WORLD TRADE G/SPS/N/USA/74
20February 1997
ORGANIZATION
(97-0691)
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: Current Good Manufacturing
Practice inManufacturing, Packing, orHolding Dietary Supplements (10pages)
5. Description ofcontent: TheFood andDrug Administration (FDA) isannouncing thatit
isconsidering whether toinstitute rulemaking todevelop Current Good Manufacturing
Practice (CGMP) regulations fordietary supplements anddietary supplement
ingredients. FDA solicits comments onwhether itshould doso,andifitshould, what
constitutes CGMP forthese products. Inissuing thisnotice, FDA isresponding tothe
section oftheFederal Food, Drug, andCosmetic Act(theAct)thatprovides thatthe
Secretary ofHealth andHuman Services may, byregulation, prescribe good
manufacturing practice fordietary supplements andtoasubmission from
representatives ofthedietary supplement industry asking FDA toconsider aframework
thattheindustry haddeveloped asabasis forCGMP regulations. FDA ispublishing
theindustry submission andisasking forpublic comment ontheframework thatthe
submission presents. Inaddition, FDA isrequesting comments onanumber ofother
related issues. These issues include:
(1)Isthere aneedtodevelop specific defect action levels fordietary ingredients?
(2)FDA requests comments onappropriate testing requirements toprovide positive
identification ofdietary ingredients, particularly plant materials, usedindietary
supplements.
(3)FDA requests comments onstandards thatshould bemetincertifying thata
dietary ingredient ordietary supplement isnotcontaminated withfilth, thatitisfreeof
harmful contaminants, pesticide residues, orother impurities; thatitis
microbiologically safe; andthatitmeets specified quality andidentify standards.G/SPS/N/USA/74
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(4)TheAgency asksforcomments onwhether there isaneedforCGMP toinclude
requirements formanufacturers toestablish procedures todocument thattheprocedures
prescribed forthemanufacture ofadietary supplement arefollowed onacontinuing or
day-to-day basis.
(5)TheAgency asksforcomments onwhether dietary supplement CGMP should
require thatreports ofinjuries orillnesses (such ascould becaused by
pharmacologically active substances orallergens intheproduct) atafirmbeevaluated
bycompetent medical authorities todetermine whether follow upaction isnecessary to
protect thepublic health.
(6)FDA asksforcomments onwhether CGMP fordietary supplements should require
thatmanufacturers establish procedures toidentify, evaluate, andrespond topotential
safety concerns withdietary ingredients.
(7)TheAgency asksforcomments onwhether specific controls arenecessary for
computer controlled orassisted operations.
(8)TheAgency asksforcomments onwhether certain, orall,oftherequirements for
manufacturing andhandling dietary ingredients anddietary supplements maybemore
effectively addressed byaregulation based ontheprinciples ofHazard Analysis and
Critical Control Points (HACCP), rather thanthesystem outlined intheindustry
submission.
(9)TheAgency asksforcomments onwhether broad CGMP regulations willbe
adequate, orwhether itwillbenecessary toaddress theoperations ofparticular
segments ofthedietary supplement industry suchasthemanufacture ordistribution of
rawdietary ingredients, themanufacture offinished products, orsolely thedistribution
andsaleoffinished products atthewholesale orretail level.
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: 62FR5700,
6February 1997; 21CFR CH.1(available inEnglish)
9. Proposed date ofadoption: Tobedetermined.
10. Proposed date ofentry intoforce: Thedateofentry intoforce willbeannounced when
thefinalruleispublished intheFederal Register.G/SPS/N/USA/74
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11. Final date forcomments: 7May1997
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) 720-2239
Fax: (202) 690-0677
E-mail address: WILSONC@FAS.USDA.GOV