To date, there have been almost 600 public submissions in response to the citizen petition filed by drug firm GlaxoSmithKline requesting that weight loss claims be considered disease claims. Filed on the regulations.gov website, these are principally comments from individual consumers, but also include submissions from health groups, consumer organizations, alternative medicine/treatment groups, academia, health professionals, and marketers of natural products. A large majority of comments were filed using a standard letter prepared by consumer advocacy Citizens for Health, which urged its members to stand up for their rights to make purchasing decisions. The letter also directly implies that the petition is an attempt by the drug industry to remove the competition from dietary supplements. Indeed, a general hostility and anger towards GSK and Big Pharma is evident in most of the submissions, which does not necessarily provide FDA with the crucial science-backed response that could counter the petition, but which does go a long way in gauging the public's feelings. Pharmattack The request put forth by the petition has been called a "ridiculous idea" and a "ridiculous and self-serving claim". "The drug company is obviously concerned about its bottom line and nothing more," runs the general thread. "It's very clear the pharmaceutical industry has undertaken a campaign to takeover the healthfood/supplement industry." "It seems perfectly obvious to me that GSK is looking out for their own interests. They are not at all interested in 'protecting' the public," says one commentator that claims to be representing the organic retail giant Whole Foods. Other thoughts commonly repeated include the consumer right to make choices for themselves, and the inappropriateness of classifying obesity as a disease state (the petition claims that although obesity is not a disease in itself, it is a significant risk factor for ailments like diabetes, cancer and heart disease.) Where to comment On initial inquiry with FDA on comments to the petition, NutraIngredients-USA.com was directed to an incomplete selection of comments (click here). FDA's Lyle Jaffe, lead legal instruments examiner, division of dockets management, this morning confirmed that the list was "not an accurate reflection of what's in the docket". The discrepancy, explained Jaffe, may be down to the petition-tracking code entered into the website (0001). He suggested that only the docket number (FDA-2008-P-0248) is used in future searchers, rather than the petition document ID (FDA-2008-P-0248-0001), which brings up the petition, but also an incomplete selection of public submissions. To view the full list of comments, click here. To comment on the petition, click here. The petition The citizen petition was filed in April by GSK together with the American Dietetic Association, The Obesity Society and Shaping America's Health, an association for weight management. The petitioners are asking the Food and Drug Association to prevent dietary supplement products from claiming they can promote, assist or otherwise help in weight loss. Such claims, they say, should be considered as disease claims. If the petition is approved, it would have wide reaching implications for the dietary supplement industry as a whole, as it would set a precedent for what the FDA considers a 'disease', and would push back the boundaries of the supplement market. But even if FDA rejects the petition, significant damage has already been done to the weight loss supplements market, which will have to face the consequences of the negative media attention generated.
