SILVER SPRING, Md., Dec. 1, 2011 /PRNewswire via COMTEX/ — Wisconsin facility previously warned not to make disease claims for products. U.S. Marshals, at the request of the FDA, today seized all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating a number of diseases.
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.
The government alleges that the company claimed in videos and promotional materials that some of its products could be used to prevent, treat, or cure diseases such as asthma, cardiovascular disease, cataracts, glaucoma and infections. The products are not FDA-approved as safe and effective for treating any diseases.
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.
According to the complaint, the company also failed to follow the current good manufacturing practice (cGMP) 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 cGMP violations, in addition to the company’s continued use of disease claims for some of its products.
“Marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA is committed to protecting consumers from unapproved new drugs.”
Each year, the FDA is responsible for overseeing more than $2 trillion worth of foods, drugs, biologics, medical devices, cosmetics, dietary supplements, tobacco products and consumer goods.
For more information:Overview of Dietary Supplements http://www.fda.gov/food/dietarysupplements/consumerinformation/ucm110417.htm
Warning Letter, March 13, 2009 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm132586.htm
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries: Pat El-Hinnawy, 301-796-4763, Patricia.El-Hinnawy@fda.hhs.govConsumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration