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November 24, 1997
COMMISSION REPORT ON DIETARY SUPPLEMENT LABELS URGES MORE RESEARCH, IMPROVED CONSUMER EDUCATION
Washington, DC-- In a final report issued today, a presidential commission recommended a number of measures to increase the public's knowledge about the role of dietary supplements in promoting good health and urged more scientific research to enhance the knowledge base about supplements.
Saying that consumers should have improved access to scientific information about the need and benefits of supplements, the Presidential Commission on Dietary Supplement Labels urged health professionals to learn more about supplements to help people make appropriate choices and recommended companies make more information available about the scientific evidence supporting nutritional support claims.
On the issue of safety, the Commission emphasized industry's responsibility to ensure product safety and recommended that the industry establish an expert advisory committee to provide guidance on product labeling, safety and benefits. It also urged the Food and Drug Administration and industry to work jointly to improve the post-marketing surveillance system and to improve the reporting for adverse reactions to identify safety concerns earlier.
"CRN congratulates the Commission on completing their assignment with a carefully considered, useful report," said CRN President and Chief Executive Officer John Cordaro. "CRN pledges not to let this report gather dust but to assess its recommendations thoroughly and to forge a partnership between our industry, the regulators, and other affected interests to ensure that consumers have continued access to safe, quality products and to information that will allow them to make informed dietary choices."
As mandated by the Dietary Supplement Health and Education Act of 1994, the seven-member commission was established to review and develop recommendations to govern the standards and processes for evaluating label claims and statements for dietary supplements. Annette Dickinson, Ph.D., CRN Director of Scientific and Regulatory Affairs, served as a member of the Commission. CRN and its member companies provided considerable input to the Commission during its public hearings and during the comment period.
The group began its work in February 1996 and issued its draft report on June 24, 1997, giving interested parties until August 4, 1997 to comment on provisions. In the final report issued today, in response to over 400 comments received from consumers and trade associations, the Commission clarified some areas and made some changes.
-- The Commission's original draft proposal stated that a notification letter for statements of nutritional support should include a summary of the evidence supporting product safety and benefit. This provision has been omitted. Industry opposed the proposal because it goes beyond the express requirements of DSHEA. Moreover, many health professionals and consumer groups also opposed the proposal, saying it would make publicly available a summary not reviewed by the Food and Drug Administration. The extensive public comments, which strengthened some Commissioners' concerns about FDA's authority to require such summaries, led to the withdrawal of the recommendation.
-- The Commission's suggestion that the industry, FDA, health professionals and industry groups work together to improve post-marketing surveillance and adverse reaction reporting system was widely interpreted as calling for mandatory reporting of adverse events. This was not the Commission's intent, and the final report has been modified to make this clear, while retaining the basic recommendations.
-- The Commission especially emphasized that it fully recognizes and supports the marketing of botanical products as dietary supplements, but it also believes FDA should permit the option of marketing some botanicals as over-the-counter (OTC) drugs. Many people misinterpreted the Commission's draft report recommendation that FDA establish an OTC review process for botanicals as a call to regulate all such products as drugs. The final report clarifies the Commission's intent.
The Commission's Executive Director is Kenneth Fisher, Ph.D., who retired in 1994 as Executive Director of the Federation of American Societies for Experimental Biology's Life Sciences Research Office. Malden Nesheim, Ph.D., Provost Emeritus, Cornell University, serves as Commission Chair. Other Commission appointees are: Annette Dickinson, Ph.D., of the Council for Responsible Nutrition; Norman R. Farnsworth, Ph.D., University of Illinois at Chicago; Margaret Gilhooley, L.L.B., Seton University School of Law; Shiriki K. Kumanyika, Ph.D., M.P.H., University of Illinois at Chicago; Robert S. McCaleb, Herb Research Foundation; and Anthony Podesta, Podesta Associates Inc.
KEY PROVISIONS AND IMPACT OF THE FINAL REPORT
The Dietary Supplement Health and Education Act requires that, within 90 days, the Food and Drug Administration announce the availability of the report and propose regulations implementing any necessary changes. There is a 2-year deadline for finalizing those regulations. If the regulations are not completed within 2 years, then regulations established under the Nutrition Labeling and Education Act which set forth general requirements for health claims for dietary supplements will be nullified. This implies that the DSHEA deadline was meant to apply especially to changes in the health claims process, although the Commission addressed many issues beyond health claims.
Health Claims. The Commission supports a "level playing field" for health claims, with the same requirements for approval of health claims relating to dietary supplements as for conventional foods. The Commission makes no recommendations for regulatory changes to the health claims process, although it does make some suggestions for improvements in implementation of the process. In particular, the Commission recommends greater use of outside experts by FDA in reviewing petitions for health claims.
Scope of Statements of Nutritional Support. The Commission makes a number of recommendations regarding the scope of statements of nutritional support. These are intended to provide guidance for industry and FDA, and do not require regulatory action.
Letters of Notification for Statements of Nutritional Support. The Commission makes some recommendations regarding the content of notification letters, but is not suggesting amendment of the FDA regulation on this topic finalized on September 23, 1997. The Commission deleted the provision which appeared in the draft report, recommending that the letters of notification should include a summary of the evidence supporting the safety and benefit of the product, as discussed above. However, the report still urges that summaries of the evidence be made available in some fashion, for the use of consumers as well as health professionals.
Substantiation Files for Statements of Nutritional Support. The Commission provides guidance on the nature of the substantiation which a responsible manufacturer should have for statements of nutritional support. This is intended to provide guidance and does not require regulatory action.
Safety. The Commission emphasizes the responsibility of the industry to continue to assure the safety of dietary supplements, and calls for improvements in post-marketing surveillance and adverse reaction reporting systems, as discussed above. Swift action by FDA is urged, when safety issues require action. No change in existing law or regulations is recommended.
OTC Review. Numerous industry witnesses at Commission hearings expressed the desire, in some cases, to have the option of marketing some botanical products as OTC drugs, when the evidence supports a therapeutic claim that goes beyond the types of statements permitted by DSHEA. The Commission agrees that the OTC option should be available, when appropriate, and believes the OTC review process may be the best way to make this possible. Accordingly, the Commission is urging FDA to promptly establish an OTC review committee for botanicals, with representation of appropriate experts, and to initiate the review process. This is virtually the only Commission recommendation which may require regulatory action by FDA.
Expert Advisory Committee. The Commission observes that industry could benefit from more scientific input into decisions regarding the safety and benefits of dietary supplements, and recommends that industry establish an Expert Advisory Committee to provide advice on these issues.
Office of Dietary Supplements. The Commission recommends that the NIH Office of Dietary Supplements be funded at the level authorized by DSHEA, that it fulfill its assigned role as an advisor to other government agencies on issues affecting dietary supplements, and that it become an effective focal point for research on dietary supplements.
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