FDA's "qualified" food label meets opposition

Washington -- The Food and Drug Administration has approved walnuts as the first food to bear the agency's new "qualified health claim" because there is some evidence that they may reduce the risk of coronary heart disease. But some believe this claim will confuse rather than enlighten shoppers.

While many physicians and nutritionists think nuts do have a place in a healthy diet -- as long as they are unsalted and eaten in moderation -- the new "qualified" label raises concern.

"I work in cardiac rehab, and when I ask my patients what low saturated fat and low cholesterol mean, they don't know," said Samantha Heller, senior clinical nutritionist at New York University Medical Center.

As obesity rates rise along with such killers as cardiovascular disease and diabetes, patients need all the help they can get to ferret out healthy foods. But they may require some guidance. Labels shout "low carb" or "fat free" but does this mean the food offers health benefits?

"At this point the labeling is so confusing that people don't understand whether they are getting something that is healthy or not," said Heller.

The wording of the FDA-allowed claim for walnuts is not likely to lift the fog. It states: "Supportive but not conclusive research shows that eating 1.5 oz of walnuts a day, as part of a low saturated fat and low cholesterol diet, and not resulting in increased caloric intake may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content."

The AMA opposed the FDA initiative at first review. "Consumers are likely to be at best confused and at worst seriously misled by such claims," wrote AMA Executive Director Michael D. Maves, MD, in a May 2003 letter to the agency.

Two groups have filed suit to stop the FDA program. The Center for Science in the Public Interest and the Public Citizen Health Research Group are charging that the agency does not have the statutory authority to allow such claims and, by going forward, will allow unproven health claims that are supported by weak science to make their way onto food labels.

The FDA said the label change is part of an initiative to provide consumers with better information.

"By using science-based information to evaluate qualified health claims, the FDA is making sure that consumers get information about the nutritional value of food," said FDA Acting Commissioner Lester M. Crawford, DVM, PhD.

The FDA has long allowed labels that promote well-researched health claims. Among them are foods containing 20% or more of the daily requirement for calcium, which can claim a health value for warding off osteoporosis. Foods containing sources of fiber can claim they guard against some cancers.

But critics of the qualified health claims program say the evidence isn't in yet.

Changing behavior

Still, some physicians welcome the added information.

"Nuts have good oils that help block inflammation whereas saturated oils can increase inflammatory markers," said Daniel Cosgrove, MD, medical director and founder of WellMax Center for Preventive Medicine in La Quinta, Calif. But nuts are high in calories, so consumption should be limited, he added.

"Anything that requires some science to be presented to an unbiased agency before a claim can be made, I can only see as beneficial to the consumer," said Stephen A. Siegel, MD, a cardiologist at New York University Medical Center.

"What I particularly have concerns about are things that don't have an FDA warning," he said. Among them are certain herbal supplements that indicate on labels that, while they are not approved for treatment or prevention of disease, they carry banners that say, for instance, "helps heart problems."

Although walnuts are the first to attain qualified health claim status, others are likely to follow. Among the foods under review are other tree nuts, green tea for its possible power to reduce cancer risk and eggs with added omega-3 fatty acids for their possible ability to reduce risk of heart attack.

"If the government is going to require the negative little reminders for cigarettes and alcohol, then why not at least allow accurate, positive food claims for healthy foods," said Dr. Cosgrove.