[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5279 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 5279
To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic
safety, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 3, 2019
Mr. Pallone introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic
safety, and for other purposes.
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 ``Cosmetic Safety
Enhancement Act of 2019''.
(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 nonfunctional constituents; safety
of finished products.
Sec. 103. Good manufacturing practices for cosmetics.
Sec. 104. Adverse event reports.
Sec. 105. Records inspection; mandatory recall authority.
Sec. 106. Labeling and internet sales.
Sec. 107. Consumer information.
Sec. 108. Small businesses.
Sec. 109. Animal testing restrictions.
Sec. 110. Counterfeit cosmetics.
Sec. 111. Foreign supplier verification.
Sec. 112. Applicability with respect to certain cosmetics.
Sec. 113. Saving clause.
Sec. 114. Enforcement.
TITLE II--FEES RELATED TO COSMETIC PRODUCTS
Sec. 201. Findings.
Sec. 202. Authority to assess and use cosmetic product fees.
Sec. 203. Direct hiring authority to support activities related to
cosmetics.
Sec. 204. Sunset dates.
TITLE I--COSMETIC SAFETY
SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND COSMETIC INGREDIENT
STATEMENTS.
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) Animal test.--The term `animal test' means the
internal or external application or exposure of a cosmetic
product, cosmetic formulation, or cosmetic ingredient to the
skin, eyes, or other body part of a live non-human vertebrate
for the purpose of evaluating the safety of a cosmetic product,
cosmetic formulation, or cosmetic ingredient.
``(2) Contract manufacturer.--The term `contract
manufacturer' means a manufacturer (including the owner,
operator, or agent in charge (or any affiliate thereof)) of a
cosmetic ingredient, cosmetic formulation, or cosmetic product
that does not sell any such cosmetic ingredient, cosmetic
formulation, or cosmetic product unless there is a specific
contractual agreement in place with respect to that sale.
``(3) Cosmetic formulation.--The term `cosmetic
formulation' means a preparation of cosmetic raw materials with
a qualitatively and quantitatively set composition.
``(4) Cosmetic ingredient.--The term `cosmetic ingredient'
means any single chemical entity or mixture used as a component
in the manufacture of a finished cosmetic product or cosmetic
formulation.
``(5) Cosmetic product.--(A) The term `cosmetic product'
means a finished cosmetic comprised of a specified set of
cosmetic ingredients, which may come in a range of possible
amounts for each cosmetic ingredient and which may include a
variety of fragrances and colors, and in some specific cosmetic
applications, flavors.
``(B) Such term shall include tattoo ink whether or not
labeled as a finished cosmetic.
``(6) Facility.--The term `facility' includes any factory,
warehouse, or establishment (including a factory, warehouse, or
establishment of an importer or of any other entity whose name
and address appear on the label of a cosmetic product) that
manufactures, processes, packs, or holds cosmetic products or
cosmetic formulations. Such term does not include--
``(A) beauty shops and salons that do not otherwise
manufacture, process, or package cosmetic products or
cosmetic formulations at that location, including
beauty stores or counters that offer customized or
personalized cosmetic products or cosmetic formulations
tailored to individual consumers for sale solely in-
person;
``(B) cosmetic product retailers, including
individual sales representatives, direct sellers (as
defined in section 3508 of the Internal Revenue Code of
1986), retail distribution facilities, retail
franchises, retail warehouses, and pharmacies, that do
not otherwise manufacture, process, or package cosmetic
products or cosmetic formulations at that location;
``(C) entities that manufacture or compound
cosmetic products solely for use in research, teaching,
or pilot plant production and not for sale;
``(D) hospitals, physicians' offices, and health
care clinics;
``(E) hotels, airlines, and other entities that
provide complimentary cosmetic products to guests;
``(F) public health agencies and other nonprofit
entities that provide cosmetic products or cosmetic
formulations directly to the consumer; or
``(G) trade shows and other venues where cosmetic
product samples are provided free of charge.
``(7) Foreign facility.--The term `foreign facility' means
a facility that manufactures, processes, packs, or holds,
cosmetic products or cosmetic formulations that are exported to
the United States without further processing or packaging
inside the United States. A cosmetic product or cosmetic
formulation 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 product or cosmetic formulation.
``(8) Nonfunctional constituent.--The term `nonfunctional
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 product.
``(9) Professional.--With respect to a cosmetic product,
the term `professional' means--
``(A) a dermatologist or other health care
professional that administers or provides cosmetic
products to patients; or
``(B) a cosmetologist, nail technician, barber, or
esthetician who administers or provides cosmetics
within the scope of their business practices.
``(10) Professional use.--With respect to a cosmetic
product, the term `professional use' means a preparation of a
cosmetic formulation intended only for use by professionals in
settings such as cosmetology, nail care, barbering, esthetics,
health care, and other professions as determined by the
Secretary through regulation.
``(11) Responsible person.--The term `responsible person'
means the brand owner, operator, or agent in charge who is the
domestic or foreign manufacturer, processor, or entity whose
name appears on the label of a cosmetic product or a cosmetic
formulation distributed in the United States.
``SEC. 605. REGISTRATION OF COSMETIC FACILITIES.
``(a) Registration for Manufacturing and Processing Facilities.--
``(1) In general.--The owner, operator, or agent in charge
of (or an affiliate thereof) a facility engaged in
manufacturing, or processing, of a cosmetic product or a
cosmetic formulation distributed in the United States shall
register with the Secretary.
``(2) Electronic registration system.--The Secretary
shall--
``(A) maintain an electronic registration system
for purposes of this section; and
``(B) not later than one year after the date of
enactment of the Cosmetic Safety Enhancement Act of
2019, announce that such system is operational.
``(3) Initial registration of existing facilities.--Not
later than the date that is 6 months after the date of the
announcement required by paragraph (2)(B), each facility
engaged in an activity described in paragraph (1) shall be
registered under such paragraph.
``(4) Initial registration of new facilities.--In the case
of a facility that first engages in an activity described in
paragraph (1) on or after the date that is 18 months after the
date of enactment of the Cosmetic Safety Enhancement Act of
2019, such a facility shall register with the Secretary
immediately upon engaging in such activity.
``(5) Single registration.--The Secretary shall require
only a single registration per registration period for a
facility required to be registered under paragraph (1),
regardless of whether such facility is manufacturing or
processing--
``(A) its own cosmetic products or cosmetic
formulations; or
``(B) cosmetic products or cosmetic formulations on
behalf of more than one owner, operator, or agent in
charge (or affiliate thereof).
``(b) Registration for Packing or Holding Facilities.--Each
facility engaged in packing or holding a cosmetic product or cosmetic
formulation distributed in the United States shall register with the
Food and Drug Administration. Each such facility shall, not later than
6 months after the Secretary announces the establishment of an
electronic registration system for purposes of this section, submit a
registration utilizing such system.
``(c) Annual Registration Renewal.--A facility that continues to
engage in any activity that would require registration under subsection
(a) or (b) shall submit to the Secretary an annual registration during
the first quarter of the fiscal year for which such renewed
registration shall be effective.
``(d) Fees.--If the average gross annual sales of cosmetic products
in the United States of all of the facilities of the responsible person
registered under subsection (a)(1) for the previous 3-fiscal-year
period is greater than $1,000,000, a registration shall not be complete
under this subsection until the responsible person has paid any
registration fee required under section 744M.
``(e) Changes to Information.--A facility that submitted a
registration under this section shall notify the Secretary of any
change to the information required under subsection (a) or (b) not
later than 30 days after the date of such change, unless otherwise
specified by the Secretary.
``(f) Format; Contents.--
``(1) Electronic format.--Each registration shall be
submitted using an electronic format, as specified in a
registration form provided by the Secretary.
``(2) Contents.--The registration shall contain the
following information:
``(A) Each facility's name (including any parent
company of the facility) and full address, identifying
the precise physical location of the facility.
``(B) The identity of the facility, including the
unique facility identifier, if any, previously assigned
by the Secretary to the facility under subsection (i).
``(C) All business trading names used by the
facility.
``(D) The product category (as identified under
section 720.4(c) of title 21, Code of Federal
Regulations (or any successor regulation)), or other
cosmetic categories as determined appropriate by the
Secretary (including by guidance) 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.
``(E) The type or types of activities conducted at
the facility (such as manufacturing, processing,
packing, or holding).
``(F) The name, title, street address, telephone
number, and electronic contact information of the
emergency contact for the facility.
``(G) In the case of a foreign facility, the name,
street address, telephone number, emergency contact
information for the facility, the name of the United
States agent for the facility, and the phone number and
electronic contact information of the United States
agent.
``(H) The name, title, street address, telephone
number, and electronic contact information of the
individual submitting the registration.
``(I) An assurance that the Secretary will be
permitted to inspect such facility at the times and in
the manner permitted by this Act.
``(J) Additional information pertaining to the
facility or to the cosmetic products or cosmetic
formulations manufactured, processed, packed, or held
at the facility, or on whose label the facility's name
and address appear, including all brand names known to
consumers, as the Secretary may require by regulation.
``(3) Abbreviated registration.--The Secretary shall
provide for an abbreviated registration renewal process for any
facility that has not had any changes to the information
submitted by the facility for the preceding registration.
``(g) Incomplete or Inaccurate Registration.--
``(1) In general.--Subject to paragraph (2), the Secretary
may cancel a registration of a facility under this section if--
``(A) the Secretary has reasonable grounds to
believe that the registration was not properly
completed or updated in accordance with this section;
``(B) a required registration fee has not been paid
within 30 days; or
``(C) the registration otherwise contains false,
incomplete, or inaccurate information.
``(2) Notification.--The Secretary shall, at least 10 days
before canceling a registration pursuant to paragraph (1),
provide notice to the facility of the intent of the Secretary
to cancel such registration that contains the Secretary's basis
for the determination to so cancel the registration.
``(3) Timely update or correction.--If, not later than 7
days after receipt of a notice of intent to cancel under
paragraph (2), the facility corrects the registration in
accordance with the basis for the cancellation, and the
required registration fee, if any, is paid, the Secretary shall
not cancel such registration.
``(h) Unique Identifier.--At the time of the initial registration
of any cosmetic facility under this section, the Secretary shall assign
a unique identifier to the facility and provide such identifier to such
facility in writing.
``(i) Registry of Facilities.--
``(1) In general.--The Secretary 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 an owner, operator, or agent in charge
of (or an affiliate thereof) a facility engaged in
manufacturing, processing, packing, or holding a cosmetic
product or formulation, or a facility owned by such person, or
that discloses specific facilities where specific brands of
cosmetic products are manufactured or processed shall not be
subject to disclosure under section 552 of title 5, United
States Code.
``SEC. 606. COSMETIC INGREDIENT STATEMENTS.
``(a) In General.--For each cosmetic product, the responsible
person shall submit to the Secretary a cosmetic ingredient statement,
at such time and in such manner as the Secretary may prescribe. The
cosmetic ingredient statement shall not become effective until the
responsible person pays any applicable fee required under section 744M.
``(b) Submission of a Cosmetic Ingredient Statement.--
``(1) Existing cosmetic products.--In the case of a
cosmetic product or cosmetic formulation that is marketed on
the date of enactment of the Cosmetic Safety Enhancement Act of
2019, the responsible person shall--
``(A) not later than the date that is 6 months
after the date of the announcement of an electronic
registration system required by section 605, submit to
the Secretary a cosmetic ingredient statement in
accordance with this section; and
``(B) beginning one year after the ingredient
statement is submitted under subparagraph (A) and each
year thereafter, submit to the Secretary a renewal of
such statement, consistent with the requirements in
subsection (e), during the first quarter of the fiscal
year for which such renewed statement is applicable.
``(2) Cosmetic ingredient statement for new cosmetic
products.--
``(A) In general.--Except as provided under
subparagraph (B), in the case of a cosmetic product or
cosmetic formulation that is first marketed after the
date of enactment of the Cosmetic Safety Enhancement
Act of 2019 or a cosmetic product or cosmetic
formulation that is reformulated after such date of
enactment, the responsible person shall--
``(i) submit to the Secretary a cosmetic
ingredient statement prior to first marketing
the new cosmetic product, new cosmetic
formulation, or the reformulated cosmetic
product or reformulated cosmetic formulation;
and
``(ii) beginning one year after the
ingredient statement is submitted under clause
(i), submit to the Secretary annually
thereafter a renewal of such statement during
the first quarter of the fiscal year for which
the cosmetic ingredient statement is
applicable, consistent with the requirements in
subsection (e).
``(B) Small businesses.--In the case of a
responsible person that is a small business, the
Secretary shall allow such responsible person to have
an additional time period, of a duration to be
determined by the Secretary, in which to submit the
first cosmetic ingredient statement under subparagraph
(A). Such responsible person shall, consistent with the
requirements in subsection (e), submit a cosmetic
ingredient statement annually thereafter during the
first quarter of the applicable fiscal year.
``(C) Applicability.--In applying subparagraph (A),
a cosmetic product or cosmetic formulation shall not be
considered to be first marketed or reformulated after
the date of enactment of the Cosmetic Safety
Enhancement Act of 2019 if the only change in such
product or formulation is--
``(i) a change in the amount of an existing
ingredient that is previously reported under
subsection (c)(2)(E); or
``(ii) the addition or subtraction of a
fragrance, flavor, or color, or such other
interchangeable ingredients specified by the
Secretary in regulations or guidance,
previously reported as a potential ingredient
under subsection (c)(2).
``(3) Abbreviated renewal.--The Secretary shall provide for
an abbreviated process for the renewal of any cosmetic
ingredient statement under this subsection with respect to
which there has been no change since the responsible person
submitted the previous statement.
``(c) Format; Contents.--
``(1) Form.--For each cosmetic ingredient statement
submitted with respect to a cosmetic product or cosmetic
formulation under this section, such statement shall be
submitted using an electronic format, in a form specified by
the Secretary.
``(2) Contents.--Each such cosmetic ingredient statement
shall include the following information:
``(A) The unique identifier, assigned under section
605(h), as applicable, of--
``(i) the facility or facilities where the
cosmetic product or cosmetic formulation is
manufactured, processed, packed, or held or, if
the same cosmetic product or cosmetic
formulation is manufactured, processed, packed,
or held in more than one facility, the unique
facility identifier of each facility where it
is manufactured, processed, packed, or held;
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 or cosmetic formulation as it appears
on the label.
``(C) The listing number, if any, previously
assigned by the Secretary under subsection (f) to the
cosmetic product or cosmetic formulation.
``(D) The applicable cosmetic category for the
cosmetic product or cosmetic formulation.
``(E) A list of ingredients in the cosmetic product
or cosmetic formulation that--
``(i) with respect to each such ingredient,
the name adopted in regulations promulgated by
the Secretary, if any, or by the common or
usual name of the ingredient;
``(ii) is consistent with the regulations
promulgated by the Food and Drug Administration
related to cosmetic labeling requirements; and
``(iii) contains a list of fragrances,
flavors, and colors that may be included in the
product, interchangeably, which shall include--
``(I) in the case of fragrances,
each fragrance allergen contained in
the cosmetic product as described in
section 615, and for fragrances that
are purchased from a fragrance
supplier, the fragrances shall be
identified by the name or code provided
by the supplier, and include the name
and contact information for the
fragrance supplier; and
``(II) in the case of flavors that
are purchased from a flavor supplier,
the flavors shall be identified by the
name or code provided by the supplier,
and include the name and contact
information for the flavor supplier;
``(iv) other appropriate interchangeable
ingredients as the Secretary may specify in
regulations or guidance that may be included in
the product; and
``(v) in the case of an ingredient (other
than a fragrance, flavor, or color) that has
been designated for review under section 608,
includes potential ranges and amounts of such
ingredient.
``(F) The title and full contact information of
each individual submitting the statement.
``(G) If applicable, information on labeling
required under section 614.
``(H) Such additional information pertaining to the
cosmetic product as the Secretary may require by
regulation.
``(3) Confidentiality.--Fragrance ingredients included in a
cosmetic ingredient statement under paragraph (2)(E), other
than fragrance allergens, shall be treated as confidential
commercial or trade secret information.
``(4) Contract manufacturing organization facilities.--If a
facility manufactures or processes cosmetic products or
cosmetic formulations on behalf of an owner, operator, or agent
in charge whose name appears on the label of such products or
formulations, the Secretary shall require only a single
cosmetic ingredient statement for such cosmetic product. Such
single cosmetic ingredient statement shall be submitted to the
Secretary by the responsible person.
``(5) Cosmetic ingredient statement for certain small
businesses.--
``(A) In general.--Notwithstanding any other
provision of this subsection, in the case of a
responsible person that has had an average of less than
$1,000,000 in annual domestic cosmetic sales over the
previous 3 years, the Secretary may allow such
responsible person--
``(i) to submit a simplified cosmetic
ingredient statement under this section; and
``(ii) an additional time period, of a
duration to be determined by the Secretary, in
which to submit such simplified cosmetic
ingredient statement.
``(B) Contents.--A responsible person described in
subparagraph (A) shall include in each cosmetic
ingredient statement submitted under this section, at a
minimum--
``(i) a list of ingredients in the cosmetic
product or cosmetic formulation, including any
fragrance allergens as described in section
615;
``(ii) the applicable cosmetic category for
the cosmetic product or cosmetic formulation;
and
``(iii) in the case of a cosmetic product
or cosmetic formulation that includes a
fragrance or flavor purchased from a fragrance
or flavor supplier, the contact information for
the fragrance or flavor supplier, including the
supplier's name, street address, telephone
number, and electronic contact information.
``(d) Incomplete or Inaccurate Cosmetic Ingredient Statement.--
``(1) In general.--Not earlier than 30 days after providing
notice under paragraph (2) and subject to paragraph (3), the
Secretary may nullify a cosmetic ingredient statement submitted
under this section if the Secretary has reasonable grounds to
believe that, except for minor or immaterial errors, the
cosmetic ingredient statement was not completed or updated in
accordance with this section or otherwise contains false,
incomplete, or inaccurate information.
``(2) Notice of nullification.--If the Secretary nullifies
a cosmetic ingredient statement under paragraph (1), the
Secretary shall provide to the responsible person submitting
such cosmetic ingredient statement under this section notice of
any such nullification, including the basis for such
nullification.
``(3) Timely update or correction.--In the case of a
cosmetic ingredient statement with respect to which the
Secretary has provided notice under paragraph (2), the
Secretary shall not nullify such cosmetic ingredient statement
if the cosmetic ingredient statement is appropriately updated
or corrected not later than 10 days after the date on which
such notice is provided.
``(4) Effect of nullification.--No person shall import,
export, or otherwise distribute any cosmetic product or
cosmetic formulation that is the subject of a cosmetic
ingredient statement that is nullified under this subsection.
``(e) Additional Requirements.--
``(1) Safety requirements.--In submitting a cosmetic
ingredient statement for each cosmetic product or cosmetic
formulation under this section, a responsible person shall
include an attestation that the safety of the product or
formulation, including the individual ingredients of such
product or formulation, has been substantiated in accordance
with section 609.
``(2) Changes to information.--Not later than 90 days after
any change to the information required to be in a cosmetic
ingredient statement under this section, the responsible person
shall notify the Secretary of such change, including the
discontinuation of the manufacture of a cosmetic product. Such
notification is not required for a change described in
subsection (b)(2)(C).
``(f) Cosmetic Products List.--
``(1) Listing number.--At the time of the initial
submission of any cosmetic ingredient statement under this
section, the Secretary shall--
``(A) assign a unique cosmetic product listing
number to the cosmetic ingredient statement; and
``(B) provide such number to the responsible person
who submitted such statement in writing.
``(2) Cosmetic products list.--Using cosmetic ingredient
statements submitted under this section, the Secretary shall--
``(A) compile and maintain a list of cosmetic
products or cosmetic formulations distributed in the
United States, including the ingredients of each such
product or formulation; and
``(B) upon request of any State, shall make such
list available to such State.
``(3) Confidentiality.--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. Such State and its
employees in possession of such information shall be subject to
the same laws governing information disclosure as employees of
the Food and Drug Administration.
``(g) Exemption.--A responsible person shall be exempt from the
requirements of this section if such person has had an average of less
than $500,000 in annual domestic cosmetic product sales over the
previous three years. Such exemption shall not apply to cosmetic
products that are intended to be injected under the skin or into the
eye, including tattoo ink, or ingredients selected by the Food and Drug
Administration for review under section 608 if such ingredient is
included in a cosmetic product or cosmetic formulation distributed by
such person described.
``SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC INGREDIENT
STATEMENT.
``(a) Suspension of Registration of a Facility.--If the Secretary
determines that a cosmetic product or cosmetic formulation
manufactured, processed, packed, or held by a facility registered under
section 605 has a reasonable probability of causing serious adverse
health consequences or death to humans, the Secretary may suspend the
registration of such facility.
``(b) Suspension of Cosmetic Ingredient Statement.--If the
Secretary determines that a cosmetic product or cosmetic formulation
manufactured in a registered facility has a reasonable probability of
causing serious adverse health consequences or death to humans, the
Secretary may suspend the cosmetic ingredient statement of that product
or formulation.
``(c) Notice of Suspension.--Before suspending the registration of
a facility or a cosmetic ingredient statement under this section, the
Secretary shall provide--
``(1) notice to the facility or responsible person, as
appropriate, of the intent to suspend such registration or the
cosmetic ingredient statement, which shall specify the basis of
the determination by the Secretary for that suspension; and
``(2) an opportunity, within 2 business days of the notice
provided under paragraph (1), for the facility or responsible
person that is the subject of such notice, as appropriate, to
address the reasons for possible suspension of the registration
of the facility or cosmetic ingredient statement.
``(d) Reinstatement.--Upon a determination by the Secretary that
adequate grounds do not exist to continue the suspension actions under
subsection (a) or (b), the Secretary shall promptly vacate the
suspension and reinstate the registration of the facility or the
cosmetic ingredient statement.
``(e) Effect of Suspension.--If the registration of a facility is
suspended under this section, no person shall import or export
cosmetics or otherwise distribute cosmetic products or cosmetic
formulations from such facility.
``(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 NONFUNCTIONAL CONSTITUENTS; SAFETY
OF FINISHED PRODUCTS.
(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. 608. REVIEW OF INGREDIENTS AND NONFUNCTIONAL CONSTITUENTS.
``(a) Ingredients and Nonfunctional Constituents Subject To
Review.--
``(1) In general.--Not later than 3 years after the date of
the enactment of the Cosmetic Safety Enhancement Act of 2019,
the Secretary shall review the safety of cosmetic ingredients
or nonfunctional constituents (or categories thereof). Upon the
completion of such review, the Secretary shall issue an order
under subsection (d) with respect to the use of each such
ingredient (or a category thereof) and presence of each such
nonfunctional constituent in cosmetic products or cosmetic
formulations (or a category thereof).
``(2) Ingredients and nonfunctional constituents to be
reviewed.--The Secretary shall select and complete a review, on
an ongoing basis, of cosmetic ingredients or nonfunctional
constituents that were not reviewed in the prior 3 years. Such
ingredients or nonfunctional constituents, including any
classes of ingredients or nonfunctional constituents, should be
selected after consultation with stakeholders, including
industry and consumer groups.
``(3) Process for review.--The Secretary shall--
``(A) publish in the Federal Register a list of the
ingredients, nonfunctional constituents (or categories
thereof) identified for review under paragraph (2); and
``(B) open a public docket to solicit public input
and data relevant to the safety of the ingredients,
nonfunctional constituents (or classes or categories
thereof) so listed for a period of not less than 60
days.
``(4) Public comment.--Comments may be submitted to the
Secretary at any time with respect to the safety of cosmetic
ingredients or nonfunctional constituents (or categories
thereof), regardless of whether such ingredients or
constituents (or categories thereof) have been selected for
review under this subsection.
``(b) Reviewed Ingredients and Nonfunctional Constituents.--The
Secretary shall maintain a list, posted on the internet website of the
Food and Drug Administration, of each cosmetic ingredient,
nonfunctional constituent, and category of ingredients or nonfunctional
constituents for which final orders have been issued under subsection
(d)(3), and with respect to each such ingredient or nonfunctional
constituent--
``(1) the finding made for each such ingredient,
nonfunctional constituent, or category under subsection (d)(4),
as modified by any order under subsection (e); and
``(2) if applicable, compliance dates that are the subject
of a final order under subsection (d)(3).
``(c) Initiative of the FDA.--The Secretary may, at any time,
propose the issuance of an order on the safety of a cosmetic ingredient
or nonfunctional constituent (or category thereof) that was not
previously listed pursuant to subsection (a).
``(d) Determination on Safety.--
``(1) Proposed administrative order.--Following
consideration of data and comments to the public docket opened
under subsection (a)(3) and any other information before the
Secretary with respect to the safety of a cosmetic ingredient
or nonfunctional constituent (or category thereof), the
Secretary shall--
``(A) determine whether there is adequate evidence
to make an initial finding for purposes of making a
determination described in paragraph (4);
``(B) if the Secretary determines that there is
adequate evidence to make such a finding, issue a
proposed administrative order containing the
Secretary's initial determination on the safety of such
ingredient or nonfunctional constituent (or category
thereof) as described in paragraph (4) 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; and
``(C) in the case of a proposed administrative
order in which the Secretary makes a determination
described in subparagraph (B) or (C) of paragraph (4),
include in such order a compliance date.
``(2) Public comment.--The Secretary shall open a public
docket for the submission of public comments (including
comments on whether any proposed compliance date included in
such order is feasible)--
``(A) in the case of a proposed administrative
order under paragraph (1), for a period of not less
than 60 days, beginning on the date of the issuance of
the order; or
``(B) in the case of a final administrative order
under paragraph (3), for a period of not less than 60
days, beginning on the date that is at least 60 days
before the effective date of the order.
``(3) Final administrative order.--Following the public
comment period under paragraph (2) and consideration of
comments to the public docket under such paragraph and any
other information before the Secretary, the Secretary shall--
``(A) determine whether there is adequate evidence
to make an initial finding for purposes of making a
determination described in paragraph (4);
``(B) if the Secretary determines that there is
adequate evidence to make such a final finding, the
Secretary 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; and
``(C) in the case of a final administrative order
in which the Secretary makes the determination
described in subparagraph (B) or (C) of paragraph (4),
include in such order a compliance date.
``(4) Determinations.--In a proposed administrative order
issued under paragraph (1) or a final administrative order
issued under paragraph (3), as applicable, the Secretary shall
make a determination that the ingredient or nonfunctional
constituent is--
``(A) safe in cosmetic products without the need
for specified conditions of use or tolerances;
``(B) safe in cosmetic products under specified
conditions of use or tolerances; or
``(C) not safe in cosmetic products.
``(5) Conditions of use and tolerances.--An order under
paragraph (4)(B) shall include such conditions on the use of an
ingredient or such tolerances on the presence of a
nonfunctional constituent (or category thereof) as are
necessary for the safety of cosmetic products containing such
ingredient or nonfunctional constituent (or category thereof),
including--
``(A) limits on the amount or concentration of the
ingredient or nonfunctional constituent (or category
thereof) that may be present in a cosmetic product,
including limits in products intended for children,
pregnant women, and other vulnerable populations, and
limits on use near the eye or mucosal membranes;
``(B) warnings that are necessary or appropriate
under section 614, 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 nonfunctional constituent (or a
category thereof); and
``(C) such other conditions as are necessary for
the safety of cosmetic products containing such
ingredient or nonfunctional constituent (or category
thereof).
``(6) Contents of order.--A final administrative order
under this subsection shall--
``(A) set forth the determination of the Secretary
on safety;
``(B) include a summary of the valid scientific
evidence supporting the determination;
``(C) include any conditions of use or tolerances
under paragraph (4)(B); and
``(D) be effective upon its publication on the
internet website of the Food and Drug Administration
and shall be considered final agency action unless a
later compliance date is otherwise specified.
``(e) Modification of an Order.--An order issued under subsection
(d) may be modified or revoked by the Secretary on the initiative of
the Secretary or in response to a petition.
``(f) Inadequate Evidence.--
``(1) Notice; extension.--If the Secretary determines that
available data and information are not adequate to make a
proposed or final determination under subsection (d), with
respect to the safety of a cosmetic ingredient or nonfunctional
constituent (or a category thereof), the Secretary shall--
``(A) publish such determination on the internet
website of the Food and Drug Administration not later
than 180 days after the close of the relevant comment
period for the ingredient or nonfunctional constituent
(or category thereof) under paragraph (2) or (3) of
subsection (d), as applicable; and
``(B) include in such publication a notice
providing interested persons an additional 30 days from
the date on which the notice is published to provide
additional data and information and an opportunity for
a meeting pursuant to paragraph (2).
``(2) Meetings.--The Secretary may offer a responsible
person of such cosmetic ingredient or nonfunctional constituent
(or category thereof) a confidential meeting with respect to a
finding under paragraph (1), to discuss matters relating to the
data and information requirements to support a determination of
safety of such ingredient or nonfunctional constituent (or
category thereof), which may involve confidential information.
Such meeting should be convened in a reasonable time period
agreed upon between the responsible person and the Secretary.
``(3) Determination; order.--
``(A) Inadequate data and information.--If the
Secretary determines that the available data and
information are not adequate to make a proposed or
final determination under subsection (d) with respect
to the safety of a cosmetic ingredient or nonfunctional
constituent (or category thereof), the Secretary
shall--
``(i) publish such finding on the internet
website of the Food and Drug Administration not
later than 180 days after the close of the
relevant comment period for the ingredient or
nonfunctional constituent (or category thereof)
under paragraph (2) or (3) of subsection (d),
as applicable; and
``(ii) include in such publication a notice
providing interested persons an additional 30
days from the date on which the notice is
published to provide additional data and
information and an opportunity for a meeting
pursuant to paragraph (2).
``(B) Adequate data and information.--If the
Secretary determines, after considering any additional
data and information submitted pursuant to paragraph
(1)(B), that the available data and information are
adequate to make a determination with respect to the
safety of a cosmetic ingredient or nonfunctional
constituent (or category thereof), the Secretary
shall--
``(i) in the case of a determination
described in subparagraph (A) of subsection
(d)(4), within 180 days of the close of the
applicable comment period under subsection
(d)(2), issue a final administrative order,
with respect to such cosmetic ingredient or
nonfunctional constituent (or category
thereof), in accordance with subsection (d)(3);
``(ii) in the case of a determination
described in subparagraph (B) of subsection
(d)(4), within 180 days of the close of the
applicable comment period under subsection
(d)(2), issue a proposed administrative order,
followed by a final administrative order, with
respect to such cosmetic ingredient or
nonfunctional constituent (or category
thereof), in accordance with subsection (d)(3);
and
``(iii) in the case of a determination
described in subparagraph (C) of subsection
(d)(4), within 180 days of the close of the
applicable comment period under subsection
(d)(2), issue a final administrative order,
with respect to such cosmetic ingredient or
nonfunctional constituent (or category
thereof), in accordance with subsection (d)(3)
specifying the date by which sale of such
ingredient or nonfunctional constituent must
cease.
