[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2100 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2100

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
                             of cosmetics.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 17, 2021

 Mrs. Feinstein (for herself and Ms. Collins) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
                             of cosmetics.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Personal Care 
Products Safety Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
                        TITLE I--COSMETIC SAFETY

Sec. 101. Registration of cosmetics facilities and cosmetic ingredient 
                            statements.
Sec. 102. Review of ingredients and non-functional constituents.
Sec. 103. Good manufacturing practices for cosmetics.
Sec. 104. Adverse event reports.
Sec. 105. Records inspection; mandatory recall authority.
Sec. 106. Labeling.
Sec. 107. Coal tar chemicals.
Sec. 108. Fragrance allergen disclosure.
Sec. 109. Sense of the Senate on animal testing.
Sec. 110. Preemption.
Sec. 111. Reporting.
Sec. 112. Small businesses.
Sec. 113. Applicability with respect to certain cosmetics.
Sec. 114. Enforcement.
Sec. 115. Consumer information.
Sec. 116. Ban on perfluoroalkyl or polyfluoroalkyl substances.
Sec. 117. Counterfeit cosmetics.
               TITLE II--FEES RELATED TO COSMETIC SAFETY

Sec. 201. Findings.
Sec. 202. Authority to assess and use cosmetic safety fees.
Sec. 203. Direct hiring authority to support activities related to 
                            cosmetics.

                        TITLE I--COSMETIC SAFETY

SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND COSMETIC INGREDIENT 
              STATEMENTS.

    (a) Amendments.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.) is amended by adding at the end the 
following:

``SEC. 604. DEFINITIONS.

    ``In this chapter:
            ``(1) Cosmetic formulation.--The term `cosmetic 
        formulation' means a preparation of cosmetic raw materials with 
        a qualitatively and quantitatively set composition.
            ``(2) Cosmetic product.--The term `cosmetic product' means 
        a preparation of cosmetic raw ingredients, which may come in a 
        range of possible amounts for each ingredient, for purposes of 
        introduction into interstate commerce as a finished product.
            ``(3) Facility.--The term `facility' includes any factory, 
        warehouse, or establishment (including a factory, warehouse, or 
        establishment of an importer) that manufactures or processes 
        cosmetic products or cosmetic formulations, or any other entity 
        whose name and address appear on the label of a cosmetic 
        product. Such term does not include--
                    ``(A) beauty shops and salons that do not otherwise 
                manufacture, process, or package cosmetics at that 
                location;
                    ``(B) cosmetic product retailers, including 
                individual sales representatives, direct sellers, 
                retail distribution facilities, and pharmacies, that do 
                not otherwise manufacture, process, or package 
                cosmetics at that location;
                    ``(C) hospitals, physicians' offices, and health 
                care clinics;
                    ``(D) public health agencies and other nonprofit 
                entities that provide cosmetics directly to the 
                consumer;
                    ``(E) hotels and other entities that provide 
                complimentary cosmetics to guests;
                    ``(F) trade shows and other venues where cosmetic 
                product samples are provided free of charge;
                    ``(G) a factory, warehouse, or establishment of--
                            ``(i) domestic manufacturers with less than 
                        $500,000 in average gross annual sales of 
                        cosmetic products in the United States for the 
                        previous 3-year period, or less than $1,000,000 
                        in such sales of cosmetic products produced in 
                        a private residence; or
                            ``(ii) entities that manufacture or 
                        compound cosmetic products solely for use in 
                        research, teaching, or pilot plant production 
                        and not for sale; or
                    ``(H) an establishment that solely performs one or 
                more of the following with respect to cosmetic 
                products: labeling, relabeling, packaging, repackaging, 
                holding, or distributing.
            ``(4) Foreign facility.--The term `foreign facility' means 
        a facility that manufactures or processes a cosmetic 
        formulation or cosmetic product that is exported to the United 
        States without further processing or packaging inside the 
        United States. A cosmetic is not considered to have undergone 
        further processing or packaging for purposes of this definition 
        solely on the basis that labeling was added or that any similar 
        activity of a de minimis nature was carried out with respect to 
        the cosmetic.
            ``(5) Non-functional constituent.--The term `non-functional 
        constituent' means any substance that is an incidental 
        component of an ingredient, a breakdown product of an 
        ingredient or a byproduct of the manufacturing process that has 
        not been intentionally added as a separate substance and serves 
        no technical function in the cosmetic.
            ``(6) Responsible person.--The term `responsible person' 
        means--
                    ``(A) the brand owner who is the domestic or 
                foreign manufacturer or entity whose name appears on a 
                cosmetic product label of a cosmetic product 
                distributed in the United States, except for entities 
                described in subparagraphs (A) through (H) of paragraph 
                (3); or
                    ``(B) a contract manufacturer who provides cosmetic 
                products to the entities described in subparagraphs (A) 
                through (H) of paragraph (3).''.

``SEC. 605. REGISTRATION OF COSMETIC FACILITIES.

    ``(a) Registration and Fees for Existing Manufacturing or 
Processing of Cosmetics.--
            ``(1) Registration, in general.--Not later than 1 year 
        after the date of enactment of the Personal Care Products 
        Safety Act, and at a similar time in each subsequent year, as 
        determined by the Food and Drug Administration, each 
        responsible person engaged in manufacturing or processing a 
        cosmetic product or a cosmetic formulation distributed in the 
        United States shall register all of the responsible person's 
        facilities with the Food and Drug Administration.
            ``(2) Fees.--If the average gross annual sales in the 
        United States of cosmetic products of all of the responsible 
        person's facilities registered under paragraph (1) for the 
        previous 3-year period is greater than $10,000,000, a 
        registration shall not be complete under this subsection until 
        the responsible person has paid any registration fee required 
        under section 744O.
    ``(b) Registration by New Facilities.--Any facility first engaging 
after the date of enactment of the Personal Care Products Safety Act in 
an activity that would require it to register under subsection (a) 
shall register with the Food and Drug Administration within 60 days of 
first engaging in such activity, and thereafter in accordance with 
subsection (a).
    ``(c) Contract Manufacturers.--If a facility manufactures or 
processes cosmetic products on behalf of a responsible person, the Food 
and Drug Administration shall require only a single registration for 
such facility even if such facility is manufacturing or processing its 
own cosmetic products or cosmetic products on behalf of more than 1 
responsible person. Such single registration may be submitted to the 
Food and Drug Administration by such facility or any responsible person 
whose products are manufactured or processed at such facility.
    ``(d) Changes to Information.--A registrant who has submitted a 
registration under this section shall notify the Food and Drug 
Administration of any change to the information required under 
subsection (a) or (b) not later than 60 days after the date of such 
change, unless otherwise specified by the Food and Drug Administration.
    ``(e) Format; Contents.--
            ``(1) Electronic format.--Each registration shall be 
        submitted using an electronic format, as specified in a 
        registration form provided by the Food and Drug Administration.
            ``(2) Contents.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the registration shall contain the 
                following information:
                            ``(i) Each facility's name and full 
                        address, identifying the precise physical 
                        location of the facility.
                            ``(ii) The identity of the facility, 
                        including the unique facility identifier, if 
                        any, previously assigned by the Food and Drug 
                        Administration to the facility under subsection 
                        (h).
                            ``(iii) All business trading names used by 
                        the facility.
                            ``(iv) The product category or categories 
                        of each cosmetic product or cosmetic 
                        formulation manufactured or processed at the 
                        facility or on whose label the facility's name 
                        and address appear.
                            ``(v) The type of activity conducted at the 
                        facility (such as manufacturing or processing).
                            ``(vi) The name, title, street address, 
                        telephone number, and electronic contact 
                        information of the emergency contact for the 
                        facility.
                            ``(vii) In the case of a foreign facility, 
                        the name, street address, telephone number, 
                        emergency contact information, and name of the 
                        United States agent for the facility, and, if 
                        available, the electronic contact information 
                        of the United States agent.
                            ``(viii) The name, title, street address, 
                        telephone number, and electronic contact 
                        information of the individual submitting the 
                        registration.
                            ``(ix) An assurance that the Food and Drug 
                        Administration will be permitted to inspect 
                        such facility at the times and in the manner 
                        permitted by this Act.
                            ``(x) Additional information pertaining to 
                        the facility or to the cosmetic products or 
                        cosmetic formulations manufactured or processed 
                        at the facility, or on whose label the 
                        facility's name and address appear, including 
                        all brand names known to consumers, as the Food 
                        and Drug Administration may require by 
                        regulation.
                            ``(xi) An ingredient listing for all 
                        cosmetic products manufactured or processed in 
                        such facility, in accordance with subsection 
                        (f), which, for each relevant cosmetic product, 
                        may be submitted to the Food and Drug 
                        Administration as part of such registration or 
                        separately.
                            ``(xii) A written assurance that each 
                        cosmetic product manufactured or processed in 
                        such facility has been substantiated for safety 
                        or carries the warning required under section 
                        740.10 of title 21, Code of Federal Regulations 
                        (or any successor regulations). The responsible 
                        person shall maintain records documenting any 
                        such substantiation of safety and the 
                        information on which such determination is 
                        based until 5 years after the finished product 
                        is no longer marketed, except that a 
                        responsible person for a domestic company whose 
                        sales are under $2,000,000 per year shall 
                        maintain such records for at least 2 years 
                        after the finished product is no longer 
                        marketed.
                    ``(B) Small businesses.--
                            ``(i) Requirements.--In the case of a 
                        registrant described in clause (ii), the 
                        registration shall contain the following 
                        information:
                                    ``(I) Each facility's name and full 
                                address, identifying the precise 
                                physical location of the facility.
                                    ``(II) The name, title, street 
                                address, telephone number, and 
                                electronic contact information of the 
                                emergency contact for the facility.
                                    ``(III) The consumer product 
                                category or categories of each cosmetic 
                                product or cosmetic formulation 
                                manufactured, processed, packed, or 
                                held at the facility or on whose label 
                                the facility's name and address appear.
                            ``(ii) Small business registrants.--A 
                        registrant described in this clause is a 
                        domestic registrant--
                                    ``(I) whose average gross annual 
                                sales in the United States of cosmetic 
                                products for the previous 3-year period 
                                is between $500,000 and $2,000,000 (or 
                                between $1,000,000 and $2,000,000 in 
                                the case of sales of cosmetic products 
                                produced in a private residence); and
                                    ``(II) who does not produce--
                                            ``(aa) products that are 
                                        intended to go on the eye area;
                                            ``(bb) lip products with 
                                        color;
                                            ``(cc) products that are 
                                        injected;
                                            ``(dd) products that are 
                                        intended for internal use; or
                                            ``(ee) products that are 
                                        meant to alter appearance for 
                                        more than 24 hours.
                            ``(iii) Guidance.--The Food and Drug 
                        Administration shall, after consultation with 
                        the Small Business Administration and small 
                        businesses that manufacture cosmetics, provide 
                        additional guidance for small businesses on 
                        compliance with the requirements of this 
                        section that would apply to small business 
                        registrants. Such guidance shall include 
                        specific examples of options for compliance 
                        that do not place an undue burden on small 
                        businesses.
            ``(3) Abbreviated registration.--The Food and Drug 
        Administration shall provide for an abbreviated registration 
        renewal process for any registrant that has not had any changes 
        to the required information with respect to the facility or 
        facilities involved since the registrant submitted the 
        preceding registration.
    ``(f) Cosmetic Product Ingredient Listing.--
            ``(1) In general.--The ingredient listing required pursuant 
        to subsection (e)(2)(A)(xi) shall include--
                    ``(A) the unique identifier assigned under section 
                (h), as applicable, of--
                            ``(i) each facility where the cosmetic 
                        product is manufactured or processed; and
                            ``(ii) the facility whose name and address 
                        appear on the label, unless the statement is 
                        filed by a contract manufacturer described in 
                        section 604(6)(B);
                    ``(B) the brand name and the full name for the 
                cosmetic product as it appears on the label;
                    ``(C) the cosmetic product listing number, if any, 
                previously assigned to the cosmetic product by the Food 
                and Drug Administration under paragraph (4);
                    ``(D) the applicable cosmetic category for the 
                cosmetic product;
                    ``(E) a list of ingredients in the cosmetic 
                product, including a range of possible amounts of each 
                ingredient, identified by the name adopted in 
                regulations promulgated by the Food and Drug 
                Administration, if any, or by the common or usual name 
                of the ingredient, which shall include--
                            ``(i) a list of fragrances, flavors, and 
                        colors that may be included in the product, 
                        interchangeably, with ranges of possible 
                        amounts, which shall include--
                                    ``(I) in the case of fragrances 
                                that are purchased from a fragrance 
                                supplier, identification of the 
                                fragrances by the name or code provided 
                                by the supplier, including the name and 
                                contact information for the fragrance 
                                supplier; and
                                    ``(II) in the case of flavors that 
                                are purchased from a flavor supplier, 
                                identification of the flavors by the 
                                name or code provided by the supplier, 
                                including the name and contact 
                                information for the flavor supplier; 
                                and
                            ``(ii) other appropriate interchangeable 
                        ingredients as the Food and Drug Administration 
                        may specify in regulations or guidance that may 
                        be included in the product, with ranges of 
                        possible amounts;
                    ``(F) the title and full contact information of 
                each individual submitting the statement;
                    ``(G) if applicable, information on the labeling 
                required under section 612; and
                    ``(H) if applicable, information showing that the 
                cosmetic ingredient or ingredients in the product meet 
                any specified conditions of use or tolerances required 
                following a final determination of safety under section 
                607(d).
            ``(2) Additional information.--In the case of a cosmetic 
        ingredient statement that includes a list of fragrances or 
        flavors that are purchased from a fragrance or flavor supplier 
        as described in paragraph (1)(E)(i), upon request by the Food 
        and Drug Administration, the fragrance or flavor supplier shall 
        submit to the Food and Drug Administration the complete list of 
        ingredients in specific fragrances or flavors, not later than 
        30 days after receiving such request.
            ``(3) Cosmetic product ingredient statement for new or 
        reformulated cosmetic products.--
                    ``(A) In general.--Except as provided under 
                subparagraph (B), in the case of a cosmetic product 
                that is first marketed after the date of enactment of 
                the Personal Care Products Safety Act or a cosmetic 
                product that is reformulated after such date of 
                enactment, the responsible person shall submit a 
                cosmetic ingredient statement to the Food and Drug 
                Administration within 60 days of first marketing the 
                new cosmetic product or reformulated cosmetic product, 
                and annually thereafter.
                    ``(B) Small businesses.--The Food and Drug 
                Administration shall allow a responsible person that is 
                a business that meets the applicable industry-based 
                small business size standard established by the 
                Administrator of the Small Business Administration 
                under section 3 of the Small Business Act to have a 
                period longer than 60 days to submit an initial new 
                cosmetic ingredient statement under subparagraph (A).
                    ``(C) Definition.--A cosmetic product shall not be 
                considered first marketed or reformulated after the 
                date of enactment under subparagraph (A) if the only 
                change in such product is in--
                            ``(i) the amount of an existing ingredient 
                        if it is within the range previously reported 
                        under paragraph (1)(E); or
                            ``(ii) the addition or subtraction of a 
                        fragrance, flavor, or color, or such other 
                        interchangeable ingredients specified by the 
                        Food and Drug Administration in regulations or 
                        guidance, previously reported as a potential 
                        ingredient under paragraph (1)(E), if, in the 
                        case of such an addition, the amount is within 
                        the range previously reported.
            ``(4) Cosmetic products list.--At the time of the initial 
        submission of any cosmetic ingredient statement under this 
        section, the Food and Drug Administration shall assign a unique 
        cosmetic product listing number to the cosmetic ingredient 
        statement. Based on such cosmetic ingredient statements, the 
        Food and Drug Administration shall compile and maintain a list 
        of cosmetic products distributed in the United States, 
        including the ingredients of each such product, and shall make 
        available such list to any State, upon request. Information 
        disclosed to a State that is exempt from disclosure under 
        section 552(b)(4) of title 5, United States Code, shall be 
        treated as a trade secret and confidential information by the 
        State.
    ``(g) Incomplete or Inaccurate Registration.--
            ``(1) In general.--Not earlier than 10 days after providing 
        notice of the intent to cancel a registration and the basis for 
        such cancellation, the Food and Drug Administration may cancel 
        a registration under this section if the Food and Drug 
        Administration has reasonable grounds to believe that the 
        registration was not properly completed or updated in 
        accordance with this section or otherwise contains false, 
        incomplete, or inaccurate information.
            ``(2) Timely update or correction.--If, not later than 7 
        days after receipt of a notice of intent to cancel, the 
        responsible person corrects the registration in accordance with 
        the basis for the cancellation, and the required registration 
        fee, if any, is paid, the Food and Drug Administration shall 
        not cancel such registration.
    ``(h) Unique Identifier.--At the time of the initial registration 
of any cosmetic facility under this section, the Food and Drug 
Administration shall assign a unique identifier to the facility.
    ``(i) Registry of Facilities.--
            ``(1) In general.--The Food and Drug Administration shall 
        compile, maintain, and update a registry of facilities that are 
        registered under this section, and shall remove from such 
        registry the name of any facility whose registration under this 
        section is cancelled. The registry shall be publicly available.
            ``(2) Public availability exceptions.--Information derived 
        from the registry or registration documents that discloses the 
        residential address of a registrant or that discloses specific 
        facilities where specific cosmetic products are manufactured or 
        processed shall not be subject to disclosure under section 552 
        of title 5, United States Code.

