[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 1425 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                S. 1425

 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 1, 2013

 Mr. Durbin (for himself and Mr. Blumenthal) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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)--
                                    ``(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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