``(g) Safety Assessment Standards.--
``(1) In general.--In assessing the safety of an ingredient
or nonfunctional constituent (or category thereof) under this
section, the Secretary shall consider--
``(A) whether there is adequate evidence to support
a reasonable certainty among competent scientists
that--
``(i) in the case of a cosmetic ingredient,
the ingredient is not harmful under the
recommended or suggested conditions of use or
customary or usual use; or
``(ii) in the case of a nonfunctional
constituent, that the nonfunctional constituent
is not harmful under the recommended or
suggested tolerance levels or the level at
which it is customarily or usually present;
``(B) the probable human exposure to the ingredient
or nonfunctional constituent (or category thereof) from
expected use in cosmetic products and cosmetic
formulations;
``(C) the probable cumulative and aggregate effect
in humans of relevant exposure to the ingredient or
nonfunctional constituent (or category thereof) 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 are available for analysis, and if
appropriate, available information on the total
exposure to a cosmetic ingredient or nonfunctional
constituent from all sources; and
``(D) whether warnings or recommendations in a
cosmetic product label, as part of any conditions of
use or tolerances imposed by the Secretary in a
determination described in subparagraph (B) of
subsection (d)(4), would be necessary and appropriate
to help ensure the safety of the ingredient or
nonfunctional constituent (or category thereof).
``(2) Minor adverse reactions.--The Secretary may not
consider a cosmetic ingredient or nonfunctional constituent (or
category thereof) harmful under paragraph (1) solely because it
can cause minor adverse health reactions, such as minor
transient allergic reactions or minor transient skin
irritations, in some users.
``(3) Data and information.--
``(A) Required information.--A determination that a
cosmetic ingredient or nonfunctional constituent (or
category thereof) is safe in cosmetics under this
section shall be based upon adequate evidence submitted
or otherwise known to the Secretary, which shall
include full reports of all available studies,
published or unpublished, that are adequately designed
to show whether the ingredient or nonfunctional
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
Secretary shall consider any other relevant information
related to the safety of a cosmetic ingredient or
nonfunctional constituent (or category thereof),
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 nonfunctional
constituent (or category thereof) is lawfully
used or present in other products regulated by
the Secretary, the scientific basis for such
use; and
``(iv) experience with the ingredient or
nonfunctional constituent (or category thereof)
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 nonfunctional constituent over time.
``(h) Coal Tar Hair Dye.--In assessing for purposes of this section
the safety of coal tar hair dye or any ingredient or nonfunctional
constituent therein, the Secretary shall not make a determination that
the dye, ingredient, or nonfunctional constituent is not safe for use
in cosmetic products solely because the dye, ingredient, or
nonfunctional constituent can cause allergic reactions.
``SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS.
``(a) Determination.--
``(1) In general.--Each responsible person for a finished
cosmetic product shall, before first distributing the product
for sale, make a written determination that the product is safe
under the conditions of use recommended in the labeling of the
product. Such determination shall be based on adequate evidence
that--
``(A) each ingredient in the finished product is
safe for the use recommended or suggested in the
labeling of the product and for the customary or usual
use of the product; and
``(B) the finished product is safe.
``(2) New information.--If new information relevant to the
determination becomes available, the responsible person shall
promptly update the determination to address that information.
``(b) Presumption of Adequate Evidence.--
``(1) In general.--Except as provided in subsection (c), a
determination made under subsection (a) with respect to a
finished cosmetic product shall be presumed to be based on
adequate evidence if it is supported by--
``(A) with respect to each ingredient in the
finished cosmetic product--
``(i) references to an official statement
by one or more expert medical or scientific
bodies that the ingredient is safe under the
conditions of use recommended or suggested in
the product's labeling or under such conditions
of use as are customary or usual; or
``(ii) appropriate safety testing of the
ingredient; and
``(B) appropriate safety substantiation of the
finished cosmetic product beyond the safety
substantiation of individual ingredients and
consideration of the combination of ingredients.
``(2) Statement of an expert medical or scientific body.--
For purposes of applying paragraph (1)(A)(i), a statement of an
expert medical or scientific body is an official statement of
that body, if--
``(A) the medical or scientific body is a Federal,
State, national, or international entity with
recognized expertise in chemical or cosmetic safety, or
other similarly recognized body composed of scientific
and medical experts;
``(B) the statement is based upon adequate data to
support the finding of safety, and such data are
available to the Secretary; and
``(C) the statement is published and endorsed by
the medical or scientific body and is not a statement
of an employee of such body made in the individual
capacity of the employee.
``(c) Rebuttal of Presumption.--Notwithstanding subsection (b), a
determination under subsection (a) will not be presumed to be based on
adequate evidence if--
``(1) the Secretary issues an order under section 608 that
an ingredient or nonfunctional constituent in the finished
product is not safe under the product's conditions of use or
customary or usual use; or
``(2) the Secretary has provided the manufacturer with
notice that--
``(A) the manufacturer has not met the criteria
under subsection (b); or
``(B) the Secretary has information that raises
significant questions about the safety of the product
or any of its ingredients.
``(d) Timely Update.--Upon notice of inadequate evidence under
subsection (c), the responsible person shall have 10 days to submit
additional evidence to the Secretary regarding the safety of an
ingredient, nonfunctional constituent, or the entire cosmetic product,
and the Secretary shall have 30 days from the date of receipt of such
additional evidence to provide the responsible person with notice that
the criteria under subsection (b) have been met or not met.
``(e) Records Maintenance.--The responsible person shall maintain
records documenting the determination required under this section and
the information on which it is based until 5 years after the finished
product is no longer marketed.
``(f) Submission of Records.--
``(1) In general.--The records required under subsection
(e) shall, upon the written request of the Secretary to the
responsible person, be provided to the Secretary within a
reasonable timeframe not to exceed 30 days, in electronic form.
``(2) Criteria.--The Secretary may require records under
paragraph (1) if--
``(A) the Secretary 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;
``(ii) scientific information raises
credible and relevant questions about the
safety of the product or any of its
ingredients;
``(iii) the determination required under
subsection (a) is not supported by adequate
evidence; or
``(iv) one or more of the criteria to
establish a presumption of adequate evidence of
safety in subsection (b) has not been
satisfied;
``(B) the Secretary, 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 Secretary concludes that submission of
the records will serve the public health or otherwise
enable the Secretary to fulfill the cosmetic safety
purposes of this section.
``(g) Guidance and Regulations.--
``(1) In general.--The Secretary shall issue guidance
describing the evidence necessary to support a determination
under subsection (a), and may, by regulation, establish
exemptions to the requirements of this section, if the
Secretary determines that such exemptions are supported by
adequate evidence and would have no adverse effect on public
health.
``(2) Small businesses.--The Secretary 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. Such guidance shall include
specific examples of options for compliance that do not place
an undue burden on small businesses.''.
(b) Effective Date.--Section 609 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall take effect 180 days
after the date of enactment of this Act.
(c) Public Meeting and Guidance.--
(1) Public meeting.--Not later than 12 months after the
date of the enactment of this Act, the Secretary of Health and
Human Services (in this subsection referred to as the
``Secretary'') shall convene a public meeting to describe and
solicit public input regarding the ingredient review process
under section 608 of the Federal Food, Drug, and Cosmetic Act
(as added by subsection (a)). Such meeting shall include
representatives from the cosmetics industry, medical
practitioners and scientific experts with cosmetic expertise,
and consumer and public health advocacy organizations.
(2) Guidance.--Not less than one year after the public
meeting conducted under paragraph (1), the Secretary shall
issue one or more guidance documents to implement section 608
of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)). Such guidance documents shall include
information regarding--
(A) the types of scientific evidence, clinical
studies, data, or other information needed to support
the review of cosmetic ingredients or nonfunctional
constituents (or categories thereof) selected for
review under such section;
(B) the recommended format in which to submit to
the Secretary such data and information, including any
applicable foreign data and information, related to a
cosmetic ingredient or nonfunctional constituent (or
category thereof) that has been selected for such
review;
(C) the manner and the number of days by which the
Secretary intends to review and respond to such data
and information, including with respect to providing a
scientific rationale for any additional data and
information;
(D) the process for communication between the
Secretary and industry related to an ingredient or
nonfunctional constituent (or a category thereof) that
has been selected for review; and
(E) includes such other information as the
Secretary determines appropriate.
(3) Timing.--Not later than 24 months after the date of the
enactment of this Act, the Secretary shall issue draft guidance
under paragraph (1) on the implementation of section 608 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)). The Secretary shall issue final guidance on the
implementation of such section not later than 6 months after
the date on which the comment period for the draft guidance
closes.
(d) GAO Study.--Not later than 6 years after the date of the
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report addressing the effectiveness and
overall impact of the ingredient review program established under
section 608 of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)), including with respect to its impact on the safety of
cosmetic ingredients--
(1) for each ingredient or nonfunctional constituent (or
category thereof) selected for review--
(A) whether the ingredient or nonfunctional
constituent (or category thereof) was determined--
(i) to be safe in cosmetic products without
the need for specified conditions of use or
tolerances;
(ii) to be safe in cosmetic products under
specified conditions of use of tolerances; or
(iii) to be not safe in cosmetic products;
(B) the timeline for such review;
(C) the types of scientific evidence, clinical
studies, data, or other information used to make such a
determination;
(D) whether, and to what extent, the review of the
ingredient or nonfunctional constituent (or category
thereof) resulted in cosmetic products being
reformulated or removed from the market; and
(E) the impact the review and determination had on
consumer use and access to such product; and
(2) an analysis of the ingredient, nonfunctional
constituent (or category thereof) review conducted under such
section 608, including--
(A) the resources used by the Secretary in
reviewing ingredients and nonfunctional constituents
(or categories thereof), including the effects of the
program on other cosmetic safety activities of the
Secretary;
(B) the impact of such section on innovation and
consumer access to cosmetic products; and
(C) whether any improvements to the program under
such section 608 are necessary for increasing the
efficiency and effectiveness of the review of cosmetic
ingredients, nonfunctional constituents, or categories
thereof.
