RESTRICTED
WORLD TRADE G/TBT/Notif.95.64
8March 1995
ORGANIZATION
(95-0502)
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 (3)
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.
ICS numbers may beprovided inaddition, where applicable): Iron-containing
supplements anddrugs
5. Titleandnumber ofpages ofthenotified document: Iron-Containing Supplements and
Drugs; Label Warning Statements andUnit-Dose Packaging Requirements (6pages)
6. Description ofcontent: TheAdministration isissuing asupplemental proposed ruleto
setforth itslegal authority, after thepassage oftheDietary Supplement Health and
Education Act(DSHEA), torequire unit-dose packaging ofiron-containing dietary
supplements thatcontain 30milligrams (mg) ormore ironperdosage unit. The
Administration isproposing regulations torequire labelwarning statements forproducts
taken insolid oraldosage form tosupplement thedietary intake ofironortoprovide
ironfortherapeutic purposes. Also proposed areregulations torequire unit-dose
packaging foriron-containing products thatcontain 30milligrams ormore ofironper
dosage unit.
7. Objective andrationale: Toreduce theriskofaccidental ironpoisoning ofyoung
children lessthansixyears ofageandtoensure thatproducts containing ironoriron
saltsdonotposeahealth hazard toyoung children andinfants.
8. Relevant documents: 60FR8989, 16February 1995; 21CFR parts 101,111,170,
310. TBT/Notif.94.391 issued 27October 1994. Willappear intheFederal Register
when adopted.
./.G/TBT/Notif.95.64
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9. Proposed dateofadoption andentry intoforce: TheAgency isproposing thatanyfinal
rulethatmaybeissued based upon thisproposal became effective 180days after its
publication intheFederal Register.
10. Final dateforcomments: 17April 1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: