Glaxo Tries To Corner The Market On Weight Loss
The drugmaker, which sells the Alli over-the-counter fat pill, has filed a citizen’s petition in hopes of convincing the FDA to change the rules governing health claims made by dietary supplement manufacturers. The gambit turns on the notion that weight-loss supplements should be vetted for claims that address a disease - and in this case, being overweight is a risk for various diseases.
In its petition (look here), Glaxo argues any claims that a supplement will reduce a risk factor for disease is, in fact, a disease claim and, as a result, weight-loss supplement manufacturers should be forced to substantiate their claims through petitions before selling their own pills. Which diseases are we talking about? High cholesterol, diabetes and high blood pressure.
“…many Americans understand the health risks of being overweight and they rely on dietary supplements to lose weight…There is little, if any, evidence, indicating that dietary supplements marketed for weight loss actually work. As a result of these three facts, many Americans are being thwarted in their efforts to lose weight, and reduce the risk of disease, by ineffective weight loss supplements,” Glaxo writes.
“If FDA were to treat weight loss claims as disease claims, then manufacturers of weight-loss supplements would be required to obtain FDA review of their claims before rushing to market…by taking the actions requested in this petition, FDA would protect millions of Americans who are currently relying on unproven and ineffective dietary supplements to lose weight.”
Talk about a food fight. This is going to be quite a battle between pharma and dietary supplement makers, given the billions of dollars spent each year in the US by Americans who try to lose weight. In fact, the petition could spark an even wider war because it would cover claims by conventional foods.
However, as the FDA Law blog points out, although the petition contends FDA rulemaking won’t be required, there are arguments that would support a need for rulemaking, given the FDA’s longstanding position that weight-loss claims, as opposed to claims to treat obesity, don’t imply disease treatment or prevention.
The petition, by the way, was jointly filed by three non-profit advocacy groups funded, in part, by Glaxo - the American Dietetic Association, The Obesity Society, Shaping America’s Health.
Hat tip to FDA Law blog
Dan
Glaxo has not won any popularity contests from what I have read from these two posts by Ed this morning.
Chris
And what exactly is the proof that the minimal weight loss that patients get with Alli does anything for any cardiovascular disease process. The weight loss is quite small and the side effects are quite problematic. We have been duped over the years by companies selling weight loss products, whether they come from ethical or nutritional companies. While I agree that nutritional companies should have to show some benefit in order to make claims, I think that GSK should get its’ silly commercials off TV because it leads people to believe that the compound does more than it actually does.
Skeptical
GSK - what a joke of a company! The commercials try to indicate that if you take Alli, you’ll look like a model. The truth is that you’ll spend most of your time in the bathroom and the rest of it cleaning or changing your underwear. What kind of risk/benefit is that? Not much!
Jack2
I’d like to see much more rigorous standards applied to the claims made on the bottle of dietary supplement.
Melody
If Glaxo succeeds, the next predictable step will be litigation against those non-MD’s who recommend exercise and natural foods as weight-loss tools.
Sam
There is an old saying, “If you build a better mouse trap, the world will beat a
path to your door’.
If there was one safe (prescription or OTC) product that really was therapeutically effective and you could loose all the weight you needed to( (depending on how long you stayed on it), don’t you think every over weight or obese person by word of mouth, would beat a path to the stores to buy this product? There would be a minimum need to advertise and there would be no need to ask the FDA to liberalize the company’s claims.
Ben
Hello,
Thanks for writing this blog and informing people of what’s going on with this issue. I work for the Dietary Supplement Information Bureau, and we have some information pertaining to this petition. Please visit our site at http://www.supplementinfo.org/GSK. Thank you,
Ben
DSIB