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. 610. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
``(a) In General.--The Secretary shall--
``(1) review national and international standards for
cosmetic good manufacturing practices that are in effect on the
date of enactment of the Cosmetic Safety Enhancement Act of
2019; and
``(2) issue a rule establishing current good manufacturing
standards consistent, to the extent the Secretary determines
practicable and appropriate, with such national and
international standards.
``(b) Content of Regulations.--The regulations issued pursuant to
subsection (a)(2)--
``(1) may specify requirements for the use of certain
analytical or recordkeeping methods by a manufacturer as may be
necessary to ensure that a cosmetic product or cosmetic
formulation is not injurious to health under the recommended or
suggested conditions of use, or customary or usual use of the
product or formulation; and
``(2) shall not--
``(A) impose standards for which there is no
current and generally available analytic method; or
``(B) apply to facilities meeting the criteria to
be considered a facility under section 604(6),
including retail stores or counters offering customized
or personalized cosmetics to consumers, or to entities
that are in compliance with the good manufacturing
practice regulations specified in parts 210 and 211 of
title 21, Code of Federal Regulations (or any successor
regulations).
``(c) Timeframe.--The Secretary shall publish a proposed rule
described in subsection (a) not later than 24 months after the date of
enactment of the Cosmetic Safety Enhancement Act of 2019 and shall
publish a final such rule not later than 36 months after such date of
enactment.''.
(b) Effective Date for Cosmetic Manufacturers.--Regulations issued
pursuant to section 610 of the Federal Food, Drug, and Cosmetic Act (as
added by subsection (a)) shall apply with respect to--
(1) large manufacturers (as defined in section 744L of such
Act (as added by section 202 of this Act)), beginning 180 days
after the date on which the final rule described in subsection
(a) is effective;
(2) midsize manufacturers (as defined in section 744L of
such Act (as added by section 202 of this Act)), beginning 210
days after such date; and
(3) small manufacturers (as defined in section 744L of such
Act (as added by section 202 of this Act)), beginning 2 years
after such date.
(c) Enforcement.--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 Secretary.''.
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. 611. ADVERSE EVENT REPORTING FOR COSMETICS.
``(a) Submission of Serious Adverse Event Reports.--
``(1) In general.--With respect to any cosmetic product
distributed in the United States, the responsible person shall
submit, not later than 15 days after the receipt by the
responsible person, using an electronic system developed under
subsection (b), to the Secretary any report of a serious
adverse event associated with the use of the cosmetic product,
accompanied by a copy of the label on or with the retail
packaging of the cosmetic product.
``(2) New medical information.--During the 12-month period
following the submission of a serious adverse event report
under paragraph (1), with respect to any cosmetic product
distributed in the United States, the responsible person shall
submit, not later than 15 days after the receipt by the
responsible person, using an electronic system developed under
subsection (b), to the Secretary any new medical information
related to such serious adverse event report that is received
by the responsible person.
``(3) Publication.--The Secretary shall make publicly
available on the internet website of the Food and Drug
Administration reports submitted under paragraph (1).
``(4) No duplication.--In the case of cosmetic product that
is also a drug for which a serious adverse event report 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 be required to submit a
serious adverse event report under paragraph (1) with respect
to that cosmetic product.
``(b) Requirements for Serious Adverse Event Reports.--
``(1) Electronic system.--
``(A) In general.--The Secretary shall, not later
than 1 year after the date of enactment of the Cosmetic
Safety Enhancement Act of 2019, develop and implement
an electronic system for use for the submission of
serious adverse event reports under this section.
``(B) Modification.--The format of the electronic
system developed and implemented under paragraph (1)
may be modified by the Secretary and the reports may
include additional information. The Secretary may, in
guidance, further specify the format and contents of
required reports.
``(2) Content of reports.--A serious adverse event report
submitted under paragraph (1) of subsection (a) shall include
all information submitted with the initial report and any
information subsequently added to such report pursuant to
paragraph (2) of such subsection and--
``(A) any report by the responsible person under
section 756 with respect to the safety of the cosmetic
product that is the subject of the report;
``(B) information on the individual or individuals
with respect to whom the adverse event report is
submitted, in accordance with the disclosure
requirements of section 552a of title 5, United States
Code;
``(C) notwithstanding section 552(b)(6) of title 5,
United States Code, medical (or similar) documentation
of the serious adverse event that is the subject of the
report, with all personally identifiable information
redacted; and
``(D) contact information for the individual or
individuals reporting the serious adverse event.
``(3) 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 reasonably available to such
person to complete and file the report with the Secretary under
subsection (a)(1).
``(4) No adverse events to report.--The Secretary 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.
``(5) Exemption.--The Secretary may establish by regulation
an exemption to any of the requirements under this section if
the Secretary determines that such exemption is supported by
adequate evidence and would have no adverse effect on public
health.
``(c) Requirements for Other Adverse Event Reports.--
``(1) In general.--Each responsible person shall maintain
records related to each report of an adverse event (including
serious adverse events) associated with each cosmetic product
marketed by such responsible person and received by such
responsible person for a period of 6 years. Such records shall
be made available to an officer or an employee duly designated
by the Secretary upon request, at reasonable times and within
reasonable limits and in a reasonable manner, including
allowing electronic access and to copy such records.
``(2) Content.--Records required to be maintained under
this paragraph shall contain all information reasonably
available, including--
``(A) a summary of all adverse events received
during the calendar year for each cosmetic product
marketed;
``(B) a complete list of individual reports of
adverse events for each cosmetic product marketed and
with respect to each such event, the same information
required to be included in a report with respect to a
serious adverse event under subsection (b)(2), subject
to the same conditions with respect to the disclosure
of such information;
``(C) an estimate of the total number of product
units estimated to have been distributed to consumers
during the period specified in paragraph (1); and
``(D) such other information as may be specified in
regulation or guidance issued by the Secretary.
``(3) Rule of construction.--This section shall not be
construed to require the inclusion in any report under this
section any consumer complaint that concerns solely efficacy
and does not contain any information about an adverse event.
``(d) Limitation With Respect to Adverse Event Reports.-- Section
756 shall apply with respect to the submission of an adverse event
report in compliance with subsection (a).
``(e) Contact Information.--The label of a cosmetic product shall
bear the domestic address, and either the domestic telephone number or
electronic contact information, through which the responsible person
may receive a report of an adverse event.
``(f) Availability to States.--The Secretary shall make records
submitted under this section available to any State, upon request, to
the extent permissible under the laws governing disclosure of
information by the Secretary. 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. Such State and its employees in possession of
such information shall be subject to the same laws governing
information disclosure as employees of the Food and Drug
Administration.
``(g) Protection of Information.--A serious adverse event report
submitted to the Secretary under subsection (a), including any new
medical information submitted under paragraph (2) of such subsection,
or an adverse event report voluntarily submitted to the Secretary,
shall be considered to be a safety report under section 756 and may be
accompanied by a statement, which shall be a part of any report that is
released for public disclosure, that denies that the report or the
records constitute an admission that the product involved caused or
contributed to the adverse event.
``(h) Effective Dates.--
``(1) Serious adverse events.--The requirement under this
section to report serious adverse events shall become effective
on the date that the Secretary publicizes the availability of
the electronic system described in subsection (b)(1).
``(2) Other adverse events.--The requirement under this
section to maintain records relating to adverse events which
are not serious adverse events shall become effective 18 months
after the date of the enactment of the Cosmetic Safety
Enhancement Act of 2019.
``(i) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means, with
respect to a cosmetic product, a health-related or medical
event associated with the use of such product, including a risk
of illness or injury. Such term does not include any instance
of a consumer complaint that such product did not work as
advertised or marketed.
``(2) Serious adverse event.--The term `serious adverse
event' means, with respect to a cosmetic product, an adverse
event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant adverse
health condition, disability, or incapacity;
``(v) congenital anomaly or birth defect;
or
``(vi) significant disfigurement, including
serious or persistent rashes and infections,
burns, or significant hair loss; or
``(B) requires, based on reasonable medical
judgment, a medical or surgical intervention to prevent
an outcome described in subparagraph (A).''.
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. 612. INSPECTION OF COSMETIC RECORDS.
``(a) Inspection of Records.--Each facility, including a facility
owned or operated by a responsible person for a cosmetic product shall,
at the request of an officer or employee duly designated by the
Secretary, 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, or receive electronically records
maintained by or on behalf of such person in any format (including
paper and electronic formats) and at any location, including--
``(1) all records maintained under section 611 and in
accordance with the rules promulgated by the Secretary under
section 610, as applicable;
``(2) all records maintained under section 609;
``(3) any records relating to the list of ingredients in
specific fragrances or flavors of a cosmetic product or
cosmetic formulation, if requested by the Secretary by means of
a written notification; and
``(4) except as provided in subsection (b), all other
records relating to the cosmetic product or cosmetic
formulation and to any other cosmetic product or cosmetic
formulation the Secretary reasonably believes is likely to be
affected in a similar manner, if the Secretary--
``(A) has a reasonable belief that the cosmetic
product or cosmetic formulation--
``(i) is adulterated;
``(ii) has caused a reportable serious
adverse event; or
``(iii) contains an ingredient for which
new scientific information shows may be unsafe
when present in a cosmetic product or cosmetic
formulation; and
``(B) provides written notice to the responsible
person of the basis for the Secretary's reasonable
belief described in subparagraph (A), as applicable.
``(b) Exclusions.--
``(1) In general.--No inspection authorized by this section
shall extend to--
``(A) recipes, 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 and
distribution data; or
``(B) except as provided in paragraph (2),
information related to ingredients in fragrances or
flavors of a cosmetic product or cosmetic formulation.
``(2) Exception.--The Secretary may obtain information
related to the ingredients in fragrances or flavors in an
identified cosmetic product or cosmetic formulation only by a
request in a written notification provided to the manufacturer
pursuant to a for-cause inspection. In response to such written
notification, the manufacturer of such fragrance or flavor
shall provide information about the ingredients in the
specified fragrance or flavor that the Secretary determines is
necessary to assist its investigation, in the manufacturer's
preferred electronic or written format, to the Secretary upon
receipt of such notification. Any information provided in
response to such written notification shall be considered a
trade secret under section 301(j) and, notwithstanding such
section, shall only be disclosed if the Secretary determines
such disclosure is necessary to protect the public health. The
authority to determine such disclosure is necessary to protect
the public health shall not be delegated to any officer or
employee other than the director of the applicable office.
