transcript - public meeting cosmetic 42012

7/23/2019 Transcript - Public Meeting Cosmetic 42012

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

U.S. FOOD AND DRUG ADMINISTRATION

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

PUBLIC MEETING: COSMETIC MICROBIOLOGICAL SAFETY ISSUES

WEDNESDAY, NOVEMBER 30, 2011


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CONTENTS

PAGE

WELCOME AND OPENI NG REMARKS 5

Dr . Li nda Kat z, FDA

FDA PERSPECTI VE 10Dr . Pat r i ci a Hansen, FDA

PUBLI C COMMENTS & QUESTI ONS:

Et an Yeshua 24Envi r onment al Worki ng Gr oup

J ay Ansel l 37Per sonal Car e Product s Counci l

Phi l Gei s 51Gei s Mi crobi ol ogi cal Qual i t y

Davi d St ei nberg 73Cosmet i c Pr eservat i ve Counci l

Ri char d Whi t i ng 102Exponent , I nc.

CLOSI NG REMARKS 117Dr . Li nda Kat z, FDA


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PROCEEDI NGS

MR. GASPER: Good mor ni ng, ever ybody. Wel come

t o t he meet i ng. I ' ve j ust got a mi nut e or t wo of

housekeepi ng not es her e. I ' m J ohn Gasper . I ' m i n t he

Of f i ce of Cosmet i cs and Col or s. I wi l l be t he

moderator .

So, f i r st t hi ng t o not e, t hi s publ i c meet i ng

i s bei ng t r anscri bed and t he t r anscr i pt i on wi l l be

post ed on t he FDA' s websi t e when compl et ed.

A shor t r emi nder , dur i ng t he quest i on and

answer sessi ons t hat we' l l have af t er t he pr esent er s,

pl ease cl ear l y st at e your name and your or gani zat i on t o

make sur e t hat t hey ar e capt ur ed f or t he t r anscr i pt s.

The r est r ooms, both of t hem, ar e t o t he r i ght as you

exi t t he bal l r oom.

Now, you shoul d have al l r ecei ved a f ol der .

And i nsi de your f ol der you shoul d f i nd t he agenda; you

shoul d f i nd copi es of bot h Dr . Kat z' s and Dr . Hansen' s

sl i de pr esent at i ons; t her e' s a copy of t he Feder al

Regi st er not i ce. And as not ed on t he agenda, J anuary

30t h, 2012 i s t he deadl i ne f or submi ssi on of any

wr i t t en comment s t o t he docket . And t he docket ' s


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addr ess i s l i st ed t her e as wel l as i n t he Feder al

Regi st er not i ce. We wi l l be put t i ng t he sl i des t o t he

docket l at er . And you al so shoul d have i n t he f ol der a

l i st of at t endees t hat have r egi st er ed i n advance.

Now, i f anybody has any medi a or pr ess cont act

quest i ons, we do have somebody f r om our pr ess of f i ce

her e, t hat ' s Mi ss Tamar a War d, she' s st andi ng i n t he

back, wavi ng, so i f you have any quest i on pl ease

cont act her .

Now, f or publ i c comment s, i f t her e' s anybody

here who has not si gned up t o make a publ i c comment

t oday, and you woul d l i ke t o do so, pl ease cont act

J uani t a Yat es. I bel i eve she' s st i l l outsi de at t he

r egi st r at i on desk- - oh, J uani t a' s r i ght t o your l ef t

here- - or one of our st af f member s, by noon t oday, by

t he l unch br eak, and we can schedul e you i n.

I f you need any - - have any more quest i ons, or

need some assi st ance, pl ease t al k t o one of our

per sonnel at t he r egi st r at i on desk. Wendy J ohnson i s

worki ng out si de; she shoul d be abl e t o answer any

quest i ons or hel p you.

Wi t h t hat bei ng sai d, I ' d l i ke t o st ar t t he


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meet i ng wi t h Dr . Li nda Kat z, who i s t he di r ect or of t he

Of f i ce of Cosmet i cs and Col or s.

DR. KATZ: Thank you, J ohn. Good mor ni ng and

wel come. I ' m gl ad t o see t hat we have such a gr eat

t ur nout t oday t o t al k about t he cosmet i c

mi cr obi ol ogi cal saf et y i ssues. And we l ook f or war d t o

hear i ng f r om al l of you, ei t her her e t oday who ar e

pr esent ers, or t hr ough publ i c comment s.

Dur i ng t he br i ef t i me t hat I have t hi s

mor ni ng, what I ' m goi ng t o do i s j ust t o gi ve an

over vi ew and t al k a l i t t l e bi t about FDA' s mi ssi on,

t al k a l i t t l e bi t about FDA' s over si ght f or our

cosmet i c saf et y wi t h r egar d t o our r egul at or y aut hor i t y

pr ogr ams and t ool s, and t hen t al k a bi t about t he

pur pose of t oday' s meet i ng, whi ch, al l of you ar e

awar e, i s why you ar e her e.

Let me st ar t of f wi t h t al ki ng about FDA' s

mi ssi on. Thi s sl i de i s ver y si mpl e. And i t ' s si mpl e

because r eal l y t he mi ssi on i t sel f i s f ai r l y si mpl e, t o

pr ot ect and pr omote t he publ i c heal t h. And we do t hi s

by l ooki ng at and f ocusi ng on cosmet i c saf et y.

FDA' s aut hor i t y f or cosmet i cs i s somewhat


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l i mi t ed. As pr obabl y al l of you ar e awar e, our

aut hor i t y i s based on t he Feder al Food, Dr ug, and

Cosmet i c Act , and i t st at es t hat cosmet i cs must not be

adul t er at ed or mi sbr anded.

So what does t hi s, basi cal l y, mean? I t means

t hat FDA' s aut hor i t y i s post - mar ket onl y. The l aw does

not pr ovi de f or FDA t o have pr e- market appr oval of

cosmet i cs. Now, t hi s i s ver y di f f er ent f r om dr ugs and

devi ces i n whi ch an appl i cat i on wi l l come i nt o t he

agency f or r evi ew and t he agency wi l l make a

determi nat i on whether a pr oduct and i ngr edi ent s are

saf e f or use, as wel l as ef f ect i ve pr i or t o mar ket i ng.

For cosmet i cs, what we know about t he pr oduct s we l ear n

af t er t he pr oduct s ar e out i n t he mar ket pl ace, i n most

cases.

So what i s our r esponsi bi l i t y at t he FDA?

Wel l , our r esponsi bi l i t y i s real l y t o moni t or saf et y

and ensure t he pr oper l abel i ng of cosmet i cs. When a

cosmet i c get s mar ket ed, i ndust r y has addi t i onal

i nf or mat i on and t he r esponsi bi l i t y t o assur e t hat

pr oduct s t hat ar e on t he mar ket pl ace ar e saf e.

So what does t hi s, basi cal l y, mean? I t means


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t hat t he cosmet i cs must be saf e when used as l abel ed

and under t he cust omar y condi t i ons f or use. So, our

mai n concer n i s f or t he saf et y and t he appr opr i at e

l abel i ng, so t hat consumers who ar e usi ng t hese

pr oduct s can use t hem saf el y.

So how does FDA deter mi ne and moni t or t he

saf et y of cosmet i cs? We do t hi s real l y by i nf or mat i on

t hat comes t o us. We do i t by t he moni t or i ng of

adver se event s t hat come i nt o t he FDA. As al l of you

know, adver se event r epor t i ng f or cosmet i cs i s

vol unt ar y, so i t ' s somewhat l i mi t ed. But , by t he same

t oken, we l ook f or t r ends. I f t her e ar e cer t ai n t r ends

t hat come t hr ough t hat suggest t hat t her e may be a

saf et y i ssue, i t set s of f a f l ag f or us t o del ve a

l i t t l e more f ul l y.

We al so l ook at t he sci ent i f i c r esear ch. We

l ook at what ' s publ i shed i n t he l i t er at ur e. We l ook at

any addi t i onal i nf or mat i on that may become avai l abl e t o

us, and her e CI R i s of t en a val uabl e sour ce f or

addi t i onal i nf or mat i on.

We wi l l do i nspect i ons of cosmet i c

manuf actur i ng f aci l i t i es, par t i cul ar l y i f we have


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concern about a pr oduct or a concern about i ngr edi ent s.

We exami ne i mpor t ed pr oduct s, agai n f or t hei r saf et y.

And we wi l l t ake enf orcement act i on agai nst cosmet i cs

t hat are adul t er at ed and/ or mi sbr anded. The abi l i t y t o

do t hat i s i n our r egul at i ons. And we al so have

gui dances and ot her publ i c communi cat i ons t o hel p

i ndust r y t o manuf act ur e saf e cosmet i cs.

Thi s agai n l eads t o i mport ant i nf or mat i on and

par t of t he r eason f or why we' r e here t oday. When we

t al k about mi crobi ol ogi cal saf et y, t he FDA' s

i nf ormat i on i s somewhat l i mi t ed. But we do gi ve advi ce

f or t hi ngs t hat we woul d l i ke t o see as you mar ket and

manuf act ur e product s. We have GMP gui del i nes t hat

pr ovi de f ai r l y gener al di r ect i ons t hat ar e avai l abl e on

our websi t e. Even t hough we al l know t hat GMPs ar e not

r equi r ed f or cosmet i cs, we hope that manuf act ur er s do

f ol l ow t hem because, agai n, t hi s i s one of our ways t o

assure t hat pr oduct s are bei ng manuf act ur ed saf el y.

We have a compl i ance pr ogr am and gener al

manual s t hat ar e al so avai l abl e, whi ch wi l l gi ve

gener al i nf or mat i on t o manuf act ur er s as t o what ki nds

of i nf or mat i on we' r e l ooki ng at , War ni ng Let t er s t hat


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may have been i ssued, and why War ni ng Let t er s have been

i ssued.

And we al so have t he BAM, whi ch i s t he

Bact er i ol ogi cal Anal yt i cal Manual , whi ch i s a t echni cal

manual . I n t he BAM i t sel f , one chapt er i s dedi cat ed t o

cosmet i cs and cosmet i c i ngr edi ent s. And Dr . Pat r i ci a

Hansen wi l l t al k a l i t t l e bi t mor e about t hat i n j ust a

f ew moment s.

So t hat br i ngs us r eal l y t o t he goal of t hi s

publ i c meet i ng. We' r e her e r eal l y t o t al k about

mi cr obi ol ogi cal saf et y of cosmet i cs and t o l i nk t hem

di r ect l y t o FDA' s publ i c heal t h mi ssi on. We' r e r eal l y

her e t o hear f r om you, t o f i nd out mor e i nf or mat i on,

and t o get more oppor t uni t i es f or us t o see where we

need t o pot ent i al l y modi f y gui dances, what addi t i onal

i nf or mat i on we mi ght need t o make avai l abl e to al l of

you, both i n i ndust r y and academi a. We need t o assur e

t hat any t i me we change any i nf ormat i on t hat we

publ i sh, t hat t her e' s a sound sci ent i f i c basi s. And

t hat , r eal l y, t hi s sessi on i t sel f i s desi gnat ed

pr i mar i l y as a l i st eni ng sessi on. Agai n, I need t o

emphasi ze, we want t o hear f r om you.


