[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1014 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1014

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 20, 2015

 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; safety 
                            of finished products.
Sec. 103. Good manufacturing practices for cosmetics.
Sec. 104. Adverse event reports.
Sec. 105. Records inspection; mandatory recall authority.
Sec. 106. Labeling.
Sec. 107. Coal tar chemicals.
Sec. 108. Animal testing alternatives.
Sec. 109. Preemption.
Sec. 110. Reporting.
Sec. 111. Small businesses.
Sec. 112. Applicability with respect to certain cosmetics.
Sec. 113. Enforcement.
Sec. 114. Consumer information.
               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 cosmetic comprised of a specified set of ingredients, which 
        may come in a range of possible amounts for each ingredient and 
        which may include a variety of fragrances, flavors, and colors.
            ``(3) Facility.--The term `facility' includes any factory, 
        warehouse, or establishment (including a factory, warehouse, or 
        establishment of an importer) that manufactures, processes, 
        packs, or holds 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, 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) domestic manufacturers with less than 
                $100,000 in gross annual sales of cosmetic products; or
                    ``(H) entities that manufacture or compound 
                cosmetic products solely for use in research, teaching, 
                or pilot plant production and not for sale.
            ``(4) Foreign facility.--The term `foreign facility' means 
        a facility that manufactures, processes, packs, or holds, 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, packer, 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 December 1, 
        2015, 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 $500,000, a registration 
        shall not be complete under this subsection until the 
        responsible person has paid any registration fee required under 
        section 744L.
    ``(b) Registration for Existing Packing or Holding of Cosmetics.--
Not later than December 1, 2015, and at a similar time once every 3 
years thereafter, as determined by the Food and Drug Administration, 
each person who owns or operates a cosmetic facility or facilities 
engaged in packing or holding a cosmetic product distributed in the 
United States shall register each such facility with the Food and Drug 
Administration.
    ``(c) 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) or 
(b) shall register with the Food and Drug Administration within 60 days 
of first engaging in such activity, and thereafter in accordance with 
subsection (a) or (b).
    ``(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.--The registration shall contain the 
        following information:
                    ``(A) Each facility's name and full address, 
                identifying the precise physical location of the 
                facility.
                    ``(B) The identity of the facility, including the 
                unique facility identifier, if any, previously assigned 
                by the Food and Drug Administration to the facility 
                under subsection (g).
                    ``(C) All business trading names used by the 
                facility.
                    ``(D) The 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.
                    ``(E) The type of activity conducted at the 
                facility (such as manufacturing, processing, packing, 
                or holding).
                    ``(F) The name, title, street address, telephone 
                number, and electronic contact information of the 
                emergency contact for the facility.
                    ``(G) In the case of a foreign facility, the name, 
                street address, telephone number, emergency contact 
                information for the facility, the name of the United 
                States agent for the facility, and, if available, the 
                electronic contact information of the United States 
                agent.
                    ``(H) The name, title, street address, telephone 
                number, and electronic contact information of the 
                individual submitting the registration.
                    ``(I) An assurance that the Food and Drug 
                Administration will be permitted to inspect such 
                facility at the times and in the manner permitted by 
                this Act.
                    ``(J) Additional information pertaining to the 
                facility or to the cosmetic products or cosmetic 
                formulations manufactured, processed, packed, or held 
                at the facility, or on whose label the facility's name 
                and address appear, including all brand names known to 
                consumers, as the Food and Drug Administration may 
                require by regulation.
            ``(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 such information with respect to the facility or facilities 
        involved since the registrant submitted the preceding 
        registration.
    ``(f) 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 sponsor 
        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.
    ``(g) 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.
    ``(h) 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. COSMETIC INGREDIENT STATEMENTS.

    ``(a) In General.--For each cosmetic product, the responsible 
person shall submit to the Food and Drug Administration a cosmetic 
ingredient statement, at such time and in such manner as the Food and 
Drug Administration may prescribe. The cosmetic ingredient statement 
shall not become effective until the responsible person pays any 
applicable fee required under section 744L.
    ``(b) Submission of a Cosmetic Ingredient Statement.--
            ``(1) Existing cosmetic products.--In the case of a 
        cosmetic product that is marketed on the date of enactment of 
        the Personal Care Products Safety Act, the responsible person 
        shall submit a cosmetic ingredient statement not later than 
        December 1, 2015. The responsible person shall submit to the 
        Food and Drug Administration a renewal of such statement on a 
        yearly basis.
            ``(2) Cosmetic ingredient statement for new 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 the 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). 
                Such responsible person shall submit a cosmetic 
                ingredient statement annually thereafter.
                    ``(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 subsection (c)(2)(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 subsection (c)(2)(E), if, in 
                        the case of such an addition, the amount is 
                        within the range previously reported.
    ``(c) Format; Contents.--
            ``(1) Form.--For each cosmetic product, the cosmetic 
        ingredient statement shall be submitted using an electronic 
        format, as specified in a cosmetic and ingredient form provided 
        by the Food and Drug Administration.
            ``(2) Contents.--The cosmetic ingredient statement shall 
        include the following information:
                    ``(A) The unique identifier, assigned under section 
                605(g), as applicable, of--
                            ``(i) the facility or facilities where the 
                        cosmetic product is manufactured, processed, 
                        packed, or held or, if the same cosmetic 
                        product is manufactured, processed, packed, or 
                        held in more than one facility, the unique 
                        facility identifier of each facility where it 
                        is manufactured, processed, packed, or held; 
                        and
                            ``(ii) the facility whose name and address 
                        appear on the label, unless the statement is 
                        filed by a contract manufacturer, described in 
                        section 604(6)(B).
                    ``(B) The brand name and the full name for the 
                cosmetic product as it appears on the label.
                    ``(C) The cosmetic product listing number, if any, 
                previously assigned by the Food and Drug Administration 
                under subsection (f) to the cosmetic product.
                    ``(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, and with 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. The cosmetic ingredient 
                statement shall contain--
                            ``(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, the fragrances shall be 
                                identified by the name or code provided 
                                by the supplier, and include the name 
                                and contact information for the 
                                fragrance supplier;
                                    ``(II) in the case of flavors that 
                                are purchased from a flavor supplier, 
                                the flavors shall be identified by the 
                                name or code provided by the supplier, 
                                and include the name and contact 
                                information for the flavor supplier; 
                                and
                                    ``(III) in the case of a 
                                notification provided by the Food and 
                                Drug Administration to the responsible 
                                person for the cosmetic manufacturer, 
                                the Food and Drug Administration may 
                                request, from the fragrance or flavor 
                                supplier, the complete list of 
                                ingredients in specific fragrances or 
                                flavors and the supplier shall have 30 
                                days to provide such list to the Food 
                                and Drug Administration; 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 614.
                    ``(H) Such additional information pertaining to the 
                cosmetic product as the Food and Drug Administration 
                may require.
            ``(3) Cosmetic ingredient statement for certain small 
        businesses.--
                    ``(A) In general.--Notwithstanding any other 
                provision of this subsection, the Food and Drug 
                Administration may permit a simplified cosmetic 
                ingredient statement under this section for a 
                responsible person that--
                            ``(i) 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; and
                            ``(ii) has had an average of less than 
                        $500,000 in annual domestic cosmetic sales over 
                        the previous 3 years.
                    ``(B) Contents.--A responsible person described in 
                subparagraph (A) shall include in each cosmetic 
                ingredient statement under this section, at a minimum, 
                a list of ingredients in the cosmetic product and the 
                applicable cosmetic category for the cosmetic product.
    ``(d) Incomplete or Inaccurate Cosmetic Ingredient Statement.--
            ``(1) In general.--Not earlier than 10 days after providing 
        notice under paragraph (2), the Food and Drug Administration 
        may nullify a cosmetic ingredient statement filed under this 
        section if the Food and Drug Administration has reasonable 
        grounds to believe that the cosmetic ingredient statement was 
        not completed or updated in accordance with this section or 
        otherwise contains false, incomplete, or inaccurate 
        information.
            ``(2) Notice of nullification.--A nullification under 
        paragraph (1) shall be preceded by notice to the responsible 
        person of the intent to cancel the cosmetic ingredient 
        statement and the basis for such cancellation.
            ``(3) Timely update or correction.--If the cosmetic 
        ingredient statement is appropriately updated or corrected not 
        later than 7 days after notice is provided under paragraph (1), 
        the Food and Drug Administration shall not nullify such 
        cosmetic ingredient statement.
    ``(e) Additional Requirements.--
            ``(1) Safety requirements.--In filing each cosmetic 
        ingredient statement cosmetic product, the responsible person 
        shall include an attestation that the safety of the product, 
        including the individual ingredients of such product and the 
        product as a whole, has been substantiated in accordance with 
        section 609. In the case of a cosmetic ingredient statement 
        that includes a range of possible amounts (as described in 
        subsection (c)(2)(E)), the responsible person shall include an 
        attestation that the safety of the full range in the finished 
        product has been substantiated, in accordance with section 609.
            ``(2) Abbreviated filing.--The Food and Drug Administration 
        shall provide for an abbreviated renewal process for any such 
        filing with respect to which there has been no change since the 
        responsible person submitted the previous filing.
            ``(3) Changes to information.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the responsible person shall notify 
                the Food and Drug Administration within 60 days of any 
                change to the information required to be in a cosmetic 
                ingredient statement, including discontinuation of the 
                manufacture of a cosmetic product, except that 
                notification under this paragraph is not required for a 
                change in--
                            ``(i) the amount of an existing ingredient 
                        if it is within the range previously reported 
                        under subsection (c)(2)(E); or
                            ``(ii) the addition or subtraction of a 
                        fragrance, flavor, or color, or such other 
                        interchangeable ingredients specified by the 
                        Food and Drug Administration in regulations or 
                        guidance, previously reported as a potential 
                        ingredient under subsection (c)(2)(E), if, in 
                        the case of an addition of such an ingredient, 
                        the amount is within the range previously 
                        reported.
                    ``(B) Small business.--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, but not longer than the 
                next annual registration deadline under section 
                605(a)(1), to submit any change to the information 
                required to be in a cosmetic ingredient statement as 
                described in subparagraph (A).
    ``(f) 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.

``SEC. 607. 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, processed, packed, or held by a registered 
facility has a reasonable probability of causing serious adverse health 
consequences or death to humans, and there is reason to believe that 
other formulations or products manufactured, processed, packed, or held 
by the facility may be similarly affected because of a failure 
affecting multiple products in that 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 import or export 
        cosmetics or otherwise distribute cosmetics from such facility.
            ``(2) Cosmetic ingredient statement.--If the cosmetic 
        ingredient statement for a cosmetic product is suspended under 
        this section, no person shall import or export such cosmetic 
        product or otherwise distribute in the United States such 
        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; SAFETY 
              OF FINISHED PRODUCTS.

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

``SEC. 608. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS.

    ``(a) Ingredients and Non-Functional Constituents Subject to 
Review.--
            ``(1) In general.--Beginning in fiscal year 2016, the Food 
        and Drug Administration shall review the safety of the cosmetic 
        ingredients and non-functional constituents 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) Ingredients to be considered in first year.--
                During fiscal year 2016, the Food and Drug 
                Administration shall initiate the review for safety of 
                the following cosmetic ingredients:
                            ``(i) Diazolidinyl urea.
                            ``(ii) Lead acetate.
                            ``(iii) Methylene glycol/methanediol/
                        formaldehyde.
                            ``(iv) Propyl paraben.
                            ``(v) Quaternium-15.
                    ``(B) Ingredients to be considered in subsequent 
                years.--
                            ``(i) In general.--Beginning in fiscal year 
                        2017, the Food and Drug Administration shall 
                        annually select and complete a 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 industry and consumer groups 
                        for review of safety. The Food and Drug 
                        Administration may modify such list under 
                        subsection (c).
                            ``(ii) 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 618, and 
                        subject to consultation as provided for in 
                        clause (iii). 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).
                            ``(iii) Consultation.--The Food and Drug 
                        Administration shall establish a Cosmetics 
                        Safety Advisory Committee, which shall include 
                        equal numbers of individuals from the cosmetics 
                        industry and consumer groups, and other 
                        individuals, as the Food and Drug 
                        Administration determines appropriate, 
                        including medical practitioners. Such advisory 
                        committee shall advise the Food and Drug 
                        Administration on cosmetic ingredients and non-
                        functional constituents to be considered for 
                        review, summarize public comments received 
                        pursuant to paragraph (4), and recommend 5 
                        cosmetic ingredients or non-functional 
                        constituents to be reviewed for safety each 
                        year, as described in clause (i). The Food and 
                        Drug Administration may consult with the 
                        Cosmetics Safety Advisory Committee on other 
                        matters pertaining to cosmetic safety.
            ``(4) Comment period.--As part of the annual reporting to 
        Congress and the public under section 618, 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 that 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), 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, after consultation with the Cosmetics Safety Advisory 
Committee, 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 618(a)(3).
    ``(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 614, including warnings related to use by 
                children, pregnant women, populations with high 
                exposure to the ingredient (such as workers who are 
                exposed through production practices or handling of 
                final products), or other vulnerable populations, to 
                help ensure safe use of cosmetic products containing 
                the ingredient or non-functional constituent; and
                    ``(C) such other 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.--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.
    ``(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, include a notice 
                specifying an additional time period, not to exceed 18 
                months from the notice date, and 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, 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.''.

``SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS.

    ``(a) Determination.--
            ``(1) In general.--Each responsible person for a finished 
        cosmetic product shall, before first distributing the product 
        for sale, make a written determination that the product is safe 
        under the conditions of use recommended in the labeling of the 
        product. Such determination shall be based on adequate evidence 
        that each ingredient in the finished product is safe for the 
        use recommended or suggested in the labeling of the product and 
        that the finished product is safe.
            ``(2) New information.--If new information relevant to the 
        determination becomes available, the responsible person shall 
        promptly update the determination to address that information.
            ``(3) Safety with respect to ranges of possible amounts.--
        In the case of a cosmetic product for which there is a range of 
        possible amounts of cosmetic ingredients included in the 
        cosmetic ingredient statement, as described in section 
        606(c)(2)(E), the safety determination under paragraph (1) 
        shall include substantiation of the safety of the full range in 
        the finished product.
    ``(b) Presumption of Adequate Evidence.--
            ``(1) In general.--Except as provided in subsection (c), a 
        determination made under subsection (a) shall be presumed to be 
        based on adequate evidence if it is supported by--
                    ``(A) with respect to each ingredient in the 
                finished product--
                            ``(i) references to an official statement 
                        by one or more expert medical or scientific 
                        bodies that the ingredient is safe under the 
                        conditions of use recommended or suggested in 
                        the product's labeling; or
                            ``(ii) appropriate safety testing of the 
                        ingredient; and
                    ``(B) appropriate safety substantiation of the 
                finished product beyond the safety substantiation of 
                individual ingredients and consideration of the 
                combination of ingredients.
            ``(2) Statement of an expert medical or scientific body.--
        For purposes of this section, a statement of an expert medical 
        or scientific body is an official statement of that body, if--
                    ``(A) the medical or scientific body is a Federal, 
                State, national, or international entity with 
                recognized expertise in chemical or cosmetic safety, or 
                other similarly recognized body composed of scientific 
                and medical experts;
                    ``(B) the statement is based upon adequate data to 
                support the finding of safety, and such data are 
                available to the Food and Drug Administration; and
                    ``(C) the statement is published and endorsed by 
                the medical or scientific body and is not a statement 
                of an employee of such body made in the individual 
                capacity of the employee.
    ``(c) Rebuttal of Presumption.--Notwithstanding subsection (b), a 
determination under subsection (a) will not be presumed to be based on 
adequate evidence if--
            ``(1) the Food and Drug Administration issues an order 
        under section 608 that an ingredient or non-functional 
        constituent in the finished product is not safe under the 
        product's conditions of use or customary or usual use; or
            ``(2) the Food and Drug Administration has provided the 
        manufacturer with notice that--
                    ``(A) the manufacturer has not met the criteria 
                under subsection (b); or
                    ``(B) the Food and Drug Administration has 
                information that raises significant questions about the 
                safety of the product or any of its ingredients.
    ``(d) Timely Update.--Upon notice of inadequate evidence under 
subsection (c), the responsible person shall have 10 days to submit 
additional evidence to the Food and Drug Administration regarding the 
safety of an ingredient, non-functional constituent, or the entire 
cosmetic product, and the Food and Drug Administration shall have 30 
days from the date of receipt of such additional evidence to provide 
the responsible person with notice that the criteria under subsection 
(b) have been met or not met.
    ``(e) Records Maintenance.--The responsible person shall maintain 
records documenting the determination required under this section and 
the information on which it is based until 5 years after the finished 
product is no longer marketed.
    ``(f) Submission of Records.--
            ``(1) In general.--The records required under subsection 
        (e) shall, upon the written request of the 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;
                            ``(ii) scientific information raises 
                        credible and relevant questions about the 
                        safety of the product or any of its 
                        ingredients;
                            ``(iii) the responsible person has not made 
                        the determination required under subsection 
                        (a), or such determination is not supported by 
                        adequate evidence; or
                            ``(iv) one or more of the criteria to 
                        establish a presumption of adequate evidence of 
                        safety in subsection (b) has not been 
                        satisfied;
                    ``(B) the 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.
    ``(g) Guidance and Regulations.--
            ``(1) In general.--The Food and Drug Administration shall 
        issue guidance describing the evidence necessary to support a 
        determination under subsection (a), and may, by regulation, 
        establish exemptions to the requirements of this section, if 
        the Food and Drug Administration determines that such 
        exemptions are supported by adequate evidence and would have no 
        adverse effect on public health.
            ``(2) Small businesses.--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. Such guidance shall 
        include specific examples of options for compliance that do not 
        place an undue burden on small businesses.''.
    (b) Effective Date.--Section 609 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), shall take effect 180 days 
after the date of enactment of this Act.

