[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2100 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
1st Session
S. 2100
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety
of cosmetics.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 17, 2021
Mrs. Feinstein (for herself and Ms. Collins) 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 ensure the safety
of cosmetics.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Personal Care
Products Safety Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--COSMETIC SAFETY
Sec. 101. Registration of cosmetics facilities and cosmetic ingredient
statements.
Sec. 102. Review of ingredients and non-functional constituents.
Sec. 103. Good manufacturing practices for cosmetics.
Sec. 104. Adverse event reports.
Sec. 105. Records inspection; mandatory recall authority.
Sec. 106. Labeling.
Sec. 107. Coal tar chemicals.
Sec. 108. Fragrance allergen disclosure.
Sec. 109. Sense of the Senate on animal testing.
Sec. 110. Preemption.
Sec. 111. Reporting.
Sec. 112. Small businesses.
Sec. 113. Applicability with respect to certain cosmetics.
Sec. 114. Enforcement.
Sec. 115. Consumer information.
Sec. 116. Ban on perfluoroalkyl or polyfluoroalkyl substances.
Sec. 117. Counterfeit cosmetics.
TITLE II--FEES RELATED TO COSMETIC SAFETY
Sec. 201. Findings.
Sec. 202. Authority to assess and use cosmetic safety fees.
Sec. 203. Direct hiring authority to support activities related to
cosmetics.
TITLE I--COSMETIC SAFETY
SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND COSMETIC INGREDIENT
STATEMENTS.
(a) Amendments.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.) is amended by adding at the end the
following:
``SEC. 604. DEFINITIONS.
``In this chapter:
``(1) Cosmetic formulation.--The term `cosmetic
formulation' means a preparation of cosmetic raw materials with
a qualitatively and quantitatively set composition.
``(2) Cosmetic product.--The term `cosmetic product' means
a preparation of cosmetic raw ingredients, which may come in a
range of possible amounts for each ingredient, for purposes of
introduction into interstate commerce as a finished product.
``(3) Facility.--The term `facility' includes any factory,
warehouse, or establishment (including a factory, warehouse, or
establishment of an importer) that manufactures or processes
cosmetic products or cosmetic formulations, or any other entity
whose name and address appear on the label of a cosmetic
product. Such term does not include--
``(A) beauty shops and salons that do not otherwise
manufacture, process, or package cosmetics at that
location;
``(B) cosmetic product retailers, including
individual sales representatives, direct sellers,
retail distribution facilities, and pharmacies, that do
not otherwise manufacture, process, or package
cosmetics at that location;
``(C) hospitals, physicians' offices, and health
care clinics;
``(D) public health agencies and other nonprofit
entities that provide cosmetics directly to the
consumer;
``(E) hotels and other entities that provide
complimentary cosmetics to guests;
``(F) trade shows and other venues where cosmetic
product samples are provided free of charge;
``(G) a factory, warehouse, or establishment of--
``(i) domestic manufacturers with less than
$500,000 in average gross annual sales of
cosmetic products in the United States for the
previous 3-year period, or less than $1,000,000
in such sales of cosmetic products produced in
a private residence; or
``(ii) entities that manufacture or
compound cosmetic products solely for use in
research, teaching, or pilot plant production
and not for sale; or
``(H) an establishment that solely performs one or
more of the following with respect to cosmetic
products: labeling, relabeling, packaging, repackaging,
holding, or distributing.
``(4) Foreign facility.--The term `foreign facility' means
a facility that manufactures or processes a cosmetic
formulation or cosmetic product that is exported to the United
States without further processing or packaging inside the
United States. A cosmetic is not considered to have undergone
further processing or packaging for purposes of this definition
solely on the basis that labeling was added or that any similar
activity of a de minimis nature was carried out with respect to
the cosmetic.
``(5) Non-functional constituent.--The term `non-functional
constituent' means any substance that is an incidental
component of an ingredient, a breakdown product of an
ingredient or a byproduct of the manufacturing process that has
not been intentionally added as a separate substance and serves
no technical function in the cosmetic.
``(6) Responsible person.--The term `responsible person'
means--
``(A) the brand owner who is the domestic or
foreign manufacturer or entity whose name appears on a
cosmetic product label of a cosmetic product
distributed in the United States, except for entities
described in subparagraphs (A) through (H) of paragraph
(3); or
``(B) a contract manufacturer who provides cosmetic
products to the entities described in subparagraphs (A)
through (H) of paragraph (3).''.
``SEC. 605. REGISTRATION OF COSMETIC FACILITIES.
``(a) Registration and Fees for Existing Manufacturing or
Processing of Cosmetics.--
``(1) Registration, in general.--Not later than 1 year
after the date of enactment of the Personal Care Products
Safety Act, and at a similar time in each subsequent year, as
determined by the Food and Drug Administration, each
responsible person engaged in manufacturing or processing a
cosmetic product or a cosmetic formulation distributed in the
United States shall register all of the responsible person's
facilities with the Food and Drug Administration.
``(2) Fees.--If the average gross annual sales in the
United States of cosmetic products of all of the responsible
person's facilities registered under paragraph (1) for the
previous 3-year period is greater than $10,000,000, a
registration shall not be complete under this subsection until
the responsible person has paid any registration fee required
under section 744O.
``(b) Registration by New Facilities.--Any facility first engaging
after the date of enactment of the Personal Care Products Safety Act in
an activity that would require it to register under subsection (a)
shall register with the Food and Drug Administration within 60 days of
first engaging in such activity, and thereafter in accordance with
subsection (a).
``(c) Contract Manufacturers.--If a facility manufactures or
processes cosmetic products on behalf of a responsible person, the Food
and Drug Administration shall require only a single registration for
such facility even if such facility is manufacturing or processing its
own cosmetic products or cosmetic products on behalf of more than 1
responsible person. Such single registration may be submitted to the
Food and Drug Administration by such facility or any responsible person
whose products are manufactured or processed at such facility.
``(d) Changes to Information.--A registrant who has submitted a
registration under this section shall notify the Food and Drug
Administration of any change to the information required under
subsection (a) or (b) not later than 60 days after the date of such
change, unless otherwise specified by the Food and Drug Administration.
``(e) Format; Contents.--
``(1) Electronic format.--Each registration shall be
submitted using an electronic format, as specified in a
registration form provided by the Food and Drug Administration.
``(2) Contents.--
``(A) In general.--Except as provided in
subparagraph (B), the registration shall contain the
following information:
``(i) Each facility's name and full
address, identifying the precise physical
location of the facility.
``(ii) The identity of the facility,
including the unique facility identifier, if
any, previously assigned by the Food and Drug
Administration to the facility under subsection
(h).
``(iii) All business trading names used by
the facility.
``(iv) The product category or categories
of each cosmetic product or cosmetic
formulation manufactured or processed at the
facility or on whose label the facility's name
and address appear.
``(v) The type of activity conducted at the
facility (such as manufacturing or processing).
``(vi) The name, title, street address,
telephone number, and electronic contact
information of the emergency contact for the
facility.
``(vii) In the case of a foreign facility,
the name, street address, telephone number,
emergency contact information, and name of the
United States agent for the facility, and, if
available, the electronic contact information
of the United States agent.
``(viii) The name, title, street address,
telephone number, and electronic contact
information of the individual submitting the
registration.
``(ix) An assurance that the Food and Drug
Administration will be permitted to inspect
such facility at the times and in the manner
permitted by this Act.
``(x) Additional information pertaining to
the facility or to the cosmetic products or
cosmetic formulations manufactured or processed
at the facility, or on whose label the
facility's name and address appear, including
all brand names known to consumers, as the Food
and Drug Administration may require by
regulation.
``(xi) An ingredient listing for all
cosmetic products manufactured or processed in
such facility, in accordance with subsection
(f), which, for each relevant cosmetic product,
may be submitted to the Food and Drug
Administration as part of such registration or
separately.
``(xii) A written assurance that each
cosmetic product manufactured or processed in
such facility has been substantiated for safety
or carries the warning required under section
740.10 of title 21, Code of Federal Regulations
(or any successor regulations). The responsible
person shall maintain records documenting any
such substantiation of safety and the
information on which such determination is
based until 5 years after the finished product
is no longer marketed, except that a
responsible person for a domestic company whose
sales are under $2,000,000 per year shall
maintain such records for at least 2 years
after the finished product is no longer
marketed.
``(B) Small businesses.--
``(i) Requirements.--In the case of a
registrant described in clause (ii), the
registration shall contain the following
information:
``(I) Each facility's name and full
address, identifying the precise
physical location of the facility.
``(II) The name, title, street
address, telephone number, and
electronic contact information of the
emergency contact for the facility.
``(III) The consumer product
category or categories of each cosmetic
product or cosmetic formulation
manufactured, processed, packed, or
held at the facility or on whose label
the facility's name and address appear.
``(ii) Small business registrants.--A
registrant described in this clause is a
domestic registrant--
``(I) whose average gross annual
sales in the United States of cosmetic
products for the previous 3-year period
is between $500,000 and $2,000,000 (or
between $1,000,000 and $2,000,000 in
the case of sales of cosmetic products
produced in a private residence); and
``(II) who does not produce--
``(aa) products that are
intended to go on the eye area;
``(bb) lip products with
color;
``(cc) products that are
injected;
``(dd) products that are
intended for internal use; or
``(ee) products that are
meant to alter appearance for
more than 24 hours.
``(iii) Guidance.--The Food and Drug
Administration shall, after consultation with
the Small Business Administration and small
businesses that manufacture cosmetics, provide
additional guidance for small businesses on
compliance with the requirements of this
section that would apply to small business
registrants. Such guidance shall include
specific examples of options for compliance
that do not place an undue burden on small
businesses.
``(3) Abbreviated registration.--The Food and Drug
Administration shall provide for an abbreviated registration
renewal process for any registrant that has not had any changes
to the required information with respect to the facility or
facilities involved since the registrant submitted the
preceding registration.
