SSW08: Industry Discusses GSK Petition

LAS VEGAS—A late addition to the program at SupplySide West was a meeting to discuss the potential ramifications of a citizen’s petition submitted to FDA by GlaxoSmithKline (GSK). Speakers included Loren Israelsen, United Natural Products Alliance (UNPA); Michael McGuffin, American Herbal Products Association (AHPA); Steven Mister, Council for Responsible Nutrition (CRN); David Seckman, Natural Products Association (NPA); and Marc Ullman, Ullman Shapiro & Ullman; Suzanne Shelton, Shelton Group PR, moderated the event, which she organized on behalf of Sabinsa Corp.

GSK’s petition stated that being overweight is a significant risk factor for certain diseases; therefore, products purported to aid weight loss should be treated as drugs. The petition further claimed there is no credible scientific evidence to back up claims on any dietary supplement products. The panelists were in agreement that it is unlikely the petition will be granted; however, McGuffin noted, “We must maintain our vigilance and acknowledge that we are in it for the long haul. We will need to continue to defend ourselves, and take responsibility for ensuring that we can substantiate product claims.” He added because the petition was submitted by GSK along with several non-profit groups, the industry should keep watch on all organizations—commercial or not—that are critical of the trade.

While several trade associations have filed comments with FDA objecting to the GSK petition, few manufacturers have done so. Ullman drafted comments to FDA on the petition on behalf of Sabinsa, which included information on the scientific efficacy of the ingredient ForsLean®. He said, “Companies have to participate. They have to pay attention and not reply on someone else to take care of it for them.”

Some attendees and panelists expressed concern that not enough industry members are recognizing and acting on legitimate threats to the long-term viability of the industry. McGuffin reminded the audience that there is historical precedent for orchestrated campaigns to remove the competition represented by the natural products industry. He said: “If you don't believe we are in it for the long haul, read Copeland’s Cure by Natalie Robins to be reminded of how aggressively and persistently the American Medical Association attacked homeopathy over most of a century, and how successful this persistent attack was in driving homeopathy from the mainstream medical option it was to the fringe that it now occupies.”