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[House Report 114-371]
[From the U.S. Government Publishing Office]

114th Congress }                                               { Report
                        HOUSE OF REPRESENTATIVES
 1st Session   }                                               { 114-371

======================================================================

 
                   MICROBEAD-FREE WATERS ACT OF 2015

                                _______
                                

December 7, 2015.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1321]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1321) to prohibit the sale or distribution of 
cosmetics containing synthetic plastic microbeads, having 
considered the same, report favorably thereon with amendments 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     3
Committee Consideration..........................................     3
Committee Votes..................................................     3
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     4
Committee Cost Estimate..........................................     4
Congressional Budget Office Estimate.............................     4
Federal Mandates Statement.......................................     5
Duplication of Federal Programs..................................     5
Disclosure of Directed Rule Makings..............................     5
Advisory Committee Statement.....................................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     6

    The amendments areas follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Microbead-Free Waters Act of 2015''.

SEC. 2. PROHIBITION AGAINST SALE OR DISTRIBUTION OF RINSE-OFF COSMETICS 
                    CONTAINING PLASTIC MICROBEADS.

  (a) In General.--Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331) is amended by adding at the end the following:
  ``(ddd)(1) The manufacture or the introduction or delivery for 
introduction into interstate commerce of a rinse-off cosmetic that 
contains intentionally-added plastic microbeads.
  ``(2) In this paragraph--
          ``(A) the term `plastic microbead' means any solid plastic 
        particle that is less than five millimeters in size and is 
        intended to be used to exfoliate or cleanse the human body or 
        any part thereof; and
          ``(B) the term `rinse-off cosmetic' includes toothpaste.''.
  (b) Applicability.--
          (1) In general.--The amendment made by subsection (a) 
        applies--
                  (A) with respect to manufacturing, beginning on July 
                1, 2017, and with respect to introduction or delivery 
                for introduction into interstate commerce, beginning on 
                July 1, 2018; and
                  (B) notwithstanding subparagraph (A), in the case of 
                a rinse-off cosmetic that is a nonprescription drug, 
                with respect to manufacturing, beginning on July 1, 
                2018, and with respect to the introduction or delivery 
                for introduction into interstate commerce, beginning on 
                July 1, 2019.
          (2) Nonprescription drug.--For purposes of this subsection, 
        the term ``nonprescription drug'' means a drug not subject to 
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 353(b)(1)).
  (c) Preemption of State Laws.--No State or political subdivision of a 
State may directly or indirectly establish under any authority or 
continue in effect restrictions with respect to the manufacture or 
introduction or delivery for introduction into interstate commerce of 
rinse-off cosmetics containing plastic microbeads (as defined in 
section 301(ddd) of the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (a)) that are not identical to the restrictions under 
such section 301(ddd) that have begun to apply under subsection (b).
  (d) Rule of Construction.--Nothing in this Act (or the amendments 
made by this Act) shall be construed to apply with respect to drugs 
that are not also cosmetics (as such terms are defined in section 201 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)).

  Amend the title so as to read: A bill to amend the Federal 
Food, Drug, and Cosmetic Act to prohibit the manufacture and 
introduction or delivery for introduction into interstate 
commerce of rinse-off cosmetics containing intentionally-added 
plastic microbeads.

                          Purpose and Summary

    The purpose of H.R. 1321 is to ban plastic microbeads from 
rinse off cosmetic products to prevent them from getting into 
waterways across the United States. The legislation also will 
preempt State and local laws related to plastic microbeads in 
rinse off cosmetics. State and local governments have created a 
patchwork of differing laws, which creates problems for 
interstate commerce. Preemption will ensure certainty for 
manufacturers and other job creators across the country.

                  Background and Need for Legislation

    Plastic Microbeads, commonly made of ``polyethylene'' or 
``polypropylene,'' are synthetic plastic particles that are 
used as an abrasive in many personal-care products, such as 
face wash, body wash, soaps, shampoos, and toothpaste. 
Microbeads are too small to be filtered out by most sewer 
treatment facilities and make their way into our waterways and 
wildlife. Microbeads can absorb chemicals commonly found in 
waterways and become large enough that they are mistaken for 
food by small fish and wildlife.
    Many manufacturers are voluntarily phasing out the use of 
microbeads because of their environmental impact. To date, nine 
States have enacted microbeads legislation. An additional 
fifteen States are considering or have pending microbeads 
legislation.
    H.R. 1321 would prohibit the manufacture, sale, or 
distribution of personal care products, including toothpaste, 
containing plastic microbeads beginning on July 1, 2017.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 1321 on 
May 1, 2015. The Subcommittee received testimony from:
           Dan Wyant, Director, Michigan Department of 
        Environmental Quality;
           Linda R. Greenstein, Senator, New Jersey 
        Legislature;
           Molly Flanagan, Alliance for the Great 
        Lakes; and
           John Hurson, Executive Vice President of 
        Government Relations, Personal Care Products Council.

                        Committee Consideration

    On May 14, 2015, the Subcommittee on Health met in open 
markup session and forwarded H.R. 1321 to the full Committee, 
without amendment, by a voice vote. On November 17 and 18, 
2015, the full Committee on Energy and Commerce met in open 
markup session and ordered H.R. 1321 reported to the House, as 
amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 1321 reported.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a hearing and made 
findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objective of H.R. 1321 is to stop the use of plastic 
microbeads in rinse off cosmetics to prevent them from entering 
waterways.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
1321 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 1321 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, December 4, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1321, the 
Microbead-Free Waters Act of 2015.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                                        Keith Hall.
    Enclosure.

H.R. 1321--Microbead-Free Waters Act of 2015

    H.R. 1321 would amend the Federal Food, Drug, and Cosmetic 
Act to prohibit the manufacture, sale, or distribution of 
cosmetics containing plastic microbeads. CBO estimates that 
implementing H.R. 1321 would have no significant cost to the 
federal government. Enacting the bill would not affect direct 
spending or revenues; therefore, pay-as-you-go procedures do 
not apply. CBO estimates that enacting H.R. 1321 would not 
increase net direct spending or on-budget deficits in any of 
the four consecutive 10-year periods beginning in 2026.
    The prohibition in the bill would impose an 
intergovernmental and private sector mandate as defined in the 
Unfunded Mandates Reform Act (UMRA). The mandate would affect 
distributors, sellers, and manufacturers of cosmetic products 
containing plastic microbeads. In addition, the bill would 
impose a separate intergovernmental mandate by preempting state 
laws.
    CBO estimates that the cost of the mandate on distributors 
and sellers, including some public entities, would be minimal, 
if any, because the bill would provide those sellers with one 
year to sell any existing stock. Affected public entities would 
include a small number of pharmacies operating in public 
hospitals and some university-affiliated retail stores. While 
the legislation also would preempt several states' laws, it 
would impose no duty on states that would result in additional 
spending or a loss of revenues. Taken together, CBO estimates 
that the aggregate costs, if any, of the intergovernmental 
mandates would fall well below the threshold established in 
UMRA for such mandates ($77 million in 2015, adjusted annually 
for inflation).
    Currently, many manufacturers of cosmetics have committed 
to removing microbeads from their products either on a 
voluntary basis or to comply with prohibitions enacted by 
states and localities. During the next few years, CBO expects 
that the incremental cost for those manufacturers to comply 
with the mandate in the bill would be minimal, if any. However, 
other manufacturers may need to reformulate their products or 
remove them from the market to comply with the mandate. Based 
on information from industry sources, CBO estimates that the 
cost of reformulating a cosmetic could total several million 
dollars and that the potential loss of income from removing a 
cosmetic from the market might be larger. Because the larger 
manufacturers of cosmetics have already announced plans to 
remove microbeads, CBO expects that only a small portion of the 
industry would need to take additional action to comply with 
the mandate. Further, some manufacturers also would experience 
savings because the bill would establish a uniform national 
standard that would preempt state and local laws, some of which 
are more stringent or have earlier deadlines than required 
under the bill. Consequently, CBO estimates that the net cost 
of the mandate would probably fall below the annual threshold 
established in UMRA for private-sector mandates ($154 million, 
adjusted annually for inflation).
    The CBO staff contacts for this estimate are Ellen Werble 
(for federal costs), J'nell Blanco Suchy (for intergovernmental 
mandates), and Amy Petz (for private-sector mandates). The 
estimate was approved by Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 1321 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 1321 
specifically directs to be completed no rule making within the 
meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    This section provides the short title of ``Microbead-Free 
Waters Act of 2015''.

