I 

114TH CONGRESS 

1ST SESSION H. R. 4075 

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

procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 18, 2015 

Mr. SESSIONS 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 manufacturing establishments, the 

submission of cosmetic and ingredient statements, and 

the reporting of serious cosmetic 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 Modernization Amendments of 2015’’. 


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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. 

9 The table of contents for this Act is as follows: 

Sec. 1. Short title and references. 

Sec. 2. Table of contents. 

Sec. 3. Definitions. 

Sec. 4. Registration of cosmetic manufacturing establishments. 

Sec. 5. Cosmetic and ingredient statement. 

Sec. 6. Serious and unexpected adverse event reporting for cosmetics. 

Sec. 7. Good manufacturing practice. 

Sec. 8. Safety substantiation for cosmetic ingredients and nonfunctional constituents. 

Sec. 9. National Cosmetic Regulatory Databank. 

Sec. 10. Special rules. 

Sec. 11. Prohibited acts. 

Sec. 12. National uniformity for cosmetics. 

Sec. 13. Importation. 

Sec. 14. Effective dates. 

10 SEC. 3. DEFINITIONS. 

11 Chapter VI (21 U.S.C. 361 et seq.) is amended by 

12 adding at the end the following: 

13 ‘‘SEC. 604. DEFINITIONS. 

14 ‘‘In this chapter: 

15 ‘‘(1) COSMETIC.—Notwithstanding section 

16 201(i), for purposes of this section and sections 

17 601(f), 605, 606, 607, 608, and 801(a), the term 


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1 ‘cosmetic’ includes only articles described in section 

2 201(i)(1). 

3 ‘‘(2) ESTABLISHMENT.— 

4 ‘‘(A) The term ‘establishment’ means a 

5 place of business where a cosmetic is manufac6 tured, without further processing outside or 

7 within the United States. 

8 ‘‘(B) A cosmetic shall not be considered to 

9 have undergone further processing for purposes 

10 of subparagraph (A) solely on the basis that 

11 packaging or other labeling was added or 

12 changed or that any similar activity of a de 

13 minimis nature was carried out with respect to 

14 the cosmetic. 

15 ‘‘(C) The term ‘domestic establishment’ 

16 means an establishment location in any State. 

17 ‘‘(D) The term ‘foreign establishment’ 

18 means an establishment location outside the 

19 United States. 

20 ‘‘(3) SAFE; SAFETY.— 

21 ‘‘(A) The terms ‘safe’ and ‘safety’, with re22 spect to a cosmetic, mean the cosmetic does not 

23 present a significant risk of serious illness or 

24 injury to humans under the conditions of use 

25 recommended or suggested in the labeling of 


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1 the cosmetic, including the limitation of ‘for 

2 professional use’ only. 

3 ‘‘(B) For purposes of subparagraph (A), 

4 the term ‘professional’ means an individual 

5 who— 

6 ‘‘(i) is licensed by an official State au7 thority to practice in the field of cosme8 tology, nail care, barbering, and or esthet9 ics; and 

10 ‘‘(ii) is in compliance with all require11 ments of the State for such licensing.’’. 

12 SEC. 4. REGISTRATION OF COSMETIC MANUFACTURING ES13 TABLISHMENTS. 

14 Chapter VI (21 U.S.C. 361 et seq.), as amended by 

15 section 3, is further amended by adding at the end the 

16 following: 

17 ‘‘SEC. 605. REGISTRATION OF COSMETIC MANUFACTURING 

18 ESTABLISHMENTS. 

19 ‘‘(a) IN GENERAL.— 

20 ‘‘(1) REGISTRATION.—The Secretary shall by 

21 regulation require that every domestic and foreign 

22 establishment engaged in the manufacture of a cos23 metic intended to be sold in the United States that 

24 is not exempt under subsection (e) be registered with 

25 the Secretary within 60 business days after the first 


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1 commercial sale of a cosmetic in the United States. 

2 If a cosmetic is processed in more than one estab3 lishment, registration shall be required under this 

4 section only for the establishment that performs the 

5 final portion of the manufacturing operation. The 

6 single registration shall cover all such cosmetics 

7 manufactured by the establishment. The registration 

8 shall state only the name of the company or other 

9 organization name of the establishment, the city, 

10 street address, State, and country of the establish11 ment, and the title, email address, and telephone 

12 number for the office within the establishment that 

13 is responsible for submitting and maintaining the 

14 registration. For a foreign establishment, the reg15 istration shall include the contact information for 

16 the initial United States agent of the establishment. 

17 ‘‘(2) UNIQUE NUMBER.—The Secretary shall 

18 establish and provide to each registrant under this 

19 section a unique cosmetic establishment registration 

20 number within 15 business days after receiving the 

21 registration. If the Secretary does not provide a 

22 unique cosmetic establishment registration number 

23 within such 15 business days, any requirement 

24 under this Act for such number shall be deemed to 

25 be inapplicable until 30 business days after such 


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1 number is received by the person who submitted the 

2 registration. Where more than one person registers 

3 the same establishment, the Secretary shall provide 

4 only one unique establishment registration number 

5 for the establishment. The unique cosmetic estab6 lishment number shall not be required to be included 

7 in cosmetic labeling. 

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

9 registration under subsection (a) or in an existing reg10 istration under subsection (e)(1)(A) shall be maintained 

11 as current and accurate by the registrant by withdrawing 

12 or amending the registration within 60 business days after 

13 the information becomes no longer current and accurate. 

14 ‘‘(c) ENFORCEMENT.—The Secretary shall enforce 

15 this section under section 301(ddd) and shall not suspend 

16 or revoke a registration under this section. 

17 ‘‘(d) LIST.—The Secretary shall compile and main18 tain an up-to-date and publicly available electronic list of 

19 establishments that are registered under this section. 

20 ‘‘(e) EXEMPTIONS.— 

21 ‘‘(1) IN GENERAL.—Registration under sub22 section (a) shall not be required for any entity based 

23 on such entity operating as— 

24 ‘‘(A) an establishment that as of the date 

25 of enactment of this section is registered as a 


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1 cosmetic establishment under part 710 of title 

2 21, Code of Federal Regulations (as in effect on 

3 such date); 

4 ‘‘(B) a beauty shop or salon or spa; 

5 ‘‘(C) a cosmetic retailer, including any 

6 such retailer that is— 

7 ‘‘(i) an individual sales representative; 

8 ‘‘(ii) a wholesale or retail distribution 

9 or sales facility; or 

10 ‘‘(iii) a pharmacy or other person or 

11 organization that— 

12 ‘‘(I) compounds cosmetics at a 

13 single location and administers, dis14 penses, or distributes such cosmetics 

15 at retail from that location; and 

16 ‘‘(II) does not otherwise manu17 facture or package cosmetics from 

18 that location; 

19 ‘‘(D) a health care provider, including a 

20 hospital or clinic; 

21 ‘‘(E) a public health agency or other non22 profit entity; 

23 ‘‘(F) a hotel or other entity that provides 

24 complimentary cosmetics; 


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1 ‘‘(G) a trade show or other venue where 

2 cosmetic samples are provided; 

3 ‘‘(H) an establishment that manufactures, 

4 prepares, compounds, or processes cosmetics for 

5 use in research, teaching, or chemical analysis 

6 or pilot plant production; 

7 ‘‘(I) a handcrafted soap or cosmetic made 

8 in a home, a community facility, or a similar es9 tablishment; or 

10 ‘‘(J) a business with less than $1,000,000 

11 annual net sales of cosmetics. 

12 ‘‘(2) ADDITIONAL EXEMPTIONS.—The Sec13 retary may supplement the list of exemptions under 

14 paragraph (1) with additional exemptions for per15 sons and activities where the cost of compliance ex16 ceeds the safety benefit to the public.’’. 

17 SEC. 5. COSMETIC AND INGREDIENT STATEMENT. 

18 Chapter VI (21 U.S.C. 361 et seq.), as amended by 

19 sections 3 and 4, is further amended by adding at the end 

20 the following: 

21 ‘‘SEC. 606. COSMETIC AND INGREDIENT STATEMENT. 

22 ‘‘(a) IN GENERAL.—The Secretary shall by regula23 tion require that every domestic establishment and foreign 

24 establishment engaged in the manufacture of a cosmetic 

25 intended to be sold in the United States submit to the 


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1 Secretary, for each cosmetic so manufactured in the estab2 lishment, except such cosmetics manufactured by entities 

3 exempted by section 605(e) from registration under sec4 tion 605, within 60 business days after the first commer5 cial sale of the cosmetic, a cosmetic and ingredient state6 ment. The Secretary shall require the statement to contain 

7 only— 

8 ‘‘(1) the unique establishment registration num9 ber of the manufacturing establishment where the 

10 cosmetic is manufactured or, if the same cosmetic is 

11 manufactured in more than one establishment, the 

12 unique establishment registration number of each es13 tablishment where it is manufactured; 

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

15 ‘‘(3) the applicable cosmetic category or cat16 egories for the cosmetic; 

17 ‘‘(4) the ingredients in the cosmetic (in accord18 ance with section 701.3 of title 21, Code of Federal 

19 Regulations (as in effect on the date of enactment 

20 of the Cosmetic Modernization Amendments of 2015 

21 and including any successor regulations), and using 

22 the name of each ingredient established under sub23 section (d), if any), in descending order of predomi24 nance by weight, except that— 


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1 ‘‘(A) flavors and fragrances may be des2 ignated as such; and 

3 ‘‘(B) all variations in color, flavor, or fra4 grance may be included in one statement; and 

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

6 number for the office within the establishment that 

7 is responsible for submitting and maintaining the 

8 statement. 

9 ‘‘(b) UNIQUE NUMBER.—The Secretary shall estab10 lish and provide to the office submitting a statement re11 quired by subsection (a) a unique cosmetic and ingredient 

12 statement number within 15 business days after receiving 

13 the statement. If the Secretary does not provide a unique 

14 cosmetic and ingredient statement number within such 15- 

15 business-day period, any requirement under this Act for 

16 such number shall be deemed to be inapplicable until the 

17 date that is 30 business days after such number is received 

18 by the office that submitted the statement. The unique 

19 cosmetic and ingredient statement number shall not be re20 quired to be included in cosmetic labeling. 

21 ‘‘(c) CHANGE IN LABELING.—An establishment shall 

22 not be required to submit a new or revised statement 

23 under subsection (a) because of a change in labeling ex24 cept to the extent necessary to maintain the accuracy of 


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1 the information included in a statement under subsection 

2 (a). 

3 ‘‘(d) NAME OF INGREDIENT.—For purposes of this 

4 section and cosmetic ingredient labeling under section 

5 701.3 of title 21, Code of Federal Regulations (as in effect 

6 on the date of enactment of the Cosmetic Modernization 

7 Amendments of 2015 and including any successor regula8 tions), the name of a cosmetic ingredient shall be the 

9 name, if any, in the most recent edition of the Inter10 national Cosmetic Ingredient Dictionary, unless the Sec11 retary by regulation establishes a different name for the 

12 ingredient. 

13 ‘‘(e) MAINTENANCE.—The information required in a 

14 statement submitted to the Secretary under subsection (a) 

15 or in an existing statement under subsection (g)(1) shall 

16 be maintained as current and accurate by the office that 

17 filed the statement by withdrawing or amending the state18 ment within 60 business days after the information be19 comes no longer current and accurate, except that no 

20 amendment shall be required for a change in the order 

21 of predominance of the ingredients or for any other type 

22 or category of change for which the costs of amending the 

23 statement exceed the safety benefit to the public. 

24 ‘‘(f) ENFORCEMENT.—The Secretary shall enforce 

25 subsections (a) and (e) under section 301(eee) and shall 


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1 not suspend or revoke a cosmetic and ingredient state2 ment. 

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

5 cosmetics and ingredients for which statements are sub6 mitted under this section. A statement submitted pursuant 

7 to this section shall not be subject to disclosure under sec8 tion 552 of title 5, United States Code. The Secretary may 

9 make publicly available information derived from such 

10 statements that discloses the names of ingredients used 

11 in cosmetics and the number of cosmetics in which a spe12 cific ingredient is used, but may not make publicly avail13 able any information that relates to any ingredient that 

14 is exempt from public disclosure under section 720.8 of 

15 title 21, Code of Federal Regulations (as in effect on the 

16 date of enactment of the Cosmetic Modernization Amend17 ments of 2015 and including any successor regulations), 

18 or that discloses at what establishment a cosmetic is man19 ufactured. At the written request of the director of a State 

20 agency responsible for regulating the safety of cosmetics 

21 stating good cause therefor, the Secretary may disclose to 

22 such official confidential business and trade secret infor23 mation contained in a statement and such official and 

24 other State employees who have access to such informa25 tion shall then be subject to the provisions of section 


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1 301(j) of this Act, section 552(b) of title 5, United States 

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

3 with respect to such information. 

4 ‘‘(h) EXEMPTIONS.—Submission of a statement 

5 under subsection (a) shall not be required— 

6 ‘‘(1) for a cosmetic for which as of the date of 

7 enactment of this section a cosmetic ingredient 

8 statement has been submitted to the Secretary 

9 under part 710 of title 21, Code of Federal Regula10 tions (as in effect on the date of enactment of the 

11 Cosmetic Modernization Amendments of 2015); 

12 ‘‘(2) for a cosmetic ingredient exempt from 

13 public disclosure under section 720.8 of title 21, 

14 Code of Federal Regulations (as in effect on the 

15 date of enactment of the Cosmetic Modernization 

16 Amendments of 2015 and including any successor 

17 regulations); or 

18 ‘‘(3) by an entity to the extent such entity is 

19 exempted by section 605(e) from registration under 

20 section 605.’’. 

21 SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT RE22 PORTING FOR COSMETICS. 

23 (a) IN GENERAL.—Chapter VI (21 U.S.C. 361 et 

24 seq.), as amended by sections 3, 4, and 5, is further 

25 amended by adding at the end the following: 


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1 ‘‘SEC. 607. SERIOUS AND UNEXPECTED ADVERSE EVENT RE2 PORTING FOR COSMETICS. 

