[Congressional Record Volume 159, Number 113 (Thursday, August 1, 2013)]
[Senate]
[Pages S6216-S6217]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Blumenthal):
  S. 1425. A bill to improve the safety of dietary supplements by 
amending the Federal Food, Drug, 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 supplements; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1425

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Dietary Supplement Labeling 
     Act of 2013''.

     SEC. 2. REGULATION OF DIETARY SUPPLEMENTS.

       (a) Registration Requirements.--
       (1) In general.--Section 415(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 350d(a)) is amended by adding at 
     the end the following:
       ``(6) Requirements with respect to dietary supplements.--
       ``(A) 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 
     paragraph, in addition to the other requirements of this 
     section.
       ``(B) Additional information.--
       ``(i) In general.--A facility described in subparagraph (A) 
     shall submit a registration under paragraph (1) that 
     includes, in addition to the information required under 
     paragraph (2)--

[[Page S6217]]

       ``(I) a description of each dietary supplement manufactured 
     or processed by such facility;
       ``(II) a list of all ingredients in each such dietary 
     supplement; and
       ``(III) a copy of the label for each such dietary 
     supplement.

       ``(ii) Public availability.--The Secretary shall make the 
     information provided under clause (i) publicly available, 
     including by posting such information on the Internet Web 
     site of the Food and Drug Administration.
       ``(C) Registration with respect to new, reformulated, and 
     discontinued dietary supplements.--
       ``(i) In general.--Not later than the date described in 
     clause (ii), if a facility described in subparagraph (A)--

       ``(I) 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 (I) through (III) of subparagraph 
     (B)(i);
       ``(II) reformulates a dietary supplement for which the 
     facility previously submitted the information required under 
     subclauses (I) through (III) of subparagraph (B)(i); or
       ``(III) no longer manufactures or processes a dietary 
     supplement for which the facility previously submitted the 
     information required under subclauses (I) through (III) of 
     subparagraph (B)(i),

     such facility shall submit to the Secretary an updated 
     registration describing the change described in subclause 
     (I), (II), or (III) and, in the case of a facility described 
     in subclause (I) or (II), containing the information required 
     under subclauses (I) through (III) of subparagraph (B)(i).
       ``(ii) Date described.--The date described in this clause 
     is--

       ``(I) in the case of a facility described in subclause (I) 
     of clause (i), 30 days after the date on which such facility 
     first markets the dietary supplement described in such 
     subclause;
       ``(II) in the case of a facility described in subclause 
     (II) of clause (i), 30 days after the date on which such 
     facility first markets the reformulated dietary supplement 
     described in such subclause; or
       ``(III) in the case of a facility described in subclause 
     (III) of clause (i), 30 days after the date on which such 
     facility removes the dietary supplement described in such 
     subclause from the market.''.

       (2) Enforcement.--Section 403 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 343) is amended by adding at the 
     end the following:
       ``(z) If it is a dietary supplement for which a facility is 
     required to submit the registration information required 
     under section 415(a)(6) and such facility has not complied 
     with the requirements of such section 415(a)(6) with respect 
     to such dietary supplement.''.
       (b) Labeling.--
       (1) Establishment of labeling requirements.--Chapter IV of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et 
     seq.) is amended by inserting after section 411 the 
     following:

     ``SEC. 411A. DIETARY SUPPLEMENTS.

       ``(a) Dietary Supplement Ingredients.--Not later than 1 
     year after the date of enactment of the Dietary Supplement 
     Labeling Act of 2013, the Secretary shall compile a list of 
     dietary supplement ingredients and proprietary blends of 
     ingredients that the Secretary determines could cause 
     potentially serious adverse events, drug interactions, or 
     contraindications, or potential risks to subgroups such as 
     children and pregnant or breastfeeding women.
       ``(b) 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 ingredients, including 
     those on the list compiled by the Secretary under subsection 
     (a), and scientific literature on dietary supplement 
     ingredients and, not later than 18 months after the date of 
     enactment of the Dietary Supplement Labeling Act of 2013, 
     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 events, drug interactions, or 
     contraindications, or potential risks to subgroups such as 
     children and pregnant or breastfeeding women.
       ``(c) Establishment of Requirements.--Not later than 2 
     years after the date on which the Institute of Medicine 
     issues the report under subsection (b), the Secretary, after 
     providing for public notice and comment and taking into 
     consideration such report, shall--
       ``(1) establish mandatory warning label requirements for 
     dietary supplement ingredients that the Secretary determines 
     to cause potentially serious adverse events, drug 
     interactions, or contraindications, or potential risks to 
     subgroups; and
       ``(2) identify proprietary blends of ingredients for which, 
     because of potentially serious adverse events, drug 
     interactions, or contraindications, or potential risks to 
     subgroups such as children and pregnant or breastfeeding 
     women, the weight per serving of the ingredient in the 
     proprietary blend shall be provided on the label.
       ``(d) Updates.--As appropriate, the Secretary, after 
     providing for public notice and comment, shall update--
       ``(1) the list compiled under subsection (a);
       ``(2) the mandatory warning label requirements established 
     under paragraph (1) of subsection (c); and
       ``(3) the requirements under paragraph (2) of subsection 
     (c).''.
       (2) Enforcement.--Section 403 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 343) is amended--
       (A) in paragraph (q)(5)(F)(ii), by inserting ``, and for 
     each proprietary blend identified by the Secretary under 
     section 411A(c)(2), the weight of such proprietary blend,'' 
     after ``ingredients)''; and
       (B) in paragraph (s)(2)--
       (i) in clause (A)(ii)(II), by inserting ``, and for each 
     proprietary blend identified by the Secretary under section 
     411A(c)(2), the weight of each such proprietary blend per 
     serving'' before the semicolon at the end;
       (ii) in clause (D)(iii), by striking ``or'' at the end;
       (iii) in clause (E)(ii)(II), by striking the period at the 
     end and inserting a semicolon; and
       (iv) by adding at the end the following:
       ``(F) the label does not include information with respect 
     to potentially serious adverse events, drug interactions, or 
     contraindications, or potential risks to subgroups such as 
     children and pregnant or breastfeeding women, as required 
     under section 411A(c)(1); or
       ``(G) the label does not include the batch number.''.
       (c) Structure and Function Claims.--Section 403(r)(6)(B) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     343(r)(6)(B)) is amended by inserting ``, and provides such 
     substantiation to the Secretary, as the Secretary may 
     require'' after ``misleading''.
       (d) Conventional Foods.--The Secretary of Health and Human 
     Services, not later than 1 year after the date of enactment 
     of this Act and after providing for public notice and 
     comment, shall establish a definition for the term 
     ``conventional food'' for purposes of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.). Such definition 
     shall take into account conventional foods marketed as 
     dietary supplements, including products marketed as dietary 
     supplements that simulate conventional foods.
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