``(f) Cosmetic Product Ingredient Listing.--
``(1) In general.--The ingredient listing required pursuant
to subsection (e)(2)(A)(xi) shall include--
``(A) the unique identifier assigned under section
(h), as applicable, of--
``(i) each facility where the cosmetic
product is manufactured or processed; and
``(ii) the facility whose name and address
appear on the label, unless the statement is
filed by a contract manufacturer described in
section 604(6)(B);
``(B) the brand name and the full name for the
cosmetic product as it appears on the label;
``(C) the cosmetic product listing number, if any,
previously assigned to the cosmetic product by the Food
and Drug Administration under paragraph (4);
``(D) the applicable cosmetic category for the
cosmetic product;
``(E) a list of ingredients in the cosmetic
product, including a range of possible amounts of each
ingredient, identified by the name adopted in
regulations promulgated by the Food and Drug
Administration, if any, or by the common or usual name
of the ingredient, which shall include--
``(i) a list of fragrances, flavors, and
colors that may be included in the product,
interchangeably, with ranges of possible
amounts, which shall include--
``(I) in the case of fragrances
that are purchased from a fragrance
supplier, identification of the
fragrances by the name or code provided
by the supplier, including the name and
contact information for the fragrance
supplier; and
``(II) in the case of flavors that
are purchased from a flavor supplier,
identification of the flavors by the
name or code provided by the supplier,
including the name and contact
information for the flavor supplier;
and
``(ii) other appropriate interchangeable
ingredients as the Food and Drug Administration
may specify in regulations or guidance that may
be included in the product, with ranges of
possible amounts;
``(F) the title and full contact information of
each individual submitting the statement;
``(G) if applicable, information on the labeling
required under section 612; and
``(H) if applicable, information showing that the
cosmetic ingredient or ingredients in the product meet
any specified conditions of use or tolerances required
following a final determination of safety under section
607(d).
``(2) Additional information.--In the case of a cosmetic
ingredient statement that includes a list of fragrances or
flavors that are purchased from a fragrance or flavor supplier
as described in paragraph (1)(E)(i), upon request by the Food
and Drug Administration, the fragrance or flavor supplier shall
submit to the Food and Drug Administration the complete list of
ingredients in specific fragrances or flavors, not later than
30 days after receiving such request.
``(3) Cosmetic product ingredient statement for new or
reformulated cosmetic products.--
``(A) In general.--Except as provided under
subparagraph (B), in the case of a cosmetic product
that is first marketed after the date of enactment of
the Personal Care Products Safety Act or a cosmetic
product that is reformulated after such date of
enactment, the responsible person shall submit a
cosmetic ingredient statement to the Food and Drug
Administration within 60 days of first marketing the
new cosmetic product or reformulated cosmetic product,
and annually thereafter.
``(B) Small businesses.--The Food and Drug
Administration shall allow a responsible person that is
a business that meets the applicable industry-based
small business size standard established by the
Administrator of the Small Business Administration
under section 3 of the Small Business Act to have a
period longer than 60 days to submit an initial new
cosmetic ingredient statement under subparagraph (A).
``(C) Definition.--A cosmetic product shall not be
considered first marketed or reformulated after the
date of enactment under subparagraph (A) if the only
change in such product is in--
``(i) the amount of an existing ingredient
if it is within the range previously reported
under paragraph (1)(E); or
``(ii) the addition or subtraction of a
fragrance, flavor, or color, or such other
interchangeable ingredients specified by the
Food and Drug Administration in regulations or
guidance, previously reported as a potential
ingredient under paragraph (1)(E), if, in the
case of such an addition, the amount is within
the range previously reported.
``(4) Cosmetic products list.--At the time of the initial
submission of any cosmetic ingredient statement under this
section, the Food and Drug Administration shall assign a unique
cosmetic product listing number to the cosmetic ingredient
statement. Based on such cosmetic ingredient statements, the
Food and Drug Administration shall compile and maintain a list
of cosmetic products distributed in the United States,
including the ingredients of each such product, and shall make
available such list to any State, upon request. Information
disclosed to a State that is exempt from disclosure under
section 552(b)(4) of title 5, United States Code, shall be
treated as a trade secret and confidential information by the
State.
``(g) Incomplete or Inaccurate Registration.--
``(1) In general.--Not earlier than 10 days after providing
notice of the intent to cancel a registration and the basis for
such cancellation, the Food and Drug Administration may cancel
a registration under this section if the Food and Drug
Administration has reasonable grounds to believe that the
registration was not properly completed or updated in
accordance with this section or otherwise contains false,
incomplete, or inaccurate information.
``(2) Timely update or correction.--If, not later than 7
days after receipt of a notice of intent to cancel, the
responsible person corrects the registration in accordance with
the basis for the cancellation, and the required registration
fee, if any, is paid, the Food and Drug Administration shall
not cancel such registration.
``(h) Unique Identifier.--At the time of the initial registration
of any cosmetic facility under this section, the Food and Drug
Administration shall assign a unique identifier to the facility.
``(i) Registry of Facilities.--
``(1) In general.--The Food and Drug Administration shall
compile, maintain, and update a registry of facilities that are
registered under this section, and shall remove from such
registry the name of any facility whose registration under this
section is cancelled. The registry shall be publicly available.
``(2) Public availability exceptions.--Information derived
from the registry or registration documents that discloses the
residential address of a registrant or that discloses specific
facilities where specific cosmetic products are manufactured or
processed shall not be subject to disclosure under section 552
of title 5, United States Code.
``SEC. 606. SUSPENSION OF REGISTRATION OR COSMETIC INGREDIENT
STATEMENT.
``(a) Suspension of Registration of a Facility.--If the Food and
Drug Administration determines that a cosmetic formulation or cosmetic
product manufactured or processed by a registered facility and
distributed in the United States has a reasonable probability of
causing serious adverse health consequences or death to humans, and the
Food and Drug Administration has a reasonable belief that other
products manufactured or processed by the facility may be similarly
affected because of a failure that cannot be isolated to a single
product or products or is sufficiently pervasive to raise concerns
about other products manufactured in the facility, the Food and Drug
Administration may suspend the registration of a facility.
``(b) Suspension of Cosmetic Ingredient Statement.--If the Food and
Drug Administration determines that a cosmetic product manufactured in
a registered facility has a reasonable probability of causing serious
adverse health consequences or death to humans, the Food and Drug
Administration may suspend the cosmetic ingredient statement of that
product.
``(c) Notice of Suspension.--Before suspending a facility
registration or a cosmetic ingredient statement under this section, the
Food and Drug Administration shall provide--
``(1) notice to the facility registrant of the cosmetic
product or formulation or other responsible person, as
appropriate, of the intent to suspend the facility registration
or the cosmetic ingredient statement, which shall specify the
basis of the determination by the Food and Drug Administration
that the facility or the cosmetic ingredient should be
suspended and recommendations for specific actions to avoid
suspension; and
``(2) an opportunity, within 2 business days of the notice
provided under paragraph (1), for the responsible person to
address the reasons for possible suspension of the facility
registration or cosmetic ingredient statement.
``(d) Reinstatement.--Upon a determination by the Food and Drug
Administration that adequate grounds do not exist to continue the
suspension actions, the Food and Drug Administration shall promptly
vacate the suspension and reinstate the registration of the facility or
the cosmetic ingredient statement.
``(e) Effect of Suspension.--
``(1) Registration.--If the registration of a facility is
suspended under this section, no person shall introduce or
deliver for introduction into interstate commerce cosmetics or
cosmetic products from such facility.
``(2) Cosmetic ingredient statement.--If the cosmetic
ingredient statement for a cosmetic product is suspended under
this section, no person shall introduce or deliver for
introduction into interstate commerce any cosmetic product that
is the subject of such statement.
``(f) No Delegation.--The authority conferred by this section to
issue an order to suspend a registration or vacate an order of
suspension shall not be delegated to any officer or employee other than
the Commissioner.''.
SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS.
(a) Amendments.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 101, is further
amended by adding at the end the following:
``SEC. 607. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS.
``(a) Ingredients and Non-Functional Constituents Subject to
Review.--
``(1) In general.--The Food and Drug Administration shall
review the safety of the cosmetic ingredients and non-
functional constituents listed under paragraph (3), as modified
under subsection (c), if applicable, and issue an order under
subsection (d) with respect to the use of each such ingredient
and presence of each such non-functional constituent.
``(2) Public notice and comment.--At the initiation of the
review of each cosmetic ingredient or non-functional
constituent, the Food and Drug Administration shall open a
docket for the submission of public comment and additional data
relevant to the safety of the ingredient or non-functional
constituent. The Food and Drug Administration shall provide 60
days for public comment.
``(3) Cosmetic ingredients.--
``(A) In general.--Beginning in fiscal year 2022,
the Food and Drug Administration shall annually select
and complete a safety review of at least 5 cosmetic
ingredients or non-functional constituents that were
not reviewed in the prior 3 years, from a list
determined in consultation with the cosmetic industry
and consumer and health groups. The Food and Drug
Administration may combine selected cosmetics
ingredients or non-functional constituents into
categories for purposes of such review. The Food and
Drug Administration may modify such list under
subsection (c).
``(B) Considerations.--The determination of which
ingredients or functional ingredients will be reviewed
in a given year shall be publicized in annual reports
to Congress and the public, in accordance with section
617. The review of any cosmetic ingredient or non-
functional constituent shall commence with a public
announcement by the Food and Drug Administration and
the opening of a docket as required under paragraph
(2).
``(4) Comment period.--As part of the annual reporting to
Congress and the public under section 617, the Food and Drug
Administration shall solicit public comment on which cosmetic
ingredients or non-functional constituents on the list are of
greatest interest to be reviewed next for early review and
which additional cosmetic ingredients or non-functional
constituents should be added to the list. The public may submit
comments to the Food and Drug Administration at any time during
the year regarding which cosmetic ingredients or non-functional
constituents of interest the Food and Drug Administration may
consider during that year or subsequent years.
