Food-Item Health Claims Subject Of Controversy

Walk into a supermarket in Japan or use one of the thousands of vending machines there and you likely will find products with a circular seal shaped like an old-fashioned keyhole.

It’s the government symbol for a Food for Special Health Use, or FOSHU. It might be a package of rice with the protein removed for people with rice allergies, cherry juice designed to enhance the growth of beneficial digestive bacteria, or a fermented soy protein drink to prevent cholesterol absorption. In all, the label has been permitted on 58 food products.

In the United States, it has taken more than two decades of research and three dozen studies on humans for the Food and Drug Administration to consider allowing Quaker Oats to print a health claim on packages of oatmeal.

In February, the FDA proposed that products high in oat bran and oatmeal could state on the package that they may reduce heart disease risk when eaten regularly as part of a low-fat diet. If approved, it will be the first time a health claim has been permitted for a specific food product rather than a substance or additive such as folate or calcium.

Some consumer groups and scientific associations - including the American Heart Association, American Dietetic Association and Center for Science in the Public Interest - have filed formal objections with the FDA, saying health claims for single food items can be misleading.

The Heart Association said it is “concerned about the possibility that the oversimplification of information on health claims may lead to the erroneous perception that individual food or food components, rather than overall dietary practices, influence heart disease.”

The official government attitude toward such foods in Japan and some other countries seems to be more positive than in the United States. The FDA, for instance, cracked down on foods adding heart stickers or using “heart” in their name to imply the product reduced the risk of cardiovascular disease.

Health claims for functional foods so far have involved a struggle between government, which has been criticized as overly cautious, and the food and supplement producers, who may be overeager to put anything on a label that may improve sales.

The FDA is conservative, says Betty Campbell, director of programs and enforcement policy in the agency’s food labeling office. It must ensure there is enough mature science and broad agreement among scientists so that what’s printed on the label can be trusted by consumers.

Even in Japan, where people seem to be more aware of the health benefits of a good diet, businesses are waiting to see whether the FOSHU label will be commercially meaningful, says Ron Bailey, a food technology consultant specializing in U.S.Japanese trade.

Some companies are not sure that assembling the research material and product testing required for the label is worth it. And some products have been approved for the FOSHU seal but have chosen not to carry it.

If the government bureaucracy and the cost of the research aren’t enough of a hindrance, U.S. companies complain that after a health claim is approved by the FDA, any similar product can use it, says Clare Hasler, director of the Department of Food Science at the University of Illinois at UrbanaChampaign.

When Quaker Oats gets final approval, likely this fall, other oat-based cereals that meet the same criteria probably will be able to use the health claim, too, even though they didn’t contribute to the research.

“This is one of the major issues with research into functional foods,” Hasler says. “The industry is uncomfortable with not getting exclusivity and profiting from what it has paid for.”

Can’t the government sponsor such research?

To an extent, it does. But this year there has been only $2 million set aside for 10 research projects into the health aspect of functional foods.