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Thi s s l i de sect i on i t sel f i s j ust t o l et you

know where you can f i nd i nf ormat i on about cosmet i cs and

FDA' s posi t i on about cosmet i cs and how we regul ate

t hem. On our home page we have mul t i pl e di f f erent

l i st i ngs. And we have quest i on and answer s to hel p t o

or i ent you about i ssues and quest i ons t hat we get asked

and what we t hi nk shoul d be t he answers. But agai n,

t he emphasi s f r om t hi s meet i ng wi l l be t o f i nd out i f

any of our answer s may potent i al l y be i ncorr ect because

t he sci ence has changed. We need t o know t hat .

So wi t h t hat , I want t o thank you and hope

t hat t hi s t ur ns out t o be a ver y pr oduct i ve meet i ng.

And we l ook f or ward t o hear i ng f r om you. Thank you.

MR. GASPER: Kei t h quest i on: I need t o make

your sl i des l ar ger . Af t er we make t hi s l ar ger , Dr .

Pat r i ci a Hansen wi l l be gi vi ng you t he FDA per spect i ve.

F5 di dn' t wor k.

DR. HANSEN: Okay. Li t t l e t echni cal det ai l s.

Good mor ni ng. I t i s r eal l y gr eat t o see so many of our

st akehol der s her e t hi s mor ni ng. And our of f i ce has

r eal l y been l ooki ng f or war d t o t hi s day, t he cosmet i c

pr ogr am, and f or t hose of you who ar e acquai nt ed wi t h


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me, you know t hat per sonal l y I ' ve r eal l y been l ooki ng

f or war d t o t hi s day and t o hear i ng f r om our

st akehol der s, your dat a, i nf or mat i on, anal ysi s, and

per spect i ve.

And I ' m goi ng t o gi ve, r eal l y, a br i ef , sor t

of overvi ew and some cont ext around FDA' s per spect i ve.

I ' m goi ng t o f ocus on saf et y and t hat wi l l be a t heme

r ecur r i ng. As Dr . Kat z ment i oned, saf et y r eal l y i s our

f ocus her e- - publ i c heal t h pr ot ect i on, and pr omot i on of

publ i c heal t h- - and we' r e goi ng t o keep comi ng back t o

t hat .

We have a var i et y of cur r ent i nf or mat i on

sour ces, FDA sour ces, i ndust r y sour ces, ot her s t hat

addr ess, i n whol e or i n par t , mi crobi ol ogi cal saf et y.

I ' m goi ng t o t al k about t hose a l i t t l e bi t . I ' m goi ng

t o t al k about our t hought s ar ound updat i ng and

r est r uct ur i ng FDA i nf or mat i on sour ces and get t i ng t o

some of t he t hemes that Dr . Kat z ment i oned. And al so

our i nf or mat i on needs i n t hi s br oad ar ea and ar eas,

excuse me, f or st akehol der i nput , because we real l y

want t o hear f r om you. Agai n, you have val uabl e

i nsi ght , i nf or mat i on, and per spect i ve and we need t o


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exchange t hat .

So mi crobi ol ogi cal saf et y and qual i t y - - t hese

are f undament al concept s and we bel i eve t hey' r e

i mpor t ant t o al l st akehol der s. We al so bel i eve t hat

st akehol der i nput i nt o FDA' s wor k and i nf or mat i on

sour ces i s cr i t i cal . We need cur r ent sci ence. We need

i nsi ght i nt o cur r ent manuf act ur i ng and t est i ng

pr act i ces, suggest i ons about ar eas, f ut ur e ar eas of

r esear ch ar e al so of i nt er est , st akehol der needs and

concer ns, and ot her consi der at i ons.

Turni ng t o t he t opi c of i nf or mat i on sources,

t her e ar e var i ous sour ces. FDA i s one, i ndust r y

i mpor t ant l y i s anot her , st andar d set t i ng or gani zat i ons

ar e agai n a sour ce addi t i onal l y of i nf or mat i on r el evant

t o mi cr obi ol ogi cal saf et y. And t her e ar e ot her

sour ces. Di f f er ent sour ces emphasi ze di f f er ent aspect s

of mi crobi ol ogi cal saf et y and/ or qual i t y.

FDA' s i nf or mat i on sour ces, Dr . Kat z ment i oned

a coupl e of t hem, I ' l l go on a l i t t l e bi t mor e i n

depth. We have a cosmet i c compl i ance progr am, whi ch

she ment i oned, l ast updated i n 2010 ( and t hese

document s ar e on a r egul ar r evi si on schedul e) . We have


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t he Cosmet i c Good Manuf act ur i ng Pr act i ce Gui del i nes and

I nspect i on Checkl i st , l ast updat ed i n 2008, cur r ent l y

under r evi si on now.

We have t he Bact er i ol ogi cal Anal yt i cal Manual ,

f ami l i ar t o many peopl e i n t he audi ence, and Chapt er

23, "Mi cr obi ol ogi cal Met hods f or Cosmet i cs. " Thi s

chapt er has not been updated i n some t i me. I t was l ast

updated i n 2001.

Then we have consumer sources. Consumer

updat es i s one vehi cl e we use and one of par t i cul ar

per t i nence her e i s t he one that addr esses usi ng eye

cosmet i cs saf el y. And we' r e i nt er est ed i n hear i ng f r om

al l of our st akehol der s t oo on i nf or mat i on sour ces and

t opi cs t hat mi ght be hel pf ul f or consumer s.

Ther e ar e i ndust r y i nf or mat i on sources. Ther e

ar e t he CTFA Mi cr obi ol ogy Gui del i nes, 2007 update, CTFA

Qual i t y Assurance Gui del i nes, al so 2007. And t her e ar e

ot her i nf or mat i on sour ces and gui del i nes out t her e, and

many of you act i ve i n t he f i el d and i n t he i ndust r y

wi l l be wel l f ami l i ar wi t h t hose. And my i nt ent i s not

t o gi ve an exhaust i ve l i st but mer el y to hi ghl i ght some

of t he cr i t i cal ones.


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St andar d set t i ng or gani zat i ons ar e anot her

sour ce of i nf or mat i on and gui del i nes. I ' m hi ghl i ght i ng

I SO here, most pr omi nent , i n my vi ew, but t her e ar e

ot her bodi es out t her e. Ther e i s t he I SO Techni cal

Commi t t ee 217 Wor k Gr oup Si x product , Cosmet i c Good

Manuf act ur i ng Pr act i ce, and I ' l l be t aki ng up t hi s

par t i cul ar i nf or mat i on sour ce i n a l i t t l e mor e det ai l

l at er on i n t he pr esent at i on.

Ther e i s a draf t I nt er nat i onal St andar d, I SO,

Eval uat i on of t he Ant i - mi crobi al Pr ot ect i on of a

Cosmet i c Product . And t hat was out and l ast di scussed

at t hi s year ' s meet i ng i n Mar ch. Al so at t hat meet i ng- -

t he 17t h meet i ng of Worki ng Gr oup 1- - a pr oposal was

sent t o t he I SO advi sor y gr oup f or di scussi on. And t hat

was t o devel op an i nt er nat i onal st andar d i dent i f yi ng

obj ect i onabl e mi cr oor gani sms and set t i ng mi cr obi al

l i mi t s f or cosmet i cs, consi der i ng cur r ent saf et y and

qual i t y st andar ds. And I hi ghl i ght t hi s one t o

emphasi ze t hat t hese t opi cs are of i mpor t ance across

t he i nt er nat i onal scene. And t her e i s some conf l uence

of i nt er est and pr i or i t y, I t hi nk, across t he gr oup of

st akehol der s: Gover nment , i ndust r y, consumer s.


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As many of you ar e awar e, we ar e updat i ng and

r est r uct ur i ng FDA i nf or mat i on sour ces and t ypi cal l y

many document s do under go per i odi c updat i ng.

We need t o al i gn r el ated FDA document s. Thi s

i s ver y i mpor t ant : t hat we t r y t o keep t hem, i f t hey

can' t be absol ut el y synchr oni zed, consi st ent and

al i gned. We don' t need one poi nt i ng of f t o t he r i ght

and one t o t he l ef t . And so t her e' s al ways t hat ef f or t

t o keep t hi ngs al i gned.

We want our i nf ormat i on sour ces t o be up to

dat e i n t er ms of sci ence and t echnol ogy. And t hat i s

somet i mes a r eal chal l enge i n r api dl y devel opi ng ar eas.

And we r eal l y, agai n, want t o hear f r om our

st akehol der s, par t i cul ar l y on sci ence and t echnol ogy.

I n any l i br ar y of i nf or mat i on sour ces, you

know, you pi ck one up of f t he shel f and when you' r e

t r yi ng t o use i t t hi ngs emer ge. Thi ngs you t hought

wer e cr ystal cl ear ar e maybe not so cr yst al cl ear . So

we need t o cl ar i f y conf usi ng or ambi guous ar eas and

t hat i s par t of t hi s ef f or t t hat t he agency i s

cont i nual l y engaged i n, i n updat i ng and r est r uct ur i ng

i t s i nf or mat i on sour ces.


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We bel i eve i t desi r abl e t o al i gn wi t h

i nt er nat i onal st andar ds t o t he gr eat est ext ent possi bl e

wi t hi n t he exi st i ng l egal f r amewor k, i mpor t ant

parameter t here, and wi t hout compr omi si ng saf et y,

anot her cri t i cal par amet er .

And we need to consi der new i nf ormat i on

sour ces t hat may be needed. And here I ' m harkeni ng

back agai n to Dr . Kat z' s r emarks where we' ve been

consi der i ng, gi ven t hat some of our i nf or mat i on sour ces

are ver y general , t here' s a need t o update. Do we need

t o devel op new i nf ormat i on sour ces, new gui del i nes, new

consumer updat es? What ki nds of t opi cs and what ki nds

of f or mat s wi l l be most usef ul ?

So I ' l l t al k about a f ew of t he t hi ngs t hat

we' r e doi ng r i ght now. You hear d me speak about t he

compl i ance pr ogr am, t hat t hat was l ast updat ed i n 2010.

And i n t hat ef f or t we r emoved a l ot of obsol et e

mat er i al , cl ar i f i ed sect i ons t hat had been f ound t o be

conf usi ng or ambi guous t o t he users, and i n gener al ,

r eal l y pul l ed i t up t o dat e.

We ar e pr esent l y engaged i n r evi si ng t he

Cosmet i c GMP Gui del i nes and I nspect i on Checkl i st .


