I 

112TH CONGRESS 

2D SESSION H. R. 4395 

To amend the Federal Food, Drug, and Cosmetic Act to establish new 

procedures and requirements for the registration of cosmetic product 

manufacturing establishments, the submission of cosmetic product and 

ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2012 

Mr. LANCE introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient 

statements, and the reporting of serious and unexpected 

cosmetic product adverse events, and for other purposes. 

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 AND REFERENCES. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Cosmetic Safety Amendments Act of 2012’’. 


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1 (b) REFERENCES TO THE FEDERAL FOOD, DRUG, 

2 AND COSMETIC ACT.—Except as otherwise specified, 

3 whenever in this Act an amendment is expressed in terms 

4 of an amendment to a section or other provision, the ref5 erence shall be considered to be made to a section or other 

6 provision of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 301 et seq.). 

8 SEC. 2. TABLE OF CONTENTS. 

Sec. 1. Short title and references. 

Sec. 2. Table of contents. 

Sec. 3. Registration of cosmetic manufacturing establishments. 

Sec. 4. Cosmetic and ingredient statement. 

Sec. 5. Serious and unexpected adverse event reporting for cosmetics. 

Sec. 6. Good manufacturing practice for cosmetics. 

Sec. 7. Tolerances for nonfunctional constituents in cosmetics. 

Sec. 8. Cosmetic ingredient review. 

Sec. 9. Cosmetic ingredient safety. 

Sec. 10. National cosmetic regulatory databank. 

Sec. 11. Cosmetic records inspection. 

Sec. 12. Rules of construction. 

Sec. 13. Conforming amendments. 

Sec. 14. National uniformity for cosmetics. 

Sec. 15. Importation. 

Sec. 16. Authorization of appropriations. 

Sec. 17. Effective dates. 

9 SEC. 3. REGISTRATION OF COSMETIC MANUFACTURING ES10 TABLISHMENTS. 

11 Chapter VI is amended by adding at the end the fol12 lowing: 

13 ‘‘SEC. 604. REGISTRATION OF COSMETIC MANUFACTURING 

14 ESTABLISHMENTS. 

15 ‘‘(a) IN GENERAL.— 

16 ‘‘(1) The Secretary shall by regulation require 

17 that every domestic and foreign establishment enVerDate Mar 15 2010 03:58 Apr 21, 2012 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4395.IH H4395

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1 gaged in the manufacture of a cosmetic intended to 

2 be marketed in the United States be registered with 

3 the Secretary within 60 days after beginning such 

4 manufacture. If a cosmetic is processed in more 

5 than one establishment, registration shall be re6 quired only for the establishment that performs the 

7 final portion of the manufacturing operation. The 

8 registration shall state the name of the company or 

9 other organization, the city, street address, State, 

10 and country of the establishment, and the title, 

11 email address, and telephone number for the office 

12 within the establishment that is responsible for sub13 mitting and maintaining the registration. 

14 ‘‘(2) The Secretary shall establish and provide 

15 to the registrant a unique cosmetic establishment 

16 registration number within 15 business days after 

17 receiving the registration. Where more than one per18 son registers the same manufacturing establishment, 

19 the Secretary shall provide only one unique estab20 lishment registration number for the establishment. 

21 ‘‘(b) MAINTENANCE.—The information required in a 

22 registration under subsection (a) or in an existing reg23 istration under subsection (e) shall be maintained as cur24 rent and accurate by the registrant by withdrawing or 


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1 amending the registration within 60 days after the infor2 mation becomes no longer current and accurate. 

3 ‘‘(c) LIST.—The Secretary shall compile and main4 tain an up-to-date and publicly available electronic list of 

5 establishments that are registered under this section. 

6 ‘‘(d) DEFINITIONS.—For purposes of this chapter the 

7 following definitions apply: 

8 ‘‘(1) The term ‘establishment’ is a place of 

9 business where a cosmetic is manufactured, without 

10 further processing outside or within the United 

11 States. 

12 ‘‘(2)(A) The term ‘domestic establishment’ 

13 means an establishment location in any State. 

14 ‘‘(B) The term ‘foreign establishment’ means 

15 an establishment location outside the States from 

16 which a cosmetic is exported to the United States. 

17 ‘‘(3) A cosmetic shall not be considered to have 

18 undergone further processing for purposes of para19 graph (1) solely on the basis that packaging or other 

20 labeling was added or that any similar activity of a 

21 de minimis nature was carried out with respect to 

22 the cosmetic. 

23 ‘‘(e) EXEMPTIONS.—Registration under subsection 

24 (a) shall not be required for any establishment that as of 

25 the date of enactment of this section is registered as a 


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1 cosmetic establishment under part 710 of title 21, Code 

2 of Federal Regulations. 

3 ‘‘(f) SUSPENSION OF REGISTRATION.— 

4 ‘‘(1) IN GENERAL.—The Secretary may suspend 

5 the registration of any facility under this section for 

6 a violation of this Act that presents a significant 

7 risk of serious adverse health consequences or death 

8 to humans. 

9 ‘‘(2) NOTICE OF SUSPENSION.—Suspension of a 

10 registration under this section shall be preceded 

11 by— 

12 ‘‘(A) notice to the establishment of the in13 tent to suspend the registration; and 

14 ‘‘(B) an opportunity for an informal hear15 ing concerning the suspension. 

16 ‘‘(3) REINSTATEMENT.—A registration that is 

17 suspended under this section may be reinstated by 

18 the Secretary. 

19 ‘‘(4) PROCEDURES.—The Secretary shall by 

20 regulations establish procedures for the implementa21 tion of this subsection. 

22 ‘‘(g) CANCELLATION OF REGISTRATION.— 

23 ‘‘(1) IN GENERAL.—Not earlier than 10 days 

24 after providing notice under paragraph (2), the Sec25 retary may cancel a registration under this section 


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1 if the Secretary determines that the registration was 

2 not updated in accordance with this section or other3 wise is not current and accurate. 

4 ‘‘(2) NOTICE OF CANCELLATION.—Cancellation 

5 shall be preceded by notice to the establishment of 

6 the intent to cancel the registration and the basis 

7 for such cancellation. 

8 ‘‘(3) TIMELY UPDATE OR CORRECTION.—If the 

9 registration for the establishment is updated or cor10 rected no later than 7 days after notice is provided 

11 under paragraph (2), the Secretary shall not cancel 

12 the registration.’’. 

13 SEC. 4. COSMETIC AND INGREDIENT STATEMENT. 

14 Chapter VI, as amended by section 3, is amended by 

15 adding at the end the following: 

16 ‘‘SEC. 605. COSMETIC AND INGREDIENT STATEMENT. 

17 ‘‘(a) IN GENERAL.—The Secretary shall by regula18 tion require that every domestic and foreign establishment 

19 engaged in the manufacture of a cosmetic intended to be 

20 marketed in the United States submit to the Secretary, 

21 for each cosmetic manufactured in the establishment, 

22 within 60 days after beginning manufacture of the prod23 uct, a cosmetic and ingredient statement containing— 

24 ‘‘(1) the unique establishment registration num25 ber of the manufacturing establishment where the 


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1 cosmetic is manufactured or, if the same cosmetic 

2 product is manufactured in more than one establish3 ment, the unique establishment registration number 

4 of each establishment where it is manufactured; 

5 ‘‘(2) the brand name or names for the cosmetic; 

6 ‘‘(3) the applicable cosmetic category or cat7 egories for the cosmetic; 

8 ‘‘(4) the ingredients in the cosmetic (in accord9 ance with section 701.3 of title 21, Code of Federal 

10 Regulations, and using the name of each ingredient 

11 established under subsection (b), if any), in descend12 ing order of predominance by weight, except that— 

13 ‘‘(A) flavors and fragrances may be des14 ignated as such; and 

15 ‘‘(B) all variations in color, flavor, or fra16 grance may be included in one statement; and 

17 ‘‘(5) the title, email address, and telephone 

18 number for the office within the establishment that 

19 is responsible for filing and maintaining the state20 ment. 

21 The Secretary shall establish and provide to the person 

22 submitting the statement a unique cosmetic and ingre23 dient statement number within 15 business days after re24 ceiving the statement. 


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1 ‘‘(b) NAME OF INGREDIENT.—For purposes of this 

2 section and cosmetic ingredient labeling under section 

3 701.3 of title 21, Code of Federal Regulations, the name 

4 of a cosmetic ingredient shall be the name, if any, in the 

5 most recent edition of the International Cosmetic Ingre6 dient Dictionary, unless the Secretary, after public notice 

7 and an opportunity for public comment, by regulation or 

8 guidance establishes a different name for the ingredient. 

9 ‘‘(c) MAINTENANCE.—The information required in a 

10 statement submitted to the Secretary under subsection (a) 

11 or in an existing statement under subsection (e)(1) shall 

12 be maintained as current and accurate by the person who 

13 filed the statement by withdrawing or amending the state14 ment within 60 days after the information becomes no 

15 longer current and accurate, except that no amendment 

16 shall be required for a change in the order of predomi17 nance of the ingredients or for any other type or category 

18 of change for which the Secretary determines that the 

19 costs of amending the statement exceed the benefits. 

20 ‘‘(d) LIST.—The Secretary shall compile and main21 tain an up-to-date and publicly available electronic list of 

22 cosmetics and ingredients for which statements are sub23 mitted under this section. A statement submitted pursuant 

24 to this section shall not be subject to disclosure under sec25 tion 552 of title 5, United States Code. The Secretary may 


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1 make publicly available information derived from such 

2 statements that discloses the names of ingredients used 

3 in cosmetic products and the number of cosmetic products 

4 in which a specific ingredient is used but may not make 

5 publicly available any information that relates to any in6 gredient that is exempt from public disclosure under sec7 tion 720.8 of title 21, Code of Federal Regulations, or that 

8 discloses at what establishment a cosmetic is manufac9 tured. At the request of the director of a State agency 

10 responsible for regulating the safety of cosmetics, the Sec11 retary may disclose to such official confidential business 

12 and trade secret information contained in a statement and 

13 such official and other State employees who have access 

14 to such information shall then be subject to the provisions 

15 of section 301(j), subsection 552(b) of title 5, United 

16 States Code, and section 1905 of title 18, United States 

17 Code, with respect to such information. 

18 ‘‘(e) EXEMPTIONS.—Submission of a statement 

19 under subsection (a) shall not be required for— 

20 ‘‘(1) a cosmetic for which as of the date of en21 actment of this section a cosmetic ingredient state22 ment has been submitted to the Secretary under 

23 part 710 of title 21, Code of Federal Regulations; or 


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1 ‘‘(2) a cosmetic ingredient exempt from public 

2 disclosure under section 720.8 of title 21, Code of 

3 Federal Regulations.’’. 

4 SEC. 5. SERIOUS AND UNEXPECTED ADVERSE EVENT RE5 PORTING FOR COSMETICS. 

6 Chapter VI, as amended by sections 3 and 4, is 

7 amended by adding at the end the following: 

8 ‘‘SEC. 606. SERIOUS AND UNEXPECTED ADVERSE EVENT RE9 PORTING FOR COSMETICS. 

10 ‘‘(a) IN GENERAL.—The Secretary shall by regula11 tion require that a domestic or foreign manufacturer, 

12 packer, or distributor whose name appears on the label 

13 pursuant to section 602(b)(1) of a cosmetic marketed in 

14 the United States submit to the Secretary under sub15 section (b) a report containing information received con16 cerning a serious and unexpected adverse event in the 

17 United States allegedly associated with the use of the 

18 product. 

19 ‘‘(b) SUBMISSION OF REPORTS.—A serious and unex20 pected adverse event report shall be submitted to the Sec21 retary no later than 15 business days after information 

22 concerning the adverse event is received at the place of 

23 business labeled on the product under section 602(b)(1). 


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1 ‘‘(c) CONTENTS.—No such report shall be submitted 

2 unless the person submitting the report has been able to 

3 verify— 

4 ‘‘(1) an identifiable patient; 

5 ‘‘(2) an identifiable reporter; 

6 ‘‘(3) a suspect cosmetic product; and 

7 ‘‘(4) a serious and unexpected adverse event. 

8 The person submitting the report may include in the sub9 mission any additional pertinent information and may 

10 supplement the report with additional information at a 

11 later time. 

12 ‘‘(d) DEFINITIONS.— 

13 ‘‘(1) A ‘serious’ adverse event is one that— 

14 ‘‘(A) results in— 

15 ‘‘(i) death; 

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

17 ‘‘(iii) inpatient hospitalization; 

18 ‘‘(iv) a persistent and significant dis19 ability or incapacity; or 

20 ‘‘(v) congenital anomaly or birth de21 fect; or 

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

23 judgment, a medical or surgical intervention to 

24 prevent an outcome described under subpara25 graph (A). 


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1 ‘‘(2) An ‘unexpected’ adverse event is one that 

2 is not identified in the current labeling for the cos3 metic. 

4 ‘‘(e) RULES OF CONSTRUCTION.— 

5 ‘‘(1) A serious and unexpected adverse event re6 port (including all information submitted in the ini7 tial report or added later) submitted to the Sec8 retary under subsection (a) is— 

9 ‘‘(A) a safety report under section 756 

10 that is subject to the provisions of that section; 

11 ‘‘(B)(i) a record about an individual under 

12 section 552a of title 5, United States Code; and 

13 ‘‘(ii) a medical or similar file the disclosure 

14 of which would constitute a violation of section 

15 552(b)(6) of such title 5, and shall not be pub16 licly disclosed. 

17 ‘‘(2) The submission of a serious and unex18 pected adverse event report in compliance with sub19 section (a) shall not constitute an admission that the 

20 cosmetic involved caused or contributed to the ad21 verse event. 

22 ‘‘(f) The label of a cosmetic shall bear the domestic 

23 telephone number through which the person whose name 

24 and place of business appear on the label may receive a 

25 report of a serious and unexpected adverse event.’’. 


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1 SEC. 6. GOOD MANUFACTURING PRACTICE FOR COS2 METICS. 

3 Chapter VI, as amended by sections 3, 4, and 5, is 

4 amended by adding at the end the following: 

5 ‘‘SEC. 607. GOOD MANUFACTURING PRACTICES FOR COS6 METICS. 

7 ‘‘The Secretary shall, after public notice and an op8 portunity for public comment, by regulation establish good 

9 manufacturing practices for the methods used in, or the 

10 facilities or controls used for, the manufacture, processing, 

11 filling, or packaging of cosmetics. In issuing such regula12 tions or guidance, the Secretary shall review international 

13 standards for cosmetic good manufacturing practices to 

14 ensure that such regulations or guidance are consistent, 

15 to the extent the Secretary determines practicable and ap16 propriate, with such standards.’’. 

17 SEC. 7. TOLERANCES FOR NONFUNCTIONAL CONSTITU18 ENTS IN COSMETICS. 

19 Chapter VI, as amended by sections 3, 4, 5, and 6, 

20 is amended by adding at the end the following: 

21 ‘‘SEC. 608. TOLERANCES FOR NONFUNCTIONAL CONSTITU22 ENTS IN COSMETICS. 

23 ‘‘(a) IN GENERAL.—The Secretary may on the Sec24 retary’s own initiative, and shall in response to a petition 

25 submitted by an interested person, including a State, 

26 under subsection (b) or in accordance with the provisions 


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1 under subsection (c), after public notice and an oppor2 tunity for public comment, establish by regulation or guid3 ance a tolerance level for a nonfunctional constituent in 

4 cosmetics. For purposes of this section, a ‘nonfunctional 

5 constituent’ in a cosmetic is any substance that is an ancil6 lary part of an ingredient or the manufacturing process, 

7 has not been added as a separate substance, and serves 

8 no cosmetic function in the cosmetic. The Secretary shall 

9 establish such a tolerance at a level that is necessary for 

10 the protection of the public health using generally recog11 nized principles of scientific risk assessment. In issuing 

12 such a regulation or guidance, the Secretary shall take 

13 into consideration the level that is reasonably achievable 

14 through good manufacturing practices and shall review 

15 tolerance levels for such nonfunctional constituent estab16 lished by authoritative scientific or regulatory organiza17 tions to ensure that such regulation or guidance is con18 sistent, to the extent the Secretary determines practicable 

19 and appropriate, with such other tolerance levels. 

20 ‘‘(b) PROCEDURE.— 

21 ‘‘(1)(A)(i) If the review of a nonfunctional con22 stituent is being conducted on the Secretary’s own 

23 initiative or under subsection (c), the Secretary shall 

24 initiate the proceeding by publishing in the Federal 

25 Register a proposed regulation or guidance. The 


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1 Secretary shall provide 180 days for public com2 ment. 

3 ‘‘(ii) Not later than 180 days after the end of 

4 the period for public comment, the Secretary shall 

5 publish in the Federal Register a final regulation or 

6 guidance. 

7 ‘‘(B)(i) If the review of a nonfunctional con8 stituent is being conducted in response to a petition 

9 submitted by an interested person, the Secretary 

10 shall publish the petition in the Federal Register for 

11 public comment not later than 60 days after receipt 

12 of the petition. All appendices to the petition shall 

13 be made available on the Secretary’s website. The 

14 Secretary shall provide 180 days for public com15 ment. 

16 ‘‘(ii) Any such petition shall specify the non17 functional constituent, the proposed tolerance level, 

18 and the scientific data and information on which the 

19 proposed tolerance level is based. 

20 ‘‘(iii) Not later than 180 days after the end of 

21 the period for public comment, the Secretary shall 

22 publish in the Federal Register a proposed regula23 tion or guidance for public comment. The Secretary 

24 shall provide 90 days for public comment. 


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1 ‘‘(iv) Not later than 90 days after the end of 

2 the period for public comment, the Secretary shall 

3 publish in the Federal Register a final regulation or 

4 guidance. 

5 ‘‘(C) The Secretary may on the Secretary’s own 

6 initiative, and shall in response to a petition sub7 mitted by an interested person, reconsider any toler8 ance level established under subparagraph (A) or 

9 (B), using the same procedure established in this 

10 paragraph (1). 

11 ‘‘(D) Any regulation or guidance, including any 

12 revised regulation or guidance, shall apply to cos13 metics first shipped in interstate commerce begin14 ning two years after the date of issue of the regula15 tion or guidance, unless the Secretary determines, 

16 after public notice and an opportunity for public 

17 comment, that an earlier effective date is required to 

18 prevent serious adverse health consequences or 

19 death. 

20 ‘‘(2) The failure of the Secretary to comply 

21 with any applicable time period requirement under 

22 paragraph (1) shall constitute final agency action for 

23 purposes of judicial review. If the court conducting 

24 such review determines that the Secretary has failed 

25 to comply with the requirement, the court shall 


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1 order the Secretary to comply within a time period 

2 determined by the court to be appropriate, but in no 

3 event later than 90 days following the court’s order. 

4 ‘‘(c) PRIORITY LIST.—Within 180 days after the date 

5 of enactment, the Secretary shall establish a publicly avail6 able electronic priority list of nonfunctional constituents 

7 in cosmetics for review under this section. The Secretary 

8 shall begin and complete a review of at least one such pri9 ority nonfunctional constituent every 365 days. 

10 ‘‘(d) APPLICATION.—A tolerance level established by 

11 the Secretary under this section shall apply in every 

12 State.’’. 

13 SEC. 8. COSMETIC INGREDIENT REVIEW. 

14 Chapter VI, as amended by sections 3, 4, 5, 6, and 

15 7, is amended by adding at the end the following: 

16 ‘‘SEC. 609. COSMETIC INGREDIENT REVIEW. 

17 ‘‘(a) PANEL’S RECOMMENDATION.—The Cosmetic 

18 Ingredient Review Expert Panel determination in an ap19 proved final report that a cosmetic ingredient— 

20 ‘‘(1) is safe for use in cosmetic products with21 out the need for specified conditions of use; 

22 ‘‘(2) is safe for use in cosmetic products under 

23 specified conditions for use; 

24 ‘‘(3) is not safe for use in a cosmetic product 

25 under any conditions of use; 


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1 ‘‘(4) requires more information in order to 

2 make a determination whether the ingredient is safe 

3 for use in a cosmetic product under any conditions 

4 of use; or 

5 ‘‘(5) is the subject of any other type of deter6 mination by the Cosmetic Ingredient Review Expert 

7 Panel, shall be deemed to constitute a recommenda8 tion that the Secretary accept that determination for 

9 purposes of implementing and enforcing this chapter 

10 in accordance with the effective dates established 

11 under subsection (d). 

12 ‘‘(b) SECRETARY’S DETERMINATION.—The Secretary 

13 shall be deemed to accept that determination and rec14 ommendation unless the Secretary at any time determines, 

15 by regulation or guidance, after public notice and an op16 portunity for public comment, to make a different deter17 mination. A determination and recommendation described 

18 in subsection (a) that is deemed to be accepted by the Sec19 retary shall be implemented and enforced by the Secretary 

20 by banning any use of any ingredient that does not con21 form to the specified safe conditions of use under sub22 section (a)(2) and any ingredient described under sub23 section (a)(3) or (4). 

24 ‘‘(c) PROPRIETARY DATA.—The determination de25 scribed in subsection (a)(4) shall not apply to a person 


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1 using the ingredient who has adequate safety substan2 tiation and provides that substantiation to the Secretary 

3 as confidential business or trade secret information that 

4 shall not be publicly disclosed under section 301(j) of this 

5 Act or sections 552(b)(4) of title 5 or 1905 of title 18, 

6 United States Code. 

7 ‘‘(d) EFFECTIVE DATES.—Subsection (b) shall be ef8 fective— 

9 ‘‘(1) three years after the date of enactment for 

10 ingredients that are the subject of an approved final 

11 report as of the date of enactment of this subsection; 

12 and 

13 ‘‘(2) two years after the date of approval of the 

14 final report for ingredients that are the subject of an 

15 approved final report after the date of enactment of 

16 this subsection. 

17 ‘‘(e) SECRETARY’S REPRESENTATIVE.—The Sec18 retary shall appoint a representative who shall be a mem19 ber of and shall participate in the deliberations of the Cos20 metic Ingredient Review Expert Panel. 

21 ‘‘(f) APPLICATION.—A safety determination accepted 

22 or made by the Secretary under this section shall apply 

23 in every State.’’. 


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1 SEC. 9. COSMETIC INGREDIENT SAFETY. 

2 Chapter VI, as amended by sections 3, 4, 5, 6, 7, 

3 and 8, is amended by adding at the end the following: 

4 ‘‘SEC. 610. COSMETIC INGREDIENT SAFETY. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) The Secretary may on the Secretary’s own 

7 initiative, and shall in response to a petition sub8 mitted by an interested person, including a State, 

9 under subsection (b) or in accordance with the provi10 sions under subsection (c), evaluate the safety of any 

11 ingredient intended for use as or in a cosmetic prod12 uct and, after public notice and an opportunity for 

13 public comment, establish by regulation or guidance 

14 the conditions, if any, under which the ingredient is 

15 safe for human use. 

16 ‘‘(2) In evaluating the safety of any such ingre17 dient, the Secretary shall apply generally recognized 

18 principles of scientific risk assessment and shall take 

19 into account— 

20 ‘‘(A) the conditions of use recommended or 

21 suggested in the labeling; 

22 ‘‘(B) any relevant safety evaluation con23 ducted by the Cosmetic Ingredient Review Ex24 pert Panel; and 


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1 ‘‘(C) all relevant unpublished and pub2 lished safety data and information, including 

3 human exposure during marketing. 

4 The Secretary shall determine the conditions for the 

5 use of the ingredient that are necessary for safe use, 

6 or that the ingredient is safe for use without the 

7 need for specified conditions of use, or that there are 

8 no conditions under which the ingredient can be 

9 safely used. 

10 ‘‘(b) PROCEDURE.— 

11 ‘‘(1)(A)(i) If the review of an ingredient is 

12 being conducted on the Secretary’s own initiative or 

13 under subsection (c), the Secretary shall initiate the 

14 proceeding by publishing in the Federal Register a 

15 proposed regulation or guidance. The Secretary shall 

16 provide 180 days for public comment. 

17 ‘‘(ii) Not later than 180 days after the end of 

18 the period for public comment, the Secretary shall 

19 publish in the Federal Register a final regulation or 

20 guidance. 

21 ‘‘(B)(i) If the review of an ingredient is being 

22 conducted in response to a petition submitted by an 

23 interested person, the Secretary shall publish the pe24 tition in the Federal Register for public comment 

25 not later than 60 days after receipt of the petition. 


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1 All appendices to the petition shall be made available 

2 on the Secretary’s website. The Secretary shall pro3 vide 180 days for public comment. 

4 ‘‘(ii) Any such petition shall specify the ingre5 dient, the uses for which the ingredient is intended, 

6 any proposed conditions of safe use, and the sci7 entific data and information, including human expo8 sure during marketing, on which the proposed condi9 tions are based. 

10 ‘‘(iii) Not later than 180 days after the end of 

11 the period for public comment, the Secretary shall 

12 publish in the Federal Register a proposed regula13 tion or guidance for public comment. The Secretary 

14 shall provide 90 days for public comment. 

15 ‘‘(iv) Not later than 90 days after the end of 

16 the period for public comment, the Secretary shall 

17 publish in the Federal Register a final regulation or 

18 guidance. 

19 ‘‘(C) The Secretary may on the Secretary’s own 

20 initiative, and shall in response to a petition sub21 mitted by an interested person, reconsider any con22 ditions for safe use established under subparagraph 

23 (A) or (B), using the same procedure established in 

24 this paragraph (1). 


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1 ‘‘(D) Any regulation or guidance, including any 

2 revised regulation or guidance, shall apply to cos3 metics first shipped in interstate commerce begin4 ning two years after the date of issuance of the reg5 ulation or guidance, unless the Secretary determines, 

6 after public notice and an opportunity for public 

7 comment, that an earlier effective date is required to 

8 prevent serious adverse health consequences or 

9 death. 

10 ‘‘(2) The failure of the Secretary to comply 

11 with any applicable time period requirement under 

12 paragraph (1) shall constitute final agency action for 

13 purposes of judicial review. If the court conducting 

14 such review determines that the Secretary has failed 

15 to comply with the requirement, the court shall 

16 order the Secretary to comply within a time period 

17 determined by the court to be appropriate, but in no 

18 event later than 90 days following the court’s order. 

19 ‘‘(c) PRIORITY LIST.—Within 180 days after the date 

20 of enactment, the Secretary shall establish a publicly avail21 able electronic priority list of cosmetic ingredients. The 

22 Secretary shall begin and complete a review of at least 

23 one such priority cosmetic ingredient every 365 days. 


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1 ‘‘(d) APPLICATION.—A safety determination accepted 

2 or made by the Secretary under this section shall apply 

3 in every State.’’. 

4 SEC. 10. NATIONAL COSMETIC REGULATORY DATABANK. 

5 Chapter VI, as amended by sections 3, 4, 5, 6, 7, 

6 8, and 9, is amended by adding at the end the following: 

7 ‘‘SEC. 613. NATIONAL COSMETIC REGULATORY DATABANK. 

8 ‘‘In order to consolidate all information pertaining to 

9 regulation of the safety of cosmetics in one place for use 

10 by State officials responsible for the regulation of cos11 metics and by the general public, the Secretary shall es12 tablish and maintain in the Center for Food Safety and 

13 Applied Nutrition (or any successor organization of such 

14 Center) of the Food and Drug Administration an elec15 tronic National Cosmetic Regulatory Databank that shall 

16 contain the information submitted to the Secretary under 

17 sections 604, 605, and 606, and such other information 

18 pertaining to the regulation of cosmetics as the Secretary 

19 shall deem appropriate. Information in the National Cos20 metic Regulatory Databank that is not subject to public 

21 disclosure under section 552 of title 5, United States 

22 Code, may be disclosed on request to the director of a 

23 State agency responsible for regulating the safety of cos24 metics, and such official and other State employees who 

25 have access to such information shall then be subject to 


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1 the provisions of section 301(j), subsection 552(b) of title 

2 5, United States Code, and section 1905 of title 18, 

3 United States Code, with respect to such information. In4 formation available in the National Cosmetic Regulatory 

5 Databank shall not be subject to State laws on submission 

6 of that information, whether in the same or a different 

7 format.’’. 

8 SEC. 11. COSMETIC RECORDS INSPECTION. 

9 Chapter VI, as amended by sections 3, 4, 5, 6, 7, 

10 8, 9, and 10, is amended by adding at the end the fol11 lowing: 

12 ‘‘SEC. 614. COSMETIC RECORDS INSPECTION. 

13 ‘‘If the Secretary has a reasonable belief that a cos14 metic product, and any other related cosmetic product 

15 that the Secretary reasonably believes is affected in the 

16 same manner, is adulterated and presents a threat of seri17 ous adverse health consequences or death to humans, each 

18 person who manufactures, processes, packs, distributes, 

19 receives, holds, or imports such article shall, at the request 

20 of an officer or employee duly designated by the Secretary, 

21 permit such officer or employee, upon presentation of ap22 propriate credentials and a written notice to such person 

23 setting forth the basis for the Secretary’s belief, at reason24 able times and within reasonable limits and in a reason25 able manner, to have access to and copy records that are 


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1 needed to assist the Secretary in determining whether the 

2 cosmetic product is adulterated and presents a threat of 

3 serious adverse health consequences or death to humans. 

4 The Secretary shall prevent the disclosure of trade secret 

5 or confidential information obtained by the Secretary pur6 suant to this section. This section does not extend to cos7 metic product formulas, financial data, pricing data, per8 sonnel data, research data, or sales data other than ship9 ment data.’’. 

10 SEC. 12. RULES OF CONSTRUCTION. 

11 Chapter VI, as amended by sections 3, 4, 5, 6, 7, 

12 8, 9, 10, and 11, is amended by adding at the end the 

13 following: 

14 ‘‘SEC. 615. RULES OF CONSTRUCTION. 

15 ‘‘(a) COSMETIC PRODUCTS.—Whenever the term cos16 metic or cosmetics is used in sections 604, 605, 606, or 

17 607, it shall be deemed to refer only to a cosmetic product 

18 or cosmetic products. A cosmetic product that is subject 

19 to the caution legend in section 601(a) shall not be subject 

20 to the provisions of sections 608, 609, or 610. 

21 ‘‘(b) CONTRACTORS.—A requirement for registration 

22 of a cosmetic establishment under section 604, submission 

23 of a cosmetic and ingredient statement under section 605, 

24 or submission of a serious and unexpected adverse event 

25 report for a cosmetic under section 606, may be satisfied 


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1 by a person who contracts to perform that function for 

2 the person who is required to register or make the submis3 sion. 

4 ‘‘(c) EXEMPTIONS.—The Secretary may, in the Sec5 retary’s discretion, establish exemptions from the require6 ments in this title for the efficient and cost-effective imple7 mentation of these provisions. 

8 ‘‘(d) SAFETY.—For purposes of chapter VI, a cos9 metic shall be deemed to be safe if it does not present 

10 a risk of significant illness or injury to humans under the 

11 conditions of use recommended or suggested in the label12 ing.’’. 

13 SEC. 13. CONFORMING AMENDMENTS. 

14 (a) Section 301 is amended by adding at the end the 

15 following: 

16 ‘‘(aaa) The failure to reg17 ister a cosmetic establishment re18 quired to be registered under sec19 tion 604 or to maintain the reg20 istration current and accurate. 

21 ‘‘(bbb) The failure to submit 

22 a cosmetic and ingredient state23 ment required under section 605 

24 or to maintain the statement cur25 rent and accurate. 


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1 ‘‘(ccc) The failure to submit 

2 a serious and unexpected adverse 

3 event report or to include on a 

4 label the domestic telephone 

5 number through which a report 

6 of a serious and unexpected ad7 verse event may be received, as 

8 required under section 606. 

9 ‘‘(ddd) The failure to comply 

10 with cosmetic good manufac11 turing practices established 

12 under section 607. 

13 ‘‘(eee) The failure to comply 

14 with a tolerance for a nonfunc15 tional constituent in cosmetics es16 tablished under section 608. 

17 ‘‘(fff) The failure to comply 

18 with a determination with respect 

19 to the safety of a cosmetic ingre20 dient under section 609 or sec21 tion 610. 

22 ‘‘(ggg) For a cosmetic prod23 uct that is being imported or of24 fered for import, the failure of 

25 the importer to present both the 


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1 unique cosmetic establishment 

2 registration number established 

3 by the Secretary under section 

4 604(a) and the unique cosmetic 

5 and ingredient statement number 

6 established by the Secretary 

7 under section 605(a).’’. 

8 (b) Section 301(j) is amended by inserting ‘‘605, 609, 

9 613,’’ after ‘‘573,’’. 

10 SEC. 14. NATIONAL UNIFORMITY FOR COSMETICS. 

11 Section 752 is amended— 

12 (1) by amending the section heading to read as 

13 follows: ‘‘NATIONAL UNIFORMITY FOR COS14 METICS’’; 

15 (2) in subsection (b), by inserting ‘‘or (f)’’ after 

16 ‘‘subsection (a)’’; and 

17 (3) by adding at the end the following: 

18 ‘‘(f) COSMETIC SAFETY.— 

19 ‘‘(1) IN GENERAL.—Subject to paragraphs (2) 

20 and (3), no State or political subdivision of a State 

21 may establish or continue in effect any law, regula22 tion, order, or other requirement relating to cosmetic 

23 constituents, cosmetic ingredients, or cosmetic prod24 ucts— 


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1 ‘‘(A) that is different from, in addition to, 

2 or otherwise not identical to, the provisions of 

3 chapter VI and the requirements and deter4 minations established or accepted by the Sec5 retary thereunder; or 

6 ‘‘(B) relating to registration, listing, or 

7 fees for establishments, products, ingredients, 

8 or constituents, or to submission of reports. 

9 ‘‘(2) STATE PETITIONS.—Not later than 180 

10 days after the date of the enactment of this sub11 section, a State may petition the Secretary under 

12 section 609 or 610 to establish as a national stand13 ard a tolerance for a nonfunctional constituent or a 

14 safety requirement for a cosmetic ingredient that ex15 ists in a State law or a duly promulgated State reg16 ulation that is effective on the date of enactment of 

17 this subsection. Pending completion of the process 

18 established under section 608 or 610, the State re19 quirement shall remain in effect for that State. 

20 Upon completion of the process established under 

21 section 608 or 610, the final regulation or guidance 

22 published by the Secretary in the Federal Register 

23 shall be the national safety standard for the con24 stituent or ingredient. 


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1 ‘‘(3) REQUIREMENTS ADOPTED BY STATE PUB2 LIC INITIATIVE OR REFERENDUM.—This subsection 

3 shall not apply to a State requirement adopted by a 

4 State public initiative or referendum enacted prior to 

5 the enactment of this subsection.’’. 

6 SEC. 15. IMPORTATION. 

7 Section 801(a) is amended by adding at the end the 

8 following: 

9 ‘‘If a cosmetic product is being imported or offered 

10 for import into the United States and the importer does 

11 not present both the unique cosmetic establishment reg12 istration number established under section 604 and the 

13 unique cosmetic and ingredient statement number estab14 lished under section 605, or the registration number or 

15 statement number is not correct and accurate, the cos16 metic product shall be denied entry.’’. 

17 SEC. 16. AUTHORIZATION OF APPROPRIATIONS. 

18 Chapter VI, as amended by sections 3, 4, 5, 6, 7, 

19 8, 9, 10, 11, and 12, is amended by adding at the end 

20 the following: 

21 ‘‘SEC. 616. AUTHORIZATION OF APPROPRIATIONS. 

22 ‘‘To carry out this chapter and section 752, there is 

23 authorized to be appropriated $11,700,000 for each of fis24 cal years 2014 through 2018. The Secretary shall annu25 ally allocate for personnel and functions for the regulation 


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1 of cosmetics during the period of such fiscal years at least 

2 $11,700,000 out of the total funds appropriated for the 

3 Food and Drug Administration, 10 full-time equivalent 

4 personnel in the Office of Regulatory Affairs, and 1 full5 time equivalent lawyer in the Office of Chief Counsel.’’. 

6 SEC. 17. EFFECTIVE DATES. 

7 (a) Sections 3, 4, 5, 6, and 15 of this Act shall be 

8 effective on the later date of— 

9 (1) one year after the Secretary of Health and 

10 Human Services promulgates final regulations or 

11 guidance implementing these sections; or 

12 (2) one year after the Secretary of Health and 

13 Human Services publishes a notice in the Federal 

14 Register determining that an effective electronic sys15 tem has been established and is operational for the 

16 submission of cosmetic manufacturing establishment 

17 registrations, cosmetic and ingredient filings, reports 

18 of serious and unexpected cosmetic adverse events, 

19 good manufacturing practices for cosmetics, and the 

20 National Cosmetic Regulatory Databank. 

21 (b) The remaining sections of this Act shall be effec22 tive on the date of the enactment of this Act. 

Æ 


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