Section 2. Prohibition against sale or distribution of rinse-off 
        cosmetics containing plastic microbeads

    Subsection (a) would provide that the manufacture or the 
introduction or delivery for introduction into interstate 
commerce of a rinse-off cosmetic that contains intentionally-
added plastic microbeads is a prohibited act under section 301 
of the Federal Food, Drug and Cosmetic Act (FFDCA). This 
section also defines the terms ``plastic microbead'' and 
``rinse-off cosmetic.''
    Subsection (b) would establish effective dates for the 
prohibition in subsection (a). Additional time is provided for 
over-the-counter products that make cosmetic claims because of 
the Food and Drug Administration's testing requirements for 
reformulations.
    Subsection (c) would preempt State and local laws regarding 
the manufacture, introduction, or delivery of rinse-off 
cosmetics containing plastic microbeads into interstate 
commerce.
    Subsection (d) would clarify that H.R. 1321 does not apply 
to drugs that are not also cosmetics, as defined in section 201 
of the FFDCA.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) The introduction or delivery for introduction into 
interstate commerce of any food, drug, device, tobacco product, 
or cosmetic that is adulterated or misbranded.
  (b) The adulteration or misbranding of any food, drug, 
device, tobacco product, or cosmetic in interstate commerce.
  (c) The receipt in interstate commerce of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded, and the delivery or proffered delivery thereof for 
pay or otherwise.
  (d) The introduction or delivery for introduction into 
interstate commerce of any article in violation of section 404, 
415, 505, or 564.
  (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 417(j), 416, 504, 564, 703, 
704(a), 760, or 761; or the failure to establish or maintain 
any record, or make any report, required under section 412, 
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j), 
(l) or (m), 572(i), 515(f), 519, 564, 760, 761, 909, or 920 or 
the refusal to permit access to or verification or copying of 
any such required record; or the violation of any recordkeeping 
requirement under section 204 of the FDA Food Safety 
Modernization Act (except when such violation is committed by a 
farm).
  (f) The refusal to permit entry or inspection as authorized 
by section 704.
  (g) The manufacture within any Territory of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded.
  (h) The giving of a guaranty or undertaking referred to in 
section 303(c)(2), which guaranty or undertaking is false, 
except by a person who relied upon a guaranty or undertaking to 
the same effect signed by, and containing the name and address 
of, the person residing in the United States from whom he 
received in good faith the food, drug, device, tobacco product, 
or cosmetic; or the giving of a guaranty or undertaking 
referred to in section 303(c)(3), which guaranty or undertaking 
is false.
  (i)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification device authorized or 
required by regulations promulgated under the provisions of 
section 404 or 721.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other thing designed to print, imprint, or reproduce 
the trademark, trade name, or other identifying mark, imprint, 
or device of another or any likeness of any of the foregoing 
upon any drug or container or labeling thereof so as to render 
such drugs a counterfeit drug.
  (3) The doing of any act which causes a drug to be a 
counterfeit drug, or the sale or dispensing, or the holding for 
sale or dispensing, of a counterfeit drug.
  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 414, 505, 510, 512, 
513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708, 
721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any 
method or process which as a trade secret is entitled to 
protection; or the violating of section 408(i)(2) or any 
regulation issued under that section.. This paragraph does not 
authorize the withholding of information from either House of 
Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.
  (k) The alteration, mutilation, destruction, obliteration, or 
removal of the whole or any part of the labeling of, or the 
doing of any other act with respect to, a food, drug, device, 
tobacco product, or cosmetic, if such act is done while such 
article is held for sale (whether or not the first sale) after 
shipment in interstate commerce and results in such article 
being adulterated or misbranded.
  (m) The sale or offering for sale of colored oleomargarine or 
colored margarine, or the possession or serving of colored 
oleomargarine or colored margarine in violation of section 
407(b) or 407(c).
  (n) The using, in labeling, advertising or other sales 
promotion of any reference to any report or analysis furnished 
in compliance with section 704.
  (o) In the case of a prescription drug distributed or offered 
for sale in interstate commerce, the failure of the 
manufacturer, packer, or distributor thereof to maintain for 
transmittal, or to transmit, to any practitioner licensed by 
applicable State law to administer such drug who makes written 
request for information as to such drug, true and correct 
copies of all printed matter which is required to be included 
in any package in which that drug is distributed or sold, or 
such other printed matter as is approved by the Secretary. 
Nothing in this paragraph shall be construed to exempt any 
person from any labeling requirement imposed by or under other 
provisions of this Act.
  (p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a 
notice required by section 510(j)(2) or 905(i)(3).
  (q)(1) The failure or refusal--
          (A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b), 907, 908, or 915;
          (B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 
        904, 909, or 920; or
          (C) to comply with a requirement under section 522 or 
        913.
  (2) With respect to any device or tobacco product, the 
submission of any report that is required by or under this Act 
