FDA's revised approach to regulating health claims for dietary supplements and foods has an advocate in acting commissioner-designate Lester Crawford, PhD.

Currently FDA deputy commissioner, Crawford will move up to acting commissioner with the pending departure of Mark McClellan, MD/PhD, to head CMS (¹ Also see "McClellan Leaves For CMS As Crawford Heads Reorganized FDA" - Pink Sheet, 23 February, 2004., p. 7).

Crawford highlighted the agency's plan to allow marketers to use a broader range of claims linking nutrients with disease prevention in a March 2 speech to the George Mason Law Review Antitrust Symposium in Washington, D.C.

"At this point I'd like to go forward with the labeling of conventional food and dietary supplements," he said. "We think this will change the way things happen."

The public "wants to know the effectiveness profile" of foods and supplements, Crawford maintained. "And if it is a health claim...FDA's current thinking is that we should not stand on ceremony - we should help firms communicate this information."

"I think we're about to do that in a very good way, and I'm very pleased with how this is turning out," he added.

FDA expects to release a proposed rule on health claims this fall, pending review of public comments and agency-sponsored label comprehension research (² Also see "Health Claims Proposal To Be Informed By FDA, FTC Consumer Research" - Pink Sheet, 19 January, 2004., p. 15).

In its advance notice of proposed rulemaking on health claims, published in November, FDA favors codifying its current interim approach, which involves ranking claims based on their level of scientific support and designating disclaimers accordingly.

Much of the industry feedback on the ANPR has been supportive of the ranking scheme; however, consumer advocacy groups Public Citizen and the Center for Science in the Public Interest have called the approach illegal for foods under the Nutrition Labeling & Education Act. The groups filed suit against FDA in September (³ Also see "FDA’s Approach To Qualified Health Claims Violates NLEA – Lawsuit" - Pink Sheet, 29 September, 2003., p. 13).

CSPI and a number of other consumer groups and medical societies reiterate that position in recent comments to FDA.

The groups argue that FDA's plan for qualified health claims "will result in the same kind of consumer confusion that convinced the Congress of the necessity for permitting only those claims that were supported by "significant scientific agreement,'" under NLEA.

The comments were co-signed by the American Association of Family & Consumer Science, the Consumer Federation of America, the National Consumers League, the American Cancer Society, the Association of American Medical Colleges and the American College of Preventive Medicine.

Crawford noted that FDA has worked closely with the Federal Trade Commission on its health claims initiative and credited outgoing Commissioner McClellan with developing a constructive new relationship between the agencies.

"In this Administration, due largely to Mark McClellan, we're actually communicating with the other agencies and it's working well," he pointed out. "We had almost no models for that but now we do."

FTC has been working with FDA on research aimed at understanding consumer takeaway on health claims. The commission also has collaborated with FDA on a crackdown on false and misleading claims for supplements.

Among other dietary supplement-related initiatives, Crawford pledged to continue consumer education programs on the potential risk of combining supplements with drugs.

"This combination...of what we treat ourselves with is something that FDA is very concerned about, and we hope to be launching some new education campaigns about this," he said.

Crawford pointed out that "even dietary supplements that have marginal efficacy can interfere with the use of other drugs, can cause the prolongation of excretion of the drugs from the body, can interfere with their effectiveness in ways that were never anticipated...about 15 years ago."

Prescription drug advertising is likely to be another priority for Crawford when he moves to his new role at the agency. He noted FDA is encouraging the European Union to allow direct-to-consumer advertising, maintaining such campaigns may make patients aware of unrecognized medical conditions and encourage increased physician consultation.

FDA Health Claims Initiative On Crawford’s Priority List

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