NEW OTC DRUG CLAIMS SHOULD BE INCORPORATED INTO FDA POLICY

Executive Summary

NEW OTC DRUG CLAIMS SHOULD BE INCORPORATED INTO FDA POLICY on health messages in food labeling, Procter & Gamble Corporate Counsel for Product Safety James O'Reilly suggested at the Food and Drug Law Institute's March 21 meeting on FDA's reproposed rule. "We should coordinate both foods and OTC drug claims so that when the consumer is considering products that will be ultimately beneficial to his or her chronic health they can consider not only foods, but also those OTC drugs," O'Reilly said. He continued: "FDA can coordinate [the claims] by recognizing" that currently unapproved health claims for OTCs "should be able to be [used] by the manufacturers of those OTCs as soon as the FDA allows the comparable food product claim for the comparable ingredient." O'Reilly suggested that FDA recognition of the OTC version of such a claim could be made in the Federal Register notice announcing a food claim change, as an amendment to the appropriate section of the OTC drug regulations. O'Reilly noted that "OTC drugs that help improve chronic health do so as an offshoot of acute relief of symptoms." He provided the example of fiber-based OTC products providing a laxative benefit and a cholesterol-lowering benefit as well. Procter & Gamble and Ciba-Geigy are both petitioning FDA to allow cholesterol-lowering claims for their respective psyllium-containing OTC laxatives Metamucil and Fiberall. Psyllium is also an ingredient in some food products like Kellogg's Heartwise and Bran Buds cereals. Kellogg recently submitted a GRAS petition to FDA for affirmation of the safety of psyllium as an ingredient in cereal. * FDA Director of Executive Operations and Chief of Staff Joseph Levitt said at the meeting that the agency is reviewing selected health claims in food labeling with an eye to inappropriate messages that could result in future regulatory action. The process is part of an interim plan for regulating claims while the agency develops a final policy on health messages for foods. The process for a final policy began when the agency published a reproposed rule on food health claims in the Feb. 13 Federal Register. Commenting on the agency's interim plan for policing health claims for foods, Levitt stated that "in terms of health messages ...we're in the process of collecting labels that exist out there right now, and trying to array them and to see which we think we ought to call the manufacturer's attentions to." Through regulatory letters, "we will be explicitly demonstrating the areas that we feel go beyond the reasonable boundaries in a way that we hope makes both a general point [as well as] a specific point," he said. "We are also trying to pick out examples that are both specific examples, but also [representative] of broader themes," Levitt added. "We urge everybody to look at the examples we pick, and to look at your own products as well, even if it's not the subject of a specific letter. We hope a notification of these will be coming out very soon." At a same-day Senate appropriations hearing, FDA Acting Commissioner James Benson also noted that the agency is in the process of singling out health messages that overstep the boundaries of truthful and non-misleading labeling, and will issue regulatory letters in order to "send a message" to the entire industry. When asked by Appropriations/Agriculture Subcommittee Chairman Burdick (D-N.D.) whether FDA has sufficient resources to police the area of health claims for foods, Benson hesitated and said: "Let the record show a long pause." At the FDLI meeting, Levitt noted that the Administration's budget for 1991 calls for an increase of about 500 positions at the agency, and that most of these are "earmarked for the field." In response to a question on whether FDA plans to add staff specifically to handle health messages, Levitt said that currently there are a number of employees working full-time on food labeling, "part on health messages and part on the general regulations."