``SEC. 606. SUSPENSION OF REGISTRATION OR COSMETIC INGREDIENT 
              STATEMENT.

    ``(a) Suspension of Registration of a Facility.--If the Food and 
Drug Administration determines that a cosmetic formulation or cosmetic 
product manufactured or processed by a registered facility and 
distributed in the United States has a reasonable probability of 
causing serious adverse health consequences or death to humans, and the 
Food and Drug Administration has a reasonable belief that other 
products manufactured or processed by the facility may be similarly 
affected because of a failure that cannot be isolated to a single 
product or products or is sufficiently pervasive to raise concerns 
about other products manufactured in the facility, the Food and Drug 
Administration may suspend the registration of a facility.
    ``(b) Suspension of Cosmetic Ingredient Statement.--If the Food and 
Drug Administration determines that a cosmetic product manufactured in 
a registered facility has a reasonable probability of causing serious 
adverse health consequences or death to humans, the Food and Drug 
Administration may suspend the cosmetic ingredient statement of that 
product.
    ``(c) Notice of Suspension.--Before suspending a facility 
registration or a cosmetic ingredient statement under this section, the 
Food and Drug Administration shall provide--
            ``(1) notice to the facility registrant of the cosmetic 
        product or formulation or other responsible person, as 
        appropriate, of the intent to suspend the facility registration 
        or the cosmetic ingredient statement, which shall specify the 
        basis of the determination by the Food and Drug Administration 
        that the facility or the cosmetic ingredient should be 
        suspended and recommendations for specific actions to avoid 
        suspension; and
            ``(2) an opportunity, within 2 business days of the notice 
        provided under paragraph (1), for the responsible person to 
        address the reasons for possible suspension of the facility 
        registration or cosmetic ingredient statement.
    ``(d) Reinstatement.--Upon a determination by the Food and Drug 
Administration that adequate grounds do not exist to continue the 
suspension actions, the Food and Drug Administration shall promptly 
vacate the suspension and reinstate the registration of the facility or 
the cosmetic ingredient statement.
    ``(e) Effect of Suspension.--
            ``(1) Registration.--If the registration of a facility is 
        suspended under this section, no person shall introduce or 
        deliver for introduction into interstate commerce cosmetics or 
        cosmetic products from such facility.
            ``(2) Cosmetic ingredient statement.--If the cosmetic 
        ingredient statement for a cosmetic product is suspended under 
        this section, no person shall introduce or deliver for 
        introduction into interstate commerce any cosmetic product that 
        is the subject of such statement.
    ``(f) No Delegation.--The authority conferred by this section to 
issue an order to suspend a registration or vacate an order of 
suspension shall not be delegated to any officer or employee other than 
the Commissioner.''.

SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS.

    (a) Amendments.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 101, is further 
amended by adding at the end the following:

``SEC. 607. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS.