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Agai n, we are r emovi ng obsol ete or ext r aneous

i nf or mat i on, cl ar i f yi ng ambi guous areas. We ar e al so

consi der i ng i ncor por at i ng el ement s f r om t he

cor r espondi ng I SO gui del i ne t hat I ment i oned t o t he

ext ent t hat ' s possi bl e - - ver y i mpor t ant . And t hi s

document i s ver y wel l devel oped, and i t i s i n

cl ear ance. We do not have a dat e cer t ai n f or i t s

i ssuance. I wi l l not e t hat , but i t ' s wel l al ong i n t he

cl ear ance pr ocess and we ant i ci pat e i t i ssui ng,

hopef ul l y, soon.

We' r e al so revi si ng Chapt er 23 of t he BAM.

We' r e seeki ng gr eat er al i gnment wi t h mor e r ecent l y

updated chapt ers. The BAM, i n t he mai n, f ocuses on

f oods and has chapt er s t hat ar e mi cr oor gani sm speci f i c.

Some of t hese chapt ers are more up t o date i n t erms of

met hodol ogy, so we ar e l ooki ng cl osel y t o, agai n, t o

al i gn t he cosmet i cs chapt er , whi ch i s br oader , t o al i gn

wi t h t hose chapt er s wher e i t i s needed, t hat ar e mor e

speci f i c t o mi cr oor gani sms and f ood pr oduct s. And so,

t hat ' s one t hi ng t hat we' r e t r yi ng t o achi eve.

We' r e seeki ng gr eat er cl ar i t y i n some of t he

sect i ons of t hat chapt er , especi al l y r egar di ng f ol l ow-


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up on ambi guous r esul t s. We' r e r emovi ng ext r aneous

non- t echni cal mat er i al t o have a t i ght er , mor e f ocused

chapt er .

And we see oppor t uni t i es her e, i n per i odi c

r evi si on, t o i ncor por at e newer met hodol ogi es, per haps

as scr eeni ng t ool s. And, i f you r ecal l f r om t he

Feder al Regi st er not i ce, we ar e par t i cul ar l y i nt er est ed

i n hear i ng f r om our st akehol der s on t est i ng met hods of

al l ki nds.

And agai n, we' r e consi der i ng t he possi bl e

devel opment of new i nf ormat i on sour ces. Shoul d we be

devel opi ng gui dance t o i ndust r y on cosmet i c

mi cr obi ol ogi cal saf et y? What speci f i c t opi cs ar e most

i n need of addr essi ng? We' r e r eal l y hopi ng t o hear

f r om you. What ki nd of f or mat s wi l l be most usef ul ?

Agai n, we' r e t r yi ng t o keep t hese i nf or mat i on sour ces

cur r ent and t her e ar e a var i et y of di f f er ent ways,

f ormat s, t hat woul d l end t hemsel ves, we bel i eve, more

easi l y t o t hat . But we want t o hear f r om you.

We' r e consi der i ng devel opi ng addi t i onal

r esour ces f or consumer s on cosmet i c mi cr obi ol ogi cal

saf et y. We don' t have an awf ul l ot . Up t her e I gave


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t he one exampl e of usi ng eye cosmet i cs saf el y; t hat i s

t he mai n one t hat we have. And we' r e l ooki ng f or other

t opi cs t hat st akehol der s bel i eve ar e i mpor t ant t o

addr ess, t opi cs i mpor t ant t o consumers, and what ki nds

of f or mats and pr esent at i on woul d be most usef ul f or

our st akehol der s.

So, I ' ve ment i oned r epeat edl y t hat t her e ar e

ar eas wher e i nf or mat i on and i nput ar e needed. And I ' l l

ampl i f y some of t hose hi ghl i ght ed i n t he Feder al

Regi st er not i ce. And I ' m goi ng t o go t hr ough t hose and

ampl i f y a l i t t l e bi t on some of t hem her e.

A number of t hi ngs gr oup under Pr oduct

Manuf act ur i ng and Cont r ol s. We' r e ver y, ver y

i nt er est ed i n hear i ng f r om st akehol der s on

mi crobi ol ogi cal t est i ng of cosmet i cs, t ypes of

pr eservat i ve syst ems, and met hods f or pr eservat i ve

ef f i cacy t est i ng, pr oduct and packagi ng char act er i st i cs

t hat af f ect mi crobi al gr owt h as wel l as ot her f act or s.

We have a number of peopl e her e who have

si gned up t o gi ve pr esent at i ons. We' r e hopi ng t o have

a gr eat deal of t echni cal i nf or mat i on i n t hi s and ot her

ar eas, and ar e hopi ng t hat peopl e wi l l al so t ake f ul l


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advant age of t he oppor t uni t y t o submi t wr i t t en mat er i al

t o t he docket .

We ar e ver y, ver y, i nt er est ed i n hear i ng f r om

you on t hese f act or s I ' ve out l i ned and ot her f act or s

t hat you, f r om your per spect i ve, bel i eve ar e i mpor t ant

t o t hat br oad umbr el l a t opi c of mi crobi ol ogi cal saf et y.

Some gr oup under mi cr obi ol ogi cal r i sk

assessment . Here I want t o emphasi ze t hat t hat ' s human

heal t h r i sk assessment . We' r e i nt er est ed i n t he

i dent i t y and pr eval ence i n cosmet i cs of mi cr oor gani sms

t hat pose speci f i c heal t h r i sks, t he quest i on of f r ank

pathogens, opport uni st i c pathogens, non- pathogens, and

t hat whol e cont i nuum. And we' r e, agai n, i nt er est ed i n

dat a and i nf or mat i on, anal ysi s and per spect i ve. Ther e

ar e emer gi ng pat hogens. Ther e ar e ant i bi ot i c r esi st ant

st r ai ns. Al l of t hese f act or s, we bel i eve wi l l be

usef ul t o hear f r om st akehol der s and t o consi der as we

move f orward. Rout es of exposure t o mi cr oor gani sms and

t he cor r espondi ng ef f ect i ve doses - - ver y i mpor t ant .

Par t i cul ar subpopul at i ons t hat may be at

gr eat er r i sk, we' r e ver y i nt er est ed i n t hi s ar ea and

ot her consi der at i ons r el evant t o human heal t h r i sk


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assessment wi t h mi cr obi al consi der at i ons.

We ar e al so ver y i nt er est ed i n hear i ng about

adver se event s. You hear d a l i t t l e bi t f r om Dr . Kat z

on t he adver se event r eport i ng syst em t hat FDA has. We

have l i mi t ed i nf or mat i on. I t ' s a passi ve syst em. And

common t o al l passi ve syst ems, we bel i eve t her e' s

si gni f i cant under r epor t i ng; t her e' s an awar eness i ssue.

We bel i eve that consumers general l y ar e not ver y aware

of FDA' s syst em f or r epor t i ng cosmet i c adver se event s.

So we ar e engaged, act ual l y, i n a separ at e ef f or t t o

promot e gr eater awar eness amongst consumer s and heal t h

pr of essi onal s.

But we ar e ver y i nt er est ed i n hear i ng f r om

you, our st akehol der s, on t opi cs r el evant t o t hi s br oad

umbr el l a. The occur r ence of adver se event s i n

di f f er ent pr oduct t ypes, t he occur r ence of adver se

event s associ at ed speci f i cal l y wi t h mi crobi al

cont ami nat i on and other aspect s of adver se event s,

i ncl udi ng r epor t i ng and moni t or i ng syst ems.

And t hi s l i st , t hat I have been goi ng t hr ough

and t hat was enumer at ed i n t he Feder al Regi st er not i ce,

i s r eal l y not meant t o be al l i ncl usi ve. Ther e ar e, we


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bel i eve, an abundance of ot her consi derat i ons t hat may

be r el evant t o mi cr obi ol ogi cal saf et y of cosmet i cs and

pr ot ect i on of consumers. And we want t o hear f r om you.

So agai n, t o r eemphasi ze, you know, we ar e

r eal l y seeki ng t o hear f r om you: Your dat a, your

i nf or mat i on, your sci ent i f i c anal ysi s, your per spect i ve

i n t he ar eas t hat I ' ve out l i ned. And t o r ecap t hem:

t he i dent i t y and pr eval ence of mi cr oor gani sms,

i ncl udi ng ant i bi ot i c r esi st ant st r ai ns, pat hogens,

f r ank or oppor t uni st i c non- pat hogens; mi cr obi ol ogi cal

t est i ng; pr eser vat i ve syst ems and pr eser vat i ve ef f i cacy

t est i ng; pr oduct and packagi ng char act er i st i cs t hat may

i mpact r out es of exposur e t o mi cr oor gani sms associ ated

wi t h cosmet i cs and i nf ect i ve doses; subpopul at i ons who

may be at gr eat er r i sk; and t he adver se event r epor t i ng

t opi cs t hat I j ust ment i oned.

We al so want t o hear f r om you beyond t hose

t opi cs of what ot her t opi cs you bel i eve woul d be usef ul

t o st akehol der s, usef ul t o i ndust r y, usef ul t o

consumers, usef ul i n t he academi c sense. And what

t ypes of f or mat s and vehi cl es woul d be most pr act i cal ,

most useabl e, and hel pf ul . And we need t o hear f r om


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you on t hat .

So, t her e ar e mul t i pl e oppor t uni t i es f or

st akehol der i nvol vement . That i s a poi nt I r eal l y want

t o emphasi ze. We' r e her e t oday wi t h r eal l y an ear l y

i nput ki nd of wor kshop, t o gat her f r om you, agai n,

dat a, i nf or mat i on, anal ysi s, and per spect i ve t o hel p

i nf or m, r eal l y, our pl an f or movi ng f or war d. Set t i ng

some pr i or i t i es ar ound t hat , what t opi cs do we need t o

address? What ar e most i mpor t ant ? Shoul d we proceed

t o f ormal gui dance? That woul d be an area where t here

ar e f ur t her oppor t uni t i es f or st akehol der i nput and

i nvol vement bui l t i nt o t he pr ocess.

But I hope t hat you r eal i ze, by our comment s

t oday, we r eal l y want t o hear f r om you and want t o

of f er as many oppor t uni t i es f or i nput and i nvol vement

as possi bl e. We bel i eve i t wi l l r eal l y st r engt hen t he

ef f or t and ensur e t he ver y best and most usef ul of

pr oduct s i n t er ms of i nf or mat i on sour ces.

Today i s a huge oppor t uni t y i n t hi s r egar d.

And agai n, I ' m r eal l y j ust so happy t o see so many

peopl e her e, t o see t he f ol ks who have l i ned t hemsel ves

up t o pr esent , ver y good. I hope t hat peopl e who have


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addi t i onal i nf or mat i on t o of f er wi l l si gn up at

l uncht i me, as our moder at or ment i oned, t o t ake t hei r

f ew mi nut es at t he mi cr ophone.

Fol l owi ng up on t hi s meet i ng t her e i s a docket

open, and a 60- day comment per i od. And I r eal l y want

t o encour age al l of our st akehol der s, whet her t hey ar e

f or mal l y pr esent i ng her e today or not , t o submi t

wr i t t en mat er i al t o t he docket .

