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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.