WORLD TRADE G/TBT/Notif.97.755
9December 1997
ORGANIZATION
(97-5389)
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 (23)
Agency orauthority designated tohandle comments regarding thenotification canbe
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): Over-the-Counter Drug
Products
5. Title, number ofpages andlanguage(s) ofthenotified document: Over-the-Counter
Drug Products Containing Analgesic/Antipyretic Active Ingredients forInternal Use;
Required Alcohol Warning (17pages, English)
6. Description ofcontent: TheAdministration isissuing anotice ofproposed rulemaking
thatwould establish alcohol warnings forallover-the-counter (OTC) drug products
containing internal analgesic/antipyretic active ingredients labelled foradult use. The
proposed warning statements advise consumers whohaveahistory ofheavy alcohol use
orabuse toconsult aphysician foradvice about theuseofOTC internal
analgesic/antipyretic drugproducts. Awarning would berequired forallOTC internal
analgesic/antipyretic drug products marketed under anOTC drug monograph oran
approved newdrugapplication.
7. Objective andrationale: Health
8. Relevant documents: 62FR61041, 14November 1997; 21CFR Part201. Will
appear intheFederal Register when adopted.
9. Proposed dateofadoption: Theagency isproposing thatanyfinalrulebased onthis
proposal beeffective 6months afterthedateofitspublication intheFederal Register.
Proposed dateofentry intoforce:
10. Final dateforcomments: 28January 1998
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: