RESTRICTED
WORLD TRADE G/TBT/Notif.96.21
7February 1996
ORGANIZATION
(96-0451)
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 (32)
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): Food
5. Titleandnumber ofpages ofthenotified document: Food Labelling; Requirements for
Nutrient Content Claims, Health Claims, andStatements ofNutritional Support for
Dietary Supplements (9pages)
6. Description ofcontent:
TheAdministration isproposing toamend itsnutrient content claims regulations
tochange theterminology usedtodescribe dietary supplements; provide fortheuseof
statements thatcharacterize thepercentage level ofdietary ingredients thatdonothave
reference daily intakes ordaily reference values; andwithdraw theprovision that
dietary supplements ofvitamins andminerals maynotgiveprominence toanyingredient
thatisnotavitamin oramineral onitslabelorinlabelling. TheAdministration isalso
proposing tospecify how(i.e., text,placement andtypesize)thedisclaimer required by
theFederal Food, Drug andCosmetic Actistobepresented with statements of
nutritional support. Additionally, theAdministration isproposing toremove the
definition of"dietary supplements" andtochange theterminology used todescribe
dietary supplements inregulations governing health claims forfoodproducts.
7. Objective andrationale: Toimplement inparttheDietary Supplement Health and
Education Actof1994 andprevent misbranded products.
./.G/TBT/Notif.96.21
Page2
8. Relevant documents: 60FR67176, 28December 1995; 21CFR 101. Willappear in
theFederal Register when adopted.
9. Proposed dateofadoption andentry intoforce: TheAdministration isproposing that
anyfinalrulethatmayissue based upon thisproposal become effective 1January 1997.
10. Final dateforcomments: 13March 1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: