,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ajccf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #aj1 #bjbf,mrs4 ,h>%b>g] introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to enc\rage innovation & increase & protect consum] access ) respect to diet>y supplem5ts by cl>ify+ ! regulatory framework gov]n+ drug preclusion1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,diet>y ,supplem5t ,innovation ,act4 #b4 ,cl>ification ( drug preclusion ) respect to food & diet>y supplem5ts 7a7 ,prohibit$ act ,section #cja7ll7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7ll77 is am5d$ to read z foll[s3 7ll7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( any food 7includ+ a diet>y supplem5t7 to :i* has be5 add$ a drug approv$ "u section #eje ( ?is ,act1 a biological product lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or a drug or biological product = :i* ,phase #b or ,phase #c 7z su* t]ms are describ$ 9 section #cab4ba7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations77 cl9ical inve/igations h be5 in/itut$ & = :i* ! exi/5ce ( su* inve/igations has be5 made public1 unless-- 7#a7 ! drug or biological product 0 m>ket$ 9 ! ,unit$ ,/ates be=e ,octob] #ae1 #aiid1 z or 9-- 7,a7 food2 or 7,b7 a product t1 if ! def9ition ( ! t]m diet>y supplem5t "u section #bja7;ff7 _h be5 9 effect at ! date ( m>ket+1 w\ld h met su* def9ition 7o!r ?an ! label+ requirem5t 9 section #bja7;ff77#b77;,c772 7#b7 su* drug or biological product 0 m>ket$ z food or 9 a diet>y supplem5t be=e-- 7,a7 any approval ( ! drug "u section #eje2 7,b7 any lic5sure ( ! biological product "u su* section #cea2 or 7,c7 any ,phase #b or ,phase #c cl9ical inve/igation involv+ ! use ( ! sub/ance z a drug or biological product has be5 in/itut$ & ! exi/5ce ( su* inve/igation has be5 made public2 7#c7 ea* ,phase #b or ,phase #c cl9ical inve/igation ref]r$ to 9 ! matt] prec$+ subp>agraph 7#a7 has be5 on inactive /atus1 )drawn1 or bo? = a cont9u\s p]iod ( at lea/ sev5 ye>s prec$+ ! addition ( ! drug or biological product 9 food 7includ+ a diet>y supplem5t71 or ! sponsor has publicly ann\nc$ discont9uation ( drug developm5t activities2 7#d7 ! drug is a new animal drug ^: use is n unsafe "u section #eab2 7#e7 ! use ( ! drug or ! biological product 9 ! food 7includ+ a diet>y supplem5t7 is to enhance ! safety ( ! food to :i* ! drug or ! biological product is add$ or appli$ & n to h indep5d5t biological or !rapeutic effects on humans1 & ! use is 9 con=mity )-- 7,a7 a regulation issu$ "u section #dji prescrib+ conditions ( safe use 9 food2 7,b7 a regulation li/+ or affirm+ conditions "u :i* ! use ( ! drug or biological product 9 food is g5]ally recogniz$ z safe2 7,c7 ! conditions ( use id5tifi$ 9 a notification to ! ,secret>y ( a claim ( exemption f ! prem>ket approval requirem5ts = food additives bas$ on ! notifi]'s det]m9ation t ! use ( ! drug or biological product 9 food is g5]ally recogniz$ z safe1 provid$ t ! ,secret>y has n que/ion$ ! g5]al recognition ( safety det]m9ation 9 a lett] to ! notifi]2 or 7,d7 a food contact sub/ance notification t is effective "u section #dji7;h72 7#f7 su* drug or biological product _h be5 m>ket$ = smok+ cessation prior to ! date ( ! enactm5t ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg2 or 7#g7 ! ,secret>y1 9 ! ,secret>y's discretion1 has issu$ an adm9i/rative ord] ?r\gh a proce$+ initiat$ by ! ,secret>y approv+ ! use ( su* drug or biological product 9 food 7includ+ a diet>y supplem5t74 4 7b7 ,det]m9ations ) respect to drug preclusion ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$ by ins]t+ aft] section #dac 7#ba ,u4,s4,c4 #cej;b7 ! foll[+3 #dac;,a4 ,det]m9ations made ) respect to drug preclusion ( food & diet>y supplem5ts 7a7 ,/&>ds ( evaluation ,= purposes ( det]m9+ :e!r a drug 7includ+ a biological product7 has be5 add$ to a food 7includ+ a diet>y supplem5t7 = purposes ( section #cja7ll77#a7 or 7#b71 ! ,secret>y %all consid] any diff]5ce betwe5 su* drug & ! sub/ance :5 add$ to su* food1 includ+ ) respect to-- 7#a7 r\te ( adm9i/ration2 7#b7 recomm5d$ dosage & s]v+ am\nt2 7#c7 conc5tration or composition2 or 7#d7 ! degree ( safety ( ! sub/ance :5 add$ to-- 7,a7 a food2 or 7,b7 a diet>y supplem5t subject to ! safety requirem5ts & burd5 ( pro( = diet>y supplem5ts z describ$ 9 section #djb7;ff74 7b7 ,judicial review 7#a7 ,imm$iately reviewable ,a w>n+ lett]1 response to a notification submitt$ pursuant to section #aja4ic7;a7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 response to in=mation provid$ pursuant to section #dac7;a77#b7 ( ?is ,act1 or /atem5t made on a website controll$ by ! ,secret>y1 f9d+ or o!rwise ass]t+ t ! introduction or deliv]y = introduction into int]/ate comm]ce ( a food 7includ+ a diet>y supplem5t7 violates section #cja7ll7 ( ?is ,act %all be imm$iately reviewable by a c\rt ( jurisdiction "u applicable law1 irrespective ( :e!r su* w>n+ lett]1 response1 or /atem5t is consid]$ to be f9al ag5cy action "u *apt] #g ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,burd5 ( pro( ,9 any action = :i* imm$iate review is s\ght pursuant to p>agraph 7#a71 ! ,unit$ ,/ates %all be> ! burd5 ( pro( to %[ t su* introduction or deliv]y = introduction w\ld violate su* section #cja7ll74 4 7c7 ,con=m+ *anges to def9ition ( diet>y supplem5t ,section #bja7;ff7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;ff77 is am5d$-- 7#a7 9 subp>agraph 7#a77;,f71 by add+ & at ! end2 7#b7 9 subp>agraph 7#b77;,c71 by /rik+ 2 & at ! end & ins]t+ a p]iod2 & 7#c7 by /rik+ 7#c7 does-- & all t foll[s ?r\gh w\ld be lawful "u ?is ,act44