Healthy Skepticism Library item: 13892

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cohen R.
Drugmaker seeks more over the counter regulation
The Star Ledger 2008 Jun 29
http://www.nj.com/news/index.ssf/2008/06/consumers_face_a_bewildering_a.html

Full text:

Consumers face a bewildering array of choices when it comes to weight-loss products. Check the shelves of almost any pharmacy and they’re stocked with everything from SlimQuick Diet Pills, billed as the “world’s first advanced fat burner,” to Relacore, a pill to “get rid of body fat.”

If pharmaceutical giant GlaxoSmithKline has its way, many of those diet products could be yanked from the market.

Glaxo, which markets the only over-the-counter diet pill approved by the Food and Drug Administration, is pressing the FDA to require supplement companies making weight-loss claims to conduct clinical studies to prove their products work, then win government approval before they can be marketed. Under current regulations, the makers of diet pills face no such requirements.

If the FDA agrees with Glaxo, it essentially could eliminate competition for Glaxo’s Alli diet pill and potentially open up challenges to numerous health-related claims made for a variety of dietary supplements.

Alli is a lower-dose version of the Roche prescription drug Xenical, and last summer it became the only FDA diet drug approved for over-the-counter sale.

“There is no credible scientific evidence to support any type of qualified health claim for a weight-loss supplement for use by an overweight population,” Glaxo said in its FDA petition.

Reclassifying the way dietary supplements are regulated and requiring more rigorous FDA oversight would advance public health, Glaxo argued, “since millions of Americans are currently relying on these unproven and ineffective dietary supplements to lose weight and reduce the risk of disease.”

Since the late 1980s, adult obesity has steadily increased in the United States, with the government estimating that 66 percent of Americans are overweight, including 32 percent who are obese. In addition, about 17 percent of children and adolescents, ages 6 to 19, are overweight — almost double the rate of two decades ago.

The American weight problem — some call it an epidemic — has led to a multibillion-dollar industry for a wide variety of diet and weight-loss plans, prescription diet drugs and over-the-counter supplements that boldly promise to help individuals shed pounds by doing little more than swallowing a pill.

The Glaxo petition, filed jointly with the American Dietetic Association and two other health groups that receive financial support from the company, has provoked a strong backlash from the supplement industry.

“The effect of this would be to make it illegal to market dietary supplements for weight loss. The only products marketed for weight loss would be drugs,” said Michael McGuffin, president of the American Herbal Products Association, a group representing supplement companies.

McGuffin said the cost of doing clinical studies would be prohibitive for supplement markers. And since there is no patent protection for commonly used herbs, he said, “companies won’t spend millions of dollars to get through the drug-approval process for herbs anyone can sell.”

Steven Mister, president of the Council for Responsible Nutrition, another dietary supplement trade association, said the “FDA has made it clear that it considers weight-loss claims appropriate and permissible under the Dietary Supplement Health & Education Act, meaning that manufacturers should not have to seek the agency’s approval before making these claims.

“CRN intends to vigorously defend the industry’s rights in this area,” he said.

The FDA can approve or deny Glaxo’s petition in whole or in part, or announce that it cannot reach a decision. If the FDA approves the petition, the ruling could, after a number of formal steps, become part of agency policy.

A finding on the pending petition, filed this spring, could be made by the end of the year.

AN ADJUNCT TO DIET
Glaxo reported $315 million in sales for Alli from its launch last July through March of this year. Information Resources, a Chicago-based market research firm, said the top 19 over-the-counter weight control brands other than Alli had $227 million in sales, excluding Wal-Mart stores, during the 52 weeks ending May 18.

The research firm said the top OTC weight-control supplements other than Alli included Hydroxycut, SlimQuick, Zantrex-3, Relacore, Mega T, Metabolife, Akavar, Dexatrim and Applied Nutrition.

Glaxo said 4 million people have tried Alli, which was tested in clinical trials and approved by the FDA as a weight-loss drug designed to be taken in combination with a reduced-calorie, low-fat diet. In clinical trials, people using Alli lost an additional two to three pounds for every five pounds lost through diet and exercise.

When taken with meals, Alli blocks the absorption of about one-quarter of all fat consumed. Side effects from Alli include diarrhea and “gas and oily anal discharge.”

Dietary supplements are essentially considered foods and, unlike drugs, do not have to go through pre-market testing for safety or efficacy, or win FDA approval. Supplement makers are allowed to make claims about the effect of a nutrient or ingredient on the body’s “structure and function” — such as “calcium builds strong bones” — but they cannot claim to treat disease and must not be misleading.

The Glaxo petition, relying on public opinion surveys and other data, argues consumers read “structure and function” claims regarding weight loss as assertions that the products can treat an unhealthy condition that is a risk factor for diseases such as diabetes or heart disease. Therefore, the products need to be more closely regulated and treated like a drug, Glaxo contends.

Marc Ullman, a New York attorney who represents dietary supplement makers, said if a company markets its product as “supporting healthy weight loss or healthy body weight,” Glaxo maintains this should be interpreted as an obesity treatment claim.

“The bottom line is the vast majority of these companies make these kind of claims,” he said.

Ullman said many of the dietary supplements have value, noting that the Federal Trade Commission and the FDA now actively crack down on those companies making fraudulent or misleading weight-loss claims.

“It is already impermissible to sell snake oil,” said Ullman.

Glaxo has relied on a number of FTC enforcement cases to help make its argument, citing a 2007 agency survey that found “more consumers were victims of fraudulent weight-loss products than any other specific frauds.”

The company’s FDA petition pointed to a number of claims it said were bogus and misleading, such as one that touted a product as having “clinically proven ingredients to increase metabolic rate, promote weight loss,” and another that said “this product is safe and can effectively burn fat to help with weight loss.”

Stephanie Patrick, a vice president of the American Dietetic Association, said the FDA petition simply says “dietary supplement makers need to be accountable in advance for the science.”

“If the science is there, it won’t affect those weight-loss products in the marketplace. If science isn’t there, it’s a different matter,” she said.