FDA should immediately apply the Pearson v. Shalala ruling on health claims to both conventional foods and dietary supplements, the Grocery Manufacturers of America asserts in an April 27 citizen petition, urging the agency to immediately withdraw and revise its implementation plan.

Under that strategy, the agency would "not begin to consider either the application of the Pearson decision to conventional food or the broader impact of the decision on all FDA-regulated labeling until after FDA finishes this current strategy, which only addresses dietary supplement labeling," GMA says.

"There is no reason for this delay," the group contends, saying Pearson arose under the same disease claims approval standard applicable to all foods under the Nutrition Labeling & Education Act. "FDA simply extended that standard to dietary supplements by regulation. Pearson then held unambiguously that FDA's application of that standard to bar proposed disease claims was unconstitutional."

Agreeing, the National Food Processors Association says FDA's Pearson strategy "evidences an intent...to develop divergent health claim policies for conventional foods and dietary supplements."

The American Medical Association also calls for FDA to mandate a single standard for health claims applicable to both conventional foods and supplements.

Unlike GMA's contention that FDA's draft guidance on significant scientific agreement should be withdrawn because it does not allow agency authorization of all truthful, non-misleading claims, AMA says the guidance "appears adequate, provided a health claim only refers to reducing the risk of a disease or health-related condition in the general population or a significant subpopulation."

AMA opposes expansion of health claims for supplements to include the effects on existing disease.

Taking a different approach to the subjects addressed at FDA's April 4 public meeting on the implementation of Pearson, supplement marketer Symbiotics urges FDA to permit health claims lacking SSA to be made in labeling materials directed solely to physicians and pharmacists (¹ Also see "Emerging Science-Based Supplement Health Claims Category Proposed" - Pink Sheet, 10 April, 2000.).

Such materials would include citations to supporting peer-reviewed literature and represent a balanced view of the scientific support, the company suggests.

Pearson Applies To Both Foods, Supplements - GMA Citizen Petition

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