One year ago, the Kellogg Co. launched a promotional campaign that made food industry history -- by discussing, on the back panel of its All-Bran cereal, the role of a high-fiber diet in reducing the risk of cancer.
The campaign sparked intense debate in the industry and at the Food and Drug Administration, which regulates food labels, about the appropriateness of permitting such health-related messages, or "health claims," on food product packages. Now FDA is preparing to lift its traditional ban prohibiting statements on food labels that a particular food or ingredient can help to prevent a disease.
The problem facing FDA, according to Joseph P. Hile, associate commissioner for regulatory affairs at FDA, "is how to permit appropriate health claims without opening the door to outright fraudulent ones." In a document to be released shortly, the agency will suggest that a committee of health experts from the Department of Health and Human Services' Public Health Service be formed to come up with standard messages, supported by scientific evidence, that could be used by food manufacturers on their products. Companies choosing not to use the standardized messages would have to devise claims that fall within certain guidelines.
FDA "may be opening a Pandora's box" by allowing health-related messages on food labels, says Bonnie Liebman, a nutritionist at the Center for Science in the Public Interest (CSPI), a consumer advocacy group. Her concern is echoed privately by some FDA enforcement officials, who fear that a new policy will encourage an onslaught of misleading claims that exaggerate the benefits of a food in preventing disease.
FDA has been in the business of battling fraudulent claims on food products since its inception in 1906. Modern-day claims are sometimes difficult to distinguish from those made a century ago. In 1983, for example, FDA seized a product called Neptone, which a U.S. District Court in California described as a "freeze-dried, homogenized, powdered New Zealand green mussel . . . in capsule form." Promotional claims for the product said it would be useful "to repel infection, prevent blood clots, and maintain the elasticity of the arteries." The court upheld FDA's seizure action.
However, Liebman believes the "tremendous financial resources of the industry ought to be used to convey" truthful information about diet and health. Her group has filed a petition with FDA calling on the agency to allow health claims, as long as they are closely regulated and approved prior to marketing of the product.
Many food manufacturers are eager to capitalize on the latest research linking diet and health in order to tout, for example, the role of calcium in preventing osteoporosis, polyunsaturated fat in preventing heart disease, and lower-fat foods in preventing cancer. Some of these claims have already been made in advertising, which is regulated not by FDA but by the Federal Trade Commission. The FTC has no ban on health claims, and FTC officials generally have been in favor of permitting health-related messages in advertising as a way to get vital information to the consumer.
Under FDA's interpretation of its laws and regulations, if food labeling represents that the product is intended for the cure, mitigation, treatment or prevention of disease, the product is considered a drug. Therefore, because the product has not met FDA requirements for drug approval, it is considered illegal. A 1979 FDA statement reaffirmed the policy of not allowing disease-related claims on food product labeling. "What Kellogg is doing is very bold. They are violating the law technically," says Bruce Silverglade, legal affairs director at CSPI.
But Kellogg looks at it in a different light. According to Celeste Clark, director of corporate publicity at the firm's headquarters in Battle Creek, Mich., Kellogg approached the National Cancer Institute (NCI) in May 1984, offering to help publicize the recommendations of NCI's Cancer Prevention Awareness Program. "We worked very closely with NCI in developing the campaign messages," Clark says, noting that the messages produced by Kellogg were checked by NCI for accurarcy.
"Our position is we're not making a health claim," says Clark. "We're delivering NCI's message and we're delivering it on our labels."
And while NCI did not actually "endorse" the Kellogg campaign, the fact that the research agency worked with the firm made it politically impossible for the FDA to take regulatory action against Kellogg. FDA and NCI are "sister" agencies under the Department of Health and Human Services. As one FDA official put it, Kellogg made an "end run" around FDA.
According to Stephen H. McNamara, a food industry lawyer with the Washington law firm of Hyman Phelps and McNamara, FDA "generally tolerates" implicit health-related messages such as "no caffeine," "no preservatives," and "no artificial coloring," which "may connote that consumers ought to avoid these substances for health-related reasons." Says FDA's Hile: "We have not moved against those kinds of claims because they are truthful non-misleading information."
However, many food manufacturers believe FDA's health claim ban does prevent the flow of truthful information. In a petition filed with FDA to permit health claims, the National Food Processors Association, a trade group, insists that food manfacturers "have a constitutional right to provide truthful, non-misleading information in labeling concerning the relationship between good nutrition and the maintenance of health or wellness, including the incidence of disease."
"For the federal government to be telling a responsible food manufacturer that he or she should not be telling truthful information -- that offends me," says McNamara.
