June 24, 1997
Contact:
Moira Saucer
(202) 872-1488
COMMISSION REPORT ON DIETARY SUPPLEMENT LABELS SUPPORTS MORE INFORMATION FOR CONSUMERS
Washington, DC-- In a report issued today, a presidential commission said that consumers should have improved access to useful scientific information about the benefits and need for dietary supplements and recommended a number of measures to enhance the public's knowledge about the role of supplements in health promotion and disease prevention.
The draft report, released by the Presidential Commission on Dietary Supplement Labels, urges more scientific research to enhance the knowledge base about supplements as well as more consumer research to evaluate consumer understanding of dietary supplement labeling. It also recommends that health care professionals learn more about supplements to help consumers make appropriate choices and that companies provide more labeling information to inform consumers about scientific evidence that supports nutritional support claims.
Addressing the issue of safety, the report says the industry bears responsibility for ensuring product safety. It also recommends that the Food and Drug Administration (FDA) and industry work together to improve the post-marketing surveillance system to identify safety problems earlier and recommends that the industry establish an advisory committee to provide guidance on product labeling, safety, and benefits.
"The Council for Responsible Nutrition (CRN) congratulates the Presidential Commission on Dietary Supplement Labels on completing its report in a timely, useful, and objective manner," said John Cordaro, CRN President and Chief Executive Officer. He added, "The ultimate value of this report will depend upon the commitment of time and effort made by affected interests--regulators, consumers, scientists, and especially industry--to assess the findings and implement appropriate next steps."
The seven-member commission was established by the Dietary Supplement Health and Education Act of 1994 (DSHEA) 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, is a member of the Commission. CRN and its member companies provided considerable input to the Commission during its public hearings, and the report incorporates a number of suggestions made by industry representatives.
Said Cordaro, "CRN recognizes that the report does not answer all of the questions and challenges faced by industry and federal regulators. However, we are pleased with the tone of the report and its generally positive attitude towards dietary supplements. We hope to work closely with federal officials to promote policies that recognize there is an appropriate role for dietary supplements and to educate consumers about their use for improving health and reducing disease risk."
Following today's release of the draft report, the public has until August 4, 1997, to comment on the report. The final report will be sent to the President, Congress, and the Department of Health and Human Services by late August or early September. CRN will use the comment period to review the Commission's recommendations with its members and to develop a response. The trade association's top priority is to ensure appropriate implementation of DSHEA to allow consumers access to safe products, made to quality standards with credible and useful information.
FDA is obligated under DSHEA to issue a notice of the Commission's recommendations and a notice of proposed rulemaking within 90 days after the date of the final report. The agency is required to complete rulemaking no later than two years after the final report date.
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., The University of Illinois at Chicago; Margaret Gilhooley, L.L.B., Seton University School of Law; Shiriki K. Kumanyika, Ph.D., M.P.H., The University of Illinois at Chicago; Robert S. McCaleb, Herb Research Foundation; and Anthony Podesta, Podesta Associates Inc.
The Commission began its work in February 1996, and held a number of public meetings to gather viewpoints from interested parties, including consumer groups and industry representatives. A summary of the Commission's major recommendations and CRN's perspective on some of the issues follows. Health Claims. A key charge of the Commission was to evaluate the process and mechanism by which the FDA approves health claims, which are label statements that acknowledge a diet and disease link. Notably, the Commission recommends that the standard of "significant scientific agreement" governing the approval of health claims should not be overly interpreted to imply "consensus." Further, it notes that FDA should make more use of outside experts and give considerable weight to recommendations made by other federal agencies. The report also says there should be a level playing field for health claims for foods and dietary supplements.
CRN has previously criticized the health claims review process. Currently, FDA interprets "significant scientific agreement" to mean virtually unanimous agreement among qualified experts. The trade association has repeatedly called for FDA to apply a more appropriate standard to the approval of health claims to permit more information about the state of scientific evidence on diet and disease relationships to reach consumers. Since the passage of the Nutrition Labeling and Education Act (NLEA) in 1990, the FDA has approved only two health claims for supplementsæone for the association between folic acid and the prevention of neural tube birth defects and the other for the link between calcium and the reduction in risk of osteoporosis. Ensuring Product Safety. Despite the fact that safety issues were not a formal charge of the Commission, it devoted considerable effort and time to discussing this important topic. The report affirms that the industry bears the responsibility for safety. Post-marketing surveillanceæespecially adverse reaction reportingæshould be improved, it says. On the other hand, the Commission emphasizes that FDA already has the power to take swift action when needed to remove unsafe products from the market but that the agency may need additional resources to meet the burden of proof on safety issues. CRN has had a number of discussions with FDA about the need for the agency to respond more quickly when problems arise. In addition, the trade association has offered to work in close partnership with the agency to develop an improved system for reporting adverse reactions that would identify problems and enable the FDA to take early action.