SEC. 103. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

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

``SEC. 610. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

    ``(a) In General.--The 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, United States 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) 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 610 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 610 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.
    (c) Enforcement.--Section 601 of Chapter VI 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.''.

SEC. 104. ADVERSE EVENT REPORTS.

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

``SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS.

    ``(a) 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 and infections; 
                        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), 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) Annual report.--
                    ``(A) In general.--Not later than March 1 of each 
                year, 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 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.
            ``(4) 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. 612. INSPECTION OF COSMETIC RECORDS.

    ``(a) Inspection of Records.--Each manufacturer, processor, packer, 
or holder 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 611 and in 
        accordance with the rules promulgated by the Food and Drug 
        Administration under section 610, 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.''.

``SEC. 613. 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,
                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 612; 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 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. 614. 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 608(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.--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, and 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, 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) Display.--The warning required under subsection (a) and the 
statement required under subsection (b)(3) shall be prominently 
displayed--
            ``(1) in the primary language used on the label; and
            ``(2) in conspicuous and legible type in contrast by 
        typography, layout, or color with other material printed or 
        displayed on the label.
    ``(d) Internet Sales.--In the case of Internet sales of cosmetics, 
each Internet website offering cosmetic products for sale to consumers 
shall provide the same information that is included on the packaging of 
the cosmetic products as regularly available, 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 domestic telephone number or 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 a cosmetic, including the ability to ask if a 
specific ingredient may be present that is not listed on the label, 
including 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) Effective Date.--Section 614 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. 615. COAL TAR CHEMICALS.

    ``(a) In General.--Under section 608, the Food and Drug 
Administration may review any cosmetic ingredient in order to determine 
if it is safe in cosmetic products without the need for specified 
conditions of use or tolerances, safe in cosmetic products under 
specified conditions of use or tolerances, or not safe in cosmetic 
products.
    ``(b) Coal Tar Hair Dyes.--Specific chemicals in coal tar hair dyes 
may be selected and reviewed under section 608(a)(3).''.

SEC. 108. ANIMAL TESTING ALTERNATIVES.

    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 
the following:

``SEC. 616. ANIMAL TESTING ALTERNATIVES.

    ``(a) In General.--To minimize the use of animal testing for safety 
of cosmetic ingredients, non-functional constituents, and finished 
cosmetic products, the Food and Drug Administration shall--
            ``(1) encourage the use of alternative testing methods that 
        provide information that is equivalent or superior in 
        scientific quality to the animal testing method to--
                    ``(A) not involve the use of an animal to test a 
                chemical substance for safe use in cosmetics; or
                    ``(B) use fewer animals than conventional animal-
                based tests for safe use in cosmetics when nonanimal 
                methods are impracticable; and
            ``(2) encourage--
                    ``(A) the sharing of data across companies and 
                organizations that are testing for safety in cosmetics, 
                so as to avoid duplication of animal tests; and
                    ``(B) funding for research and validation of 
                alternative testing methods.
    ``(b) Guidance.--Not later than 3 years after the date of enactment 
of the Personal Care Products Safety Act, the Food and Drug 
Administration shall issue guidance on the acceptability of 
scientifically reliable and relevant alternatives to animal testing for 
the safety of cosmetic ingredients, non-functional constituents, and 
finished cosmetic products, and encouraging the use of such methods. 
The Food and Drug Administration shall update such guidance on an 
annual basis.
    ``(c) Resources Regarding Animal Testing Alternatives.--Not later 
than 180 days after the date of enactment of the Personal Care Products 
Safety Act, the Food and Drug Administration shall provide information 
on the Internet website of the Food and Drug Administration regarding 
resources available for information about non-animal methods, and 
methods that reduce animal usage, in testing for the safety of cosmetic 
ingredients, non-functional constituents, and finished cosmetic 
products.''.

SEC. 109. PREEMPTION.

    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. 617. PREEMPTION.

    ``(a) Registration, Good Manufacturing Practices, Recalls, Adverse 
Event Reporting.--Except for a State requirement that is in full effect 
and implemented on the date of enactment of the Personal Care Products 
Safety Act, no State or political subdivision of a State may establish 
or continue in effect any requirement for cosmetics with respect to 
registration, good manufacturing practices, mandatory recalls, or 
adverse event reporting.
    ``(b) Safety of Cosmetic Ingredients and Non-Functional 
Constituents.--
            ``(1) In general.--Except for a State requirement that is 
        more restrictive than a final order issued under section 
        608(d)(3) and that is in full effect and implemented on the 
        date of enactment of the Personal Care Products Safety Act, no 
        State or political subdivision of a State may establish or 
        continue in effect any requirement with respect to the safety 
        of a cosmetic ingredient or non-functional constituent that is 
        the subject of a final order under section 608(d)(3) that is 
        different from, or in addition to, a final order issued under 
        section 608(d)(3).
            ``(2) Delayed effect of new state requirements.--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 
        608(a)(3)(B), and opened the public comment period under 
        section 608(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.
            ``(3) Scope.--This subsection shall not be construed to 
        modify or affect the authority of a State or political 
        subdivision of a State with respect to such safety requirements 
        unrelated to the scope of the safety assessment under section 
        608.
            ``(4) 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 608 should utilize the safety assessment criteria 
        described in section 608(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) Rule of Construction Regarding Product Liability.--
Notwithstanding any other provision of this Act, no provision of this 
chapter relating to a cosmetic shall be construed to modify or 
otherwise affect any action or the liability of any person under State 
or Federal common law.
    ``(e) Limitation.--The Personal Care Products Safety Act, including 
the amendments made by such Act, shall not be construed to preempt any 
State statute, public initiative, referendum, or common law, except as 
expressly provided in this section.''.

SEC. 110. REPORTING.

    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 
at the end the following:

``SEC. 618. REPORTING.

    ``(a) Performance Report.--Beginning with fiscal year 2016, and not 
later than 60 days prior to the end of each fiscal year for which fees 
are collected under section 744L, 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;
            ``(6) any trends identified by the Food and Drug 
        Administration about adverse event reports related to specific 
        cosmetic ingredients or non-functional constituents; and
            ``(7) efforts of the Food and Drug Administration to reduce 
        animal testing for safety of cosmetic ingredients, non-
        functional constituents, and cosmetic products.
    ``(b) Public Availability.--The Food and Drug Administration shall 
make the reports required under subsections (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 on 
subsection (a)(3) by--
            ``(1) providing an electronic portal, upon release of the 
        report, enabling the public to--
                    ``(A) recommend additional cosmetic ingredients and 
                non-functional constituents to be considered for review 
                for safety in future years; and
                    ``(B) 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 subsection (a)(3) based on public 
        input, pursuant to paragraph (1); and
            ``(3) together with the final announcement of 5 specific 
        cosmetic ingredients and non-functional constituents that will 
        be reviewed in the coming year under subsection (a)(3), 
        providing a comment period for further public input, pursuant 
        to section 608(a)(2).''.

SEC. 111. SMALL BUSINESSES.

    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. 619. 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. 112. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.

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

``SEC. 620. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.

    ``In the case of a cosmetic product or a facility that is subject 
to the requirements under this chapter and chapter V, if any 
requirement under chapter V with respect to such cosmetic or facility 
is substantially similar to a requirement under this chapter, the 
cosmetic product or facility shall be deemed to be in compliance with 
the applicable requirement under this chapter if such product or 
facility is in compliance with such substantially similar requirement 
under chapter V, provided that the product or facility has not obtained 
a waiver from the requirement under chapter V.''.

