II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Cosmetic Safety 

5 and Modernization Act’’. 

6 SEC. 2. ADVERSE EVENT REPORTING. 

7 (a) IN GENERAL.—Subchapter H of chapter VII of 

8 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 379aa et seq.) is amended by adding at the end the fol10 lowing: 


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1 ‘‘SEC. 762. SERIOUS ADVERSE EVENT REPORTING FOR COS2 METICS. 

3 ‘‘(a) DEFINITIONS.—In this section: 

4 ‘‘(1) The term ‘adverse event’ means any 

5 health-related event associated with the use of a cos6 metic that is adverse. 

7 ‘‘(2) The term ‘serious adverse event’ means an 

8 adverse event that— 

9 ‘‘(A) results in— 

10 ‘‘(i) death; 

11 ‘‘(ii) a life-threatening experience; 

12 ‘‘(iii) inpatient hospitalization; 

13 ‘‘(iv) a persistent or significant dis14 ability, incapacity, or disfigurement; 

15 ‘‘(v) a congenital abnormality or birth 

16 defect; or 

17 ‘‘(vi) permanent alteration of appear18 ance other than as intended, under condi19 tions of use that are customary or usual; 

20 or 

21 ‘‘(B) requires, based on reasonable medical 

22 judgment, a medical or surgical intervention to 

23 prevent an outcome described in subparagraph 

24 (A). 


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1 ‘‘(3) The term ‘serious adverse event report’ 

2 means a report that is required to be submitted to 

3 the Secretary under subsection (b). 

4 ‘‘(b) REPORTING REQUIREMENT.—The manufac5 turer or distributor of a cosmetic whose name appears on 

6 the label of such cosmetic pursuant to section 602 (re7 ferred to in this section as a ‘responsible person’) shall 

8 submit to the Secretary any report received of a serious 

9 adverse event associated with such cosmetic when used in 

10 the United States, accompanied by a copy of the label on 

11 or within the retail packaging of such cosmetic. 

12 ‘‘(c) SUBMISSION OF REPORTS.— 

13 ‘‘(1) TIMING OF REPORTS.—The responsible 

14 person shall submit to the Secretary a serious ad15 verse event report no later than 15 business days 

16 after the report is received. 

17 ‘‘(2) NEW MEDICAL INFORMATION.—The re18 sponsible person shall submit to the Secretary any 

19 new and material medical information, related to a 

20 submitted serious adverse event report that is re21 ceived by the responsible person within 1 year of the 

22 initial report, no later than 15 business days after 

23 such information is received by such responsible per24 son. 


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1 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec2 retary shall provide for systems to enable responsible 

3 persons to submit a single report that includes du4 plicate reports of, or new medical information re5 lated to, a serious adverse event. 

6 ‘‘(4) EXEMPTION.—The Secretary may estab7 lish an exemption to the requirements under para8 graphs (1) and (2) if— 

9 ‘‘(A) the Secretary receives a report in ac10 cordance with section 760; or 

11 ‘‘(B) after providing notice and an oppor12 tunity for comment from interested parties, the 

13 Secretary determines that such exemption 

14 would have no significant adverse effect on pub15 lic health. 

16 ‘‘(d) CONTENT OF REPORT.—Each serious adverse 

17 event report under this section shall be submitted to the 

18 Secretary, and may be accompanied by additional informa19 tion. 

20 ‘‘(e) MAINTENANCE AND INSPECTION OF

21 RECORDS.— 

22 ‘‘(1) MAINTENANCE.—The responsible person 

23 shall maintain records related to each report of a se24 rious adverse event received by the responsible per25 son for a period of 6 years. 


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1 ‘‘(2) RECORDS INSPECTION.— 

2 ‘‘(A) IN GENERAL.—The responsible per3 son shall permit an authorized person to have 

4 access to records required to be maintained 

5 under this section during an inspection pursu6 ant to section 704. 

7 ‘‘(B) AUTHORIZED PERSON.—For pur8 poses of this paragraph, the term ‘authorized 

9 person’ means an officer or employee of the De10 partment of Health and Human Services, who 

11 has— 

12 ‘‘(i) appropriate credentials, as deter13 mined by the Secretary; and 

14 ‘‘(ii) been duly designated by the Sec15 retary to have access to the records re16 quired under this section. 

17 ‘‘(f) PROTECTED INFORMATION.—A serious adverse 

18 event report submitted to the Secretary under this section, 

19 including any new medical information submitted under 

20 subsection (c)(2), or an adverse event report voluntarily 

21 submitted to the Secretary shall be considered to be— 

22 ‘‘(1) a safety report under section 756 and may 

23 be accompanied by a statement, which shall be a 

24 part of any report that is released for public disclo25 sure, that denies that the report or the records conVerDate Sep 11 2014 23:34 Oct 26, 2017 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2003.IS S2003

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1 stitute an admission that the product involved 

2 caused or contributed to the adverse event; and 

3 ‘‘(2) a record about an individual under section 

4 552a of title 5, United States Code (commonly re5 ferred to as the ‘Privacy Act of 1974’), and a med6 ical or similar file the disclosure of which would con7 stitute a violation of section 552 of such title 5 

8 (commonly referred to as the ‘Freedom of Informa9 tion Act’), and shall not be publicly disclosed unless 

10 all personally identifiable information is redacted. 

11 ‘‘(g) RULE OF CONSTRUCTION.—The submission of 

12 any adverse event report under this section shall not be 

13 construed as an admission that the cosmetic involved 

14 caused or contributed to the adverse event. 

15 ‘‘(h) PREEMPTION.— 

16 ‘‘(1) IN GENERAL.—No State or local govern17 ment shall establish or continue in effect any law, 

18 regulation, order, or other requirement related to a 

19 mandatory system for adverse event reports for cos20 metics. 

21 ‘‘(2) EFFECT OF SECTION.— 

22 ‘‘(A) IN GENERAL.—Nothing in this sec23 tion shall affect the authority of the Secretary 

24 to provide adverse event reports and informa25 tion to any health, food, or drug officer or emVerDate Sep 11 2014 23:34 Oct 26, 2017 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2003.IS S2003

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1 ployee of any State, territory, or political sub2 division of a State or territory, under a memo3 randum of understanding between the Secretary 

4 and such State, territory, or political subdivi5 sion. 

6 ‘‘(B) PERSONALLY-IDENTIFIABLE INFOR7 MATION.—Notwithstanding any other provision 

8 of law, personally-identifiable information in ad9 verse event reports provided by the Secretary to 

10 any health, food, or drug officer or employee of 

11 any State, territory, or political subdivision of a 

12 State or territory, shall not— 

13 ‘‘(i) be made publicly available pursu14 ant to any State or other law requiring dis15 closure of information or records; or 

16 ‘‘(ii) otherwise be disclosed or distrib17 uted to any party without the written con18 sent of the Secretary and the person sub19 mitting such information to the Secretary. 

20 ‘‘(C) USE OF SAFETY REPORTS.—Nothing 

21 in this section shall permit a State, territory, or 

22 political subdivision of a State or territory, to 

23 use any safety report received from the Sec24 retary in a manner inconsistent with subsection 

25 (g) or section 756. 


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1 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 such sums as may be necessary.’’. 

4 (b) CONFORMING AMENDMENTS.—The Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) 

6 is amended— 

7 (1) in section 301(ii) (21 U.S.C. 331(ii)), by 

8 striking ‘‘section 760 or 761’’ each place it appears 

9 and inserting ‘‘section 760, 761, or 762’’; and 

10 (2) in section 801 (21 U.S.C. 381), by striking 

11 ‘‘section 760 or 761’’ each place it appears in sub12 sections (a) and (b) and inserting ‘‘section 760, 761, 

13 or 762’’. 

14 SEC. 3. ADULTERATED COSMETICS. 

15 Section 601(a) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 361(a)) is amended— 

17 (1) by inserting ‘‘, or consists in whole or in 

18 part of,’’ after ‘‘bears or contains’’; and 

19 (2) by striking ‘‘usual, except that this’’ and in20 serting ‘‘usual. For purposes of this clause, a cos21 metic may be adulterated regardless of whether it is 

22 known which particular substance or substances may 

23 render the cosmetic injurious to users under the con24 ditions of use prescribed in the labeling thereof, or 


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1 under such conditions of use as are customary or 

2 usual. This’’. 

3 SEC. 4. LABELING. 

4 Section 602 of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 362) is amended by adding at the end the 

6 following: 

7 ‘‘(g) If it is a cosmetic that is marketed in the United 

8 States, unless its label includes a domestic address, do9 mestic phone number, or Internet address through which 

10 the responsible person (as described in section 762) can 

11 receive a report of a serious adverse event with respect 

12 to such cosmetic product.’’. 

13 SEC. 5. REGISTRATION OF COSMETIC FACILITIES. 

14 Chapter VI of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 361 et seq.) is amended by adding at the 

16 end the following: 

17 ‘‘SEC. 604. REGISTRATION OF COSMETIC FACILITIES. 

18 ‘‘(a) REGISTRATION.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall by reg20 ulation require the manufacturer or distributor 

21 whose name appears on the label of a cosmetic mar22 keted in the United States to register all facilities 

23 engaged in manufacturing of such cosmetic with the 

24 Secretary. To be registered— 


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1 ‘‘(A) for a domestic facility, the responsible 

2 person, owner, or agent in charge of the facility 

3 shall submit a registration to the Secretary; and 

4 ‘‘(B) for a foreign facility, the responsible 

5 person, owner, or agent in charge of the facility 

6 shall submit a registration to the Secretary and 

7 shall include with the registration the name of 

8 the United States agent for the facility. 

9 ‘‘(2) REGISTRATION.— 

10 ‘‘(A) IN GENERAL.—An entity (referred to 

11 in this section as the ‘registrant’) shall submit 

12 a registration under paragraph (1) to the Sec13 retary containing information necessary to no14 tify the Secretary of the name and address of 

15 each facility at which, and all the trade names 

16 under which, the registrant conducts business, 

17 the e-mail address for the responsible person 

18 (as described in section 762(b)) of the facility 

19 or, in the case of a foreign facility, the United 

20 States agent for the facility. 

21 ‘‘(B) AVAILABILITY OF INFORMATION.— 

22 The Secretary shall require— 

23 ‘‘(i) the information submitted under 

24 subparagraph (A) to be maintained and 

25 available, at the request of the Secretary, 


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1 for a period to be determined by the Sec2 retary; and 

3 ‘‘(ii) the name and address of each fa4 cility with which the registrant contracts 

5 related to cosmetic manufacturing, proc6 essing, distributing, or other activities, as 

7 the Secretary determines appropriate, to be 

8 maintained and available at the request of 

9 the Secretary, for a period to be deter10 mined by the Secretary. 

11 ‘‘(C) ADDITIONAL REQUIREMENTS.—The 

12 registration shall contain an assurance that— 

13 ‘‘(i) the Secretary will be permitted to 

14 inspect the facility at the times and in the 

15 manner permitted by this Act; and 

16 ‘‘(ii) the registrant will notify the Sec17 retary in a timely manner of changes to 

18 the information submitted. 

19 ‘‘(3) REGISTRATION RENEWAL.—A registrant 

20 that has submitted a registration under paragraph 

21 (1) shall submit to the Secretary a renewal registra22 tion containing the information described in para23 graph (2) every 2 years during a period of time as 

24 determined by the Secretary. The Secretary shall 

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1 ess for any registrant that has not had any changes 

2 to such information since the registrant submitted 

3 the preceding registration or registration renewal for 

4 the facility involved. 

5 ‘‘(4) PROCEDURE.—Upon receipt of a com6 pleted registration described in paragraph (1), the 

7 Secretary shall notify the registrant of the receipt of 

8 such registration and assign a registration number 

9 to each registered facility. 

10 ‘‘(5) LIST.—The Secretary shall compile and 

11 maintain an up-to-date list of facilities that are reg12 istered under this section. Such list and any reg13 istration documents submitted pursuant to this sub14 section shall not be subject to disclosure under sec15 tion 552 of title 5, United States Code. Information 

16 derived from such list or registration documents 

17 shall not be subject to disclosure under section 552 

18 of title 5, United States Code, to the extent that it 

19 discloses the identity or location of a specific reg20 istered person. 

21 ‘‘(b) SUSPENSION OF REGISTRATION.— 

22 ‘‘(1) IN GENERAL.—If the Secretary determines 

23 that cosmetics manufactured or processed by a facil24 ity registered under this section has a reasonable 

25 probability of causing serious adverse health conVerDate Sep 11 2014 23:34 Oct 26, 2017 Jkt 079200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2003.IS S2003

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1 sequences or death to humans, the Secretary may by 

2 order suspend the registration of any facility that is 

3 responsible for such reasonable probability or that 

4 knew of, or had reason to know of, such reasonable 

5 probability related to such cosmetics. 

6 ‘‘(2) HEARING ON SUSPENSION.—The Secretary 

7 shall provide the registrant subject to an order 

8 under paragraph (1) with an opportunity for an in9 formal hearing, to be held as soon as possible but 

10 not later than 2 business days after the issuance of 

11 the order or such other time period, as agreed upon 

12 by the Secretary and the registrant, on the actions 

13 required for reinstatement of registration and why 

14 the registration that is subject to the suspension 

15 should be reinstated. The Secretary shall reinstate a 

16 registration if the Secretary determines, based on 

17 evidence presented, that adequate grounds do not 

18 exist to continue the suspension of the registration. 

19 ‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; 

20 VACATING OF ORDER.— 

21 ‘‘(A) CORRECTIVE ACTION PLAN.—If, after 

22 providing opportunity for an informal hearing 

23 under paragraph (2), the Secretary determines 

24 that the suspension of registration remains nec25 essary, the Secretary shall require the regVerDate Sep 11 2014 23:34 Oct 26, 2017 Jkt 079200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2003.IS S2003

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1 istrant to submit a corrective action plan to 

2 demonstrate how the registrant plans to correct 

3 the conditions found by the Secretary. The Sec4 retary shall review such plan not later than 14 

5 days after the submission of the corrective ac6 tion plan or such other time period as deter7 mined by the Secretary, in consultation with the 

8 registrant. 

9 ‘‘(B) VACATING OF ORDER.—Upon a de10 termination by the Secretary that adequate 

11 grounds do not exist to continue the suspension 

12 actions required by the order, or that such ac13 tions should be modified, the Secretary shall 

14 promptly vacate the order and reinstate the reg15 istration of the facility subject to the order or 

16 modify the order, as appropriate. 

17 ‘‘(4) EFFECT OF SUSPENSION.—If the registra18 tion of a facility is suspended under this subsection, 

19 no person shall import or export cosmetics into the 

20 United States from such facility, offer to import or 

21 export cosmetics into the United States from such 

22 facility, or otherwise introduce cosmetics from such 

23 facility into interstate or intrastate commerce in the 

24 United States. 

25 ‘‘(5) REGULATIONS.— 


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1 ‘‘(A) IN GENERAL.—The Secretary shall 

2 promulgate regulations to implement this sub3 section. 

4 ‘‘(B) ELECTRONIC REGISTRATION RE5 QUIREMENT.—The Secretary may require that 

6 registration under this section be submitted in 

7 an electronic format. 

8 ‘‘(6) APPLICATION DATE.—Facilities shall not 

9 be subject to the requirements of this subsection 

10 prior to the date that is 180 days after the date on 

11 which the Secretary issues final regulations under 

12 paragraph (5). 

13 ‘‘(7) NO DELEGATION.—The authority con14 ferred by this subsection to issue an order to sus15 pend a registration or vacate an order of suspension 

16 shall not be delegated to any officer or employee 

17 other than the Commissioner. 

18 ‘‘(c) FACILITY.—For purposes of this section: 

19 ‘‘(1) The term ‘facility’— 

20 ‘‘(A) includes any factory or other estab21 lishment that is engaged in the manufacturing 

22 or processing of a cosmetic or cosmetics; and 

23 ‘‘(B) does not include— 

24 ‘‘(i) beauty salons, spas, retailers (in25 cluding individual sales representatives, 


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1 wholesale distributors, or pharmacy loca2 tions); 

3 ‘‘(ii) homes where persons are en4 gaged in making handcrafted soaps or 

5 other cosmetics; or 

6 ‘‘(iii) any business with less than 

7 $1,000,000 in annual net revenue in the 

8 previous year, other than any such busi9 ness that is engaged in the manufacturing 

10 or processing of products intended to be 

11 injected under the skin, including tattoo 

12 ink. 

13 ‘‘(2) The term ‘domestic facility’ means a facil14 ity located in any of the States or Territories. 

15 ‘‘(3) The term ‘foreign facility’ means a facility 

16 located outside of the United States or Territories, 

17 but only if the cosmetics from such facility are ex18 ported to the United States without further manu19 facturing outside the United States or Territories. 

20 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec21 tion shall be construed to authorize the Secretary to re22 quire an application, review, or licensing process for a fa23 cility to be registered, except with respect to the reinstate24 ment of a registration that is suspended under subsection 

25 (b). 


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1 ‘‘(e) PREEMPTION.—No State or political subdivision 

2 of a State may establish or continue in effect any law, 

3 regulation, order, or other requirement with respect to the 

4 registration of facilities engaged in the manufacturing or 

5 processing of a cosmetic or cosmetics that is different from 

6 the requirements under this section.’’. 

7 SEC. 6. GOOD MANUFACTURING PRACTICES. 

8 (a) GOOD MANUFACTURING PRACTICE STAND9 ARDS.—Chapter VI of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 361 et seq.), as amended by section 

11 5, is further amended by adding at the end the following: 

12 ‘‘SEC. 605. GOOD MANUFACTURING PRACTICES. 

13 ‘‘(a) ESTABLISHMENT OF GOOD MANUFACTURING

14 PRACTICES.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall by reg16 ulation establish good manufacturing practices for 

17 cosmetics in accordance with paragraphs (a) and (d) 

18 of section 601. Such regulations— 

19 ‘‘(A) shall be modeled after comparable 

20 good manufacturing practice standards for cos21 metics in effect at the time of promulgation; 

22 ‘‘(B) may not impose standards for which 

23 there is no current and generally available ana24 lytical methodology; 


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1 ‘‘(C) may ensure that cosmetics do not 

2 cause serious adverse health consequences or 

3 death; 

4 ‘‘(D) shall be intended to protect the pub5 lic health; and 

6 ‘‘(E) shall not apply to entities described 

7 in clauses (i) and (ii) of section 604(c)(1)(B). 

8 ‘‘(2) CONSIDERATIONS.—In promulgating regu9 lations under paragraph (1), the Secretary shall con10 sider facilities that are subject to other, similar reg11 ulations, as appropriate. 

12 ‘‘(b) NOTICE AND COMMENT.—A regulation under 

13 subsection (a) shall be promulgated only after providing 

14 notice and an opportunity for comment in accordance with 

15 chapter 5 of title 5, United States Code. 

16 ‘‘(c) SMALL BUSINESSES.— 

17 ‘‘(1) APPLICABILITY TO SMALL BUSINESSES.— 

18 The Secretary shall provide for an additional year 

19 after the effective date of the regulations under sub20 section (a) for small businesses (as described in sec21 tion 604(c)(1)(B)(iii)) to comply with the good man22 ufacturing practices established in accordance with 

23 subsection (a), and issue guidance for small busi24 nesses for purposes of compliance with this section. 


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1 ‘‘(2) CONSIDERATIONS.—In establishing good 

2 manufacturing practices under this section, the Sec3 retary shall take into account the practices of small 

4 business, including the size and scope of the busi5 ness, and consult with the Small Business Adminis6 tration, as appropriate. 

7 ‘‘(d) PREEMPTION.—No State or political subdivision 

8 of a State may establish or continue in effect any law, 

9 regulation, order, or other requirement with respect to 

10 good manufacturing practice standards for cosmetics that 

11 is different from the requirements under this section.’’. 

12 (b) PROHIBITION.—Section 601 of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 361) is amended by 

14 adding at the end the following: 

15 ‘‘(f) If it has been manufactured under conditions 

16 that do not meet current good manufacturing practice reg17 ulations established under section 605.’’. 

18 SEC. 7. IDENTIFICATION AND REVIEW OF COSMETIC IN19 GREDIENTS. 

20 Chapter VI of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 361 et seq.), as amended by section 6, 

22 is further amended by adding at the end the following: 


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1 ‘‘SEC. 606. IDENTIFICATION AND REVIEW OF COSMETIC IN2 GREDIENTS. 

3 ‘‘(a) IDENTIFICATION OF INGREDIENTS AND NON4 FUNCTIONAL CONSTITUENTS TO BE REVIEWED.—Each 

5 year, the Secretary, in consultation with industry and con6 sumer groups, and taking into consideration ingredients 

7 identified by a State or political subdivision as presenting 

8 a public health concern, shall identify cosmetic ingredi9 ents, as appropriate, that may present a public health con10 cern to be reviewed for safety, including a class or classes 

11 of ingredients, or a non-functional constituent or class of 

12 non-functional constituents. The Secretary shall publish in 

13 the Federal Register a list of the ingredients or non-func14 tional constituents, or classes of ingredients or constitu15 ents identified for review, and solicit public input and pro16 vide the public notice and a period of 60 days to comment 

17 on any such ingredient, constituent, or class. The Sec18 retary may identify a cosmetic ingredient or ingredients, 

19 as appropriate, to be reviewed for safety outside such an20 nual process. 

21 ‘‘(b) ADMINISTRATIVE ORDERS AND STANDARDS.— 

22 ‘‘(1) PUBLICATION OF DETERMINATIONS AND

23 FINDINGS.— 

24 ‘‘(A) PROPOSED ORDERS.—If the Sec25 retary determines that there is adequate sci26 entific evidence to support a determination that 


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1 there is reasonable certainty that an ingredient, 

2 class of ingredients, non-functional constituent, 

3 or class of non-functional constituents is safe 

4 for use, not safe for use, or not safe for speci5 fied conditions of use, the Secretary shall post 

6 on the Internet website of the Food and Drug 

7 Administration a proposed administrative order 

8 consistent with such determination. 

9 ‘‘(B) FINDINGS OF INADEQUATE EVI10 DENCE.—If the Secretary determines that there 

11 is inadequate scientific evidence to support a 

12 determination described in subparagraph (A), 

13 the Secretary shall post on the Internet website 

14 of the Food and Drug Administration such 

15 findings, together with a rationale for the find16 ings. 

17 ‘‘(C) ADDITIONAL EVIDENCE.—Nothing in 

18 this paragraph shall prevent the Secretary from 

19 considering additional scientific information or 

20 safety data related to the ingredient that is sub21 mitted to the Secretary. 

22 ‘‘(2) FINAL ORDERS.— 

23 ‘‘(A) IN GENERAL.—After allowing not less 

24 than 90 days for public comment on a proposed 

25 order under paragraph (1)(A) and a period for 


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1 consideration of any such comments, if the Sec2 retary determines that there is adequate sci3 entific evidence to make a final determination 

4 on the safety of the applicable ingredient, class 

5 of ingredients, non-functional constituent, or 

6 class of non-functional constituents, the Sec7 retary shall issue a final administrative order 

8 that there is reasonable certainty that— 

9 ‘‘(i) the ingredient, class of ingredi10 ents, non-functional constituent, or class of 

11 non-functional constituents is safe for use; 

12 ‘‘(ii) the ingredient, class of ingredi13 ents, non-functional constituent, or class of 

14 non-functional constituents is not safe for 

15 any use; or 

16 ‘‘(iii) the ingredient, class of ingredi17 ents, non-functional constituent, or class of 

18 non-functional constituents is not safe 

19 under specified conditions of use. 

20 ‘‘(B) FINAL ACTION.—A final administra21 tive order under subparagraph (A) shall be con22 sidered final agency action for purposes of judi23 cial review. 

24 ‘‘(3) STANDARDS.—A determination that an in25 gredient, class of ingredients, non-functional conVerDate Sep 11 2014 23:34 Oct 26, 2017 Jkt 079200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S2003.IS S2003

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1 stituent, or class of non-functional constituents is 

2 not safe under specified conditions of use may speci3 fy conditions of use such as— 

4 ‘‘(A) the amount or concentration of such 

5 ingredient; 

6 ‘‘(B) the populations which may specifi7 cally use such ingredient or not use such ingre8 dient; 

9 ‘‘(C) the area of the human body on which 

10 or near which such ingredient should not be 

11 used; or 

12 ‘‘(D) such other conditions that may affect 

13 the safety of the cosmetic as a whole or in part. 

14 ‘‘(c) COSMETIC SAFETY STANDARD.—For purposes 

15 of this Act, including reviews for safety under this section 

16 and section 607, a cosmetic is safe if there is reasonable 

17 certainty that the cosmetic is not injurious to users under 

18 conditions of use prescribed in labeling or under such con19 ditions of use as are customary or usual. 

20 ‘‘(d) PREEMPTION.—Upon identification of a cos21 metic ingredient or non-functional constituent by the Sec22 retary under subsection (a), no State or local government 

23 may establish or continue in effect any law, regulation, 

24 order, or other requirement with respect to such ingre25 dient or non-functional constituent, except that a State or 


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1 local government may continue in effect such a require2 ment that was in full effect with respect to such ingredient 

3 on the date of enactment of the FDA Cosmetic Safety and 

4 Modernization Act, or that is exempted from preemption 

5 under section 752(b) of the Federal Food, Drug, and Cos6 metic Act. 

7 ‘‘(e) DEFINITIONS.—For purposes of this Act— 

8 ‘‘(1) the term ‘non-functional constituent’ 

9 means a substance or chemical, or other contami10 nant, that was not intentionally added or included in 

11 the formula of a cosmetic product and serves no 

12 technical purpose, but may be present as a break13 down product or by-product of manufacturing; and 

14 ‘‘(2) the term ‘cosmetic’ means a cosmetic prod15 uct in finished form consistent with section 

16 201(i)(1). 

17 ‘‘(f) RULE OF CONSTRUCTION.—This section shall 

18 not be construed to affect the right of a person to lawfully 

19 market a cosmetic product that is or that contains an in20 gredient, class of ingredients, non-functional constituent, 

21 or class of non-functional constituents while such sub22 stance is under review or has been identified for review 

23 by the Secretary for safety. 


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1 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

2 carry out this section, there are authorized to be appro3 priated such sums as may be necessary.’’. 

4 SEC. 8. ACCREDITED THIRD-PARTY REVIEW. 

5 Chapter VI of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 361 et seq.), as amended by section 7, 

7 is further amended by adding at the end the following: 

8 ‘‘SEC. 607. ACCREDITED THIRD-PARTY REVIEW. 

9 ‘‘(a) IN GENERAL.—The Secretary may accredit per10 sons to review and assess for safety cosmetic ingredients 

11 or non-functional constituents identified by the Secretary 

12 under section 606(a) and make recommendations to the 

13 Secretary for proposed administrative orders under section 

14 606(b)(1)(A). 

15 ‘‘(b) ACCREDITATION AND REVIEW.—Not later than 

16 2 years after the date of enactment of the FDA Cosmetic 

17 Safety and Modernization Act, the Secretary shall promul18 gate regulations establishing— 

19 ‘‘(1) a process to accredit third parties for pur20 poses of reviewing cosmetic ingredients, classes of 

21 ingredients, non-functional constituents, and classes 

22 of non-functional constituents identified by the Sec23 retary under section 606(a); and 

24 ‘‘(2) criteria and qualifications for such accredi25 tation of third parties. 


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1 ‘‘(c) REQUIREMENTS REGARDING REVIEW.—In mak2 ing a recommendation to the Secretary under subsection 

3 (a), an accredited third party shall notify the Secretary 

4 in writing of the reasons for the recommendation, and pro5 vide relevant scientific literature or data, as the Secretary 

6 requires. 

7 ‘‘(d) REVIEW AND ADMINISTRATIVE ORDER.—The 

8 Secretary shall establish a process by which to review rec9 ommendations from such accredited third party and to de10 termine whether an Administrative Order is appropriate. 

11 Not later than 180 calendar days after the date on which 

12 the Secretary receives a recommendation from an accred13 ited third party pertaining to a cosmetic ingredient or non14 functional ingredient identified by the Secretary under 

15 section 606(a), the Secretary shall issue a proposed ad16 ministrative order, or issue a public rationale on the Sec17 retary’s determination not to issue a proposed administra18 tive order. 

19 ‘‘(e) QUALIFICATIONS.—An accredited third party 

20 shall, at a minimum, meet the following requirements: 

21 ‘‘(1) Such third party may not be affiliated with 

22 a government entity. 

23 ‘‘(2) Such third party shall be an independent 

24 organization that is not owned or controlled by a 

25 manufacturer, supplier, or vendor of cosmetics and 


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1 that has no financial affiliation with such a manu2 facturer, supplier, or vendor. 

3 ‘‘(3) Such third party shall be a legally con4 stituted entity permitted to conduct the activities for 

5 which it seeks accreditation. 

6 ‘‘(4) Such third party shall not engage in the 

7 design, manufacturer, promotion, or sale of cos8 metics. 

9 ‘‘(5) Such third party shall have scientific ex10 pertise in ingredient safety, toxicology, or chemical 

11 safety. 

12 ‘‘(6) The operations of such third party shall be 

13 in accordance with generally accepted professional 

14 and ethical business practices and such third party 

15 shall agree in writing that it will— 

16 ‘‘(A) certify that reported information ac17 curately reflects data reviewed; 

18 ‘‘(B) limit work to that within its com19 petence and capacity; 

20 ‘‘(C) treat proprietary, confidential, and 

21 commercial information received, including 

22 records, reports, and recommendations, as con23 fidential information; 


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1 ‘‘(D) promptly respond and attempt to re2 solve complaints regarding the activities for 

3 which it is accredited; and 

4 ‘‘(E) protect against the use, in carrying 

5 out subsection (a) with respect to a cosmetic, of 

6 any officer or employee of the entity who has a 

7 financial conflict of interest regarding the cos8 metic, and annually make available to the pub9 lic disclosures of the extent to which the entity, 

10 and the officers and employees of the entity, 

11 have maintained compliance with requirements 

12 under this subparagraph relating to financial 

13 conflicts of interest. 

14 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec15 tion is intended to affect the Secretary’s authority to enter 

16 into contracts with non-accredited third parties for pur17 poses of cosmetic safety review.’’. 

18 SEC. 9. REPORTING. 

19 Chapter VI of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 361 et seq.), as amended by section 8, 

21 is further amended by adding at the end the following: 

22 ‘‘SEC. 608. COSMETIC INGREDIENT REPORT. 

23 ‘‘(a) ANNUAL REPORT TO CONGRESS.—The Commis24 sioner shall submit an annual report to the appropriate 


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1 committees of Congress that includes a report or summary 

2 of— 

3 ‘‘(1) the ingredients or non-functional constitu4 ents that the Commissioner has identified for review 

5 under section 606(a); 

6 ‘‘(2) the ingredients or non-functional constitu7 ents for which the Commissioner has issued a pro8 posed order, a final order, or a finding of incomplete 

9 evidence under section 606(b); 

10 ‘‘(3) the ongoing ingredient or non-functional 

11 constituents being reviewed for safety at the time of 

12 submission of the report, reviews the Commissioner 

13 has determined to be needed, and reviews for which 

14 Commissioner is contracting with an accredited third 

15 party; 

16 ‘‘(4) a summary of serious adverse event re17 ports submitted under section 762, and the associ18 ated product category and serious adverse health 

19 consequence for each such report; and 

20 ‘‘(5) enforcement actions, if any, the Commis21 sioner has taken as a result of serious adverse event 

22 reports or facility inspections, including warning let23 ters, untitled letters, suspension of registration, or 

24 any other type of action.’’. 


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1 SEC. 10. GAO REPORT. 

2 Not later than 2 years after the date of enactment 

3 of this Act, the Comptroller General of the United States 

4 shall analyze, and submit a report to Congress on— 

5 (1) the types of ingredients or non-functional 

6 constituents that the Food and Drug Administration 

7 has identified for purposes of a safety review under 

8 section 606 of the Federal Food, Drug, and Cos9 metic Act (as added by section 7) and the factors or 

10 methods, if any, that such agency considers in deter11 mining the need for a safety review; 

12 (2) the level of coordination between the Food 

13 and Drug Administration and the States in identi14 fying ingredients that may present a public health 

15 concern for review, and the process by which the 

16 Food and Drug Administration considers public 

17 input as part of identifying ingredients that may 

18 present a public health concern; 

19 (3) how the Food and Drug Administration ac20 counts for reports of serious adverse events under 

21 section 762 of the Federal Food, Drug, and Cos22 metic Act (as added by section 2) to inform cosmetic 

23 related inspections; 

24 (4) the frequency and type of inspections con25 ducted by the Food and Drug Administration, in26 cluding inspections in response to reports of serious 


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1 adverse events, and an analysis of the outcome and 

2 related facility compliance; 

3 (5) the time between identifying ingredients to 

4 be reviewed for safety under section 606(a) of the 

5 Federal Food, Drug, and Cosmetic Act and issuance 

6 of final administrative orders under section 

7 606(b)(2) of such Act; 

8 (6) ingredients, if any, that the Food and Drug 

9 Administration took action to include on the prohib10 ited and restricted ingredients list of the Food and 

11 Drug Administration, and a summary of ingredients 

12 with respect to which such agency has issued an ad13 ministrative order; and 

14 (7) the Food and Drug Administration’s use of 

15 accredited third parties for purposes of cosmetic in16 gredient safety reviews in accordance with section 

17 607 of the Federal Food, Drug, and Cosmetic Act 

18 (as added by section 8). 

Æ 


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