Introduction
On March 31, 2004, the Food and Drug Administration (FDA) gave its final approval for the first time of a qualified health claim which can be used on food packaging and advertising. The FDA will allow companies selling walnuts to state on packaging that walnuts can reduce the risk of heart disease. The FDA will permit companies to state on packages of chopped and whole walnuts that: "Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat (and calorie) content." The FDA explained that the reference to calorie content was optional.

In conjunction with its announcement, acting FDA Commissioner Lester Crawford commented that "while this research is not conclusive, the FDA believes that consumers will benefit from having information that may help them improve their dietary health." He also stated: "By putting credible, science-based information in the hands of consumers, FDA hopes to foster competition based on the real nutritional values of the foods, rather than on portion size or bogus and unreliable claims." FDA officials said that similar health claims for other nuts are being reviewed, and indicated that they will be acted on shortly.

FDA Procedures
The FDA's decision was reached in accordance with the procedures outlined in its July 2003 Guidance on qualified health claims for food products. Last September, the FDA began accepting requests from food industry members for approval of health claims that lack conclusive support. The FDA allowed a similar health claim for various nuts, including walnuts, on a provisional basis as part of a separate process last year.

The FDA's decision to allow the qualified health claim for walnuts was made in response to a petition filed by the California Walnut Commission, which proposed the claim: "Diets including walnuts can reduce the risk of heart disease." The petition was based on studies showing that eating walnuts can help reduce the level of low-density lipoprotein (LDL), the "bad" cholesterol in the blood. The FDA concluded that "there is not significant scientific agreement" that the requested claim "is supported by the totality of publicly available scientific evidence." However, the FDA allowed the qualified health claim based on the following conclusion: "After reviewing the scientific evidence in your petition, FDA concludes that there is very limited and preliminary scientific evidence supporting the relationship between consumption of walnuts and reduced CHD [coronary heart disease]."

Controversial Decision
The decision to allow qualified health claims for food labeling is controversial. Two non-profit groups, the Center for Science in the Public Interest and Public Citizen (http://www.citizen.org/documents/compl-3.8xx.pdf), sued the FDA in federal court in the District of Columbia last September arguing that qualified health claims violate the labeling requirements in the Nutrition Labeling and Education Act (http://www.foodmarketexchange.com/datacenter/laws/detail/dc_lr_reference_dt08.htm) passed by Congress in 1990. The law mandates that the FDA may approve only those health claims for food that are supported by "significant scientific agreement." The consumer groups believe that qualified claims are in effect unsubstantiated and will only serve to confuse and mislead consumers. "Consumers don't want wishy-washy health advice from the federal government," said Bruce Silverglade, Legal Director of the Center for Science in the Public Interest according to The Washington Post, April 5, 2004. "Putting out shaky scientific advice goes against 100 years of public health tradition."

Long-term Significance
If used effectively, qualified claims should give advertisers useful, additional information with which to sell their products and services. However, some may see the heavy-handed FDA-imposed qualified language as diluting the effectiveness of their advertising. The language required by the FDA is not exactly pithy. Advertisers should also continue to be mindful of the perceived controversial nature of health claims that are coupled with disclaimers and the pending lawsuit challenging their use.