Dietary-Supplement-Health-and-Education-Act-of-199

DietarySupplementHealthandEducationActof1994AnActToamendtheFederalFood,Drug,andCosmeticActtoestablishstandardswithrespecttodietarysupplements,andforotherpurposes.BeitenactedbytheSenateandHouseofRepresentativesoftheUnitedStatesofAmericainCongressassembled,§1.ShortTitle;Reference;TableOfContents.(a)ShortTitle.ThisActmaybecitedastheDietarySupplementHealthandEducationActof1994.(b)Reference.WheneverinthisActanamendmentorrepealisexpressedintermsofanamendmentto,orrepealof,asectionorotherprovision,thereferenceshallbeconsideredtobemadetoasectionorotherprovisionoftheFederalFood,Drug,andCosmeticAct.(c)TableofContents.ThetableofcontentsofthisActisasfollows:Sec.1.Shorttitle;reference;tableofcontents.Sec.2.Findings.Sec.3.Definitions.Sec.4.SafetyofdietarysupplementsandburdenofproofonFDA.Sec.5.Dietarysupplementclaims.Sec.6.Statementsofnutritionalsupport.Sec.7.Dietarysupplementingredientlabelingandnutritioninformationlabeling.Sec.8.Newdietaryingredients.Sec.9.Goodmanufacturingpractices.Sec.10.Conformingamendments.Sec.11.Withdrawaloftheregulationsandnotice.Sec.12.Commissionondietarysupplementlabels.Sec.13.Officeofdietarysupplements.§2.Findings.Congressfindsthat-(1)improvingthehealthstatusofUnitedStatescitizensranksatthetopofthenationalprioritiesoftheFederalGovernment;(2)theimportanceofnutritionandthebenefitsofdietarysupplementstohealthpromotionanddiseasepreventionhavebeendocumentedincreasinglyinscientificstudies;(3)(A)thereisalinkbetweentheingestionofcertainnutrientsordietarysupplementsandthepreventionofchronicdiseasessuchascancer,heartdisease,andosteoporosis;and(B)clinicalresearchhasshownthatseveralchronicdiseasescanbepreventedsimplywithahealthfuldiet,suchasadietthatislowinfat,saturatedfat,cholesterol,andsodium,withahighproportionofplant-basedfoods;(4)healthfuldietsmaymitigatetheneedforexpensivemedicalprocedures,suchascoronarybypasssurgeryorangioplasty;(5)preventivehealthmeasures,includingeducation,goodnutrition,andappropriateuseofsafenutritionalsupplementswilllimittheincidenceofchronicdiseases,andreducelong-termhealthcareexpenditures;(6)(A)promotionofgoodhealthandhealthylifestylesimprovesandextendsliveswhilereducinghealthcareexpenditures;and(B)reductioninhealthcareexpendituresisofparamountimportancetothefutureofthecountryandtheeconomicwell-beingofthecountry;(7)thereisagrowingneedforemphasisonthedisseminationofinformationlinkingnutritionandlong-termgoodhealth;(8)consumersshouldbeempoweredtomakechoicesaboutpreventivehealthcareprogramsbasedondatafromscientificstudiesofhealthbenefitsrelatedtoparticulardietarysupplements;(9)nationalsurveyshaverevealedthatalmost50percentofthe260,000,000Americansregularlyconsumedietarysupplementsofvitamins,minerals,orherbsasameansofimprovingtheirnutrition;(10)studiesindicatethatconsumersareplacingincreasedrelianceontheuseofnontraditionalhealthcareproviderstoavoidtheexcessivecostsoftraditionalmedicalservicesandtoobtainmoreholisticconsiderationoftheirneeds;(11)theUnitedStateswillspendover$1,000,000,000,000onhealthcarein1994,whichisabout12percentoftheGrossNationalProductoftheUnitedStates,andthisamountandpercentagewillcontinuetoincreaseunlesssignificanteffortsareundertakentoreversetheincrease;(12)(A)thenutritionalsupplementindustryisanintegralpartoftheeconomyoftheUnitedStates;(B)theindustryconsistentlyprojectsapositivetradebalance;and(C)theestimated600dietarysupplementmanufacturersintheUnitedStatesproduceapproximately4,000products,withtotalannualsalesofsuchproductsalonereachingatleast$4,000,000,000;(13)althoughtheFederalGovernmentshouldtakeswiftactionagainstproductsthatareunsafeoradulterated,theFederalGovernmentshouldnottakeanyactionstoimposeunreasonableregulatorybarrierslimitingorslowingtheflowofsafeproductsandaccurateinformationtoconsumers;(14)dietarysupplementsaresafewithinabroadrangeofintake,andsafetyproblemswiththesupplementsarerelativelyrare;and(15)(A)legislativeactionthatprotectstherightofaccessofconsumerstosafedietarysupplementsisnecessaryinordertopromotewellness;and(B)arationalFederalframeworkmustbeestablishedtosupersedethecurrentadhoc,patchworkregulatorypolicyondietarysupplements.§3.Definitions.(a)DefinitionofCertainFoodsasDietarySupplements.Section201(21U.S.C.321)isamendedbyaddingattheendthefollowing:(ff)Thetermdietarysupplement-o(1)meansaproduct(otherthantobacco)intendedtosupplementthedietthatbearsorcontainsoneormoreofthefollowingdietaryingredients:(A)avitamin;(B)amineral;(C)anherborotherbotanical;(D)anaminoacid;(E)adietarysubstanceforusebymantosupplementthedietbyincreasingthetotaldietaryintake;or(F)aconcentrate,metabolite,constituent,extract,orcombinationofanyingredientdescribedinclause(A),(B),(C),(D),or(E);o(2)meansaproductthat-(A)(i)isintendedforingestioninaformdescribedinsection411(c)(1)(B)(i);or(ii)complieswithsection411(c)(1)(B)(ii);(B)isnotrepresentedforuseasaconventionalfoodorasasoleitemofamealorthediet;and(C)islabeledasadietarysupplement;ando(3)does-(A)includeanarticlethatisapprovedasanewdrugundersection505,certifiedasanantibioticundersection507