,,ii #aaith ,,congress #b;d ,session ,s4 #cfgg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #ae1 #bjbf,mr4 ,durbin introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve transparency and the availability of information regarding dietary supplements by amending the ,federal ,food1 ,drug1 and ,cosmetic ,act to require manufacturers of dietary supplements to list dietary supplements with the ,food and ,drug ,administration4 #a4 ,short title ,this ,act may be cited as the ,dietary ,supplement ,listing ,act of #bjbf4 #b4 ,regulation of dietary supplements 7a7 ,in general ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by adding after section #djc;,c of such ,act 7#ba ,u4,s4,c4 #cdc-c7 the following3 #djc;,d4 ,dietary supplement listing requirement 7a7 ,in general ,beginning on the date specified in subsection 7b77#d71 each dietary supplement marketed in the ,united ,states shall be listed with the ,secretary in accordance with this section4 ,each such listing shall include1 with respect to the dietary supplement1 the information specified in subsection 7b77#a74 7b7 ,requirements 7#a7 ,in general ,the manufacturer1 packer1 or distributor of a dietary supplement whose name 7pursuant to section #djc7;e77#a77 appears on the label of a dietary supplement marketed in the ,united ,states 7referred to in this section as the responsible person71 or if the responsible person is a foreign entity1 the ,united ,states agent of such person1 shall submit to the ,secretary in accordance with this section the following information for a dietary supplement that is marketed in the ,united ,states3 7,a7 ,any name of the dietary supplement and the statement of identity1 including brand name and specified flavors1 if applicable4 7,b7 ,the name and address of the responsible person and the name and email address of the owner1 operator1 or agent in charge of the responsible person4 7,c7 ,the name1 domestic address1 and email address for the ,united ,states agent1 if the responsible person is a foreign entity4 7,d7 ,the business name and place of business the responsible person provided on the label pursuant to section #djc7;e77#a74 7,e7 ,an electronic copy of the label for the dietary supplement4 7,f7 ,a list of all ingredients in each such dietary supplement required under sections #aja4d and #aja4cf1 title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 to appear on the label of a dietary supplement1 including-- 7i7 where applicable1 ingredients in a proprietary blend as described in section #aja4cf7;c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7ii7 the amount per serving of each listed dietary ingredient2 7iii7 if required by section #aja4cf of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 the percent of the daily value of each listed dietary ingredient2 and 7iv7 the amount per serving of dietary ingredients within a proprietary blend 7which shall remain confidential and not subject to public disclosure74 7,g7 ,the number of servings per container for each container size4 7,h7 ,the directions for use4 7,i7 ,warnings1 notice1 and safe handling statements1 as required by section #aja4ag of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,j7 ,allergen statements for major food allergens 7pursuant to sections #djc7w7 and #djc7x774 7,k7 ,the form of the dietary supplement 7such as tablets1 capsules1 powders1 liquids1 softgels1 and gummies74 7,l7 ,any claim that appears on the label or package insert that-- 7i7 characterizes the relationship of any ingredient to a disease or a health-related condition and is described in section #djc7r77#a77;,b72 or 7ii7 is subject to notification under section #djc7r77#f71 provided that no additional listing or change to listing information is required under this paragraph for any minor variation or modification to a claim for which notification under section #djc7r77#f7 is not required4 7,m7 ,the dietary supplement product listing number for the dietary supplement provided by the ,secretary in accordance with subsection 7c74 7#b7 ,format2 notification of receipt 7,a7 ,format ,the ,secretary may require that a listing submitted under paragraph 7#a7 be submitted in an electronic format4 7,b7 ,notification of receipt 7i7 ,in general ,upon receipt of a listing under paragraph 7#a71 the ,secretary shall promptly notify the responsible person of-- 7,i7 the receipt of a complete listing2 or 7,,ii7 the receipt of a listing that is not complete1 together with a statement describing the reasons why the listing is not complete4 7ii7 ,complete receipts described ,a listing under paragraph 7#a7 is deemed complete once all fields of required information have been completed by the responsible person who represents that the product will be marketed in the ,united ,states as a dietary supplement4 7#c7 ,listing content ,a single listing submission for a dietary supplement under paragraph 7#a7 may include multiple dietary supplements with identical formulations and forms1 or formulations of the same form1 that differ only with respect to color1 excipients1 or flavorings1 whether offered in a single package size or in multiple package sizes4 7#d7 ,timing 7,a7 ,in general 7i7 ,dietary supplements on the market ,in the case of a dietary supplement that is being offered in interstate commerce on or before ,january #a1 #bjbg1 a listing for each such dietary supplement introduced or delivered for introduction into interstate commerce shall be submitted by the responsible person to the ,secretary under this subsection not later than #ah months after the date of enactment of the ,dietary ,supplement ,listing ,act of #bjbf4 7ii7 ,new dietary supplements ,in the case of a dietary supplement that is not being offered in interstate commerce on or before ,january #a1 #bjbg1 a listing for each such dietary supplement introduced or delivered for introduction into interstate commerce that has not been included in any listing previously submitted by the responsible person to the ,secretary under this subsection shall be submitted to the ,secretary at the time of introduction into interstate commerce4 7,b7 ,discontinued dietary supplements ,the responsible person shall notify the ,secretary not later than #a year after the date the responsible person discontinues the introduction into interstate commerce of a dietary supplement required to be listed with the ,secretary under paragraph 7#a74 7,c7 ,changes to existing listings ,the responsible person shall submit to the ,secretary any change or modification to listing information submitted under paragraph 7#a7 included on the label of a dietary supplement not later than #cj days after the dietary supplement with the change or modification is first introduced into interstate commerce4 7#e7 ,additional information ,the responsible person shall provide1 upon request from the ,secretary1 not later than #aj calendar days after such request-- 7,a7 the full business name and physical and mailing address of all locations at which the responsible person manufactures1 packages1 labels1 or holds the dietary supplement2 and 7,b7 the full business name and physical and mailing address from which the responsible person receives a dietary ingredient or combination of dietary ingredients that the responsible person uses in the manufacture of the dietary supplement or1 if applicable1 from which the responsible person receives the dietary supplement4 7c7 ,product listing number and dietary supplement electronic database 7#a7 ,dietary supplement product listing number ,the ,secretary shall provide each dietary supplement listed in accordance with subsection 7b77#a7 a dietary supplement product listing number1 which may apply to multiple dietary supplements with identical formulations1 or formulations that differ only with respect to color1 excipients1 or flavorings1 including dietary supplements offered in a single package size or in multiple package sizes4 ,the ,secretary shall provide a process for a responsible person to reserve dietary supplement listing numbers in advance of listing under subsection 7b77#a74 7#b7 ,electronic database ,not later than #b years after the date of enactment of the ,dietary ,supplement ,listing ,act of #bjbf1 the ,secretary shall establish and maintain an electronic database that is publicly available and contains information submitted under subsection 7b77#a7 7except for the information submitted under subparagraph 7,b71 7,c71 and 7,f77iv7 of such subsection74 ,the ,secretary shall make such information maintained in the electronic database publicly searchable1 including by dietary supplement product listing number1 and by any field of information or combination of fields of information provided under subsection 7b77#a7 7except for the information submitted under subparagraph 7,b71 7,c71 and 7,f77iv7 of such subsection74 7#c7 ,confidential information ,in response to a request under section #eeb of title #e1 ,united ,states ,code1 information described in subparagraph 7,b71 7,c71 and 7,f77iv7 of subsection 7b77#a7 that is derived from a listing under this section1 and information described in subparagraph 7b77#e71 shall be withheld under section #eeb7;b77#c7 of title #e1 ,united ,states ,code4 7d7 ,rule of construction ,nothing in this section shall be construed-- 7#a7 to limit the authority of the ,secretary to inspect or copy records or to require the establishment and maintenance of records under any other provision of this ,act2 7#b7 to authorize the disclosure of information that is prohibited from disclosure under section #cja7;j7 of this ,act or section #aije of title #ah1 ,united ,states ,code1 or that is subject to withholding under section #eeb7;b77#d7 of title #e1 ,united ,states ,code2 7#c7 to authorize or permit the release in the public database1 or to make subject to disclosure under section #eeb of title #e1 ,united ,states ,code1 information that discloses the identity or location of a specific registered person or facility not identified on the label1 or the quantity of any individual ingredients in a proprietary blend2 or 7#d7 to grant the ,secretary authority to require the approval of a dietary supplement prior to marketing4 7e7 ,authorization of appropriations ,there is authorized to be appropriated #g1hgb1ihd for fiscal year #bjbf1 and #f1fae1jjj for each of fiscal years #bjbg through #bjcj1 for purposes of conducting the activities under this section and hiring personnel required to carry out this section4 4 7b7 ,misbranding ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following3 7z7 ,if it is a dietary supplement for which a responsible person or the ,united ,states agent of such a person is required under section #djc;,d to file a listing1 file a change to an existing listing1 or provide additional information to the ,secretary1 and such person or agent has failed to comply with any such requirements under section #djc;,d with respect to such dietary supplement4 4 7c7 ,new prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7jjj7 ,the introduction or delivery for introduction into interstate commerce of a dietary supplement that has been prepared1 packed1 or held using the assistance of1 or at the direction of1 a person debarred under section #cjf4 4