SEC. 113. ENFORCEMENT.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in subsection (e)--
                    (A) by striking ``504, 564'' and inserting ``504, 
                564, 611, or 612''; and
                    (B) by striking ``519, 564'' and inserting ``519, 
                564, 611,'';
            (2) in subsection (j) by inserting ``607, 608, 610,'' 
        before ``704'';
            (3) in subsection (ii)--
                    (A) by striking ``760 or 761)'' and inserting 
                ``604, 760, or 761)''; and
                    (B) by striking ``760 or 761) submitted'' and 
                inserting ``611, 760, or 761) submitted'';
            (4) in subsection (xx) by inserting ``or 613'' after 
        ``423''; and
            (5) by adding at the end the following:
    ``(ddd) The failure to register in accordance with section 605, the 
failure to submit a cosmetic ingredient statement under section 606, 
the failure to provide any information required by section 605 or 606, 
or the failure to update the information required by section 605 or 
606, as required.''.
    (b) Adulteration.--Section 601 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361), as amended by section 103, is further 
amended by adding at the end the following:
    ``(g) If it contains, after the date prescribed under section 
608(e), an ingredient that the Food and Drug Administration has 
determined under section 608(d)(4) to be not safe, or not safe under 
the conditions of use recommended or suggested in the label or a non-
functional constituent that the Food and Drug Administration has 
determined under section 608(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 any requirement of 
section 609 (relating to safety substantiation) is not met.''.
    (c) Misbranding.--Section 602 is amended--
            (1) in subsection (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, processed, packed, or held 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 614.''.
    (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) is amended--
            (1) by striking ``section 760 or 761'' the first, third, 
        and fourth place such term appears and inserting ``section 611, 
        760, or 761''; and
            (2) by striking ``760 or 761)'' and inserting ``604, 760, 
        or 761)''.
    (f) Factory Inspection.--Section 704(a)(1) is amended by inserting 
after the third sentence the following: ``In the case of any person who 
manufactures, processes, packs, holds, distributes, or imports a 
cosmetic product, or distributes a cosmetic product and affixes its 
name on the cosmetic label, the inspection shall extend to all records 
and other information described in section 612 (regarding inspection of 
cosmetic records), when the standard for records inspections under 
paragraph (1) or (2) of subsection (a) of such section applies, subject 
to the limitations under subsection (d) of such section.''.

SEC. 114. 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 
        608(d)(3);
            (2) cosmetic product recalls (including voluntary and 
        mandatory recalls); and
            (3) identified counterfeit cosmetic products.

               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 10 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 10--FEES RELATING TO COSMETICS

``SEC. 744L. REGISTRATION FEE.