that is false or misleading in any material respect.
  (r) The movement of a device or tobacco product in violation 
of an order under section 304(g) or the removal or alteration 
of any mark or label required by the order to identify the 
device or tobacco product as detained.
  (s) The failure to provide the notice required by section 
412(c) or 412(e), the failure to make the reports required by 
section 412(f)(1)(B), the failure to retain the records 
required by section 412(b)(4), or the failure to meet the 
requirements prescribed under section 412(f)(3).
  (t) The importation of a drug in violation of section 
801(d)(1), the sale, purchase, or trade of a drug or drug 
sample or the offer to sell, purchase, or trade a drug or drug 
sample in violation of section 503(c), the sale, purchase, or 
trade of a coupon, the offer to sell, purchase, or trade such a 
coupon, or the counterfeiting of such a coupon in violation of 
section 503(c)(2), the distribution of a drug sample in 
violation of section 503(d) or the failure to otherwise comply 
with the requirements of section 503(d), the distribution of 
drugs in violation of section 503(e), failure to comply with 
the requirements under section 582, the failure to comply with 
the requirements under section 584, as applicable, or the 
failure to otherwise comply with the requirements of section 
503(e).
  (u) The failure to comply with any requirements of the 
provisions of, or any regulations or orders of the Secretary, 
under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
  (v) The introduction or delivery for introduction into 
interstate commerce of a dietary supplement that is unsafe 
under section 413.
  (w) The making of a knowingly false statement in any 
statement, certificate of analysis, record, or report required 
or requested under section 801(d)(3); the failure to submit a 
certificate of analysis as required under such section; the 
failure to maintain records or to submit records or reports as 
required by such section; the release into interstate commerce 
of any article or portion thereof imported into the United 
States under such section or any finished product made from 
such article or portion, except for export in accordance with 
section 801(e) or 802, or with section 351(h) of the Public 
Health Service Act; or the failure to so export or to destroy 
such an article or portions thereof, or such a finished 
product.
  (x) The falsification of a declaration of conformity 
submitted under section 514(c) or the failure or refusal to 
provide data or information requested by the Secretary under 
paragraph (3) of such section.
  (y) In the case of a drug, device, or food--
          (1) the submission of a report or recommendation by a 
        person accredited under section 523 that is false or 
        misleading in any material respect;
          (2) the disclosure by a person accredited under 
        section 523 of confidential commercial information or 
        any trade secret without the express written consent of 
        the person who submitted such information or secret to 
        such person; or
          (3) the receipt by a person accredited under section 
        523 of a bribe in any form or the doing of any corrupt 
        act by such person associated with a responsibility 
        delegated to such person under this Act.
  (z) The dissemination of information in violation of section 
551.
  (aa) The importation of a prescription drug in violation of 
section 804, the falsification of any record required to be 
maintained or provided to the Secretary under such section, or 
any other violation of regulations under such section.
  (bb) The transfer of an article of food in violation of an 
order under section 304(h), or the removal or alteration of any 
mark or label required by the order to identify the article as 
detained.
  (cc) The importing or offering for import into the United 
States of an article of food by, with the assistance of, or at 
the direction of, a person debarred under section 306(b)(3).
  (dd) The failure to register in accordance with section 415.
  (ee) The importing or offering for import into the United 
States of an article of food in violation of the requirements 
under section 801(m).
  (ff) The importing or offering for import into the United 
States of a drug or device with respect to which there is a 
failure to comply with a request of the Secretary to submit to 
the Secretary a statement under section 801(o).
  (gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited 
under paragraph (2) of such section of false information in an 
inspection report under paragraph (7)(A) of such section; or 
the knowing failure of such a person to include material facts 
in such a report.
  (hh) The failure by a shipper, carrier by motor vehicle or 
rail vehicle, receiver, or any other person engaged in the 
transportation of food to comply with the sanitary 
transportation practices prescribed by the Secretary under 
section 416.
  (ii) The falsification of a report of a serious adverse event 
submitted to a responsible person (as defined under section 760 
or 761) or the falsification of a serious adverse event report 
(as defined under section 760 or 761) submitted to the 
Secretary.
  (jj)(1) The failure to submit the certification required by 
section 402(j)(5)(B) of the Public Health Service Act, or 
knowingly submitting a false certification under such section.
  (2) The failure to submit clinical trial information required 
under subsection (j) of section 402 of the Public Health 
Service Act.
  (3) The submission of clinical trial information under 
subsection (j) of section 402 of the Public Health Service Act 
that is false or misleading in any particular under paragraph 
(5)(D) of such subsection (j).
  (kk) The dissemination of a television advertisement without 
complying with section 503B.
  (ll) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added a drug 
approved under section 505, a biological product licensed under 
section 351 of the Public Health Service Act, or a drug or a 