    ``(a) Ingredients and Non-Functional Constituents Subject to 
Review.--
            ``(1) In general.--The Food and Drug Administration shall 
        review the safety of the cosmetic ingredients and non-
        functional constituents listed under paragraph (3), as modified 
        under subsection (c), if applicable, and issue an order under 
        subsection (d) with respect to the use of each such ingredient 
        and presence of each such non-functional constituent.
            ``(2) Public notice and comment.--At the initiation of the 
        review of each cosmetic ingredient or non-functional 
        constituent, the Food and Drug Administration shall open a 
        docket for the submission of public comment and additional data 
        relevant to the safety of the ingredient or non-functional 
        constituent. The Food and Drug Administration shall provide 60 
        days for public comment.
            ``(3) Cosmetic ingredients.--
                    ``(A) In general.--Beginning in fiscal year 2022, 
                the Food and Drug Administration shall annually select 
                and complete a safety review of at least 5 cosmetic 
                ingredients or non-functional constituents that were 
                not reviewed in the prior 3 years, from a list 
                determined in consultation with the cosmetic industry 
                and consumer and health groups. The Food and Drug 
                Administration may combine selected cosmetics 
                ingredients or non-functional constituents into 
                categories for purposes of such review. The Food and 
                Drug Administration may modify such list under 
                subsection (c).
                    ``(B) Considerations.--The determination of which 
                ingredients or functional ingredients will be reviewed 
                in a given year shall be publicized in annual reports 
                to Congress and the public, in accordance with section 
                617. The review of any cosmetic ingredient or non-
                functional constituent shall commence with a public 
                announcement by the Food and Drug Administration and 
                the opening of a docket as required under paragraph 
                (2).
            ``(4) Comment period.--As part of the annual reporting to 
        Congress and the public under section 617, the Food and Drug 
        Administration shall solicit public comment on which cosmetic 
        ingredients or non-functional constituents on the list are of 
        greatest interest to be reviewed next for early review and 
        which additional cosmetic ingredients or non-functional 
        constituents should be added to the list. The public may submit 
        comments to the Food and Drug Administration at any time during 
        the year regarding which cosmetic ingredients or non-functional 
        constituents of interest the Food and Drug Administration may 
        consider during that year or subsequent years.
    ``(b) List.--The Food and Drug Administration shall maintain a 
list, posted on the internet website of the Food and Drug 
Administration, of the cosmetic ingredients and non-functional 
constituents for which final orders have been issued under subsection 
(d)(3), the finding made for each such ingredient or non-functional 
constituent under subsection (d)(4), as modified by any order under 
subsection (f), if applicable, and, if applicable, compliance dates 
that are the subject of a final order under subsection (e).
    ``(c) Initiative of the FDA.--The Food and Drug Administration may 
at any time propose the issuance of an order on the safety of a 
cosmetic ingredient or non-functional constituent that was not 
previously listed in subsection (a) or under section 617(a)(3). The 
Food and Drug Administration shall follow the same procedures and 
policies for review of any cosmetic ingredient or non-functional 
constituent so proposed as for the ingredients and constituents 
reviewed pursuant to subsection (a).
    ``(d) Determination on Safety.--
            ``(1) Initial proposed administrative order.--Following 
        consideration of data and comments to the public docket and any 
        other information before the Food and Drug Administration, the 
        Food and Drug Administration shall determine whether there is 
        adequate evidence to make an initial finding on the safety of 
        the ingredient or non-functional constituent. If the Food and 
        Drug Administration determines that there is adequate evidence, 
        the Food and Drug Administration shall issue a proposed 
        administrative order and shall post such order on the internet 
        website of the Food and Drug Administration, notwithstanding 
        subchapter II of chapter 5 of title 5, United States Code.
            ``(2) Public comment.--Upon publication of the proposed 
        administrative order described in paragraph (1), the Food and 
        Drug Administration shall open a docket for the submission of 
        public comment. The Food and Drug Administration shall provide 
        30 days for public comment following publication of the 
        proposed administrative order.
            ``(3) Final administrative order.--Following the public 
        comment period described in paragraph (2) and consideration of 
        comments to the public docket and any other information before 
        the Food and Drug Administration, the Food and Drug 
        Administration shall determine whether there is adequate 
        evidence to make a final finding on the safety of the 
        ingredient or non-functional constituent. If the Food and Drug 
        Administration determines that there is adequate evidence, the 
        Food and Drug Administration shall issue a final administrative 
        order and shall post such order on the internet website of the 
        Food and Drug Administration, notwithstanding subchapter II of 
        chapter 5 of title 5, United States Code.
            ``(4) Determinations.--In the proposed administrative order 
        or the final administrative order, as applicable, the Food and 
        Drug Administration shall make a determination that the 
        ingredient or non-functional constituent is--
                    ``(A) safe in cosmetic products under specified 
                conditions of use or tolerances;
                    ``(B) safe in cosmetic products without the need 
                for specified conditions of use or tolerances; or
                    ``(C) not safe in cosmetic products.
            ``(5) Conditions of use and tolerances.--An order under 
        paragraph (4)(A) shall include such conditions on the use of an 
        ingredient or such tolerances on the presence of a non-
        functional constituent as are necessary for the safety of 
        cosmetic products containing such ingredient or non-functional 
        constituent, including--
                    ``(A) limits on the amount or concentration of the 
                ingredient or non-functional constituent that may be 
                present in a cosmetic product, including limits in 
                products intended for children and other vulnerable 
                populations, and limits on use near the eye or mucosal 
                membranes;
                    ``(B) warnings that are necessary or appropriate 
                under section 612, including warnings related to use by 
                children, pregnant women, populations with high 
                exposure to the ingredient (such as workers who are 
                exposed through production practices or handling of 
                final products), or other vulnerable populations, to 
                help ensure safe use of cosmetic products containing 
                the ingredient or non-functional constituent; and
                    ``(C) such other screening, safety protocol, or 
                other similar conditions as are necessary for the 
                safety of cosmetic products containing such ingredient 
                or non-functional constituent.
            ``(6) Public notice.--A final order under this subsection 
        shall set forth the determination of the Food and Drug 
        Administration on safety, any conditions of use or tolerances 
        under subparagraph (A) or (B) of paragraph (4) and a summary of 
        the valid scientific evidence supporting the finding. The order 
        shall be effective upon its publication on the internet website 
        of the Food and Drug Administration and shall be considered 
        final agency action.
    ``(e) Order.--
            ``(1) In general.--If the Food and Drug Administration 
        issues a final administrative order under subparagraph (A) or 
        (C) of subsection (d)(4), the Food and Drug Administration 
        shall, at the same time as publication of the notice under 
        subsection (d)(6), publish a proposed order identifying dates 
        by which use of the ingredient or non-functional constituent in 
        cosmetic products shall comply with the final administrative 
        order, and provide 60 days for public comment, including 
        comment on whether compliance is feasible within the proposed 
        dates. After considering comments on the proposed order, the 
        Food and Drug Administration shall publish in the Federal 
        Register a final order.
            ``(2) Content.--The public notice information regarding the 
        final order under paragraph (1) shall include a summary that is 
        written in plain and understandable language that is 
        comprehensible and meaningful for consumers. The summary shall 
        include information on any conditions of use or warnings 
        required under section 612, including the application to 
        vulnerable populations, the types of safety studies evaluated, 
        and any additional relevant information that was part of the 
        review process.
    ``(f) Modification of an Order.--An order issued under subsection 
(d) or (e) may be modified or revoked by the Food and Drug 
Administration on the initiative of the Food and Drug Administration or 
in response to a petition.
    ``(g) Inadequate Evidence.--
            ``(1) Notice; extension.--If the Food and Drug 
        Administration determines that the available data and 
        information are not adequate to make a proposed or final 
        determination regarding safety under subsection (d)(4), with 
        respect to a cosmetic ingredient or non-functional constituent, 
        the Food and Drug Administration shall--
                    ``(A) publish such finding on the internet website 
                of the Food and Drug Administration not later than 90 
                days after the close of the relevant comment period for 
                the ingredient or non-functional constituent under 
                subsection (a)(2), in the case of a proposed order, or 
                subsection (d)(2), in the case of a final order; and
                    ``(B)(i) include a notice providing interested 
                persons an additional 30 days from the notice date to 
                provide additional data and information; and
                    ``(ii) if, after the 30-day period under clause 
                (i), the Food and Drug Administration determines that 
                additional safety substantiation with respect to such 
                ingredient or non-functional constituent is necessary 
                to make a safety determination--
                            ``(I) include a notice specifying an 
                        additional time period, not to exceed 18 months 
                        from the notice date, during which time the 
                        assurance made by a responsible person under 
                        section 605(e)(2)(A)(xii) with respect to the 
                        safety of such cosmetic ingredient or non-
                        functional constituent shall be deemed to be in 
                        compliance with the requirements of this Act, 
                        but shall not affect final determinations of 
                        safety under subsection (d); and
                            ``(II) plan to obtain such data and 
                        information.
            ``(2) Determination; order.--
                    ``(A) Inadequate data and information.--If the Food 
                and Drug Administration determines, after considering 
                any additional data and information submitted under 
                paragraph (1)(B), that the available data and 
                information still are not adequate to make a 
                determination regarding safety under subsection (d)(4), 
                the Food and Drug Administration shall, within 90 days 
                of the close of the additional time period provided 
                under paragraph (1)(B), issue a proposed order or a 
                final administrative order--
                            ``(i) making a determination that the 
                        ingredient or non-functional constituent has 
                        not been shown to be safe in cosmetic products; 
                        and
                            ``(ii) explaining why the available data 
                        and information are not adequate to assess the 
                        safety of the ingredient or non-functional 
                        constituent.
                    ``(B) Adequate data and information.--If the Food 
                and Drug Administration determines, after considering 
                any additional data and information submitted under 
                paragraph (1)(B), that the available data and 
                information are adequate to make a determination 
                regarding safety under subsection (d)(4), the Food and 
                Drug Administration shall, within 180 days of the close 
                of the comment period, issue a proposed order, followed 
                by a final order, on such cosmetic ingredient or non-
                functional constituent, in accordance with such 
                subsection.
    ``(h) Safety Assessment.--
            ``(1) In general.--In assessing the safety of an ingredient 
        or non-functional constituent, the Food and Drug Administration 
        shall consider whether there is adequate evidence to support a 
        reasonable certainty among competent scientists that the 
        ingredient is not harmful under the recommended or suggested 
        conditions of use or customary or usual use, or that a non-
        functional constituent is not harmful under the recommended or 
        suggested tolerance levels or the level at which it is 
        customarily or usually present. The Food and Drug 
        Administration may not consider an ingredient or non-functional 
        constituent harmful solely because it can cause minor adverse 
        health reactions, such as minor transient allergic reactions or 
        minor transient skin irritations, in some users.
            ``(2) Factors.--In assessing the safety of an ingredient or 
        non-functional constituent, the Food and Drug Administration 
        shall consider, among other relevant factors, the following:
                    ``(A) The probable human exposure to the ingredient 
                or non-functional constituent from expected use in 
                cosmetics.
                    ``(B) The probable cumulative and aggregate effect 
                in humans of relevant exposure to the ingredient or 
                non-functional constituent or to any chemically or 
                pharmacologically related substances from use in 
                cosmetics or other products with similar routes of 
                exposure under recommended or suggested conditions of 
                use or their customary use, to the extent adequate data 
                is available for analysis. In appropriate cases, the 
                Food and Drug Administration may consider available 
                information on the total exposure to an ingredient or 
                non-functional constituent from all sources.
                    ``(C) Whether warnings or recommendations in a 
                product label required under section 612, as part of 
                any conditions of use or tolerances imposed by the Food 
                and Drug Administration, would be necessary and 
                appropriate to help ensure the safety of the ingredient 
                or non-functional constituent.
            ``(3) Data and information.--
                    ``(A) Required information.--A determination that 
                an ingredient or non-functional constituent is safe in 
                cosmetics shall be based upon adequate evidence 
                submitted or otherwise known to the Food and Drug 
                Administration, which shall include full reports of all 
                available studies, published or unpublished, that are 
                adequately designed to show whether the ingredient or 
                non-functional constituent is safe. Such studies may 
                include in vitro and in silico studies and 
                epidemiological studies, biomonitoring studies, and 
                studies focused on various points during the lifespan 
                of the subject, that use scientifically valid 
                methodology.
                    ``(B) Additional relevant information.--The Food 
                and Drug Administration shall consider any other 
                relevant information related to the safety of the 
                ingredient or non-functional constituent, including--
                            ``(i) adverse event reports;
                            ``(ii) findings and information from State, 
                        Federal, national, and international entities 
                        and other bodies composed of scientific and 
                        medical experts;
                            ``(iii) if the ingredient or non-functional 
                        constituent is lawfully used or present in 
                        other products regulated by the Food and Drug 
                        Administration, the scientific basis for such 
                        use; and
                            ``(iv) experience with the ingredient or 
                        non-functional constituent in products that are 
                        distributed in the United States or in other 
                        countries, if such experience is well-
                        documented and has resulted in substantial 
                        human exposure to the ingredient or non-
                        functional constituent over time.
    ``(i) Coal-Tar Hair Dye.--Coal-tar hair dye shall be subject to the 
conditions of section 601(a) unless the Food and Drug Administration 
has issued a final determination for a coal-tar hair dye ingredient 
under subsection (d)(4)(C).
    ``(j) Certain Ingredients Imparting Pigment.--Ingredients imparting 
pigment to cosmetic products that are subject to review and approval 
pursuant to section 721(b) shall not be subject to review under this 
section.''.
    (b) GAO Report.--The Comptroller General of the United States shall 
conduct a review of the program of review of cosmetic ingredients and 
non-functional constituents under section 607 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), and, not later than 
5 years after the date of enactment of this Act, issue a report on such 
review.

SEC. 103. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

    (a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 102, is further 
amended by adding at the end the following:

``SEC. 608. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

    ``(a) In General.--The Food and Drug Administration shall review 
national and international standards for cosmetic good manufacturing 
practices that are in existence on the date of enactment of the 
Personal Care Products Safety Act and shall develop and implement, 
through regulations, standards consistent, to the extent the Food and 
Drug Administration determines practicable and appropriate, with such 
national and international standards for cosmetic good manufacturing 
practices to ensure that requirements of this chapter with respect to 
the manufacture of cosmetic products are in harmony.
    ``(b) Consultation.--The standards under subsection (a) shall 
include simplified good manufacturing practices for small businesses 
that take into account the size and scope of the business, developed in 
consultation with the Small Business Administration.
    ``(c) Timeframe.--The Food and Drug Administration shall publish a 
proposed rule described in subsection (a) not later than 18 months 
after the date of enactment of the Personal Care Products Safety Act 
and shall publish a final such rule not later than 3 years after such 
date of enactment.''.
    (b) Effective Date for Cosmetic Manufacturers.--
            (1) Large businesses.--For businesses of a size greater 
        than the Small Business Administration's standard for a small 
        business, section 608 of the Federal Food, Drug, and Cosmetic 
        Act (as added by subsection (a)) shall take effect beginning 
        180 days after the date on which the Food and Drug 
        Administration makes effective cosmetic good manufacturing 
        practices.
            (2) Small businesses.--For businesses of a size that meets 
        the Small Business Administration's standard for a small 
        business, section 608 of the Federal Food, Drug, and Cosmetic 
        Act (as added by subsection (a)) shall take effect beginning 2 
        years after the date the Food and Drug Administration makes 
        effective cosmetic good manufacturing practices.

SEC. 104. ADVERSE EVENT REPORTS.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 103(a), is further amended by 
adding at the end the following:

``SEC. 609. ADVERSE EVENT REPORTING FOR COSMETICS.

    ``(a) In General.--With respect to any cosmetic product distributed 
in the United States, the responsible person shall submit to the Food 
and Drug Administration a report of any serious adverse event 
associated with such cosmetic product, when used in the United States, 
accompanied by a copy of the label on or with the retail packaging of 
the cosmetic, any new medical information, related to a submitted 
serious adverse event report that is received by the responsible 
person, and an annual report for all adverse events received by the 
responsible person.
    ``(b) Definitions.--In this section:
            ``(1) An `adverse event' for a cosmetic product is a 
        health-related event associated with the use of this product 
        that is adverse.
            ``(2) A `serious adverse event' for a cosmetic product is 
        an adverse event that--
                    ``(A) results in--
                            ``(i) death;
                            ``(ii) a life-threatening experience;
                            ``(iii) inpatient hospitalization;
                            ``(iv) a persistent or significant 
                        disability or incapacity;
                            ``(v) congenital anomaly or birth defect; 
                        or
                            ``(vi) significant disfigurement, including 
                        serious and persistent rashes or infections and 
                        significant hair loss; or
                    ``(B) requires, based on appropriate medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described in subparagraph (A).
    ``(c) Submission of Reports.--
            ``(1) Serious adverse event reports.--Except as provided in 
        paragraph (2), with respect to a cosmetic product distributed 
        in the United States, the responsible person shall submit a 
        serious adverse event report to the Food and Drug 
        Administration not later than 15 business days after 
        information concerning the adverse event is received. If a 
        serious adverse event report for a cosmetic with drug 
        properties is filed using Form FDA 3500A (or any successor form 
        developed for such purpose) or its electronic equivalent for 
        over-the-counter drugs, the responsible person shall not have 
        to submit a duplicative serious adverse event report under this 
        section.
            ``(2) New medical information.--The responsible person 
        shall submit to the Food and Drug Administration any new 
        medical information, related to a submitted serious adverse 
        event report that is received by the responsible person within 
        1 year of the initial report, and shall submit such information 
        not later than 15 business days after the new information is 
        received by the responsible person.
            ``(3) Consolidation of reports.--The Food and Drug 
        Administration shall provide for systems to enable the 
        responsible person to submit a single report that includes 
        duplicate reports of, or new medical information related to, a 
        serious adverse event.
            ``(4) Annual report.--
                    ``(A) In general.--Not later than March 1 of each 
                year, except as provided under subparagraph (C), the 
                responsible person shall submit an electronic report 
                for the prior calendar year for each cosmetic product 
                marketed during that year.
                    ``(B) Contents.--Each report under this paragraph 
                shall contain a summary of all adverse events received 
                during the reporting period, a complete list of 
                individual reports, and an estimate of the total number 
                of product units estimated to have been distributed to 
                consumers in the United States during such period. The 
                report shall not include consumer complaints that are 
                solely regarding efficacy and do not contain any 
                information about an adverse event. The Food and Drug 
                Administration shall further specify the contents of 
                the annual electronic report by regulation or guidance.
                    ``(C) Small business exception.--In the case of a 
                domestic facility for which the average gross annual 
                sales in cosmetic products in the United States over 
                the previous 3-year period is not more than $2,000,000, 
                the responsible person is not required to submit an 
                annual report under this paragraph.
            ``(5) Exemption.--The Food and Drug Administration may 
        establish by regulation an exemption to any of the requirements 
        under this subsection if the Food and Drug Administration 
        determines that such exemption is supported by adequate 
        evidence and would have no adverse effect on public health.
    ``(d) Requirements.--
            ``(1) In general.--Each serious adverse event report under 
        this section shall be submitted to the Food and Drug 
        Administration using an electronic system of the Food and Drug 
        Administration. The Food and Drug Administration shall make 
        such electronic system available not later than 1 year after 
        the date of enactment of the Personal Care Products Safety Act.
            ``(2) Modification.--The format of the reporting system may 
        be modified by the Food and Drug Administration and the reports 
        may include additional information. The Food and Drug 
        Administration may, in guidance, further specify the format and 
        contents of required reports.
            ``(3) Scope of serious adverse event report.--A serious 
        adverse event report (including all information submitted in 
        the initial report or added later) submitted to the Food and 
        Drug Administration under subsection (a) includes--
                    ``(A) a report under section 756 with respect to 
                safety and related to a specific cosmetic product;
                    ``(B) a record about an individual who suffered the 
                serious adverse event under section 552a of title 5, 
                United States Code;
                    ``(C) a medical or similar file documenting the 
                serious adverse event, the disclosure of which would 
                constitute a violation of section 552(b)(6) of such 
                title 5, and shall not be publicly disclosed unless all 
                personally identifiable information is redacted; and
                    ``(D) contact information for the individual 
                reporting the serious adverse event.
            ``(4) Responsibility to gather information.--After an 
        individual initiates the reporting of a serious adverse event, 
        the responsible person for the cosmetic product shall actively 
        gather all of the information to complete and file the report 
        with the Food and Drug Administration.
            ``(5) No adverse events to report.--The Food and Drug 
        Administration shall provide an option as part of the 
        electronic registration process for the responsible person to 
        indicate if such responsible person had no adverse events to 
        report over the previous year. With respect to a responsible 
        person who received no adverse event reports for a year, the 
        annual adverse event report requirement may be met by 
        indicating no such events on the annual registration form.
    ``(e) Limitation With Respect to Adverse Event Reports.--The 
submission of an adverse event report in compliance with subsection (a) 
shall not constitute an admission that the cosmetic involved caused or 
contributed to the adverse event.
    ``(f) Contact Information.--The label of a cosmetic shall bear the 
domestic telephone number or electronic contact information, and it is 
encouraged that the label include both the telephone number and 
electronic contact information, through which the responsible person 
may receive a report of an adverse event.
    ``(g) Maintenance of Records.--The responsible person shall 
maintain records related to each report of an adverse event received by 
the responsible person for a period of 6 years.
    ``(h) Availability to States.--The Food and Drug Administration 
shall make available records submitted under this section to any State, 
upon request. Information disclosed to a State that is exempt from 
disclosure under section 552(b)(4) of title 5, United States Code, 
shall be treated as a trade secret and confidential information by the 
State.
    ``(i) Effective Date of Requirement With Respect to Serious Adverse 
Events.--The requirement under this section to report serious adverse 
events shall become effective on the date that the Food and Drug 
Administration publicizes the availability of the electronic system 
described in subsection (d)(1).''.

SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AUTHORITY.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 104, is further amended by adding 
at the end the following:

``SEC. 610. INSPECTION OF COSMETIC RECORDS.

    ``(a) Inspection of Records.--Each manufacturer or processor of a 
cosmetic shall, at the request of an officer or employee duly 
designated by the Food and Drug Administration, permit such officer or 
employee, upon presentation of appropriate credentials and written 
notice to such person, at reasonable times and within reasonable limits 
and in a reasonable manner, to have access to and copy--
            ``(1) all records maintained under section 
        605(e)(2)(A)(xii) or 609 and in accordance with the rules 
        promulgated by the Food and Drug Administration under section 
        608, as applicable; and
            ``(2) except as provided in subsection (b), all other 
        records, if the Food and Drug Administration--
                    ``(A) has a reasonable belief that the cosmetic--
                            ``(i) is adulterated;
                            ``(ii) has caused a reportable serious 
                        adverse event; or
                            ``(iii) contains an ingredient that 
                        substantial new scientific information shows 
                        may be unsafe when present in a cosmetic; and
                    ``(B) provides written notice of the basis for the 
                Food and Drug Administration's reasonable belief 
                described in subparagraph (A).
    ``(b) Exclusions.--No inspection authorized by this section shall 
extend to financial data, pricing data, personnel data (other than data 
as to qualification of technical and professional personnel performing 
functions subject to this Act), research data (other than safety data), 
or sales data other than shipment data.
    ``(c) Scope.--The requirements under subsection (a) apply to 
records maintained by or on behalf of such person in any format 
(including paper and electronic formats) and at any location.
    ``(d) Protection of Sensitive Information.--The Food and Drug 
Administration shall take appropriate measures to ensure that there are 
effective procedures to prevent the unauthorized disclosure of any 
trade secret or confidential information that is obtained by the Food 
and Drug Administration pursuant to this section. Information disclosed 
to a State that is exempt from disclosure under section 552(b)(4) of 
title 5, United States Code, shall be treated as a trade secret and 
confidential information by the State.
    ``(e) Limitations.--This section shall not be construed--
            ``(1) to limit the authority of the Food and Drug 
        Administration to inspect records or to require establishment 
        and maintenance of records under any other provision of this 
        Act; or
            ``(2) to have any legal effect on section 552 of title 5, 
        United States Code, or section 1905 of title 18, United States 
        Code.
    ``(f) Submission of Records.--
            ``(1) In general.--Any records required to be maintained by 
        a responsible person under section 605(e)(2)(A)(xii) shall, 
        upon the written request of the Food and Drug Administration to 
        the responsible person, be provided to the Food and Drug 
        Administration within a reasonable timeframe not to exceed 60 
        days, in either electronic or paper form.
            ``(2) Criteria.--The Food and Drug Administration may 
        require records under paragraph (1) if--
                    ``(A) the Food and Drug Administration has a 
                reasonable belief, described in written notice, that--
                            ``(i) the finished product may be harmful 
                        based on adverse event reports or other 
                        scientific information; or
                            ``(ii) scientific information raises 
                        credible and relevant questions about the 
                        safety of the product or any of its 
                        ingredients;
                    ``(B) the Food and Drug Administration, an expert 
                regulatory body, or an expert body composed of 
                scientific and medical experts finds an ingredient in 
                the product to be unsafe under the conditions of use of 
                the product; or
                    ``(C) the Food and Drug Administration concludes 
                that submission of the records will serve the public 
                health or otherwise enable the Food and Drug 
                Administration to fulfill the cosmetic safety purposes 
                of this section.''.

