3rdJanuary2012 FoodandNutraceuticalRegulationsGlobalSnapshot

January03,2012

Theregulatoryframeworkgoverningfoodsinmajorjurisdictionsisevolving.Foodresearch,productandprocess
innovationandchangeinconsumerbehaviourfacilitateadaptationoffoodregulations.Increasingly,the
awarenessismanifestedthroughconsumptionofparticularfoodsanddietarysupplementsbelievedtocontribute
togoodhealthandinsomecases,toholdtherapeuticvalueinthetreatmentorpreventionofspecificdiseases.
Manyofthesefoodproductsarebecomingcommonlyknownasnutraceuticalsor"functionalfoods."
Nutraceuticalsareproductsthathavethecharacteristicsofbothanutrientandapharmaceutical.Takenas
dietarysupplements,theycanmodulatethesymptomsofvariousdiseaseconditionsbyprovidingtheadditional
nutrientsourbodiesmayneedtomaintainwellbeing.Foodlawsineverycountryisthebasisofregulationsofall
kindsoffoodincludinghealthfood,dietarysupplement,functionalfoodandnutraceuticalsasspecificguidelines/
regulationsareframedtoregulatehealthfood.
StephenDeFelice,defined'nutraceutical'as'afoodorpartoffoodthatprovidesmedicalorhealthbenefits
includingthepreventionandtreatmentofdisease.'
OverviewUS,EU,Japan,Canada,China,IndiaRegulations
TheUnitedStatesofAmericaintroducedtheDietarySupplementandHealthEducationAct(DSHEA)in1994,
whichallowedconsiderableflexibilitybetweenfoodsandmedicinesfoundinotherpartsoftheworld.Under
DSHEAadietarysupplementmaycontain'aherborotherbotanical'or'aconcentrate,metabolite,constituent,
extractorcombinationofanyingredientfromtheothercategories.'
TheAmericanfoodsafetyregulatorysystemisfarmorecentralisedthantheEuropeansystem.Theissueof
adulterationbecameanationalissuein1848whenCongresspassedtheDrugImportationAct,requiring
inspectionbytheUSCustomsServicetopreventtheentryofadulterateddrugsfromabroad.In1862,inorderto
addresstheissueofadulteratedfood,thechemicaldivisionoftheUnitedStatesDepartmentofAgriculture
(USDA)wasestablishedandthenrenamedtheBureauofChemistry(nowFDA).
ThegenesisofUSfoodlegislationgoesbackto1906whenamajorpieceoflegislationwaspassed.TheFood
andDrugsActwasenactedinJune1906andprohibitedinterstatecommerceofmisbrandedandadulterated
foods,drinks,anddrugs.In1938,theFoodandDrugsActwaspreemptedbytheFederalFood,Drug,and
CosmeticAct(FDCA).ThisActfocussesonfoodmisbrandingandadulterationandservesasthebasic
frameworkforfoodregulationbytheFDAandtheUSDA.Thislegislationcreatedfoodstandards,mandated
inspectionsoffactories,andprovidedfortheissuanceofcourtinjunctionsinadditiontothealreadyexisting
seizureandprosecutionremedies.Since1938,theFDCAhasbeenamendedanumberoftimesandadditional
supportinglawshavebeenenactedrelatingtofoodsafety,securitythreats,andnutrition.Additionally,thisfederal
frameworkissupplementedbystatelaws.
TheUSDAandtheFDAarethemainauthoritiesinfoodregulationintheUnitedStates.Thesetwofederal
agenciesencompassallphasesofthefoodregulatorysystem:Theyevaluate,investigate,regulate,inspect,and
sanction.However,eveninacentralisedsystemliketheUnitedStates,somearguethattheUSDAandtheFDA
shouldconsolidateintoonesinglefoodagency.FDAregulatesbothfinisheddietarysupplementproductsand
dietaryingredientsunderadifferentsetofregulationsthanthosecovering"conventional"foodsanddrug
products.
UndertheDSHEA,thedietarysupplementordietaryingredientmanufacturerisresponsibleforensuringthata
dietarysupplementoringredientissafebeforeitismarketed.FDAisresponsiblefortakingactionagainstany
unsafedietarysupplementproductafteritreachesthemarket.Alldomesticandforeigncompaniesthat
manufacture,package,labelorholddietarysupplement,includingthoseinvolvedwithtesting,qualitycontrol,and
dietarysupplementdistributionintheUS,mustcomplywiththeDietarySupplementCurrentGoodManufacturing

Practices(cGMPS)forqualitycontrol.
Inaddition,themanufacturer,packer,ordistributorwhosenameappearsonthelabelofadietarysupplement
marketedintheUnitedStatesisrequiredtosubmittoFDAallseriousadverseeventreports.Further,FDA's
otherresponsibilitiesincludeproductinformation,suchaslabelling,claims,packageinserts,andaccompanying
literature.
EuropeanRegulation
Awidevarietyofbotanicalsandothersubstanceshavebeensoldasdietarysupplementingredients,including
manythatareconsideredtobemedicinalsubstancesundermostregulatoryregimesinEUcountries.Thereport
publishedbytheEuropeanAssociationofSelfMedicationIndustry,titled'HerbalMedicinalProductsinthe
EuropeanUnion'hasfoundthattherewasnoconsistencybetweenthememberstatesintheinterpretationofthe
medicinesDirectivewithrespecttoherbs.Thecriteriausedtodifferentiatebetweenmedicinalandfoodherbs
variedwidely.
TheEUfoodsafetyregulatorysystemneededacentralisedregulatorypowerthatwouldbringamore
homogeneoustypeofregulationwherememberstateswouldletEuropeaninstitutionsoverseebothrisk
assessmentandriskmanagement.Recognisingtheneedtoharmoniselaws,theECissuedcompositional
directivesinthe1970s.Thesedirectivescreatedstandardsofcompositionforcertainfoodstuffs.Thestandards
allowedsomeingredientsandprohibitedothersthatdidnotmeettherequirementssetbythecommission.
Pertinently,thegoalofthosedirectivesatthattimewastoguaranteethefreemovementoffoodwithinthe
EuropeanCommonMarket,ratherthantoadvanceconsumerhealth.Thedirectivesappliedonlytoparticular
ingredients,includingsugars,jams,chocolateproducts,andpreservedmilks.Ultimately,however,thisformula
failedbecausethedifferingculinaryculturesofthememberstatespreventedthemfromagreeingontheadoption
ofthoseingredients'requirements.In1985,theEUcameupwithanewapproach.Insteadoftryingtoharmonise
allofthefoodregulations,itdecidedtouselabellingtoindicatethedifferencesincompositionandproduction
methods,allowingconsumerstomakeaninformeddecision.Itadoptedtheprincipleofmutualrecognition,
requiringamemberstatetoallowthefreecirculationofgoodsproducedinconformitytoequivalentstandardsof
othermemberstates.
In2002,theCounciloftheEUandtheEuropeanParliamentadoptedregulationandcreatedtheprinciplesof
foodlawandcreatingtheEuropeanFoodSafetyAuthority(EFSA).Eachmemberstatehadregulateditsown
foodstuffs.Incontrast,theEFSAisanindependentagencythatprovidesscientificadvicetomemberstatesand
EUinstitutions.Itgathersdatatohelpanticipaterisksandissuesopinionsonmattersandprovidesscientific
assessmentsbutdoesnothandleanyoftheriskmanagement.
Instead,theEUinstitutionsandthememberstatesthemselvesareresponsibleforriskmanagement,adivisionof
authoritythatposesanobstacletogreatercentralisation.UndertheEuropeansystemtheauthorityisnotonly
dividedamongvariouscountries,butthosecountriesalsohaveflexibilitybothinthewaytheycontroltheirfood
safetyregulationsandinthewaytheyimplementEUregulationsanddirectives.Traceabilityandlabellingare
probablythebiggestpartoftheharmonisationofstandardsandprinciplesthattheEUhasundertakeninthe
realmoffoodsafetyregulation.
Japan
TheJapanesegovernmentenactedaregulatorysystemcalled'Foodswithhealthclaims'inApril2001,which
consistsofFoodsforSpecifiedHealthUse(FOSHU)andFoodswithNutrientFunctionClaims(FNFC).The
FOSHUwassetupbytheministryofhealthandwelfarein1991toapprovedescriptionsonalabelregardingan
effectoffoodonthehumanbody.Itwasenactedasapartof'foodforspecifieddietaryuse'undertheNutrition
ImprovementLaw.
TherearethreeimportantrequirementsforFOSHUapproval.Thefirstisscientificevidenceoftheefficacy,
includingclinicaltesting.Thesecondissafetyforconsumption.Thethirdisanalyticaldeterminationofthe
effectivecomponent.MostofthedescriptionsoffoodsundertheFOSHUsystemaresimilartothecategoryof
enhancedfunctionclaimsofCodex.UnderFNFC,12vitaminsandtwominerals(calciumandiron)are
standardised.TheseclaimsaresimilartothenutrientfunctionclaimsapprovedbyCodexin1997.TheFOSHU

