Dietary Supplements, Drugs Made by Syntec Seized

FDA directed U.S. marshals to seize all dietary supplements by a Wisconsin maker because of false claims made about their safety and effectiveness in treating a number of diseases, FDA reported on its Web site.

"The products manufactured at the Hillsboro, Wis., facility of Syntec Inc. are not FDA-approved and a complaint filed in the United States 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," FDA stated.

Products include SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare, and SynOmega.

In addition, the company "also failed to follow the current good manufacturing practice (cGMP) requirements for dietary supplements, as required by federal law," FDA stated.

The agency had sent the company a warning letter regarding the disease claims in March 2009, and during multiple subsequent inspections, FDA documented serious cGMP violations.