NEWS

FDA Reviews Expanded Claims on Health Benefits of Certain Foods

Brian Vastag

After 5 years of legal wrangling and U.S. Food and Drug Administration red tape, food makers may soon be shipping soy products that announce their propensity for reducing the risk of certain cancers.

The FDA already allows a few food–cancer claims about diets that reduce the risk of cancer—those low in fat, high in fiber, or high in fruits and vegetables. These claims pass the FDA's standard of "significant scientific agreement."

But a court ruling has lowered the evidence bar, meaning that claims without ironclad support can now appear on food packaging. "It was basically a free speech case," said Todd Hamilton, J.D., who advises food companies on FDA regulations at the Washington, D.C., law firm Buchanan Ingersoll, PC.

In January 1999, the District of Columbia Circuit Court of Appeals struck down the "significant scientific agreement" standard as "unconstitutionally vague." More specifically, the court ruled that the FDA is required to permit a health claim if the quality of scientific evidence supporting the claim is at least equal to the quality of the scientific evidence against the claim. In July 2003, the FDA finalized its regulations for considering qualified health claims and began accepting petitions in September 2003.

Sebastian Cianci, spokesman for the FDA's Center for Food Safety and Nutrition, said that companies have been slow to submit qualified claim petitions. The agency has accepted only 15 petitions for review, including four for reduction of cancer risk: soy protein, lycopene (found in tomato products), calcium, and green tea.

If the agency agrees with the petitioning parties, it will allow packaging language that suggests the product may reduce the risk of cancer, but that the science supporting the claim remains uncertain.

"We wanted a graduated scale—the more and better [scientific] information you have, the stronger the claim could be," said Cianci. "So it's an alternative to the all-or-nothing approach" available for so-called unqualified health claims. Since the 1990 passage of the Nutrition Labeling and Education Act allowing health claims on food products, the FDA has approved only 12 unqualified health claims, including the three cancer claims.

Soy First?

Solae Inc., a St. Louis soy manufacturer, spent 3 years compiling evidence of soy protein's ability to reduce the risk of prostate, breast, and gastrointestinal cancers. The company felt it had built a case strong enough to warrant an unqualified health claim, but the FDA steered the company toward applying instead for a qualified claim. A meta-analysis of 58 human studies included in the company's petition concludes that regular, long-term consumption of soy protein reduces the lifetime risk of prostate cancer by 34%, gastrointestinal cancers by 30%, and breast cancer by 22%.

The FDA is now reviewing the science presented in the 150-page petition, but observers say that the decision is not a slam-dunk.

"It's going to be a long, hard haul for Solae," said Hamilton. The reason: some research suggests that large amounts of soy protein encourages tumor growth in animals. Also, nearly all of the epidemiology on soy protein has been conducted in Asia, where people tend to consume tofu and other minimally processed soy products that have a different overall nutrient profile than soymilk and other more highly processed forms of soy favored in the United States. The FDA's decision on Solae's petition is due by the end of the year.

In 2005, the agency will decide whether to accept a qualified claim from H. J. Heinz Company regarding the propensity of lycopene to reduce the risk of certain cancers. Next year it will also decide whether to accept claims that calcium reduces the risk of recurring colon polyps (a petition made by Marine Bio USA Inc.) and whether green tea reduces the risk of various cancers (a petition made by an individual, Sin Hang Lee, M.D.).



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A Larger Campaign

As the FDA developed its regulations for qualified health claims, the agency decided to pitch the program as part of a larger effort to provide consumers with "more and better" information regarding the nutritional value of foods. In a statement, acting FDA Commissioner Lester Crawford, D.V.M., Ph.D., said that the agency is encouraging companies to compete for consumer dollars based on the healthfulness of food products, "not just on flavor, texture, and the amount of fullness" the foods provide.

As part of the effort, the agency will require food makers to list the amount of "hidden" or trans fat on all products starting in 2006. It is also considering a proposal to revise labeling guidelines to require calories and nutrients to be listed per package, instead of the sometimes misleading per serving measurement now used. (Many sugary beverages, for instance, hold 2 or more servings per can or bottle, but a quick glance may leave the buyer with the false impression that they are consuming a relatively small number of calories.)

This fall, the FDA will decide how to present qualified health claims to consumers. Research conducted this spring by the agency sought to gauge consumer reaction to several schemes, said Cianti, including a numerical scale (1 through 4, with 4 being the strongest qualified claim), and a symbolic representation similar to that found in Consumer Reports (the strongest claims would be represented by a filled circle, the weakest by an empty circle).

The scheme the agency ultimately adopts matters little to two heavy-hitting consumer advocacy groups. Last September, Public Citizen and the Center for Science in the Public Interest filed a lawsuit seeking to ban all qualified health claims. They argue that claims based on "weak or inconclusive evidence" will mislead consumers. Peter Lurie, M.D., director of Public Citizen's health research group, went so far as to call the qualified claims program a "dereliction of the FDA's duty" to protect consumers.

Legal observers say that the District of Columbia court, which had originally ruled in favor of qualified claims on the basis of First Amendment free speech rights, will be loath to reverse itself. Said Hamilton: "I'd be astounded, frankly, if the lawsuit gains any traction."



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