certificationisnoteasilyobtained.Thereisa3stageapprovalprocessandinthecaseofdomestic
manufacturers(applicant)thereisaprocesswhichamountstoaselfregulatorypeerreviewbytheJapanHealth
FoodAssociation(JHFA).FOSHUcanbeappliedtofoodsonlyandnotisolatednutrientsormanufactured
nutritionalsupplementsandonlythosefoodswhichhaveidentifiablehealthbenefitsbasedonsoundscientific
research.Thismarkstheopportunityforthemarketingandpromotionofawiderangeoffoodstuffswhichalready
haveasignificantdegreeofconsumeracceptance.
Canada
InCanada,theFoodandDrugsActandRegulationsistheprimarystatutewhichgovernsthesaleoffoods,
drugs,cosmeticsandmedicaldevices.Thisstatutewhichisremarkablysimpleinconcept,cantraceitsoriginsto
an1860BritishlawentitledABillforPreventingtheAdulterationofArticlesofFoodandDrink.TheCanadianlaw
evolvedfroman1874statutetothecurrentActwhichwaspassedin1953.
InCanadatherearenospecificregulationsdealingwithfunctionalfoodsandsuchfoodsaregovernedbythe
existinglegislativeandregulatoryframeworkTheFoodandDrugsActandRegulations.
UnderCanadianfoodanddruglaw,ingestibleproductsmustbeeithersoldasa"food"or"drug."Theterm
"HealthFood,"thoughwidelyusedbyindustryandtheconsumer,isproblematicfortheHealthProtectionBranch
(HPB).
Thedefinitionof"food"intheFoodandDrugsActmakesnodifferentiationabouttypesoffoodandstatesin
anothersectionthatfoodmustbefreefrompoisonousorharmfulsubstances.Thus,inlegalterms,anyfoodin
compliancewiththeFoodandDrugsActandRegulationsshouldassistinsustaininggoodhealthandshouldnot
presentanyappreciablehazardtotheconsumer."HealthFoods"shouldnotbeconfusedwith"organically
produced"foodswhichrepresent,byinternationalconsensus,foodsderivedfromorganicagricultureandarepart
ofthebroadspectrumofmethodologiessupportiveoftheenvironment.
China
TheStateFoodandDrugAdministration(SFDA)wasfoundedonthebasisofitsformercounterpart,SDA,and
gotitscurrentnameonApril16,2003.SFDAisresponsibleforprotectingthepublichealthbyassuringthesafety,
efficacy,andsecurityofdrugs,biologicalproducts,medicaldevices,foodsupplyandcosmetics.Asadirectpart
oftheStateCouncil,SFDAhasregulatoryandlegalenforcementfunctions.
TheNationalInstituteofNutritionandFoodSafety(NINFS)isaresearchagencyfornutritionandfoodhygiene.
Theinstitutefacilitatesimprovementofnutritionalstatus,preventingfoodbornediseases,andstrengtheningthe
physicalfitnessofthepeople.TheinstitutewasformerlyknownastheNutritionDivisionoftheNationalInstitute
ofHealthofthePublicHealthAdministration,whichwasestablishedin1941.AfterthefoundingofthePeople's
RepublicofChina,theinstitutewasaffiliatedwiththefollowingleadingbodiesunderthetitleoftheDepartmentof
NutritionortheDepartmentofNutritionandFoodHygiene:
Thefirstsuchnationallaw,theFoodHygieneLawofthePeople'sRepublicofChina,wasadoptedonOctober
30,1995,anditdefinedfoodas"anyfinishedproductorrawmaterialintendedforpeopletoeatordrink,aswell
asanyproductthathastraditionallyservedasbothfoodandmedication,withtheexceptionofproductsused
solelyformedicalpurposes.
InJune2003,SFDAtookovertheresponsibilityofhealthfoodregistrationapprovalfromtheMinistryofHealth
(MoH).TheSFDA'sDepartmentofDrugRegistrationiscompletelyresponsiblefortheapprovalofhealthfood,
includingnutritionsupplements.InaccordancewiththeFoodHygieneLawofthePeople'sRepublicofChinaand
theAdministrativeLicensingLawofthePeople'sRepublicofChina,theInterimAdministrativeMeasuresfor
HealthFoodRegistrationwerepromulgatedbytheSFDAandwentintoeffectonJuly1,2005.Withthese
provisions,theresponsibilityfortheassessmentandreviewoffoodsafety,effectiveness,qualitycontrol,and
labellingcontentwasassignedformallytoSFDAanditssubsidiaries.
Incontrasttothewellsubstantiatedscientificevidencecollectedaccordingtostrictscientificprocedures
employedbymanycountries,Chineseregulationsrelymoreonlongestablishedandacceptedpracticeand
experiencedevelopedinTraditionalChineseMedicine.Healthclaimsareallowedonhealthfoodsprovided

