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FDA to grant more leeway with health claims on food labels

(Friday, July 11, 2003 -- CropChoice news) -- Mark Kaufman, Washington Post: Food producers will be given far more leeway to make claims about the health benefits of their products, the government said [July 10] as it announced a far-reaching policy shift presented as giving shoppers information they can use to make smarter choices at the supermarket.

Under the plan, companies will be allowed to petition the Food and Drug Administration for approval to make health claims based on a wide range of evidence. Currently, the agency allows only health claims shown to be conclusively researched and that have achieved scientific consensus, a difficult standard to meet.

Critics in Congress and from some consumer groups charged that the plan, which will also apply to dietary supplements, violates the law and would open the door to confusing and dubious claims supported by weak or inconclusive scientific evidence.

Announcing the new policy, Food and Drug Commissioner Mark McClellan said it will arm consumers with far more information about the healthfulness of products they buy, and promote increased competition among food providers on health-related grounds.

"There's good competition now in the marketplace on price and taste and ease of preparation, but the number one area of competition should be the health consequences of a food product," McClellan said. "This is aimed at making companies want to develop healthy products and to do the science that supports their health claims."

The FDA action follows years of lobbying by the food industry for broader discretion in making claims that their products can help promote good health and reduce the risk of particular diseases. Decisions in recent years by the Supreme Court in cases involving pharmaceutical drugs also have challenged the FDA's authority to restrict producers' claims for their products, and the Bush administration was sympathetic to that position. The man who is now FDA's top lawyer, Daniel Troy, argued against the FDA in one of those cases.

The FDA is creating a system for grading health claims on food labels on an A-through-D scale, based on the strength of the science behind them. A grade of A will mean there is "significant scientific agreement," while a D will mean there is "little scientific evidence supporting this claim."

McClellan said the agency will first entertain claims related to the benefits of fruits and vegetables; of food containing omega-3 fatty acids plentiful in fish such as salmon and mackerel; of vegetable oils instead of solid fats; and of proteins from nuts, instead of from meat and dairy products high in saturated fats.

The announcement ran into immediate opposition. Rep. Henry A. Waxman, (Dem.-California), who led a successful congressional effort in 1990 to strictly regulate food claims, said the FDA plan poses unnecessary dangers.

"The new and weaker FDA standard violates existing law and means claims can be made on the basis of hope, not fact," he said. "That makes a mockery of food labels and will lead to the return of what former HHS Secretary Louis Sullivan rightly called 'a tower of Babel' in the supermarket."

"This is the biggest rollback in food-labeling standards in 20 years," said Bruce Silverglade of the Center for Science in the Public Interest, a consumer group. "Food companies have wanted to make these claims for a decade, and now the Bush administration gave them what they wanted. We think it will lead to consumers being misled and confused."

In announcing the plan, McClellan cited several Supreme Court decisions in recent years that struck down FDA regulations on product claims, saying they raised questions about the legality of the agency's long-standing restrictions on commercial speech.

But he said the primary motivation was to promote public health. With obesity and other chronic diseases becoming increasingly important and expensive problems for the country, he said, consumers need to take more responsibility for their diets and health. Having more health information available on food labels, he said, would help.

Companies will be able to submit proposals for health claims beginning September 1. Each submission will trigger a 30-day public comment period and an assessment of the supporting science.

Officials said the FDA will use its "enforcement discretion" to take quick action on the four specific health claims McClellan cited, and initiate a formal rule-making process later.

The Grocery Manufacturers of America, which represents many of the largest food companies, has actively pushed for greater leeway on health claims.

"This is an important and much-anticipated step," said Alison Kretser, the group's director of scientific and nutrition policy. "This will allow the food industry to get information to consumers quickly, and that will improve public health."

However, she said the group strongly opposes the FDA's plan to allow only standard preapproved phrasing for health claims. "We think we know how to best communicate with consumers, and should be allowed to do that," she said.

Silverglade, the consumer advocate, also raised the possibility of a legal challenge. "This is a case where Congress passed a law that expressly described what it wanted regarding health claims. And what it wanted wasn't this."

Under the 1990 law, health claims are allowed only if there is "significant scientific agreement" --- such as statements that calcium prevents osteoporosis or that a diet low in fat and cholesterol can reduce the risk of heart disease.

The issue became clouded when courts ruled that dietary supplement makers could make claims based on scientific research that is not conclusive. McClellan said health claims for foods will now be treated on the same basis as those for supplements.