And yet in the controversial area of diet and health, it is often difficult to know the truth. Hile notes that in many instances, "reasonable scientists still differ about what dietary practices to recommend to combat specific ailments." Liebman of CSPI believes there ought to be a consensus among scientific experts in a given area before a claim is permitted.
Petitions to permit health claims filed with FDA by NEPA, Kellogg and the Council for Responsible Nutrition, a trade group of vitamin and mineral supplement manufacturers, say health claims must be adequately substantiated by reliable studies but specifically do not endorse the consensus approach. Waiting to see if a consensus has been reached in a particular scientific area, says J.B. Cordaro, president of the Council for Responsible Nutrition, would be like "waiting for the white smoke after the election of the Pope."
But Liebman fears that manufacturers could find studies in the scientific literature to support their point of view, even if there were "hundreds of studies saying the opposite."
To minimize the possibility of misleading or deceptive claims, CSPI has recommended to FDA the following guidelines:
*Prohibit claims for foods that could prevent and promote the same disease.
For example, CSPI says, it would be misleading for a product containing coconut oil to claim "no cholesterol -- helps prevent heart disease," since the saturated fat in coconut oil raises blood cholesterol, thereby invalidating the heart disease claim. A whole-wheat croissant that bears a cancer prevention claim because it contains fiber would be misleading since croissants are also high in fat, which may promote cancer.
*Prohibit claims for nutrients not linked to major health problems facing Americans.
Liebman fears that companies will highlight foods rich in nutrients that most Americans get in adequate amounts, such as thiamin, riboflavin, niacin, vitamin D, E, B-12, pantothenic acid, or biotin. Ads of one vitamin supplement manufacturer state that its Vitamin B complex is an "energy releaser" involved in the process of changing food into fuel, notes Liebman. "There's no shred of evidence" that energy is not already being released, she says, but such statements imply that without the product, the metabolic process won't happen.
*A health claim should trigger full disclosure of all health information, including substances in the food that could increase the risk of a disease.
For example, a high-fiber, low-fat, high-sodium food such as bean soup could make a claim concerning diet and cancer. But Liebman believes the label should also have to state that the soup contains a certain quantity of sodium per serving and that experts recommend only about 1,000 to 3,300 milligrams of sodium per day to reduce the risk of high pressure. Another example offered by Liebman: A whole milk product bearing a message about calcium and osteoporosis should also state that half of the calories in whole milk come from fat and that experts recommend that the overall diet contain no more than 30 percent of calories from fat to reduce the risk of cancer and heart disease.
Such a disclosure requirement would probably cause most companies to refrain from making any health claim, Liebman acknowledges, but, she says, that's just "fine" since "the same health experts that want you to eat less sodium also want you to eat less fat."
CSPI also has asked FDA to prohibit companies from making health claims on the front panel of a food package, contending that a statement such as "helps prevent heart disease" on a margarine package is misleading without further explanation that margarine can only prevent heart disease if one makes other dietary changes.
It appears FDA may take some of these recommendations to heart. For example, the agency will ask the Public Health Service committee to develop claims first relating to heart disease and cancer, the most prevalent chronic diseases in the United States. It will also require that messages emphasize that good nutrition is a function of the total diet. If health claims are made, according to Hile, FDA will require nutritional labeling on the product label.
Not all food manufacturers are eager to see FDA's policy change. In June, General Foods Chairman James L. Ferguson warned in a speech that food companies may damage their credibility by making such claims, and that the competitive environment will promote more exaggerated health claims for food products.
Janet Dubek, a nutritionist with the National Food Processors Association, says some of the group's members "weren't quite sure if they were ready to proceed" with making health claims.
Asked if member companies of the Council for Responsible Nutrition have a lot of health-claim campaigns ready for use when given the go-ahead, Cordaro said, "Whether they're ready with a whole bunch of claims, quite frankly they're not."
One concern expressed by Hile and others is that health claims may generate dietary "power" races in the marketplace, with companies adding more and more of a particular "beneficial" substance in order to beat out the competition. Kellogg is currently test marketing a breakfast cereal called "All-Bran With Extra Fiber," which contains 12 grams of dietary fiber per serving instead of the nine grams in its regular All-Bran cereal.
Declining to comment on whether the marketing move represented a dietary power race, Kellogg's Clark says in the end the consumer will decide if he wants a product with four grams or 12 grams of fiber. "Ultimately, they will dictate what is successful," Clark says.
There is little doubt that the Kellogg campaign has been successful. Sales of the company's bran cereal category have "shown very positive performance," Clark acknowledges, which she attributes partially to the campaign and partially to heightened concern among consumers about health. And that concern, says Clark, "is consistent with our commitment to provide them with additional information."