II 115th CONGRESS 1st Session S. 2003 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.

1. Short title This Act may be cited as the FDA Cosmetic Safety and Modernization Act . 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: 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 . 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 . 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. . 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: 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. . 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: 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. . 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: 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. . 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: 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. . 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: 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. . 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).