Kenneth D. Fisher, Ph.D.
Commission on Dietary Supplement Labels
Office of Disease Prevention and Health Promotion
Room 738G, Hubert H. Humphrey Building
200 Independence Ave., S.W.
Washington, D.C. 20201
RE: FTC Staff Comment on Draft Report of the Commission on Dietary Supplement Labels(1)
Dear Mr. Fisher:
Thank you for the opportunity to comment on the June 1997 draft Report of the Commission on Dietary Supplement Labels ("Report"). As you know, the Federal Trade Commission ("FTC") has responsibility, pursuant to Section 5 of the Federal Trade Commission Act ("FTC Act"), 5 U.S.C. § 45, for the regulation of claims made in advertising about dietary supplements.
The staff of the FTC has followed closely the work of the Commission. We appreciated the opportunity to participate in the September 1996 Commission meeting to discuss the FTC's approach to evaluating substantiation for advertising claims. As we indicated at the September meeting, we believe that consumers benefit from accurate, nonmisleading information about the potential benefits of dietary supplements. The recommendations outlined in the Report will help ensure that consumers are given balanced information about the benefits of supplements, that discussions of the evidence supporting those benefits and any limitations of the evidence are fairly presented, and that consumers are adequately protected from any potential safety risks. These goals are consistent with the FTC's approach to supplement advertising.
Staff would like to offer our comment on a few specific issues. For reference, staff has organized these comments to follow the subject categories of the Report.
Statements of Nutritional Support
Use of Specific Terms in Statements of Nutritional Support
The Report includes several recommendations relating to statements of nutritional support in dietary supplement labeling. First, the Report seeks to provide industry with clearer boundaries between permissible statements of nutritional support and unauthorized health or drug claims. Among other recommendations, the Report identifies specific terms that may be used in labeling, such as "stimulate," "maintain," "support," "regulate," or "promote," as long as they do not suggest disease prevention or treatment. The Report also identifies terms that should not be used, such as "diagnose," "treat," "prevent," "cure," or "mitigate." Staff supports the goal of providing guidance to industry about how to frame permissible claims under DSHEA. As the Report suggests, however, terms used to describe healthy body structure and function may well suggest disease prevention or treatment, depending on context.(2)
Recognizing that many other elements of a product label or ad can influence how consumers interpret claims, our approach is to examine all express and implied messages conveyed by the entire context of the label or advertisement. Thus, additional consumer research may be needed before finalizing a list of approved or unapproved terms. Such consumer research could provide valuable insights about how consumers make distinctions, if any, between health claims, drug claims, and statements of nutritional support. In any event, we believe that it will be important to emphasize that the propriety of using any "approved" term will necessarily depend on the context in which it is used.
Content of Substantiation Files and Use of Consumer Summaries
The Report also provides detailed suggestions about what information should be included in the notification letters that must be filed with FDA, and in the company's own substantiation files for such claims. Among other things, the Report recommends that companies making statements of nutritional support include, both in their substantiation file and in their FDA notification letter, an interpretive summary, prepared by a qualified expert, of the evidence supporting the claim. The Report also recommends that companies prepare a consumer version of the summary to be included in the notification letter and to be made publicly available.
Staff supports the recommendation that appropriate experts prepare a summary of the scientific evidence substantiating a claim. In fact, the first step that FTC staff often takes in evaluating substantiation for a claim is to obtain an evaluation of the supporting evidence by an independent expert. Staff believes that such a summary requirement could assist companies in framing claims that accurately reflect the supporting evidence. It could also be a valuable starting point for both FDA and the FTC in assessing claims for dietary supplements.
Consumers should, as well, be given accurate and understandable information so that they can assess the benefits and safety of a particular supplement. Yet we share the concern noted in the Report that consumer summaries, if not objectively prepared and carefully qualified, could themselves be misleading or be misunderstood.(3)(4)
In order to reasonably inform consumers about the implications of the scientific evidence, consumer summaries would need to fairly present the state of the evidence available to support the claim. Where the supporting evidence is consistent, clear and compelling, a summary would be unlikely to deceive. But where the evidence is mixed, conflicting or preliminary, summaries would need to be carefully crafted and qualified. Consumer research indicates that caveats about the limitations of supporting scientific evidence are often ineffective to prevent a significant number of consumers from taking an absolute message that science has proven the claimed effect.
It is also important to ensure that any consumer summary included in any FDA filing not be understood by consumers as government approved. For example, if a manufacturer claims that the scientific support for the benefits of its supplement are "on file with the United States Food and Drug Administration," consumers may expect that the FDA has reviewed and endorsed that summary. In the absence of some process for government review and approval of the consumer summary before it is made publicly available, staff would recommend inclusion of a clear and prominent disclaimer advising consumers that the summary was prepared by the manufacturer and that the FDA has not made any determination about its accuracy. To help ensure that these summaries are accurate and informative, staff believes that it may also be worthwhile to consider including in any implementing regulations guidelines on how to prepare such summaries, e.g., that the consumer summary be prepared by an objective and independent party, that it be balanced and accurate, that it include a discussion of any conflicting evidence of which the company is or should be aware, and that the submitter certify that the information provided is accurate and complete.
