Regulating Claims

In the United States, statutes and regulations have not been implemented specifically for functional foods, although dietary supplements are considered distinct from functional foods in some portions of the regulatory structure. Functional foods are addressed through regulation of the claims about their health benefits.

Labeling Statements
Regardless of the type of claim, all food labeling statements must be truthful and not misleading in any particular, as required by the Federal Food, Drug, and Cosmetic Act.

In general, any claim that a food cures, mitigates, treats, or prevents a disease would subject the food to regulation as a drug. However, the Nutrition Labeling and Education Act of 1990 authorized the Food and Drug Administration to allow certain disease-risk-reduction claims, known as health claims, to appear in food labeling. Health claims approved to date have generally been statements to the effect that inclusion of a substance in the diet on a regular basis “may help to reduce the risk” of a named disease.

Evaluating Claims
FDA has evaluated health claims using a standard of significant scientific agreement (SSA)—the conclusion that a sufficient body of sound, relevant scientific evidence shows consistency across different studies and among different researchers. According to the agency, “although SSA is not consensus in the sense of unanimity, it represents considerably more than an initial body of emerging evidence.” When SSA has been achieved, qualified experts would agree that the evidence supports the substance–disease relationship and the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be refined.

In 2002, FDA began allowing “qualified health claims” that would be evaluated using a weight of the scientific evidence (WOSE) standard. The WOSE standard is less stringent than the SSA standard. These qualified health claims would not be formally codified as health claims, but would be allowed under “enforcement discretion.” The agency has published interim guidelines that will be used until the formal rulemaking is complete.

Different levels of scientific evidence would trigger qualifying language that describes the evidence supporting the claim. The agency has developed an evidence- ranking system that is used to assign a final rank to the evidence in support of the claim. The first-level scientific ranking is SSA, used for health claims; claims that meet this standard do not require any clarifying language. The second level may require a disclaimer—appropriate qualifying language—such as, “Although there is scientific evidence supporting the claim, the evidence is not conclusive.” The third-level disclaimer may read, “Some scientific evidence suggests . . ..” However, FDA has determined that this evidence is “limited and not conclusive.” The fourth-level disclaimer notes that “Very limited and preliminary scientific research suggests . . . FDA concludes that there is little scientific evidence supporting this claim.”

Another type of claim that may apply to functional foods (including dietary supplements) is known as a structure/ function claim. The current requirements for these claims differ slightly for foods and dietary supplements, but in general, a structure/function claim describes the dietary impact of the substance on the structure or function of the human body. Structure/ function claims may not claim to treat a disease or its symptoms, and they must not trigger some other requirement for FDA preclearance. Examples of structure/ function claims include, “Calcium helps build strong bones,” and “Protein helps build strong muscles.”

The Expert Report takes issue with the restrictive nature of structure/function claims, noting that “sometimes compliance with the regulations results in misleading (if not outright false) statements of the underlying science.” To avoid drug classification, some claims may not accurately convey the actual effects of the food and may confuse consumers.

Defining Nutritive Value
Another area of current controversy is FDA’s policy regarding nutritive value, which requires that the health benefit of a food component be derived from its nutritive value. FDA defines nutritive value as having “a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.”

There is no consensus on the meaning of this definition, and conflicts exist between legislation, regulations, and other agency documents.

This Expert Report recommends that the benefits for functional foods be based on nutritive value or through the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for a plausible mechanism.

Recognizing the tremendous health benefits offered by functional foods, the Institute of Food Technologists commissioned an expert panel to review the available scientific literature related to functional food development. The panel’s report is divided into nine sections: Definitions, Introduction, Food and Genes, Current Legal Standards, Scientific Standards, Policy Limitations, Bringing Functional Foods to Market, Role of Research, and Conclusions. Copies of the report are available at Founded in 1939, the Institute of Food Technologists is an international not-for-profit scientific society for food science and technology.