,,ii #aagth ,,congress #b;d ,session ,s4 #djij ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bf1 #bjbb,mr4 ,durbin 7for himself and ,mr4 ,braun7 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 #bjbb4 #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 inserting after section #djc;,c of such ,act the following3 #djc;,d4 ,dietary supplement listing requirement 7a7 ,in general ,each dietary supplement shall be listed with the ,secretary in accordance with this section4 7b7 ,listing submissions 7#a7 ,in general ,each responsible person1 or1 if the responsible person is a foreign entity1 the ,united ,states agent1 shall submit to the ,secretary in accordance with this section the following information for each dietary supplement that will be marketed3 7,a7 ,any proprietary name of the dietary supplement and the statement of identity1 including brand name and specified flavors1 if applicable4 7,b7 ,the full name1 address1 and telephone number for the responsible person1 and the name and e-mail address of the owner1 operator1 or agent in charge of the responsible person4 7,c7 ,the full name1 address1 telephone number1 and e-mail address for the ,united ,states agent1 if the responsible person is a foreign entity4 7,d7 ,the full business name and address of all locations at which the responsible person manufactures1 packages1 labels1 or holds the dietary supplement4 7,e7 ,an electronic copy of the label for the dietary supplement1 and an electronic copy of the package insert1 if any4 7,f7 ,a list of all ingredients in the dietary supplement required to appear on the label under sections #aja4d and #aja4cf of title #ba1 ,code of ,federal ,regulations1 including-- 7i7 the amount per serving of each listed ingredient1 if such information is required to appear on the label2 and 7ii7 if required by section #aja4cf of title #ba1 ,code of ,federal ,regulations1 the percent of the daily value of each listed ingredient4 7,g7 ,the number of servings per container for each container size4 7,h7 ,the conditions of use4 7,i7 ,warnings and precautions4 7,j7 ,statements regarding major food allergens1 as defined in section #bja7qq7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7qq774 7,k7 ,the dosage form1 such as pill1 capsule1 liquid1 or powder4 7,l7 ,any claim that-- 7i7 characterizes the relationship of any nutrient which is of the type required by section #djc7q77#a7 or section 7q77#b7 to be in the label or labeling of the food to a disease or a health-related condition2 or 7ii7 is subject to notification under section #djc7r77#f7 that appears in the supplement's labeling4 7,m7 ,the unique dietary supplement identifier for the product1 provided in accordance with paragraph 7#c74 7#b7 ,format ,a listing submitted under this section shall be in such electronic form and manner as the ,secretary may prescribe4 ,the ,secretary shall promptly confirm1 electronically1 receipt of a complete listing under this section4 7#c7 ,unique listing identification numbers 7,a7 ,in general ,the ,secretary shall establish a unique dietary supplement identifier system that shall be used by the responsible person under this section4 7,b7 ,reservation of numbers ,the system shall allow a responsible person to reserve multiple dietary supplement identifier numbers in advance of listing4 7,c7 ,use requirement ,any unique dietary supplement identifier shall be used only in connection with the product for which the identifier was used during the listing process4 7#d7 ,submission dates ,a responsible person under this section shall report to the ,secretary the listing information described in paragraph 7#a7 pursuant to the following timelines3 7,a7 ,in general 7i7 ,existing dietary supplements ,in the case of a dietary supplement that is being offered in interstate commerce on the date that is #ah months after the date of enactment of the ,dietary ,supplement ,listing ,act of #bjbb1 a listing for each such dietary supplement formulation introduced or delivered for introduction into interstate commerce by the responsible person for commercial distribution shall be submitted by the responsible person with the ,secretary under this section not later than #fj days after the date that is #ah months after the date of enactment of such ,act4 7ii7 ,new dietary supplements ,in the case of a dietary supplement that is not being offered in interstate commerce on the date that is #ah months after the date of enactment4 of the ,dietary ,supplement ,listing ,act of #bjbb1 a listing for each such dietary supplement formulation introduced or delivered for introduction into interstate commerce by the responsible person for commercial distribution which has not been included in any listing previously submitted by the responsible person to the ,secretary under this section shall be submitted to the ,secretary prior to introducing the dietary supplement into interstate commerce4 7,b7 ,reformulations ,a listing of each dietary supplement formulation introduced by the responsible person for commercial distribution that has a label that differs for such dietary supplement from the representative label provided under subsection 7a7 with respect to the product name1 amount of dietary ingredients1 or other distinguishing characteristics such as dosage form 7such as pill1 capsule1 liquid1 or powder7 shall be submitted to the ,secretary not later than #ae business days after introducing the dietary supplement with the change into interstate commerce4 7,c7 ,discontinued dietary supplements ,if the responsible person has discontinued the commercial marketing of a dietary supplement formulation included in a listing submitted by the responsible person under subparagraph 7,a7 or 7,b71 the responsible person shall report to the ,secretary the date of such discontinuance1 within #ij days of the discontinuance of the dietary supplement4 7#e7 ,supplier information record keeping requirement ,each responsible person subject to the requirements of this subsection shall maintain a record of the full business name and address from which the responsible person receives any dietary ingredient or combination of dietary ingredients that the responsible person uses in the manufacture of the dietary supplement1 or1 if applicable1 from which the responsible person receives the dietary supplement4 ,the responsible person shall make this information available to the ,secretary within #gb hours of request from the ,secretary4 7c7 ,electronic database ,beginning not later than #b years after the ,secretary specifies a unique dietary supplement identifier system pursuant to subsection 7b77#c71 the ,secretary shall maintain an electronic database that-- 7#a7 is publicly accessible2 7#b7 is populated with information regarding dietary supplements that is provided under this section or any other provision of this ,act2 and 7#c7 enables the public to search the database by a dietary supplement's unique dietary supplement identifier or other field of information or combination of fields4 7d7 ,authorization of appropriations ,for purposes of conducting activities under this section and hiring personnel to carry out this section1 there are authorized to be appropriated #d1jjj1jjj for fiscal year #bjbb and #a1jjj1jjj for each of fiscal years #bjbc through #bjbf4 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 is required to file a listing under section #djc;,d and such responsible person has not made a listing 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 7fff7 ,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 7d7 ,rule of construction ,nothing in the amendments made by subsections 7a7 through subsection 7c7 shall be construed to expand the existing authorities of the ,food and ,drug ,administration1 other than as specified in such amendments4 ,this subsection shall not be construed to-- 7#a7 limit the existing authorities of the ,food and ,drug ,administration2 or 7#b7 limit the authorities specified in the amendments made by subsections 7a7 through subsection 7c74