U.S. marshals seize supplements marketed as drugs
HILLSBORO, Wis. — At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.
The products manufactured by Syntec are not FDA-approved and a complaint filed in the U.S. District Court for the Western District of Wisconsin alleged that 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.
"Marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments," FDA associate commissioner for regulatory affairs Dara Corrigan said. "The FDA is committed to protecting consumers from unapproved new drugs."
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.
The government alleged that the company claimed in videos and promotional materials that some of its products could be used to prevent, treat or cure such diseases as asthma, cardiovascular disease, cataracts, glaucoma and infections.
According to the complaint, the company also failed to follow the current good manufacturing practice requirements for dietary supplements, as required by federal law.
The FDA sent the company a warning letter regarding the disease claims in March 2009. During inspections in October and November 2010, June 2011 and September 2011, FDA investigators documented serious current good manufacturing practices (cGMP) violations, in addition to the company's continued use of disease claims for some of its products.