,,ii  #aae? ,,congress  #a/ ,session    
,s4 #bjjc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,octob] #be1 #bjag ,mr4
 ,hat* introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to mod]nize ! regulation (  
cosmetics4  #a4 ,%ort title  ,?is ,act  
may be cit$ z ! ,,fda ,cosmetic ,safety 
& ,mod]nization ,act4  #b4 ,adv]se ev5t 
report+  7a7 ,9 g5]al ,sub*apt] ,h (    
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;aa et
 seq47 is am5d$ by add+ at ! end !      
foll[+3  #gfb4 ,s]i\s adv]se ev5t       
report+ = cosmetics  7a7 ,def9itions ,9 
?is section3 7#a7 ,! t]m adv]se ev5t    
means any heal?-relat$ ev5t associat$ ) 
! use ( a cosmetic t is adv]se4  7#b7 ,!
 t]m s]i\s adv]se ev5t means an adv]se  
ev5t t-- 7,a7 results 9--  7i7 dea?2    
7ii7 a life-?reat5+ exp]i5ce2  7iii7    
inpati5t hospitalization2  7iv7 a       
p]si/5t or significant disability1      
incapacity1 or disfigurem5t2  7v7 a     

cong5ital abnormality or bir? defect2 or
  7vi7 p]man5t alt]ation ( appe>ance o!r
 ?an z int5d$1 "u conditions ( use t are
 cu/om>y or usual2 or  7,b7 requires1   
bas$ on reasonable m$ical judgm5t1 a    
m$ical or surgical int]v5tion to prev5t 
an outcome describ$ 9 subp>agraph 7,a74 
7#c7 ,! t]m s]i\s adv]se ev5t report    
means a report t is requir$ to be       
submitt$ to ! ,secret>y "u subsection   
7b74  7b7 ,report+ requirem5t ,!        
manufactur] or di/ributor ( a cosmetic  
^: "n appe>s on ! label ( su* cosmetic  
pursuant to section #fjb 7ref]r$ to 9   
?is section z a responsible p]son7 %all 
submit to ! ,secret>y any report receiv$
 ( a s]i\s adv]se ev5t associat$ ) su*  
cosmetic :5 us$ 9 ! ,unit$ ,/ates1      
accompani$ by a copy ( ! label on or )9 
! retail packag+ ( su* cosmetic4  7c7   
,submission ( reports  7#a7 ,tim+ (     
reports ,! responsible p]son %all submit
 to ! ,secret>y a s]i\s adv]se ev5t     
report no lat] ?an #ae bus9ess days aft]
 ! report is receiv$4  7#b7 ,new m$ical 

in=mation ,! responsible p]son %all     
submit to ! ,secret>y any new & mat]ial 
m$ical in=mation1 relat$ to a submitt$  
s]i\s adv]se ev5t report t is receiv$ by
 ! responsible p]son )9 #a ye> ( !      
initial report1 no lat] ?an #ae bus9ess 
days aft] su* in=mation is receiv$ by   
su* responsible p]son4  7#c7            
,consolidation ( reports ,! ,secret>y   
%all provide = sy/ems to enable         
responsible p]sons to submit a s+le     
report t includes duplicate reports (1  
or new m$ical in=mation relat$ to1 a    
s]i\s adv]se ev5t4  7#d7 ,exemption ,!  
,secret>y may e/abli% an exemption to ! 
requirem5ts "u p>agraphs 7#a7 & 7#b7    
if--  7,a7 ! ,secret>y receives a report
 9 accordance ) section #gfj2 or  7,b7  
aft] provid+ notice & an opportunity =  
comm5t f int]e/$ p>ties1 ! ,secret>y    
det]m9es t su* exemption w\ld h no      
significant adv]se effect on public     
heal?4  7d7 ,cont5t ( report ,ea* s]i\s 
adv]se ev5t report "u ?is section %all  
be submitt$ to ! ,secret>y1 & may be    

accompani$ by additional in=mation4  7e7
 ,ma9t5ance & inspection ( records  7#a7
 ,ma9t5ance ,! responsible p]son %all   
ma9ta9 records relat$ to ea* report ( a 
s]i\s adv]se ev5t receiv$ by !          
responsible p]son = a p]iod ( #f ye>s4  
7#b7 ,records inspection  7,a7 ,9 g5]al 
,! responsible p]son %all p]mit an      
au?oriz$ p]son to h access to records   
requir$ to be ma9ta9$ "u ?is section    
dur+ an inspection pursuant to section  
#gjd4  7,b7 ,au?oriz$ p]son ,= purposes 
( ?is p>agraph1 ! t]m au?oriz$ p]son    
means an (fic] or employee ( ! ,dep>tm5t
 ( ,heal? & ,human ,s]vices1 :o has--   
7i7 appropriate cr$5tials1 z det]m9$ by 
! ,secret>y2 &  7ii7 be5 duly designat$ 
by ! ,secret>y to h access to ! records 
requir$ "u ?is section4  7f7 ,protect$  
in=mation ,a s]i\s adv]se ev5t report   
submitt$ to ! ,secret>y "u ?is section1 
includ+ any new m$ical in=mation        
submitt$ "u subsection 7c77#b71 or an   
adv]se ev5t report volunt>ily submitt$  
to ! ,secret>y %all be consid]$ to be-- 

7#a7 a safety report "u section #gef &  
may be accompani$ by a /atem5t1 :i* %all
 be a "p ( any report t is releas$ =    
public disclosure1 t d5ies t ! report or
 ! records con/itute an admission t !   
product involv$ caus$ or contribut$ to !
 adv]se ev5t2 &  7#b7 a record ab\t an  
individual "u section #eeb;a ( title #e1
 ,unit$ ,/ates ,code 7commonly ref]r$ to
 z ! ,privacy ,act ( #aigd71 & a m$ical 
or simil> file ! disclosure ( :i* w\ld  
con/itute a violation ( section #eeb (  
su* title #e 7commonly ref]r$ to z !    
,fre$om ( ,in=mation ,act71 & %all n be 
publicly disclos$ unless all p]sonally  
id5tifiable in=mation is r$act$4  7g7   
,rule ( con/ruction ,! submission ( any 
adv]se ev5t report "u ?is section %all n
 be con/ru$ z an admission t ! cosmetic 
involv$ caus$ or contribut$ to ! adv]se 
ev5t4  7h7 ,preemption  7#a7 ,9 g5]al   
,no ,/ate or local gov]nm5t %all e/abli%
 or cont9ue 9 effect any law1           
regulation1 ord]1 or o!r requirem5t     
relat$ to a m&atory sy/em = adv]se ev5t 

reports = cosmetics4  7#b7 ,effect (    
section  7,a7 ,9 g5]al ,no?+ 9 ?is      
section %all affect ! au?ority ( !      
,secret>y to provide adv]se ev5t reports
 & in=mation to any heal?1 food1 or drug
 (fic] or employee ( any ,/ate1         
t]ritory1 or political subdivision ( a  
,/ate or t]ritory1 "u a memor&um (      
und]/&+ betwe5 ! ,secret>y & su* ,/ate1 
t]ritory1 or political subdivision4     
7,b7 ,p]sonally-id5tifiable in=mation   
,not)/&+ any o!r provision ( law1       
p]sonally-id5tifiable in=mation 9 adv]se
 ev5t reports provid$ by ! ,secret>y to 
any heal?1 food1 or drug (fic] or       
employee ( any ,/ate1 t]ritory1 or      
political subdivision ( a ,/ate or      
t]ritory1 %all n--  7i7 be made publicly
 available pursuant to any ,/ate or o!r 
law requir+ disclosure ( in=mation or   
records2 or  7ii7 o!rwise be disclos$ or
 di/ribut$ to any p>ty )\t ! writt5     
cons5t ( ! ,secret>y & ! p]son submitt+ 
su* in=mation to ! ,secret>y4  7,c7 ,use
 ( safety reports ,no?+ 9 ?is section   

%all p]mit a ,/ate1 t]ritory1 or        
political subdivision ( a ,/ate or      
t]ritory1 to use any safety report      
receiv$ f ! ,secret>y 9 a mann]         
inconsi/5t ) subsection 7g7 or section  
#gef4  7i7 ,au?orization (              
appropriations ,!re are au?oriz$ to be  
appropriat$ to c>ry out ?is section su* 
sums z may be necess>y4  4  7b7 ,con=m+ 
am5dm5ts ,! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cba et   
seq47 is am5d$--  7#a7 9 section        
#cja7;ii7 7#ba ,u4,s4,c4 #cca7;ii771 by 
/rik+ section #gfj or #gfa ea* place x  
appe>s & ins]t+ section #gfj1 #gfa1 or  
#gfb2 &  7#b7 9 section #hja 7#ba       
,u4,s4,c4 #cha71 by /rik+ section #gfj  
or #gfa ea* place x appe>s 9 subsections
 7a7 & 7b7 & ins]t+ section #gfj1 #gfa1 
or #gfb4  #c4 ,adult]at$ cosmetics      
,section #fja7;a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfa7;a77 is am5d$-- 7#a7 by ins]t+ 1 or
 consi/s 9 :ole or 9 "p (1 aft] be>s or 
conta9s2 &  7#b7 by /rik+ usual1 except 

t ?is & ins]t+ usual4 ,= purposes ( ?is 
clause1 a cosmetic may be adult]at$     
reg>dless ( :e!r x is kn[n :i* p>ticul> 
sub/ance or sub/ances may r5d] !        
cosmetic injuri\s to us]s "u !          
conditions ( use prescrib$ 9 ! label+   
!re(1 or "u su* conditions ( use z are  
cu/om>y or usual4 ,?is4  #d4 ,label+    
,section #fjb ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is 
am5d$ by add+ at ! end ! foll[+3  7g7   
,if x is a cosmetic t is m>ket$ 9 !     
,unit$ ,/ates1 unless its label includes
 a dome/ic address1 dome/ic phone numb]1
 or ,int]net address ?r\gh :i* !        
responsible p]son 7z describ$ 9 section 
#gfb7 c receive a report ( a s]i\s      
adv]se ev5t ) respect to su* cosmetic   
product4  4  #e4 ,regi/ration ( cosmetic
 facilities ,*apt] ,,vi ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfa et seq47 is am5d$ by add+
 at ! end ! foll[+3  #fjd4 ,regi/ration 
( cosmetic facilities  7a7 ,regi/ration 
7#a7 ,9 g5]al ,! ,secret>y %all by      

regulation require ! manufactur] or     
di/ributor ^: "n appe>s on ! label ( a  
cosmetic m>ket$ 9 ! ,unit$ ,/ates to    
regi/] all facilities engag$ 9          
manufactur+ ( su* cosmetic ) !          
,secret>y4 ,to be regi/]$--  7,a7 = a   
dome/ic facility1 ! responsible p]son1  
own]1 or ag5t 9 *>ge ( ! facility %all  
submit a regi/ration to ! ,secret>y2 &  
7,b7 = a =eign facility1 ! responsible  
p]son1 own]1 or ag5t 9 *>ge ( ! facility
 %all submit a regi/ration to !         
,secret>y & %all include ) ! regi/ration
 ! "n ( ! ,unit$ ,/ates ag5t = !        
facility4  7#b7 ,regi/ration  7,a7 ,9   
g5]al ,an entity 7ref]r$ to 9 ?is       
section z ! regi/rant7 %all submit a    
regi/ration "u p>agraph 7#a7 to !       
,secret>y conta9+ in=mation necess>y to 
notify ! ,secret>y ( ! "n & address (   
ea* facility at :i*1 & all ! trade names
 "u :i*1 ! regi/rant conducts bus9ess1 !
 e-mail address = ! responsible p]son 7z
 describ$ 9 section #gfb7;b77 ( !       
facility or1 9 ! case ( a =eign         

facility1 ! ,unit$ ,/ates ag5t = !      
facility4  7,b7 ,availability (         
in=mation ,! ,secret>y %all require--   
7i7 ! in=mation submitt$ "u subp>agraph 
7,a7 to be ma9ta9$ & available1 at !    
reque/ ( ! ,secret>y1 = a p]iod to be   
det]m9$ by ! ,secret>y2 &  7ii7 ! "n &  
address ( ea* facility ) :i* ! regi/rant
 contracts relat$ to cosmetic           
manufactur+1 process+1 di/ribut+1 or o!r
 activities1 z ! ,secret>y det]m9es     
appropriate1 to be ma9ta9$ & available  
at ! reque/ ( ! ,secret>y1 = a p]iod to 
be det]m9$ by ! ,secret>y4  7,c7        
,additional requirem5ts ,! regi/ration  
%all conta9 an assurance t--  7i7 !     
,secret>y w be p]mitt$ to inspect !     
facility at ! times & 9 ! mann] p]mitt$ 
by ?is ,act2 &  7ii7 ! regi/rant w      
notify ! ,secret>y 9 a timely mann] (   
*anges to ! in=mation submitt$4  7#c7   
,regi/ration r5ewal ,a regi/rant t has  
submitt$ a regi/ration "u p>agraph 7#a7 
%all submit to ! ,secret>y a r5ewal     
regi/ration conta9+ ! in=mation describ$

 9 p>agraph 7#b7 e #b ye>s dur+ a p]iod 
( "t z det]m9$ by ! ,secret>y4 ,!       
,secret>y %all provide = an abbreviat$  
regi/ration r5ewal process = any        
regi/rant t has n _h any *anges to su*  
in=mation s9ce ! regi/rant submitt$ !   
prec$+ regi/ration or regi/ration r5ewal
 = ! facility involv$4  7#d7 ,proc$ure  
,^u receipt ( a complet$ regi/ration    
describ$ 9 p>agraph 7#a71 ! ,secret>y   
%all notify ! regi/rant ( ! receipt (   
su* regi/ration & assign a regi/ration  
numb] to ea* regi/]$ facility4  7#e7    
,li/ ,! ,secret>y %all compile & ma9ta9 
an up-to-date li/ ( facilities t are    
regi/]$ "u ?is section4 ,su* li/ & any  
regi/ration docum5ts submitt$ pursuant  
to ?is subsection %all n be subject to  
disclosure "u section #eeb ( title #e1  
,unit$ ,/ates ,code4 ,in=mation d]iv$ f 
su* li/ or regi/ration docum5ts %all n  
be subject to disclosure "u section #eeb
 ( title #e1 ,unit$ ,/ates ,code1 to !  
ext5t t x discloses ! id5tity or        
location ( a specific regi/]$ p]son4    

7b7 ,susp5sion ( regi/ration  7#a7 ,9   
g5]al ,if ! ,secret>y det]m9es t        
cosmetics manufactur$ or process$ by a  
facility regi/]$ "u ?is section has a   
reasonable probability ( caus+ s]i\s    
adv]se heal? consequ5ces or dea? to     
humans1 ! ,secret>y may by ord] susp5d !
 regi/ration ( any facility t is        
responsible = su* reasonable probability
 or t knew (1 or _h reason to "k (1 su* 
reasonable probability relat$ to su*    
cosmetics4  7#b7 ,he>+ on susp5sion ,!  
,secret>y %all provide ! regi/rant      
subject to an ord] "u p>agraph 7#a7 ) an
 opportunity = an in=mal he>+1 to be    
held z soon z possible b n lat] ?an #b  
bus9ess days aft] ! issuance ( ! ord] or
 su* o!r "t p]iod1 z agre$ ^u by !      
,secret>y & ! regi/rant1 on ! actions   
requir$ = re9/atem5t ( regi/ration & :y 
! regi/ration t is subject to !         
susp5sion %\ld be re9/at$4 ,! ,secret>y 
%all re9/ate a regi/ration if !         
,secret>y det]m9es1 bas$ on evid5ce     
pres5t$1 t adequate gr\nds d n exi/ to  

cont9ue ! susp5sion ( ! regi/ration4    
7#c7 ,po/-he>+ corrective action plan2  
vacat+ ( ord]  7,a7 ,corrective action  
plan ,if1 aft] provid+ opportunity = an 
in=mal he>+ "u p>agraph 7#b71 !         
,secret>y det]m9es t ! susp5sion (      
regi/ration rema9s necess>y1 ! ,secret>y
 %all require ! regi/rant to submit a   
corrective action plan to demon/rate h[ 
! regi/rant plans to correct !          
conditions f\nd by ! ,secret>y4 ,!      
,secret>y %all review su* plan n lat]   
?an #ad days aft] ! submission ( !      
corrective action plan or su* o!r "t    
p]iod z det]m9$ by ! ,secret>y1 9       
consultation ) ! regi/rant4  7,b7       
,vacat+ ( ord] ,^u a det]m9ation by !   
,secret>y t adequate gr\nds d n exi/ to 
cont9ue ! susp5sion actions requir$ by !
 ord]1 or t su* actions %\ld be modifi$1
 ! ,secret>y %all promptly vacate ! ord]
 & re9/ate ! regi/ration ( ! facility   
subject to ! ord] or modify ! ord]1 z   
appropriate4  7#d7 ,effect ( susp5sion  
,if ! regi/ration ( a facility is       

susp5d$ "u ?is subsection1 no p]son %all
 import or export cosmetics into !      
,unit$ ,/ates f su* facility1 (f] to    
import or export cosmetics into ! ,unit$
 ,/ates f su* facility1 or o!rwise      
introduce cosmetics f su* facility into 
int]/ate or intra/ate comm]ce 9 ! ,unit$
 ,/ates4  7#e7 ,regulations  7,a7 ,9    
g5]al ,! ,secret>y %all promulgate      
regulations to implem5t ?is subsection4 
7,b7 ,electronic regi/ration requirem5t 
,! ,secret>y may require t regi/ration  
"u ?is section be submitt$ 9 an         
electronic =mat4  7#f7 ,application date
 ,facilities %all n be subject to !     
requirem5ts ( ?is subsection prior to ! 
date t is #ahj days aft] ! date on :i* !
 ,secret>y issues f9al regulations "u   
p>agraph 7#e74  7#g7 ,no delegation ,!  
au?ority conf]r$ by ?is subsection to   
issue an ord] to susp5d a regi/ration or
 vacate an ord] ( susp5sion %all n be   
delegat$ to any (fic] or employee o!r   
?an ! ,commission]4  7c7 ,facility ,=   
purposes ( ?is section3 7#a7 ,! t]m     

facility--  7,a7 includes any factory or
 o!r e/abli%m5t t is engag$ 9 !         
manufactur+ or process+ ( a cosmetic or 
cosmetics2 &  7,b7 does n include-- 7i7 
beauty salons1 spas1 retail]s 7includ+  
individual sales repres5tatives1        
:olesale di/ributors1 or ph>macy        
locations72  7ii7 homes :]e p]sons are  
engag$ 9 mak+ h&craft$ soaps or o!r     
cosmetics2 or  7iii7 any bus9ess ) less 
?an #a1jjj1jjj 9 annual net rev5ue 9 !  
previ\s ye>1 o!r ?an any su* bus9ess t  
is engag$ 9 ! manufactur+ or process+ ( 
products int5d$ to be inject$ "u ! sk91 
includ+ tattoo ink4  7#b7 ,! t]m dome/ic
 facility means a facility locat$ 9 any 
( ! ,/ates or ,t]ritories4  7#c7 ,! t]m 
=eign facility means a facility locat$  
outside ( ! ,unit$ ,/ates or            
,t]ritories1 b only if ! cosmetics f su*
 facility are export$ to ! ,unit$ ,/ates
 )\t fur!r manufactur+ outside ! ,unit$ 
,/ates or ,t]ritories4  7d7 ,rule (     
con/ruction ,no?+ 9 ?is section %all be 
con/ru$ to au?orize ! ,secret>y to      