``SEC. 611. MANDATORY RECALL AUTHORITY.

    ``(a) Voluntary Procedures.--If the Food and Drug Administration 
determines that there is a reasonable probability that a cosmetic is 
adulterated under section 601 or misbranded under section 602 and the 
use of or exposure to such cosmetic is likely to cause serious adverse 
health consequences or death, the Food and Drug Administration shall 
provide the responsible person with an opportunity to voluntarily cease 
distribution and recall such article.
    ``(b) Prehearing Order To Mandatorily Cease Distribution and Give 
Notice.--
            ``(1) In general.--If the responsible person refuses to or 
        does not voluntarily cease distribution or recall such cosmetic 
        within the time and in the manner prescribed by the Food and 
        Drug Administration, the Food and Drug Administration may order 
        such person to--
                    ``(A) immediately cease distribution of such 
                cosmetic; and
                    ``(B) as applicable, immediately notify all 
                persons--
                            ``(i) manufacturing, processing, packing, 
                        transporting, holding, receiving, distributing, 
                        or importing and selling such cosmetic; and
                            ``(ii) to which such cosmetic has been 
                        distributed, transported, or sold (except 
                        consumers),
                to immediately cease distribution of such cosmetic.
            ``(2) Required additional information.--
                    ``(A) In general.--If a cosmetic covered by a 
                recall order issued under paragraph (1)(B) has been 
                distributed to a warehouse-based third-party logistics 
                provider without providing such provider sufficient 
                information to know or reasonably determine the precise 
                identity of such cosmetic covered by a recall order 
                that is in its possession, the notice provided by the 
                responsible person subject to the order issued under 
                paragraph (1)(B) shall include such information as is 
                necessary for the warehouse-based third-party logistics 
                provider to identify the cosmetic.
                    ``(B) Rules of construction.--Nothing in this 
                paragraph shall be construed--
                            ``(i) to exempt a warehouse-based third-
                        party logistics provider from the requirements 
                        of this chapter, including the requirements of 
                        this section and section 610; or
                            ``(ii) to exempt a warehouse-based third-
                        party logistics provider from being the subject 
                        of a mandatory recall order.
            ``(3) Determination to limit areas affected.--If the Food 
        and Drug Administration requires a responsible person to cease 
        distribution under paragraph (1)(A) of a cosmetic, the Food and 
        Drug Administration may limit the size of the geographic area 
        and the markets affected by such cessation if such limitation 
        would not compromise the public health.
    ``(c) Hearing on Order.--The Food and Drug Administration shall 
provide the responsible party subject to an order under subsection (b) 
with an opportunity for an informal hearing, to be held as soon as 
possible, but not later than 2 days after the issuance of the order, on 
the actions required by the order and on why the cosmetic that is the 
subject of the order should not be recalled.
    ``(d) Post-Hearing Recall Order and Modification of Order.--
            ``(1) Amendment of order.--If, after providing opportunity 
        for an informal hearing under subsection (c), the Food and Drug 
        Administration determines that removal of the cosmetic from 
        commerce is necessary, the Food and Drug Administration shall, 
        as appropriate--
                    ``(A) amend the order to require recall of such 
                cosmetic or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Food and Drug 
                Administration describing the progress of the recall; 
                and
                    ``(D) provide notice to consumers to whom such 
                cosmetic was, or may have been, distributed.
            ``(2) Vacating of order.--If, after such hearing, the Food 
        and Drug Administration determines that adequate grounds do not 
        exist to continue the actions required by the order, or that 
        such actions should be modified, the Food and Drug 
        Administration shall vacate the order or modify the order.
    ``(e) Cooperation and Consultation.--The Food and Drug 
Administration shall work with State and local public health officials 
in carrying out this section, as appropriate.
    ``(f) Public Notification.--In conducting a recall under this 
section, the Food and Drug Administration shall--
            ``(1) ensure that a press release is published regarding 
        the recall, and that alerts and public notices are issued, as 
        appropriate, in order to provide notification--
                    ``(A) of the recall to consumers and retailers to 
                whom such cosmetic was, or may have been, distributed; 
                and
                    ``(B) that includes, at a minimum--
                            ``(i) the name of the cosmetic subject to 
                        the recall;
                            ``(ii) a description of the risk associated 
                        with such article; and
                            ``(iii) to the extent practicable, 
                        information for consumers about similar 
                        cosmetics that are not affected by the recall; 
                        and
            ``(2) ensure publication on the internet website of the 
        Food and Drug Administration of an image of the cosmetic that 
        is the subject of the press release described in paragraph (1), 
        if available.
    ``(g) No Delegation.--The authority conferred by this section to 
order a recall or vacate a recall order shall not be delegated to any 
officer or employee other than the Commissioner.
    ``(h) Effect.--Nothing in this section shall affect the authority 
of the Food and Drug Administration to request or participate in a 
voluntary recall, or to issue an order to cease distribution or to 
recall under any other provision of this chapter or under the Public 
Health Service Act.''.

SEC. 106. LABELING.

    (a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 105, is further 
amended by adding at the end the following:

``SEC. 612. LABELING.

    ``(a) Safety Review and Labeling.--Following a review of cosmetic 
ingredients that determines that warnings are required to help ensure 
safe use of cosmetic products under section 607(d)(5), the Food and 
Drug Administration shall require labeling of cosmetics that are not 
appropriate for use in the entire population, including warnings that 
vulnerable populations, such as children or pregnant women, should 
limit or avoid using the product.
    ``(b) Cosmetic Products for Professional Use.--
            ``(1) Definition of professional.--For purposes of this 
        section, with respect to cosmetics, the term `professional' 
        means an individual who--
                    ``(A) is licensed by an official State authority to 
                practice in the field of cosmetology, nail care, 
                barbering, or esthetics;
                    ``(B) has complied with all requirements set forth 
                by the State for such licensing; and
                    ``(C) has been granted a license by a State board 
                or legal agency or legal authority.
            ``(2) Listing of ingredients.--Cosmetic products used and 
        sold by professionals shall list all ingredients and warnings, 
        as required for other cosmetic products under this chapter.
            ``(3) Professional use labeling.--In the case of a cosmetic 
        product intended to be used only by a professional on account 
        of a specific ingredient or increased concentration of an 
        ingredient that requires safe handling by trained 
        professionals, the product shall bear a statement as follows: 
        `To be Administered Only by Licensed Professionals'.
    ``(c) Requirements.--
            ``(1) Display.--A warning required under subsection (a) and 
        a statement required under subsection (b)(3) shall be 
        prominently displayed--
                    ``(A) in the primary language used on the label; 
                and
                    ``(B) in conspicuous and legible type in contrast 
                by typography, layout, or color with other material 
                printed or displayed on the label.
            ``(2) Minimum warning requirements.--A responsible person 
        may include on the labeling any additional warnings in addition 
        to the minimum warnings required under subsection (a).
    ``(d) Internet Sales.--In the case of internet sales of cosmetics, 
each internet website offering a cosmetic product for sale to consumers 
shall provide the same information, in an electronically readable 
format, that is included on the packaging of the cosmetic product as 
regularly available through in-person sales, except information that is 
unique to a single cosmetic product sold in a retail facility, such as 
a lot number or expiration date, and the warnings and statements 
described in subsection (c) shall be prominently and conspicuously 
displayed on the website.
    ``(e) Contact Information.--The label on each cosmetic shall bear 
the manufacturer's toll-free domestic telephone number and electronic 
contact information, and it is encouraged that the label include both 
the telephone number and electronic contact information, that consumers 
may use to contact the responsible person with respect to adverse 
events. The contact number shall provide a means for consumers to 
obtain additional information about ingredients in the designated 
cosmetic, including the ability to ask if a specific ingredient may be 
present that is not listed on the label and whether a specific 
ingredient may be contained in the fragrance or flavor used in the 
cosmetic. The manufacturer of the cosmetic is responsible for providing 
such information, including obtaining the information from suppliers if 
it is not readily available. Suppliers are required to release such 
information upon request of the cosmetic manufacturer.''.
    (b) Use of the Term ``Natural'' in Labeling.--The Food and Drug 
Administration--
            (1) in consultation with consumer protection stakeholders 
        and the scientific community, shall establish a definition of 
        the term ``natural'' with respect to the use of such term in 
        the labeling of cosmetics;
            (2) not later than 1 year after the date of enactment of 
        this Act, shall issue proposed regulations setting forth such 
        definition; and
            (3) not later than 2 years after such date of enactment, 
        issue final regulations setting forth such definition.
    (c) Effective Date.--Section 612 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), shall take effect on the date 
that is 1 year after the date of enactment of this Act.

SEC. 107. COAL TAR CHEMICALS.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 106, is further amended by adding 
at the end the following:

``SEC. 613. COAL TAR CHEMICALS.

    ``Specific ingredients in coal tar hair dyes may be selected and 
reviewed under section 607. If the Food and Drug Administration reviews 
a coal-tar ingredient found in hair dye and makes a safety 
determination under section 607(d) for such ingredient, such 
determination shall include consideration for the safe use of such 
ingredient through appropriate conditions of use, which may include a 
specific label requirement, specified limits of concentrations, or 
other such conditions of use as the Food and Drug Administration 
determines appropriate, including a finding of not safe under any 
conditions if appropriate.''.

SEC. 108. FRAGRANCE ALLERGEN DISCLOSURE.

    (a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 107, is further 
amended by adding at the end the following:

``SEC. 614. FRAGRANCE ALLERGENS.