requirementsforpublichealtharemetandtheclaiminquestiondoesnotemploymedicaljargonortermslikely
tobeconfusedwithpharmaceuticals.SinceAugust1,2005,nohealthfoodadvertisementshavebeenallowedto
bereleasedinthemediapriortoexaminationandapprovalbyfoodanddrugadministrationdepartmentsatthe
provinciallevel.
Chinaisfastbecomingaglobalpowerhouse,anditsimpacthascertainlybeenfeltinthenutraceuticalsindustry,
especiallyiningredientsegments.SowhiletheevolutionforChinawasbeinganetsuppliertotheglobal
nutraceuticalsindustry,nowChinaisenteringthenextphaseofitsevolutionwhereiteventuallybecomesanet
consumerofnutraceuticals.
India
ThereweremultiplelawsandregulationscoveringthefoodsinIndia,buttherewasnosinglelawthatcouldhave
significantlyregulatedthefunctionalfoodsordietarysupplementornutraceuticals.
In2006,theIndiangovernmentpassedFoodSafetyandStandardAct,2006,tointegrateandstreamlinethe
manyregulationscoveringnutraceuticals,foodsanddietarysupplements.TheActcallsforthecreationofthe
FoodSafetyandStandardsAuthority(FSSA).TheFSSAisresponsiblefordraftingrulesandregulationsfor
companiesinthefoodsectortobelicensedbylocalauthorities,asystemofchecksandbalances,including
productrecallproceduresenforcementsandpenalties,andtodevelopsciencebasedstandardsforfoodandto
regulateandmonitorthemanufacture,processing,andstorage.Allfoodimportswillthereforebesubjecttothe
provisionsoftheActandanyrulesandregulationsmadeundertheAct.Further,itincorporatesthesalient
provisionsofthePreventionofFoodAdulterationAct,1954,andisbasedoninternationallegislations,
InstrumentalitiesandCodexAlimentariusCommission.UnliketheUS,wheretheDSHEAisinplacetoregulate
healthrelatedproducts,inIndia,thegovernmentisintheprocessofdraftingalawtoregulatemanufacturing,
importingandmarketingofhealthfoods,dietarysupplementsandothernutraceuticals.
Theconceptof"nutraceuticals"isstilldevelopinginIndia.IthasbeendefinedintheFSSAbutitisyettobe
implementedastherulesarenotcompletelyframed.
However,FSSAlaysdownthesuggestivestructureoftheregulationforFoodsforSpecialPurposeand
NutritionalUsesFSSAActbasedonthelearningfrominternationalbestpracticestheFoodSafetyand
Standards(PackagingandLabelling)Regulation,2011,dealswithnutritionandhealthclaims.
FinalComments
Everysystemofregulationhasitsprosandcons.Thelabellingofhealthrelatedfoodsshouldbebasedon
scientificevidence,alwaysbearinginmindharmonisationwithglobalinternationalstandards.Thereshouldbea
harmonisationoffoodregulationsaroundtheworld.Economicgrowthandurbanisationarenotenoughevidence
ofthefuturegrowthofnutraceuticals,healthdemographictrendsalsosupportthesegrowthforecasts.
Consumersaredeeplyconcernedabouthowtheirhealthcareismanaged,administeredandpriced.Ashealth
carecosthasbecomehightheconsumersarefrustratedwiththeexpensivediseasetreatmentapproach
predominantinmodernmedicinetheconsumerisnowseekingalternativebeneficialproductslikedietary
supplement,functionalfoodandnutraceuticals.
Withinnovativedeliverymechanismtofacilitatetheuseofnutraceuticalsamongstitstargetgroups,theworld
marketisexpectedtowitnessagradualshifttowardnaturalingredients.Further,EUfocussingonthefoodsafety
regulationsystembycentralisingoffoodregulatorypowers,whichwouldprotectthepublichealthaswellasthe
futureoftheEUinamoregeneralsense
Globally,theUSandJapanarethemostdevelopedmarketsfornutraceuticals,duetotheconsumeracceptability
achievedintheseregions.India,ChinaandBrazilaredevelopingnationswhichshowhugepotentialforthe
nutraceuticalsmarket,IndiaandChinahaveemergedasakeysourcingdestinationfornaturalingredients.
(Thewriterispartner,CorporateLawGroup,NewDelhi)
Posted3rdJanuary2012byFoodSafetyInIndia