``(b) List.--The Food and Drug Administration shall maintain a
list, posted on the internet website of the Food and Drug
Administration, of the cosmetic ingredients and non-functional
constituents for which final orders have been issued under subsection
(d)(3), the finding made for each such ingredient or non-functional
constituent under subsection (d)(4), as modified by any order under
subsection (f), if applicable, and, if applicable, compliance dates
that are the subject of a final order under subsection (e).
``(c) Initiative of the FDA.--The Food and Drug Administration may
at any time propose the issuance of an order on the safety of a
cosmetic ingredient or non-functional constituent that was not
previously listed in subsection (a) or under section 617(a)(3). The
Food and Drug Administration shall follow the same procedures and
policies for review of any cosmetic ingredient or non-functional
constituent so proposed as for the ingredients and constituents
reviewed pursuant to subsection (a).
``(d) Determination on Safety.--
``(1) Initial proposed administrative order.--Following
consideration of data and comments to the public docket and any
other information before the Food and Drug Administration, the
Food and Drug Administration shall determine whether there is
adequate evidence to make an initial finding on the safety of
the ingredient or non-functional constituent. If the Food and
Drug Administration determines that there is adequate evidence,
the Food and Drug Administration shall issue a proposed
administrative order and shall post such order on the internet
website of the Food and Drug Administration, notwithstanding
subchapter II of chapter 5 of title 5, United States Code.
``(2) Public comment.--Upon publication of the proposed
administrative order described in paragraph (1), the Food and
Drug Administration shall open a docket for the submission of
public comment. The Food and Drug Administration shall provide
30 days for public comment following publication of the
proposed administrative order.
``(3) Final administrative order.--Following the public
comment period described in paragraph (2) and consideration of
comments to the public docket and any other information before
the Food and Drug Administration, the Food and Drug
Administration shall determine whether there is adequate
evidence to make a final finding on the safety of the
ingredient or non-functional constituent. If the Food and Drug
Administration determines that there is adequate evidence, the
Food and Drug Administration shall issue a final administrative
order and shall post such order on the internet website of the
Food and Drug Administration, notwithstanding subchapter II of
chapter 5 of title 5, United States Code.
``(4) Determinations.--In the proposed administrative order
or the final administrative order, as applicable, the Food and
Drug Administration shall make a determination that the
ingredient or non-functional constituent is--
``(A) safe in cosmetic products under specified
conditions of use or tolerances;
``(B) safe in cosmetic products without the need
for specified conditions of use or tolerances; or
``(C) not safe in cosmetic products.
``(5) Conditions of use and tolerances.--An order under
paragraph (4)(A) shall include such conditions on the use of an
ingredient or such tolerances on the presence of a non-
functional constituent as are necessary for the safety of
cosmetic products containing such ingredient or non-functional
constituent, including--
``(A) limits on the amount or concentration of the
ingredient or non-functional constituent that may be
present in a cosmetic product, including limits in
products intended for children and other vulnerable
populations, and limits on use near the eye or mucosal
membranes;
``(B) warnings that are necessary or appropriate
under section 612, including warnings related to use by
children, pregnant women, populations with high
exposure to the ingredient (such as workers who are
exposed through production practices or handling of
final products), or other vulnerable populations, to
help ensure safe use of cosmetic products containing
the ingredient or non-functional constituent; and
``(C) such other screening, safety protocol, or
other similar conditions as are necessary for the
safety of cosmetic products containing such ingredient
or non-functional constituent.
``(6) Public notice.--A final order under this subsection
shall set forth the determination of the Food and Drug
Administration on safety, any conditions of use or tolerances
under subparagraph (A) or (B) of paragraph (4) and a summary of
the valid scientific evidence supporting the finding. The order
shall be effective upon its publication on the internet website
of the Food and Drug Administration and shall be considered
final agency action.
``(e) Order.--
``(1) In general.--If the Food and Drug Administration
issues a final administrative order under subparagraph (A) or
(C) of subsection (d)(4), the Food and Drug Administration
shall, at the same time as publication of the notice under
subsection (d)(6), publish a proposed order identifying dates
by which use of the ingredient or non-functional constituent in
cosmetic products shall comply with the final administrative
order, and provide 60 days for public comment, including
comment on whether compliance is feasible within the proposed
dates. After considering comments on the proposed order, the
Food and Drug Administration shall publish in the Federal
Register a final order.
``(2) Content.--The public notice information regarding the
final order under paragraph (1) shall include a summary that is
written in plain and understandable language that is
comprehensible and meaningful for consumers. The summary shall
include information on any conditions of use or warnings
required under section 612, including the application to
vulnerable populations, the types of safety studies evaluated,
and any additional relevant information that was part of the
review process.
``(f) Modification of an Order.--An order issued under subsection
(d) or (e) may be modified or revoked by the Food and Drug
Administration on the initiative of the Food and Drug Administration or
in response to a petition.
``(g) Inadequate Evidence.--
``(1) Notice; extension.--If the Food and Drug
Administration determines that the available data and
information are not adequate to make a proposed or final
determination regarding safety under subsection (d)(4), with
respect to a cosmetic ingredient or non-functional constituent,
the Food and Drug Administration shall--
``(A) publish such finding on the internet website
of the Food and Drug Administration not later than 90
days after the close of the relevant comment period for
the ingredient or non-functional constituent under
subsection (a)(2), in the case of a proposed order, or
subsection (d)(2), in the case of a final order; and
``(B)(i) include a notice providing interested
persons an additional 30 days from the notice date to
provide additional data and information; and
``(ii) if, after the 30-day period under clause
(i), the Food and Drug Administration determines that
additional safety substantiation with respect to such
ingredient or non-functional constituent is necessary
to make a safety determination--
``(I) include a notice specifying an
additional time period, not to exceed 18 months
from the notice date, during which time the
assurance made by a responsible person under
section 605(e)(2)(A)(xii) with respect to the
safety of such cosmetic ingredient or non-
functional constituent shall be deemed to be in
compliance with the requirements of this Act,
but shall not affect final determinations of
safety under subsection (d); and
``(II) plan to obtain such data and
information.
``(2) Determination; order.--
``(A) Inadequate data and information.--If the Food
and Drug Administration determines, after considering
any additional data and information submitted under
paragraph (1)(B), that the available data and
information still are not adequate to make a
determination regarding safety under subsection (d)(4),
the Food and Drug Administration shall, within 90 days
of the close of the additional time period provided
under paragraph (1)(B), issue a proposed order or a
final administrative order--
``(i) making a determination that the
ingredient or non-functional constituent has
not been shown to be safe in cosmetic products;
and
``(ii) explaining why the available data
and information are not adequate to assess the
safety of the ingredient or non-functional
constituent.
``(B) Adequate data and information.--If the Food
and Drug Administration determines, after considering
any additional data and information submitted under
paragraph (1)(B), that the available data and
information are adequate to make a determination
regarding safety under subsection (d)(4), the Food and
Drug Administration shall, within 180 days of the close
of the comment period, issue a proposed order, followed
by a final order, on such cosmetic ingredient or non-
functional constituent, in accordance with such
subsection.
``(h) Safety Assessment.--
``(1) In general.--In assessing the safety of an ingredient
or non-functional constituent, the Food and Drug Administration
shall consider whether there is adequate evidence to support a
reasonable certainty among competent scientists that the
ingredient is not harmful under the recommended or suggested
conditions of use or customary or usual use, or that a non-
functional constituent is not harmful under the recommended or
suggested tolerance levels or the level at which it is
customarily or usually present. The Food and Drug
Administration may not consider an ingredient or non-functional
constituent harmful solely because it can cause minor adverse
health reactions, such as minor transient allergic reactions or
minor transient skin irritations, in some users.
``(2) Factors.--In assessing the safety of an ingredient or
non-functional constituent, the Food and Drug Administration
shall consider, among other relevant factors, the following:
``(A) The probable human exposure to the ingredient
or non-functional constituent from expected use in
cosmetics.
``(B) The probable cumulative and aggregate effect
in humans of relevant exposure to the ingredient or
non-functional constituent or to any chemically or
pharmacologically related substances from use in
cosmetics or other products with similar routes of
exposure under recommended or suggested conditions of
use or their customary use, to the extent adequate data
is available for analysis. In appropriate cases, the
Food and Drug Administration may consider available
information on the total exposure to an ingredient or
non-functional constituent from all sources.
``(C) Whether warnings or recommendations in a
product label required under section 612, as part of
any conditions of use or tolerances imposed by the Food
and Drug Administration, would be necessary and
appropriate to help ensure the safety of the ingredient
or non-functional constituent.
``(3) Data and information.--
``(A) Required information.--A determination that
an ingredient or non-functional constituent is safe in
cosmetics shall be based upon adequate evidence
submitted or otherwise known to the Food and Drug
Administration, which shall include full reports of all
available studies, published or unpublished, that are
adequately designed to show whether the ingredient or
non-functional constituent is safe. Such studies may
include in vitro and in silico studies and
epidemiological studies, biomonitoring studies, and
studies focused on various points during the lifespan
of the subject, that use scientifically valid
methodology.
``(B) Additional relevant information.--The Food
and Drug Administration shall consider any other
relevant information related to the safety of the
ingredient or non-functional constituent, including--
``(i) adverse event reports;
``(ii) findings and information from State,
Federal, national, and international entities
and other bodies composed of scientific and
medical experts;
``(iii) if the ingredient or non-functional
constituent is lawfully used or present in
other products regulated by the Food and Drug
Administration, the scientific basis for such
use; and
``(iv) experience with the ingredient or
non-functional constituent in products that are
distributed in the United States or in other
countries, if such experience is well-
documented and has resulted in substantial
human exposure to the ingredient or non-
functional constituent over time.
``(i) Coal-Tar Hair Dye.--Coal-tar hair dye shall be subject to the
conditions of section 601(a) unless the Food and Drug Administration
has issued a final determination for a coal-tar hair dye ingredient
under subsection (d)(4)(C).
``(j) Certain Ingredients Imparting Pigment.--Ingredients imparting
pigment to cosmetic products that are subject to review and approval
pursuant to section 721(b) shall not be subject to review under this
section.''.
