WORLD TRADE G/SPS/N/USA/84
13June1997
ORGANIZATION
(97-2448)
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
4. Title andnumber ofpages ofthenotified document: Dietary Supplements Containing
Ephedrine Alkaloids (40pages)
5. Description ofcontent: TheFood andDrug Administration (FDA) isproposing tomake
afinding, which willhavetheforce andeffect oflaw,thatadietary supplement is
adulterated ifitcontains 8milligrams (8MG) ormore ofEphedrine Alkaloids per
serving, orifitslabelling suggests orrecommends conditions ofusethatwould result
inintake of8MGormore ina6-hour period oratotaldaily intake of24MGormore
ofEphedrine Alkaloids; require thatthelabelofdietary supplements thatcontain
Ephedrine Alkaloids state"Donotusethisproduct formore than7days"; prohibit the
useofEphedrine Alkaloids withingredients, orwithingredients thatcontain substances
thathaveaknown stimulant effect (e.g., sources ofcaffeine oryohimbine), which may
interact withEphedrine Alkaloids; prohibit labelling claims thatrequire long-term
intake toachieve thepurported effect (e.g., weight lossandbody building); require a
statement inconjunction withclaims thatencourage short-term excessive intake to
enhance thepurported effect (e.g., energy) that"taking more thantherecommended
serving mayresult inheart attack, stroke, seizure ordeath"; andrequire specific
warning statements toappear onproduct labels. FDA isproposing these actions in
response toserious illnesses andinjuries, including multiple deaths, associated withthe
useofdietary supplement products thatcontain Ephedrine Alkaloids andtheAgency 's
investigations andanalyses ofthese illnesses andinjuries, FDA isalsoincorporating by
reference itsLaboratory Information Bulletin (LIB) No.4053, thatFDA willusein
determining thelevelofEphedrine Alkaloids inadietary supplement.
6. Objective andrationale: Public health protection
./.G/SPS/N/USA/84
Page2
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: 62FR30678,
4June1997; 21CFR Part111
9. Proposed date ofadoption: Tobedetermined
10. Proposed date ofentry intoforce: Thedateofentry intoforce willbeannounced when
thefinalruleispublished intheFederal Register.
11. Final date forcomments: 18August 1997
Agency orauthority designated tohandle comments: Food andDrug Administration
12. Texts available from: National enquiry point []oraddress, telefax number andE-mail
address (ifavailable) ofother body:
United States SPSEnquiry Point
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