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GKS petition threatens weight loss supplements
By Ben Wasserman
May 18, 2008 - 10:25:56 AM

Many may not have known this: GlaxoSimthKline (GSK) on April 17, 2008 submitted its 33-page petition to the FDA asking the agency to consider weight loss claims for dietary supplements as disease claims.

This petition means that the FDA should consider overweight and obesity as disease.   When a condition is considered as a disease, dietary supplements should have no health claims on such a disease.   Under the FDA regulation, dietary supplements can't be claimed to have any effect on any disease.   In effect, this regulation prevents dietary supplements from competing with drugs.

GSK is the manufacturer of Alli, the first over-the-counter weight loss drug, which the Public Citizen said is not effective enough for the FDA to approve its sales in the United States.  The FDA approved Alli for over-the-counter sales on Feb 17, 2007.

Supplementinfo.org has posted a message on its website saying that "This may have huge implications for not only the supplement weight loss industry, which is rapidly growing and estimated to currently be worth $1.3 billion in annual sales, but for the dietary supplements industry overall; some see it as another step in the overregulation of dietary supplements and attacks from big pharma, which, should FDA decide to rule in favor of GSK, some say could be a death knell for our industry."