HerbalEGram: Volume 5, Number 1, January 2008

The US Food and Drug Administration (FDA) announced in the Federal Register on December 21, 2007, that it intends to reevaluate the scientific evidence regarding certain health claims for dietary lipids and soy protein, as well as certain qualified health claims for antioxidant vitamins and selenium. The deadline to submit public comments to the FDA regarding the reevaluation of these claims is February 19, 2008.

Health claims refer to disease risk reduction claims in the labeling of conventional foods and dietary supplements, which must be pre-approved by the FDA. The FDA authorizes health claims only if the agency determines there is significant scientific agreement among qualified experts that the claim is supported, based on the totality of publicly available scientific evidence, including evidence from well-designed studies. Qualified health claims also require pre-market authorization from FDA, based on the agency’s review of the scientific data and a finding that some credible scientific evidence exists to support such claims.

The FDA originally authorized a health claim for soy protein and risk of coronary heart disease in 1999. According to the Federal Register notice, numerous studies in subsequent years have evaluated the relationship between soy protein and coronary heart disease, and findings have been inconsistent. Likewise, the FDA authorized a health claim for dietary lipids (fat) and cancer in 1993, but subsequent studies have indicated that there might be weak or insufficient evidence to support an association between diets high in fat and increased cancer risk. FDA plans to reevaluate whether the available scientific evidence continues to support FDA’s original decisions on these authorized health claims.

In 2003, the FDA issued 2 letters regarding the agency’s enforcement discretion for qualified health claims on vitamins E and C and risk of certain cancers and selenium and certain cancers. According to the Federal Register notice, a report recently concluded that the total evidence supporting an association between vitamin E and cancer risk is very low and that such an association is also low for selenium. FDA plans to reevaluate the available scientific evidence to determine if there is still support for the qualified health claims, and if so, whether the language of the claims should be modified to reflect a stronger or weaker relationship.

“The FDA is simply requesting assistance from the stakeholder community in identifying recently published and relevant research in these areas that the agency may have overlooked or does not have access to,” said Andrew Shao, PhD, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (e-mail, January 3, 2008). “This represents the initial step in the process of reevaluating the status of health claims (and qualified health claims). This process is important because science evolves over time, especially for the nutrient-disease relationship. We’re seeing benefits from supplementation (in terms of reduction of disease risk) years after clinical trials have been completed and supplementation ceased. Or take beta-carotene as an example. Years of epidemiological data suggested that consumption of beta-carotene-containing foods was inversely related to cancer risk. Then a few clinical trials in smokers or asbestos workers showed that high doses of beta-carotene increased the risk of lung cancer. Now, emerging data suggest that low doses of beta-carotene may be protective against lung cancer in smokers. So the pendulum has swung one way, then the other way, and back again. So it is critical that FDA and other authoritative bodies review and evaluate the data on a regular basis in order to support the best public policy decisions.”

“From a procedural standpoint, I'm not sure how the agency can legally taketh away without some sort of general or broad administrative standard in place to do such,” said Daniel Fabricant, PhD, vice president of scientific and regulatory affairs for the Natural Products Association (e-mail, January 10, 2008).

The Federal Register notice, with instructions on how to send comments, is available here.

—Courtney Cavaliere

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