[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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