biological product for which substantial clinical 
investigations have been instituted and for which the existence 
of such investigations has been made public, unless--
          (1) such drug or such biological product was marketed 
        in food before any approval of the drug under section 
        505, before licensure of the biological product under 
        such section 351, and before any substantial clinical 
        investigations involving the drug or the biological 
        product have been instituted;
          (2) the Secretary, in the Secretary's discretion, has 
        issued a regulation, after notice and comment, 
        approving the use of such drug or such biological 
        product in the food;
          (3) the use of the drug or the biological product in 
        the food is to enhance the safety of the food to which 
        the drug or the biological product is added or applied 
        and not to have independent biological or therapeutic 
        effects on humans, and the use is in conformity with--
                  (A) a regulation issued under section 409 
                prescribing conditions of safe use in food;
                  (B) a regulation listing or affirming 
                conditions under which the use of the drug or 
                the biological product in food is generally 
                recognized as safe;
                  (C) the conditions of use identified in a 
                notification to the Secretary of a claim of 
                exemption from the premarket approval 
                requirements for food additives based on the 
                notifier's determination that the use of the 
                drug or the biological product in food is 
                generally recognized as safe, provided that the 
                Secretary has not questioned the general 
                recognition of safety determination in a letter 
                to the notifier;
                  (D) a food contact substance notification 
                that is effective under section 409(h); or
                  (E) such drug or biological product had been 
                marketed for smoking cessation prior to the 
                date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007; or
          (4) the drug is a new animal drug whose use is not 
        unsafe under section 512.
  (mm) The failure to submit a report or provide a notification 
required under section 417(d).
  (nn) The falsification of a report or notification required 
under section 417(d).
  (oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
  (pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of 
section 911.
  (qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification 
device upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other item that is designed to print, imprint, or 
reproduce the trademark, trade name, or other identifying mark, 
imprint, or device of another or any likeness of any of the 
foregoing upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (3) The doing of any act that causes a tobacco product to be 
a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco 
product.
  (rr) The charitable distribution of tobacco products.
  (ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade.
  (tt) Making any express or implied statement or 
representation directed to consumers with respect to a tobacco 
product, in a label or labeling or through the media or 
advertising, that either conveys, or misleads or would mislead 
consumers into believing, that--
          (1) the product is approved by the Food and Drug 
        Administration;
          (2) the Food and Drug Administration deems the 
        product to be safe for use by consumers;
          (3) the product is endorsed by the Food and Drug 
        Administration for use by consumers; or
          (4) the product is safe or less harmful by virtue 
        of--
                  (A) its regulation or inspection by the Food 
                and Drug Administration; or
                  (B) its compliance with regulatory 
                requirements set by the Food and Drug 
                Administration;
        including any such statement or representation 
        rendering the product misbranded under section 903.
  (uu) The operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States 
if the owner, operator, or agent in charge of such facility is 
not in compliance with section 418.
  (vv) The failure to comply with the requirements under 
section 419.
  (ww) The failure to comply with section 420.
  (xx) The refusal or failure to follow an order under section 
423.
  (yy) The knowing and willful failure to comply with the 
notification requirement under section 417(h).
  (zz) The importation or offering for importation of a food if 
the importer (as defined in section 805) does not have in place 
a foreign supplier verification program in compliance with such 
section 805.
  (aaa) The failure to register in accordance with section 
801(s).
  (bbb) The failure to notify the Secretary in violation of 
section 568.
  (ccc)(1) The resale of a compounded drug that is labeled 
``not for resale'' in accordance with section 503B.
  (2) With respect to a drug to be compounded pursuant to 
section 503A or 503B, the intentional falsification of a 
prescription, as applicable.
  (3) The failure to report drugs or adverse events by an 
entity that is registered in accordance with subsection (b) of 
section 503B.
  (ddd)(1) The manufacture or the introduction or delivery for 
introduction into interstate commerce of a rinse-off cosmetic 
that contains intentionally-added plastic microbeads.
  (2) In this paragraph--
          (A) the term ``plastic microbead'' means any solid 
        plastic particle that is less than five millimeters in 
        size and is intended to be used to exfoliate or cleanse 
        the human body or any part thereof; and
          (B) the term ``rinse-off cosmetic'' includes 
        toothpaste.

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```