require an application1 review1 or      
lic5s+ process = a facility to be       
regi/]$1 except ) respect to !          
re9/atem5t ( a regi/ration t is susp5d$ 
"u subsection 7b74  7e7 ,preemption ,no 
,/ate or political subdivision ( a ,/ate
 may e/abli% or cont9ue 9 effect any    
law1 regulation1 ord]1 or o!r requirem5t
 ) respect to ! regi/ration ( facilities
 engag$ 9 ! manufactur+ or process+ ( a 
cosmetic or cosmetics t is diff]5t f !  
requirem5ts "u ?is section4  4  #f4     
,good manufactur+ practices  7a7 ,good  
manufactur+ practice /&>ds ,*apt] ,,vi (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$  
by section #e1 is fur!r am5d$ by add+ at
 ! end ! foll[+3  #fje4 ,good           
manufactur+ practices  7a7 ,e/abli%m5t (
 good manufactur+ practices  7#a7 ,9    
g5]al ,! ,secret>y %all by regulation   
e/abli% good manufactur+ practices =    
cosmetics 9 accordance ) p>agraphs 7a7 &
 7d7 ( section #fja4 ,su* regulations-- 
7,a7 %all be model$ aft] comp>able good 

manufactur+ practice /&>ds = cosmetics 9
 effect at ! "t ( promulgation2  7,b7   
may n impose /&>ds = :i* !re is no      
curr5t & g5]ally available analytical   
me?odology2  7,c7 may ensure t cosmetics
 d n cause s]i\s adv]se heal?           
consequ5ces or dea?2  7,d7 %all be      
int5d$ to protect ! public heal?2 &     
7,e7 %all n apply to entities describ$ 9
 clauses 7i7 & 7ii7 ( section           
#fjd7;c77#a77;,b74  7#b7 ,consid]ations 
,9 promulgat+ regulations "u p>agraph   
7#a71 ! ,secret>y %all consid]          
facilities t are subject to o!r1 simil> 
regulations1 z appropriate4  7b7 ,notice
 & comm5t ,a regulation "u subsection   
7a7 %all be promulgat$ only aft] provid+
 notice & an opportunity = comm5t 9     
accordance ) *apt] #e ( title #e1 ,unit$
 ,/ates ,code4  7c7 ,small bus9esses    
7#a7 ,applicability to small bus9esses  
,! ,secret>y %all provide = an          
additional ye> aft] ! effective date ( !
 regulations "u subsection 7a7 = small  
bus9esses 7z describ$ 9 section         

#fjd7;c77#a77;,b77iii77 to comply ) !   
good manufactur+ practices e/abli%$ 9   
accordance ) subsection 7a71 & issue    
guidance = small bus9esses = purposes ( 
compliance ) ?is section4  7#b7         
,consid]ations ,9 e/abli%+ good         
manufactur+ practices "u ?is section1 ! 
,secret>y %all take into acc\nt !       
practices ( small bus9ess1 includ+ !    
size & scope ( ! bus9ess1 & consult ) ! 
,small ,bus9ess ,adm9i/ration1 z        
appropriate4  7d7 ,preemption ,no ,/ate 
or political subdivision ( a ,/ate may  
e/abli% or cont9ue 9 effect any law1    
regulation1 ord]1 or o!r requirem5t )   
respect to good manufactur+ practice    
/&>ds = cosmetics t is diff]5t f !      
requirem5ts "u ?is section4  4  7b7     
,prohibition ,section #fja ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfa7 is am5d$ by add+ at !   
end ! foll[+3  7f7 ,if x has be5        
manufactur$ "u conditions t d n meet    
curr5t good manufactur+ practice        
regulations e/abli%$ "u section #fje4  4

  #g4 ,id5tification & review ( cosmetic
 +r$i5ts ,*apt] ,,vi ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfa et seq471 z am5d$ by section #f1 is
 fur!r am5d$ by add+ at ! end ! foll[+3 
#fjf4 ,id5tification & review ( cosmetic
 +r$i5ts  7a7 ,id5tification ( +r$i5ts &
 non-,functional con/itu5ts ,to be      
review$ ,ea* ye>1 ! ,secret>y1 9        
consultation ) indu/ry & consum] gr\ps1 
& tak+ into consid]ation +r$i5ts        
id5tifi$ by a ,/ate or political        
subdivision z pres5t+ a public heal?    
conc]n1 %all id5tify cosmetic +r$i5ts1 z
 appropriate1 t may pres5t a public     
heal? conc]n to be review$ = safety1    
includ+ a class or classes ( +r$i5ts1 or
 a non-functional con/itu5t or class (  
non-functional con/itu5ts4 ,! ,secret>y 
%all publi% 9 ! ,f$]al ,regi/] a li/ ( !
 +r$i5ts or non-functional con/itu5ts1  
or classes ( +r$i5ts or con/itu5ts      
id5tifi$ = review1 & solicit public     
input & provide ! public notice & a     
p]iod ( #fj days to comm5t on any su*   

