Title: FDA Cosmetic Safety and Modernization Act
Policy area: Health

Summary:
FDA Cosmetic Safety and Modernization Act
This bill establishes a series of requirements relating to cosmetics regulation, including requiring cosmetics manufacturers and distributors to report serious adverse health events to the Food and Drug Administration.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2003 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                S. 2003

               To modernize the regulation of cosmetics.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 25, 2017

   Mr. Hatch introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
               To modernize the regulation 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.

    This Act may be cited as the ``FDA Cosmetic Safety and 
Modernization Act''.

SEC. 2. ADVERSE EVENT REPORTING.

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

``SEC. 762. SERIOUS ADVERSE EVENT REPORTING FOR COSMETICS.

    ``(a) Definitions.--In this section:
            ``(1) The term `adverse event' means any health-related 
        event associated with the use of a cosmetic that is adverse.
            ``(2) The term `serious adverse event' means an adverse 
        event that--
                    ``(A) results in--
                            ``(i) death;
                            ``(ii) a life-threatening experience;
                            ``(iii) inpatient hospitalization;
                            ``(iv) a persistent or significant 
                        disability, incapacity, or disfigurement;
                            ``(v) a congenital abnormality or birth 
                        defect; or
                            ``(vi) permanent alteration of appearance 
                        other than as intended, under conditions of use 
                        that are customary or usual; or
                    ``(B) requires, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described in subparagraph (A).
            ``(3) The term `serious adverse event report' means a 
        report that is required to be submitted to the Secretary under 
        subsection (b).
    ``(b) Reporting Requirement.--The manufacturer or distributor of a 
cosmetic whose name appears on the label of such cosmetic pursuant to 
section 602 (referred to in this section as a `responsible person') 
shall submit to the Secretary any report received of a serious adverse 
event associated with such cosmetic when used in the United States, 
accompanied by a copy of the label on or within the retail packaging of 
such cosmetic.
    ``(c) Submission of Reports.--
            ``(1) Timing of reports.--The responsible person shall 
        submit to the Secretary a serious adverse event report no later 
        than 15 business days after the report is received.
            ``(2) New medical information.--The responsible person 
        shall submit to the Secretary any new and material medical 
        information, related to a submitted serious adverse event 
        report that is received by the responsible person within 1 year 
        of the initial report, no later than 15 business days after 
        such information is received by such responsible person.
            ``(3) Consolidation of reports.--The Secretary shall 
        provide for systems to enable responsible persons to submit a 
        single report that includes duplicate reports of, or new 
        medical information related to, a serious adverse event.
            ``(4) Exemption.--The Secretary may establish an exemption 
        to the requirements under paragraphs (1) and (2) if--
                    ``(A) the Secretary receives a report in accordance 
                with section 760; or
                    ``(B) after providing notice and an opportunity for 
                comment from interested parties, the Secretary 
                determines that such exemption would have no 
                significant adverse effect on public health.
    ``(d) Content of Report.--Each serious adverse event report under 
this section shall be submitted to the Secretary, and may be 
accompanied by additional information.
    ``(e) Maintenance and Inspection of Records.--
            ``(1) Maintenance.--The responsible person shall maintain 
        records related to each report of a serious adverse event 
        received by the responsible person for a period of 6 years.
            ``(2) Records inspection.--
                    ``(A) In general.--The responsible person shall 
                permit an authorized person to have access to records 
                required to be maintained under this section during an 
                inspection pursuant to section 704.
                    ``(B) Authorized person.--For purposes of this 
                paragraph, the term `authorized person' means an 
                officer or employee of the Department of Health and 
                Human Services, who has--
                            ``(i) appropriate credentials, as 
                        determined by the Secretary; and
                            ``(ii) been duly designated by the 
                        Secretary to have access to the records 
                        required under this section.
    ``(f) Protected Information.--A serious adverse event report 
submitted to the Secretary under this section, including any new 
medical information submitted under subsection (c)(2), or an adverse 
event report voluntarily submitted to the Secretary shall be considered 
to be--
            ``(1) a safety report under section 756 and may be 
        accompanied by a statement, which shall be a part of any report 
        that is released for public disclosure, that denies that the 
        report or the records constitute an admission that the product 
        involved caused or contributed to the adverse event; and
            ``(2) a record about an individual under section 552a of 
        title 5, United States Code (commonly referred to as the 
        `Privacy Act of 1974'), and a medical or similar file the 
        disclosure of which would constitute a violation of section 552 
        of such title 5 (commonly referred to as the `Freedom of 
        Information Act'), and shall not be publicly disclosed unless 
        all personally identifiable information is redacted.
    ``(g) Rule of Construction.--The submission of any adverse event 
report under this section shall not be construed as an admission that 
the cosmetic involved caused or contributed to the adverse event.
    ``(h) Preemption.--
            ``(1) In general.--No State or local government shall 
        establish or continue in effect any law, regulation, order, or 
        other requirement related to a mandatory system for adverse 
        event reports for cosmetics.
            ``(2) Effect of section.--
                    ``(A) In general.--Nothing in this section shall 
                affect the authority of the Secretary to provide 
                adverse event reports and information to any health, 
                food, or drug officer or employee of any State, 
                territory, or political subdivision of a State or 
                territory, under a memorandum of understanding between 
                the Secretary and such State, territory, or political 
                subdivision.
                    ``(B) Personally-identifiable information.--
                Notwithstanding any other provision of law, personally-
                identifiable information in adverse event reports 
                provided by the Secretary to any health, food, or drug 
                officer or employee of any State, territory, or 
                political subdivision of a State or territory, shall 
                not--
                            ``(i) be made publicly available pursuant 
                        to any State or other law requiring disclosure 
                        of information or records; or
                            ``(ii) otherwise be disclosed or 
                        distributed to any party without the written 
                        consent of the Secretary and the person 
                        submitting such information to the Secretary.
                    ``(C) Use of safety reports.--Nothing in this 
                section shall permit a State, territory, or political 
                subdivision of a State or territory, to use any safety 
                report received from the Secretary in a manner 
                inconsistent with subsection (g) or section 756.
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be 
necessary.''.
    (b) Conforming Amendments.--The Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321 et seq.) is amended--
            (1) in section 301(ii) (21 U.S.C. 331(ii)), by striking 
        ``section 760 or 761'' each place it appears and inserting 
        ``section 760, 761, or 762''; and
            (2) in section 801 (21 U.S.C. 381), by striking ``section 
        760 or 761'' each place it appears in subsections (a) and (b) 
        and inserting ``section 760, 761, or 762''.

