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FDA Plans to Curb Food Health Claims : Regulation: Critics say no rules exist to stop misleading messages on cereal and margarine labels. A 1987 policy change is blamed.


WASHINGTON — Food and Drug Administration officials admitted Tuesday that efforts to regulate health benefit claims on food labels by manufacturers have been deficient.

FDA Commissioner Frank Young, testifying at a House Government Operations subcommittee, said that, in order to combat the proliferation of deceptive and misleading packaging, "small and immediate fixes" were needed on a 1987 policy change that enabled food manufacturers to make disease-prevention claims on food labels.

The change in policy occurred after lawmakers and industry executives had agreed that food manufacturers should include some health information on their packages to help promote healthful diets, but there has been little agreement about what claims are scientifically sound enough to be displayed on packages.

Young said the FDA has identified five areas where claims might be appropriate. These would deal with the links between calcium and osteoporosis, sodium and high blood pressure, fats and heart disease, fats and cancer and fiber and cancer.

During the last two years, numerous products, including breakfast cereals, margarine and even doughnuts, have published claims that their contents are able to reduce the risk of heart disease, cancer and other illnesses.

Critics of the FDA contend that, after the policy change, the agency bypassed normal procedures and allowed companies to make health claims immediately, rather than after establishing new rules. New rules have not been approved yet by the FDA.

"We have a fiber war worse than the cold war on our hands," Young said, referring to the number of foods containing fiber that claim to reduce the risk of cancer or lower cholesterol levels. "There is a need to more systematically and cautiously develop truthful, non-misleading health messages that consumers can understand and rely upon . . . . We have a new strategy that we are going to pursue relentlessly."

Young, however, refused to give details of that strategy, saying it has not been completed.

The comments came after committee members and other witnesses blasted the FDA, chastising the agency for abandoning its authority over the issue.

The policy change "has seriously weakened the FDA's ability to challenge even what the agency itself believes are deceptive claims," said Rep. Ted Weiss (D-N.Y.), chairman of the human resources and intergovernmental relations subcommittee.

"I strongly suggest public health is being harmed by that policy (of inaction)," Weiss added. "The proliferation of health claims . . . is destroying the credibility of the food label."

Drugs are not allowed on the market until manufacturers submit data to the FDA proving they are safe and effective. But, under current law, food makers do not have to present any research findings to back up health claims made for their products.

"What we have is a de facto policy of non-enforcement," said Robert Abrams, attorney general for the state of New York. "It sent a powerful signal to industry that health claims were now acceptable to federal regulators, and it unleashed a flood of misleading assertions."

At the same time, Abrams said, a Federal Trade Commission relaxation of false advertising laws placed a heavy burden on states to take protective action of their own against the claims--claims that FDA officials concede have not been required to meet the same standard of scientific proof required for drugs.

Bruce A. Silverglade, director of legal affairs for the Center for Science in the Public Interest, said the lack of government clearance of health claims is a return to the "arcane days of consumer beware."

"We're going to see a return to hucksterism," Silverglade said. "The food label is simply an inappropriate place to give complex nutritional information and health advice. There's no one in government looking out for the consumer."

Witnesses and committee members urged a return to the health-claim ban and said new legislation may not be capable of defining acceptable claims.

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