The Dietary Supplement Health and Education Act (DSHEA), signed into law on October 25, 1994, mandated the establishment of the Commission on Dietary Supplement Labels. The appointments of the seven members of the Commission were confirmed by the President on November 9, 1995. The Commission received its charter from the Secretary of Health and Human Services on February 13, 1996.
From February 1996, to August 1997, the Commission held nine meetings. The first four meetings focused on obtaining comments, data, and information from interested individuals and organizations. In addition, the Commission invited testimony from the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and several organizations that represent consumer groups as well as the dietary supplement and food industries. Based in part on the testimony received during the course of the eight meetings, the Commission continually revised its list of key issues. Each of these key issues was assigned to an ad hoc subcommittee of the Commission or to the Commission staff for further research and study, and for development of draft materials for discussion by the full Commission at subsequent meetings.
Meeting # 1. February 16, 1996, Washington, D.C. The Commission agreed on procedural aspects and the scope of work. Testimony was received from the Food and Drug Administration, the Office of Dietary Supplements of the National Institutes of Health, and three interested organizations. The former two discussed their responsibilities under DSHEA; the latter three provided their perspectives on the scope and responsibilities of the Commission.
Meeting # 2. March 8, 1996, Salt Lake City, Utah. Nineteen individuals, representing consumers, manufacturers, retailers, and dietary supplement industry organizations, addressed the Commission, commenting on the Commission's charge and discussing issues they thought should be considered by the Commission.
Meeting # 3. April 26, 1996, San Francisco, California. Sixteen individuals and organizations provided comments to the Commission. Four represented dietary supplement producers, three presenters had specific information and comments on herbs and phytomedicines, three others offered comments and information from the perspective of educational institutions, five presented views of consumers, and one provided a view as a registered dietitian. Two ad hoc Subcommittees discussed key issues for Commission consideration and reviewed health claim regulations; both ad hoc Subcommittees reported to the full Commission. The Commission agreed that the meeting on June 6, 1996, in Orlando, Florida would complete the oral testimony component of the Commission's efforts and June 30, 1996 would be the cutoff date for submission of public comments.
Meeting # 4. June 6, 1996, Orlando, Florida. Thirteen persons, representing scientific societies, consumer organizations, State government officials, and supplement manufacturers, presented information and views to the Commission. Ad hoc Subcommittee reported to Commission on current regulations governing label statements. Commission agreed to extend the deadline for public input of written submissions to August 30, 1996.
Meeting # 5. September 19 and 20, 1996, Reston, Virginia. Written comments submitted to the Commission as of the extended deadline date, August 30, 1996, were summarized; a number of recurrent themes were noted. These included safety issues; effects of label statements; truthfulness of label statements; consumer information; content, and review of, and access to the substantiation files supporting product label statements; possible use of external third-party review panels; regulatory categorizations of botanical products; and clarification of what constitutes a structure/function type of statement of nutritional support. Commission discussions focused on the process, procedures, and guidelines for review of label claims and petitions for marketing herbals and botanicals. A representative from the Division of Over-The-Counter Drug Products, FDA, answered questions concerning the possible application of the over-the-counter drug review process to botanical dietary supplements that make preventive or treatment claims. A representative from the Division of Advertising Practices, FTC, provided an overview of the agency's regulatory procedures for dealing with dietary supplements and foods. Summaries of the progress of several ad hoc subcommittees held since June 7, 1996, were reviewed by the full Commission.
Meeting # 6. October 24 and 25, 1996, Washington, D.C. The Commission reviewed and reached tentative agreement on findings and recommendations about several key issues: safety of dietary supplements, literature at point of sale, content of notification letters, and regulatory management of dietary supplements in other countries. In addition, the Commission discussed regulatory options for herbals and botanicals and explored issues relating to structure/function statements and health claims raised by the content of notification letters.
Meeting # 7. December 16, 1996, Washington, D.C. The Commission met to review draft materials on events that led to passage of DSHEA and characteristics of consumer use of dietary supplements. Drafts of tentative findings and possible recommendations for the Commission's report were reviewed. The Commission decided to revise these findings and recommendations and have the redrafts recirculated to the full Commission prior to the meeting on March 4, 1997. The Commission approved the establishment of an Information Response Center to handle inquiries form the public. The Commission discussed the possibility of making a draft of the report available for public comment.
Meeting # 8. March 4, 1997, Baltimore, Maryland. The Commission invited testimony from specific groups that had testified previously on the regulatory management of botanical remedies and possible use of third-party evaluation of dietary supplement label statements. Five presenters represented various trade organizations in the dietary supplement and food industries, two represented public interest groups, and two represented scientific and professional groups. In addition, the Commission discussed revised drafts of sections of the report. Comments on revised drafts of the findings and recommendations were forwarded to the Executive staff for inclusion in the draft report of the Commission. The Commission agreed to make the draft report available for public comments.
Revisions of the several sections of the draft report prepared by individual Commission members and the staff were circulated to the full Commission from March 5 to May 23, 1997. With the agreement of the Commission members, the publicly available draft report was prepared and released for public comment. Submission of written comments from all interested parties was solicited.
Draft Report Release. Consistent with the decision of the Commission on March 8th, the draft report was released on June 24, 1997. There is no requirement for release of a draft report in either DSHEA or the Federal Advisory Committee Act. However, the Commission was aware of the public interest in its work and desired to have an additional period for public comment on the Commission's findings and recommendations. Because the Commission's funding was about to expire at the end of Fiscal Year 1997, only a limited time was available for comments.
Meeting # 9. August 14 and 15, 1997, Reston, Virginia. The Commission reviewed over 400 comments submitted by the public on the draft report. In addition, the Commission identified portions of the draft report that needed further clarification and explanation. The Chair assigned responsibilities for revisions to the Commission members and staff. A revised final draft was prepared and circulated to the Commission members for review and approval.
Final Report Release. The final report of the Commission on Dietary Supplement Labels was delivered to the Office of the President, the Congress, and the Secretary of the Department of Health and Human Services on November 24, 1997. The final report is available from the Government Printing Office and is on the Internet at http://www.health.gov/dietsupp.
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Commission on Dietary Supplement Labels