To Your Health

Qualified and unqualified health claims

Q. The FDA recently allowed a "qualified health claim" for foods containing EPA and DHA. Does this mean they aren't really sure the claim is true?

A. The primary job of the Federal Food and Drug Administration is to ensure food and drug safety. Until the early 1990s, they interpreted this directive to also embrace control over information relating to the use of food supplements. As late as 1992, FDA agents were conducting armed raids on stores and physicians' offices that were selling or recommending coenzyme Q10 and other such nutritional products. The negative public reaction to these tactics was likely part of the reason for passage of the Dietary Supplement Health and Education Act of 1994, which increased the amount of information that can be legally provided directly to prospective buyers of food supplements.

In 2002, the FDA announced a new proposal, known as the Better Nutrition Information for Consumer Health Initiative, designed to encourage the flow of science-based information regarding the health benefits of dietary supplements as well as conventional foods. Under this plan, marketers are allowed to make health claims for foods and food supplements based on "Significant Scientific Agreement." An example of a claim with Significant Scientific Agreement would be that "Calcium supplements may reduce the risk of osteoporosis." This would be an "unqualified" health claim.

However, the courts ruled that prohibiting even those health claims not supported by Significant Scientific Agreement violated First Amendment rights to free speech. As a result, the FDA has begun to allow "qualified health claims" that allow marketers to make truthful claims based on less scientific support than that required for unqualified health claims. Statements about diet and disease relationships are allowed as long as the claim about the relationship is "qualified" in such a way as to not mislead consumers. The claim that eicosapentaenoic acid and docosahexaenoic acid, the major omega-3 fatty acids in foods, reduce risk of coronary heart disease can be stated: "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease." "Scientific evidence suggests but does not prove ..." and "Some scientific evidence shows that ..." are examples of other qualifiers.

Both unqualified and qualified health claims describe a relationship between a nutrient and a disease or health-related condition, and are supported by scientific evidence. All claims are reviewed by the FDA, and the amount of evidence and the degree of consensus among researchers determines whether an "unqualified" or "qualified" claim is allowed. A nutrient that has been studied for decades, such as calcium, has a much easier time of achieving an "unqualified health claim." For nutrients such as EPA and DHA, with only a few years of research information on which to base a claim, it should be only a matter of time before a "qualified health claim" can be converted to an "unqualified health claim."

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