FDA Plans to Grade Product Health Claims

July 10, 2003 -- Teachers won't be the only ones issuing grades from now on. The Food and Drug Administration plans to start grading health claims on product labels.

The ranking system will assign letter grades — ranging from "A" to "D" — on each claim a company makes, indicating the quality and strength of the scientific evidence that supports the claim.

"We want to see more of a focus on getting that information out to consumers and we want to see more of a focus on food producers competing based on the health consequences of their products," says FDA Commissioner Dr. Mark McClellan.

The measure is intended to encourage the manufacturers of foods, beverages and dietary supplements to present only health claims that are firmly backed by sound science. An FDA spokesperson said the new grades are intended to inform consumers about the products they buy.

But consumers won't see the changes right away. "The new regulations take effect in September, but it'll likely be months after that before consumers see any change in their food labels," reports ABCNEWS correspondent Lisa Stark.

Health Claim Report Card

Under the new plan, an "A" grade will be assigned to claims supported by many well-designed studies. For instance, if a food high in fiber boasts the ability to one's reduce risk of colon cancer, the claim will be given an "A" since the link between fiber and gastrointestinal cancers has been well established by scientific research.

Health claims with "good" but not entirely "conclusive" supporting evidence will be assigned a "B" designation. Label statements made with little or no conclusive evidence to back them up will fall into "C" and "D" categories.

This new proposal does not censor the health claims; rather, it retains claims while noting their strength. The measure might have been prompted by the 1999 court decision, Pearson v. Shalala, which requires the FDA to permit all truthful and non-misleading health information on herbal supplement labels, says Dr. Alice Lichtenstein, director and senior scientist at the Cardiovascular Nutrition Laboratory at Tufts University in Medford, Mass.

"The system is an excellent approach," says Dr. David Katz, director of Yale University's Prevention Research Center in New Haven, Conn.

Katz says the program will be particularly helpful because consumers are becoming increasingly responsible for reaching their own health-care decisions, which may often be based on direct-to-consumer advertising. This initiative would provide consumers with information in a recognizable way so that they are informed about what it is they are buying.

A changing and flexible grading system can also mirror the advances made in science as new health claims are studied and explored, adds Lichtenstein. Consumers could therefore be kept up to speed on the latest scientific evidence and what they are buying.

Noralyn Wilson, a registered dietitian and spokeswoman for the American Dietetic Association, believes consumers will be well-protected by this particular measure, particularly people who consume dietary supplements. "The FDA is just trying to get its arms around it [the dietary supplement industry]," she says.

Consumer Concern

Currently, only health claims proven conclusively through science are printed on product labels. Some experts say that this new measure is a step in the wrong direction.

"Today's FDA action lowers the standard for making health claims and it means that health claims on food packages will be less reliable. The agency is presenting a marketing advantage to the food companies at the expense of consumer welfare," says Bruce Silverglade of the Washington-based Center for Science in the Public Interest.

"I think the grading system is going to make American shoppers even more confused about nutrition," says Jeffrey Hampl, a registered dietitian at Arizona State University in Mesa. "Shoppers won't be paying close attention to the A, B, C or D. They'll see the health claim and base their decision to buy on that."

Other experts assert that a passing out letter grades may not be so easily applied to health promises as it is to students, and believe that only claims for which there is sound scientific proof should be allowed on labels.

"No more fables on labels, please," says Dr. Keith-Thomas Ayoob, associate professor of nutrition at Albert Einstein College of Medicine in New York. He contends that because claims receiving "C" and "D" statements are not sufficiently backed by scientific research, they simply have no place on a product label.

Although expert opinions are mixed, all agree that consumers deserve to be informed. "[We] need to focus resources in answering these uncertainties," says Lichtenstein, "and potentially modify the system on the basis of what is learned."