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FDA Revises Rules on Promotion of Health Benefits of Foods

May 11, 2002

New ruling could affect choice for those with diabetes. Food manufacturers will for the first time be allowed to tout the health benefits of their products even if there is no scientific consensus as to the foods’ benefit, under a plan announced last week by Bush Administration officials.

Food and Drug Administration (FDA) officials also announced that they would step up enforcement against several categories of dietary supplements where misleading claims about health benefits are rampant.

The change in food labels allows manufacturers to make health claims as long as the "weight of scientific evidence" supports the claim. Up until now, such claims were barred unless manufacturers could show that they were supported by complete agreement among scientists. For example, oatmeal makers could advertise the cholesterol-lowering properties of their product because there was scientific consensus on the subject.

Administration officials said that the plan would promote public health by attracting consumers to healthier foods when most of the evidence supports their benefits. "Our goal is to help consumers make sound decisions," said Dr. Mark B. McClellan, commissioner of the Food and Drug Administration.

Dr. McClellan said that the program would also spur competition among manufacturers to produce more nutritious products.

Food manufacturers praised the move, saying that it would give shoppers better information about which foods are best for their health. But the plan drew harsh criticism from one consumer group, which argued that it would only serve to encourage food companies to produce junk science in support of the claims.

Under the plan, food manufacturers will submit a proposed health claim and scientific data supporting it to FDA for a food ingredient such as omega-3 fatty acids. The compound, found in oily deep-sea fish like salmon, has been shown in some studies to reduce the risk of heart disease.

FDA regulators will review the science supporting the claim and will approve its use on product labeling if the "weight of the scientific evidence" supports it, according to FDA documents. Dr. McClellan said that the lower scientific burden would allow consumers to benefit from healthier foods even when "it’s not a completely settled scientific issue."

The FDA has yet to finalize the process it will use to review the claims, or exactly how it will define the amount of scientific evidence needed to make a claim legal, officials said. The agency has set up a task force to establish a review process and recommend final regulation that will govern the process, they said.

Larry Sasich, a research analyst with the Public Citizen health research group, attacked the program, saying it would allow companies to plant low-quality studies in research journals and then submit them as scientific proof of a food’s health benefits.

"What is going to be fostered is spurious and unreliable studies," Sasich said. "No matter how bad the science is, if the guys that wrote it are persistent enough, they’re going to get it published somewhere in the medical literature."

Officials also announced a move to crack down on unsubstantiated health claims made by dietary supplements makers. Regulators at both FDA and the Federal Trade Commission have become increasingly concerned about supplements makers who claim health benefits on product labels without scientific backup.

Dr. McClellan said that FDA planned to step up scrutiny of supplements in 9 major categories, including supplements that claim to treat life-threatening diseases like cancer, diabetes, HIV/AIDS, and lupus, as well as weight loss products and autism treatments.

Supplements claiming to treat mental retardation, to prevent Alzheimer’s disease and to prevent hangovers could also be targeted, he said.