    ``(a) Assessment and Collection.--
            ``(1) In general.--Beginning in fiscal year 2016, 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 cosmetic facility 
        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 entities described in subparagraphs (A) through (H) of 
        section 604(3).
            ``(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 2015.
            ``(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 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 sections 605 and 606, 
                        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 608, regarding the review of cosmetic 
                ingredients and non-functional constituents.
            ``(4) 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 2016, 
        based on the methodology described in paragraph (3)(B), 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 average 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 $500,000, shall be exempt from 
        registration fees under this section for that fiscal year.
            ``(3) Annual fee setting.--
                    ``(A) Fiscal year 2016.--For fiscal year 2016, to 
                generate a total estimated revenue amount of 
                $20,600,000, the amount of the registration fee under 
                subsection (a) shall be as follows:
                            ``(i) Tier i-a.--For a registrant that has 
                        gross annual sales of $5,000,000,000 or more in 
                        2015, $1,100,000.
                            ``(ii) 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 2015, 
                        $840,000.
                            ``(iii) 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 2015, $720,000.
                            ``(iv) 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 2015, $600,000.
                            ``(v) 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 2015, $500,000.
                            ``(vi) 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 2015, 
                        $395,000.
                            ``(vii) 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 2015, 
                        $325,000.
                            ``(viii) 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 2015, 
                        $275,000.
                            ``(ix) 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 2015, 
                        $185,000.
                            ``(x) 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 2015, 
                        $95,000.
                            ``(xi) 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 2015, 
                        $15,000.
                            ``(xii) 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 2015, 
                        $12,000.
                            ``(xiii) Tier vii-a.--For a registrant that 
                        has gross annual sales of at least $2,500,000 
                        per annum but less than $20,000,000 in 2015, 
                        $500.
                            ``(xiv) Tier vii-b.--For a registrant that 
                        has gross annual sales of at least $500,000 per 
                        annum but less than $2,500,000 in 2015, $250.
                    ``(B) Fiscal years 2017-2022.--For fiscal years 
                2017-2022, fees under subsection (a) shall be 
                established to generate a total estimated revenue 
                amount of $20,600,000, as adjusted by subsection (d). 
                Of that amount:
                            ``(i) Tier i-a.--Registrants that have 
                        gross annual sales of $5,000,000,000 or more in 
                        the fiscal year immediately preceding the 
                        fiscal year in which the annual fee will be 
                        paid, shall be responsible, collectively, for 
                        10.7 percent.
                            ``(ii) Tier i-b.--Registrants that have 
                        gross annual sales of at least $4,000,000,000 
                        per annum but less than $5,000,000,000 in the 
                        fiscal year immediately preceding the fiscal 
                        year in which the annual fee will be paid, 
                        shall be responsible, collectively, for 4.1 
                        percent.
                            ``(iii) Tier ii-a.--Registrants that have 
                        gross annual sales of at least $3,000,000,000 
                        per annum but less than $4,000,000,000 in the 
                        fiscal year immediately preceding the fiscal 
                        year in which the annual fee will be paid, 
                        shall be responsible, collectively, for 3.5 
                        percent.
                            ``(iv) Tier ii-b.--Registrants that have 
                        gross annual sales of at least $2,000,000,000 
                        per annum but less than $3,000,000,000 in the 
                        fiscal year immediately preceding the fiscal 
                        year in which the annual fee will be paid, 
                        shall be responsible, collectively, for 2.9 
                        percent.
                            ``(v) Tier iii-a.--Registrants that have 
                        gross annual sales of at least $1,000,000,000 
                        per annum but less than $2,000,000,000 in the 
                        fiscal year immediately preceding the fiscal 
                        year in which the annual fee will be paid, 
                        shall be responsible, collectively, for 7.3 
                        percent.
                            ``(vi) Tier iii-b.--Registrants that have 
                        gross annual sales of at least $500,000,000 per 
                        annum but less than $1,000,000,000 in the 
                        fiscal year immediately preceding the fiscal 
                        year in which the annual fee will be paid, 
                        shall be responsible, collectively, for 13.4 
                        percent.
                            ``(vii) Tier iv-a.--Registrants that have 
                        gross annual sales of at least $200,000,000 per 
                        annum but less than $500,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 15.8 percent.
                            ``(viii) Tier iv-b.--Registrants that have 
                        gross annual sales of at least $100,000,000 per 
                        annum but less than $200,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 13.3 percent.
                            ``(ix) Tier v-a.--Registrants that have 
                        gross annual sales of at least $80,000,000 per 
                        annum but less than $100,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 9 percent.
                            ``(x) Tier v-b.--Registrants that have 
                        gross annual sales of at least $60,000,000 per 
                        annum but less than $80,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 6.9 percent.
                            ``(xi) Tier vi-a.--Registrants that have 
                        gross annual sales of at least $40,000,000 per 
                        annum but less than $60,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 5.1 percent.
                            ``(xii) Tier vi-b.--Registrants that have 
                        gross annual sales of at least $20,000,000 per 
                        annum but less than $40,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 4.4 percent.
                            ``(xiii) Tier vii-a.--Registrants that have 
                        gross annual sales of at least $2,500,000 per 
                        annum but less than $20,000,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 1.2 percent.
                            ``(xiv) Tier vii-b.--Registrants that have 
                        gross annual sales of at least $500,000 per 
                        annum but less than $2,500,000 in the fiscal 
                        year immediately preceding the fiscal year in 
                        which the annual fee will be paid, shall be 
                        responsible, collectively, for 2.4 percent, 
                        except that no such registrant shall be 
                        responsible for more than $250 per fiscal year.
    ``(d) Adjustments.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For fiscal year 2017 and each 
                subsequent fiscal year, the revenues and fee amounts 
                under subsection (c)(3)(B) 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 2016 under this 
                subsection.
            ``(2) Final year adjustment.--For fiscal year 2022, 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 2023. 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 2022. 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 2017 and each 
                subsequent fiscal year, after fee revenues established 
                in subsection (c)(3)(B) 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 
                608(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)(B), 
                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 2015, 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.--The fees 
        authorized by this section--
                    ``(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, 2015, for the 
                salaries and expenses account of the Food and Drug 
                Administration, fees authorized by this section for 
                fiscal year 2016 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 sections 
                605 and 606, 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 2016-2022, 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 2016 through 2020 exceeds the 
                cumulative amount appropriated pursuant to paragraph 
                (3) for fiscal years 2016-2021, 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 2022.
                    ``(B) Recovery of collection shortfalls.--
                            ``(i) 2018.--For fiscal year 2018, 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 2016 falls below the amount of 
                        fees authorized for fiscal year 2016 under 
                        paragraph (3).
                            ``(ii) 2019.--For fiscal year 2019, 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 2017 falls below the amount of 
                        fees authorized for fiscal year 2017 under 
                        paragraph (3).
                            ``(iii) 2020.--For fiscal year 2020, 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 2018 falls below the amount of 
                        fees authorized for fiscal year 2018 under 
                        paragraph (3).
                            ``(iv) 2021.--For fiscal year 2021, 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 2019 falls below the amount of 
                        fees authorized for fiscal year 2019 under 
                        paragraph (3).
                            ``(v) 2022.--For fiscal year 2022, 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 2020 falls below the amount of 
                        fees authorized for fiscal year 2020 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 10 of subchapter C of chapter VII, as added by section 202, is 
amended by inserting after section 744L the following:

``SEC. 744M. 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>