I nf or mat i on on t he docket i s cont ai ned i n t he

f ol der s t hat you have at t he meet i ng. But i t ' s her e

agai n f or r ef er ence, up on t he scr een. And t hese

comment s, we' r e l ooki ng f or t hem by J anuar y 30t h i n t he

comi ng year .

And mor e of j ust how t o get hol d of us. I f

you' ve got quest i ons and i nf or mat i on out si de t hat

docket pr ocess t hat you want t o pr opose. And wi t h

t hat , I t hi nk I wi l l cl ose. Thank you.

MR. GASPER: Okay. Our f i r st pr esent er i s Mr .

Et an Yeshua, f r om Envi r onment al Worki ng Gr oup.

MR. YESHUA: Good mor ni ng. I don' t have any

sl i des f or you al l , so hopef ul l y I ' m enough t o capt ur e


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your at t ent i on f or t he next 20 mi nut es.

Thanks f or provi di ng EWG t he oppor t uni t y t o

comment on t he i ssue of cosmet i c mi cr obi ol ogi cal

saf et y. My name i s Et an Yeshua, I ' m t he 2011 St abi l e

Law Fel l ow at t he Envi r onment al Wor ki ng Gr oup, wher e my

wor k f ocuses on t he r egul at i on of cosmet i c pr oduct s.

EWG i s a non- pr of i t r esear ch and advocacy

or gani zat i on based i n Washi ngt on, D. C. and Oakl and,

Cal i f or ni a. Our mi ssi on i s t o use t he power of publ i c

i nf or mat i on t o pr ot ect publ i c heal t h and t he

envi r onment . We appr eci ate FDA' s i nt erest i n and

commi t ment t o ensur i ng the saf et y of cosmet i cs or

per sonal car e pr oduct s.

The aver age consumer uses near l y t en di f f er ent

personal care pr oduct s ever y day. That means t here are

t en oppor t uni t i es dai l y f or a mi crobi ol ogi cal l y

cont ami nat ed cosmet i c product t o spr ead i nf ect i on t o an

unknowi ng consumer . Mor eover , t he 126 uni que

i ngr edi ent s t hat t he aver age per son appl i es t o hi s or

her ski n ever y day cont ai n pr eser vat i ves, chemi cal s

t hat may of t en be t oxi c, and pr esent hazar dous heal t h

r i sks.


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The f eder al government does not r equi r e t he

vast maj or i t y of t hese pr oduct s t o under go heal t h

st udi es or pr e- mar ket t est i ng. The i nf or mat i on gap

makes i t al l t he mor e al ar mi ng t hen, i n t hat young

chi l dr en, who ar e of cour se mor e suscept i bl e t o

mi cr obi al and t oxi c cont ami nat i on, ar e exposed t o 61

uni que cosmet i c i ngr edi ent s i n a handf ul of di f f er ent

pr oduct s ever y day.

Gi ven t he l ack of r egul at or y aut hor i t y

pr ovi ded FDA under t he Federal Food, Dr ug, and

Cosmet i cs Act , FDA gui dance f or i ndust r y woul d be one

of t he most ef f ect i ve ways t o ensure cosmet i c pr oduct s

t o ensur e t hat consumer s ar e pr ot ect ed f r om mi cr obi al

cont ami nat i on.

EWG suppor t s t he agency' s ef f or t s t o pr omote

saf e i ndust r y pr act i ces, especi al l y gi ven t he nar r ow

conf i nes of FDA st at ut or y aut hor i t y. As a consumer

advocacy group, and as a f oundi ng member of t he

Campai gn f or Saf e Cosmet i cs, EWG has l ong backed t he

cal l f or ef f ect i ve and ef f i ci ent cosmet i c saf et y

r egul at i on wi t h sound sci ent i f i c r esear ch.

To t hat end, EWG r ecommends t hat FDA devel op


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r esear ch has hi ghl i ght ed t wo speci f i c ar eas of concer n

wi t h r egar d t o cosmet i c pr eservat i on as wel l as a

number of addi t i onal ar eas wher e f ur t her r esear ch i s

needed.

Si nce 2004, EWG' s Ski n Deep Dat abase has

pr ovi ded consumer s wi t h a f r ee, publ i cal l y accessi bl e,

on- l i ne t ool wi t h hazar d pr of i l es of al most 70, 000

cosmet i c pr oduct s, and more t han 8, 000 cosmet i c

i ngr edi ent s.

Our r esear cher s cont i nual l y compi l e and

anal yze i nf or mat i on f r om mor e than 60 t oxi ci t y and

r egul at or y dat abases t o gener at e saf et y r at i ngs f or

what has become t he wor l d' s l argest personal care

pr oduct s saf ety gui de accessed every mont h by over one

mi l l i on peopl e.

Wi t h ei ght year s' wor t h of dat a, our Ski n Deep

Database ser ves as t he basi s f or our r esear ch and

pol i cy concl usi ons about cosmet i c pr oduct r i sk and

r egul at i on. The dat a we have amassed has r eveal ed

hi dden heal t h r i sks, spur r ed r egul at or y act i on, and l ed

t o changes i n pr oduct f or mul at i on. The dat a al so

hi ghl i ght t he need f or FDA gui dance wi t h r egar d t o


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agent , package desi gn or pr oduct l abel i ng.

Second, pr oduct s wi t h pot ent i al l y t oxi c

pr eser vat i ves. Some 3, 579 pr oduct s i n our database ar e

pr eserved wi t h one or mor e of 22 di f f er ent

pr eser vat i ves f or whi ch t her e' s evi dence of t oxi ci t y

and r i sk t o human heal t h, i ncl udi ng t he heal t h of

chi l dr en and devel opi ng f et uses. The per sonal car e

pr oduct s shoul d not t hr eat en consumer s wi t h i nf ect i on

f r om pr event abl e mi cr obi al cont ami nat i on. Nei t her

shoul d t hey f orce consumers t o choose between mi cr obi al

cont ami nat i on and cont ami nat i on due to harmf ul

pr eser vat i ves.

Whi l e FDA shoul d gui de i ndust r y t owar d ant i -

pathogeni c and bet t er pr eser ved pr oduct s, t he agency

shoul d si mul t aneousl y pr omot e saf er , l ess t oxi c met hods

of pr eser vat i on. Per sonal car e pr oduct s ought t o be

manuf actur ed and used saf el y wi t h mi ni mal r i sk of

mi cr obi al cont ami nat i on, but wi t hout t r adi ng one r i sk

f or anot her .

For exampl e, par abens ar e f r equent l y used as

pr eser vat i ves i n per sonal car e pr oduct s t hat cont ai n a

si gni f i cant amount of wat er . Of t he 40, 000 cur r ent l y


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ar e exposed t o t hi s car ci nogeni c i nt oxi cant . Even t he

i ndust r y- dr i ven Cosmet i c I ngr edi ent Revi ew Panel t hi s

year decl ar ed f or mal dehyde an unsaf e i ngr edi ent i n

cer t ai n hai r pr oduct s. The car ci nogeni c chemi cal i s a

di st i nct i ngr edi ent i n at l east seven cur r ent l y

market ed pr oduct s; 11, 000 others cont ai n f ormal dehyde-

r el easi ng i ngredi ent s such as quat erni um- 15 and DMDM

hydant oi n.

I n l i ght of t hese danger s associ at ed wi t h bot h

under - pr eservat i on and pr eservat i on t hr ough t he use of

hazardous chemi cal s, more r esear ch i s needed t o

det er mi ne t he r i sks and benef i t s of di f f er ent

pr eser vat i on syst ems. Wher e t oxi c chemi cal s can be

r educed or r epl aced wi t h pr oduct r ef or mul at i ons or

car ef ul package desi gn, f or exampl e, t hey shoul d be.

I n addi t i on, EWG suggest s t hat FDA consi der

t he f ol l owi ng ar eas of i nvest i gat i on bef or e i ssui ng

gui dance on cosmet i c mi crobi ol ogi cal saf et y. Fi r st i s

a compar at i ve anal ysi s of domest i c and f or ei gn mar ket s.

The Eur opean Uni on enf or ces mor e st r i ngent r egul at i ons

t han t he Uni t ed St ates does wi t h r egar d t o cosmet i c

i ngr edi ent and pr oduct saf ety. Whereas FDA has banned


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or r est r i ct ed onl y a handf ul of i ngr edi ent s, t he

Eur opean Uni on' s 2003 Cosmet i cs Di r ect i ve banned 1, 100

chemi cal s f r om use i n cosmet i c pr oduct s.

The mor e r est r i ct i ve bans do not necessar i l y

equat e t o smar t er r egul at i on and saf er pr oduct s. FDA

shoul d not i gnore t he data amassed and l essons l ear ned

f r om years of pol i cy devel opment by t he Eur opean Uni on.

I ndeed, i t was a comparat i ve anal ysi s by t he Campai gn

f or Saf e Cosmet i cs t hat l ed t o t he di scover y that a

saf er f or mul at i on was bei ng used i n f or ei gn baby

shampoos t han i n the same pr oduct market ed i n t he U. S.

Because manuf act ur ers are f aced wi t h more

st r i ngent r egul at i ons i n t he Eur opean mar ket , t hey may,

and i n at l east one case most cer t ai nl y have, al r eady

demonst r at ed an abi l i t y t o r ef or mul at e t hei r pr oduct s

t o be saf er whi l e mai nt ai ni ng pr of i t abi l i t y.

The second ar ea f or f ur t her i nvest i gat i on i s

pr oduct l abel i ng. Legi bl e pr oduct l abel i ng, i ncl udi ng

i ngr edi ent l i st s and expi r at i on dat es may be an

ef f ect i ve means of encour agi ng saf e use and t i mel y

di sposal of per sonal car e pr oduct s. Whet her seeki ng

saf er i ngr edi ent s or avoi di ng known al l er gens, a


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dates and whi ch of t en cont ai n t he same pr eser vat i ves

used i n cosmet i cs.

Comparat i ve anal ysi s woul d be usef ul here as

wel l . The Eur opean Uni on r ecent l y i nt r oduced "best

used bef or e dat e" and "per i od af t er openi ng" l abel i ng.

Moreover , pr oduct s wi t h expi r at i on dat es may be abl e t o

cont ai n saf er pr eser vat i ves because t he shel f l i f e of

t he pr oduct may be shor t er t han t hose of cosmet i cs

l acki ng expi r at i on dat es. Of cour se, t he cont ami nat i ng

ef f ect s on t he envi r onment of di sposed cosmet i c

pr oduct s shoul d be consi der ed as wel l .

Fi nal l y, concent r at i on di spar i t i es. St udi es

of cosmet i c product s i n t he Eur opean market have

r eveal ed a gr eat var i at i on i n pr eser vat i ve

concent r at i on among t he i nvest i gat ed pr oduct s. Though

t hi s var i at i on may be at t r i but abl e t o var i at i ons i n

f or mul a and t o var i ous combi nat i ons of di f f er ent

pr eser vat i ves i n a si ngl e pr oduct , i t may al so i ndi cat e

t hat some pr oduct s ar e over pr eser ved whi l e ot her s

under - pr eserved.