+r$i5t1 con/itu5t1 or class4 ,!         
,secret>y may id5tify a cosmetic +r$i5t 
or +r$i5ts1 z appropriate1 to be review$
 = safety outside su* annual process4   
7b7 ,adm9i/rative ord]s & /&>ds  7#a7   
,publication ( det]m9ations & f9d+s     
7,a7 ,propos$ ord]s ,if ! ,secret>y     
det]m9es t !re is adequate sci5tific    
evid5ce to support a det]m9ation t !re  
is reasonable c]ta9ty t an +r$i5t1 class
 ( +r$i5ts1 non-functional con/itu5t1 or
 class ( non-functional con/itu5ts is   
safe = use1 n safe = use1 or n safe =   
specifi$ conditions ( use1 ! ,secret>y  
%all po/ on ! ,int]net website ( ! ,food
 & ,drug ,adm9i/ration a propos$        
adm9i/rative ord] consi/5t ) su*        
det]m9ation4  7,b7 ,f9d+s ( inadequate  
evid5ce ,if ! ,secret>y det]m9es t !re  
is inadequate sci5tific evid5ce to      
support a det]m9ation describ$ 9        
subp>agraph 7,a71 ! ,secret>y %all po/  
on ! ,int]net website ( ! ,food & ,drug 
,adm9i/ration su* f9d+s1 toge!r ) a     
rationale = ! f9d+s4  7,c7 ,additional  

evid5ce ,no?+ 9 ?is p>agraph %all prev5t
 ! ,secret>y f consid]+ additional      
sci5tific in=mation or safety data      
relat$ to ! +r$i5t t is submitt$ to !   
,secret>y4  7#b7 ,f9al ord]s  7,a7 ,9   
g5]al ,aft] all[+ n less ?an #ij days = 
public comm5t on a propos$ ord] "u      
p>agraph 7#a77;,a7 & a p]iod =          
consid]ation ( any su* comm5ts1 if !    
,secret>y det]m9es t !re is adequate    
sci5tific evid5ce to make a f9al        
det]m9ation on ! safety ( ! applicable  
+r$i5t1 class ( +r$i5ts1 non-functional 
con/itu5t1 or class ( non-functional    
con/itu5ts1 ! ,secret>y %all issue a    
f9al adm9i/rative ord] t !re is         
reasonable c]ta9ty t--  7i7 ! +r$i5t1   
class ( +r$i5ts1 non-functional         
con/itu5t1 or class ( non-functional    
con/itu5ts is safe = use2  7ii7 !       
+r$i5t1 class ( +r$i5ts1 non-functional 
con/itu5t1 or class ( non-functional    
con/itu5ts is n safe = any use2 or      
7iii7 ! +r$i5t1 class ( +r$i5ts1        
non-functional con/itu5t1 or class (    

non-functional con/itu5ts is n safe "u  
specifi$ conditions ( use4  7,b7 ,f9al  
action ,a f9al adm9i/rative ord] "u     
subp>agraph 7,a7 %all be consid]$ f9al  
ag5cy action = purposes ( judicial      
review4  7#c7 ,/&>ds ,a det]m9ation t an
 +r$i5t1 class ( +r$i5ts1 non-functional
 con/itu5t1 or class ( non-functional   
con/itu5ts is n safe "u specifi$        
conditions ( use may specify conditions 
( use su* z--  7,a7 ! am\nt or          
conc5tration ( su* +r$i5t2  7,b7 !      
populations :i* may specifically use su*
 +r$i5t or n use su* +r$i5t2  7,c7 !    
area ( ! human body on :i* or ne> :i*   
su* +r$i5t %\ld n be us$2 or  7,d7 su*  
o!r conditions t may affect ! safety ( !
 cosmetic z a :ole or 9 "p4  7c7        
,cosmetic safety /&>d ,= purposes ( ?is 
,act1 includ+ reviews = safety "u ?is   
section & section #fjg1 a cosmetic is   
safe if !re is reasonable c]ta9ty t !   
cosmetic is n injuri\s to us]s "u       
conditions ( use prescrib$ 9 label+ or  
"u su* conditions ( use z are cu/om>y or

 usual4  7d7 ,preemption ,^u            
id5tification ( a cosmetic +r$i5t or    
non-functional con/itu5t by ! ,secret>y 
"u subsection 7a71 no ,/ate or local    
gov]nm5t may e/abli% or cont9ue 9 effect
 any law1 regulation1 ord]1 or o!r      
requirem5t ) respect to su* +r$i5t or   
non-functional con/itu5t1 except t a    
,/ate or local gov]nm5t may cont9ue 9   
effect su* a requirem5t t 0 9 full      
effect ) respect to su* +r$i5t on ! date
 ( enactm5t ( ! ,,fda ,cosmetic ,safety 
& ,mod]nization ,act1 or t is exempt$ f 
preemption "u section #geb7;b7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act4  
7e7 ,def9itions ,= purposes ( ?is ,act--
 7#a7 ! t]m non-functional con/itu5t    
means a sub/ance or *emical1 or o!r     
contam9ant1 t 0 n int5tionally add$ or  
includ$ 9 ! =mula ( a cosmetic product &
 s]ves no te*nical purpose1 b may be    
pres5t z a breakd[n product or          
by-product ( manufactur+2 &  7#b7 ! t]m 
cosmetic means a cosmetic product 9     
f9i%$ =m consi/5t ) section             

