[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1310 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1310

 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 supplement products with the Food and 
Drug Administration and to amend labeling requirements with respect to 
                          dietary supplements.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 30, 2011

  Mr. Durbin 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 supplement products 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 
2011''.

SEC. 2. REGULATION OF DIETARY SUPPLEMENTS.

    (a) Registration.--
            (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 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.--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 product manufactured by such 
                        facility;
                            ``(ii) a list of all ingredients in each 
                        such dietary supplement product; and
                            ``(iii) a copy of the label and labeling 
                        for each such product.
                    ``(C) Registration with respect to new, 
                reformulated, and discontinued dietary supplement 
                products.--
                            ``(i) In general.--Not later than the date 
                        described in clause (ii), if a facility 
                        described in subparagraph (A)--
                                    ``(I) manufactures a dietary 
                                supplement product that the facility 
                                previously did not manufacture and for 
                                which the facility did not submit the 
                                information required under clauses (i) 
                                through (iii) of subparagraph (B);
                                    ``(II) reformulates a dietary 
                                supplement product for which the 
                                facility previously submitted the 
                                information required under clauses (i) 
                                through (iii) of subparagraph (B); or
                                    ``(III) no longer manufactures a 
                                dietary supplement for which the 
                                facility previously submitted the 
                                information required under clauses (i) 
                                through (iii) of subparagraph (B),
                        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 clauses (i) through 
                        (iii) of subparagraph (B).
                            ``(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 product 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 product 
                                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 product 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 2011, 
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, 
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 2011, 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, 
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, 
        contraindications, or potential risks to subgroups; and
            ``(2) identify proprietary blends of ingredients for which, 
        because of potentially serious adverse events, drug 
        interactions, 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 subsection (q)(5)(F)(ii), by inserting ``, 
                and for each proprietary blend identified by the 
                Secretary under section 411A(c)(1)(B), the weight of 
                such proprietary blend,'' after ``ingredients)''; and
                    (B) in subsection (s)(2)--
                            (i) in subparagraph (A)(ii)(II), by 
                        inserting ``, and for each proprietary blend 
                        identified by the Secretary under section 
                        411A(c)(1)(B), the weight of each such 
                        proprietary blend per serving'' before the 
                        semicolon at the end;
                            (ii) in subparagraph (D)(iii), by striking 
                        ``or'' at the end;
                            (iii) in subparagraph (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 or labeling does not include 
                information with respect to potentially serious adverse 
                events, drug interactions, contraindications, or 
                potential risks to subgroups such as children and 
                pregnant or breastfeeding women, as required under 
                section 411A(c); or
                    ``(G) the label does not include the batch 
                number.''.
    (c) 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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