Last week the Food and Drug Administration proposed controversial regulations that would permit food manufacturers to print messages on food labels about the health benefits of their products. Yet such health-related claims are not entirely new to consumers.
For the past several years the food industry has been experimenting with health claims in advertising -- with the blessing of the Federal Trade Commission, the agency that regulates food advertising.
Food industry officials are applauding the new FDA proposal, arguing that food manufacturers should be allowed to communicate the health advantages of their products via the product label as well as in advertising. Others are concerned that the rule, if implemented in final form, could lead to a plethora of unsubstantiated, misleading claims that tell only the positive and not the negative health effects of a product.
A sampling of recent health claims made in advertising, which consumers may eventually see on labels:
Calling apples the "original health food," the Washington State Apple Growers claimed that the "pectin in apples seems to trap cholesterol before your body has a chance to absorb it." The same ad called fructose, the sugar found in fruit, a "good appetite suppressor."
The Florida Citrus Commision stated that grapefruit juice is "sodium-free and full of potassium -- a combination that helps control blood pressure."
Warner-Lambert Co., claimed that chewing Trident sugarless gum after sugary snacks "reduces acids that form on your teeth." It's these acids, the ad said, that cause cavities.
An ad for Fleishmann's corn oil margarine said that because the product is high in polyunsaturated fat and low in saturated fat, "Fleishmann's can actually help reduce the serum cholesterol that's already there."
"What we've seen is a very considerable area of experimentation in advertising," notes Ronald H. Smithies, vice president of the Better Business Bureau's National Advertising Division in New York City. He says because ads are more "transient" than labels, it is a "better place to test the waters."
The National Advertising Division (NAD), an industry watchdog group that resolves challenges to advertising claims, has recorded a steady increase in the number of cases dealing with health claims over the last five years. About half of the 24 health-claim cases that NAD has resolved came up last year, according to Smithies.
But manufacturers are likely to be more conservative in the kinds of claims that are made on the product label, says Smithies, since it's more difficult and expensive to change stocks of labels than it is to change ads.
Since 1984, FTC has encouraged advertisers to make health claims as a way of getting more health-related information to the consumer. While many in the industry lauded FTC's policy, consumer groups criticized the agency for not taking action against obviously misleading claims.
By contrast, it took FDA almost three years after announcing its intention to permit health claims to get its proposed regulations published -- partly because the document was stalled at the Office of Management and Budget for more than a year. During that time, says Charles J. Carey, president of the National Food Processors Association, a trade group, food manufacturers found themselves in "a no-man's land."
Most companies held back from making health claims, but others began to put claims on labels, says Carey, since the traditional FDA ban on health-related claims was not being enforced. Such firms "were being guided by their own interests of what might be appropriate." Carey notes, adding, "We needed a uniform policy that was universally understood and agreed upon that everyone could follow."
Carey says he "hopes and expects" that more companies will begin using health claims on labels, and notes that the new regulation may end up benefitting some of the more basic foods, such as processed vegetables. These are "not the most glamourous products in the supermarket," says Carey, yet most health experts are advocating that consumers include more vegetables in their diet.
However, John L. Stanton, Jr., professor of food marketing at St. Joseph's University in Philadelphia, does not expect to see an explosion in health claims, because such promotions are not necessarily a benefit to individual food manufacturers.
The problem is that the conscientious food marketer is aware that there's nothing special about the health benefits of his product as compared to his competitor's. "You lose brand differentiation," says Stanton, and the manufacturer ends up "advertising for everybody."
In 1984, the Kellogg Co., became the first major firm to defy the FDA prohibition on health claims in labeling by discussing the role of fiber in reducing the risk of cancer on the back panel of its high-fiber cereals. The successful promotion resulted in an increase in the market share of all high-fiber cereals, according to a recent FDA study.
Because of this factor, Stanton predicts that many health claims will be made by trade associations that want to boost the image of a commodity rather than to sell an individual brand.
