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[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).''.
                                 <all>
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