[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Page 64957-64958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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.


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 

    Dated: October 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24870 Filed 11-4-04; 8:45 am]