#bja7;i77#a74  7f7 ,rule ( con/ruction  
,?is section %all n be con/ru$ to affect
 ! "r ( a p]son to lawfully m>ket a     
cosmetic product t is or t conta9s an   
+r$i5t1 class ( +r$i5ts1 non-functional 
con/itu5t1 or class ( non-functional    
con/itu5ts :ile su* sub/ance is "u      
review or has be5 id5tifi$ = review by !
 ,secret>y = safety4  7g7 ,au?orization 
( appropriations ,to c>ry out ?is       
section1 !re are au?oriz$ to be         
appropriat$ su* sums z may be necess>y4 
4  #h4 ,accr$it$ ?ird-p>ty review ,*apt]
 ,,vi ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et   
seq471 z am5d$ by section #g1 is fur!r  
am5d$ by add+ at ! end ! foll[+3  #fjg4 
,accr$it$ ?ird-p>ty review  7a7 ,9 g5]al
 ,! ,secret>y may accr$it p]sons to     
review & assess = safety cosmetic       
+r$i5ts or non-functional con/itu5ts    
id5tifi$ by ! ,secret>y "u section      
#fjf7;a7 & make recomm5dations to !     
,secret>y = propos$ adm9i/rative ord]s  
"u section #fjf7;b77#a77;,a74  7b7      

,accr$itation & review ,n lat] ?an #b   
ye>s aft] ! date ( enactm5t ( ! ,,fda   
,cosmetic ,safety & ,mod]nization ,act1 
! ,secret>y %all promulgate regulations 
e/abli%+-- 7#a7 a process to accr$it    
?ird p>ties = purposes ( review+        
cosmetic +r$i5ts1 classes ( +r$i5ts1    
non-functional con/itu5ts1 & classes (  
non-functional con/itu5ts id5tifi$ by ! 
,secret>y "u section #fjf7;a72 &  7#b7  
crit]ia & qualifications = su*          
accr$itation ( ?ird p>ties4  7c7        
,requirem5ts reg>d+ review ,9 mak+ a    
recomm5dation to ! ,secret>y "u         
subsection 7a71 an accr$it$ ?ird p>ty   
%all notify ! ,secret>y 9 writ+ ( !     
reasons = ! recomm5dation1 & provide    
relevant sci5tific lit]ature or data1 z 
! ,secret>y requires4  7d7 ,review &    
adm9i/rative ord] ,! ,secret>y %all     
e/abli% a process by :i* to review      
recomm5dations f su* accr$it$ ?ird p>ty 
& to det]m9e :e!r an ,adm9i/rative ,ord]
 is appropriate4 ,n lat] ?an #ahj cal5d>
 days aft] ! date on :i* ! ,secret>y    

receives a recomm5dation f an accr$it$  
?ird p>ty p]ta9+ to a cosmetic +r$i5t or
 non-functional +r$i5t id5tifi$ by !    
,secret>y "u section #fjf7;a71 !        
,secret>y %all issue a propos$          
adm9i/rative ord]1 or issue a public    
rationale on ! ,secret>y's det]m9ation n
 to issue a propos$ adm9i/rative ord]4  
7e7 ,qualifications ,an accr$it$ ?ird   
p>ty %all1 at a m9imum1 meet ! foll[+   
requirem5ts3 7#a7 ,su* ?ird p>ty may n  
be affiliat$ ) a gov]nm5t entity4  7#b7 
,su* ?ird p>ty %all be an indep5d5t     
organization t is n own$ or controll$ by
 a manufactur]1 suppli]1 or v5dor (     
cosmetics & t has no f9ancial           
affiliation ) su* a manufactur]1        
suppli]1 or v5dor4  7#c7 ,su* ?ird p>ty 
%all be a legally con/itut$ entity      
p]mitt$ to conduct ! activities = :i* x 
seeks accr$itation4  7#d7 ,su* ?ird p>ty
 %all n engage 9 ! design1 manufactur]1 
promotion1 or sale ( cosmetics4  7#e7   
,su* ?ird p>ty %all h sci5tific exp]tise
 9 +r$i5t safety1 toxicology1 or *emical