    ``(a) Fragrance Allergens.--Not later than 2 years after the date 
of enactment of the Personal Care Products Safety Act, the responsible 
person shall include on the label of any cosmetic product containing 
one or more fragrance allergens, a list of each such fragrance allergen 
present in a rinse-off cosmetic at a concentration above 0.01 percent 
(100 ppm) or present in a leave-on cosmetic product at a concentration 
above .001 percent (10 ppm), in a form and manner as specified by the 
Food and Drug Administration.''.
    ``(b) Identified Fragrance Allergens.--The fragrance allergens 
required to be identified on a label of a cosmetic product pursuant to 
subsection (a) include--
            ``(1) alpha-Isomethyl ionone;
            ``(2) amyl cinnamal;
            ``(3) amylcinnamyl alcohol;
            ``(4) anise alcohol;
            ``(5) benzyl alcohol;
            ``(6) benzyl benzoate;
            ``(7) benzyl cinnamate;
            ``(8) benzyl salicylate;
            ``(9) butylphenyl methylpropional;
            ``(10) cinnamal;
            ``(11) cinnamyl alcohol;
            ``(12) citral;
            ``(13) citronellol;
            ``(14) coumarin;
            ``(15) eugenol;
            ``(16) evernia prunastri (oak moss);
            ``(17) evernia furfuracea (tree moss);
            ``(18) farnesol;
            ``(19) geraniol;
            ``(20) hexyl cinnamal;
            ``(21) hydroxycitronellal;
            ``(22) hydroxyisohexyl 3-cyclohexene carboxaldehyde;
            ``(23) isoeugenol;
            ``(24) limonene;
            ``(25) linalool;
            ``(26) methyl 2-octynoate; and
            ``(27) other substances as identified by the Food and Drug 
        Administration in guidance issued pursuant to this section.
    ``(c) Guidance.--
            ``(1) Issuance.--Not later than one year after the date of 
        enactment of the Personal Care Products Safety Act, the Food 
        and Drug Administration shall issue guidance specifying the 
        form and manner of fragrance allergen listing on the label of 
        cosmetic products pursuant to subsection (a).
            ``(2) Content.--The guidance described in paragraph (1) 
        shall--
                    ``(A) specify the form and manner of fragrance 
                allergen listing for cosmetic products where the 
                package or label is too small or otherwise is unable to 
                accommodate a label with sufficient space to bear the 
                information required for compliance with this section; 
                and
                    ``(B) take into consideration requirements under 
                international regulations for fragrance allergen 
                labeling, as appropriate.
            ``(3) Updates.--The Food and Drug Administration may, as 
        appropriate, update the list of fragrance allergens to include 
        additional substances pursuant to guidance issued under this 
        subsection and taking into consideration international 
        regulations, as appropriate.
    ``(d) Contact Information.--
            ``(1) In general.--The contact information on the label on 
        a cosmetic product for consumers to report adverse events shall 
        also provide a means for consumers to obtain additional 
        information about the inclusion of any recognized fragrance 
        allergen required to be included on such label under subsection 
        (a).
            ``(2) Response.--
                    ``(A) In general.--The responsible person shall--
                            ``(i) upon receipt of a request for 
                        information under paragraph (1), promptly 
                        obtain and provide such information to the 
                        requesting consumer; and
                            ``(ii) in the case of information in the 
                        possession of a supplier, promptly obtain such 
                        information from such supplier, if reasonably 
                        available.
                    ``(B) Supplier.--A relevant supplier shall promptly 
                provide information requested to a responsible person 
                pursuant to subparagraph (A)(ii).''.
    (b) Ingredient Statement.--Section 602 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 362), as amended by section 114(c), is 
further amended by adding at the end the following:
    ``(i) If its labeling or packaging does not contain a listing of 
ingredients that meets the requirements of section 614.''.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to cosmetics introduced or delivered for 
introduction into interstate commerce on or after the date that is 2 
years after the date of enactment of this Act.

SEC. 109. SENSE OF THE SENATE ON ANIMAL TESTING.

    (a) Animal Testing.--Chapter VI of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361 et seq.), as amended by section 108, is 
further amended by adding the following:

``SEC. 615. ANIMAL TESTING.

    ``It is the sense of the Senate that animal testing should not be 
used for the purposes of safety testing on cosmetic products and should 
be phased out with the exception of appropriate allowances.''.

SEC. 110. PREEMPTION.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 109, is further amended by adding 
the following:

``SEC. 616. PREEMPTION.

    ``(a) In General.--No State or political subdivision of a State may 
establish or continue in effect any requirement for cosmetics, other 
than a requirement that is in full effect and implemented on the date 
of enactment of the Personal Care Products Safety Act--
            ``(1) with respect to registration, good manufacturing 
        practices, mandatory recalls, or adverse event reporting; or
            ``(2) with respect to the safety of a cosmetic ingredient 
        or non-functional constituent that is the subject of a final 
        order on a determination of safety under this chapter, unless 
        the requirement of the State or political subdivision is more 
        restrictive than the final order under section 607(d)(3).
    ``(b) Safety of Cosmetic Ingredients and Non-Functional 
Constituents.--
            ``(1) Delayed effect of new state requirements.--
                    ``(A) In general.--From the date that the Food and 
                Drug Administration has made public the final selection 
                of a cosmetic ingredient or non-functional constituent 
                to be reviewed in the coming year under section 
                607(a)(3) and opened the public comment period under 
                section 607(a)(2), until the date that is one year 
                after the Food and Drug Administration has made public 
                such selection, no State or political subdivision of a 
                State may establish any new requirement related to such 
                cosmetic ingredient or non-functional constituent.
                    ``(B) Initial review.--With respect to the cosmetic 
                ingredients to be reviewed in the first year, in 
                accordance with section 607(a)(3), for the 1-year 
                period beginning on the date that is 6 months after the 
                date of enactment of the Personal Care Products Safety 
                Act, no State or political subdivision of a State may 
                establish any new requirement related to such cosmetic 
                ingredient or non-functional constituent.
            ``(2) Scope.--Subsection (a)(2) shall not be construed to 
        affect the authority of a State or political subdivision of a 
        State with respect to any requirement for the safety of a 
        cosmetic ingredient or non-functional constituent that is 
        unrelated to the scope of the safety assessment under section 
        607.
            ``(3) Sense of congress.--It is the sense of Congress that 
        a State or political subdivision that regulates the safety of 
        cosmetics with respect to the health of humans beyond the scope 
        of section 607 should utilize the safety assessment criteria 
        described in section 607(h).
    ``(c) State Requirement That Is in Full Effect and Implemented.--
For purposes of this section:
            ``(1) State requirement.--A State requirement includes a 
        State requirement that is adopted by a State public initiative 
        or referendum.
            ``(2) Full effect and implemented.--The term `full effect 
        and implemented' includes requirements of States that are 
        implemented after the date of enactment of the Personal Care 
        Products Safety Act, if such requirements are under a law that 
        was in effect, or a lawful program that was established and 
        functioning, prior to the date of enactment of the Personal 
        Care Products Safety Act.
    ``(d) Limitation.--Nothing in the amendments to this Act made by 
the Personal Care Products Safety Act shall be construed to preempt any 
State statute, public initiative, referendum, or other State action, 
except as expressly provided in this section.
    ``(e) Savings.--Nothing in the amendments to this Act made by the 
Personal Care Products Safety Act, nor any standard, rule, requirement, 
regulation, adverse event report, safety assessment, safety 
determination, scientific assessment, or order issued or implemented 
pursuant to such amendments, shall be construed to modify or otherwise 
affect, preempt, or displace any cause of action or State or Federal 
law creating a remedy for civil relief or criminal cause of action, 
whether statutory or based in common law.
    ``(f) Sense of the Senate.--It is the sense of the Senate that 
subsection (e) does not negate the other provisions of this section.''.

SEC. 111. REPORTING.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 110, is further amended by adding 
at the end the following:

``SEC. 617. REPORTING.

    ``(a) Performance Report.--Not later than 1 year after the date of 
enactment of the Personal Care Products Safety Act, and not later than 
60 days prior to the end of each fiscal year for which fees are 
collected under section 744O, the Food and Drug Administration shall 
prepare and submit to Congress a report concerning the progress of the 
Food and Drug Administration in achieving the objectives of the 
Personal Care Products Safety Act during such fiscal year and the 
future plans of the Food and Drug Administration for meeting the 
objectives. The annual report for a fiscal year shall include--
            ``(1) the number of registered facilities and cosmetic 
        ingredient statements on file with the Food and Drug 
        Administration;
            ``(2) identification of the cosmetic ingredients and non-
        functional constituents that have been fully reviewed for 
        safety by the Food and Drug Administration in the prior fiscal 
        year and for which a final administrative order has been 
        released;
            ``(3) identification of at least 5 specific cosmetic 
        ingredients and non-functional constituents that will be 
        reviewed by the Food and Drug Administration in the next fiscal 
        year;
            ``(4) the number of facilities inspected and mandatory 
        recalls that transpired during that fiscal year;
            ``(5) the number of serious adverse event reports received 
        by the Food and Drug Administration during that fiscal year; 
        and
            ``(6) any trends identified by the Food and Drug 
        Administration about adverse event reports related to specific 
        cosmetic ingredients or non-functional constituents.
    ``(b) Public Availability.--The Food and Drug Administration shall 
make the reports required under subsection (a) available to the public 
on the internet website of the Food and Drug Administration on the date 
of submission of such reports to Congress.
    ``(c) Public Input on Safety Review.--Upon release of the report 
described in subsection (a), the Food and Drug Administration shall 
provide the public with an opportunity to provide feedback, at any time 
during the year, on the identification of ingredients under subsection 
(a)(3) by--
            ``(1) providing an electronic portal, upon release of the 
        report, enabling the public to--
                    ``(A) comment on the cosmetic ingredients or non-
                functional constituents under review for the current 
                year;
                    ``(B) recommend additional cosmetic ingredients and 
                non-functional constituents to be considered for review 
                for safety in future years; and
                    ``(C) comment on the priorities for the specific 
                cosmetic ingredients and non-functional constituents 
                that the Food and Drug Administration anticipates will 
                be reviewed in the next fiscal year;
            ``(2) announcing on the internet website of the Food and 
        Drug Administration, within the first 30 days of the new fiscal 
        year, any amendments to the list of cosmetic ingredients and 
        non-functional constituents submitted pursuant to subsection 
        (a)(3) based on public input, pursuant to paragraph (1); and
            ``(3) together with the final announcement of at least 5 
        specific cosmetic ingredients and non-functional constituents 
        that will be reviewed in the coming year under section 607, 
        providing a comment period for further public input, pursuant 
        to section 607(a)(2).''.

SEC. 112. SMALL BUSINESSES.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 111, is further amended by adding 
at the end the following:

``SEC. 618. SMALL BUSINESSES.

    ``The Commissioner, in coordination with the Administrator of the 
Small Business Administration, shall provide technical assistance, such 
as guidance and expertise, to small businesses regarding compliance 
with the Personal Care Products Safety Act, including the amendments 
made by such Act.''.

SEC. 113. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 112, is further amended by adding 
at the end the following:

``SEC. 619. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.

    ``In the case of a cosmetic product or a facility that is subject 
to the requirements under this chapter and chapter V, if any 
requirement under chapter V with respect to such cosmetic or facility 
is substantially similar to a requirement under this chapter, the 
cosmetic product or facility shall be deemed to be in compliance with 
the applicable requirement under this chapter if such product or 
facility is in compliance with such substantially similar requirement 
under chapter V, provided that the product or facility has not obtained 
a waiver from the requirement under chapter V. In the case of a 
cosmetic product or facility that is subject to, and in compliance 
with, a fee under subchapter C of chapter VII, other than a fee under 
part 11 of such subchapter, any fee under such part 11 shall be waived 
with respect to such cosmetic product or facility (with respect to 
cosmetic products).''.