Expert Advisory Committee Proposed. The Commission recommends that the industry consider establishing an Expert Advisory Committee on Dietary Supplements. This group would provide scientific review of label statements and guidance to the industry regarding safety, benefit, and labeling. CRN will recommend the establishment of a permanent mechanism such as a foundation to support such an Expert Advisory Panel. Statements of Nutritional Support. The Commission confirms that statements of nutritional support, which are general statements about the health effects of supplements on the body, should provide useful information to consumers and should be substantiated. It also emphasizes that such statements should not imply a nutrient/disease link, as health claims do, should not use drug terminology, and should not refer to the ability of a supplement to "restore" or "correct" any abnormal function that implies the presence of disease. However, the report does reflect the views of some Commissioners who believe that statements about the cholesterol-lowering action of a supplement should be permissible. Substantiation of Claims for Consumers. The Commission supports the idea of providing a consumer version of scientific evidence substantiating statements of nutritional support. This information would put the available scientific research into context and could be conveyed on product labels, in package inserts, or in brochures. It would most likely be viewed as product labeling and be required to meet FDA's standards for such labeling. Publications Used in Connection with Sale. The Commission reaffirmed that third party literature should meet the five requirements established by DSHEA for exemption from labeling regulations. The report notes that this information should be "balanced," acknowledging negative as well as positive studies and fairly reflecting the evidence. Claims Notification and Substantiation. The Commission specifies the types of information that a manufacturer should be required to supply when giving notice to FDA about its use of a statement of nutritional support on a product label. A letter of notification to the agency with basic information about the company and the product (name, product description, copy of the label) should be supplied, as well as the following:
-- the identity of the "active" ingredient
-- a statement of intended use
-- any contraindications or warnings
-- the wording of the statement of nutritional support
-- a brief summary of substantiation for safety and benefit
-- a consumer version of evidence substantiating the benefit
The company must have a substantiation file with additional information, including:
-- a copy of key evidence substantiating the statements and an interpretive summary
-- key evidence supporting safety
-- assurance of good manufacturing practices
-- the qualifications of those individuals reviewing the substantiation and safety evidence
The Commission's recommendations for claims notification and substantiation go beyond the requirements recently proposed by FDA. More Research Needed to Support the Health Benefits of Supplements. The Commission said that more scientific study is needed to enhance knowledge about the role of dietary supplements in promoting health. Specifically, the report recommends that the National Institutes of Health's Office of Dietary Supplements become more pro-active and that industry be given more incentives for research. Moreover, the report says that research by Federal agencies should be expanded beyond the study of vitamins and minerals to include research on promising botanical products used as dietary supplements. Research Needed on Consumer Understanding of Label Claims. The Commission says that consumer research is needed to evaluate consumer understanding of dietary supplement labeling. Moreover, health professionalsæphysicians, nutritionists, and dietitiansæshould become more knowledgeable about dietary supplements in order to assist consumers in making appropriate choices. CRN has urged the US Department of Agriculture to sponsor a White House Conference on human nutrition research to focus on potential prevention benefits and to determine what needs to be done to translate research results into messages consumers can use to improve their health and well-being. Botanicals. The Commission reaffirms that herbal and botanical products are eligible for claims authorized by NLEA and DSHEA, yet cautions that drug claims go beyond the scope of permissible claims under DSHEA. However, recognizing that some botanicals may be eligible for drug claims, the Commission recommends FDA establish an over-the-counter review process with appropriate experts and move forward promptly with a botanical OTC review. The report says that more study is needed regarding possible alternative systems for regulating therapeutic claims for botanicals but this issue falls outside of the Commission's mandate. CRN has previously said that DSHEA does not allow therapeutic drug claims for dietary supplements and has opposed the creation of a new statutory or regulatory category for herbal products that would require an amendment to DSHEA.
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