SEC. 3. ADULTERATED COSMETICS.

    Section 601(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 361(a)) is amended--
            (1) by inserting ``, or consists in whole or in part of,'' 
        after ``bears or contains''; and
            (2) by striking ``usual, except that this'' and inserting 
        ``usual. For purposes of this clause, a cosmetic may be 
        adulterated regardless of whether it is known which particular 
        substance or substances may render the cosmetic injurious to 
        users under the conditions of use prescribed in the labeling 
        thereof, or under such conditions of use as are customary or 
        usual. This''.

SEC. 4. LABELING.

    Section 602 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
362) is amended by adding at the end the following:
    ``(g) If it is a cosmetic that is marketed in the United States, 
unless its label includes a domestic address, domestic phone number, or 
Internet address through which the responsible person (as described in 
section 762) can receive a report of a serious adverse event with 
respect to such cosmetic product.''.

SEC. 5. REGISTRATION OF COSMETIC FACILITIES.

    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. REGISTRATION OF COSMETIC FACILITIES.

    ``(a) Registration.--
            ``(1) In general.--The Secretary shall by regulation 
        require the manufacturer or distributor whose name appears on 
        the label of a cosmetic marketed in the United States to 
        register all facilities engaged in manufacturing of such 
        cosmetic with the Secretary. To be registered--
                    ``(A) for a domestic facility, the responsible 
                person, owner, or agent in charge of the facility shall 
                submit a registration to the Secretary; and
                    ``(B) for a foreign facility, the responsible 
                person, owner, or agent in charge of the facility shall 
                submit a registration to the Secretary and shall 
                include with the registration the name of the United 
                States agent for the facility.
            ``(2) Registration.--
                    ``(A) In general.--An entity (referred to in this 
                section as the `registrant') shall submit a 
                registration under paragraph (1) to the Secretary 
                containing information necessary to notify the 
                Secretary of the name and address of each facility at 
                which, and all the trade names under which, the 
                registrant conducts business, the e-mail address for 
                the responsible person (as described in section 762(b)) 
                of the facility or, in the case of a foreign facility, 
                the United States agent for the facility.
                    ``(B) Availability of information.--The Secretary 
                shall require--
                            ``(i) the information submitted under 
                        subparagraph (A) to be maintained and 
                        available, at the request of the Secretary, for 
                        a period to be determined by the Secretary; and
                            ``(ii) the name and address of each 
                        facility with which the registrant contracts 
                        related to cosmetic manufacturing, processing, 
                        distributing, or other activities, as the 
                        Secretary determines appropriate, to be 
                        maintained and available at the request of the 
                        Secretary, for a period to be determined by the 
                        Secretary.
                    ``(C) Additional requirements.--The registration 
                shall contain an assurance that--
                            ``(i) the Secretary will be permitted to 
                        inspect the facility at the times and in the 
                        manner permitted by this Act; and
                            ``(ii) the registrant will notify the 
                        Secretary in a timely manner of changes to the 
                        information submitted.
            ``(3) Registration renewal.--A registrant that has 
        submitted a registration under paragraph (1) shall submit to 
        the Secretary a renewal registration containing the information 
        described in paragraph (2) every 2 years during a period of 
        time as determined by the Secretary. The Secretary shall 
        provide for an abbreviated registration renewal process for any 
        registrant that has not had any changes to such information 
        since the registrant submitted the preceding registration or 
        registration renewal for the facility involved.
            ``(4) Procedure.--Upon receipt of a completed registration 
        described in paragraph (1), the Secretary shall notify the 
        registrant of the receipt of such registration and assign a 
        registration number to each registered facility.
            ``(5) List.--The Secretary shall compile and maintain an 
        up-to-date list of facilities that are registered under this 
        section. Such list and any registration documents submitted 
        pursuant to this subsection shall not be subject to disclosure 
        under section 552 of title 5, United States Code. Information 
        derived from such list or registration documents shall not be 
        subject to disclosure under section 552 of title 5, United 
        States Code, to the extent that it discloses the identity or 
        location of a specific registered person.
    ``(b) Suspension of Registration.--
            ``(1) In general.--If the Secretary determines that 