FDA shoul d consi der t he di spar i t i es, i f any,

i n cosmet i c pr eser vat i ve concent r at i ons i n t he Uni t ed


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St at es and pr ovi de i ndust r y wi t h gui dance r egar di ng

pr oduct desi gn, f or mul at i on, t est i ng and l abel i ng, as

wel l as t he use of pr eser vat i ves t hat woul d pr ovi de a

r easonabl e cer t ai nt y of no har m f or vul ner abl e

popul at i ons exposed t o cosmet i c pr oduct s.

Gi ven t he many aspect s of cosmet i c saf ety f or

whi ch mor e resear ch i s needed, EWG bel i eves FDA

gui dance and anal ysi s coul d go a l ong way t o pr omote

t he saf et y of per sonal car e pr oduct s. EWG l ooks

f orwar d to worki ng wi t h FDA t o addr ess t hese i ssues and

t o ensur e t hat per sonal car e pr oduct s ar e f or mul at ed,

manuf actur ed, l abel ed, and used so as t o pr event

cont ami nat i on by both mi cr obi ol ogi cal pathogens and

t oxi c pr eser vat i ves. Thanks.

MR. GASPER: Okay. We have schedul ed t en

mi nut es f or any quest i ons f or Mr . Yeshua. And i f you

woul d, we have t wo peopl e wi t h hand- hel d mi cs. I f you

woul d j ust r ai se your hand, and as I st at ed ear l i er

pl ease st at e your name and your or gani zat i on cl ear l y,

so i t can be accur at el y caught i n t he t r anscr i pt .

I s ther e anyone who has any quest i ons? Okay.

I guess we don' t . Last cal l .


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Al l r i ght . Wel l , I bel i eve we' r e schedul ed

f or a t went y mi nut e br eak now. So, I guess si nce i t ' s

j ust about quar t er t o, i f we can r econvene at 10: 05,

al l r i ght . Okay. I ' l l see you her e i n 20 mi nut es.

( Recess)

MR. GASPER: Our next present er i s J ay Ansel l

f r om t he Per sonal Car e Pr oduct s Counci l .

DR. ANSELL: Good morni ng, al l . My name' s J ay

Ansel l and I ' m cur r ent l y Vi ce Pr esi dent of Cosmet i c

Progr ams at t he Per sonal Care Pr oduct s Counci l , where

I ' m r esponsi bl e f or pr ovi di ng t echni cal suppor t f or t he

counci l st af f and var i ous commi t t ees addr essi ng t he

sci ence and r egul at i on of per sonal car e pr oduct s.

I pr evi ousl y l ed pr oduct saf et y and r egul at or y

af f ai r s at r aw mat er i al suppl i er s and a f i ni shed

pr oduct s company. My academi c t r ai ni ng i s as a

chemi st , compl et i ng my Ph. D. at t he St at e Uni ver si t y of

New Yor k at Bi nghamt on, and I was f i r st cer t i f i ed as a

Di pl omat by t he Amer i can Boar d of Toxi col ogy i n 1986.

Based i n Washi ngt on, D. C. , t he Counci l ,

f or mer l y CTFA, i s t he l eadi ng nat i onal t r ade

associ at i on r epr esent i ng t he $250 bi l l i on gl obal


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cosmet i c and personal care pr oduct s i ndust r y. Founded

i n 1894, t he Counci l ' s mor e t han 600 member compani es

manuf act ur e, di st r i but e, and suppl y t he vast maj or i t y

of f i ni shed per sonal car e pr oduct s mar ket ed i n t he

Uni t ed St at es.

As such, we ar e most pl eased t o be abl e t o

pr ovi de t hese r emar ks and par t i ci pat e i n t oday' s publ i c

meet i ng on t he mi cr obi ol ogi cal saf et y of cosmet i cs. I n

addi t i on t o mysel f , Phi l Gei s and Ri char d Whi t i ng wi l l

be speaki ng l at er . And of cour se, we wi l l be f i l i ng

addi t i onal det ai l ed wr i t t en comment s by t he J anuar y

30t h deadl i ne.

The U. S. cosmet i c i ndust r y and t he Counci l

have a l ong hi st or y of wor ki ng cooper at i vel y wi t h FDA

i n assur i ng t he saf et y and qual i t y of cosmet i c

pr oduct s. I n 1974, t hen Commi ssi oner Al exander Schmi dt

sai d I know of no i ndust r y whi ch has bet t er - - a bet t er

r ecor d of vol unt ar y accompl i shment s. Agai n, i n 1980,

Act i ng Deput y Commi ssi oner Novi t ch ci t ed Commi ssi oner

Schmi dt , addi ng, what was t r ue i n 1974 i s, i f anythi ng,

mor e t r ue t oday. We t ake pr i de i n t hat hi st or y and

st r i ve t o mai nt ai n t hat r ecor d of accompl i shment .


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compr ehensi ve nat i onal sur vey of t he mi cr obi ol ogi cal

qual i t y of cosmet i cs and publ i shed t hose f i ndi ngs i n

1977. Of par t i cul ar not e, t he sur vey f ound t hat of t he

3, 967 pr oduct s t est ed, 97. 7 per cent wer e f r ee of

measur abl e mi cr oor gani sms, and 99. 6 percent were wi t hi n

t he r ecommended mi cr obi ol ogi cal l i mi t s.

I n 1975, FDA conduct ed i t s own sur vey. And

t he f i ndi ngs of t hi s and l at er sur veys, i n addi t i on t o

t he i nf or mat i on f r om i nspect i ons of cosmet i c

manuf actur ers, l ed FDA t o concl ude t hat t he

cont ami nat i on of cosmet i cs ent er i ng t he market was no

l onger a maj or r egul at or y i ssue.

Thus, t he mai n concer n voi ced by t he agency

t hen became the adequacy of pr oduct pr eservat i on,

especi al l y i n t he hands of t he consumer . I ndust r y

agr ees. And pr eservat i on of cosmet i cs i s i ndeed an

i mpor t ant consi der at i on, and i n f act , t he or i gi nal 1973

mi crobi ol ogi cal gui del i nes cont ai n subst ant i al

i nf or mat i on addr essi ng t he pr eser vat i on and pr ot ect i on

of cosmet i c f or mul at i ons.

Now, i t shoul d be not ed t hat t he st at e of

sci ence i s not st at i c. And so, t he gui del i nes under go


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cont i nual r evi ew and updat i ng as new i nf or mat i on

becomes avai l abl e. New gui del i nes ar e r out i nel y added,

whi l e t he exi st i ng gui del i nes are updat ed and r evi sed

t o r ef l ect t he most cur r ent sci ence. For exampl e,

gui del i nes speci f i cal l y f or aqueous eye ar ea pr oduct s

were added i n 1975, and i ncl uded methods f or t est i ng

wat er - based cosmet i cs, t oi l et r i es, and eye ar ea

cosmet i cs.

As anot her exampl e, t he 1993 edi t i on i ncl uded

gui del i nes f or t he mi cr obi ol ogi cal assessment of

pr oduct qual i t y af t er use, i nt ended t o assi st

manuf act ur er s i n assessi ng t he mi cr obi ol ogi cal qual i t y

of t he pr oduct s dur i ng use by consumer s.

I n f act , t he abi l i t y of i n- use t ests t o

cor r obor at e pr eser vat i on ef f i cacy t est r esul t s has been

t he subj ect of sever al publ i shed st udi es. Most

r ecent l y, t he 2007 edi t i on i ncl uded new chapt er s on t he

det er mi nat i on of pr eser vat i on ef f i cacy i n non- woven

subst r at es. Met hods f or pr eser vat i on of at ypi cal

pr oduct s, r api d met hod pr eser vat i on t est i ng of wat er -

mi sci bl e per sonal car e pr oduct s, and seven addi t i onal

chapt er s under went si gni f i cant r evi si ons.


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Fi nal l y, as par t of our l ong hi st or y of

act i on, we shoul d al so ment i on t he Counci l ' s

par t i ci pat i on, at t he agency' s r equest , i n t he

devel opment of a pr eser vat i on ef f i cacy t est

speci f i cal l y f or cosmet i cs. Thr ough AOAC, a method was

t est ed col l abor at i vel y i n a st udy i nvol vi ng 19

l abor at or i es, wi t h t he r esul t s bei ng publ i shed i n t he

2001 J our nal of t he AOAC I nt er nat i onal . Today t hi s

met hod i s st i l l t he onl y val i dat ed chal l enge t est

avai l abl e.

Today t he Counci l ' s mi cr obi ol ogi cal gui del i nes

ar e an i mpor t ant t ool t o assi st manuf act ur er s i n

est abl i shi ng mi cr obi ol ogi cal qual i t y assur ance pr ogr ams

and cont r ol s, t o assure pr oduct qual i t y, and consumer

saf et y. Based on modern qual i t y management t echni ques,

i ncl udi ng qual i t y syst em appr oaches, t he gui del i nes

addr ess assessi ng per sonnel qual i f i cat i ons, t he

mi cr obi ol ogi cal eval uat i on of t he physi cal envi r onment

i ncl udi ng t he pl ant , gr ounds, equi pment , cl eani ng and

sani t at i on, pr ocedur es f or sampl i ng, t est i ng, assessi ng

wat er qual i t y, l ab pr act i ces f or met hod val i dat i on,

document at i on, and assessi ng t he adequacy of pr oduct


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pr eser vat i on, i ncl udi ng pr oduct s af t er use.

The Counci l i s al so act i ve i n t he devel opment

i n i nt er nat i onal advancement of best bi ol ogi cal

pr act i ces t hr ough act i ve par t i ci pat i on i n t he I SO

Techni cal Commi t t ee 217 we hear d about ear l i er . The

U. S. Techni cal Advi sor y Gr oup r epr esent i ng t he Amer i can

Nat i onal St andar ds I nst i t ut e i s chai r ed and

admi ni st er ed by the Counci l and cur r ent l y has 22

exper t s, i ncl udi ng exper t s f r om FDA par t i ci pat i ng.

The U. S. exper t s, al ong wi t h exper t s f r om 57

ot her nat i onal del egat i ons have wr i t t en ni ne

i nt er nat i onal st andar ds i n t he ar ea of mi cr obi ol ogy

si nce 2005. These addr ess gener al di r ect i ons f or

mi cr obi ol ogi cal exami nat i ons, met hods f or det ect i on of

aer obi c mesophi l i c bact er i a, E. col i , Pseudomonas

aer ugi nosa, St aph aur eus, Candi da al bi cans, and a

met hod f or t he enumerat i on of mol d and yeast .

