,,ii #aai? ,,congress #b;d ,session ,s4 #cfgg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #ae1 #bjbf,mr4 ,durb9 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to improve transp>5cy & ! availability ( in=mation reg>d+ diet>y supplem5ts by am5d+ ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to require manufactur]s ( diet>y supplem5ts to li/ diet>y supplem5ts ) ! ,food & ,drug ,adm9i/ration4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,diet>y ,supplem5t ,li/+ ,act ( #bjbf4 #b4 ,regulation ( diet>y supplem5ts 7a7 ,9 g5]al ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by add+ aft] section #djc;,c ( su* ,act 7#ba ,u4,s4,c4 #cdc-c7 ! foll[+3 #djc;,d4 ,diet>y supplem5t li/+ requirem5t 7a7 ,9 g5]al ,beg9n+ on ! date specifi$ 9 subsection 7b77#d71 ea* diet>y supplem5t m>ket$ 9 ! ,unit$ ,/ates %all be li/$ ) ! ,secret>y 9 accordance ) ?is section4 ,ea* su* li/+ %all include1 ) respect to ! diet>y supplem5t1 ! in=mation specifi$ 9 subsection 7b77#a74 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! manufactur]1 pack]1 or di/ributor ( a diet>y supplem5t ^: "n 7pursuant to section #djc7;e77#a77 appe>s on ! label ( a diet>y supplem5t m>ket$ 9 ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! responsible p]son71 or if ! responsible p]son is a =eign entity1 ! ,unit$ ,/ates ag5t ( su* p]son1 %all submit to ! ,secret>y 9 accordance ) ?is section ! foll[+ in=mation = a diet>y supplem5t t is m>ket$ 9 ! ,unit$ ,/ates3 7,a7 ,any "n ( ! diet>y supplem5t & ! /atem5t ( id5tity1 includ+ br& "n & specifi$ flavors1 if applicable4 7,b7 ,! "n & address ( ! responsible p]son & ! "n & email address ( ! own]1 op]ator1 or ag5t 9 *>ge ( ! responsible p]son4 7,c7 ,! "n1 dome/ic address1 & email address = ! ,unit$ ,/ates ag5t1 if ! responsible p]son is a =eign entity4 7,d7 ,! bus9ess "n & place ( bus9ess ! responsible p]son provid$ on ! label pursuant to section #djc7;e77#a74 7,e7 ,an electronic copy ( ! label = ! diet>y supplem5t4 7,f7 ,a li/ ( all +r$i5ts 9 ea* su* diet>y supplem5t requir$ "u sections #aja4d & #aja4cf1 title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 to appe> on ! label ( a diet>y supplem5t1 includ+-- 7i7 :]e applicable1 +r$i5ts 9 a propriet>y bl5d z describ$ 9 section #aja4cf7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7ii7 ! am\nt p] s]v+ ( ea* li/$ diet>y +r$i5t2 7iii7 if requir$ by section #aja4cf ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ! p]c5t ( ! daily value ( ea* li/$ diet>y +r$i5t2 & 7iv7 ! am\nt p] s]v+ ( diet>y +r$i5ts )9 a propriet>y bl5d 7:i* %all rema9 confid5tial & n subject to public disclosure74 7,g7 ,! numb] ( s]v+s p] conta9] = ea* conta9] size4 7,h7 ,! directions = use4 7,i7 ,w>n+s1 notice1 & safe h&l+ /atem5ts1 z requir$ by section #aja4ag ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,j7 ,all]g5 /atem5ts = major food all]g5s 7pursuant to sections #djc7w7 & #djc7x774 7,k7 ,! =m ( ! diet>y supplem5t 7su* z tablets1 capsules1 p[d]s1 liquids1 s(tgels1 & gummies74 7,l7 ,any claim t appe>s on ! label or package ins]t t-- 7i7 *>act]izes ! relation%ip ( any +r$i5t to a disease or a heal?-relat$ condition & is describ$ 9 section #djc7r77#a77;,b72 or 7ii7 is subject to notification "u section #djc7r77#f71 provid$ t no additional li/+ or *ange to li/+ in=mation is requir$ "u ?is p>agraph = any m9or v>iation or modification to a claim = :i* notification "u section #djc7r77#f7 is n requir$4 7,m7 ,! diet>y supplem5t product li/+ numb] = ! diet>y supplem5t provid$ by ! ,secret>y 9 accordance ) subsection 7c74 7#b7 ,=mat2 notification ( receipt 7,a7 ,=mat ,! ,secret>y may require t a li/+ submitt$ "u p>agraph 7#a7 be submitt$ 9 an electronic =mat4 7,b7 ,notification ( receipt 7i7 ,9 g5]al ,^u receipt ( a li/+ "u p>agraph 7#a71 ! ,secret>y %all promptly notify ! responsible p]son (-- 7,i7 ! receipt ( a complete li/+2 or 7,,ii7 ! receipt ( a li/+ t is n complete1 toge!r ) a /atem5t describ+ ! reasons :y ! li/+ is n complete4 7ii7 ,complete receipts describ$ ,a li/+ "u p>agraph 7#a7 is deem$ complete once all fields ( requir$ in=mation h be5 complet$ by ! responsible p]son :o repres5ts t ! product w be m>ket$ 9 ! ,unit$ ,/ates z a diet>y supplem5t4 7#c7 ,li/+ cont5t ,a s+le li/+ submission = a diet>y supplem5t "u p>agraph 7#a7 may include multiple diet>y supplem5ts ) id5tical =mulations & =ms1 or =mulations ( ! same =m1 t diff] only ) respect to color1 excipi5ts1 or flavor+s1 :e!r (f]$ 9 a s+le package size or 9 multiple package sizes4 7#d7 ,tim+ 7,a7 ,9 g5]al 7i7 ,diet>y supplem5ts on ! m>ket ,9 ! case ( a diet>y supplem5t t is be+ (f]$ 9 int]/ate comm]ce on or be=e ,janu>y #a1 #bjbg1 a li/+ = ea* su* diet>y supplem5t introduc$ or deliv]$ = introduction into int]/ate comm]ce %all be submitt$ by ! responsible p]son to ! ,secret>y "u ?is subsection n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,diet>y ,supplem5t ,li/+ ,act ( #bjbf4 7ii7 ,new diet>y supplem5ts ,9 ! case ( a diet>y supplem5t t is n be+ (f]$ 9 int]/ate comm]ce on or be=e ,janu>y #a1 #bjbg1 a li/+ = ea* su* diet>y supplem5t introduc$ or deliv]$ = introduction into int]/ate comm]ce t has n be5 includ$ 9 any li/+ previ\sly submitt$ by ! responsible p]son to ! ,secret>y "u ?is subsection %all be submitt$ to ! ,secret>y at ! "t ( introduction into int]/ate comm]ce4 7,b7 ,discont9u$ diet>y supplem5ts ,! responsible p]son %all notify ! ,secret>y n lat] ?an #a ye> aft] ! date ! responsible p]son discont9ues ! introduction into int]/ate comm]ce ( a diet>y supplem5t requir$ to be li/$ ) ! ,secret>y "u p>agraph 7#a74 7,c7 ,*anges to exi/+ li/+s ,! responsible p]son %all submit to ! ,secret>y any *ange or modification to li/+ in=mation submitt$ "u p>agraph 7#a7 includ$ on ! label ( a diet>y supplem5t n lat] ?an #cj days aft] ! diet>y supplem5t ) ! *ange or modification is fir/ introduc$ into int]/ate comm]ce4 7#e7 ,additional in=mation ,! responsible p]son %all provide1 ^u reque/ f ! ,secret>y1 n lat] ?an #aj cal5d> days aft] su* reque/-- 7,a7 ! full bus9ess "n & physical & mail+ address ( all locations at :i* ! responsible p]son manufactures1 packages1 labels1 or holds ! diet>y supplem5t2 & 7,b7 ! full bus9ess "n & physical & mail+ address f :i* ! responsible p]son receives a diet>y +r$i5t or comb9ation ( diet>y +r$i5ts t ! responsible p]son uses 9 ! manufacture ( ! diet>y supplem5t or1 if applicable1 f :i* ! responsible p]son receives ! diet>y supplem5t4 7c7 ,product li/+ numb] & diet>y supplem5t electronic database 7#a7 ,diet>y supplem5t product li/+ numb] ,! ,secret>y %all provide ea* diet>y supplem5t li/$ 9 accordance ) subsection 7b77#a7 a diet>y supplem5t product li/+ numb]1 :i* may apply to multiple diet>y supplem5ts ) id5tical =mulations1 or =mulations t diff] only ) respect to color1 excipi5ts1 or flavor+s1 includ+ diet>y supplem5ts (f]$ 9 a s+le package size or 9 multiple package sizes4 ,! ,secret>y %all provide a process = a responsible p]son to res]ve diet>y supplem5t li/+ numb]s 9 advance ( li/+ "u subsection 7b77#a74 7#b7 ,electronic database ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,diet>y ,supplem5t ,li/+ ,act ( #bjbf1 ! ,secret>y %all e/abli% & ma9ta9 an electronic database t is publicly available & conta9s in=mation submitt$ "u subsection 7b77#a7 7except = ! in=mation submitt$ "u subp>agraph 7,b71 7,c71 & 7,f77iv7 ( su* subsection74 ,! ,secret>y %all make su* in=mation ma9ta9$ 9 ! electronic database publicly se>*able1 includ+ by diet>y supplem5t product li/+ numb]1 & by any field ( in=mation or comb9ation ( fields ( in=mation provid$ "u subsection 7b77#a7 7except = ! in=mation submitt$ "u subp>agraph 7,b71 7,c71 & 7,f77iv7 ( su* subsection74 7#c7 ,confid5tial in=mation ,9 response to a reque/ "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 in=mation describ$ 9 subp>agraph 7,b71 7,c71 & 7,f77iv7 ( subsection 7b77#a7 t is d]iv$ f a li/+ "u ?is section1 & in=mation describ$ 9 subp>agraph 7b77#e71 %all be )held "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to limit ! au?ority ( ! ,secret>y to inspect or copy records or to require ! e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act2 7#b7 to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code1 or t is subject to )hold+ "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code2 7#c7 to au?orize or p]mit ! release 9 ! public database1 or to make subject to disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 in=mation t discloses ! id5tity or location ( a specific regi/]$ p]son or facility n id5tifi$ on ! label1 or ! quantity ( any individual +r$i5ts 9 a propriet>y bl5d2 or 7#d7 to grant ! ,secret>y au?ority to require ! approval ( a diet>y supplem5t prior to m>ket+4 7e7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #g1hgb1ihd = fiscal ye> #bjbf1 & #f1fae1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjcj1 = purposes ( conduct+ ! activities "u ?is section & hir+ p]sonnel requir$ to c>ry out ?is section4 4 7b7 ,misbr&+ ,section #djc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is am5d$ by add+ at ! end ! foll[+3 7z7 ,if x is a diet>y supplem5t = :i* a responsible p]son or ! ,unit$ ,/ates ag5t ( su* a p]son is requir$ "u section #djc;,d to file a li/+1 file a *ange to an exi/+ li/+1 or provide additional in=mation to ! ,secret>y1 & su* p]son or ag5t has fail$ to comply ) any su* requirem5ts "u section #djc;,d ) respect to su* diet>y supplem5t4 4 7c7 ,new prohibit$ act ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7jjj7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( a diet>y supplem5t t has be5 prep>$1 pack$1 or held us+ ! assi/ance (1 or at ! direction (1 a p]son deb>r$ "u section #cjf4 4