FDA's Response to the Report of the Commission on Dietary Supplement Labels

In today's notice in the Federal Register, FDA responds to the recommendations and guidance by the Commission on Dietary Supplement Labels on regulatory and other issues raised by the Dietary Supplement Health and Education Act (DSHEA) of 1994.

The Commission's final report, included guidance for claims about the effect of dietary supplements on the structure or function of the body. FDA's general concurrence with the Commission's views is reflected in the agency's proposal, also published today, for "Regulations on Statements made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body." (See separate fact sheet.)

In today's notice, the agency discusses guidance and recommendations the Commission report addressed to FDA, industry, scientific and other groups dealing with dietary supplements. The Commission's suggestions and FDA's responses are summarized below:

• FDA should work with others to improve postmarket surveillance of dietary supplements. FDA collects reports on serious adverse events associated with dietary supplements through two monitoring systems, but agrees that greater cooperation would be helpful. The agency presented this issue to its Food Advisory Committee (FAC) of outside experts. FAC has appointed a working group whose findings will be discussed at a later meeting.

• Manufacturers should include appropriate warning statements in their product information. FDA intends to work with the Food and Advisory Committee and industry to develop guidance on the use of warning statements in dietary supplement labeling.

• FDA should use its enforcement authority under DSHEA to swiftly resolve potential safety issues. FDA is committed to quickly removing unsafe products from the market, or to take other timely actions to protect consumers.

• FDA should ensure that there is broad input to ascertain the degree of scientific agreement for a health claim. FDA has considered and will continue considering the opinion of outside scientific experts in determining whether there is significant scientific agreement supporting the validity of health claims for foods and dietary supplements. This standard of significant scientific agreement is not affected by the FDA Modernization Act of 1997, which has provisions affecting health claims. The agency is open to suggestions from interested parties on how to improve its current approval process.

• Manufacturers should include in their notification letters for statements of nutritional support such additional information as a copy of the product label or the label mockup, and affirm that they can substantiate, i.e., the truthfulness, scientific validity, and nonmisleading nature of their labeling claims. FDA agrees, and will consider new rulemaking on this subject if experience warrants.

• Manufacturers' substantiation for statements of nutritional support should include such information as identification of the product's ingredients, evidence of safety, assurances that good manufacturing practices were followed, and the qualification of the person(s) who reviewed the data on safety and efficacy. The agency agrees with this guidance.

• FDA should monitor the use of publications used in connection with the sale of dietary supplements. The agency intends to monitor the use of "third-party" publications to promote the sale of dietary supplements and, if necessary, will develop appropriate regulatory guidance to ensure that the information is balanced and truthful.

• A study is needed on the establishment of an alternative system for regulating botanicals with medical uses, and FDA should "promptly establish a review panel" for over-the-counter (OTC) claims made for such products. When there is sufficient support, FDA should consider the feasibility of approving botanicals for OTC uses. FDA has examined the regulatory status of botanicals with possible OTC uses for years, and has participated in conferences and symposia dealing with characterization of, and the safety and effectiveness of, botanical products for the past five years. The agency agrees that a much more comprehensive evaluation of a possible alternative system would be helpful. FDA personnel are available to cooperate with outside researchers on such matters, but FDA lacks the resources to initiate the comprehensive evaluation suggested by the Commission. FDA is in the process of proposing criteria for eligibility in the OTC drug review system that may allow the consideration of certain botanicals. The convening of a review panel, as suggested by the Commission would be premature until such criteria have been finalized.

• A study should be conducted to determine whether consumers want and can use the available dietary supplement information to select helpful products. FDA agrees, and has asked FAC to consider how to best gather data on how consumers use dietary supplement label information. FAC has appointed an internal working group to develop recommendations for the full advisory panel.

• FDA should encourage research about dietary supplements. FDA agrees that additional research should be undertaken to assess the relationships between dietary supplements and the maintenance of health and/or prevention of disease, and it will continue to provide assistance and guidance for such research by industry and other federal agencies. FDA will also continue working closely with the Office of Dietary Supplements of the National Institutes of Health.