Of par t i cul ar not e, t he exper t s have al so

publ i shed gui del i nes f or r i sk assessment of

mi cr obi ol ogi cal l y l ow r i sk pr oduct s and est abl i shed a

st andar d f or cosmet i c good manuf act ur i ng pr act i ces t hat

has now been adopt ed or r ef erenced by aut hor i t i es


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wor l dwi de. These i ncl ude t he U. S. FDA, t he Eur opean

Commi ssi on, J apan' s Mi ni st r y of Heal t h, Labour and

Wel f ar e, and Heal t h Canada. Addi t i onal l y, we ar e

wor ki ng cur r ent l y on new st andar ds f or t he eval uat i on

of ant i - mi crobi al pr ot ect i on of a cosmet i c pr oduct ,

mi crobi ol ogi cal l i mi t s, and pr epar i ng a t echni cal

r epor t t o assi st i n conduct i ng mi crobi ol ogi cal r i sk

assessment .

Now, t hose of you who ar e f ami l i ar wi t h I SO

know t hat t he cor e mi ssi on of I SO i s i nt er nat i onal

har moni zat i on t o f aci l i t at e t r ade, al l owi ng ever yone t o

compete on an equal f oot i ng, everywhere. However , as a

par t i ci pant , I can say t hat t he exper t s al so f i r ml y

bel i eve t hat advanci ng best pr act i ces t hr ough t he

st andards, and wi t h t hei r adopt i on by t he 160 members

of I SO, i ncl udi ng bot h advanced and devel opi ng

count r i es, al so has a di r ect i mpact on i mpr ovi ng human

heal t h and saf et y.

Now, ear l i er I ment i oned t hat t he cur r ent

Counci l gui del i nes r el y on moder n concept s of qual i t y

management and t hat our means t o cont r ol t he mi cr obi al

cont ent of a cosmet i c begi ns dur i ng t he ear l i est st ages


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Ul t i mat el y, wi t h t hi s i nf or mat i on, we have a

pr oduct pr eser vat i on syst em desi gned t o assur e not onl y

t he pr oduct i s adequat el y pr eserved t o assure t he

qual i t y at t he poi nt of pur chase, but al so ensur e t hat

t he mi cr obes i nt r oduced dur i ng normal and cust omary use

of t he pr oduct wi l l not adver sel y af f ect qual i t y and

saf et y of t he pr oduct .

Wi t h t hat sai d, I bel i eve we can say wi t h

conf i dence t hat cur r ent i ndust r y pr act i ces assur e t hat

cosmet i cs are saf e. However , as conf i dent as we may

be, a cr i t i cal component of any qual i t y syst em i s post -

mar ket sur vei l l ance.

To t hat end, cosmet i c manuf act urer s have i n

pl ace r obust syst ems f or post - mar ket sur vei l l ance.

Her e compani es put i n pl ace syst ems wher e consumer

cal l s ar e moni t or ed, t r acked, sor t ed i nt o

subcat egor i es, l i ke t hose f or mul at i on r el at ed,

compl i ment s on t he ef f ect i veness, packagi ng, or heal t h,

and conduct i nvest i gat i ons i ni t i at ed wher e appr opr i at e.

These data show a ver y l ow i nci dent r at e,

over al l , consi st i ng pr i mar i l y of r epor t s associ at ed

wi t h i r r i t at i on or sensi t i zat i on. I ndeed, t hose


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at t r i but ed t o mi crobi ol ogi cal af f ect s ar e even l ower .

As exampl es, i n 1971 and 1972, t he FDA, at t he request

of CTFA, di d est abl i sh vol unt ar y pr ogr ams f or f aci l i t y

r egi st r at i on, f i l i ng of f or mul at i on i nf or mat i on, and

f i l i ng of cosmet i c pr oduct exper i ence r epor t s. Whi l e

t he pr ogr ams were di scont i nued i n 1996, I shoul d add

par ent het i cal l y t hat t he vol unt ar y cosmet i c repor t i ng

pr ogr am has r ecent l y been r ei nvi gor at ed wi t h t he

compl et i on of an on- l i ne f i l i ng syst em.

However , cer t ai n dat a f r om FDA' s pr oduct

exper i ence r epor t s f r om t he per i od of oper at i on ar e

avai l abl e. A summar y f r om t he f i r st si x bi - annual

r epor t i ng per i ods, f r om 1974 t o 1976, showed an

est i mat ed 125 compani es par t i ci pat i ng, wi t h an

est i mat ed di st r i but i on of 9. 75 bi l l i on uni t s. Wi t h

t hat , FDA r epor t ed an i nci dent r at e of 2. 03 exper i ences

per mi l l i on uni t s sol d. Even gi ven FDA' s est i mat e t hat

t hi s may repr esent onl y 30 t o 40 per cent of cosmet i c

sal es, i t woul d st i l l onl y r epr esent f i ve t o seven

unconf i r med exper i ences r epor t ed f or ever y mi l l i on

uni t s sol d. Thi s woul d gi ve an i nci dent r at e of f i ve

t en- t housandt hs of a per cent .


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Today, more f ocused on eye area r epor t s, a

r equest f or r epor t ed adver se event s t o FDA s CFSAN

Adver se Event Database showed t en r epor t s i n t he per i od

2004 t o 2011. Whi l e compar i son of t he same ei ght - year

sal es per i od wasn' t avai l abl e, sal es f i gur es f or t he

si x- year per i od, 2005 t o 2010, showed 2. 7 bi l l i on eye

makeup uni t s sol d dur i ng t hat per i od. From t hat , we

see l ess t han one r epor t ed adver se react i on f or ever y

270 mi l l i on uni t s sol d, or an i nci dent r at e of t hr ee

t en mi l l i ont hs of a per cent .

Now, whi l e we do under st and that i nci dent s

based compar i sons of cosmet i c and dr ugs are di f f i cul t ,

I t hi nk i t i s i nst r uct i ve t o have some compar i son.

Dur i ng t he seven- year per i od, 2004 t o 2010, t he FDA' s

Adver se Event Repor t i ng Syst em f or dr ugs and

t her apeut i c dr ugs r ecei ved 3. 7 mi l l i on r epor t s.

Si mi l ar l y, t he Cent er f or Vet er i nar y Medi ci ne has an

adver se dr ug exper i ence syst em f or domest i c dr ug

exper i ences t hat have been det er mi ned t o be at l east

possi bl y dr ug r el at ed. The cumul at i ve summary r eport

f or t he per i od 1987 t o 2011 exceeded 2, 000 pages.

Now, whi l e my comment s have demonst r at ed that


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t he i ndust r y' s qual i t y pr ogr ams ar e del i ver i ng saf e

cosmet i cs t o consumer s, I t hought i t mi ght be usef ul t o

see how t he mi cr obi al l i mi t s set by ot her i nt er nat i onal

aut hor i t i es compar e. Per haps not surpri si ngl y, as t he

st andards ar e sci ence based, t he U. S. r ecommendat i ons

ar e ent i r el y consi st ent wi t h wor l dwi de st andar ds. I SO

TC- 217 has j ust begun a program of wor k on new

mi cr obi al st andar ds t hat began wi t h a compr ehensi ve

sur vey of obj ect i onabl e or gani sms and mi cr obi ol ogi cal

l i mi t s .

The r epor t i ncl uded i ndi vi dual nat i ons and

communi t y of nat i ons t hat encompassed 71 separ at e

nat i ons. I n br i ef , t he r epor t f ound t hat t he l i mi t s

r ecommended by t he i ndust r y associ at i on on thi s sl i de

are t he same or l ower t han t hose set f or baby and eye

ar ea pr oduct s, wi t h t he si ngl e except i on of Al ger i a,

whi ch had set a l i mi t of 50 CFU f or eye pr oduct s.

The same net r esul t s may be f ound i n

i dent i f i cat i on of obj ect i onabl e or gani sms. The

or gani sms sel ect ed her e ar e ent i r el y consi st ent among

al l t he aut hor i t i es wi t h mi nor devi at i ons l i ke t he

i ncl usi on of a sul f i t o- r educt or Cl ostr i di um i n Al ger i a


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and i n t al c pr oduct s i n t he Mi r acor count r i es, as wel l

as t he addi t i on of sal monel l a i n Mexi co and Chi l e.

Wi t h t hat sai d, i ndust r y does have a l ong

hi st or y of ef f ect i ve cooper at i on wi t h FDA i n assur i ng

t hat cosmet i cs are saf e and we ar e commi t t ed t o

cont i nui ng t hi s cooper at i ve appr oach. To t he ext ent

t hat FDA bel i eves addi t i onal gui dance i s needed, we ar e

r eady t o par t i ci pat e i n devel opi ng t hat gui dance.

Consi st ent wi t h t he gui dance t hat appl i es t o

modern qual i t y management t echni ques, i ncl udi ng

i mpl ement at i on of qual i t y syst ems appr oaches t o al l

aspect s of cosmet i c pr oduct i on, and qual i t y assurance

t hat encour ages i mpl ement at i on of r i sk- based appr oaches

t hat f ocus i ndust r y and t he agency' s at t ent i on on

cr i t i cal ar eas, ensur es t hat t he r egul at or y r evi ew,

compl i ance, and i nspect i on pol i ci es are based on st at e

of t he ar t sci ence, and enhances t he consi st ency and

coor di nat i on of FDA' s cosmet i c qual i t y regul at or y

pr ogr ams, i n par t , by f ur t her i nt egr at i ng and enhanci ng

qual i t y syst ems appr oaches i nt o t he agency' s busi ness

pr ocesses and r egul at or y pol i ci es concer ni ng r evi ew and

i nspect i on act i vi t i es.


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But , l et me f i r st i nt r oduce mysel f , I ' m Phi l

Gei s. I am - - was t r ai ned i ni t i al l y as a medi cal

mi cr obi ol ogi st . Af t er my under gr aduat e car eer at t he

Uni ver si t y of Texas, I ent er ed t he Ar my, wher e I was

t r ai ned as a medi cal mi cr obi ol ogi st , my l ast assi gnment

bei ng est abl i shment of a f ul l mi crobi ol ogi cal

capabi l i t y f or t he Ar my' s 45t h Fi el d Hospi t al . Af t er

t he Ar my, I r et ur ned t o t he Uni ver si t y of Texas, ear ned

a Ph. D. i n mi cr obi ol ogy mycol ogy, and t hen j oi ned t he

Pr oct er & Gambl e company, wher e I spent t he next 30

year s st udyi ng mi cr obi ol ogy, appl i ed mi cr obi ol ogy,

especi al l y i n t he cont ext of cosmet i cs.

I r et i r ed about t hr ee mont hs ago and f ormed

t hi s consul t i ng gr oup you see her e i n af f i l i at i on wi t h

t he Advanced Test i ng Labor at or y, and I ' m an adj unct

pr of essor at t he Uni ver si t y of Fl or i da, wher e I ' l l be

t eachi ng cour ses i n mi crobi ol ogy, st ar t i ng i n t he f i r st

of t he year .

I ' ve had t he pl easur e t o be par t of a dynami c

i ndust r y, an i ndust r y t hat st ar t ed t o do i t s sci ence i n

var i ous f ocused manner s. I t wasn' t one t hat di scussed

esot er i c sci ent i f i c pr i nci pl es; i t was one t hat was


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f ocused on appl i ed mi cr o. Basi cal l y, j ust a f ew

subj ect s: Pr eser vat i on, pr eser vat i ve t est i ng,

det ect i on of mi cr oor gani sms, det ect i on of - -

est abl i shment of good manuf act ur i ng pr ocedur es, and

under st andi ng how consumer s use and may have used our

pr oduct s i n pr ot ect i ng agai nst t hat .

