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In response to an Advance Notice of Proposed Rulemaking, the staff of the �鶹��ý Trade Commission has submitted a comment to the U.S. Food and Drug Administration (FDA) addressing how “qualified health claims” in the labeling of conventional human foods and dietary supplements should be regulated. Health claims are statements about the relationship of a substance in the diet to a disease or health-related condition. “Qualified health claims” are statements that have been qualified to convey that a diet-disease relationship is supported by less than significant scientific agreement. The FTC staff comment, which is now available on the FTC’s Web site, also provides the FDA with information about consumer research conducted by the FTC staff. This research suggests that consumers can distinguish between levels of scientific support for health claims, but that strongly worded qualifiers may be needed to avoid deception.

Overall, the comment states the staff’s support for allowing marketers to communicate truthful, non-misleading health claims for foods and dietary supplements when appropriately qualified to indicate the level of scientific support for the claim. Howard Beales, Director of the FTC’s Bureau of Consumer Protection, states, “Truthful health information empowers consumers and spurs product innovation. Thus, permitting appropriately qualified health claims likely would help consumers to make better-informed food choices and encourages food marketers to develop and market foods based on their health attributes.”

The staff believes that regulation of qualified health claims should recognize the importance of protecting consumers from deception, promote truthful, non-misleading commercial speech, and ensure flexibility in accommodating changes in science. Todd Zywicki, the Director of the FTC’s Office of Policy Planning, notes, “The comment, which describes FTC staff research on qualified health claims, continues a long FTC tradition of using empirical evidence to analyze policy.” The comment also states that FDA’s “evidence-based” ranking system, described below, would provide marketers with an incentive to seek scientific support for their claims.

Background

Under the Nutrition Labeling Education Act and the FDA’s implementing regulations, the agency approves only “unqualified health claims” for foods and dietary supplements that are supported by significant scientific agreement. Accordingly, the FDA had refused to approve health claims that were not supported by significant scientific agreement, even if the claim as qualified was truthful, on the basis that the claim would potentially mislead consumers. This refusal resulted in the ability of marketers to communicate promising scientific developments until the scientific community had arrived at significant scientific agreement. Several courts, however, held that the prohibition on claims not supported by significant scientific agreement violates the First Amendment unless the government can prove that, even with qualifying language the claims would still mislead consumers.

As a result of the court decisions, the FDA has begun to implement an interim enforcement approach that allows marketers to communicate truthful, non-misleading claims that are qualified appropriately to indicate the level of the scientific support for the claims. Together with this enforcement approach – which is described in the staff comment – the FDA is developing an “evidence-based ranking system.” Under this system, the agency reviews the science submitted in support of a claim, assesses the science (considering such factors as the number of individuals in the study, the type of study, the study methodology), and ranks the claim with a letter (A, B, C, or D) corresponding to the level of support for the claim.

Through the ANPR, the FDA seeks comment on whether to adopt the interim enforcement approach and the evidence-based ranking system on a permanent basis, or whether to adopt some other approach. The FDA also solicits current empirical research relevant to consumer interpretation of qualified health claims to supplement its own research to ensure that the rankings communicate the level of support for a qualified claim effectively. The ANPR also asks what incentives marketers have to gather data or take other steps to advance the science to the point of SSA, if marketers are permitted to make qualified claims that are not supported by SSA.

The Staff Comment

• The FTC staff supports FDA’s initiative to allow properly qualified health claims because it is likely to increase the flow of truthful, non-misleading health information to consumers, while at the same time maintaining strong protections against deception.
  
  
• The comment emphasizes that the FDA’s regulatory approach should have two key elements: 1) given the importance of truthful, non-misleading information to both consumers and competition, any approach should be designed to maximize communication of this information; and 2) the approach must be flexible enough to allow claims to be changed as the science changes.
  
  
• The FTC staff believes that codifying the FDA’s interim approach is acceptable, although more experience with the approach and further consumer research are needed to reach definite conclusions about its merits. The comment, however, takes no position on whether some other approach might be preferable, given the FDA’s mission, authority, and resources.
  
  
• Consumer research conducted by the FTC staff suggests that consumers can distinguish between levels of scientific support, but that strongly worded qualifiers are needed to avoid deception when the level of scientific support is weak.
  
  
• The FDA’s evidence-based ranking system provides marketers with some incentives to further develop the science in support of their claims. The FDA can provide additional incentive by taking steps to emphasize the distinctions between the levels of science supporting claims.

Concluding its comment, the staff wrote, “The FDA’s ongoing efforts to develop an empirically based approach to qualified health claims for food and dietary supplement labeling will likely benefit consumers and competition. We believe that the development and adoption of this approach will lead to better informed consumers who will be able to select from a broader range of healthier products. We therefore support the FDA’s efforts to develop such an approach.”

The Commission vote authorizing staff to file the comment in response to the FDA’s request was 5-0. (FTC File No. V040006; the staff contacts are Maureen K. Ohlhausen, Office of Policy Planning, 202-326-2632; Thomas B. Pahl, Division of Advertising Practices, 202-326-2128; see related press release dated December 15, 2003.)

NOTE: The views expressed in the comment are those of the staff of the FTC’s Bureaus of Consumer Protection and Economics and the Office of Policy Planning, and do not necessarily represent those of the Commission or any individual commissioner.

Copies of the comment to the FDA are available from the FTC’s Web site at and also from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at . The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.