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Comments still sparse to GSK weight loss petition

By Lorraine Heller , 10-Jun-2008 has published an update to this article here .




The controversial drug petition that threatens to squeeze dietary supplements out of the weight loss market has as yet generated only a handful of comments, although there are signs that industry is quietly gathering its defenses as it prepares for battle.

Filed on April 18 by drug firm GlaxoSmithKline (GSK), the citizen petition has so far resulted in 14 responses, the majority of which were spurred by consumer advocacy group Citizens for Health. Comments Thirteen of the 14 comments filed on the website came from individuals submitting a standard letter prepared by the consumer group, 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. It calls the Food and Drug Administration (FDA) to "put the rights of the consumer ahead of the vested interests of the pharmaceutical industry" and to reject the petition. Another comment was submitted by the British Association for Applied Nutrition and Nutritional Therapy (BANT), which stated that the petition "takes a pre-genome 'one-size-fits-all', overly reductionist approach to a complex area". The group, which represents nutritional therapists, highlighted that weight control methods are not used only by the overweight and obese, but also by people of normal weight wishing to lose weight or avoid weight gain. These people, it said, have a disease-risk status that remains unchanged in the context of the petition. This directly responds to the petition's request that all weight loss claims be considered disease claims. The petition is hinged on the idea that although obesity is not a 'disease' in itself, it can lead to a host of conditions including diabetes and heart disease, and weight loss products should therefore carry disease claims rather than health claims. Can of worms 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. With such crucial repercussions hanging in the balance, it is somewhat surprising that the supplement industry has not yet made its voice heard. There have been some general comments that the industry will "vigorously defend" its rights, but no formal and comprehensive response has yet been made. However, this does not mean it is not coming. Caught off guard by the thoroughness of the petition, the supplement industry has simply retreated into its barracks in order to prepare an equally thorough response. Trade groups such as the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) have hinted that more is coming. And although the petition specifically points out that FDA does not need to initiate a notice and comment rulemaking period, this does not prevent comments from being submitted. Indeed, an FDA spokesperson told that "the entire reason for posting a petition publicly in a docket is to allow for interested parties to comment. (…) Anyone can submit a comment to a petition by sending it to the relevant docket via the web site." To view comments submitted, click here . To submit a comment via the website, click here .

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