WORLD TRADE G/TBT/Notif.97.267
19June1997
ORGANIZATION
(97-2525)
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 (11)
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): Dietary Supplements
5. Title, number ofpages andlanguage(s) ofthenotified document: Dietary Supplements
Containing Ephedrine Alkaloids (47pages, English)
6. Description ofcontent: TheAdministration isproposing tomake afinding, which will
havetheforce andeffect oflaw,thatadietary supplement isadulterated ifitcontains 8
milligrams (mg)ormore ofephedrine alkaloids perserving, orifitslabeling suggests or
recommends conditions ofusethatwould result inintake of8mgormore ina6-hour
period oratotaldaily intake of24mgormore ofephedrine alkaloids; require thatthe
label ofdietary supplements thatcontain ephedrine alkaloids state “Donotusethis
product formore than7days”’;prohibit theuseofephedrine alkaloids withingredients,
orwith ingredients thatcontain substances, thathave aknow stimulant effect (e.g.,
sources ofcaffeine oryohimbine), which mayinteract withephedrine alkaloids; prohibit
labeling claims thatrequire long-term intake toachieve thepurported effect (e.g., weight
lossandbody building); require astatement inconjunction withclaims thatencourage
short-term excessive intake toenhance thepurported effect (e.g., energy) that“Taking
more than therecommended serving may result inheart attack, stroke, seizure or
death”;andrequire specific warning statements toappear onproduct labels. The
Administration isalsoincorporating byreference itsLaboratory Information Bulletin No.
4053, thattheAdministration willuseindetermining thelevel ofephedrine alkaloids in
adietary supplement.
7. Objective andrationale: Health andsafety.
8. Relevant documents: 62FR30678, 4June1997; 21CFR Part111. Willappear inthe
Federal Register when adopted.
./.G/TBT/Notif.97.267
Page2
9. Proposed dateofadoption: Theagency proposes thatanyfinal rulethatmayissue
based onthisproposal become effective 180daysafterdateofpublication ofthefinal
rule.
Proposed dateofentry intoforce:
10. Final dateforcomments: 18August 1997
11. Texts available from: National enquiry point [x]oraddress andtelefax number ofother
body: