![](https://webarchive.library.unt.edu/eot2008/20090117172307im_/http://www.cfsan.fda.gov/lineblue.gif)
U. S. Food and Drug Administration
FDA Fact Sheet
April 27, 1998
![](https://webarchive.library.unt.edu/eot2008/20090117172307im_/http://www.cfsan.fda.gov/lineblue.gif)
FDA's Response to the Report of the Commission
on Dietary Supplement Labels
In today's notice in the Federal Register, FDA responds to the
recommendations and guidance by the Commission on Dietary Supplement Labels
on regulatory and other issues raised by the Dietary Supplement Health and
Education Act (DSHEA) of 1994.
The Commission's final report, included guidance for claims about the
effect of dietary supplements on the structure or function of the body.
FDA's general concurrence with the Commission's views is reflected in the
agency's proposal, also published today, for "Regulations on Statements
made for Dietary Supplements Concerning the Effect of the Product on the
Structure or Function of the Body." (See
separate fact sheet.)
In today's notice, the agency discusses guidance and recommendations
the Commission report addressed to FDA, industry, scientific and other
groups dealing with dietary supplements. The Commission's suggestions and
FDA's responses are summarized below:
- FDA should work with others to improve postmarket surveillance of
dietary supplements. FDA collects reports on serious adverse events
associated with dietary supplements through two monitoring systems, but
agrees that greater cooperation would be helpful. The agency presented this
issue to its Food Advisory Committee (FAC) of outside experts. FAC has
appointed a working group whose findings will be discussed at a later
meeting.
- Manufacturers should include appropriate warning statements in
their product information. FDA intends to work with the Food and Advisory
Committee and industry to develop guidance on the use of warning statements
in dietary supplement labeling.
- FDA should use its enforcement authority under DSHEA to swiftly
resolve potential safety issues. FDA is committed to quickly removing unsafe
products from the market, or to take other timely actions to protect consumers.
- FDA should ensure that there is broad input to ascertain the degree
of scientific agreement for a health claim. FDA has considered and will
continue considering the opinion of outside scientific experts in
determining whether there is significant scientific agreement supporting the
validity of health claims for foods and dietary supplements. This standard
of significant scientific agreement is not affected by the FDA Modernization
Act of 1997, which has provisions affecting health claims. The agency is open
to suggestions from interested parties on how to improve its current approval
process.
- Manufacturers should include in their notification letters for statements
of nutritional support such additional information
as a copy of the product label or the label mockup, and affirm
that they can substantiate, i.e., the truthfulness, scientific validity, and
nonmisleading nature of their labeling claims. FDA agrees, and will consider
new rulemaking on this subject if experience warrants.
- Manufacturers' substantiation for statements of nutritional support
should include such information as identification of the product's ingredients,
evidence of safety, assurances that good manufacturing practices were followed,
and the qualification of the person(s) who reviewed the data on safety and
efficacy. The agency agrees with this guidance.
- FDA should monitor the use of publications used in connection with the
sale of dietary supplements. The agency intends to monitor the use of
"third-party" publications to promote the sale of dietary supplements and,
if necessary, will develop appropriate regulatory guidance to ensure that
the information is balanced and truthful.
- A study is needed on the establishment of an alternative system for
regulating botanicals with medical uses, and FDA should "promptly establish
a review panel" for over-the-counter (OTC) claims made for such products.
When there is sufficient support, FDA should consider the feasibility of
approving
botanicals for OTC uses. FDA has examined the regulatory status
of botanicals with possible OTC uses for years, and has participated in
conferences and symposia dealing with
characterization of, and the safety and effectiveness of, botanical products
for the past five years. The agency agrees that a much more comprehensive
evaluation of a possible alternative system would be helpful. FDA
personnel are available to cooperate with outside researchers on such matters,
but FDA lacks the resources to initiate the comprehensive evaluation suggested
by the Commission. FDA is in the process of proposing criteria for eligibility
in the OTC drug review system that may allow the consideration of
certain botanicals.
The convening of a review panel, as suggested by the Commission would be
premature until such criteria have been finalized.
- A study should be conducted to determine whether consumers want and
can use the available dietary supplement information to select helpful products.
FDA agrees, and has asked FAC to consider how to best gather data on how
consumers
use dietary supplement label information. FAC has appointed an internal working
group to develop recommendations for the full advisory panel.
- FDA should encourage research about dietary supplements. FDA agrees
that additional research should be undertaken to assess the relationships
between
dietary supplements and the maintenance
of health and/or prevention of disease, and it will continue to provide
assistance
and guidance for such research by industry and other federal agencies.
FDA will also continue working closely
with the Office of Dietary Supplements of the National Institutes of Health.
This is a mirror of the page at
http://www.fda.gov/bbs/topics/FACTSHEETS/fs_diet2.html
This document was issued on April 27, 1998.
For more recent information on Dietary Supplements
See
http://www.cfsan.fda.gov/~dms/supplmnt.html
Dietary Supplements
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