The publ i cat i on r ecor d goes back over 50 year s

f or t hi s i ndustr y. And i f you l ook at i t , i t ' s

somewhat sur pr i si ng as t o t he det ai l t hat t hese guys

went t o. As J ay sai d, i n t he l at e ' 60s ear l y ' 70s,

agency concerns as wel l as i ndust r y concerns of

cont ami nat i on l ed us t o f or m commi t t ees, and t he PCPC,

whi ch was at t hat t i me the CTFA, was t he or gani zat i on

t hat gover ned t hese commi t t ees. I t brought t he

sci ent i st s t oget her t o combi ne t hei r knowl edge wi t h t he

i dea of f or mi ng some gui del i nes t hat woul d gui de t hi s

i ndust r y to pr ovi de good qual i t y pr oduct s f or consumer s

and l ower t he consumer r i sk f or mi cr o cont ami nat i on.

The r i sk assessments i n t hi s cont ext t hat l ed

us t o gui del i nes and compendi al pr otocol s and methods

are t he ones J ay ment i oned. And t hese are ver y

ef f ect i ve means, and t hey have br ought us decades of


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success.

The l ast met hod t hat J ay ment i oned was i n t he

AOAC. Thi s i s a pr eservat i ve t est met hod and i f you

exami ne t hi s method, you' l l see that we go wel l beyond

what i s t r adi t i onal l y t r ue f or dr ugs. He showed t he

f our bacter i a t her e, t he St aph, t he E. col i , t he

Candi da al bi cans, Asper gi l l us. You exami ne t hi s

met hod, you' l l see t hat t her e' s a wi de r ange of

bact er i a agai nst whi ch we t r y t o cont r ol cont ami nat i on.

Not onl y do we do gui del i nes and met hods, but

we al so est abl i sh a gr eat er l evel of capaci t y i n our

own col l eagues. The PCPC commi t t ee has ment or i ng

oppor t uni t i es wher e t he ol der f ol ks, l i ke mysel f , woul d

ment or young mi cr obi ol ogi st s t hat ar e j ust ent er i ng

t hi s r at her ar cane f i el d of cosmet i c mi cr obi ol ogy. We

do t r ai ni ng. We' ve conduct ed webi nars, workshops, and

sci ent i f i c sessi ons t o communi cate what we underst and

about cosmet i c mi cr obi ol ogy. And we' ve enj oyed t he

FDA, who has j oi ned us at t hese t r ai ni ng sessi ons, t o

br i ng t hei r under st andi ng of pol i cy and t hei r

underst andi ng of t he sci ence so our young f ol ks comi ng

up wi l l under st and what t he agency t hi nks.


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J ay ment i oned gl obal har moni zat i on. Thi s i s

ver y i mpor t ant because I bel i eve t hi s i ndust r y i n t he

Uni t ed St at es i s probabl y t he most advanced i n t erms of

qual i t y i n t he wor l d. And cer t ai nl y our maj or

compani es, Proct er & Gambl e, Uni l ever , J ohnson &

J ohnson, Est e Lauder and Avon, we manuf act ure ar ound

t he wor l d t o t he same qual i t y st andards t hat we make

her e i n t he U. S.

And by vi r t ue of t hat passi ve pr esence out si de

t he Uni t ed St at es, we have est abl i shed some addi t i onal

knowl edge i n t er ms of what est abl i shes qual i t y. And

now we ar e act i vel y pur sui ng I SO harmoni zat i on t o meet

t hese same qual i t y st andar ds.

So I bel i eve, as J ay sai d, we' ve est abl i shed a

super i or qual i t y r ecor d, not onl y j ust i n t he U. S. , but

one t hat bot h act i vel y and passi vel y i nf l uences t he

ent i r e wor l d. We' ve done t hi s by under st andi ng t he

ent i r e scope of pr oduct qual i t y.

And I hope t hi s car t oon i s not t oo goof y f or

you t o see. What I t r y t o por t r ay her e i s t hi s i s not

a mat t er of j ust pr eser vat i on or t est i ng pr oduct s.

Those t hi ngs bui l d - - at t empt t o bui l d qual i t y i nt o t he


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pr oduct . What we' ve done her e i s at t empt t o cont r ol

t he whol e scope of pr oduct qual i t y f r om t he f i r st r aw

mat er i al t o t he l ast consumer use. Our i ndust r y has

set up pr ot ocol s, dynami c pr ot ocol s, t hat change wi t h

t he changi ng nat ur e of our bact er i a, changi ng nat ur e of

our pr oduct s, t hat addr ess each of t hese i t ems f r om t he

vagar i es of r aw mat er i al s t o t he pr ocesses by whi ch we

combi ne t hese r aw mater i al s t o make our f i ni shed

pr oduct , t o how t he consumer wi l l use i t and how t hat

pr oduct may be abused by t he - - even the r easonabl e

consumer .

The product l ef t i n t he car t o f r eeze i n t he

wi nt er , or t o be baked i n t he summer i n El Paso. The

human bat hr oom wher e ther e' s al l sor t s of mol d f l oat i ng

ar ound i n a mi l dewed bat hroom. We under st and t hese

el ement s and we' ve devel oped pr otocol s t o addr ess

t hese. And t hese are t he t hi ngs we t each each ot her as

we go f orward.

Let me go t hr ough t he var i ous aspect s. The

f i r st one i s pr oduct desi gn. When our f or mul at i on

chemi st s and our engi neer s f i r st f i gur e a pr oduct , t hey

t hi nk of a consumer benef i t t hat wi l l del i ght our


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consumer s. The mi cr obi ol ogi st i s, at t he same t i me,

f or mul at i ng a qual i t y desi gn t hat ' s consi st ent wi t h hi s

commi t ment t o qual i t y. Try and underst and how t hey can

make t hi s pr oduct and gi ve i t t o consumer s so one, i t ' s

cl ean when t hey get i t , and t wo, t hey won' t cont ami nate

i t dur i ng use, dur i ng a l ong per i od of use, because

agai n, t hi s i s year s' wor t h of st abi l i t y we bui l d i nt o

our pr oduct s.

I t st ar t s wi t h t he r aw mat er i al qual i f i cat i on.

When a r aw mat er i al i s i dent i f i ed, we go t o t hat r aw

mat er i al suppl i er and det er mi ne how t hey wi l l gi ve us a

hi gh qual i t y r aw mat er i al consi st ent l y, bat ch af t er

bat ch af t er bat ch. We don' t t ake what t hey gi ve us.

I t has t o meet our st andar ds. And t o be successf ul i n

busi ness we have t o l ook at consi st ency of t hat suppl y.

Of t en t i mes, t hi s means we have t o go to t hi s suppl i er

or t hat suppl i er . But i n or der t o est abl i sh t he r obust

suppl y syst em we have, t hat i s necessary f or our

pr oduct desi gn mi cr obi ol ogy.

Of cour se, t her e' s pr eservat i on. And we have

a smal l number of pr eser vat i ves. You hear d ear l y t oday

t her e ar e a bunch of pr eser vat i ves. Ther e ar en' t a


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bunch of pr eser vat i ves. We' ve l ost pr eser vat i ves. We

have vi r t ual l y a handf ul of pr eser vat i ves l ef t t hat ar e

saf e and ef f ect i ve, i ncl udi ng par abens and f or mal dehyde

r el easer s.

We use t hese t o est abl i sh pr eservat i on i n

pi l ot pl ant bat ches, l ab bat ches, and we demonst r at e i t

i n our manuf act ur i ng as wel l . And i t ' s not j ust

pr eser vat i ve capaci t y i mmedi at el y, i t ' s chr oni c

pr eser vat i ve capaci t y t hat t hr ough t he l i f e of t hi s

pr oduct , t he consumer ' s goi ng t o be pr ot ect ed.

That preser vat i ve syst em and t hat product

qual i t y al so af f ect s packagi ng. Packagi ng and t he

i mpl ement s we use t o appl y t he makeup t o t he f ace,

appl y t he wi pe t o t he hands, t he var i ous el ement s of

del i ver y.

We do ant i ci pat e r easonabl e consumer use. We

do t hi s ear l y i n t he pr ocess and i ndeed, i f t he

consumer , i n our ear l y i n- use t est i ng, cont ami nat es t he

pr oduct , we r ef or mul ate or r epackage. We don' t accept

any l evel of cont ami nat i on.

And f i nal l y, t hi s i s a par t of t he r i sk

assessment . The overal l r i sk assessment goes beyond


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t hat - - I ' l l t el l you about t hat i n a second- - but t hi s i s

t he f i r st st ep of our r i sk assessment .

The next aspect i s i n manuf act ur i ng, qual i t y

assur ance, and qual i t y cont r ol . I showed you t hat

di agr am t hat f r om begi nni ng t o end; we cont r ol t he

process by whi ch we make pr oduct s and make them cl ean,

make t hem saf e f or consumer use. But i t goes, agai n, t o

t he desi gn. Our const r uct i on and desi gn of our

manuf act ur i ng equi pment i s done i n a manner t hat br i ngs

us a hi gh l evel of hygi ene, a hi gh l evel of capabi l i t y

of r emovi ng and el i mi nat i ng mi cr oorgani sms.

I t st ar t s wi t h r aw mat er i al cont r ol . We' ve

est abl i shed by thi s t i me a r el i abl e sour ce of r aw

mat er i al s. That doesn' t mean we st op t est i ng. Our

af f i r mat i ve r i sk assessment says we had t o est abl i sh

qual i t y upf r ont . We t est t o conf i r m t hat qual i t y.

Good manuf actur i ng pr act i ces ar e, as ment i oned bef ore,

ar e consi st ent acr oss our i ndust r y.

We al so bor r ow f r om ot her i ndust r i es. HACCP,

whi ch i s Hazar d Anal ysi s and Cr i t i cal Cont r ol Poi nt , i s

a concept adopt ed f r om t he f ood i ndust r y. And her e

t hi s concept i dent i f i es t hose ar eas i n t he maki ng, i n


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t hat di agr am I showed you, perhaps a pump, perhaps a

heat exchanger wher e t her e' s great er r i sk, we

i dent i f i ed t hose and cont r ol t he r i sk at t hat poi nt .

Envi r onment al moni t or i ng, whi ch i s somet hi ng f r om t he

dr ug i ndust r y. We eval uate t he bugs t hat may be

appear i ng i n our pr oduct st r eam, or adj acent t o our

pr oduct st r eam t hat can cont ami nat e the pr oduct dur i ng

maki ng.

And f i nal l y, our QC t est i ng, f i ni shed pr oduct

t est i ng. And al l t hi s i s val i dat ed, val i dat ed t o show

t hat we can r ecover bact er i a i f t hey' r e t her e. Our

f i ni shed pr oduct t est i ng i s wel l bel ow t he st andar ds

J ay ment i oned. Those ar e gover ni ng st andar ds. I n a

pr act i cal ef f ect , t he gr eat est per cent age of pr oduct we

make has no det ect abl e mi cr oor gani sms i n our t est i ng.