        cosmetics manufactured or processed by a facility registered 
        under this section has a reasonable probability of causing 
        serious adverse health consequences or death to humans, the 
        Secretary may by order suspend the registration of any facility 
        that is responsible for such reasonable probability or that 
        knew of, or had reason to know of, such reasonable probability 
        related to such cosmetics.
            ``(2) Hearing on suspension.--The Secretary shall provide 
        the registrant subject to an order under paragraph (1) with an 
        opportunity for an informal hearing, to be held as soon as 
        possible but not later than 2 business days after the issuance 
        of the order or such other time period, as agreed upon by the 
        Secretary and the registrant, on the actions required for 
        reinstatement of registration and why the registration that is 
        subject to the suspension should be reinstated. The Secretary 
        shall reinstate a registration if the Secretary determines, 
        based on evidence presented, that adequate grounds do not exist 
        to continue the suspension of the registration.
            ``(3) Post-hearing corrective action plan; vacating of 
        order.--
                    ``(A) Corrective action plan.--If, after providing 
                opportunity for an informal hearing under paragraph 
                (2), the Secretary determines that the suspension of 
                registration remains necessary, the Secretary shall 
                require the registrant to submit a corrective action 
                plan to demonstrate how the registrant plans to correct 
                the conditions found by the Secretary. The Secretary 
                shall review such plan not later than 14 days after the 
                submission of the corrective action plan or such other 
                time period as determined by the Secretary, in 
                consultation with the registrant.
                    ``(B) Vacating of order.--Upon a determination by 
                the Secretary that adequate grounds do not exist to 
                continue the suspension actions required by the order, 
                or that such actions should be modified, the Secretary 
                shall promptly vacate the order and reinstate the 
                registration of the facility subject to the order or 
                modify the order, as appropriate.
            ``(4) Effect of suspension.--If the registration of a 
        facility is suspended under this subsection, no person shall 
        import or export cosmetics into the United States from such 
        facility, offer to import or export cosmetics into the United 
        States from such facility, or otherwise introduce cosmetics 
        from such facility into interstate or intrastate commerce in 
        the United States.
            ``(5) Regulations.--
                    ``(A) In general.--The Secretary shall promulgate 
                regulations to implement this subsection.
                    ``(B) Electronic registration requirement.--The 
                Secretary may require that registration under this 
                section be submitted in an electronic format.
            ``(6) Application date.--Facilities shall not be subject to 
        the requirements of this subsection prior to the date that is 
        180 days after the date on which the Secretary issues final 
        regulations under paragraph (5).
            ``(7) No delegation.--The authority conferred by this 
        subsection 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.
    ``(c) Facility.--For purposes of this section:
            ``(1) The term `facility'--
                    ``(A) includes any factory or other establishment 
                that is engaged in the manufacturing or processing of a 
                cosmetic or cosmetics; and
                    ``(B) does not include--
                            ``(i) beauty salons, spas, retailers 
                        (including individual sales representatives, 
                        wholesale distributors, or pharmacy locations);
                            ``(ii) homes where persons are engaged in 
                        making handcrafted soaps or other cosmetics; or
                            ``(iii) any business with less than 
                        $1,000,000 in annual net revenue in the 
                        previous year, other than any such business 
                        that is engaged in the manufacturing or 
                        processing of products intended to be injected 
                        under the skin, including tattoo ink.
            ``(2) The term `domestic facility' means a facility located 
        in any of the States or Territories.
            ``(3) The term `foreign facility' means a facility located 
        outside of the United States or Territories, but only if the 
        cosmetics from such facility are exported to the United States 
        without further manufacturing outside the United States or 
        Territories.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to authorize the Secretary to require an application, review, 
or licensing process for a facility to be registered, except with 
respect to the reinstatement of a registration that is suspended under 
subsection (b).
    ``(e) Preemption.--No State or political subdivision of a State may 
establish or continue in effect any law, regulation, order, or other 
requirement with respect to the registration of facilities engaged in 
the manufacturing or processing of a cosmetic or cosmetics that is 
different from the requirements under this section.''.