27 Viewcomments

W.Home 17January2012at8:45PM
Proper food safety training and information will lead to a more safe environment that will let them stop such
outbreaksandmaintainsafefoodforallconsumersandfamilies.
Reply

sandhyabandi 9October2012at4:42PM
Nice blog. Akums Drugs & Pharmaceuticals Limited, Haridwar, (India), is globally recognized WHOGMP, ISO
9001:2008. ISO 14001:2004 and QMSHACCP certificates which have been implemented and granted by
international systems after comprehensive and strict examination. Akums honors Safety Health Atmosphere
(SHE),U.K.M.H.R.A.andU.S.FDA.Nutraceuticalproducts
Reply

invisionmedi 29May2013at4:07PM
Igothroughyourwebsiteitsverygoodandwearealsohavingsimilarwebsiteyoucanvisitus.
PharmaceuticalProductsManufacturersinIndia
Reply

invisionmedi 31May2013at1:25PM
Igothroughyourwebsiteitsverygoodandwearealsohavingsimilarwebsiteyoucanvisitus.
PharmaceuticalProductsManufacturersinNutraceuticalProductsManufacturersinIndia,PharmaCompanyIn
IndiaIndia
Reply

Dr.SateeshKumar 10October2013at2:34PM
Can anyone tell me if i nanotize the herbal formulation in polylactic acid can i market the new product with
simplelabelingonitordoineedtogetanyapprovalbeforemarketing
Reply

ASHESSHGUPTA 10October2013at4:17PM
Nicepost,IbookmarkyourblogbecauseIfoundverygoodinformationonyourblog,Thanksforsharing
QualityServices&TrainingPvt.Ltd.
Reply

PritamWagh 2July2014at11:54AM
Chitosanisasugarthatisobtainedfromthehardouterskeletonofshellfish,includingcrab,lobster,andshrimp.
Itisusedformedicine.
Reply

jaspreetsingh 23July2014at7:38PM
it'sgoodtoIndiaismakingainitiativeinfoodsafety.
NutraceuticalsSingapore
Reply

FoodSafetyNetIreland 5August2014at4:03PM
ItishelpfulblogabouttheFoodsafety.
Primarycourseinfoodsafety
Reply

