The Pearson Decision and Qualified Health Claims

On October 31, 2000, the Food and Drug Administration responded to the third of four proposed health claims for dietary supplements that were the subject of the infamous “Pearson decision” with a new twist in the health claims arena: a “qualified health claim” approved solely for a dietary supplement, and thus far only for the alleged relationship between omega-3 fatty acids and coronary heart disease (CHD).

The case of Pearson and Shaw v. Shalala challenged FDA’s 1993 decision to deny four health claims: antioxidant vitamins and certain cancers, omega-3 fatty acids and CHD, fiber and colorectal cancer, and dietary supplements as a superior source of folic acid for reducing the risk of neural tube defects. Ultimately, the U.S. Court of Appeals for the D.C. Circuit found for the plaintiffs and directed FDA to reconsider authorization of these claims; further clarify the “significant scientific agreement” standard it requires for authorization of new health claims, and consider whether health claims could be approved with appropriate disclaimers such that the label statement would still meet the regulatory standard of being “truthful and not misleading.”

FDA has updated the scientific evidence for the four health claims, issued guidance clarifying the significant scientific agreement standard, and held a public meeting regarding health claims for dietary supplements. In October 2000, FDA revoked its regulations that disallowed the health claims, but then denied a health claim for fiber and colorectal cancer (saying that scientific studies have not shown a relationship between dietary fiber supplements and risk of colorectal cancer) and a health claim for folic acid provided by dietary supplements (saying that the claim could not be qualified without being misleading). At the time of this writing, FDA has not responded to the proposed claim for antioxidant vitamins and cancer.

FDA also issued an interim enforcement strategy in which it will permit qualified health claims for dietary supplements if a petition for the claim has been accepted for filing; the evidence in support of the claim outweighs the evidence against the claim; the claim is appropriately qualified to reflect the weight of the supporting evidence; the claim is not otherwise misleading; there is no health or safety issue; and all of the other health claims requirements are met except for the significant scientific agreement standard.

This brings us to the qualified health claim for omega-3 fatty acids: “The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population.”

Even in its review of recent scientific evidence, FDA did not find the evidence linking omega-3 fatty acids and reduced CHD risk to be either conclusive or specific; therefore the significant scientific agreement standard has not been met. FDA concluded that use of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as dietary supplements is safe, as long as daily intake does not exceed 3 g/day from a combination of foods and dietary supplements.

FDA also concluded that the weight of the scientific evidence for the claim outweighs the evidence against the claim and that products that use the qualified health claim must limit the amount of EPA and DHA recommended in the labeling to no more than 2 g/day or the product would be considered misbranded.

But does FDA’s example claim above communicate this to the consumer? Is it even clear that omega-3 fatty acids may reduce the risk of CHD, or is that lost in the qualifiers? Will consumers even notice, or care? And what about food sources of omega-3 fatty acids, which currently cannot even list the content of omega-3 fatty acids separately because there is no established Daily Value for this dietary component?

FDA has clearly focused on dietary supplements, but how can food sources of the same components be ignored? Rich sources of omega-3 fatty acids include fatty fish such as salmon, tuna, mackerel, and swordfish, and also flaxseed and canola oil. In addition, one company, Gold Circle Farms, has altered its chicken feed to boost the amount of DHA in a single egg to 150 mg, about the same amount as in 3 oz of salmon. How can foods be denied the opportunity to inform consumers of the same suggestive evidence that would encourage consumption of their DHA- or EPA-rich products?

We know very little about consumers’ perceptions of health claims on dietary supplements, or for that matter their perceptions of structure/function claims. Do consumers even notice the required disclaimer statement? If they do, are they more cautious of the claims made, or do they applaud the fact that FDA hasn’t restricted the information provided? These are questions that need answers before the market is flooded with murky label statements that leave consumers (and professionals) scratching their heads wondering what to eat or not eat, what supplements to take or to avoid.

The Pearson decision was certainly a victory for the First Amendment, but it has opened the door for health claims that may require so many qualifiers that they are unintelligible. In that sense, the Pearson decision may not turn out to be a victory for the consumer.

by R. Elaine Turner is Assistant Professor, Food Science and Human Nutrition Dept., University of Florida, Gainesville.