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."