WORLD TRADE G/SPS/N/USA/70
5November 1996
ORGANIZATION
(96-4655)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: Food andDrug Administration
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Dietary
supplements ornewdietary ingredients
4. Title andnumber ofpages ofthenotified document: Premarket Notification foraNew
Dietary Ingredient (5pages)
5. Description ofcontent: TheFood andDrug Administration (FDA) isproposing to
establish theprocedure bywhich amanufacturer ordistributor ofdietary supplements,
orofanewdietary ingredient, istosubmit, under theFederal Food, Drug, and
Cosmetic Act(TheAct), theinformation onwhich ithasconcluded thatadietary
supplement containing anewdietary ingredient willreasonably beexpected tobesafe.
FDA issetting outthose steps thatithastentatively concluded arenecessary toensure
thatnotification isaccomplished efficiently butwiththeleastburden possible onthe
industry. FDA isissuing thisproposal inresponse totheDietary Supplement Health
andEducation Actof1994.
6. Objective andrationale: Human health
7. Aninternational standard, guideline orrecommendation does notexist [X].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents andlanguage(s) inwhich these areavailable: 61FR50774,
27September 1996; 21CFR Part190(available inEnglish)
9. Proposed date ofadoption: Tobedetermined.
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10. Proposed date ofentry intoforce: Thedateofentry intoforce willbeannounced when
thefinalruleispublished intheFederal Register.
11. Final date forcomments: 26December 1996
Agency orauthority designated tohandle comments: Food andDrug Administration
12. Texts available from: National enquiry point []oraddress, telefax number andE-mail
address (ifavailable) ofother body:
USDA/FAS/OFSTS
Attn: Carolyn F.Wilson
Room 5545 South Agriculture Building
14thandIndependence
Washington, D.C. 20250
Tel: (202) 7202239
Fax: (202) 6900677
E-mail: Wilsonc@fas.usda.gov