On June 15, the FDA announced that it had already sent out more than 50 warning letters to dietary supplement manufacturers and marketers for making claims about a dietary supplement product’s ability to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus on company websites. With more than 6 months to go before the end of the year, it’s safe to say that the level of FDA enforcement that the industry is seeing in regard to false or misleading dietary supplement claims is unprecedented.
The FDA has proven to be especially diligent in keeping up with new claims popping up on the internet. “We are committed to aggressively pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, uncleared, or unauthorized products,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “We have achieved some success and will remain vigilant in our efforts to protect consumers from these fraudulent, potentially dangerous products.” The agency advised operators of the offending websites that they must take immediate action to ensure they are abiding by FDA standards.
The FDA cites a number of unauthorized products that were targeted by the recent wave of warning letters including a dietary supplement that claimed to protect infants and young children from contracting the H1N1 flu virus and a “new” supplement that claimed to cure H1N1 flu infection within four to eight hours. The FDA has posted a list of fraudulent H1N1 Flu Virus products here.
United Natural Products Association (UNPA) Executive Director Loren Israelsen told NBJ that supplement manufacturers need to wake up to the reality that the FDA is going to take a more hands-on approach in regard to the enforcement of supplement regulations. “This is the new FDA. They have money, manpower and mandate. I try to tell people things are changing. You can't get away with things,” Israelsen said.
NBJ will host the 2009 Direct-to-Consumer Selling in the Nutrition Industry Web Seminar on June 25, which will feature a presentation and Q&A session with regulatory expert Ivan Wasserman. Wasserman will be available to answer questions about product claims and FDA regulatory compliance. In addition, NBJ experts will analyze and discuss the 2008 nutrition industry sales performance of the Internet, multi-level marketers (MLMs), practitioners, direct-response television (DRTV), direct-response radio (DR radio), and mail-order catalog sales channels. Click here to register for the Web Seminar.
Related NBJ links:
FDA to General Mills: Cholesterol Claims Render Cheerios a Drug
FDA to Address Economically Motivated Adulteration of Supplements and Other Products
FDA Sets Melamine Standard for Formula after Traces of Chemical Found in U.S.-Made Products