SEC. 114. ENFORCEMENT.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in paragraph (e)--
                    (A) by striking ``504, 564,'' and inserting ``504, 
                564, 609, 610,''; and
                    (B) by striking ``519, 564,'' and inserting ``519, 
                564, 609,'';
            (2) in paragraph (j), by inserting ``606, 607, 608,'' 
        before ``704'';
            (3) in paragraph (ii)--
                    (A) by striking ``760 or 761) or'' and inserting 
                ``604, 760, or 761) or''; and
                    (B) by striking ``761) submitted'' and inserting 
                ``761 or as described in section 609) submitted'';
            (4) in paragraph (xx) by inserting ``or 611'' after 
        ``423''; and
            (5) by adding at the end the following:
    ``(fff) The failure to register in accordance with section 605, the 
failure to provide any information required by section 605, or the 
failure to update the information required by section 605, as 
required.''.
    (b) Adulteration.--Section 601 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the 
following:
    ``(f) If the methods used in, or the facilities or controls used 
for, its manufacture, processing, packing, or holding do not conform to 
current good manufacturing practice, as prescribed by the Food and Drug 
Administration in accordance with section 608.
    ``(g) If it contains, after the date prescribed under section 
607(e), an ingredient that the Food and Drug Administration has 
determined under section 607(d)(4) to be not safe, or not safe under 
the conditions of use recommended or suggested in the label or a non-
functional constituent that the Food and Drug Administration has 
determined under section 607(d)(4) to be not safe or not safe in the 
amount present in the cosmetic.
    ``(h) If it is a cosmetic product for which assurances regarding 
safety substantiation have not been supplied under section 
605(e)(2)(A)(xii).''.
    (c) Misbranding.--Section 602 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 362) is amended--
            (1) in paragraph (b)--
                    (A) by striking ``and (2)'' and inserting ``(2)''; 
                and
                    (B) by inserting ``; and (3) a domestic address or 
                a domestic telephone number, and it is encouraged that 
                the label include both a domestic address and a 
                domestic telephone number, through which the 
                responsible person may receive a report of an adverse 
                event associated with the use of such cosmetic 
                product'' after ``numerical count''; and
            (2) by adding at the end the following:
    ``(g) If it has been manufactured or processed in any factory, 
warehouse, or establishment and the responsible person, operator, or 
agent of such factory, warehouse, or establishment delays, denies, or 
limits an inspection, or refuses to permit entry or inspection.
    ``(h) If its labeling does not conform with a requirement under 
section 612.''.
    (d) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Food and Drug Administration shall issue guidance that 
defines the circumstances that would constitute delaying, denying, or 
limiting inspection, or refusing to permit entry or inspection, for 
purposes of section 602(g) of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (c)(2).
    (e) Imports.--Section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended--
            (1) by striking ``section 760 or 761'' the first, third, 
        and fourth place such term appears and inserting ``section 609, 
        760, or 761''; and
            (2) by striking ``760 or 761)'' and inserting ``604, 760, 
        or 761)''.
    (f) Factory Inspection.--Section 704(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by inserting 
after the third sentence the following: ``In the case of any person who 
manufactures, processes, distributes, or imports a cosmetic product, or 
distributes a cosmetic product and affixes its name on the cosmetic 
label, the inspection shall extend to all records and other information 
described in section 610 (regarding inspection of cosmetic records), 
when the standard for records inspections under paragraph (1) or (2) of 
subsection (a) of such section applies, subject to the limitations 
under subsections (d) and (e) of such section.''.

SEC. 115. CONSUMER INFORMATION.

    The Food and Drug Administration shall post on its internet website 
information for consumers regarding--
            (1) final orders regarding the safety of a cosmetic 
        ingredient or non-functional constituent under section 
        607(d)(3) of the Federal Food, Drug, and Cosmetic Act;
            (2) cosmetic product recalls (including voluntary and 
        mandatory recalls); and
            (3) identified counterfeit cosmetic products.

SEC. 116. BAN ON PERFLUOROALKYL OR POLYFLUOROALKYL SUBSTANCES.

    Not later than 6 months after the date of enactment of this Act, 
the Food and Drug Administration shall issue a proposed rule to ban the 
use of intentionally added perfluoroalkyl or polyfluoroalkyl substances 
in cosmetics.

SEC. 117. COUNTERFEIT COSMETICS.

    (a) Counterfeit Cosmetics Defined.--Section 201(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(i)) is amended--
            (1) by striking ``(i) The term'' inserting ``(i)(1) The 
        term'';
            (2) by striking ``(1) articles intended to be'' and 
        inserting ``(A) articles intended to be'';
            (3) by striking ``(2) articles intended for use'' and 
        inserting ``(B) articles intended for use''; and
            (4) by adding at the end the following:
    ``(2) The term `counterfeit cosmetic' means a cosmetic which, or 
the container or labeling of which, without authorization--
            ``(A) bears the trademark, trade name, or other identifying 
        mark, imprint, or device, or any likeness thereof, of a 
        cosmetic manufacturer, processor, packer, or distributor other 
        than the person or persons who in fact manufactured, processed, 
        packed, or distributed such cosmetic; and
            ``(B) thereby falsely purports or is represented to be the 
        product of, or to have been packed or distributed by, such 
        other cosmetic manufacturer, processor, packer, or 
        distributor.''.
    (b) Prohibited Act.--Section 301(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(i)) is amended--
            (1) in subparagraph (2)--
                    (A) by inserting ``digital printer,'' after 
                ``stone,'';
                    (B) by inserting ``cosmetic'' after ``drug or''; 
                and
                    (C) by inserting before the period at the end the 
                following: ``or such cosmetic a counterfeit cosmetic''; 
                and
            (2) in subparagraph (3)--
                    (A) by inserting ``or a cosmetic to be a 
                counterfeit cosmetic'' after ``to be a counterfeit 
                drug''; and
                    (B) by inserting ``or counterfeit cosmetic'' before 
                the period at the end.
    (c) Penalties.--Section 303(c)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(c)(5)) is amended--
            (1) by inserting ``digital printer'' after ``stone,'';
            (2) by inserting ``or a cosmetic being a counterfeit 
        cosmetic'' after ``drug being a counterfeit drug''; and
            (3) by inserting before the period at the end the 
        following: ``or the cosmetic was a counterfeit cosmetic''.
    (d) Seizure.--Section 304(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334(a)(2)) is amended--
            (1) by striking ``(B) Any container'' and all that follows 
        through ``(D) Any adulterated'' and inserting ``(B) Any 
        cosmetic that is a counterfeit cosmetic, (C) Any container of a 
        counterfeit drug or counterfeit cosmetic, (D) Any punch, die, 
        plate, stone, labeling, container, digital printer, or other 
        thing used or designed for use in making a counterfeit drug or 
        drugs or a counterfeit cosmetic or cosmetics, (E) Any 
        adulterated''; and
            (2) by striking ``(E)'' and inserting ``(F)'' before ``Any 
        adulterated or misbranded tobacco product''.
    (e) Examinations and Investigations.--Section 702(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 372(e)) is amended--
            (1) in the matter preceding paragraph (1), by inserting 
        ``or counterfeit cosmetics'' after ``counterfeit drugs'';
            (2) in paragraph (4), by inserting ``or cosmetics'' after 
        ``such drugs''; and
            (3) in paragraph (5)--
                    (A) by striking ``drugs or containers'' and 
                inserting ``drugs, cosmetics, or containers''; and
                    (B) by inserting ``digital printers,'' after 
                ``labeling,''.

               TITLE II--FEES RELATED TO COSMETIC SAFETY

SEC. 201. FINDINGS.

    Congress finds that the fees authorized by the amendments made by 
this title will be dedicated to cosmetic safety activities, as set 
forth in the goals identified for purposes of part 11 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the 
letters from the Secretary of Health and Human Services to the Chairman 
of the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Chairman of the Committee on Energy and Commerce of the 
House of Representatives, as set forth in the Congressional Record.

SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFETY FEES.

    Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379f et seq.) is amended by adding at the end the 
following:

                 ``PART 11--FEES RELATING TO COSMETICS

``SEC. 744O. REGISTRATION FEE.