QualityServices 22November2014at4:34PM
nice blog!! thanks to author for sharing the information about fssai certification india . this blog is really
interestedtoreadalso.
Reply

ankushsharma 23December2014at1:32PM
niceblog!!iwaslookingforblogsrelatedofwhogmpcertificationindia.thenifoundthisblog,thisisreallynice
andinterestedtoread.
Reply

DietKundli 18February2015at11:32AM
Goodtopic.ThisGreatblogreferringtogoodtopic.Itisveryinteresting.Ilikeitbecauseithasgivemevery
useful information. thank you for sharing. High Blood Pressure Diet || Non Communicable Disease || Foods in
DifferentLanguages
Reply

DietKundli 18February2015at11:32AM
First time I visited this blog. Really this is awesome blog. It is very pleasure to get it as I got huge helps right
here.Idolikeyourhardworkingsandappreciateyourconcept.Thanksalot.CholesterolLoweringFoods || Diet
forGlowingSkin||DiabeticDiet
Reply

DietKundli 18February2015at11:32AM
Really,Thisisawonderfulpost.Ienjoyedtheinformationlot.Iwillbookmarkthispage.Thanksforsharingthis
importantinformation.WeightManagement||CausesofHighBloodPressure||HealthyDiet
Reply

DietKundli 18February2015at11:33AM
This is really a nice blog..very informative & very interesting..I m Glad that fortunately i found it on Google,
thanksforthisGreatInfo.DietChart||BalancedDietChart||FoodSupplements
Reply

DietKundli 18February2015at11:33AM
Great thanks for sharing this post. I was looking for something like this. Your blog have inspires me a
lot.Thanks.BalancedDiet||DietPlan||BalancedDietPlan
Reply

MabelMargaret 30March2015at2:40PM
Thankyouformentioningsafetydetails.
nutraceuticalmanufacturers
Reply

mubarak 21May2015at3:39PM
Rewarded for its commitment to Quality and Hygiene, the Hilton Shanghai is the proud recipient of the first
official Outside Catering Service License issued by the Shanghai Food and Drug Regulatory Administration. To
knowmorevisitcateringservicesinchennai
Reply

anisealexlex 30June2015at6:30PM
oneofthebestwaysolderpeoplecangettheirdailydoseofnutritionalsupplementsthattheyareunabletoget
throughmealsalone.Therearesomanysupplementmanufacturer businesses available today But you can buy
affordableSupplementatinexpensivecost.
Reply

HiteshModi 4July2015at1:09PM
Organicproductarebestforlivinghealthy&safelife.
Buycertifiedorganicproductsatreasonablepricefromwww.organikart.in
Tolinkyourorganicproductswithourstoresendemailtoinfo@organikart.inwithsubject"SupplierInquiry"
Reply

manavfatepuria 17July2015at3:20PM
heythanksforthisinformation
ifounditveryuseful
ihaveusedHealthkartoffersfromgrabontheyarereallygood
Reply

viswa 30July2015at5:41PM
ReallyItwasIncrediblepost,thanksforshareussafetyprecautions...
Reply

MabelMargaret 29September2015at10:27AM
Ilikethisarticle.
nutraceuticalmanufacturers
Reply

tomhokky 6October2015at5:59PM
hopeeverythinkisgood&well
idon'tknowmoreaboutu,butunfortunatelyisearchedurblog,ilikedtheplanverymuchthankuverymuchfor
puttingthisgoodthinksonurblogplzcontinuethis
babyfoodconsumerreports
babyfoodmakerconsumerreports
babyfoodmillconsumerreports
babyfoodindiaonline
babyfoodindia1year
Reply

DiscountCoupons 7April2016at5:12PM
Nicepost.iusedregularlyforonlinefoodorderbydominoscouponsatpick4call
Reply

HyperbaricOxygenTherapyChamber(HBOT)India. 23June2016at8:29PM
GreatPost.WhataretheprospectsforacandidatewhowantstopursueaMScdegreeinNutraceuticalsinIndia
?
Reply

EmploymentLawyerDelhi 25July2016at12:50PM
Niceblogandveryinformativethankyouforsharingsuchagreatblog.
Reply

Enteryourcomment...

Commentas:

Publish

Selectprofile...

Preview