirements for dietary supplements, as required by federal law.

FDA sent the company a warning letter regarding the disease claims in March 2009.  During inspections in October 2010, November 2010, June 2011 and September 2011, FDA investigators documented serious cGMP (current good manufacturing practice) violations, in addition to the company's continued use of disease claims for some of its products.

The company's dietary supplements 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.

This seizure is part of a growing trend of increased federal enforcement against supplement manufacturers that break the law. Within the past month, FTC filed a permanent injunction against one company, three supplement company workers were imprisoned, and FTC filed a complaint seeking to permanently stop one company's operation.