Food Fight : Heart Association Plan to Label ‘Healthy’ Foods Drawing Fire From Agencies, Nutritionists

A major new American Heart Assn. program that will award “heart-healthy” seals of approval to processed foods low in fat, cholesterol and sodium and high in quality nutrients has touched off a controversy over whether it is a valuable public service or a distortion of nutrition principles that may illegally interfere with federal regulatory authority.

While the U.S. Food and Drug Administration has taken no official position, a staff memorandum asserts that the enterprise could lead to a “proliferation of product approval schemes” and that their heart association’s seal might itself be classified as an illegal health claim. Internal U.S. Department of Agriculture documents, obtained by The Times under the Freedom of Information Act, contend “ a positive outcome is in all likelihood impossible.”

The program, the internal analysis argues, may result in the further polarization of food producers and consumers as well as public confusion, leading inevitably to consumers believing there are certified “good” and “bad” foods. In late May, Suzanne Harris, a deputy assistant agriculture secretary, officially urged the heart association not to go ahead with the program.

The opposition has surprised heart association officials who authorized creation of the program, scheduled to begin in about a year, after the organization’s marketing surveys found the association to be one of the nation’s most trusted voluntary health groups.

Irritation Over Labels

The controversy comes against a backdrop of increasing agitation, among consumers and politicians, for change in the labeling of foods for nutrients and health risks. Increasingly, according to food-science experts, consumers are expressing irritation at labels that ignore or obfuscate fat and salt content or say products contain “one or more of the following” oils.

In his report on nutrition and health released last week, Surgeon General C. Everett Koop urged labeling reform under which manufacturers would clearly spell out calories, protein, carbohydrates, fats, cholesterol, sodium, vitamins and minerals in their products. Koop urged particular attention to information on saturated and unsaturated fats--a crucial distinction in assessing potential cardiovascular risk in foods--and total fiber.

Legislation to mandate more stringent labeling requirements for fat and sodium content is pending in Congress. At the same time, the FDA is reworking a proposal--opposed by most consumer groups--that would permit food processors to include some unsubstantiated health benefit claims on their packaging. And in California, a seal-of-approval program has been started by a dietitians’ group.

It was in this climate that the Dallas-based heart association’s policy-making body voted overwhelmingly in June to establish the new certification program. Under the plan, the association will establish an independently financed product-approval subsidiary that will also organize a public education program advocating a healthy approach to the diet and related life-style change, like quitting smoking. Companies that wish to submit products for certification will pay a fee and agree to participate in the association’s public education program, not just the product labeling component.

Products, limited to processed foods, will be subjected to several laboratory analyses and will be reviewed, according to Dr. Louis Rakita, vice chairman of the association’s task force on commercial ventures, to ensure they avoid ingredients known to be associated with health problems other than heart disease. Margarines may be the first foods included.

If a product passes, the manufacturer can use the association’s approval logo. But the fate of products that fail isn’t completely clear.

Rakita and Dr. W. Virgil Brown, a task force member, said products that fail won’t be identified and the association will not make public complete lists of products that had been tested. But Dr. Reagan Bradford, another task force member, said he thought the association would probably identify failed products in response to specific requests.

When association representatives met with the USDA in May and with the FDA in early June--weeks before the association approved the product-approval program--opposition quickly materialized.

An internal USDA memo concluded that, in light of intense controversy that has surrounded Vitamin C and other individual food components, “the development of criteria applicable to all healthy Americans for individual food products is fraught with difficulty.” The memo, to Laura Sims, administrator of USDA’s Human Nutrition Information Service from Susan Welsh, director of the subordinate nutrition education division, contended that “any set of criteria is likely to ignite a battle that will be front page material.”

Welsh even questioned the legality of the association’s proposal, asserting that it might transfer control of food labeling from the government to a private entity. “My reaction is that a positive outcome is in all likelihood impossible and very costly,” Welsh said.

In late May, Harris, who oversees the Human Nutrition Information Service, formally notified Dr. John LaRosa, chairman of the heart association’s nutrition committee, that the USDA opposed the plan because it “cannot by its nature convey the importance of the total diet.” Harris urged LaRosa to reconsider the then-pending approval of the program. In a separate letter to the heart association’s Washington office, Harris repeated her opposition, suggesting that the association’s “scheme” might prompt duplication by other organizations and that the program had “the potential for real harm.”