(b) GAO Report.--The Comptroller General of the United States shall
conduct a review of the program of review of cosmetic ingredients and
non-functional constituents under section 607 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), and, not later than
5 years after the date of enactment of this Act, issue a report on such
review.
SEC. 103. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
(a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 102, is further
amended by adding at the end the following:
``SEC. 608. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
``(a) In General.--The Food and Drug Administration shall review
national and international standards for cosmetic good manufacturing
practices that are in existence on the date of enactment of the
Personal Care Products Safety Act and shall develop and implement,
through regulations, standards consistent, to the extent the Food and
Drug Administration determines practicable and appropriate, with such
national and international standards for cosmetic good manufacturing
practices to ensure that requirements of this chapter with respect to
the manufacture of cosmetic products are in harmony.
``(b) Consultation.--The standards under subsection (a) shall
include simplified good manufacturing practices for small businesses
that take into account the size and scope of the business, developed in
consultation with the Small Business Administration.
``(c) Timeframe.--The Food and Drug Administration shall publish a
proposed rule described in subsection (a) not later than 18 months
after the date of enactment of the Personal Care Products Safety Act
and shall publish a final such rule not later than 3 years after such
date of enactment.''.
(b) Effective Date for Cosmetic Manufacturers.--
(1) Large businesses.--For businesses of a size greater
than the Small Business Administration's standard for a small
business, section 608 of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)) shall take effect beginning
180 days after the date on which the Food and Drug
Administration makes effective cosmetic good manufacturing
practices.
(2) Small businesses.--For businesses of a size that meets
the Small Business Administration's standard for a small
business, section 608 of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)) shall take effect beginning 2
years after the date the Food and Drug Administration makes
effective cosmetic good manufacturing practices.
SEC. 104. ADVERSE EVENT REPORTS.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 103(a), is further amended by
adding at the end the following:
``SEC. 609. ADVERSE EVENT REPORTING FOR COSMETICS.
``(a) In General.--With respect to any cosmetic product distributed
in the United States, the responsible person shall submit to the Food
and Drug Administration a report of any serious adverse event
associated with such cosmetic product, when used in the United States,
accompanied by a copy of the label on or with the retail packaging of
the cosmetic, any new medical information, related to a submitted
serious adverse event report that is received by the responsible
person, and an annual report for all adverse events received by the
responsible person.
``(b) Definitions.--In this section:
``(1) An `adverse event' for a cosmetic product is a
health-related event associated with the use of this product
that is adverse.
``(2) A `serious adverse event' for a cosmetic product is
an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant
disability or incapacity;
``(v) congenital anomaly or birth defect;
or
``(vi) significant disfigurement, including
serious and persistent rashes or infections and
significant hair loss; or
``(B) requires, based on appropriate medical
judgment, a medical or surgical intervention to prevent
an outcome described in subparagraph (A).
``(c) Submission of Reports.--
``(1) Serious adverse event reports.--Except as provided in
paragraph (2), with respect to a cosmetic product distributed
in the United States, the responsible person shall submit a
serious adverse event report to the Food and Drug
Administration not later than 15 business days after
information concerning the adverse event is received. If a
serious adverse event report for a cosmetic with drug
properties is filed using Form FDA 3500A (or any successor form
developed for such purpose) or its electronic equivalent for
over-the-counter drugs, the responsible person shall not have
to submit a duplicative serious adverse event report under this
section.
``(2) New medical information.--The responsible person
shall submit to the Food and Drug Administration any new
medical information, related to a submitted serious adverse
event report that is received by the responsible person within
1 year of the initial report, and shall submit such information
not later than 15 business days after the new information is
received by the responsible person.
``(3) Consolidation of reports.--The Food and Drug
Administration shall provide for systems to enable the
responsible person to submit a single report that includes
duplicate reports of, or new medical information related to, a
serious adverse event.
``(4) Annual report.--
``(A) In general.--Not later than March 1 of each
year, except as provided under subparagraph (C), the
responsible person shall submit an electronic report
for the prior calendar year for each cosmetic product
marketed during that year.
``(B) Contents.--Each report under this paragraph
shall contain a summary of all adverse events received
during the reporting period, a complete list of
individual reports, and an estimate of the total number
of product units estimated to have been distributed to
consumers in the United States during such period. The
report shall not include consumer complaints that are
solely regarding efficacy and do not contain any
information about an adverse event. The Food and Drug
Administration shall further specify the contents of
the annual electronic report by regulation or guidance.
``(C) Small business exception.--In the case of a
domestic facility for which the average gross annual
sales in cosmetic products in the United States over
the previous 3-year period is not more than $2,000,000,
the responsible person is not required to submit an
annual report under this paragraph.
``(5) Exemption.--The Food and Drug Administration may
establish by regulation an exemption to any of the requirements
under this subsection if the Food and Drug Administration
determines that such exemption is supported by adequate
evidence and would have no adverse effect on public health.
``(d) Requirements.--
``(1) In general.--Each serious adverse event report under
this section shall be submitted to the Food and Drug
Administration using an electronic system of the Food and Drug
Administration. The Food and Drug Administration shall make
such electronic system available not later than 1 year after
the date of enactment of the Personal Care Products Safety Act.
``(2) Modification.--The format of the reporting system may
be modified by the Food and Drug Administration and the reports
may include additional information. The Food and Drug
Administration may, in guidance, further specify the format and
contents of required reports.
``(3) Scope of serious adverse event report.--A serious
adverse event report (including all information submitted in
the initial report or added later) submitted to the Food and
Drug Administration under subsection (a) includes--
``(A) a report under section 756 with respect to
safety and related to a specific cosmetic product;
``(B) a record about an individual who suffered the
serious adverse event under section 552a of title 5,
United States Code;
``(C) a medical or similar file documenting the
serious adverse event, the disclosure of which would
constitute a violation of section 552(b)(6) of such
title 5, and shall not be publicly disclosed unless all
personally identifiable information is redacted; and
``(D) contact information for the individual
reporting the serious adverse event.
``(4) Responsibility to gather information.--After an
individual initiates the reporting of a serious adverse event,
the responsible person for the cosmetic product shall actively
gather all of the information to complete and file the report
with the Food and Drug Administration.
``(5) No adverse events to report.--The Food and Drug
Administration shall provide an option as part of the
electronic registration process for the responsible person to
indicate if such responsible person had no adverse events to
report over the previous year. With respect to a responsible
person who received no adverse event reports for a year, the
annual adverse event report requirement may be met by
indicating no such events on the annual registration form.
``(e) Limitation With Respect to Adverse Event Reports.--The
submission of an adverse event report in compliance with subsection (a)
shall not constitute an admission that the cosmetic involved caused or
contributed to the adverse event.
``(f) Contact Information.--The label of a cosmetic shall bear the
domestic telephone number or electronic contact information, and it is
encouraged that the label include both the telephone number and
electronic contact information, through which the responsible person
may receive a report of an adverse event.
``(g) Maintenance of Records.--The responsible person shall
maintain records related to each report of an adverse event received by
the responsible person for a period of 6 years.
``(h) Availability to States.--The Food and Drug Administration
shall make available records submitted under this section to any State,
upon request. Information disclosed to a State that is exempt from
disclosure under section 552(b)(4) of title 5, United States Code,
shall be treated as a trade secret and confidential information by the
State.
``(i) Effective Date of Requirement With Respect to Serious Adverse
Events.--The requirement under this section to report serious adverse
events shall become effective on the date that the Food and Drug
Administration publicizes the availability of the electronic system
described in subsection (d)(1).''.
SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AUTHORITY.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 104, is further amended by adding
at the end the following:
``SEC. 610. INSPECTION OF COSMETIC RECORDS.
``(a) Inspection of Records.--Each manufacturer or processor of a
cosmetic shall, at the request of an officer or employee duly
designated by the Food and Drug Administration, permit such officer or
employee, upon presentation of appropriate credentials and written
notice to such person, at reasonable times and within reasonable limits
and in a reasonable manner, to have access to and copy--
``(1) all records maintained under section
605(e)(2)(A)(xii) or 609 and in accordance with the rules
promulgated by the Food and Drug Administration under section
608, as applicable; and
``(2) except as provided in subsection (b), all other
records, if the Food and Drug Administration--
``(A) has a reasonable belief that the cosmetic--
``(i) is adulterated;
``(ii) has caused a reportable serious
adverse event; or
``(iii) contains an ingredient that
substantial new scientific information shows
may be unsafe when present in a cosmetic; and
``(B) provides written notice of the basis for the
Food and Drug Administration's reasonable belief
described in subparagraph (A).
``(b) Exclusions.--No inspection authorized by this section shall
extend to financial data, pricing data, personnel data (other than data
as to qualification of technical and professional personnel performing
functions subject to this Act), research data (other than safety data),
or sales data other than shipment data.
``(c) Scope.--The requirements under subsection (a) apply to
records maintained by or on behalf of such person in any format
(including paper and electronic formats) and at any location.
``(d) Protection of Sensitive Information.--The Food and Drug
Administration shall take appropriate measures to ensure that there are
effective procedures to prevent the unauthorized disclosure of any
trade secret or confidential information that is obtained by the Food
and Drug Administration pursuant to this section. Information disclosed
to a State that is exempt from disclosure under section 552(b)(4) of
title 5, United States Code, shall be treated as a trade secret and
confidential information by the State.
``(e) Limitations.--This section shall not be construed--
``(1) to limit the authority of the Food and Drug
Administration to inspect records or to require establishment
and maintenance of records under any other provision of this
Act; or
``(2) to have any legal effect on section 552 of title 5,
United States Code, or section 1905 of title 18, United States
Code.
``(f) Submission of Records.--
``(1) In general.--Any records required to be maintained by
a responsible person under section 605(e)(2)(A)(xii) shall,
upon the written request of the Food and Drug Administration to
the responsible person, be provided to the Food and Drug
Administration within a reasonable timeframe not to exceed 60
days, in either electronic or paper form.
