FDA Seeks Comment for Regulating Health Claims

WASHINGTON--The Food and Drug Administration (FDA) issued an advance notice of proposed rulemaking (ANPR), requesting comments on three alternative methods to regulate qualified health claims for foods and dietary supplements. FDA's Task Force on Consumer Health Information for Better Nutrition suggested three alternatives FDA could use to regulate health claims not meeting significant scientific agreement.

The first option is to continue using the interim ranking system. (For more on the system, visit www.naturalproductsinsider.com/articles/391onlineonly15.html.) According to FDA, this allows for faster review of qualified health claims. Also, approval of qualified health claims would be in the form of an enforcement discretion letter rather than a regulation, allowing FDA to more easily revise its decision as more substantiated evidence came to light supporting or contradicting a health claim. The task force suggested turning the system into a regulation, but FDA said this would allow for misleading claims to stay in circulation until the regulation was revised.

The second option is to apply the accuracy of the nature of the evidence supporting the claim, rather than the underlying substance/disease relationship, and subject qualified claims to notice-and-comment rulemaking. However, FDA reported this alternative would be vulnerable to First Amendment challenges.

The final option was to treat qualified health claims as outside the realm of NLEA and regulate them solely on a post-market basis if found to be false or misleading--which would include lacking substantiation. This third option would be similar to the approach taken by the Federal Trade Commission (FTC); however, FDA reported it would not have FTC's subpoena power to obtain a company's substantiating data, evaluate the data and/or take enforcement action with relative speed. Instead, FDA would have to build enforcement cases by searching the literature and consulting with experts, followed by tests on how consumers interpret the claim. Based on FDA's verbiage in describing this approach, the agency does not support this option. "This option could be inefficient and too resource-intensive for FDA to protect consumers from misleading claims that would already be in the labeling of products in the marketplace," wrote Jeffrey Shuren, FDA's assistant commissioner for policy.

Of the three claims, FDA appears to heavily favor the interim ranking system. "It makes the most sense," said Marc Ullman of New York-based Ullman, Shapiro & Ullman. "There's a lot of merit to the ranking system, although the procedure seems a little bit cumbersome. Maybe there's a better way to develop that."

FDA is seeking comment for the task force's three suggestions, and is open to further suggestions for regulating qualified health claims. The Federal Register notice with FDA's ANPRM can be found at www.fda.gov/OHRMS/DOCKETS/98fr/cf0362.pdf. The comment period is open for 60 days, starting Nov. 24.