    ``(a) Assessment and Collection.--
            ``(1) In general.--Beginning in fiscal year 2022, the Food 
        and Drug Administration shall assess and collect an annual fee 
        from every responsible person (referred to in this section as a 
        `registrant') who owns or operates any facility (as defined in 
        section 604(3)) engaged in manufacturing or processing, or 
        whose name and address appear on the label of a cosmetic 
        product distributed in the United States, except that this 
        subsection shall not apply to contract manufacturers if a 
        responsible person has already paid the appropriate fee with 
        respect to the cosmetic product, to ensure no double fees are 
        paid.
            ``(2) Payable date.--A fee under this section shall be 
        payable during the period of initial registration and on the 
        date of registration each year thereafter as prescribed in 
        section 605(a)(1).
    ``(b) Definitions.--In this section:
            ``(1) Adjustment factor.--The term `adjustment factor' 
        applicable to a fiscal year means the Consumer Price Index for 
        all urban consumers (all items; United States city average) for 
        October of the preceding fiscal year divided by such index for 
        October 2021.
            ``(2) Affiliate.--The term `affiliate' means any business 
        entity that has a relationship with a second business entity 
        if, directly or indirectly--
                    ``(A) one business entity controls, or has power to 
                control, the other business entity; or
                    ``(B) a third party controls, or has the power to 
                control, both of the business entities.
            ``(3) Cosmetic product.--The term `cosmetic product' has 
        the meaning given such term in section 604(2).
            ``(4) Cosmetic safety activities.--The term `cosmetic 
        safety activities'--
                    ``(A) means activities related to compliance by 
                registrants under section 605 with the requirements of 
                this Act with respect to cosmetics, including--
                            ``(i) administrative activities, such as 
                        information technology support, human 
                        resources, financial management, the 
                        administration and maintenance of the cosmetic 
                        registration system and the cosmetic ingredient 
                        statement system under section 605, and fee 
                        assessment and collection under this section; 
                        and
                            ``(ii) implementation and enforcement 
                        activities, such as the establishment of good 
                        manufacturing practices, the review of adverse 
                        event reports, inspection planning and 
                        inspections, and use of enforcement tools; and
                    ``(B) includes activities related to implementation 
                of section 607, regarding the review of cosmetic 
                ingredients and non-functional constituents.
            ``(5) Gross annual sales.--The term `gross annual sales' 
        means the average United States gross annual sales for the 
        previous 3-year period of cosmetics for a registrant, including 
        the sales of all of its affiliates, as reported in the 
        registration under section 605.
    ``(c) Fee Setting and Amounts.--
            ``(1) In general.--Subject to subsection (d), the Food and 
        Drug Administration shall establish the fees to be collected 
        under this section for each fiscal year after fiscal year 2022, 
        based on the methodology described in paragraph (3), and shall 
        publish such fees in a Federal Register notice not later than 
        60 days before the beginning of each such fiscal year.
            ``(2) Fee exemption.--Any registrant whose gross annual 
        sales of cosmetic products in the 3-year period immediately 
        preceding the fiscal year for which the annual fee will be paid 
        was not more than $10,000,000, shall be exempt from 
        registration fees under this section for that fiscal year.
            ``(3) Annual fee setting.--For fiscal years 2022 through 
        2027, to generate a total estimated annual revenue amount of 
        $20,600,000, the amount of the registration fee under 
        subsection (a) shall be as follows:
                    ``(A) Tier i-a.--For a registrant that has gross 
                annual sales of $5,000,000,000 or more in 2020, 
                $1,350,000.
                    ``(B) Tier i-b.--For a registrant that has gross 
                annual sales of at least $4,000,000,000 per annum but 
                less than $5,000,000,000 in 2020, $850,000.
                    ``(C) Tier ii-a.--For a registrant that has gross 
                annual sales of at least $3,000,000,000 per annum but 
                less than $4,000,000,000 in 2020, $730,000.
                    ``(D) Tier ii-b.--For a registrant that has gross 
                annual sales of at least $2,000,000,000 per annum but 
                less than $3,000,000,000 in 2020, $610,000.
                    ``(E) Tier iii-a.--For a registrant that has gross 
                annual sales of at least $1,000,000,000 per annum but 
                less than $2,000,000,000 in 2020, $500,000.
                    ``(F) Tier iii-b.--For a registrant that has gross 
                annual sales of at least $500,000,000 per annum but 
                less than $1,000,000,000 in 2020, $395,000.
                    ``(G) Tier iv-a.--For a registrant that has gross 
                annual sales of at least $200,000,000 per annum but 
                less than $500,000,000 in 2020, $325,000.
                    ``(H) Tier iv-b.--For a registrant that has gross 
                annual sales of at least $100,000,000 per annum but 
                less than $200,000,000 in 2020, $275,000.
                    ``(I) Tier v-a.--For a registrant that has gross 
                annual sales of at least $80,000,000 per annum but less 
                than $100,000,000 in 2020, $185,000.
                    ``(J) Tier v-b.--For a registrant that has gross 
                annual sales of at least $60,000,000 per annum but less 
                than $80,000,000 in 2020, $95,000.
                    ``(K) Tier vi-a.--For a registrant that has gross 
                annual sales of at least $40,000,000 per annum but less 
                than $60,000,000 in 2020, $15,000.
                    ``(L) Tier iv-b.--For a registrant that has gross 
                annual sales of at least $20,000,000 per annum but less 
                than $40,000,000 in 2020, $12,000.
                    ``(M) Tier vii-a.--For a registrant that has gross 
                annual sales of at least $10,000,000 per annum but less 
                than $20,000,000 in 2020, $500.
    ``(d) Adjustments.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For fiscal year 2023 and each 
                subsequent fiscal year, the revenues and fee amounts 
                under subsection (c)(3) shall be adjusted by the Food 
                and Drug Administration in the annual Federal Register 
                notice establishing fees in subsection (c)(1), by an 
                amount equal to the sum of--
                            ``(i) one;
                            ``(ii) the average annual percent change in 
                        the cost, per full-time equivalent position of 
                        the Food and Drug Administration, of all 
                        personnel compensation and benefits paid with 
                        respect to such positions for the first 3 of 
                        the preceding 4 fiscal years for which data are 
                        available, multiplied by the average proportion 
                        of personnel compensation and benefits costs to 
                        total Food and Drug Administration costs for 
                        the first 3 years of the preceding 4 fiscal 
                        years for which data are available; and
                            ``(iii) the average annual percent change 
                        that occurred in the Consumer Price Index for 
                        urban consumers (Washington-Baltimore, DC6 MD-
                        VA-WV; not seasonally adjusted; all items less 
                        food and energy; annual index) for the first 3 
                        years of the preceding 4 years for which data 
                        are available multiplied by the average 
                        proportion of all costs other than personnel 
                        compensation and benefits costs to total Food 
                        and Drug Administration costs for the first 3 
                        years of the preceding 4 fiscal years for which 
                        data are available.
                    ``(B) Compounded basis.--The adjustment made each 
                fiscal year under this subsection shall be added on a 
                compounded basis to the sum of all adjustments made 
                each fiscal year after fiscal year 2022 under this 
                subsection.
            ``(2) Final year adjustment.--For fiscal year 2027, the 
        Food and Drug Administration may, in addition to adjustments 
        under paragraph (1), further increase the fee revenues and fees 
        established in subsection (c) if such an adjustment is 
        necessary to provide for not more than 3 months of operating 
        reserves of carryover fees for cosmetic safety activities for 
        the first 3 months of fiscal year 2028. If such an adjustment 
        is necessary, the rationale for the increase, shall be 
        contained in the annual Federal Register notice establishing 
        fees, in subsection (c)(1), for fiscal year 2027. If the Food 
        and Drug Administration has carryover balances for such 
        activities in excess of 3 months of such operating reserves, 
        the adjustment under this subparagraph shall not be made.
            ``(3) Workload adjustment.--
                    ``(A) In general.--For fiscal year 2023 and each 
                subsequent fiscal year, after fee revenues established 
                in subsection (c)(3) are adjusted for a fiscal year for 
                inflation in accordance with paragraph (1), the fee 
                revenues shall be adjusted further for each fiscal year 
                to reflect changes in the workload of the Food and Drug 
                Administration for actual changes in workload volume 
                due to the process of reviewing cosmetic ingredients or 
                non-functional constituents not listed under section 
                607(b).
                    ``(B) Determination of adjustment.--The adjustment 
                shall be determined by the Food and Drug Administration 
                based on the workload in the most recent 1-year period 
                for which workload data is available. The Food and Drug 
                Administration shall publish in the Federal Register 
                the fee revenues and fees resulting from the adjustment 
                and the supporting methodologies.
                    ``(C) Minimum revenues.--The adjustment shall not 
                result in fee revenues for a fiscal year that are less 
                than the sum of the amount under subsection (c)(3), as 
                adjusted for inflation under subparagraph (1).
    ``(e) Limitations.--
            ``(1) In general.--With respect to the amount that, under 
        the salaries and expenses account of the Food and Drug 
        Administration, is appropriated for a fiscal year for the 
        cosmetics program in the Center for Food Safety and Applied 
        Nutrition and related field activities, fees may not be 
        assessed under subsection (a) for the fiscal year unless the 
        amount so appropriated for the fiscal year (excluding the 
        amount of fees appropriated for the fiscal year), is equal to 
        or greater than that assessed for fiscal year 2021, multiplied 
        by the adjustment factor applicable to the fiscal year 
        involved.
            ``(2) Authority.--If the Food and Drug Administration does 
        not assess fees under subsection (a) during any portion of a 
        fiscal year because of paragraph (1) and if at a later date in 
        such fiscal year the Food and Drug Administration may assess 
        such fees, the Food and Drug Administration may assess and 
        collect such fees, without any modification in the rate, for 
        registration under section 605 at any time in such fiscal year.
    ``(f) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for cosmetic safety activities.
            ``(2) Collections and appropriations acts.--
                    ``(A) In general.--Subject to subparagraphs (C) and 
                (D), the fees authorized by this section shall be 
                collected and available in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation for such fiscal year.
                    ``(B) Use of fees and limitation.--The fees 
                authorized by this section shall be collected and 
                available only to defray the costs of cosmetic safety 
                activities.
                    ``(C) Fee collections during first program year.--
                Until the date of enactment of an Act making 
                appropriations through September 30, 2020, for the 
                salaries and expenses account of the Food and Drug 
                Administration, fees authorized by this section for 
                fiscal year 2022 may be collected and shall be credited 
                to such account to remain available until expended. 
                Fees collected under this subparagraph shall be 
                considered discretionary for purposes of the Balanced 
                Budget and Emergency Deficit Control Act of 1985.
                    ``(D) Reimbursement of start-up amounts.--Any 
                amounts allocated to establish programs under section 
                605, prior to collection of fees, may be reimbursed 
                through any appropriated fees collected under this 
                section, in such manner as the Food and Drug 
                Administration determines appropriate. Any amounts 
                reimbursed under this subparagraph shall be available 
                for the programs and activities for which funds 
                allocated to establish the programs were available, 
                prior to such allocation, until the end of the fiscal 
                year in which the reimbursement occurs, notwithstanding 
                any otherwise applicable limits on amounts for such 
                program or activities for a fiscal year.
            ``(3) Authorization of appropriations.--For each of fiscal 
        years 2022 through 2028, there are authorized to be 
        appropriated for fees under this section $20,600,000, as 
        adjusted by subsection (d).
            ``(4) Offset of overcollections; recovery of collection 
        shortfalls.--
                    ``(A) Offset of overcollections.--If the sum of the 
                cumulative amount of fees collected under this section 
                for the fiscal years 2022 through 2026 exceeds the 
                cumulative amount appropriated pursuant to paragraph 
                (3) for fiscal years 2022 through 2027, the excess 
                amount shall be credited to the appropriation account 
                of the Food and Drug Administration as provided in 
                paragraph (1), and shall be subtracted from the amount 
                of fees that would otherwise be authorized to be 
                collected under this section pursuant to appropriation 
                Acts for fiscal year 2028.
                    ``(B) Recovery of collection shortfalls.--
                            ``(i) 2024.--For fiscal year 2024, the 
                        amount of fees otherwise authorized to be 
                        collected under this section shall be increased 
                        by the amount, if any, by which the amount 
                        collected under this section and appropriated 
                        for fiscal year 2022 falls below the amount of 
                        fees authorized for fiscal year 2022 under 
                        paragraph (3).
                            ``(ii) 2025.--For fiscal year 2025, the 
                        amount of fees otherwise authorized to be 
                        collected under this section shall be increased 
                        by the amount, if any, by which the amount 
                        collected under this section and appropriated 
                        for fiscal year 221 falls below the amount of 
                        fees authorized for fiscal year 2023 under 
                        paragraph (3).
                            ``(iii) 2026.--For fiscal year 2026, the 
                        amount of fees otherwise authorized to be 
                        collected under this section shall be increased 
                        by the amount, if any, by which the amount 
                        collected under this section and appropriated 
                        for fiscal year 2024 falls below the amount of 
                        fees authorized for fiscal year 2024 under 
                        paragraph (3).
                            ``(iv) 2027.--For fiscal year 2027, the 
                        amount of fees otherwise authorized to be 
                        collected under this section shall be increased 
                        by the amount, if any, by which the amount 
                        collected under this section and appropriated 
                        for fiscal year 2025 falls below the amount of 
                        fees authorized for fiscal year 2025 under 
                        paragraph (3).
                            ``(v) 2028.--For fiscal year 2028, the 
                        amount of fees otherwise authorized to be 
                        collected under this section shall be increased 
                        by the amount, if any, by which the amount 
                        collected under this section and appropriated 
                        for fiscal year 2026 falls below the amount of 
                        fees authorized for fiscal year 2026 under 
                        paragraph (3).
    ``(g) Effect of Failure To Pay Fees.--The Food and Drug 
Administration shall not consider a registration submitted to be 
complete until such fee under subsection (a) is paid. Until the fee is 
paid, the registration is incomplete and the registrant is deemed to 
have failed to register in accordance with section 605.
    ``(h) False Statements.--Any statement or representation made to 
the Food and Drug Administration shall be subject to section 1001 of 
title 18, United States Code.
    ``(i) Collection of Unpaid Fees.--In any case where the Food and 
Drug Administration does not receive payment of a fee assessed under 
subsection (a), such fee shall be treated as a claim of the United 
States Government subject to subchapter II of chapter 37 of title 31, 
United States Code.
    ``(j) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in cosmetic activities, be reduced to offset the 
number of officers, employees, and advisory committees so engaged.
    ``(k) Records.--Each facility shall retain all records necessary to 
demonstrate the facility's gross annual sales for at least 2 fiscal 
years after such information is reported in the facility's 
registration. Such records shall be made available to the Food and Drug 
Administration for review and duplication upon request of the Food and 
Drug Administration.''.

SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO 
              COSMETICS.

    Part 11 of subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act, as added by section 202, is amended by inserting 
after section 744O the following:

``SEC. 744P. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO 
              COSMETICS.

    ``(a) In General.--The Food and Drug Administration shall have 
direct hiring authority with respect to the appointment of employees 
into the competitive service or the excepted service to administer the 
amendments made by title I of the Personal Care Products Safety Act.
    ``(b) Sunset.--The authority under subsection (a) shall terminate 
on the date that is 3 years after the date of enactment of such 
title.''.
                                 <all>