At the FDA, a staff memorandum summarizing the meeting echoed the USDA objections and warned that the heart association program could inspire unscrupulous organizations to set up bogus, for-profit food-approval seal agencies. “Although the AHA program might be cautious and balanced, there is no guarantee that other programs would be.” It added that “we could readily interpret the AHA logo as a health claim in and of itself.”

Opposition at FDA

The FDA refused to name a representative to the heart association’s program’s steering committee. The memo indicated two FDA officials emphasized that the FDA could take regulatory action against any product carrying the association’s seal if it was found to violate federal food regulations.

“We don’t feel this is a proper way to go about educating people to eat a balanced diet,” Harris said. “Most any food can be incorporated in a person’s diet in such a way as to be appropriate.”

“We don’t know for any individual in our society what is the precise appropriate amount of fat, sodium, cholesterol or fiber,” said Frank Scarbrough, director of the FDA’s division of food sciences. He said the agency has taken no official position, though the situation has been referred to FDA Commissioner Frank Young for review.

But Scarbrough said FDA officials were concerned about the possible ramifications of the heart association program. “I think our concerns are parallel to the ones by (USDA),” Scarbrough said.

David Livingston, a Dallas-based heart association attorney, said the association was surprised by the depth of opposition from the Agriculture Department.

“It is not our intent to violate any USDA regulation nor do I believe that our program will be in violation,” Livingston said. “We don’t need USDA’s affirmative approval to conduct the program. Were the USDA answering the need that we perceive to be out there, the AHA would not feel inclined to implement the program.”

Livingston said the heart association does not believe use of its logo would interfere with the FDA’s regulatory authority. “The issue is whether the use of the logo, by itself, will make a reasonable person believe the product is therapeutic or diagnostic,” Livingston said. “We don’t think that’s the case.”

He said the association considers the positions of the two government agencies to result from “turf issues” concerning regulatory authority. He said the association is prepared to abandon the program if there is any indication the concerns of the two federal agencies are justified.

Some consumer groups argued the association’s proposal is testimony to the failure of the FDA and USDA to promulgate effective mandatory labeling standards. Last year, the FDA proposed to permit unsubstantiated health claims on packaging but the proposal prompted such a furor that the agency is reworking the plan and will introduce a revised version later this year.

Dr. Sidney Wolfe of the Ralph Nader-affiliated Health Research Group said the heart association’s voluntary program “comes in the context of the FDA largely abdicating its responsibilities in the area of nutritional value of foods. If the FDA was doing a good job in not allowing industry to sell food with misleading advertising or labeling, it would be another thing. But they don’t.”

Room for Misinterpretation

Wolfe said he opposed keeping secret the identities of foods that do not pass the heart association tests and that the seal of approval could be misconstrued by some consumers who might believe a “heart healthy” food could be eaten in any quantity.

Bonnie Liebman, chief nutritionist at the Washington-based Center for Science in the Public Interest, said the heart association’s plan has virtue in its simplicity. “What I like about it and what we have always wanted is a green light-red light, thumbs up-thumbs down for those people who will never read all the details,” she said.

But Liebman said she was not totally enthusiastic. “My concern is they (the heart association) are going to be too lenient and lax (in terms of) which foods get approval,” she said.

Serious opposition to the heart association plan, however, comes from nationally prominent nutritionists--including some influential members of the heart association itself. Dr. Herman Hellerstein, a former heart association vice president on the staff of University Hospitals of Cleveland, said he was concerned that taking on responsibility for certifying the health safety of even a portion of the food supply was beyond the abilities of any private organization.

Dr. C. Wayne Callaway, a Washington nutrition expert who is a member of the heart association’s council on nutrition, said he had reservations about whether the association would be able to succeed in forcing rational change in food labeling. Callaway was a senior editor of Koop’s recent nutrition report and often serves as a spokesman for the American Institute of Nutrition and American Society for Clinical Nutrition.

The California Dietetic Assn.’s program has already taken the concept of private sector food approval off the drawing board. The program requires companies whose products are to be certified to submit samples to private laboratories approved by the FDA or USDA. Products that pass may use a logo identifying them as meeting the organization’s standards for fat, cholesterol, sodium and sugar.