The public debate over the proposal to permit health claims on food packages has quieted since the Food and Drug Administration closed its comment period last month. But behind the doors of government, the issue is still generating noise -- a lot of it political. Regulators are completing a policy during the closing months of the Reagan Administration that could have a lasting impact on how consumers choose the foods they buy.

The long debate over health claims started back in October of 1984 when the Kellogg Company began a national advertising campaign, for its All-Bran cereal, based on the value of high-fiber diets in reducing the risk of certain kinds of cancer. The health claim, communicated by ads and package labels, touched off an immediate controversy because of the government's prohibition against manufacturers attributing health benefits to their food products.

The discussion also centered around the appropriateness of a government agency, the National Cancer Institute, helping a private company formulate its labeling and advertising. NCI's role has caused particular conflict because other major scientific bodies, including the FDA and the National Academy of Sciences, do not believe the evidence is conclusive enough about the role of fiber in cancer-prevention.

Since then, most food companies have resisted following in Kellogg's footsteps, instead awaiting FDA's final policy. Other food companies, however, have already entered the health claims arena, none without some criticism of the messages' contents. The proposal permits manufacturers to make claims while it is pending.

While many food labels contain statements such as "fortified with calcium" or "contains no cholesterol," the label's leap to a disease condition is what is under consideration. For example, some brands of milk have been carrying messages that the product contains calcium, which may reduce the risk of osteoporosis; the back panel on Mazola margarine discusses the product's benefits for a healthy heart, and several months ago, the label on Land O' Lakes Butter stated that the product contained Vitamin A, which "keeps skin soft and smooth."

These kinds of claims -- and the ones that observers believe companies may want to make -- have spurred a steady debate among groups with different backgrounds, biases and impressions. Health professionals, food manufacturers, consumer groups, government regulators, legal experts and, most recently, members of Congress all have strong opinions.

"Paper Tiger" Politics

In December, a Congressional subcommittee charged that FDA's health claims proposal published this summer had been watered down by political appointees in the Office of Management and Budget, where the document was reviewed before its release.

Under the threat of a congressional subpoena by Rep. Ted Weiss (D-NY), chairman of the House Government Operations subcommittee that oversees the FDA, internal memoranda that had been exchanged between the FDA and OMB were released. Weiss believed the documents showed that the final proposal was more vague and less restrictive for industry than the original version.

Weiss also charged that FDA had destroyed internal memos between the two agencies. FDA personnel involved in the exchanges considered these documents drafts rather than official policy documents, according to the agency.

"The final version of the health claims proposal, in many critical respects, bears little resemblance to the more cautious, deliberate, tentative document prepared by FDA ... it now strongly reflects the intervention of OMB ideologues who seek unregulated market entry of food products bearing disease-specific health claims ... ," said Weiss at the subcommittee hearing. Weiss claimed that FDA was telegraphing to industry that it is becoming a "paper tiger."

FDA originally intended to require preapproval of label claims and the final proposal does not, Weiss pointed out. He was also concerned that FDA backed off from a stronger version of the rule that would have required that health claims result from "general agreement among qualified experts" -- in other words, a consensus. 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.

In defense of FDA's role, a FDA official who asked not to be named, said that "the agency {FDA} believes that OMB is part of the same government. These expressions that one part of the government is influencing another seem beside the point. It's difficult to say that the Office of the President ought not to influence the policy decisions of various parts of the government."

Other FDA staffers believe that OMB's changes are only in wording, rather than policy. Richard Ronk, acting director of the FDA's Center for Food Safety and Applied Nutrition, said that OMB's alterations will not change the truthfulness of a food label, nor will it change FDA's ability to go after fraudulent claims. OMB had no comment.

The Legal Question

Both Weiss and the American Law Division of the Library of Congress believe that making health claims for foods is simply against the law. Weiss contends that making a disease-related claim about a food turns it into a new drug claim, and that the conditions for making such a claim would not be met by the proposal.

Under current law products intended to cure, treat, mitigate or prevent a disease are considered drugs. Before a new drug can be approved by FDA for marketing, it must be proven safe and effective for intended use, substantial evidence must be produced to support claims of benefit and the label must include directions for use. The concern is that food companies would be making statements similar to drug claims without having to substantiate them.

FDA's position has been that mere mention of a disease condition does not make a product that is a food into a drug, that there is an "implied exception" that foods are not drugs. "We're talking about prudent dietary advice," contends FDA's Ronk, which is not necessarily a therapeutic claim.

The Comments

Privately, some industry representatives and FDA staff have expressed reservations about the current proposal. Officially, the comment period for interested parties to express their views on the proposal ended early last month. More than 400 different parties submitted comments.

According to Dave Hattan, chief of FDA's regulatory affairs staff, the majority of the comments oppose the proposal. In particular, the scientific and health communities are "strongly against" it, according to Hattan.

Among the groups that are opposed to the current proposal are the American Medical Association, the American Cancer Society, the American Heart Association, the American Academy of Pediatrics and the National Council of Senior Citizens.

Those who oppose the whole concept of health claims on foods are fearful that the messages would only serve to confuse consumers, that the credibility of the food label may be diminished and that enforcement would be inadequate for an already resource-strapped FDA. Other concerns focus on whether food manufacturers would use claims to secure a marketing edge, and that their ultimate goal of selling products makes them inappropriate as nutrition educators.

In addition, critics fear that there are few noncontroversial areas regarding the relationship between diet and health, and that disclosing all sides of the issue would be impractical, if not impossible, on a food label. Promoting a single food product in the prevention of a specific disease would also not take into consideration other aspects of life style and diet.

Several respondents would be in favor of the proposal only if it required preapproval of claims and if both the positive and negative aspects of the food appeared on the label, Hattan said. A positive and negative disclosure, for example, would require the labels on whole milk to state that the product is also high in fat, which may contribute to heart disease. (Negative disclosure requirements would likely discourage manufacturers from making any claims, observers believe.)

As for the food industry, it is not "monolithic by any means," Hattan said. Food industry representatives who are opposed to the idea are primarily those that have something to lose from making health claims. The American Salt Institute is one of them, Hattan said.

The National Food Processors Association, in strong support of the proposal, has asserted that health claims are "very much in the interest of public health" and that manufacturers would be discouraged from using unfounded claims because of the threat of enforcement action and loss of consumer confidence.

The Claims

While a few health claims are already being made, most companies are close-mouthed about their marketing plans.

FDA's Ronk believes that initially most claims would focus on the sodium, fat, cholesterol, fiber, omega-3 fatty acids or calcium in foods, but did not identify specific companies or products. Each component would probably be linked to heart disease, cancer or osteoporosis.

There has been some discussion that processors of canned fruits or vegetables might be interested in highlighting certain attributes of the nutrients in their products and that cranberry juice manufacturers are mulling over claims that their product is beneficial to those with urinary tract infections. A spokesman from Ocean Spray would not confirm the rumor, but did say that the company is conducting a search of the medical literature on the subject.

John Vanderveen, director of nutrition at FDA, said that messages would probably fall within three categories: 1) claims of a particular nutrient playing a role in normal well being, 2) claims that a particular food may help lower the risk of a certain disease, and 3) claims that a particular food may prevent a certain disease. Vanderveen said that the last category would be the most difficult to substantiate and might make the message a drug claim.