Agai n, i t ' s t he pr oduct of an af f i r mat i ve r i sk

assessment . We bui l t qual i t y i n. We expect t o see

not hi ng and we see not hi ng i n our f i ni shed pr oduct .

The product s ar e not st er i l e, and i ndeed, i f

we want ed t o guar ant ee st er i l i t y i t woul d have a maj or

ef f ect , and be unnecessar y and not be wor t h i t t o

consumer s. But most of our pr oduct s have l ess - - have


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si gni f i cant l y l ess t han one mi cr oor gani sm per gr am.

I n f act , we do most of our r el ease t est i ng i n

t hi s i ndust r y by vi r t ue of r api d met hods. These r api d

methods ar e go, no go. Det ect , no det ect . And t hey' r e

ver y sensi t i ve, down t o l ess t han one per gr am.

Economi cal l y we coul d not sust ai n these r api d met hods

i f we had mul t i pl e thi ngs t hat had any pr esence of

mi cr oor gani sms. So by and l arge, we have no mi cr obes

det ect abl e i n our pr oduct s.

Consumer saf et y: J ay ment i oned some of t he

pr ot ocol s devel oped t o underst and consumer use and

ant i ci pate consumer cont ami nat i on of our pr oduct s. We

ar e ver y wel l awar e of t hi s. And t o do t hi s, we

est abl i sh st abi l i t y of pr eser vat i on t hr ough t he var i ous

vagar i es of consumer use and pr act i ces. I n- use t est i ng

i s a ver y common el ement . I n t he l ate ' 80s Pr octer &

Gambl e publ i shed a l andmark st udy wher e we cal i br at ed

t he l evel of pr eser vat i on ver sus t he l evel of consumer

cont ami nat i on. Of cour se, t he obj ect i ve was zer o, zer o

consumer cont ami nat i on. And t hat became t he st andard

by whi ch Proct er & Gambl e pur sued pr eservat i on f or

cosmet i cs, i n addi t i on t o saf et y and ot her el ement s, t o


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have zer o cont ami nat i on i n t he hands of t he consumer ,

t he reasonabl e consumer .

We cont i nue to moni t or , t hough; t hi s i s a

dynami c i ndust r y. I t ' s a sci ent i f i c ef f or t ; we moni t or

t he gl obe i n t er ms of mi cr obi ol ogy, t he r ecal l s of t he

Eur opean RAPEX I ndex, t he r ecal l s i n Aust r al i a, Chi na,

J apan, Canada, t o see how t hese product s t hat ar e

r ecal l ed f ai l ed. What made t hem f ai l ? What was t he

nat ur e of t he mi cr oor gani sm t hat gr ew up i n t hese

pr oduct s t hat subst ant i at ed t he r ecal l ? And why di d i t

happen? And we modi f y our pr ot ocol s and address t hese

i n our own pr act i ces.

We l ook car ef ul l y at consumer comment s and

adver se r epor t s. As J ay sai d, t hese ar e ver y r ar e.

But when we have t hese, we f ol l ow t hese up, especi al l y

i f t hey have anyt hi ng t hat i ndi cat es mi cr obi ol ogy, a

bad smel l , a bad col or . I f a consumer compl ai ns about

t hi s, we f ol l ow t hese t hi ngs up. And t hi s i s

consi st ent across our i ndust r y.

So l et me gi ve you an over vi ew. I bel i eve t he

cosmet i c i ndust r y i n t he U. S. i s a gl obal l eader . And

I t hi nk t hat over al l , t he wor l d has, f r ankl y,


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di f f er ence. We don' t consi der any popul at i on t o be

l ess deser vi ng of pr ot ect i on.

MS. TALLENT: Hi , I ' m Sandr a Tal l ent f r om t he

FDA. You ment i oned t hat you had r api d met hods t o

det ect one CFU per gr am. Can you el aborat e on your

met hods?

DR. GEI S: Sur e. These are based on

enr i chment , enr i chment of a quant i t y of pr oduct i n a

l ar ge vessel , i n a l ar ge vol ume of br ot h. So, per - -

so whatever vol ume of pr oduct i s put i n t her e, whet her

i t ' s one gr am of pr oduct or t en gr ams of pr oduct ,

anyt hi ng vi abl e i n t her e wi l l gr ow. So anyt hi ng t hat

gr ows i n t her e, we' l l say t hi s pr oduct doesn' t meet our

st andar ds.

And by vi r t ue of our t est i ng, by vi r t ue of

t est i ng t o t hat l evel - - and t hen we val i dat e i t ,

i ndeed t o be - - t o show t hat we can detect at t hat

l evel - - by r el easi ng by t hi s met hod we have ver y

vani shi ng l evel s of mi cr oor gani sms at any l evel i n our

pr oduct s. I s t hat what you wer e t hi nki ng? Okay.

Wel l , t hank you very much.

MR. GASPER: Al l r i ght . Si nce we' r e r unni ng a


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pr eser vat i ve ef f i cacy t est . And t hi s i s a si mpl e t est

t hat basi cal l y we use and we' l l t al k about i n a coupl e

seconds. What di d t he FDA say about t he adequacy of

pr eser vat i on? And agai n I ' l l dat e mysel f , because t hi s

goes back t o t he ' 60s and ' 70s, i t went up unt i l t he

' 90s, t he FDA had a cosmet i c handbook. And I guess

St an Mi l st ei n and mysel f who st i l l have or i gi nal

copi es, I don' t know whet her anyone el se does. I st i l l

have mi ne, I st i l l use i t ver y r egul ar l y.

And i t says t her e - - and i t says t hat

cosmet i cs and t opi cal pharmaceut i cal s need not be

st er i l e. And t he r eason f or t hat i s t hey' r e not

appl i ed t o st er i l e sur f aces. We have bact er i a gr owi ng

on our ski n al l t he t i me, so appl yi ng a st er i l e pr oduct

t o a non- st er i l e sur f ace r eal l y doesn' t seem t o make

t oo much sense.

However , t hey say t hat our pr oduct s cannot be

cont ami nated wi t h pathogeni c mi cr oor gani sms, bugs t hat

can cause di sease and i l l ness. And f ur t her , t hat t he

ot her l evel s of mi cr oor gani sms must be l ow, wi t hout

r eal l y a def i ni t i on of what t hat means.

Fi nal l y, t he most i mpor t ant t hi ng, whi ch I


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t r emendous number s of cosmet i cs t hat f ai l ed chal l enge

t est i ng f or C. al bi cans, but I j ust never coul d get C.

al bi cans t o gr ow.

I al ways t hought i t was because cosmet i cs were

host i l e t o C. al bi cans, but actual l y t her e i s a r eal

val i d sci ent i f i c reason and t hi s came out i n

publ i cat i on by a col l eague of mi ne about 10, 12 year s

ago i n a ver y obscur e phar maceut i cal j our nal . And

basi cal l y what i t sai d was t hat C. al bi cans need a

ver y, ver y nar r ow r ange of wat er act i vi t y. Now wat er

act i vi t y has been ment i oned bef or e. Wat er act i vi t y i s

not t he amount of wat er pr esent , wat er act i vi t y i s t he

amount of wat er t hat ' s avai l abl e f or mi cr obi al gr owt h.

And C. al bi cans needs a wat er act i vi t y of

bet ween . 88 and about . 91 and we j ust don' t manuf act ure

cosmet i cs i n t hat wat er act i vi t y range, whi ch i s why

we' ve never seen cont ami nat i on.

Fi nal l y, about f i ve year s ago I was cal l ed

i nt o an account t hat had a cont ami nat i on of C.

al bi cans, i t was act ual l y gr owi ng, i t was t hr i vi ng

t her e. We r an wat er act i vi t y, . 9.

What does t he FDA r ecommend? That each bat ch,


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whi ch i s not sel f - pr eser vi ng, shoul d be t est ed f or

mi cr obi al cont ami nat i on bef or e i t i s r el eased. We' r e

goi ng t o t al k a l i t t l e bi t mor e about t hat . And

f i nal l y, t hat each bat ch, especi al l y each cosmet i c

bat ch t hat i s i nt ended f or eye ar ea cosmet i cs, dur i ng

t hei r devel opment , we check f or adequacy of

pr eser vat i on under normal and r easonabl e f or eseeabl e

consumer condi t i ons of use.

Chal l enge t est s, we' ve al r eady sai d a coupl e

wor ds. I t ' s a shor t t er m t est t o see whet her our

pr oduct wi l l wi t hst and t he cont ami nat i ons t hat

consumers do t o our pr oduct s.

Thi s wor ks ver y wel l f or t ypi cal cosmet i cs,

and you' ve hear d t hat st atement bef ore. Let me say

t hat t ypi cal cosmet i cs ar e pr oduct s whi ch have wat er as

t he sol vent , wat er i s t he cont i nuous phase. Chal l enge

t est i ng does not wor k wel l f or at ypi cal cosmet i cs and

at ypi cal cosmet i cs are pr oduct s t hat do not cont ai n

wat er or do not have ver y hi gh l evel s of wat er or wat er

i s not t he cont i nuous phase. For exampl e, a water and

oi l emul si on. When we go and r un a t ypi cal chal l enge

t est on a wat er and oi l emul si on, we i nver t t he


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or 72 hour s l at er .

So, i f you t ur n up wi t h a count of l et ' s say

50 CFUs, you ar e t aki ng a snapshot at one moment of

t i me. Come back 24 hours l at er and see what number s

you have. Coul d i t be t oo numerous t o count ? Then you

have a pr oduct t hat ' s i nadequatel y pr eser ved and shoul d

not be shi pped. Has i t di ed of f so we can' t det ect i t ?

Or i s i t st asi s, meani ng i t ' s st ayi ng t he same?

And t hi s i s what we concl uded. The most

common t est f or t hi s pl at e count i s USP- 61, I won' t go

i nt o det ai l s t o i t , j ust t hat t hi s seems t o have been

adopt ed as t he uni ver sal st andard. When we t al k about

pr eser vat i ves, I have wr i t t en sever al books on t hi s,

and pl ease save your money, t he t hi r d edi t i on i s comi ng

out next year . Pl ease buy i t . I def i ne pr eser vat i ves

by t hei r chemi cal st r uct ur es. And I ' m goi ng t o go

t hr ough t hem ver y br i ef l y her e. We have a l ot of aci ds

t hat ar e used, t hey' r e pr i nci pal l y act i ve agai nst

f ungi . Many of t he aci di c pr eser vat i ves ar e al so

al l owed i n f oods, t hese woul d i ncl ude t hi ngs l i ke

benzoi c aci d and sor bi c aci d.

Ar omat i c al cohol s are most l y act i ve agai nst


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St at es ar e vol unt ar y. And gues

transcript - public meeting cosmetic 42012

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