HEALTH CLAIMS FOR FOODS: FDA PROPOSED REGS DUE BY SPRING 1990

HEALTH CLAIMS FOR FOODS: FDA PROPOSED REGS DUE BY SPRING 1990, according to FDA Commissioner Young. In a presentation to the House Energy & Commerce Committee/Health Subcommittee on Aug. 3, Young discussed the agency's current plan for developing and promulgating regulations for nutritional labeling and health claims for foods. He noted the agency plans to solicit public input through an Advanced Notice of Proposed Rulemaking (ANPR) and public hearings ("The Pink Sheet" July 31, T&G-15). The hearings are slated to be completed by the end of December. Afterwards, Young said, the agency plans to publish a proposed regulation in the spring of 1990, followed by a final reg in the spring of 1991. FDA is "interested" in developing a program for allowing manufacturers to make claims for foods that have previously been considered acceptable only as drug claims, the agency said in the ANPR, released for public display on Aug. 3. The ANPR, which requests comments on five different areas of food labeling issues, states: "The agency is interested in exploring the possibility of establishing a program that would permit manufacturers to make health claims that describe the nutritional qualities of a food and that explain, in a manner that is not false or misleading, how these nutritional qualities affect the structure or function of the body in ways that will contribute to good health." The notice points out that a 1987 proposal by the agency to allow health claims for foods will be the starting point for a new policy. FDA suggests either revising or withdrawing the 1987 proposal and publishing a "new proposal to permit food labeling to bear factual health-related statements on how, based on their normal use in a well-balanced diet, food components will affect the structure or function of the body to promote good health." * Health claims for foods may provide necessary information for aiding the treatment or prevention of a disease or condition, Young suggested at the hearing. He cited information with regard to fat content as one example of an appropriate, and even necessary, claim. "I think there needs to be some sort of a health message in regard to fat," he said. "I think there must be some way that consumers can monitor their diet." When asked by subcommittee member Rep. Wyden (D-Ore.) whether it would "make sense" for FDA to revert to its original policy that health claims for foods made a product an unapproved new drug, Young answered: "I don't think so." The FDA commissioner noted that when the agency had proposed relaxing its position on health claims for foods in 1987, a school of thought "both inside and outside the agency" held that "there is a difference . . . in a drug that usually acts on a short-term basis, versus say the reduction of fat, which is a reduction in the dietary mode that takes many years to have its effect." He added: "we're asking in this particular notice of proposed rulemaking whether or not this can be addressed." FDA's new initiative in food claims follows the introduction on July 27 of identical pieces of legislation by Rep. Waxman and Sen. Metzenbaum (D-Ohio). The bills would require that any health claims on labels that characterize the amount or relationship of calories, fat, cholesterol, sodium, carbohydrates, sugar, protein or dietary fiber to a disease, use terms defined by the HHS secretary. The hearing was called to discuss the legislation. Young told the subcommittee that FDA could accomplish what is needed in health claims regulation administratively and suggested that legislation is not needed at this time. "It is unclear whether legislation is necessary to achieve most or all of our shared goals," he said. "I believe many, if not all, of the changes contemplated can be made administratively. In any event, during the course of our hearing, we expect that these issues will be further clarified." * On Aug. 3, Sen. Hatch (R-Utah) introduced another bill on nutritional labeling. His bill differs from the Waxman/Metzenbaum legislation primarily in its requirement for nationwide uniform product labeling.