SEC. 6. GOOD MANUFACTURING PRACTICES.

    (a) Good Manufacturing Practice Standards.--Chapter VI of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 
amended by section 5, is further amended by adding at the end the 
following:

``SEC. 605. GOOD MANUFACTURING PRACTICES.

    ``(a) Establishment of Good Manufacturing Practices.--
            ``(1) In general.--The Secretary shall by regulation 
        establish good manufacturing practices for cosmetics in 
        accordance with paragraphs (a) and (d) of section 601. Such 
        regulations--
                    ``(A) shall be modeled after comparable good 
                manufacturing practice standards for cosmetics in 
                effect at the time of promulgation;
                    ``(B) may not impose standards for which there is 
                no current and generally available analytical 
                methodology;
                    ``(C) may ensure that cosmetics do not cause 
                serious adverse health consequences or death;
                    ``(D) shall be intended to protect the public 
                health; and
                    ``(E) shall not apply to entities described in 
                clauses (i) and (ii) of section 604(c)(1)(B).
            ``(2) Considerations.--In promulgating regulations under 
        paragraph (1), the Secretary shall consider facilities that are 
        subject to other, similar regulations, as appropriate.
    ``(b) Notice and Comment.--A regulation under subsection (a) shall 
be promulgated only after providing notice and an opportunity for 
comment in accordance with chapter 5 of title 5, United States Code.
    ``(c) Small Businesses.--
            ``(1) Applicability to small businesses.--The Secretary 
        shall provide for an additional year after the effective date 
        of the regulations under subsection (a) for small businesses 
        (as described in section 604(c)(1)(B)(iii)) to comply with the 
        good manufacturing practices established in accordance with 
        subsection (a), and issue guidance for small businesses for 
        purposes of compliance with this section.
            ``(2) Considerations.--In establishing good manufacturing 
        practices under this section, the Secretary shall take into 
        account the practices of small business, including the size and 
        scope of the business, and consult with the Small Business 
        Administration, as appropriate.
    ``(d) Preemption.--No State or political subdivision of a State may 
establish or continue in effect any law, regulation, order, or other 
requirement with respect to good manufacturing practice standards for 
cosmetics that is different from the requirements under this 
section.''.
    (b) Prohibition.--Section 601 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the 
following:
    ``(f) If it has been manufactured under conditions that do not meet 
current good manufacturing practice regulations established under 
section 605.''.