``(2) Criteria.--The Food and Drug Administration may
require records under paragraph (1) if--
``(A) the Food and Drug Administration has a
reasonable belief, described in written notice, that--
``(i) the finished product may be harmful
based on adverse event reports or other
scientific information; or
``(ii) scientific information raises
credible and relevant questions about the
safety of the product or any of its
ingredients;
``(B) the Food and Drug Administration, an expert
regulatory body, or an expert body composed of
scientific and medical experts finds an ingredient in
the product to be unsafe under the conditions of use of
the product; or
``(C) the Food and Drug Administration concludes
that submission of the records will serve the public
health or otherwise enable the Food and Drug
Administration to fulfill the cosmetic safety purposes
of this section.''.
``SEC. 611. MANDATORY RECALL AUTHORITY.
``(a) Voluntary Procedures.--If the Food and Drug Administration
determines that there is a reasonable probability that a cosmetic is
adulterated under section 601 or misbranded under section 602 and the
use of or exposure to such cosmetic is likely to cause serious adverse
health consequences or death, the Food and Drug Administration shall
provide the responsible person with an opportunity to voluntarily cease
distribution and recall such article.
``(b) Prehearing Order To Mandatorily Cease Distribution and Give
Notice.--
``(1) In general.--If the responsible person refuses to or
does not voluntarily cease distribution or recall such cosmetic
within the time and in the manner prescribed by the Food and
Drug Administration, the Food and Drug Administration may order
such person to--
``(A) immediately cease distribution of such
cosmetic; and
``(B) as applicable, immediately notify all
persons--
``(i) manufacturing, processing, packing,
transporting, holding, receiving, distributing,
or importing and selling such cosmetic; and
``(ii) to which such cosmetic has been
distributed, transported, or sold (except
consumers),
to immediately cease distribution of such cosmetic.
``(2) Required additional information.--
``(A) In general.--If a cosmetic covered by a
recall order issued under paragraph (1)(B) has been
distributed to a warehouse-based third-party logistics
provider without providing such provider sufficient
information to know or reasonably determine the precise
identity of such cosmetic covered by a recall order
that is in its possession, the notice provided by the
responsible person subject to the order issued under
paragraph (1)(B) shall include such information as is
necessary for the warehouse-based third-party logistics
provider to identify the cosmetic.
``(B) Rules of construction.--Nothing in this
paragraph shall be construed--
``(i) to exempt a warehouse-based third-
party logistics provider from the requirements
of this chapter, including the requirements of
this section and section 610; or
``(ii) to exempt a warehouse-based third-
party logistics provider from being the subject
of a mandatory recall order.
``(3) Determination to limit areas affected.--If the Food
and Drug Administration requires a responsible person to cease
distribution under paragraph (1)(A) of a cosmetic, the Food and
Drug Administration may limit the size of the geographic area
and the markets affected by such cessation if such limitation
would not compromise the public health.
``(c) Hearing on Order.--The Food and Drug Administration shall
provide the responsible party subject to an order under subsection (b)
with an opportunity for an informal hearing, to be held as soon as
possible, but not later than 2 days after the issuance of the order, on
the actions required by the order and on why the cosmetic that is the
subject of the order should not be recalled.
``(d) Post-Hearing Recall Order and Modification of Order.--
``(1) Amendment of order.--If, after providing opportunity
for an informal hearing under subsection (c), the Food and Drug
Administration determines that removal of the cosmetic from
commerce is necessary, the Food and Drug Administration shall,
as appropriate--
``(A) amend the order to require recall of such
cosmetic or other appropriate action;
``(B) specify a timetable in which the recall shall
occur;
``(C) require periodic reports to the Food and Drug
Administration describing the progress of the recall;
and
``(D) provide notice to consumers to whom such
cosmetic was, or may have been, distributed.
``(2) Vacating of order.--If, after such hearing, the Food
and Drug Administration determines that adequate grounds do not
exist to continue the actions required by the order, or that
such actions should be modified, the Food and Drug
Administration shall vacate the order or modify the order.
``(e) Cooperation and Consultation.--The Food and Drug
Administration shall work with State and local public health officials
in carrying out this section, as appropriate.
``(f) Public Notification.--In conducting a recall under this
section, the Food and Drug Administration shall--
``(1) ensure that a press release is published regarding
the recall, and that alerts and public notices are issued, as
appropriate, in order to provide notification--
``(A) of the recall to consumers and retailers to
whom such cosmetic was, or may have been, distributed;
and
``(B) that includes, at a minimum--
``(i) the name of the cosmetic subject to
the recall;
``(ii) a description of the risk associated
with such article; and
``(iii) to the extent practicable,
information for consumers about similar
cosmetics that are not affected by the recall;
and
``(2) ensure publication on the internet website of the
Food and Drug Administration of an image of the cosmetic that
is the subject of the press release described in paragraph (1),
if available.
``(g) No Delegation.--The authority conferred by this section to
order a recall or vacate a recall order shall not be delegated to any
officer or employee other than the Commissioner.
``(h) Effect.--Nothing in this section shall affect the authority
of the Food and Drug Administration to request or participate in a
voluntary recall, or to issue an order to cease distribution or to
recall under any other provision of this chapter or under the Public
Health Service Act.''.
SEC. 106. LABELING.
(a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 105, is further
amended by adding at the end the following:
``SEC. 612. LABELING.
``(a) Safety Review and Labeling.--Following a review of cosmetic
ingredients that determines that warnings are required to help ensure
safe use of cosmetic products under section 607(d)(5), the Food and
Drug Administration shall require labeling of cosmetics that are not
appropriate for use in the entire population, including warnings that
vulnerable populations, such as children or pregnant women, should
limit or avoid using the product.
``(b) Cosmetic Products for Professional Use.--
``(1) Definition of professional.--For purposes of this
section, with respect to cosmetics, the term `professional'
means an individual who--
``(A) is licensed by an official State authority to
practice in the field of cosmetology, nail care,
barbering, or esthetics;
``(B) has complied with all requirements set forth
by the State for such licensing; and
``(C) has been granted a license by a State board
or legal agency or legal authority.
``(2) Listing of ingredients.--Cosmetic products used and
sold by professionals shall list all ingredients and warnings,
as required for other cosmetic products under this chapter.
``(3) Professional use labeling.--In the case of a cosmetic
product intended to be used only by a professional on account
of a specific ingredient or increased concentration of an
ingredient that requires safe handling by trained
professionals, the product shall bear a statement as follows:
`To be Administered Only by Licensed Professionals'.
``(c) Requirements.--
``(1) Display.--A warning required under subsection (a) and
a statement required under subsection (b)(3) shall be
prominently displayed--
``(A) in the primary language used on the label;
and
``(B) in conspicuous and legible type in contrast
by typography, layout, or color with other material
printed or displayed on the label.
``(2) Minimum warning requirements.--A responsible person
may include on the labeling any additional warnings in addition
to the minimum warnings required under subsection (a).
``(d) Internet Sales.--In the case of internet sales of cosmetics,
each internet website offering a cosmetic product for sale to consumers
shall provide the same information, in an electronically readable
format, that is included on the packaging of the cosmetic product as
regularly available through in-person sales, except information that is
unique to a single cosmetic product sold in a retail facility, such as
a lot number or expiration date, and the warnings and statements
described in subsection (c) shall be prominently and conspicuously
displayed on the website.
``(e) Contact Information.--The label on each cosmetic shall bear
the manufacturer's toll-free domestic telephone number and electronic
contact information, and it is encouraged that the label include both
the telephone number and electronic contact information, that consumers
may use to contact the responsible person with respect to adverse
events. The contact number shall provide a means for consumers to
obtain additional information about ingredients in the designated
cosmetic, including the ability to ask if a specific ingredient may be
present that is not listed on the label and whether a specific
ingredient may be contained in the fragrance or flavor used in the
cosmetic. The manufacturer of the cosmetic is responsible for providing
such information, including obtaining the information from suppliers if
it is not readily available. Suppliers are required to release such
information upon request of the cosmetic manufacturer.''.
(b) Use of the Term ``Natural'' in Labeling.--The Food and Drug
Administration--
(1) in consultation with consumer protection stakeholders
and the scientific community, shall establish a definition of
the term ``natural'' with respect to the use of such term in
the labeling of cosmetics;
(2) not later than 1 year after the date of enactment of
this Act, shall issue proposed regulations setting forth such
definition; and
(3) not later than 2 years after such date of enactment,
issue final regulations setting forth such definition.
(c) Effective Date.--Section 612 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall take effect on the date
that is 1 year after the date of enactment of this Act.
SEC. 107. COAL TAR CHEMICALS.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 106, is further amended by adding
at the end the following:
``SEC. 613. COAL TAR CHEMICALS.
``Specific ingredients in coal tar hair dyes may be selected and
reviewed under section 607. If the Food and Drug Administration reviews
a coal-tar ingredient found in hair dye and makes a safety
determination under section 607(d) for such ingredient, such
determination shall include consideration for the safe use of such
ingredient through appropriate conditions of use, which may include a
specific label requirement, specified limits of concentrations, or
other such conditions of use as the Food and Drug Administration
determines appropriate, including a finding of not safe under any
conditions if appropriate.''.
SEC. 108. FRAGRANCE ALLERGEN DISCLOSURE.
(a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 107, is further
amended by adding at the end the following:
``SEC. 614. FRAGRANCE ALLERGENS.
``(a) Fragrance Allergens.--Not later than 2 years after the date
of enactment of the Personal Care Products Safety Act, the responsible
person shall include on the label of any cosmetic product containing
one or more fragrance allergens, a list of each such fragrance allergen
present in a rinse-off cosmetic at a concentration above 0.01 percent
(100 ppm) or present in a leave-on cosmetic product at a concentration
above .001 percent (10 ppm), in a form and manner as specified by the
Food and Drug Administration.''.
``(b) Identified Fragrance Allergens.--The fragrance allergens
required to be identified on a label of a cosmetic product pursuant to
subsection (a) include--
``(1) alpha-Isomethyl ionone;
``(2) amyl cinnamal;
``(3) amylcinnamyl alcohol;
``(4) anise alcohol;
``(5) benzyl alcohol;
``(6) benzyl benzoate;
``(7) benzyl cinnamate;
``(8) benzyl salicylate;
``(9) butylphenyl methylpropional;
``(10) cinnamal;
``(11) cinnamyl alcohol;
``(12) citral;
``(13) citronellol;
``(14) coumarin;
``(15) eugenol;
``(16) evernia prunastri (oak moss);
``(17) evernia furfuracea (tree moss);
``(18) farnesol;
``(19) geraniol;
``(20) hexyl cinnamal;
``(21) hydroxycitronellal;
``(22) hydroxyisohexyl 3-cyclohexene carboxaldehyde;
``(23) isoeugenol;
``(24) limonene;
``(25) linalool;
``(26) methyl 2-octynoate; and
``(27) other substances as identified by the Food and Drug
Administration in guidance issued pursuant to this section.
``(c) Guidance.--
``(1) Issuance.--Not later than one year after the date of
enactment of the Personal Care Products Safety Act, the Food
and Drug Administration shall issue guidance specifying the
form and manner of fragrance allergen listing on the label of
cosmetic products pursuant to subsection (a).
``(2) Content.--The guidance described in paragraph (1)
shall--
``(A) specify the form and manner of fragrance
allergen listing for cosmetic products where the
package or label is too small or otherwise is unable to
accommodate a label with sufficient space to bear the
information required for compliance with this section;
and
``(B) take into consideration requirements under
international regulations for fragrance allergen
labeling, as appropriate.
``(3) Updates.--The Food and Drug Administration may, as
appropriate, update the list of fragrance allergens to include
additional substances pursuant to guidance issued under this
subsection and taking into consideration international
regulations, as appropriate.
``(d) Contact Information.--
``(1) In general.--The contact information on the label on
a cosmetic product for consumers to report adverse events shall
also provide a means for consumers to obtain additional
information about the inclusion of any recognized fragrance
allergen required to be included on such label under subsection
(a).
``(2) Response.--
``(A) In general.--The responsible person shall--
``(i) upon receipt of a request for
information under paragraph (1), promptly
obtain and provide such information to the
requesting consumer; and
``(ii) in the case of information in the
possession of a supplier, promptly obtain such
information from such supplier, if reasonably
available.
``(B) Supplier.--A relevant supplier shall promptly
provide information requested to a responsible person
pursuant to subparagraph (A)(ii).''.
(b) Ingredient Statement.--Section 602 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 362), as amended by section 114(c), is
further amended by adding at the end the following:
``(i) If its labeling or packaging does not contain a listing of
ingredients that meets the requirements of section 614.''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to cosmetics introduced or delivered for
introduction into interstate commerce on or after the date that is 2
years after the date of enactment of this Act.
SEC. 109. SENSE OF THE SENATE ON ANIMAL TESTING.
(a) Animal Testing.--Chapter VI of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 361 et seq.), as amended by section 108, is
further amended by adding the following:
``SEC. 615. ANIMAL TESTING.
``It is the sense of the Senate that animal testing should not be
used for the purposes of safety testing on cosmetic products and should
be phased out with the exception of appropriate allowances.''.
SEC. 110. PREEMPTION.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 109, is further amended by adding
the following:
``SEC. 616. PREEMPTION.
``(a) In General.--No State or political subdivision of a State may
establish or continue in effect any requirement for cosmetics, other
than a requirement that is in full effect and implemented on the date
of enactment of the Personal Care Products Safety Act--
``(1) with respect to registration, good manufacturing
practices, mandatory recalls, or adverse event reporting; or
``(2) with respect to the safety of a cosmetic ingredient
or non-functional constituent that is the subject of a final
order on a determination of safety under this chapter, unless
the requirement of the State or political subdivision is more
restrictive than the final order under section 607(d)(3).
``(b) Safety of Cosmetic Ingredients and Non-Functional
Constituents.--
``(1) Delayed effect of new state requirements.--
``(A) In general.--From the date that the Food and
Drug Administration has made public the final selection
of a cosmetic ingredient or non-functional constituent
to be reviewed in the coming year under section
607(a)(3) and opened the public comment period under
section 607(a)(2), until the date that is one year
after the Food and Drug Administration has made public
such selection, no State or political subdivision of a
State may establish any new requirement related to such
cosmetic ingredient or non-functional constituent.
``(B) Initial review.--With respect to the cosmetic
ingredients to be reviewed in the first year, in
accordance with section 607(a)(3), for the 1-year
period beginning on the date that is 6 months after the
date of enactment of the Personal Care Products Safety
Act, no State or political subdivision of a State may
establish any new requirement related to such cosmetic
ingredient or non-functional constituent.
``(2) Scope.--Subsection (a)(2) shall not be construed to
affect the authority of a State or political subdivision of a
State with respect to any requirement for the safety of a
cosmetic ingredient or non-functional constituent that is
unrelated to the scope of the safety assessment under section
607.
``(3) Sense of congress.--It is the sense of Congress that
a State or political subdivision that regulates the safety of
cosmetics with respect to the health of humans beyond the scope
of section 607 should utilize the safety assessment criteria
described in section 607(h).
``(c) State Requirement That Is in Full Effect and Implemented.--
For purposes of this section:
``(1) State requirement.--A State requirement includes a
State requirement that is adopted by a State public initiative
or referendum.
``(2) Full effect and implemented.--The term `full effect
and implemented' includes requirements of States that are
implemented after the date of enactment of the Personal Care
Products Safety Act, if such requirements are under a law that
was in effect, or a lawful program that was established and
functioning, prior to the date of enactment of the Personal
Care Products Safety Act.
``(d) Limitation.--Nothing in the amendments to this Act made by
the Personal Care Products Safety Act shall be construed to preempt any
State statute, public initiative, referendum, or other State action,
except as expressly provided in this section.
``(e) Savings.--Nothing in the amendments to this Act made by the
Personal Care Products Safety Act, nor any standard, rule, requirement,
regulation, adverse event report, safety assessment, safety
determination, scientific assessment, or order issued or implemented
pursuant to such amendments, shall be construed to modify or otherwise
affect, preempt, or displace any cause of action or State or Federal
law creating a remedy for civil relief or criminal cause of action,
whether statutory or based in common law.
``(f) Sense of the Senate.--It is the sense of the Senate that
subsection (e) does not negate the other provisions of this section.''.
SEC. 111. REPORTING.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 110, is further amended by adding
at the end the following:
``SEC. 617. REPORTING.
``(a) Performance Report.--Not later than 1 year after the date of
enactment of the Personal Care Products Safety Act, and not later than
60 days prior to the end of each fiscal year for which fees are
collected under section 744O, the Food and Drug Administration shall
prepare and submit to Congress a report concerning the progress of the
Food and Drug Administration in achieving the objectives of the
Personal Care Products Safety Act during such fiscal year and the
future plans of the Food and Drug Administration for meeting the
objectives. The annual report for a fiscal year shall include--
``(1) the number of registered facilities and cosmetic
ingredient statements on file with the Food and Drug
Administration;
``(2) identification of the cosmetic ingredients and non-
functional constituents that have been fully reviewed for
safety by the Food and Drug Administration in the prior fiscal
year and for which a final administrative order has been
released;
``(3) identification of at least 5 specific cosmetic
ingredients and non-functional constituents that will be
reviewed by the Food and Drug Administration in the next fiscal
year;
``(4) the number of facilities inspected and mandatory
recalls that transpired during that fiscal year;
``(5) the number of serious adverse event reports received
by the Food and Drug Administration during that fiscal year;
and
``(6) any trends identified by the Food and Drug
Administration about adverse event reports related to specific
cosmetic ingredients or non-functional constituents.
``(b) Public Availability.--The Food and Drug Administration shall
make the reports required under subsection (a) available to the public
on the internet website of the Food and Drug Administration on the date
of submission of such reports to Congress.
``(c) Public Input on Safety Review.--Upon release of the report
described in subsection (a), the Food and Drug Administration shall
provide the public with an opportunity to provide feedback, at any time
during the year, on the identification of ingredients under subsection
(a)(3) by--
``(1) providing an electronic portal, upon release of the
report, enabling the public to--
``(A) comment on the cosmetic ingredients or non-
functional constituents under review for the current
year;
``(B) recommend additional cosmetic ingredients and
non-functional constituents to be considered for review
for safety in future years; and
``(C) comment on the priorities for the specific
cosmetic ingredients and non-functional constituents
that the Food and Drug Administration anticipates will
be reviewed in the next fiscal year;
``(2) announcing on the internet website of the Food and
Drug Administration, within the first 30 days of the new fiscal
year, any amendments to the list of cosmetic ingredients and
non-functional constituents submitted pursuant to subsection
(a)(3) based on public input, pursuant to paragraph (1); and
``(3) together with the final announcement of at least 5
specific cosmetic ingredients and non-functional constituents
that will be reviewed in the coming year under section 607,
providing a comment period for further public input, pursuant
to section 607(a)(2).''.
SEC. 112. SMALL BUSINESSES.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 111, is further amended by adding
at the end the following:
``SEC. 618. SMALL BUSINESSES.
``The Commissioner, in coordination with the Administrator of the
Small Business Administration, shall provide technical assistance, such
as guidance and expertise, to small businesses regarding compliance
with the Personal Care Products Safety Act, including the amendments
made by such Act.''.
SEC. 113. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 112, is further amended by adding
at the end the following:
``SEC. 619. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.
``In the case of a cosmetic product or a facility that is subject
to the requirements under this chapter and chapter V, if any
requirement under chapter V with respect to such cosmetic or facility
is substantially similar to a requirement under this chapter, the
cosmetic product or facility shall be deemed to be in compliance with
the applicable requirement under this chapter if such product or
facility is in compliance with such substantially similar requirement
under chapter V, provided that the product or facility has not obtained
a waiver from the requirement under chapter V. In the case of a
cosmetic product or facility that is subject to, and in compliance
with, a fee under subchapter C of chapter VII, other than a fee under
part 11 of such subchapter, any fee under such part 11 shall be waived
with respect to such cosmetic product or facility (with respect to
cosmetic products).''.
SEC. 114. ENFORCEMENT.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraph (e)--
(A) by striking ``504, 564,'' and inserting ``504,
564, 609, 610,''; and
(B) by striking ``519, 564,'' and inserting ``519,
564, 609,'';
(2) in paragraph (j), by inserting ``606, 607, 608,''
before ``704'';
(3) in paragraph (ii)--
(A) by striking ``760 or 761) or'' and inserting
``604, 760, or 761) or''; and
(B) by striking ``761) submitted'' and inserting
``761 or as described in section 609) submitted'';
(4) in paragraph (xx) by inserting ``or 611'' after
``423''; and
(5) by adding at the end the following:
``(fff) The failure to register in accordance with section 605, the
failure to provide any information required by section 605, or the
failure to update the information required by section 605, as
required.''.
(b) Adulteration.--Section 601 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the
following:
``(f) If the methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or holding do not conform to
current good manufacturing practice, as prescribed by the Food and Drug
Administration in accordance with section 608.
``(g) If it contains, after the date prescribed under section
607(e), an ingredient that the Food and Drug Administration has
determined under section 607(d)(4) to be not safe, or not safe under
the conditions of use recommended or suggested in the label or a non-
functional constituent that the Food and Drug Administration has
determined under section 607(d)(4) to be not safe or not safe in the
amount present in the cosmetic.
``(h) If it is a cosmetic product for which assurances regarding
safety substantiation have not been supplied under section
605(e)(2)(A)(xii).''.
(c) Misbranding.--Section 602 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 362) is amended--
(1) in paragraph (b)--
(A) by striking ``and (2)'' and inserting ``(2)'';
and
(B) by inserting ``; and (3) a domestic address or
a domestic telephone number, and it is encouraged that
the label include both a domestic address and a
domestic telephone number, through which the
responsible person may receive a report of an adverse
event associated with the use of such cosmetic
product'' after ``numerical count''; and
(2) by adding at the end the following:
``(g) If it has been manufactured or processed in any factory,
warehouse, or establishment and the responsible person, operator, or
agent of such factory, warehouse, or establishment delays, denies, or
limits an inspection, or refuses to permit entry or inspection.
``(h) If its labeling does not conform with a requirement under
section 612.''.
(d) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Food and Drug Administration shall issue guidance that
defines the circumstances that would constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection, for
purposes of section 602(g) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (c)(2).
(e) Imports.--Section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) is amended--
(1) by striking ``section 760 or 761'' the first, third,
and fourth place such term appears and inserting ``section 609,
760, or 761''; and
(2) by striking ``760 or 761)'' and inserting ``604, 760,
or 761)''.
(f) Factory Inspection.--Section 704(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by inserting
after the third sentence the following: ``In the case of any person who
manufactures, processes, distributes, or imports a cosmetic product, or
distributes a cosmetic product and affixes its name on the cosmetic
label, the inspection shall extend to all records and other information
described in section 610 (regarding inspection of cosmetic records),
when the standard for records inspections under paragraph (1) or (2) of
subsection (a) of such section applies, subject to the limitations
under subsections (d) and (e) of such section.''.
SEC. 115. CONSUMER INFORMATION.
The Food and Drug Administration shall post on its internet website
information for consumers regarding--
(1) final orders regarding the safety of a cosmetic
ingredient or non-functional constituent under section
607(d)(3) of the Federal Food, Drug, and Cosmetic Act;
(2) cosmetic product recalls (including voluntary and
mandatory recalls); and
(3) identified counterfeit cosmetic products.
SEC. 116. BAN ON PERFLUOROALKYL OR POLYFLUOROALKYL SUBSTANCES.
Not later than 6 months after the date of enactment of this Act,
the Food and Drug Administration shall issue a proposed rule to ban the
use of intentionally added perfluoroalkyl or polyfluoroalkyl substances
in cosmetics.
SEC. 117. COUNTERFEIT COSMETICS.
(a) Counterfeit Cosmetics Defined.--Section 201(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(i)) is amended--
(1) by striking ``(i) The term'' inserting ``(i)(1) The
term'';
(2) by striking ``(1) articles intended to be'' and
inserting ``(A) articles intended to be'';
(3) by striking ``(2) articles intended for use'' and
inserting ``(B) articles intended for use''; and
(4) by adding at the end the following:
``(2) The term `counterfeit cosmetic' means a cosmetic which, or
the container or labeling of which, without authorization--
``(A) bears the trademark, trade name, or other identifying
mark, imprint, or device, or any likeness thereof, of a
cosmetic manufacturer, processor, packer, or distributor other
than the person or persons who in fact manufactured, processed,
packed, or distributed such cosmetic; and
``(B) thereby falsely purports or is represented to be the
product of, or to have been packed or distributed by, such
other cosmetic manufacturer, processor, packer, or
distributor.''.
(b) Prohibited Act.--Section 301(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(i)) is amended--
(1) in subparagraph (2)--
(A) by inserting ``digital printer,'' after
``stone,'';
(B) by inserting ``cosmetic'' after ``drug or'';
and
(C) by inserting before the period at the end the
following: ``or such cosmetic a counterfeit cosmetic'';
and
(2) in subparagraph (3)--
(A) by inserting ``or a cosmetic to be a
counterfeit cosmetic'' after ``to be a counterfeit
drug''; and
(B) by inserting ``or counterfeit cosmetic'' before
the period at the end.
(c) Penalties.--Section 303(c)(5) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(c)(5)) is amended--
(1) by inserting ``digital printer'' after ``stone,'';
(2) by inserting ``or a cosmetic being a counterfeit
cosmetic'' after ``drug being a counterfeit drug''; and
(3) by inserting before the period at the end the
following: ``or the cosmetic was a counterfeit cosmetic''.
(d) Seizure.--Section 304(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334(a)(2)) is amended--
(1) by striking ``(B) Any container'' and all that follows
through ``(D) Any adulterated'' and inserting ``(B) Any
cosmetic that is a counterfeit cosmetic, (C) Any container of a
counterfeit drug or counterfeit cosmetic, (D) Any punch, die,
plate, stone, labeling, container, digital printer, or other
thing used or designed for use in making a counterfeit drug or
drugs or a counterfeit cosmetic or cosmetics, (E) Any
adulterated''; and
(2) by striking ``(E)'' and inserting ``(F)'' before ``Any
adulterated or misbranded tobacco product''.
(e) Examinations and Investigations.--Section 702(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 372(e)) is amended--
(1) in the matter preceding paragraph (1), by inserting
``or counterfeit cosmetics'' after ``counterfeit drugs'';
(2) in paragraph (4), by inserting ``or cosmetics'' after
``such drugs''; and
(3) in paragraph (5)--
(A) by striking ``drugs or containers'' and
inserting ``drugs, cosmetics, or containers''; and
(B) by inserting ``digital printers,'' after
``labeling,''.
TITLE II--FEES RELATED TO COSMETIC SAFETY
SEC. 201. FINDINGS.
Congress finds that the fees authorized by the amendments made by
this title will be dedicated to cosmetic safety activities, as set
forth in the goals identified for purposes of part 11 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the Chairman
of the Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record.
SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFETY FEES.
Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379f et seq.) is amended by adding at the end the
following:
``PART 11--FEES RELATING TO COSMETICS
``SEC. 744O. REGISTRATION FEE.
``(a) Assessment and Collection.--
``(1) In general.--Beginning in fiscal year 2022, the Food
and Drug Administration shall assess and collect an annual fee
from every responsible person (referred to in this section as a
`registrant') who owns or operates any facility (as defined in
section 604(3)) engaged in manufacturing or processing, or
whose name and address appear on the label of a cosmetic
product distributed in the United States, except that this
subsection shall not apply to contract manufacturers if a
responsible person has already paid the appropriate fee with
respect to the cosmetic product, to ensure no double fees are
paid.
``(2) Payable date.--A fee under this section shall be
payable during the period of initial registration and on the
date of registration each year thereafter as prescribed in
section 605(a)(1).
``(b) Definitions.--In this section:
``(1) Adjustment factor.--The term `adjustment factor'
applicable to a fiscal year means the Consumer Price Index for
all urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by such index for
October 2021.
``(2) Affiliate.--The term `affiliate' means any business
entity that has a relationship with a second business entity
if, directly or indirectly--
``(A) one business entity controls, or has power to
control, the other business entity; or
``(B) a third party controls, or has the power to
control, both of the business entities.
``(3) Cosmetic product.--The term `cosmetic product' has
the meaning given such term in section 604(2).
``(4) Cosmetic safety activities.--The term `cosmetic
safety activities'--
``(A) means activities related to compliance by
registrants under section 605 with the requirements of
this Act with respect to cosmetics, including--
``(i) administrative activities, such as
information technology support, human
resources, financial management, the
administration and maintenance of the cosmetic
registration system and the cosmetic ingredient
statement system under section 605, and fee
assessment and collection under this section;
and
``(ii) implementation and enforcement
activities, such as the establishment of good
manufacturing practices, the review of adverse
event reports, inspection planning and
inspections, and use of enforcement tools; and
``(B) includes activities related to implementation
of section 607, regarding the review of cosmetic
ingredients and non-functional constituents.
``(5) Gross annual sales.--The term `gross annual sales'
means the average United States gross annual sales for the
previous 3-year period of cosmetics for a registrant, including
the sales of all of its affiliates, as reported in the
registration under section 605.
``(c) Fee Setting and Amounts.--
``(1) In general.--Subject to subsection (d), the Food and
Drug Administration shall establish the fees to be collected
under this section for each fiscal year after fiscal year 2022,
based on the methodology described in paragraph (3), and shall
publish such fees in a Federal Register notice not later than
60 days before the beginning of each such fiscal year.
