Should Weight Loss Claims be Classified as Disease Claims?

Wednesday, July 9th, 2008

On April 17, 2008, three public interest groups and an OTC manufacturer of a weight-loss drug have filed a petition with the FDA to treat weight-loss claims for supplements as disease claims!

What Petition Wants to Classify Weight Loss Claims as Disease Claims?

In a petition sent to the FDA commissioner, Andrew von Eschenbach, MD, the Obesity Society, the American Dietetic Association, Shaping American’s Health and GlaxoSmithKline asked the FDA to reconsider it’s regulatory approach to weight loss supplements. Keep in mind, GlaxoSmithKline is the maker of Alli, currently the ONLY FDA approved OTC drug for weight loss.

Here’s the angle being taken…

Although not technically a disease, being overweight can be a risk factor for other diseases. Such close ties from weight loss supplements like it can lower high cholesterol, which is not a disease itself but is a sign of cardiovascular disease makes this a fine line to walk.

Based on a University of Connecticut study funded by GlaxoSmithKline, the study showed that consumers may misunderstand the regulation of supplements today by the FDA.

GSK-Funded Study Shows Confusion about Supplements

  • 54% of survey respondents that believed weight loss supplements are tested and proven safe before they are allowed to be sold.
  • 45% believed that weight loss supplements are tested and proven effective before they can be sold.
  • 64% believed that the FDA requires all weight loss supplement companies to mention any ill side-effects on the labels.
  • 50% believe that weight loss supplements by enlarge are somewhat effective.
  • 37% believe herbal supplements are safer than OTC or prescription drugs.

Source: National Dietary Survey

Given this potential misunderstanding, the petitioners argue that supplement manufactures are making weight loss claims with little data to back it up. Many independent studies against specific weight loss supplements have shown there’s no difference in a person who takes a weight loss supplement and somebody who does not. Most of them have concluded that there is little if any evidence to suggest that any weight loss product on the market today available to the consumer actually works.

This is inline with what fitness expert Tom Venuto has said in his Fat Burners – The Unadulterated Truth. Other fitness experts, including myself, agree that consumer available weight loss supplements are a multi-billion dollar industry with a severe lack of strong evidence to suggest any significant weight loss. Even green tea, once the best bet for natural and small amounts of weight loss, may not make any difference at all. Although it has other serious health benefits.

As a counter to the petition, CEO Steve Mister of the Council for Responsible Nutrition (CRN) said in the April 28th statement that his group plans to oppose the petition.

“We believe the weight loss claims are legitimate and appropriate claims for the products in the dietary supplement category, provided these products have substantiation to support the truthfulness of these claims.”

The DSHEA, commonly know as the Dietary Supplement Health and Education Act of 1994, does allow for weight loss supplement companies to make such claims within some guidelines. To think the supplement industry is totally unregulated would be a false statement.

While I fully agree with the statistics provided above, the study was paid for by a major pharmaceutical company. It stands to benefit from this proposed change to regulation.

Should Weight Loss Claims be Classifed as Disease Claims?

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Photo of the confused consumer by Saffanna Used under a Creative Commons license

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