PersonalCareProductsSafetyAct
Background
Issue
NPAPosition
ThislegislationwasintroducedbySenatorDianneFeinstein(D‐CA)onApril
20,2015asS.1014.
The legislation would amend the Federal Food, Drug and Cosmetics Act
(FFDCA)torequirecosmeticscompaniestoregistertheirfacilitieswithFDA
andtosubmittotheFDAcosmeticingredientstatementsthatwillincludethe
amounts of each ingredient contained in each product. Cosmetic companies
wouldberequiredtopayafacilityregistrationfeebasedontheannualgross
sales of the cosmetics of that company. All collected fees will be used for
cosmeticssafetyactivities.
The legislation was developed to provide clear mandates on Good
Manufacturing Practices (GMPs), funding for associated facility inspections,
andtotiefundingtoenforcementofcosmetics.
S. 1014 has been co‐sponsored by Senators Susan Collins (R‐ME), Barbara
Boxer(D‐CA),AmyKlobuchar(D‐MN),MarkKirk(R‐IL),MazieHirono(D‐HI),
andKirstenGillibrand(D‐NY).
Currently, there is only a GMP guidance, not a final rule, for cosmetics
regulation. Any FDA guidance document is not legally binding and does not
have the force of law. Only formal rulemaking through public notice and
comment will provide effective enforcement of GMPs in the cosmetics
industry.
In the absence ofa formaldefinitionforthe term“natural” in thecosmetics
industry,U.S.courtsarelefttoruleonthelegitimacyofnaturalclaims.False‐
advertisingclassactionshaveincreasedinthepersonalcarespace,following
a similar trend that began in the food sector. Once FDA defines the term
“natural,”itwillalleviatethecurrentbacklogofcongestioninthecourtsand
futurepotentiallawsuitsfromthePlaintiff’sbaroveruseofthetermandhow
itisperceivedbyconsumers.
NPAsupportsacosmeticsbillthatwillincludemandatoryGMPstobeissued
forthecosmeticsindustryintheformoffinalrulemakingandcomment.
NPAbelievesbetterclarityovertheterm“natural”willbepositiveforthe
cosmeticindustryandconsumersandstronglyurgesCongresstopushfor
FDAtofinallydefinetheterminpersonalcareproducts.
NPAdefined“natural”forpersonalcareproducts.Sincethen,morethan
1,300productsandingredientshavebeencertifiedundertheNPANatural
Standard.
AbouttheNaturalProductsAssociation
Foundedin1936,theNaturalProductsAssociation(NPA)isthenation’slargestandoldestnonprofitorganizationdedicatedtothenatural
productsindustry.NPArepresentsover1,400membersaccountingformorethan10,000retail,manufacturing,wholesale,anddistribution
locationsofnaturalproducts,includingfoods,dietarysupplements,andhealth/beautyaids.Theassociationsupportsastronggrassroots
networkofmembersandconsumerswhoarepassionateaboutproductsthatcontributetohealthierlifestyles.
HeadquarteredinWashington,DC,NPAhasbeentheleadingindustrywatchdogfor80years,actingasanadvocateonregulatoryand
legislativeissuesaffectingnaturalproducts.