``(c) Protection of Sensitive Information.--The Secretary 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 Secretary pursuant to
this section. Information disclosed to a State shall be pursuant to the
laws governing disclosure of information. Confidential information
disclosed to the State that is exempt from disclosure under section
552(b)(4) of title 5, United States Code, shall be treated as
confidential information by the State. Such State and its employees in
possession of such information under this section shall be subject to
the same laws governing information disclosure as employees of the Food
and Drug Administration.
``(d) Limitations.--This section shall not be construed--
``(1) to limit the authority of the Secretary to inspect
records or to require establishment and maintenance of records
under any other provision of this Act; or
``(2) to require the Secretary to publicly disclose any
information that is exempt from disclosure under section 522 of
title 5, United States Code, or section 1905 of title 18,
United States Code.
``SEC. 613. MANDATORY RECALL AUTHORITY.
``(a) Voluntary Procedures.--If the Secretary determines that there
is a reasonable probability that a cosmetic product is adulterated
under section 601 or misbranded under section 602 and the use of, and
exposure to, such cosmetic product is likely to cause serious adverse
health consequences or death, the Secretary 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 domestic responsible person
refuses to or does not voluntarily cease distribution or recall
such cosmetic product within the time and in the manner
prescribed by the Secretary, the Secretary may order such
person to--
``(A) immediately cease distribution of such
cosmetic product; and
``(B) as applicable, immediately order all
facilities--
``(i) manufacturing, processing, packing,
transporting, holding, receiving, distributing,
or importing and selling such cosmetic product;
and
``(ii) to which such cosmetic product has
been distributed, transported, or sold,
to immediately cease distribution of such cosmetic
product.
``(2) Required additional information.--
``(A) In general.--In the case of a cosmetic
product that is subject to a recall order issued under
paragraph (1)(B) with respect to which the responsible
person, before the issuance of such order, distributed
to a warehouse-based, third-party logistics provider
without providing such logistics provider with
sufficient information to know or reasonably determine
the precise identity of such cosmetic product, the
notice provided by the domestic responsible person
pursuant to such order shall include such information
as is necessary for the logistics provider to identify
the cosmetic product.
``(B) Rules of construction.--Nothing in this
paragraph shall be construed to exempt a warehouse-
based, third-party logistics provider from--
``(i) the requirements of this chapter,
including the requirements of this section and
section 612; or
``(ii) being the subject of a mandatory
recall order under this section.
``(3) Determination to limit areas affected.--If the
Secretary requires a domestic responsible person to cease
distribution under paragraph (1)(A) of a cosmetic product, the
Secretary 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 Secretary shall provide the
responsible person 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 product that is
the subject of the order should not be recalled.
``(d) Posthearing Recall Order and Modification of Order.--
``(1) Amendment of order.--If, after providing opportunity
for an informal hearing under subsection (c), the Secretary
determines that removal of the cosmetic product from commerce
is necessary, the Secretary shall, as appropriate--
``(A) amend the order to require recall of such
cosmetic product or other appropriate action;
``(B) specify a timetable in which the recall shall
occur;
``(C) require periodic reports to the Secretary
describing the progress of the recall; and
``(D) provide notice to consumers to whom such
cosmetic product was, or may have been, distributed.
``(2) Vacating of order.--If, after such hearing, the
Secretary determines that adequate grounds do not exist to
continue the actions required by the order, or that such
actions should be modified, the Secretary shall vacate the
order or modify the order.
``(e) Cooperation and Consultation.--The Secretary 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 Secretary 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 product was, or may have been,
distributed; and
``(B) that includes, at a minimum--
``(i) the name of the cosmetic product
subject to the recall;
``(ii) a description of the risk associated
with the use of such cosmetic product; and
``(iii) to the extent practicable,
information for consumers about similar
cosmetic products 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
product 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 of Food and Drugs.
``(h) Rule of Construction.--Nothing in this section shall affect
the authority of the Secretary to request or participate in a voluntary
recall, or to issue an order to cease distribution or to recall any
article under any other provision of this Act or under the Public
Health Service Act.
``(i) Definition.--In this section, the term `domestic responsible
person' means a person who is the domestic contact for a responsible
person.''.
SEC. 106. LABELING AND INTERNET SALES.
(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. 614. LABELING AND INTERNET SALES.
``(a) Safety Review and Labeling.--If a warning or condition of use
is required pursuant to section 608(d)(4) to ensure the safe use of a
cosmetic ingredient, the Secretary shall require appropriate labeling
of any cosmetic product that contains such ingredient, including if
such ingredient--
``(1) is not appropriate for use in the entire population;
or
``(2) requires warnings that children, pregnant women, and
other vulnerable populations should limit or avoid using the
product.
``(b) Cosmetic Products for Professional Use.--
``(1) Listing of ingredients.--The labeling of cosmetic
products used and sold by professionals shall list all
ingredients, as required for other cosmetic products pursuant
to section 602(g).
``(2) Professional use labeling.--In the case of a cosmetic
product that is intended to be used only by a professional on
account of a specific ingredient or increased concentration of
an ingredient and requires safe handling by trained
professionals, the product shall bear a statement as follows:
`For Professional Use Only'.
``(c) Display.--A warning required under subsection (a) and any
statement required under subsection (b)(2) shall be prominently
displayed--
``(1) in the primary language used on the label or on
packaging; and
``(2) in conspicuous and legible type in contrast by
typography, layout, or color with other material printed or
displayed on the label.
``(d) Internet Sales.--
``(1) In general.--In the case of internet sales of
cosmetic products, each primary seller offering a cosmetic
product for sale to consumers on an internet website shall
prominently and conspicuously display on such internet
website--
``(A) the same information that is included on the
packaging of the cosmetic product as regularly
available, such as any warnings, ingredient list, and
contact information; and
``(B) the warnings and statements described in
subsection (c).
``(2) Definition.--For purposes of this subsection, the
term `primary seller' refers to the entity who offers a
cosmetic product for sale on an internet website, including the
responsible person.
``SEC. 615. FRAGRANCE INGREDIENTS.
``(a) Fragrance Ingredients.--Not later than 2 years after the date
of enactment of the Cosmetic Safety Enhancement Act of 2019, the
responsible person shall include on the label of any cosmetic products
containing one or more fragrance allergens, a list of each such
fragrance allergen included in such cosmetic product that is consistent
with national and international regulations for fragrance allergens
labeling.
``(b) 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 supplier shall promptly provide
information requested pursuant to subparagraph
(A)(ii).''.
(b) Ingredient Statement.--Section 602 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 362) is amended by adding at the end the
following:
``(g) If its labeling or packaging does not contain a listing of
ingredients that meets the requirements of part 701 of title 21, Code
of Federal Regulations (as in effect on date of enactment of the
Cosmetic Safety Enhancement Act of 2019) (or any successor
regulations).''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to products 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. 107. CONSUMER INFORMATION.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall post on its internet website
information for consumers regarding--
(1) final orders regarding the safety of a cosmetic
ingredient or nonfunctional constituent under section
608(d)(3);
(2) cosmetic product recalls (including voluntary and
mandatory recalls); and
(3) identified counterfeit cosmetic products.
SEC. 108. SMALL BUSINESSES.
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. 616. SMALL BUSINESSES.
``(a) In General.--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 Cosmetic Safety Enhancement
Act of 2019, including the amendments made by such Act.
``(b) Compliance Guide.--Not later than 180 days after the date of
the enactment of Cosmetic Safety Enhancement Act of 2019, the Secretary
shall issue a small business guide setting forth in plain language the
requirements of sections 605 and 606 in order to assist small
businesses in complying with such requirements.''.
SEC. 109. ANIMAL TESTING RESTRICTIONS.
(a) In General.--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 cosmetic product, cosmetic formulation, or cosmetic
ingredient was developed or manufactured using an animal test that was
conducted or contracted by the manufacturer, or any affiliate or
supplier of the manufacturer, unless one of the following applies:
``(1) With respect to a cosmetic ingredient of the cosmetic
product or cosmetic formulation, an animal test is required by
the Secretary to evaluate the safety of such ingredient or
formulation.
``(2) With respect to a cosmetic ingredient of the cosmetic
product or cosmetic formulation, the cosmetic ingredient or
cosmetic formulation is in wide use and cannot be replaced by
another ingredient that is capable of performing a similar
function without posing a potentially greater risk to human
health and there is not an alternative method for testing the
cosmetic ingredient that is accepted by the Secretary and the
Interagency Coordinating Committee on Validation of Alternative
Methods.
``(3) The animal test was conducted to comply with a
requirement of another Federal agency or a State or foreign
regulatory authority.
``(4) In the case of a cosmetic product, cosmetic
formulation, or cosmetic ingredient that is also a drug, the
animal test was conducted with respect to the approval under
chapter V of the application submitted with respect to such
product, formulation, or ingredient.
``(5) The animal test was conducted for purposes not
related to developing or manufacturing the cosmetic product,
cosmetic formulation, or cosmetic ingredient, and in response
to a requirement of a Federal, State, or foreign regulatory
authority.''.
(b) Applicability.--The amendment made by subsection (a) shall
apply with respect to cosmetic products or cosmetic formulations
introduced or delivered for introduction into interstate commerce on or
after the date that is two years after the date of enactment of this
Act.
(c) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Secretary shall issue guidance on the acceptability of
scientifically reliable and relevant alternatives to animal testing for
the safety of cosmetic products, cosmetic formulations, and cosmetic
ingredients, and encouraging the use of such methods.
(d) Resources Regarding Animal Testing Alternatives.--Not later
than 180 days after the date of enactment of this Act, the Secretary
shall publish information on the internet website of the Food and Drug
Administration regarding resources available for information about non-
animal methods, and methods that reduce animal usage, in testing for
the safety of cosmetic products, cosmetic formulations, and cosmetic
ingredients.
(e) Rules of Construction.--
(1) Use of evidence.--Nothing in this section, or the
amendment made by this section, shall be construed to prohibit
any entity from reviewing, assessing, or retaining evidence
generated from animal testing.
(2) Acceptance of data by secretary.--Nothing in this
section, or the amendment made by this section, shall be
construed to prohibit the Secretary from accepting data from
animal testing conducted--
(A) prior to the date specified in subsection (b);
or
(B) on or after such date--
(i) in the case of a cosmetic product,
cosmetic formulation, or cosmetic ingredient
that is also a drug, with respect to the
approval under chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.)
of the application submitted with respect to
such product, formulation, or ingredient; or
(ii) pursuant to requirements of a Federal,
State, or foreign regulatory authority.
SEC. 110. 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,''.
SEC. 111. FOREIGN SUPPLIER VERIFICATION.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end
the following:
``SEC. 810. COSMETICS FOREIGN SUPPLIER VERIFICATION PROGRAM.
``(a) In General.--
``(1) Verification requirement.--Except as provided under
subsection (e), each importer shall perform risk-based foreign
supplier verification activities for the purpose of verifying
that the cosmetic product or cosmetic ingredient imported by
the importer (or agent thereof)--
``(A) has been manufactured according to the
cosmetic product good manufacturing practices
established under section 610; and
``(B) is not adulterated under section 601 or
misbranded under section 602.
``(2) Importer defined.--For purposes of this section, the
term `importer' means, with respect to a cosmetic product or
cosmetic ingredient--
``(A) the United States owner or consignee of the
cosmetic product or cosmetic ingredient at the time of
entry of such cosmetic product or cosmetic ingredient
into the United States; or
``(B) in the case when there is no United States
owner or consignee as described in subparagraph (A),
the United States agent or representative of a foreign
owner or consignee of the cosmetic product or cosmetic
ingredient at the time of entry of such article into
the United States.
``(b) Guidance.--Not later than 1 year after the date of enactment
of the Cosmetic Safety Enhancement Act of 2019, the Secretary shall
issue guidance to assist importers in developing foreign supplier
verification programs.
``(c) Regulations.--
``(1) In general.--Not later than 1 year after the date of
enactment of Cosmetic Safety Enhancement Act of 2019, the
Secretary shall promulgate regulations to provide for the
content of the foreign supplier verification program
established under subsection (a).
``(2) Requirements.--The regulations promulgated under
paragraph (1)--
``(A) shall require that the foreign supplier
verification program of each importer be adequate to
provide assurances that each foreign supplier to the
importer produces the imported cosmetic product or
cosmetic ingredient in compliance with--
``(i) with cosmetic good manufacturing
practices established under section 610; and
``(ii) sections 601 and 602; and
``(B) shall include such other requirements as the
Secretary deems necessary and appropriate to verify
that cosmetic products and cosmetic ingredients
imported into the United States are as safe as cosmetic
products and cosmetic ingredients produced and sold
within the United States.
``(3) Considerations.--In promulgating regulations under
this subsection, the Secretary shall, as appropriate, take into
account differences among importers and types of imported
cosmetic products and cosmetic ingredients, including based on
the level of risk posed by the imported cosmetic product or
cosmetic ingredient.
``(4) Activities.--Verification activities under a foreign
supplier verification program under this section may include
monitoring records for shipments, lot-by-lot certification of
compliance, annual on-site inspections, compliance with
cosmetic good manufacturing practices and other safety
processes, and periodically testing and sampling shipments.
``(d) Record Maintenance and Access.--Records of an importer
related to a foreign supplier verification program shall--
``(1) be maintained for a period of not less than 2 years;
and
``(2) be made available promptly to a duly authorized
representative of the Secretary upon request.
``(e) Exemptions.--The Secretary, by notice published in the
Federal Register, shall establish an exemption from the requirements of
this section for cosmetic products or cosmetic ingredients imported in
small quantities for research and evaluation purposes or for personal
consumption, provided that such cosmetic products or cosmetic
ingredients are not intended for retail sale and are not sold or
distributed to the public.
``(f) Publication of List of Participants.--The Secretary shall
publish and maintain on the internet website of the Food and Drug
Administration a current list that includes the name of, location of,
and other information deemed necessary by the Secretary about,
importers participating under this section.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 113, is further
amended by adding at the end the following:
``(ggg) The importation or offering for importation of a cosmetic
product or cosmetic ingredient if the importer (as defined in section
810) does not have in place a foreign supplier verification program in
compliance with such section 810.''.
(c) Imports.--Section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) is amended by striking ``or the
importer (as defined in section 805) is in violation of such section
805'' and inserting ``, or being imported or offered for import into
the United States by an importer (as defined in section 805 or 810, as
applicable) that is in violation of section 805 or 810, respectively''.
(d) Effective Date.--The amendments made by this section shall take
effect 2 years after the date of enactment of this Act.
SEC. 112. 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 108, is further amended by adding
at the end the following:
``SEC. 617. 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.''.
SEC. 113. SAVING CLAUSE.
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
the following:
``SEC. 616. SAVINGS CLAUSE.
``Nothing in the amendments to this Act made by the Cosmetic Safety
Enhancement Act of 2019, 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.''.
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, 611, 612''; and
(B) by striking ``519, 564,'' and inserting ``519,
564, 609, 611,'';
(2) in paragraph (j) by inserting ``607, 608, 610, 611''
before ``704'';
(3) in paragraph (ii)--
(A) by striking ``760 or 761)'' and inserting
``604, 760, or 761)''; and
(B) by striking ``760 or 761) submitted'' and
inserting ``611, 760, or 761) submitted'';
(4) in paragraph (xx), by inserting ``or 613'' after
``423''; and
(5) by adding at the end the following:
``(fff) The failure to register in accordance with section 605, the
failure to submit a cosmetic ingredient statement under section 606,
the failure to provide information required by section 605 or 606, or
the failure to update the information required by section 605 or 606,
as required.''.
(b) Adulteration.--Section 601 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 361), as amended by section 603, is further
amended by adding at the end the following:
``(g) If it contains, after the date prescribed under section
608(d)(3), an ingredient that the Secretary has determined under
section 608(d)(4) to be not safe, or not safe under the conditions of
use recommended or suggested in the label based on an order issued by
the Secretary under section 608(d)(4).
``(h) If it is a cosmetic product for which any requirement of
section 609 is not met.''.
(c) Misbranding.--Section 602 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 362), as amended by section 106, is further
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, or electronic contact
information, 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:
``(h) If it is a cosmetic product and it has been manufactured,
processed, packed, or held in any factory, warehouse, or establishment
and the responsible person delays, denies, or limits an inspection, or
refuses to permit entry or inspection.
``(i) If a fragrance ingredient described in section 615 is not
disclosed to consumers through a method identified by the Food and Drug
Administration in the guidance document issued under such section.
``(j) If its labeling does not conform with a requirement under
section 614.''.
(d) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, 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 611,
760, or 761''; and
(2) by striking ``760 or 761)'' and inserting ``604, 760,
or 761)''.
(f) Facility 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, packs, holds, 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 612 (regarding inspection of
cosmetic records), subject to the limitations under of such section.''.
TITLE II--FEES RELATED TO COSMETIC PRODUCTS
SEC. 201. FINDINGS.
The Congress finds that the fees authorized by the amendment made
by section 202 of this Act will be dedicated to cosmetic safety
activities, as defined in section 744L of the Federal Food, Drug, and
Cosmetic Act, as added by such section 202. Such fees should
supplement, not supplant, funding dedicated to cosmetic safety
activities of the Food and Drug Administration. Future fees authorized
by the reauthorization of part 10 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act to be collected by the Secretary
of Health and Human Services should be dedicated to cosmetic safety
activities as set forth in the goals identified for purposes of such
part 10, 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 PRODUCT 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 10--FEES RELATING TO COSMETIC PRODUCTS
``SEC. 744L. DEFINITIONS.
``For the purposes of this part:
``(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 2018.
``(2) Cosmetic formulation.--The term `cosmetic
formulation' has the meaning given to such term in section 604.
``(3) Contract manufacturer.--The term `contract
manufacturer' means a cosmetic manufacturer where neither the
owner, operator, or agent in charge of such entity nor any
affiliate of such owner, operator, or agent in charge sells the
cosmetic ingredient, cosmetic formulation, or cosmetic product
unless there is a specific contractual agreement in place.
``(4) Cosmetic product.--The term `cosmetic product' has
the meaning given to such term in section 604.
``(5) Cosmetic safety activities.--The term `cosmetic
safety activities'--
``(A) means activities of the Secretary related to
compliance by responsible persons required to register
under section 605 with respect to cosmetics, including
administrative activities, such as--
``(i) information technology acquisition,
management, maintenance, and support;
``(ii) the acquisition, administration, and
maintenance of the cosmetic registration system
under section 605 and the cosmetic ingredient
statement system under section 606;
``(iii) fee assessment and collection under
this part; and
``(iv) the acquisition, leasing,
maintenance, renovation, and repair of
facilities, fixtures, furniture, scientific
equipment, and other necessary materials and
supplies for purposes of clauses (i) through
(iii);
``(B) includes activities of the Secretary related
to implementation of section 608, regarding the review
of cosmetic ingredients and nonfunctional constituents;
``(C) includes activities of the Secretary related
to implementation of section 606;
``(D) includes activities of the Secretary related
to implementation and enforcement, such as the
establishment of good manufacturing practices, the
review of adverse event reports, inspection planning
and inspections, and use of enforcement tools; and
``(E) includes activities of the Secretary related
to meetings with regulated industry regarding
determinations under section 608.
``(6) Gross annual sales.--The term `gross annual sales'
means the average United States gross annual sales for the
previous 3 fiscal years of cosmetic products for a responsible
person, including the sales of cosmetic products of all of its
affiliates, as reported in the registration under section 605.
``(7) Large manufacturer.--The term `large manufacturer'
means any entity that manufactures cosmetic products or
cosmetic formulations for sale or distribution in the United
States and has gross annual sales of over $500,000,000.
``(8) Midsize manufacturer.--The term `midsize
manufacturer' means any entity that manufactures cosmetic
products or cosmetic formulations for sale or distribution in
the United States and has gross annual sales that are not more
than $500,000,000 and over $30,000,000.
``(9) Small manufacturer.--The term `small manufacturer'
means any entity that manufactures cosmetic products or
cosmetic formulations for sale or distribution in the United
States and has gross annual sales that are not more than
$30,000,000 and over $1,000,000.
``(10) Responsible person.--The term `responsible person'
means the owner, operator, agent in charge, or affiliate that
owns the brand under which a cosmetic product is sold.
``SEC. 744M. REGISTRATION FEE.
