. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/766
18 July 2003
(03-3892)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved:
2. Agency responsible:   U.S. Food and Drug  Administration – FDA
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Food (including dietary supplements) for human consumption in the United
States, except for meat, poultry and egg products  that are exclusively regulated by the US
Department of Agriculture
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Trading partners who import food into the United States.
5. Title, language and number of pages of the notified document:  Release of Task Force
Report; Guidance for Industry and FDA: Interim Evidence-Based Ranking System for
Scientific Data; Interim Procedures for Health Claims on the Labeling of Conventional
Human Food and Human Dietary Supplements; Availability (4 pages single spaced,
English).
6. Description of content:   The US Food and Drug Admini stration (FDA) has announced the
availability of the report of its Task Force on Consumer Health Information for Better
Nutrition (the Task force) and two final guid ance documents entitled "Guidance for Industry
and FDA:  Interim Evidence-Based Ranking Syst em for Scientific Data" and "Guidance for
Industry and FDA:  Interim Procedures for H ealth Claims in the Labeling of Conventional
Human Food and Human Dietary Supplements".  FDA is taking this action to inform
interested persons of the release of the Task Force report and to make available the guidances
announced in the Task Force report in accord ance with FDA's good guidance practices.  The
guidances are final on 11 July 2003.  However, you may submit written or electronic
comments on the guidances at any time.  FDA intends to use the evidence-based ranking
system and these procedures on an interim basis.  In the near future, FDA intends to publishan advance notice of proposed rulemaking cons istent with the recommendations of the Task
Force.  As also recommended by the Task Fo rce, FDA intends, within one year, to initiate
notice-and-comment rulemaking to establish scientific review criteria and procedures for
qualified health claim petitions.  By that time, FDA expects to complete the consumer studies
research as described in the Task Force report (Attachment D).  The results of this research,
together with further evaluation of the regulato ry alternatives identified by the Task Force,
with the benefit of public comment, and ev aluation of any additional alternatives that
stakeholders suggest in response to the adva nce notice of proposed rulemaking, will inform
the rulemaking FDA intends to initiate.
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[   ] protect humans from animal/plant pest or  disease, [   ] protect territory from other
damage from pestsG/SPS/N/USA/766
Page 2
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s) in which these are available:  Notice in the Federal
Register  (FR), 68 FR 41387-41390  (available in English):
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-17702.htm .  Submit written requests for
single copies of the Task Force report and the final guidances to the Office of Nutritional
Products, Labeling, and Dietary Supplement s (HFS-800), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740.  Send one self-addressed adhesive
label to assist that office in processing your request.  The Task Force report is also
available on FDA's Web sites at: http://www.fda.gov/oc/mcclellan/chbn.html  or
http://www.fda.gov/ohrms/dockets/default.htm  .  The final guidances are available at:
http://www.cfsan.fda.gov/  or http://www.cfsan.fda.gov/~dms/guidance.html   (available in
English).
http://www.cfsan.fda.gov/~dms/hclmgui4.html
http://www.cfsan.fda.gov/~dms/hclmgui3.html
10. Proposed date of adoption:  11 July  2003
11. Proposed date of entry into force: 1 September 2003
12. Final date for comments:   The guidances are final on 11 July 2003.  However, you may
submit written or electronic comments at any time.
Agency or authority designated to handle comments:  [   ] National notification
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if
available) of other body:  Submit written comments to the Division of Dockets
Management Branch (HFA-305), Food and Dr ug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, U.S.A.  Please identify whether you are commenting on one
or both of the guidances when you submit your written comments.  It is possible to submitelectronic comments to: http://www.fda.gov/dockets/ecomments.  Submit comments by
indicating DOCKET No. 2003N-0069 and TITLE Release of Task Force Report; Guidancefor Industry and FDA:  Interim Evidence-Based Ranking System for Scientific Data;
Interim Procedures for Health Claims on the Labeling of Conventional Human Food and
Human Dietary Supplements.
13. Texts available from:  [   ] National notification authority,  [ X ] National enquiry point,
or address, fax number and E-mail address (if available) of other body:
Ms. Roseanne Freese, US Department of Agriculture, Stop 1027, Washington, DC  20250.
Tel (202) 690-1642 (202) 690-1642, fstsd@usda.gov .  Complete text can be also be found
on the Internet:  http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking
under DOCKET No. 2003N-0069.