1.This Act may be cited as
the Dietary Supplement Labeling Act of
2011
.
2.Regulation of
dietary supplements
(a)
(1)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)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)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)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)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)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)
(1)Establishment
of labeling requirementsChapter 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:
411A.
(a)Dietary
supplement ingredientsNot 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)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 requirementsNot 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)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)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)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.