SEC. 7. IDENTIFICATION AND REVIEW OF COSMETIC INGREDIENTS.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 6, is further amended by adding at 
the end the following:

``SEC. 606. IDENTIFICATION AND REVIEW OF COSMETIC INGREDIENTS.

    ``(a) Identification of Ingredients and Non-Functional Constituents 
To Be Reviewed.--Each year, the Secretary, in consultation with 
industry and consumer groups, and taking into consideration ingredients 
identified by a State or political subdivision as presenting a public 
health concern, shall identify cosmetic ingredients, as appropriate, 
that may present a public health concern to be reviewed for safety, 
including a class or classes of ingredients, or a non-functional 
constituent or class of non-functional constituents. The Secretary 
shall publish in the Federal Register a list of the ingredients or non-
functional constituents, or classes of ingredients or constituents 
identified for review, and solicit public input and provide the public 
notice and a period of 60 days to comment on any such ingredient, 
constituent, or class. The Secretary may identify a cosmetic ingredient 
or ingredients, as appropriate, to be reviewed for safety outside such 
annual process.
    ``(b) Administrative Orders and Standards.--
            ``(1) Publication of determinations and findings.--
                    ``(A) Proposed orders.--If the Secretary determines 
                that there is adequate scientific evidence to support a 
                determination that there is reasonable certainty that 
                an ingredient, class of ingredients, non-functional 
                constituent, or class of non-functional constituents is 
                safe for use, not safe for use, or not safe for 
                specified conditions of use, the Secretary shall post 
                on the Internet website of the Food and Drug 
                Administration a proposed administrative order 
                consistent with such determination.
                    ``(B) Findings of inadequate evidence.--If the 
                Secretary determines that there is inadequate 
                scientific evidence to support a determination 
                described in subparagraph (A), the Secretary shall post 
                on the Internet website of the Food and Drug 
                Administration such findings, together with a rationale 
                for the findings.
                    ``(C) Additional evidence.--Nothing in this 
                paragraph shall prevent the Secretary from considering 
                additional scientific information or safety data 
                related to the ingredient that is submitted to the 
                Secretary.
            ``(2) Final orders.--
                    ``(A) In general.--After allowing not less than 90 
                days for public comment on a proposed order under 
                paragraph (1)(A) and a period for consideration of any 
                such comments, if the Secretary determines that there 
                is adequate scientific evidence to make a final 
                determination on the safety of the applicable 
                ingredient, class of ingredients, non-functional 
                constituent, or class of non-functional constituents, 
                the Secretary shall issue a final administrative order 
                that there is reasonable certainty that--
                            ``(i) the ingredient, class of ingredients, 
                        non-functional constituent, or class of non-
                        functional constituents is safe for use;
                            ``(ii) the ingredient, class of 
                        ingredients, non-functional constituent, or 
                        class of non-functional constituents is not 
                        safe for any use; or
                            ``(iii) the ingredient, class of 
                        ingredients, non-functional constituent, or 
                        class of non-functional constituents is not 
                        safe under specified conditions of use.
                    ``(B) Final action.--A final administrative order 
                under subparagraph (A) shall be considered final agency 
                action for purposes of judicial review.
            ``(3) Standards.--A determination that an ingredient, class 
        of ingredients, non-functional constituent, or class of non-
        functional constituents is not safe under specified conditions 
        of use may specify conditions of use such as--
                    ``(A) the amount or concentration of such 
                ingredient;
                    ``(B) the populations which may specifically use 
                such ingredient or not use such ingredient;
                    ``(C) the area of the human body on which or near 
                which such ingredient should not be used; or
                    ``(D) such other conditions that may affect the 
                safety of the cosmetic as a whole or in part.
    ``(c) Cosmetic Safety Standard.--For purposes of this Act, 
including reviews for safety under this section and section 607, a 
cosmetic is safe if there is reasonable certainty that the cosmetic is 
not injurious to users under conditions of use prescribed in labeling 
or under such conditions of use as are customary or usual.
    ``(d) Preemption.--Upon identification of a cosmetic ingredient or 
non-functional constituent by the Secretary under subsection (a), no 
State or local government may establish or continue in effect any law, 
regulation, order, or other requirement with respect to such ingredient 
or non-functional constituent, except that a State or local government 
may continue in effect such a requirement that was in full effect with 
respect to such ingredient on the date of enactment of the FDA Cosmetic 
Safety and Modernization Act, or that is exempted from preemption under 
section 752(b) of the Federal Food, Drug, and Cosmetic Act.
    ``(e) Definitions.--For purposes of this Act--
            ``(1) the term `non-functional constituent' means a 
        substance or chemical, or other contaminant, that was not 
        intentionally added or included in the formula of a cosmetic 
        product and serves no technical purpose, but may be present as 
        a breakdown product or by-product of manufacturing; and
            ``(2) the term `cosmetic' means a cosmetic product in 
        finished form consistent with section 201(i)(1).
    ``(f) Rule of Construction.--This section shall not be construed to 
affect the right of a person to lawfully market a cosmetic product that 
is or that contains an ingredient, class of ingredients, non-functional 
constituent, or class of non-functional constituents while such 
substance is under review or has been identified for review by the 
Secretary for safety.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be 
necessary.''.

