WORLD TRADE G/SPS/N/USA/72
9December 1996
ORGANIZATION
(96-5120)
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): Medical foods
4. Title andnumber ofpages ofthenotified document: Regulation ofMedical Foods
(11pages)
5. Description ofcontent: TheFood andDrug Administration (FDA) haspublished an
advance notice ofproposed rulemaking andissoliciting comments toinitiate a
reevaluation ofitsapproach totheregulation oftheBroad Group ofHeterogeneous
Products thataremarketed asmedical foods. FDA'sgoalistoarrive ataregulatory
regime thatwillensure that: these products aresafefortheirintended uses, especially
because theyarelikely tobethesoleoramajor source ofnutrients forsickand
otherwise vulnerable people; claims forthese products aretruthful, notmisleading and
supported bysound science; andthelabelling ofthese products isadequate toinform
consumers about howtousethem inasafeandappropriate manner. TheAgency
believes thatthere isaneedtoreevaluate itspolicy forregulating medical foods
because ofanumber ofdevelopments, including enactment ofastatutory definition of
"medical food," therapid increase inthevariety andnumber ofproducts thatare
marketed asmedical foods, safety problems associated withthemanufacture andquality
control ofthese products, andthepotential forfraud asclaims thatarenotsupported
bysound science proliferate forthese products.
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: 61FR60661,
29November 1996; 21CFR CH.1; 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: 27February 1997
Agency orauthority designated tohandle comments: Food andDrug Administration
12. Texts available from: National enquiry point [X]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 address: wilsonc@fas.usda.gov