FDA Pursues Consumer Products With Questionable Flu Treatment Claims
This article was originally published in The Tan Sheet
Executive Summary
FDA continues its efforts to protect consumers from the ongoing H1N1 flu outbreak, as well as from opportunistic marketers selling potentially deceptive "cures" for the virus
FDA continues its efforts to protect consumers from the ongoing H1N1 flu outbreak, as well as from opportunistic marketers selling potentially deceptive "cures" for the virus. As of May 8, the agency listed eight "fraudulent" products using unapproved, uncleared or unauthorized claims related to protection against H1N1. FDA said Charles Town, W.Va.-based ReBuilder Medical Technologies was marketing SilverCure "swine flu protection kit" and shampoo with unauthorized claims. The agency also highlights supplement products of concern, including an alleged "Swine Flu Formula" marketed by Susan Ambrosino's Herb Club Inc. of Alachua, Fla., and Edmonton, Alberta-based Guardian Silver's Guardian Silver Sol. The firms have removed H1N1 claims from their Web sites. Dietary supplement trade groups say they know of no data supporting the use of supplements to treat H1N1. FDA's consumer protection team, first assembled during the 2004 avian flu scare, collaborates with the Federal Trade Commission to advise prompt revisions to Web site operators selling deceptive products (1 (Also see "FDA Learned Consumer Protection Lesson From 2004 Flu Scare" - Pink Sheet, 4 May, 2009.), p. 5). To combat pandemic flu scenarios on a larger scale, the House Appropriations Committee said May 7 it approved a supplemental appropriations package that includes $1.5 billion to enhance the Department of Health and Human Services' antiviral stockpiles, vaccine development and detection efforts. House Majority Leader Rep. Steny Hoyer, D-Md., said he intends to bring the bill to the floor for a vote the week of May 11. FDA Commissioner-designate Peggy Hamburg told a Senate panel May 7 that, if confirmed to head the agency, her first priority would be to "review FDA's work on the H1N1 influenza situation to determine if there are additional steps FDA can take to make safe and effective medical products and laboratory tests available" (see story p. 8). As of May 8, the Centers for Disease Control and Prevention reported 1,639 lab-confirmed U.S. cases of the H1N1 virus, including two deaths. - Dan Schiff ([email protected]) and Malcolm Spicer ([email protected]) |