SEC. 8. ACCREDITED THIRD-PARTY REVIEW.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 7, is further amended by adding at 
the end the following:

``SEC. 607. ACCREDITED THIRD-PARTY REVIEW.

    ``(a) In General.--The Secretary may accredit persons to review and 
assess for safety cosmetic ingredients or non-functional constituents 
identified by the Secretary under section 606(a) and make 
recommendations to the Secretary for proposed administrative orders 
under section 606(b)(1)(A).
    ``(b) Accreditation and Review.--Not later than 2 years after the 
date of enactment of the FDA Cosmetic Safety and Modernization Act, the 
Secretary shall promulgate regulations establishing--
            ``(1) a process to accredit third parties for purposes of 
        reviewing cosmetic ingredients, classes of ingredients, non-
        functional constituents, and classes of non-functional 
        constituents identified by the Secretary under section 606(a); 
        and
            ``(2) criteria and qualifications for such accreditation of 
        third parties.
    ``(c) Requirements Regarding Review.--In making a recommendation to 
the Secretary under subsection (a), an accredited third party shall 
notify the Secretary in writing of the reasons for the recommendation, 
and provide relevant scientific literature or data, as the Secretary 
requires.
    ``(d) Review and Administrative Order.--The Secretary shall 
establish a process by which to review recommendations from such 
accredited third party and to determine whether an Administrative Order 
is appropriate. Not later than 180 calendar days after the date on 
which the Secretary receives a recommendation from an accredited third 
party pertaining to a cosmetic ingredient or non-functional ingredient 
identified by the Secretary under section 606(a), the Secretary shall 
issue a proposed administrative order, or issue a public rationale on 
the Secretary's determination not to issue a proposed administrative 
order.
    ``(e) Qualifications.--An accredited third party shall, at a 
minimum, meet the following requirements:
            ``(1) Such third party may not be affiliated with a 
        government entity.
            ``(2) Such third party shall be an independent organization 
        that is not owned or controlled by a manufacturer, supplier, or 
        vendor of cosmetics and that has no financial affiliation with 
        such a manufacturer, supplier, or vendor.
            ``(3) Such third party shall be a legally constituted 
        entity permitted to conduct the activities for which it seeks 
        accreditation.
            ``(4) Such third party shall not engage in the design, 
        manufacturer, promotion, or sale of cosmetics.
            ``(5) Such third party shall have scientific expertise in 
        ingredient safety, toxicology, or chemical safety.
            ``(6) The operations of such third party shall be in 
        accordance with generally accepted professional and ethical 
        business practices and such third party shall agree in writing 
        that it will--
                    ``(A) certify that reported information accurately 
                reflects data reviewed;
                    ``(B) limit work to that within its competence and 
                capacity;
                    ``(C) treat proprietary, confidential, and 
                commercial information received, including records, 
                reports, and recommendations, as confidential 
                information;
                    ``(D) promptly respond and attempt to resolve 
                complaints regarding the activities for which it is 
                accredited; and
                    ``(E) protect against the use, in carrying out 
                subsection (a) with respect to a cosmetic, of any 
                officer or employee of the entity who has a financial 
                conflict of interest regarding the cosmetic, and 
                annually make available to the public disclosures of 
                the extent to which the entity, and the officers and 
                employees of the entity, have maintained compliance 
                with requirements under this subparagraph relating to 
                financial conflicts of interest.
    ``(f) Rule of Construction.--Nothing in this section is intended to 
affect the Secretary's authority to enter into contracts with non-
accredited third parties for purposes of cosmetic safety review.''.

