,,ii #aacth ,,congress #ast ,session ,s4 #adbe ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #a1 #bjac ,mr4 ,durbin 7for himself and ,mr4 ,blumenthal7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve the safety of dietary supplements by amending the ,federal ,food1 ,drug1 and ,cosmetic ,act to require manufacturers of dietary supplements to register dietary supplements with the ,food and ,drug ,administration and to amend labeling requirements with respect to dietary supplements4 #a4 ,short title ,this ,act may be cited as the ,dietary ,supplement ,labeling ,act of #bjac4 #b4 ,regulation of dietary supplements 7a7 ,registration requirements 7#a7 ,in general ,section #dae7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;d7a77 is amended by adding at the end the following3 7#f7 ,requirements with respect to dietary supplements 7,a7 ,in general ,a facility engaged in manufacturing or processing dietary supplements that is required to register under this section shall comply with the requirements of this paragraph1 in addition to the other requirements of this section4 7,b7 ,additional information 7i7 ,in general ,a facility described in subparagraph 7,a7 shall submit a registration under paragraph 7#a7 that includes1 in addition to the information required under paragraph 7#b7-- 7,i7 a description of each dietary supplement manufactured or processed by such facility2 7,,ii7 a list of all ingredients in each such dietary supplement2 and 7,,iii7 a copy of the label for each such dietary supplement4 7ii7 ,public availability ,the ,secretary shall make the information provided under clause 7i7 publicly available1 including by posting such information on the ,internet ,web site of the ,food and ,drug ,administration4 7,c7 ,registration with respect to new1 reformulated1 and discontinued dietary supplements 7i7 ,in general ,not later than the date described in clause 7ii71 if a facility described in subparagraph 7,a7-- 7,i7 manufactures or processes a dietary supplement that the facility previously did not manufacture or process and for which the facility did not submit the information required under subclauses 7,i7 through 7,,iii7 of subparagraph 7,b77i72 7,,ii7 reformulates a dietary supplement for which the facility previously submitted the information required under subclauses 7,i7 through 7,,iii7 of subparagraph 7,b77i72 or 7,,iii7 no longer manufactures or processes a dietary supplement for which the facility previously submitted the information required under subclauses 7,i7 through 7,,iii7 of subparagraph 7,b77i71 such facility shall submit to the ,secretary an updated registration describing the change described in subclause 7,i71 7,,ii71 or 7,,iii7 and1 in the case of a facility described in subclause 7,i7 or 7,,ii71 containing the information required under subclauses 7,i7 through 7,,iii7 of subparagraph 7,b77i74 7ii7 ,date described ,the date described in this clause is-- 7,i7 in the case of a facility described in subclause 7,i7 of clause 7i71 #cj days after the date on which such facility first markets the dietary supplement described in such subclause2 7,,ii7 in the case of a facility described in subclause 7,,ii7 of clause 7i71 #cj days after the date on which such facility first markets the reformulated dietary supplement described in such subclause2 or 7,,iii7 in the case of a facility described in subclause 7,,iii7 of clause 7i71 #cj days after the date on which such facility removes the dietary supplement described in such subclause from the market4 4 7#b7 ,enforcement ,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 facility is required to submit the registration information required under section #dae7;a77#f7 and such facility has not complied with the requirements of such section #dae7;a77#f7 with respect to such dietary supplement4 4 7b7 ,labeling 7#a7 ,establishment of labeling requirements ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by inserting after section #daa the following3 #daa;,a4 ,dietary supplements 7a7 ,dietary supplement ingredients ,not later than #a year after the date of enactment of the ,dietary ,supplement ,labeling ,act of #bjac1 the ,secretary shall compile a list of dietary supplement ingredients and proprietary blends of ingredients that the ,secretary determines could cause potentially serious adverse events1 drug interactions1 or contraindications1 or potential risks to subgroups such as children and pregnant or breastfeeding women4 7b7 ,,iom study ,the ,secretary shall seek to enter into a contract with the ,institute of ,medicine under which the ,institute of ,medicine shall evaluate dietary supplement ingredients and proprietary blends of ingredients1 including those on the list compiled by the ,secretary under subsection 7a71 and scientific literature on dietary supplement ingredients and1 not later than #ah months after the date of enactment of the ,dietary ,supplement ,labeling ,act of #bjac1 submit to the ,secretary a report evaluating the safety of dietary supplement ingredients and proprietary blends of ingredients the ,institute of ,medicine determines could cause potentially serious adverse events1 drug interactions1 or contraindications1 or potential risks to subgroups such as children and pregnant or breastfeeding women4 7c7 ,establishment of requirements ,not later than #b years after the date on which the ,institute of ,medicine issues the report under subsection 7b71 the ,secretary1 after providing for public notice and comment and taking into consideration such report1 shall-- 7#a7 establish mandatory warning label requirements for dietary supplement ingredients that the ,secretary determines to cause potentially serious adverse events1 drug interactions1 or contraindications1 or potential risks to subgroups2 and 7#b7 identify proprietary blends of ingredients for which1 because of potentially serious adverse events1 drug interactions1 or contraindications1 or potential risks to subgroups such as children and pregnant or breastfeeding women1 the weight per serving of the ingredient in the proprietary blend shall be provided on the label4 7d7 ,updates ,as appropriate1 the ,secretary1 after providing for public notice and comment1 shall update-- 7#a7 the list compiled under subsection 7a72 7#b7 the mandatory warning label requirements established under paragraph 7#a7 of subsection 7c72 and 7#c7 the requirements under paragraph 7#b7 of subsection 7c74 4 7#b7 ,enforcement ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended-- 7,a7 in paragraph 7q77#e77;,f77ii71 by inserting 1 and for each proprietary blend identified by the ,secretary under section #daa;,a7c77#b71 the weight of such proprietary blend1 after ingredients72 and 7,b7 in paragraph 7s77#b7-- 7i7 in clause 7,a77ii77,,ii71 by inserting 1 and for each proprietary blend identified by the ,secretary under section #daa;,a7c77#b71 the weight of each such proprietary blend per serving before the semicolon at the end2 7ii7 in clause 7,d77iii71 by striking or at the end2 7iii7 in clause 7,e77ii77,,ii71 by striking the period at the end and inserting a semicolon2 and 7iv7 by adding at the end the following3 7,f7 the label does not include information with respect to potentially serious adverse events1 drug interactions1 or contraindications1 or potential risks to subgroups such as children and pregnant or breastfeeding women1 as required under section #daa;,a7c77#a72 or 7,g7 the label does not include the batch number4 4 7c7 ,structure and function claims ,section #djc7r77#f77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7r77#f77;,b77 is amended by inserting 1 and provides such substantiation to the ,secretary1 as the ,secretary may require after misleading4 7d7 ,conventional foods ,the ,secretary of ,health and ,human ,services1 not later than #a year after the date of enactment of this ,act and after providing for public notice and comment1 shall establish a definition for the term conventional food for purposes of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 ,such definition shall take into account conventional foods marketed as dietary supplements1 including products marketed as dietary supplements that simulate conventional foods4