[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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