WORLD TRADE G/TBT/Notif.98.228
6May1998
ORGANIZATION
(98-1807)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Food andDrug Administration (12)
Agency orauthority designated tohandle comments regarding thenotification shallbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Dietary Supplements
5. Title, number ofpages andlanguage(s) ofthenotified document: Regulations on
Statements Made forDietary Supplements Concerning theEffect oftheProduct onthe
Structure orFunction oftheBody (9pages, English)
6. Description ofcontent: TheAdministration isproposing regulations defining thetypes
ofstatements thatcanbemade concerning theeffect ofadietary supplement onthe
structure orfunction ofthebody. Theproposed regulations alsoestablish criteria for
determining when astatement about adietary supplement isaclaim todiagnose, cure,
mitigate, treatorprevent disease.
7. Objective andrationale, including thenature ofurgent problems where applicable: To
provide direction tothedietary supplement industry.
8. Relevant documents: 63FR23624, 29April 1998; 21CFR Part101. Willappear in
theFederal Register when adopted.
9. Proposed dateofadoption:
Proposed dateofentry intoforce: Tobedetermined
10. Final dateforcomments: 27August 1998
11. Texts available from: National enquiry point [X]oraddress, e-mail andtelefax number
ofother body: