[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3002 Introduced in Senate (IS)]
111th CONGRESS
2d Session
S. 3002
To amend the Federal Food, Drug, and Cosmetic Act to more effectively
regulate dietary supplements that may pose safety risks unknown to
consumers.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 4, 2010
Mr. McCain (for himself and Mr. Dorgan) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to more effectively
regulate dietary supplements that may pose safety risks unknown to
consumers.
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 Safety Act of
2010''.
SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
``(ss) Dietary Supplement Facility.--The term `dietary supplement
facility' means any business or operation engaged in manufacturing,
packaging, holding, distributing, labeling, or licensing a dietary
supplement for consumption in the United States.''.
(b) Registration of Dietary Supplement Facilities.--
(1) Adulterated food.--Section 402 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342) is amended by inserting
at the end the following:
``(j) If it is a dietary supplement that is manufactured, packaged,
held, distributed, labeled, or licensed by a dietary supplement
facility that is not registered with the Secretary.''.
(2) Registration of food facilities.--Section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is
amended--
(A) in the section heading, by striking
``facilities'' and inserting ``and dietary supplement
facilities''; and
(B) in subsection (a)--
(i) in paragraph (2)--
(I) by striking ``An entity'' and
inserting the following:
``(A) Food facilities.--An entity''; and
(II) by adding at the end the
following:
``(B) Dietary supplement facilities.--
``(i) In general.--A dietary supplement
facility (referred to in the section as a
`dietary supplement registrant') shall submit a
registration under paragraph (1) to the
Secretary containing information necessary to
notify the Secretary of the name and address of
each facility at which, and all trade names
under which, the dietary supplement registrant
conducts business. At the time of registration,
the dietary supplement registrant shall also
file with the Secretary a list of all dietary
supplements manufactured, packaged, held,
distributed, labeled, or licensed by the
facility. Such list shall be prepared in such
form and manner as the Secretary may prescribe,
and shall be accompanied by a full list of the
ingredients contained in each dietary
supplement, and a copy of the labeling used by
the facility for each dietary supplement.
``(ii) Updates.--Each dietary supplement
registrant shall update the registrant's
registration annually on or before the
anniversary date of the registrant's initial
registration. Each dietary supplement
registrant shall also update the registrant's
registration to include information regarding
any new dietary supplement, or reformulation of
an existing dietary supplement, on or before
the date such dietary supplement is marketed
for consumption in the United States.''; and
(ii) in paragraph (3), by inserting ``or
dietary supplement registrant'' after ``notify
the registrant''.
(c) New Dietary Ingredients.--Section 413 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350b) is amended--
(1) by striking subsection (a) and inserting the following:
``(a) In General.--A dietary supplement which contains a new
dietary ingredient shall be deemed adulterated under section 402(f)
unless there is a history of use or other evidence of safety
establishing that the dietary ingredient when used under the conditions
recommended or suggested in the labeling of the dietary supplement will
reasonably be expected to be safe and, at least 75 days before being
introduced or delivered for introduction into interstate commerce, the
manufacturer or distributor of the dietary ingredient or dietary
supplement provides the Secretary with information, including any
citation to published articles, which is the basis on which the
manufacturer or distributor has concluded that a dietary supplement
containing such dietary ingredient will reasonably be expected to be
safe. The Secretary shall keep confidential any information provided
under this subsection for 90 days following its receipt. After the
expiration of such 90 days, the Secretary shall place such information
on public display, except matters in the information which are trade
secrets or otherwise confidential, commercial information.'';
(2) in subsection (c), by striking ``was not marketed in
the United States before October 15, 1994 and does not include
any dietary ingredient which was marketed in the United States
before October 15, 1994'' and inserting ``is not included on
the list of `Accepted Dietary Ingredients', to be prepared,
published, and maintained by the Secretary''; and
(3) by adding at the end the following:
``(d) Maintaining Substantiation File.--Any person submitting
information to the Secretary under subsection (a) shall create and
maintain a scientifically reasonable substantiation file relating to
the claim that the dietary ingredient or dietary supplement will
reasonably be expected to be safe. The substantiation file shall be
prepared and maintained in such form and manner as the Secretary may
prescribe and shall be available for review and inspection by the
Secretary upon request.
``(e) Evidence of Compliance.--A dietary supplement facility or
retailer shall, prior to manufacturing, packaging, holding,
distributing, labeling, or licensing the dietary supplement, obtain
adequate written evidence from the preceding responsible entity in the
chain of commerce that the product is registered as required by section
415 and that the requirements of subsection (a) have been met. Such
facility or retailer shall maintain such evidence of compliance for
review and inspection by the Secretary upon request.''.
(d) Civil Monetary Penalty for Non-Compliance.--Section 303 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by
adding at the end the following:
``(h) Civil Monetary Penalty for Non-Compliance.--Notwithstanding
the provisions of subsection (a), any person who manufacturers,
packages, holds, distributes, labels, or licenses a dietary supplement
in violation of section 301, 402, 413, 415, 501, 502, 505, or 761, may,
in addition to other penalties imposed in this section, be fined not
more than twice the gross profits or other proceeds derived from the
manufacture, packaging, holding, distribution, labeling, or license of
such dietary supplement.''.
(e) Adverse Event Reporting for Dietary Supplements.--Section 761
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379aa-1) is
amended--
(1) in the section heading, by striking ``serious adverse''
and inserting ``adverse'';
(2) in subsection (a), by adding at the end the following:
``(4) Adverse event report.--The term `adverse event
report' means a report of non-serious adverse events that is
required to be submitted to the Secretary under subsection
(b).'';
(3) in subsection (b)(1)--
(A) by striking ``The manufacturer'' and inserting
the following:
``(A) Serious adverse events.--The manufacturer'';
and
(B) by adding at the end the following:
``(B) Non-serious adverse events.--The
manufacturer, packer, holder, distributor, labeler, or
licensee of a dietary supplement, whose name appears on
the label of a dietary supplement marketed in the
United States, shall submit to the Secretary, in such
form and manner as the Secretary shall determine, a
compilation report of all non-serious adverse events
associated with such dietary supplement when used in
the United States, accompanied by a copy of the label
on or within the retail packaging of such dietary
supplement.'';
(4) in subsection (c)(1), by adding at the end: ``The
responsible person shall annually submit to the Secretary a
compilation report of all non-serious adverse events received
during the preceding year.'';
(5) in subsection (e)(1), by adding at the end: ``The
responsible person shall maintain records related to each
annually submitted adverse event report for a period of 3
years.''; and
(6) in subsection (f), by striking ``or an adverse event
report voluntarily submitted'' and inserting ``or a non-serious
adverse report submitted annually''.
(f) Recall Authority for Dietary Supplements.--
(1) In general.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following:
``SEC. 418. RECALL AUTHORITY FOR DIETARY SUPPLEMENTS.
``(a) Recall Authority.--
``(1) Cease distribution and notification order.--
``(A) In general.--If the Secretary finds there is
a reasonable probability that a dietary supplement or a
product marketed or sold as a dietary supplement would
cause serious, adverse health consequences or death, or
is adulterated or misbranded, the Secretary shall issue
a cease distribution and notification order requiring
the person named in the order to immediately--
``(i) cease distribution of such dietary
supplement or a product marketed or sold as a
dietary supplement;
``(ii) notify distributors, importers,
retailers, and consumers of the order; and
``(iii) instruct those distributors,
importers, retailers, and consumers to cease
distributing, importing, selling, and using the
dietary supplement.
``(B) Informal hearing.--An order described in
subparagraph (A) shall provide the person subject to
the order with an opportunity for an informal hearing,
to be held not later than 10 days after the date of the
issuance of the order, on the actions required by the
order and on whether the order should be amended to
require a recall of the dietary supplement or the
product marketed or sold as a dietary supplement. The
person subject to the order shall have 5 days to notify
the Secretary of the person's intent to challenge the
order. If, after providing an opportunity for such a
hearing, the Secretary determines that inadequate
grounds exist to support the actions required by the
order, the Secretary shall vacate the order.
``(2) Recall.--
``(A) In general.--If, after providing an
opportunity for an informal hearing under paragraph
(1), the Secretary determines that the order should be
amended to include a recall of the dietary supplement
or the product marketed or sold as a dietary supplement
with respect to which the order was issued, the
Secretary shall, except as provided in subparagraphs
(B) and (C), amend the order to require a recall. The
Secretary shall specify a timetable in which the
dietary supplement recall will occur and shall require
periodic reports to the Secretary describing the
progress of the recall. The Secretary shall have the
authority to initiate the action prescribed in this
subparagraph regardless of whether or not the person
subject to the order elects to exercise the right to
challenge the initial order as permitted under
paragraph (1).
``(B) Content of amended order.--An amended order
under subparagraph (A)--
``(i) shall not include recall of the
dietary supplement or the product marketed or
sold as a dietary supplement from individuals;
and
``(ii) shall provide for notice to
individuals, at the expense of retailers and to
the satisfaction of the Secretary, subject to
the risks associated with the use of such
dietary supplement.
``(C) Notification.--In providing the notice
required by subparagraph (B)(ii), if a significant
number of such individuals cannot be identified, the
Secretary shall notify such individuals pursuant to
section 705(b).''.
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