FDA has permitted nutrition claims such as "no caffiene" or "no preservatives" for many years, but such claims do not take the final leap in telling consumers explicitly why such properties are desirable for their health. In a study tracking the number of health claims made by advertisers in major women's and general interest magazines, Stanton characterized only about 3 percent of all the claims for food products made in the magazine ads as health claims.
Still, sometimes it is difficult to tell where a nutrition claim ends and a health claim begins. Stanton characterized an ad for Snickers candy bar, which called the product a "wholesome snack," as a health claim because wholesome can be defined as "healthful."
Bruce Silverglade, legal affairs director at the Washington-based Center for Science in the Public Interest, a consumer group, says now that FDA has come out with its policy on health claims, "we expect to see the floodgates opened. We're going to see a lot of problems."
Silverglade bemoans the fact that the new regulations do not require FDA pre-clearance of claims. In addition, the rules will not require that a company disclose, along with a claim about the health benefit of an ingredient, whether another ingredient in the same product can have an adverse effect on health.
For example, he says, Fleishmann's margarine ads state that the product contains no cholesterol and is low in saturated fat, but does not disclose that oil is made up entirely of fat and that high-fat diets are associated with a higher risk of cancer and heart disease.
One of the thorniest issues FDA faced in developing the rule was defining the level of substantiation that would be needed to back up a claim. The proposed rule states that messages be based on "valid, reliable scientific evidence that is publicly available" and reflect the weight of the scientific evidence.
The substantiation issue reportedly concerned OMB officials, and FDA backed off from a stronger version in an earlier draft of the rule, which would have required that health claims "result from general agreement among quailified experts" -- in other words, a consensus.
Food industry officials, however, opposed a consensus standard, believing it would be too difficult to meet. Many FDA scientists are not even sold on the fiber/cancer claims used by Kellogg. FDA Commissioner Dr. Frank D. Young has stated publicly that there is "no basis" for the National Cancer Institute's recommendation that Americans consume 20 to 30 grams of fiber per day.
"In advertising you don't see an awful lot of claims based on consensus," says Smithies, who notes that these claims -- such as "a balanced diet is good for you" -- are not very exciting. Instead, he says, advertisers are much more concerned with questions such as, "Is it true that one vegetable oil is better for you than another?"
A recent NAD case involved a claim that a polyunsaturated margarine was "better for you" than corn oil margarine with a slighly lower polyunsaturated to saturated fat ratio. Smithies said NAD concluded "that the observed difference was chemical and there was no clinical proof of any difference in the health benefits of the margarines in the context of the total diet."
However, sometimes a claim can be based on valid scientific data that has not yet been widely disseminated in the scientific community, Smithies notes. Recent claims made by CPC International for Mazola margarine were based on a series of clinical studies linking polyunsaturated oils to lower blood pressure. The claims were "very well substantiated" by the clinical data, but it is "quite possible," says Smithies, that medical experts aren't yet aware of the studies.
One potential problem with allowing explicit health claims is that it can generate nutritional "horse races," where companies add more of a particular ingredient, such as fiber or calcium, to a variety of products in order to boost sales. Former director of FDA's Center for Food Safety and Applied Nutrition, Sanford Miller, has warned of such dietary power races, calling new calcium-fortified products such as orange juice and soft drinks "outrageous," and pointing out that the safety on prolonged intake of calcium and other nutrients has not been studied.
Another question is whether FDA will have the funds to enforce its own regulations on health claims. "I don't see where it will be a terribly expensive thing to enforce," says Carey of NFPA. Some FDA officials are not so sure, noting that the agency has in the past placed a low priority on policing labeling claims.
FDA has proposed forming a public health panel staffed with government experts who will develop prototype health messages that are truthful and in compliance with FDA regulations. While companies would be free to devise their own messages, FDA says they then risk violating the law if the labeling "exceeds legal bounds."
Consumers can comment on the proposed regulations until Nov. 2, by writing to Dockets Management Branch, FDA, 5600 Fishers Lane, Rockville, Md. 20857