``(a) Assessment and Collection.--
``(1) In general.--Beginning in fiscal year 2020, the
Secretary shall in accordance with this section assess and
collect an annual fee from every responsible person that
manufactures or distributes cosmetic products or cosmetic
formulations in the United States.
``(2) Payable date.--Fees under this section shall be due
and payable--
``(A) for fiscal year 2020, with respect to
responsible persons as described in paragraph (1) for
such first program year, on the date that is 180 days
after the identification in subsection (b); and
``(B) for fiscal year 2021 and each subsequent
fiscal year, on the later of--
``(i) the date of registration or
registration renewal, as applicable, under
section 605; or
``(ii) the date of enactment of an
appropriations Act providing for the collection
and obligation of fees under this section for
the fiscal year involved.
``(b) One-Time Identification of Responsible Persons for Purposes
of Apportioning Fees.--
``(1) Required identification of responsible persons.--Not
later than 120 days after enactment of the Cosmetic Safety
Enhancement Act of 2019, each responsible person that markets
or sells a cosmetic product shall submit to the Secretary the
information required under this subsection.
``(2) Information required to be submitted.--At a minimum,
the submission required by paragraph (1) shall include for each
such responsible person--
``(A) the gross annual sales of cosmetic products
or cosmetic formulations for the previous 3 fiscal
years as will be reported in the first registration
under section 605 for such responsible person, and an
assessment of whether such responsible person qualifies
as a small, midsize, or large manufacturer for the
purposes of subsection (c)(3)(A);
``(B) identification of facilities where such
responsible person's cosmetic products or cosmetic
formulations are manufactured, which cosmetic products
or cosmetic formulations are manufactured there, and
any other products regulated under this Act that the
facility manufactures;
``(C) the location of all such facilities
identified in subparagraph (B); and
``(D) whether the facility is owned and operated by
a contract manufacturer.
``(3) Notice.--The Secretary may, by notice published in
the Federal Register, specify the means and format for
submission of the information under paragraph (2) and may
specify, as necessary for purposes of this section, any
additional information relevant to setting the annual fee under
this section to be submitted.
``(c) Fee Setting and Amounts.--
``(1) In general.--Subject to subsection (d), the Secretary
shall establish the fees to be collected under this section for
each fiscal year beginning in fiscal year 2020, based on the
methodology described in paragraph (3)(A), and shall publish
such fees in each fiscal year after fiscal year 2020 in a
Federal Register notice not later than 60 days before the
beginning of each such fiscal year. For fiscal year 2020, the
Secretary shall publish the fees 150 days after the date of
enactment of the Cosmetic Safety Enhancement Act of 2019.
``(2) Fee exemption.--Any facility required to register
under section 605 whose average gross annual sales of cosmetic
products in the 3 fiscal years immediately preceding the fiscal
year for which the annual fee will be paid was not more than
$1,000,000, shall be exempt from registration fees under this
section for that fiscal year.
``(3) Annual fee setting.--
``(A) Fee setting.--For fiscal years 2020 to 2027,
the amount of the registration fee under subsection (a)
shall be apportioned as follows:
``(i) Seventy percent shall be derived from
fees from large manufacturers.
``(ii) Twenty percent shall be derived from
fees from midsize manufacturers.
``(iii) Ten percent shall be derived from
fees from small manufacturers.
``(B) Total revenue.--The Secretary shall establish
the fee amounts for each fiscal year in accordance with
subparagraph (A), in order to generate a total
estimated revenue of--
``(i) $10,000,000 for fiscal year 2020;
``(ii) $20,000,000 for fiscal year 2021;
``(iii) $35,000,000 for fiscal year 2022;
and
``(iv) $46,000,000 for each of fiscal years
2023 through 2027.
``(d) Adjustments.--
``(1) Inflation adjustments.--
``(A) Adjustment to total revenue amounts.--For
fiscal year 2020 and each subsequent fiscal year, the
Secretary shall adjust the total revenue amount
specified in subsection (c)(3) for such fiscal year by
multiplying such amount by the applicable inflation
adjustment under subparagraph (B) for such year.
``(B) Applicable inflation adjustment.--The
applicable inflation adjustment for fiscal year 2022
and each subsequent fiscal year is the product of--
``(i) the base inflation adjustment under
subparagraph (C) for such fiscal year; and
``(ii) the product of the base inflation
adjustment under subparagraph (C) for each of
the fiscal years preceding such fiscal year,
beginning with fiscal year 2020.
``(C) Base inflation adjustment.--
``(i) In general.--Subject to further
adjustment under clause (ii), the base
inflation adjustment for a fiscal year is the
sum of one plus--
``(I) 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 fiscal years of the preceding 4
fiscal years, multiplied by 0.60; and
``(II) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
(Washington-Arlington-Alexandria; Not
Seasonally Adjusted; All items; Annual
Index) for the first 3 fiscal years of
the preceding 4 years of available data
multiplied by 0.40.
``(ii) Limitations.--For purposes of
subparagraph (B), if the base inflation
adjustment for a fiscal year under clause (i)--
``(I) is less than 1, such
adjustment shall be considered to be
equal to 1; or
``(II) is greater than 1.04, such
adjustment shall be considered to be
equal to 1.04.
``(2) Final year adjustment.--For fiscal year 2027, the
Secretary 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 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 paragraph shall not be
made.
``(e) Limitations.--
``(1) In general.--With respect to the amount that is
appropriated for a fiscal year for the cosmetics program of the
Center for Food Safety and Applied Nutrition of the Food and
Drug Administration and related field activities, fees may not
be assessed under subsection (a) for the fiscal year unless the
amount so appropriated (excluding the amount of fees
appropriated for the fiscal year), is equal to or greater than
the amount that is appropriated for such program for fiscal
year 2019, multiplied by the adjustment factor applicable to
the fiscal year involved. If the amount so appropriated
prevents the Secretary from assessing fees under subsection
(a), the Secretary is not required to carry out any activities
described in section 608 during that fiscal year.
``(2) Authority.--If the Secretary 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 Secretary may assess such fees, the Secretary 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 discretionary
appropriations through September 30, 2020, for the
`Food and Drug Administration--Salaries and Expenses'
account, fees authorized by this section for fiscal
year 2020 may be collected, and any fees so collected
shall be credited to such account, to remain available
until expended.
``(D) Startup costs.--Until one year after the
Secretary begins collecting user fees under subsection
(a), any amounts available for the Center for Food
Safety and Applied Nutrition and related field
activities (excluding user fees) shall be available and
allocated as needed to pay the costs of any cosmetic
safety activities not authorized before enactment of
the Cosmetic Safety Enhancement Act of 2019.
``(E) Reimbursement of startup amounts.--
``(i) In general.--Any amounts allocated
for the startup period pursuant to subparagraph
(D) shall be reimbursed through any
appropriated fees collected under subsection
(a), in such manner as the Secretary determines
appropriate to ensure that such allocation
results in no net change in the total amount of
funds otherwise available, for a period not to
exceed two years after the Secretary begins
collecting user fees under subsection (a), for
the Center for Food Safety and Applied
Nutrition and related field activities (other
than cosmetic safety activities and related
field activities funded through such
allocation) for such period.
``(ii) Treatment of reimbursed amounts.--
Amounts reimbursed under clause (i) shall be
available for the programs and activities for
which funds allocated for the startup period
were available, prior to such allocation, until
1 year after the Secretary begins collecting
user fees under subsection (a), notwithstanding
any otherwise applicable limits on amounts for
such programs or activities for a fiscal year.
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section the
following:
``(A) $10,000,000 for fiscal year 2020;
``(B) $20,000,000 for fiscal year 2021;
``(C) $35,000,000 for fiscal year 2022; and
``(D) $46,000,000 for each of fiscal years 2023
through 2027.
``(g) Effect of Failure To Pay Fees.--The Secretary shall not
consider a registration by a responsible person submitted under section
605 to be complete until all fees owed by such person under subsection
(a) are paid. Until the fees are paid, the registration is incomplete
and the responsible person is deemed to have failed to register in
accordance with section 605.
``(h) Collection of Unpaid Fees.--In any case where the Secretary
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.
``(i) 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 safety activities, be reduced to
offset the number of officers, employees, and advisory committees so
engaged.
``(j) Records.--Each responsible person that is required to
register under section 605 shall retain all records necessary to
demonstrate gross annual sales for at least 2 fiscal years after such
information is reported in its registration. Such records shall be made
available to the Secretary for review and duplication upon request of
the Secretary.
``(k) Limitation.--This part does not authorize the assessment or
collection of a fee for registration under section 605 occurring after
fiscal year 2027.''.
SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO
COSMETICS.
Part 10 of subchapter C of chapter VII, as added by section 202, is
amended by inserting after section 744M the following:
``SEC. 744N. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO
COSMETICS.
``The Secretary shall have direct hiring authority with respect to
the appointment of employees into the competitive service or the
excepted service to administer the Cosmetic Safety Enhancement Act of
2019 and the amendments made thereby.
``SEC. 744O. REPORTING REQUIREMENTS; REAUTHORIZATION.
``(a) Performance Report.--Beginning with fiscal year 2021, and not
later than 120 calendar days after the end of each fiscal year
thereafter for which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of the Food
and Drug Administration on cosmetic safety activities during such
fiscal year, including the future plans of the Food and Drug
Administration for such activities.
``(b) Fiscal Report.--Not later than 120 calendar days after the
end of fiscal year 2021 and each subsequent fiscal year for which fees
are collected under this part, the Secretary shall prepare and submit
to the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate a report on the implementation of the authority for such fees
during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.
``(c) Public Availability.--The Secretary shall make the reports
required under subsections (a) and (b) available to the public on the
internet website of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to performance goals
developed by the Food and Drug Administration, and plans for
meeting the goals, for cosmetic safety activities for the first
5 fiscal years after fiscal year 2027, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor,
and Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of public health and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 calendar days for
the public to provide written comments on such
recommendations;
``(D) hold a meeting at which the public may
present its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2026, the Secretary shall transmit to the Congress
the revised recommendations under paragraph (2), a summary of
the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.''.
SEC. 204. SUNSET DATES.
(a) Authorization.--Sections 744L, 744M, and 744N of the Federal
Food, Drug, and Cosmetic Act, as added by section 202, shall cease to
be effective October 1, 2027.
(b) Reporting Requirements.--Section 744O of the Federal Food,
Drug, and Cosmetic Act, as added by section 203, shall cease to be
effective January 31, 2028.
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