. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/699
26 March 2003
(03-1741)
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:   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):  Dietary Ingredients and Dietar y Supplements (HS Section IV)
4. Regions or countries likely to be affected, to the extent relevant or practicable:
US Trading Partners, specifically firms and entities seeking to manufacture, pack or hold
covered products for or participate in the expo rt to or import from the United States of such
products.
5. Title, language and number of pages of the notified document:  "Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and
Dietary Supplements".  (Available in English, 171 pages)
6. Description of content:   The Food and Drug Administration (FDA) is proposing current
good manufacturing practice (CGMP) regulations for dietary ingredients and dietary
supplements.  The proposed rule would establish the minimum CGMPs necessary to ensurethat, if you engage in activities related to manufacturing, packaging, or holding dietary
ingredients or dietary supplements, you do so in a manner that will not adulterate and
misbrand such dietary ingredients or dietary supplements.  The provisions would require
manufacturers to evaluate the identity, purity, quality, strength, and composition of their
dietary ingredients and dietary supplements.  The proposed rule is one of many actionsrelated to dietary supplements that we (FDA) are taking to promote and protect the public
health.
Since 1993, FDA has received many  dietary supplement-related adverse event reports. Many
of these reports relate to misbranding and/ or adulteration, and private laboratory studies
suggest that some supplements do not contain the amount of dietary ingredients claimed in
their labeling.  This proposed rule will es tablish mandatory minimum CGMPs necessary to
ensure that dietary ingredients are neither adulterated nor misbranded.  The proposed rule
includes requirements for designing and constructing physical plants, establishing quality
control procedures and testing manufactured di etary ingredients and dietary supplements.  It
also includes proposed requirements for maintaining records and for handling consumer
complaints related to CGMPs.  It does not limit consumer access to dietary supplements nordoes it ensure the safety or claimed effect of  a particular dietary ingredient independent
whether the product is produced under CGMPs.
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/699
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:  This document
represents a new proposed rule and is available in English, 171 pages:
http://www.cfsan.fda.gov/~lrd/fr030313.html , English.
The Advanced Notice of Proposed Rulemaking (ANPR, 62FR 25:5699-5709,
6 February 1997) can be found at http://www.cfsan.fda.gov/~lrd/fr970206.html , English.
10. Proposed date of adoption:  To be determined
11. Proposed date of entry into force:  Staggered following final rule:  one year large business,
two years medium business, and three years small business.
12. Final date for comments:  Submit written or electronic comments by 11 June 2003.
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 on the document to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852, U.S.A. It is possible to submit electronic comments to:
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating DOCKET
No. 96N-0417 and title of document "C urrent Good Manufacturing Practice in
Manufacturing, Packing, or Holding Dietary Ingredients and 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:
United States SPS Enquiry Point / Notification Point
Mr. William Janis
U.S. Department of Agriculture
Stop 1027Washington, DC 20250
Tel:  (202) 720-9047
Fax:  (202) 720-0677
E-mail:  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. 96N-0417.