SEC. 9. REPORTING.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.), as amended by section 8, is further amended by adding at 
the end the following:

``SEC. 608. COSMETIC INGREDIENT REPORT.

    ``(a) Annual Report to Congress.--The Commissioner shall submit an 
annual report to the appropriate committees of Congress that includes a 
report or summary of--
            ``(1) the ingredients or non-functional constituents that 
        the Commissioner has identified for review under section 
        606(a);
            ``(2) the ingredients or non-functional constituents for 
        which the Commissioner has issued a proposed order, a final 
        order, or a finding of incomplete evidence under section 
        606(b);
            ``(3) the ongoing ingredient or non-functional constituents 
        being reviewed for safety at the time of submission of the 
        report, reviews the Commissioner has determined to be needed, 
        and reviews for which Commissioner is contracting with an 
        accredited third party;
            ``(4) a summary of serious adverse event reports submitted 
        under section 762, and the associated product category and 
        serious adverse health consequence for each such report; and
            ``(5) enforcement actions, if any, the Commissioner has 
        taken as a result of serious adverse event reports or facility 
        inspections, including warning letters, untitled letters, 
        suspension of registration, or any other type of action.''.

SEC. 10. GAO REPORT.

    Not later than 2 years after the date of enactment of this Act, the 
Comptroller General of the United States shall analyze, and submit a 
report to Congress on--
            (1) the types of ingredients or non-functional constituents 
        that the Food and Drug Administration has identified for 
        purposes of a safety review under section 606 of the Federal 
        Food, Drug, and Cosmetic Act (as added by section 7) and the 
        factors or methods, if any, that such agency considers in 
        determining the need for a safety review;
            (2) the level of coordination between the Food and Drug 
        Administration and the States in identifying ingredients that 
        may present a public health concern for review, and the process 
        by which the Food and Drug Administration considers public 
        input as part of identifying ingredients that may present a 
        public health concern;
            (3) how the Food and Drug Administration accounts for 
        reports of serious adverse events under section 762 of the 
        Federal Food, Drug, and Cosmetic Act (as added by section 2) to 
        inform cosmetic related inspections;
            (4) the frequency and type of inspections conducted by the 
        Food and Drug Administration, including inspections in response 
        to reports of serious adverse events, and an analysis of the 
        outcome and related facility compliance;
            (5) the time between identifying ingredients to be reviewed 
        for safety under section 606(a) of the Federal Food, Drug, and 
        Cosmetic Act and issuance of final administrative orders under 
        section 606(b)(2) of such Act;
            (6) ingredients, if any, that the Food and Drug 
        Administration took action to include on the prohibited and 
        restricted ingredients list of the Food and Drug 
        Administration, and a summary of ingredients with respect to 
        which such agency has issued an administrative order; and
            (7) the Food and Drug Administration's use of accredited 
        third parties for purposes of cosmetic ingredient safety 
        reviews in accordance with section 607 of the Federal Food, 
        Drug, and Cosmetic Act (as added by section 8).
                                 <all>