[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Notices]
[Page 64957-64958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0458]
Dietary Supplements; Strategy for the Further Implementation and
Enforcement of the Dietary Supplement Health and Education Act of 1994;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of its strategy for the further implementation of the
Dietary Supplement Health and Education Act of 1994 (DSHEA). The
strategy sets forth a series of specific, integrated research and
regulatory measures, including guidance, regulations, and science-based
compliance and enforcement mechanisms. Through implementation of these
measures, FDA hopes to improve the transparency, predictability, and
consistency both of the agency's scientific evaluations of dietary
supplement product and ingredient safety, and of its regulatory actions
to protect consumers against unsafe dietary supplements and dietary
supplements making unauthorized, false, or misleading claims. FDA
expects that this improved transparency will help engage stakeholders
in the development of further measures to implement DSHEA.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written requests for single copies of the strategy
for the further implementation of DSHEA to Vickey Lutwak, Center for
Food Safety and Applied Nutrition (HFS-810), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1775, FAX: 301-436-2636, e-mail: Vickey.Lutwak@fda.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Vickey Lutwak, Center for Food Safety
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1775, FAX: 301-436-
2636, e-mail: Vickey.Lutwak@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In January 2000, FDA's Center for Food Safety and Applied Nutrition
(CFSAN) issued its ``Dietary Supplement Strategy: Ten Year Plan'' (the
10-year plan) (accessible at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/ds-strat.html
). The 10-year plan sets as a goal a science-based regulatory
program that fully implements DSHEA and affords consumers a high level
of confidence in the safety, composition, and labeling of dietary
supplement products. The 10-year plan sets forth a series of critical
initiatives: (1) Improving the safety of products through, for example,
regulations on current good manufacturing practice requirements for
dietary supplements, guidance on premarket safety notifications for new
dietary ingredients, and better adverse event report monitoring; (2)
improving the labeling of products by, for example, clarifying what
data and information are needed to substantiate structure/function and
related claims in the labeling of a product; (3) clarifying the
boundaries between dietary supplements, conventional foods, and drugs;
(4) taking enforcement action against unsafe products and products
whose labels are inaccurate or
[[Page 64958]]
misleading; (5) developing a sound science base for dietary supplement
regulation through enhanced research and analytical capabilities and
collaboration with governmental and external partners; and (6)
expanding outreach to stakeholders.
The strategy now being announced describes a series of specific,
integrated steps that will bring CFSAN closer to achieving each of its
longer-term goals for DSHEA implementation and enforcement under the
10-year plan. This strategy also is consistent with the ``Dietary
Supplement Enforcement Report'' announced in December 2002 (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/mcclellan/chbn.html
), and it incorporates and is in
furtherance of CFSAN's 2004 Program Priorities, announced in May 2004
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/cfsan404.html). We are making this
strategy available to maximize the sharing of information among the
agency, consumers, and stakeholders about implementation of DSHEA.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
strategy. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. The strategy and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Person with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/ds-stra3.html.
Dated: October 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24870 Filed 11-4-04; 8:45 am]
BILLING CODE 4160-01-S