Title: Cosmetic Safety Enhancement Act of 2019
Policy area: Health

Summary:
Cosmetic Safety Enhancement Act of 2019


[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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