In considering how to implement the Report's recommendations on substantiation statements and the consumer summaries of those statements, it may also be helpful to examine regulatory models of other agencies that require filing of detailed information summaries for possible guidance.(5)
Standard for Substantiating Statements of Nutritional Support
The Report also outlines some general principles on the evidence needed to substantiate statements of nutritional support. The principles correspond, in many ways, to the FTC's approach to substantiation of claims in advertising. For example, the Report indicates that the evidence needed to substantiate a statement of nutritional support will vary depending on a number of factors including the nature of the statement made; that it is appropriate to consider various types of evidence, including epidemiologic studies, human clinical studies, animal studies and in vitro studies; that all relevant evidence, including contrary evidence, must be considered; and that the weight of the evidence should substantiate the claim.(6) Staff supports the Report's proposed flexible approach to evaluating substantiation.
Therapeutic Claims for Botanical Products
The Report calls for a comprehensive evaluation of the regulatory systems of other countries for botanical products, including the current efforts to develop World Health Organization ("WHO") model monographs for botanicals. The Report recommends study of whether an alternative regulatory approach, perhaps modeled after one of these systems, could be implemented to permit certain therapeutic claims for botanical products, in cases where the scientific data would not support approval of the claim under the current standard for OTC drug review. As part of this study, the Report recommends examining what disclaimers might be effective in conveying the distinction between a claim approved under the OTC drug standard and a claim approved under an alternative process for botanicals.
Staff believes the proposal for review of other countries' regulatory approaches to botanical products has merit. Given a growing body of literature suggesting the difficulty of fashioning meaningful disclosures, research may be needed testing disclaimers in the context of actual labeling and advertising to see if consumers understand the basis for the claimed effect. Disclaimers used in other countries are an important starting point, but may not be effective in the United States if consumers here have less familiarity with the therapeutic use of botanical products. Would U.S. consumers, for instance, understand that the disclaimer, "traditional medicine," used for botanical products in Canada, is an indication that the medicinal effects of the product have not been evaluated under the same criteria used for drug products?
The Commission on Dietary Supplement Labels and FDA should also consider how any disclaimer would be communicated. Our anecdotal observations about those instances where the DSHEA disclaimer has been included in advertising suggest that it is often presented in a format that may have little, if any, communicative value. For example, the DSHEA disclaimer has often appeared in fine print at the bottom of the ad where it is unlikely to be noticed by most consumers.
Finally, it is staff's understanding that some botanical products can have powerful pharmacological effects, which may raise safety concerns. Consumers may make incorrect assumptions that these products are inherently safe or safer than synthetic drug products because they are "natural." Staff believes that it may be appropriate in certain circumstances to require warnings about significant safety risks associated with use of these products and particularly about the safety implications of exceeding recommended doses.(7) Staff therefore strongly supports the Report's recommendation that supplement manufacturers include appropriate warnings in product information where necessary.
We look forward to the publication of this valuable Report and will continue to work with FDA staff to ensure consistent approaches to enforcement for dietary supplement labeling and advertising claims.
C. Lee Peeler
Division of Advertising Practices
1. The views expressed in this letter are those of the staff of the Division of Advertising Practices of the FTC's Bureau of Consumer Protection and do not necessarily represent the views of the Federal Trade Commission or any individual Commissioner.
2. A recent study cited by the Report, of how consumers perceive health claims and nutrient content claims in food labeling, stated that 90% of consumers interpreted a nutrient content claim as a claim about the food's health benefits. A. Levy et al., "Consumer Impacts of Health Claims: An Experimental Study," Division of Market Studies, Center for Food Safety and Applied Nutrition, FDA (1997).
4. Consumers, for example, may not be able to make accurate assessments about the relative weight of in vitro, animal and controlled human clinical studies, or to understand certain basic principles of scientific research that may have a significant impact on the strength of support for a claim -- such as whether a study has a control, whether it is double-blinded, or whether it uses the same form and strength of active ingredient as that contained in the supplement. Several recent FTC cases challenged misleading ads that referred to scientific studies as proving the product's efficacy, when in fact for various methodological reasons the studies were not supportive of the specific claims made in the advertising.
5. For instance, one model to consider for preparing summaries of the evidence supporting the safety of a supplement would be the regulations of Department of Labor's Occupational Safety and Health Administration (OSHA) for Material Safety Data Sheets that summarize the science relating to a chemical's health hazards. The material safety data sheets (MSDSs), which are completed by chemical manufacturers, include comprehensive technical information on the physical and health hazards of specific chemicals and serve as a reference document for workers that may come in contact with the chemicals. One pertinent provision of the regulations specifies that if there is any study that reports a statistically significant conclusion regarding the health effects of a chemical it must be reported in the MSDS. The manufacturer may also report results of other scientifically valid studies that tend to refute the findings of a health hazard. See 29 C.F.R. § 1910.1200 Appendix B. In addition, a compliance directive issued by OSHA indicates that the MSDS may not claim that OSHA has made a finding as to whether a particular chemical is hazardous, since the agency does not make case-by-case determinations. See OSHA Instruction CPL 2-2.38C, "Inspection Procedures for the Hazard Communication Standard," Oct. 22, 1990.
6. This last principle is similar to that articulated in the FTC's Food Policy Statement that, where a claim is based on science that is inconsistent with the larger body of evidence, it is likely to be misleading, even if qualified. 59 Fed. Reg. at 28,393-94.
7. The FTC's recently announced consent agreement in Global World Media Corporation provides an example of circumstances where such a safety warning is necessary to alert consumers to the potentially serious health risks of a product. Global World Media Corporation, File No. 9623210 (July 22, 1997)(consent agreement accepted for public comment). The Global World case involved the marketing of an ephedra supplement, Herbal Ecstacy, as a street drug alternative being promoted in large doses, as a safe and natural high. The proposed consent order requires respondents to include a warning in all advertising and labeling for such products about the safety risks of consuming ephedra.