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Major Recommendations from the
Dietary Supplement Commission

Stephen Barrett, M.D.

The Dietary Supplement Health and Education Act (DSHEA) of 1994, defined "dietary supplements" as a separate regulatory category and liberalized what information could be distributed by their sellers. It also created an NIH Office of Dietary Supplements and directed the President to appoint a Commission on Dietary Supplement Labels to recommend ways to implement the act. The Commission's final recommendations were released on November 24, 1997. Here are the highlights.

Safety

• Safety of supplement products must be assured.
• The FDA, the supplement industry, scientific groups, and consumers groups should work together to expand and improve postmarketing surveillance, including adverse reporting systems.
• Product information should include appropriate warnings.
• The FDA should take swift enforcement action to address safety issues, such as those posed by ephedra-containing products. The agency should be given additional resources to do this.

Health Claims

• The approval process for health claims should be the same for dietary supplements and conventional foods.
• The standard of "significant scientific agreement is appropriate but should not require unanimous or near unanimous support.
• To determine whether significant scientific agreement exists for particular claims, the FDA should obtain broad input and use appropriate outside expert panels.

Statements of Nutritional Support

• Statements of nutritional support should provide useful information about the product's intended use.
• Statements of nutritional support should be supported by scientifically valid evidence substantiating that the statements are truthful and not misleading.
• Structure/function statements should not suggest disease prevention or treatment.
• Statements that mention a body system, organ, or function affected by a supplement using such terms as "stimulate," "maintain," "support," "regulate," or "promote" can be appropriate when the statements do not suggest disease prevention or treatment or use for a serious health condition beyond the ability of the consumer to evaluate.
• Statements should not be made for products to "restore" normal or "correct" abnormal function where the abnormality implies the presence of disease. (For example, a claim to "restore" normal blood pressure when the abnormality implies hypertension.)
• Statements of nutritional support are not to be drug claims. They should not refer to specific diseases, disorders, or classes of diseases and should not use such drug-related terms as "diagnose," "treat," "prevent," "cure," or "mitigate."

Substantiation of Nutritional Support Statements

• DSHEA requires manufacturers marketing supplements labeled for "nutritional support" to notify the Secretary of Health and Human Services within 30 days after marketing of a product bearing such a statement. To satisfy this requirement, the notice should include: (1) the identify of the ingredient(s) for which the statement is made, (2) the product's intended use, including recommended dosage, (3) appropriate contraindications or warnings, (4) a brief summary of the evidence and conclusions about safety and effectiveness of the stated dosage, and (5) a consumer version of the evidence on which any claim is made.
• DSHEA requires manufacturers marketing supplements labeled for "nutritional support" to have substantiation. To satisfy that requirement, the manufacturer's substantiation files should contain: (1) a copy of the notification letter, (2) key evidence, including an interpretive summary by a qualified individual, (3) the identity and quantity of the pertinent dietary ingredients, (4) evidence substantiating the ingredient's safety, (5) assurance that good manufacturing practices were followed, and (6) the qualifications of the individual(s) who reviewed the evidence for safety and effectiveness.
• A consumer version of the evidence should be made available to the public for each product bearing a statement of nutritional support. This version should not state or imply use for preventing or treating disease.

Publications Connected to Sales

• Articles provided to consumers must be balanced and truthful. The FDA should promptly issue warnings or undertake enforcement action if it becomes aware of violations.
• The FDA should monitor practices in this area and issue guidelines as needed.

Botanical Products

• The FDA should establish an OTC review panel to review botanical products intended for preventive or therapeutic use.
• For products unable to meet FDA review requirements, creation of an alternative approval system should be considered.

Assessment of Consumer Education

• Research should be done to determine whether consumers want and can utilize information required by existing FDA regulations, DSHEA requirements, and Dietary Supplement Commission recommendations. This would include statements of nutritional support as well as point-of-sale literature.

Expert Evaluation

• The dietary supplement industry should consider establishing an expert advisory committee to provide scientific review of label statements and claims and guidance on safety and appropriate labeling. Such a committee might be supported by one or more trade associations or might be established as an independent entity funded by grants and/or fees for services.

Research Issues

• More research is needed to document relationships between dietary supplements and maintenance of health and/or avoidance of disease.
• Incentive mechanisms should be developed to encourage the dietary supplement industry to invest in more research on consumer products.
• Federal agencies should support research on dietary supplements and botanical products.

Full text of report: [PDF], [HTML]
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This article was posted on September 20, 1999.