Salt Lake Tribune
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Measure targets FDA, FTC
This is an archived article that was published on sltrib.com in 2005, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

Republican Congressmen Rob Bishop and Chris Cannon are backing a new bill that would make it possible for dietary supplement makers to claim their products cure, treat, prevent and reduce the risk of disease even if there is overwhelming scientific evidence to the contrary.

And yet the bill does not have the endorsement of Utah's supplement community and in fact has generated concerns that the proposed changes could flood the market with dubious claims and dilute any credibility the industry has achieved.

The Health Freedom Protection Act, introduced Nov. 9, targets the U.S. Food and Drug Administration and the Federal Trade Commission, and the way they decide what health-related claims can be made on supplement labels and in advertisements.

Supplement companies do not need prior approval to describe how a nutrient or dietary ingredient affects normal physical structure or bodily functions in humans - such as "calcium builds strong bones" and "fiber maintains bowel regularity." But they must petition the FDA for permission to make specific health claims, such as "fiber reduces the risk of colon cancer." And the standard is fairly strict: There must be significant scientific agreement of a well-established relationship between a nutrient and a disease before the FDA will sign on.

In addition, the agency disallows any assertions that a product prevents, treats or cures a disease under the rationale that those are drug claims.

The result, supporters say, is that the public is denied important and, in some cases, life-saving information. Numerous studies have documented the role of folic acid in preventing spina bifida and related birth defects, the ability of fish oil fatty acids to reduce the risk of coronary heart disease and the relief raw palmetto provides to men with enlarged prostates. While doctors are free to make the link, companies who market those products cannot.

"If you look at the way the claims are worded there is nothing too drastic or earthshaking," said Bishop's spokesman, Scott Parker.

The House bill his boss is co-sponsoring not only forces the FDA to consider disease-related claims, it lowers the approval standard for all health claims.

Currently, a health claim is approved if there is significant agreement in the scientific community that the link between product and the health condition is well-established. Under the bill, the FDA could not deny the claim unless there was no scientific evidence to support it and no disclaimer capable of clearing up misleading discrepancies.

The bill then limits such disclaimers to three "concise" sentences and gives the FDA 100 days to approve or deny the petition or the claims are automatically allowed.

The problem, says Loren Israelsen of the Utah Health Products Alliance, is that all supplements have some scientific support and not all of it is adequate. The alliance, which counts many of Utah's most established supplement companies as members, has serious misgivings about the bill.

"I'm sympathetic to some of the bill's goals, but I really, really worry that if you pop the flood gates open that the credibility of everyone is likely to be eroded and companies that truly have exceptional products with exceptional science will look like everyone else," Israelsen said. "So you end up in an environment where nobody believes anything and the credibility of the industry and of government is shot.

"There is a fine line between free speech and the rules needed to ensure a legitimate marketplace," Israelsen said.

Yet Bishop and Cannon suggest they are co-sponsoring the bill because it is in line with what their constituents want. Both declined interviews for this story, deferring instead to their spokesmen.

"As one of the co-founders of the House Dietary Supplement Caucus, I take an active role in issues that affect the supplement industry," Cannon said through spokesman Charles Isom. "I don't want to put the FDA in an impossible position, but unless we force them into action, they will continue to put approving supplement claims on the back burner.

"This is an ongoing process, and I look forward to working with the FDA and others to resolve any concerns as we move this legislation along."

lfantin@sltrib.com

The Health Freedom Protection Act would force the U.S. Food and Drug Administration to:

* Allow disease treatment claims for foods and dietary supplements, claims currently reserved for FDA-approved drugs.

* Permit such claims unless FDA proves there to be no scientific evidence to support the claims and no disclaimer capable of avoiding misleadingness.

* Limit FDA disclaimers on health claims to no more than three concise sentences.

* Stop waiving conflicts of interest in its food advisory panels considering health claims.

* Approve or disapprove health claim petitions within 100 days or the claims will be automatically allowed.

* Allow food and supplement companies to send consumers government reports and consumer scientific publications on nutrient-disease associations.

* Allow structure-function claims that include terms that refer to signs or symptoms of disease so long as the disease itself is not mentioned.

* Reverse its denial or restriction of the following nutrient-disease association claims: (a) raw palmetto treating benign prostatic hyperplasia; (b) omega-3 fatty acids and coronary heart disease; (c) omega-3 fatty acids and sudden death heart attacks; (d) glucosamine and chondroitin sulfate treating osteoarthritis; and (e) calcium reducing the risk of bone fractures.

The Health Freedom Protection Act would require the Federal Trade Commission to:

* Stop regulating as advertising any truthful and accurate summary of findings from peer-reviewed scientific publications.

* Give companies suspected of engaging in deceptive advertising a heads up and a chance to fix the problem before taking punitive action.

* Prove that a health-benefit promotional ad is false and misleading before commencing a deceptive advertising investigation.

* Prove that an ad is false and misleading and that it actually misleads consumers before FTC may hold an advertiser guilty of deceptive advertising.

Bishop, Cannon push dietary supplement bill
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