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FDA to Allow Food Manufacturers to Make Certain Health Claims

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Chicago Tribune


WASHINGTON - New guidelines from the Food and Drug Administration will make it easier for food companies to make claims about the health benefits of their products, even if the science supporting those claims isn't conclusive.

The FDA's decision to relax the restrictions on health claims was the culmination of a years-long campaign by the food industry, which had argued that the old system was onerous and deprived consumers of important nutritional information.

FDA officials said the decision to allow qualified health claims - assertions that a food may have a certain benefit - was part of an overall government strategy to help consumers make smart choices about what they eat. Also, officials hope the decision will encourage food manufacturers to compete on the basis of nutrition rather than portion size or taste.

"The reason we are interested in this is that Americans can do more good for their health by making sound dietary choices than almost anything else they can do," said Joseph Levitt, director of the FDA's Center for Food Safety and Applied Nutrition. "This initiative arose as a way to get consumers up-to-date scientific information about foods that can help them reduce the risk of chronic disease and make them healthier in the long run."

The FDA's announcement earlier this month was particularly good news for the producers of certain nuts, such as almonds, walnuts and peanuts, which were picked as the first food that can make a qualified health claim.

"We're ecstatic," said Russ Barker, president of the Peanut and Tree Nut Processors Association. "In a nutshell, it's all positive for our industry."

But while the new guidelines were hailed by many in the industry and by the American Heart Association, others suggested the FDA had overstepped its authority and encouraged companies to lure consumers with flimsy health claims.

Among the skeptics is the American Medical Association, which argued that health claims based on "equivocal scientific data" would not help consumers trying to select healthful food to eat.

"Qualified health claims are likely to be confusing and potentially misleading, regardless of disclaimers," the AMA said in a May 23 letter to the FDA.

Rep. Henry Waxman, D-Calif., argued the FDA does not have the authority to rewrite the rules on health claims without Congress' approval. Congress enacted the current standards, which require "significant scientific agreement" before a claim can be made, as part of the Nutrition Labeling and Education Act of 1990.

"What the FDA is doing is to rewrite the law on its own," said Waxman, who wrote the act.

Using the more stringent standard, he added, "70 percent of the claims that were turned down by the FDA turned out to be false. Under this (new) process, those claims will be out there circulating."

Under the new guidelines, health claims will be ranked according to the strength of the scientific evidence supporting them, based on a letter grade system. The highest grade, "A," will be designated an "unqualified health claim," meaning there is significant scientific agreement supporting it.

A grade of "B" will be reserved for products in which the scientific evidence is good but not conclusive; "C" for claims in which the evidence is limited and inconclusive; and "D" for those claims with little scientific evidence. Products receiving a "B," "C" or "D" will be considered "qualified" health claims that require a disclaimer.

The worse the grade, the stronger the qualifying language that will be required on the disclaimer.

"We view qualified health claims as one of the ways consumers can make decisions about point-of-purchase decisions," said Stephanie Childs, spokeswoman for the Grocery Manufacturers of America, which lobbied for the revision.

She added that a qualified health claim will increase competition among food manufacturers to "create new and healthier ... products."

However, Childs said her group was unhappy with the FDA's decision to require specific wording for qualified health claims, contending it would limit the information provided to consumers.

"Each claim needs to be evaluated on its own merits," Childs said. "Each benefit for these products will be different."

Nut producers spent the last two years petitioning the FDA to allow them to tout the potential health benefits of nuts. Ultimately, the FDA awarded almonds, hazelnuts, pecans, pistachios, walnuts and peanuts the grade of "B." That allows for this claim on the products: "Scientific evidence suggests, but does not prove, that eating 1.5 ounces per day of most nuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease."

The FDA did not approve the claim for fattier products such as macadamia nuts, cashews, Brazil nuts and peanut butter, because they contain too much saturated fat.

Guy Johnson, a consultant for the nut industry, said the FDA's decision was the talk of a nut symposium at the recent Institute of Food Technologists convention.

"It was one of the most exciting messages to be communicated at (the convention)," Johnson said. "It was a very happy day."


(c) 2003, Chicago Tribune. Distributed by Knight Ridder/Tribune News Service.

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