``(2) Fee exemption.--Any registrant whose gross annual
sales of cosmetic products in the 3-year period immediately
preceding the fiscal year for which the annual fee will be paid
was not more than $10,000,000, shall be exempt from
registration fees under this section for that fiscal year.
``(3) Annual fee setting.--For fiscal years 2022 through
2027, to generate a total estimated annual revenue amount of
$20,600,000, the amount of the registration fee under
subsection (a) shall be as follows:
``(A) Tier i-a.--For a registrant that has gross
annual sales of $5,000,000,000 or more in 2020,
$1,350,000.
``(B) Tier i-b.--For a registrant that has gross
annual sales of at least $4,000,000,000 per annum but
less than $5,000,000,000 in 2020, $850,000.
``(C) Tier ii-a.--For a registrant that has gross
annual sales of at least $3,000,000,000 per annum but
less than $4,000,000,000 in 2020, $730,000.
``(D) Tier ii-b.--For a registrant that has gross
annual sales of at least $2,000,000,000 per annum but
less than $3,000,000,000 in 2020, $610,000.
``(E) Tier iii-a.--For a registrant that has gross
annual sales of at least $1,000,000,000 per annum but
less than $2,000,000,000 in 2020, $500,000.
``(F) Tier iii-b.--For a registrant that has gross
annual sales of at least $500,000,000 per annum but
less than $1,000,000,000 in 2020, $395,000.
``(G) Tier iv-a.--For a registrant that has gross
annual sales of at least $200,000,000 per annum but
less than $500,000,000 in 2020, $325,000.
``(H) Tier iv-b.--For a registrant that has gross
annual sales of at least $100,000,000 per annum but
less than $200,000,000 in 2020, $275,000.
``(I) Tier v-a.--For a registrant that has gross
annual sales of at least $80,000,000 per annum but less
than $100,000,000 in 2020, $185,000.
``(J) Tier v-b.--For a registrant that has gross
annual sales of at least $60,000,000 per annum but less
than $80,000,000 in 2020, $95,000.
``(K) Tier vi-a.--For a registrant that has gross
annual sales of at least $40,000,000 per annum but less
than $60,000,000 in 2020, $15,000.
``(L) Tier iv-b.--For a registrant that has gross
annual sales of at least $20,000,000 per annum but less
than $40,000,000 in 2020, $12,000.
``(M) Tier vii-a.--For a registrant that has gross
annual sales of at least $10,000,000 per annum but less
than $20,000,000 in 2020, $500.
``(d) Adjustments.--
``(1) Inflation adjustment.--
``(A) In general.--For fiscal year 2023 and each
subsequent fiscal year, the revenues and fee amounts
under subsection (c)(3) shall be adjusted by the Food
and Drug Administration in the annual Federal Register
notice establishing fees in subsection (c)(1), by an
amount equal to the sum of--
``(i) one;
``(ii) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 of
the preceding 4 fiscal years for which data are
available, multiplied by the average proportion
of personnel compensation and benefits costs to
total Food and Drug Administration costs for
the first 3 years of the preceding 4 fiscal
years for which data are available; and
``(iii) the average annual percent change
that occurred in the Consumer Price Index for
urban consumers (Washington-Baltimore, DC6 MD-
VA-WV; not seasonally adjusted; all items less
food and energy; annual index) for the first 3
years of the preceding 4 years for which data
are available multiplied by the average
proportion of all costs other than personnel
compensation and benefits costs to total Food
and Drug Administration costs for the first 3
years of the preceding 4 fiscal years for which
data are available.
``(B) Compounded basis.--The adjustment made each
fiscal year under this subsection shall be added on a
compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2022 under this
subsection.
``(2) Final year adjustment.--For fiscal year 2027, the
Food and Drug Administration may, in addition to adjustments
under paragraph (1), further increase the fee revenues and fees
established in subsection (c) if such an adjustment is
necessary to provide for not more than 3 months of operating
reserves of carryover fees for cosmetic safety activities for
the first 3 months of fiscal year 2028. If such an adjustment
is necessary, the rationale for the increase, shall be
contained in the annual Federal Register notice establishing
fees, in subsection (c)(1), for fiscal year 2027. If the Food
and Drug Administration has carryover balances for such
activities in excess of 3 months of such operating reserves,
the adjustment under this subparagraph shall not be made.
``(3) Workload adjustment.--
``(A) In general.--For fiscal year 2023 and each
subsequent fiscal year, after fee revenues established
in subsection (c)(3) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee
revenues shall be adjusted further for each fiscal year
to reflect changes in the workload of the Food and Drug
Administration for actual changes in workload volume
due to the process of reviewing cosmetic ingredients or
non-functional constituents not listed under section
607(b).
``(B) Determination of adjustment.--The adjustment
shall be determined by the Food and Drug Administration
based on the workload in the most recent 1-year period
for which workload data is available. The Food and Drug
Administration shall publish in the Federal Register
the fee revenues and fees resulting from the adjustment
and the supporting methodologies.
``(C) Minimum revenues.--The adjustment shall not
result in fee revenues for a fiscal year that are less
than the sum of the amount under subsection (c)(3), as
adjusted for inflation under subparagraph (1).
``(e) Limitations.--
``(1) In general.--With respect to the amount that, under
the salaries and expenses account of the Food and Drug
Administration, is appropriated for a fiscal year for the
cosmetics program in the Center for Food Safety and Applied
Nutrition and related field activities, fees may not be
assessed under subsection (a) for the fiscal year unless the
amount so appropriated for the fiscal year (excluding the
amount of fees appropriated for the fiscal year), is equal to
or greater than that assessed for fiscal year 2021, multiplied
by the adjustment factor applicable to the fiscal year
involved.
``(2) Authority.--If the Food and Drug Administration does
not assess fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later date in
such fiscal year the Food and Drug Administration may assess
such fees, the Food and Drug Administration may assess and
collect such fees, without any modification in the rate, for
registration under section 605 at any time in such fiscal year.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for cosmetic safety activities.
``(2) Collections and appropriations acts.--
``(A) In general.--Subject to subparagraphs (C) and
(D), the fees authorized by this section shall be
collected and available in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation for such fiscal year.
``(B) Use of fees and limitation.--The fees
authorized by this section shall be collected and
available only to defray the costs of cosmetic safety
activities.
``(C) Fee collections during first program year.--
Until the date of enactment of an Act making
appropriations through September 30, 2020, for the
salaries and expenses account of the Food and Drug
Administration, fees authorized by this section for
fiscal year 2022 may be collected and shall be credited
to such account to remain available until expended.
Fees collected under this subparagraph shall be
considered discretionary for purposes of the Balanced
Budget and Emergency Deficit Control Act of 1985.
``(D) Reimbursement of start-up amounts.--Any
amounts allocated to establish programs under section
605, prior to collection of fees, may be reimbursed
through any appropriated fees collected under this
section, in such manner as the Food and Drug
Administration determines appropriate. Any amounts
reimbursed under this subparagraph shall be available
for the programs and activities for which funds
allocated to establish the programs were available,
prior to such allocation, until the end of the fiscal
year in which the reimbursement occurs, notwithstanding
any otherwise applicable limits on amounts for such
program or activities for a fiscal year.
``(3) Authorization of appropriations.--For each of fiscal
years 2022 through 2028, there are authorized to be
appropriated for fees under this section $20,600,000, as
adjusted by subsection (d).
``(4) Offset of overcollections; recovery of collection
shortfalls.--
``(A) Offset of overcollections.--If the sum of the
cumulative amount of fees collected under this section
for the fiscal years 2022 through 2026 exceeds the
cumulative amount appropriated pursuant to paragraph
(3) for fiscal years 2022 through 2027, the excess
amount shall be credited to the appropriation account
of the Food and Drug Administration as provided in
paragraph (1), and shall be subtracted from the amount
of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation
Acts for fiscal year 2028.
``(B) Recovery of collection shortfalls.--
``(i) 2024.--For fiscal year 2024, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2022 falls below the amount of
fees authorized for fiscal year 2022 under
paragraph (3).
``(ii) 2025.--For fiscal year 2025, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 221 falls below the amount of
fees authorized for fiscal year 2023 under
paragraph (3).
``(iii) 2026.--For fiscal year 2026, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2024 falls below the amount of
fees authorized for fiscal year 2024 under
paragraph (3).
``(iv) 2027.--For fiscal year 2027, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2025 falls below the amount of
fees authorized for fiscal year 2025 under
paragraph (3).
``(v) 2028.--For fiscal year 2028, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2026 falls below the amount of
fees authorized for fiscal year 2026 under
paragraph (3).
``(g) Effect of Failure To Pay Fees.--The Food and Drug
Administration shall not consider a registration submitted to be
complete until such fee under subsection (a) is paid. Until the fee is
paid, the registration is incomplete and the registrant is deemed to
have failed to register in accordance with section 605.
``(h) False Statements.--Any statement or representation made to
the Food and Drug Administration shall be subject to section 1001 of
title 18, United States Code.
``(i) Collection of Unpaid Fees.--In any case where the Food and
Drug Administration does not receive payment of a fee assessed under
subsection (a), such fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37 of title 31,
United States Code.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in cosmetic activities, be reduced to offset the
number of officers, employees, and advisory committees so engaged.
``(k) Records.--Each facility shall retain all records necessary to
demonstrate the facility's gross annual sales for at least 2 fiscal
years after such information is reported in the facility's
registration. Such records shall be made available to the Food and Drug
Administration for review and duplication upon request of the Food and
Drug Administration.''.
SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO
COSMETICS.
Part 11 of subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act, as added by section 202, is amended by inserting
after section 744O the following:
``SEC. 744P. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO
COSMETICS.
``(a) In General.--The Food and Drug Administration shall have
direct hiring authority with respect to the appointment of employees
into the competitive service or the excepted service to administer the
amendments made by title I of the Personal Care Products Safety Act.
``(b) Sunset.--The authority under subsection (a) shall terminate
on the date that is 3 years after the date of enactment of such
title.''.
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