 safety4  7#f7 ,! op]ations ( su* ?ird  
p>ty %all be 9 accordance ) g5]ally     
accept$ pr(essional & e?ical bus9ess    
practices & su* ?ird p>ty %all agree 9  
writ+ t x w--  7,a7 c]tify t report$    
in=mation accurately reflects data      
review$2  7,b7 limit "w to t )9 its     
compet5ce & capacity2  7,c7 treat       
propriet>y1 confid5tial1 & comm]cial    
in=mation receiv$1 includ+ records1     
reports1 & recomm5dations1 z confid5tial
 in=mation2  7,d7 promptly respond &    
attempt to resolve compla9ts reg>d+ !   
activities = :i* x is accr$it$2 &  7,e7 
protect aga9/ ! use1 9 c>ry+ out        
subsection 7a7 ) respect to a cosmetic1 
( any (fic] or employee ( ! entity :o   
has a f9ancial conflict ( int]e/ reg>d+ 
! cosmetic1 & annually make available to
 ! public disclosures ( ! ext5t to :i* !
 entity1 & ! (fic]s & employees ( !     
entity1 h ma9ta9$ compliance )          
requirem5ts "u ?is subp>agraph relat+ to
 f9ancial conflicts ( int]e/4  7f7 ,rule
 ( ,con/ruction ,no?+ 9 ?is section is  

int5d$ to affect ! ,secret>y's au?ority 
to ent] into contracts ) non-accr$it$   
?ird p>ties = purposes ( cosmetic safety
 review4  4  #i4 ,report+ ,*apt] ,,vi ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by
 section #h1 is fur!r am5d$ by add+ at !
 end ! foll[+3  #fjh4 ,cosmetic +r$i5t  
report  7a7 ,annual report to ,congress 
,! ,commission] %all submit an annual   
report to ! appropriate committees (    
,congress t includes a report or summ>y 
(--  7#a7 ! +r$i5ts or non-functional   
con/itu5ts t ! ,commission] has id5tifi$
 = review "u section #fjf7;a72  7#b7 !  
+r$i5ts or non-functional con/itu5ts =  
:i* ! ,commission] has issu$ a propos$  
ord]1 a f9al ord]1 or a f9d+ (          
incomplete evid5ce "u section #fjf7;b72 
7#c7 ! ongo+ +r$i5t or non-functional   
con/itu5ts be+ review$ = safety at ! "t 
( submission ( ! report1 reviews !      
,commission] has det]m9$ to be ne$$1 &  
reviews = :i* ,commission] is contract+ 
) an accr$it$ ?ird p>ty2  7#d7 a summ>y 

( s]i\s adv]se ev5t reports submitt$ "u 
section #gfb1 & ! associat$ product     
category & s]i\s adv]se heal? consequ5ce
 = ea* su* report2 &  7#e7 en=cem5t     
actions1 if any1 ! ,commission] has tak5
 z a result ( s]i\s adv]se ev5t reports 
or facility inspections1 includ+ w>n+   
lett]s1 untitl$ lett]s1 susp5sion (     
regi/ration1 or any o!r type ( action4  
4  #aj4 ,,gao report ,n lat] ?an #b ye>s
 aft] ! date ( enactm5t ( ?is ,act1 !   
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all analyze1 & submit a report to      
,congress on--  7#a7 ! types ( +r$i5ts  
or non-functional con/itu5ts t ! ,food &
 ,drug ,adm9i/ration has id5tifi$ =     
purposes ( a safety review "u section   
#fjf ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7z add$ by section #g7 & 
! factors or me?ods1 if any1 t su* ag5cy
 consid]s 9 det]m9+ ! ne$ = a safety    
review2  7#b7 ! level ( coord9ation     
betwe5 ! ,food & ,drug ,adm9i/ration & !
 ,/ates 9 id5tify+ +r$i5ts t may pres5t 
a public heal? conc]n = review1 & !     

process by :i* ! ,food & ,drug          
,adm9i/ration consid]s public input z "p
 ( id5tify+ +r$i5ts t may pres5t a      
public heal? conc]n2  7#c7 h[ ! ,food & 
,drug ,adm9i/ration acc\nts = reports ( 
s]i\s adv]se ev5ts "u section #gfb ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z
 add$ by section #b7 to in=m cosmetic   
relat$ inspections2  7#d7 ! frequ5cy &  
type ( inspections conduct$ by ! ,food &
 ,drug ,adm9i/ration1 includ+           
inspections 9 response to reports (     
s]i\s adv]se ev5ts1 & an analysis ( !   
outcome & relat$ facility compliance2   
7#e7 ! "t betwe5 id5tify+ +r$i5ts to be 
review$ = safety "u section #fjf7;a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act &
 issuance ( f9al adm9i/rative ord]s "u  
section #fjf7;b77#b7 ( su* ,act2  7#f7  
+r$i5ts1 if any1 t ! ,food & ,drug      
,adm9i/ration took action to include on 
! prohibit$ & re/rict$ +r$i5ts li/ ( !  
,food & ,drug ,adm9i/ration1 & a summ>y 
( +r$i5ts ) respect to :i* su* ag5cy has
 issu$ an adm9i/rative ord]2 &  7#g7 !  

,food & ,drug ,adm9i/ration's use (     
accr$it$ ?ird p>ties = purposes (       
cosmetic +r$i5t safety reviews 9        
accordance ) section #fjg ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7z add$  
by section #h74