3 ‘‘(a) IN GENERAL.—The Secretary shall by regula4 tion require that a domestic or foreign manufacturer, 

5 packer, or distributor whose name appears on the label 

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

7 the United States submit to the Secretary under sub8 section (b) a report containing— 

9 ‘‘(1) information received concerning any seri10 ous and unexpected adverse event in the United 

11 States allegedly associated with the use of the cos12 metic for which it is reasonably likely that the ad13 verse event was caused by the cosmetic when used 

14 as recommended or suggested in the labeling; and 

15 ‘‘(2) a copy of the label for the cosmetic. 

16 ‘‘(b) SUBMISSION OF REPORTS.—A report on an ad17 verse event under subsection (a) shall be submitted to the 

18 Secretary not later than 15 business days after informa19 tion concerning the adverse event is received at the place 

20 of business labeled on the cosmetic pursuant to section 

21 602(b)(1). 

22 ‘‘(c) REQUIRED CONTENTS.—A report under sub23 section (a) shall include all of the following information: 

24 ‘‘(1) An identifiable patient. 

25 ‘‘(2) An identifiable reporter. 

26 ‘‘(3) A suspect cosmetic or component thereof. 


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1 ‘‘(4) A serious adverse event. 

2 ‘‘(d) ADDITIONAL CONTENTS; SUPPLEMENTAL RE3 PORTING.—The person submitting a report under sub4 section (a) may— 

5 ‘‘(1) include pertinent information in addition 

6 to the information listed in subsection (c); and 

7 ‘‘(2) after submitting the initial report, supple8 ment the report with additional information. 

9 ‘‘(e) SPECIAL RULES.— 

10 ‘‘(1) PROTECTED INFORMATION.—A serious 

11 and unexpected adverse event report (including all 

12 information submitted in the initial report or added 

13 later) submitted under subsection (a)— 

14 ‘‘(A) shall be considered to be a safety re15 port under section 756 that is subject to the 

16 provisions of that section; and 

17 ‘‘(B) shall be considered to be a record 

18 about an individual under section 552a of title 

19 5, United States Code, and a medical or similar 

20 file the disclosure of which would constitute a 

21 violation of section 552 of such title 5, and 

22 shall not be publicly disclosed unless all person23 ally identifiable information is redacted. 


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1 ‘‘(2) NO TREATMENT AS ADMISSION.—The sub2 mission of a serious and unexpected adverse event 

3 report in compliance with subsection (a)— 

4 ‘‘(A) shall not be construed as an admis5 sion that the cosmetic involved caused or con6 tributed to the adverse event; and 

7 ‘‘(B) may be accompanied by a statement 

8 that denies that the report constitutes an ad9 mission that the cosmetic involved caused or 

10 contributed to the adverse event. 

11 ‘‘(3) INCLUSION OF STATEMENT IN PUBLIC DIS12 CLOSURE.—In releasing any report under subsection 

13 (a) or portion thereof for public disclosure, the Sec14 retary shall include any statement under paragraph 

15 (2)(B). 

16 ‘‘(f) LABELING.—The label of a cosmetic shall bear 

17 the domestic telephone number, email address, or mailing 

18 address through which the person whose name and place 

19 of business appear on the label may receive a report of 

20 a serious adverse event. 

21 ‘‘(g) EXEMPTION.—The Secretary may, by regula22 tion, establish an exemption to the requirements under 

23 subsections (b) and (d) if the Secretary determines that 

24 such exemption would have no adverse effect on public 

25 health. 


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1 ‘‘(h) DEFINITIONS.—In this section: 

2 ‘‘(1) The term ‘serious’, with respect to an ad3 verse event, means— 

4 ‘‘(A) resulting in— 

5 ‘‘(i) death; 

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

7 ‘‘(iii) inpatient hospitalization; 

8 ‘‘(iv) a persistent and significant dis9 ability or incapacity; 

10 ‘‘(v) a congenital anomaly or birth de11 fect; or 

12 ‘‘(vi) permanent disfiguration; or 

13 ‘‘(B) requiring, based on reasonable med14 ical judgment, a medical or surgical interven15 tion to prevent an outcome described under 

16 subparagraph (A). 

17 ‘‘(2) The term ‘unexpected’, with respect to an 

18 adverse event, means not identified on the cosmetic 

19 label.’’. 

20 (b) MISBRANDING.—Section 602 of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend22 ed by adding at the end the following: 

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

24 States, unless the label of such cosmetic includes a domes25 tic address or domestic phone number through which a 


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1 report of a serious and unexpected adverse event (as such 

2 term is used in section 607) associated with the use of 

3 such cosmetic may be submitted to the person described 

4 in section 607(f).’’. 

5 SEC. 7. GOOD MANUFACTURING PRACTICE. 

6 (a) PROHIBITION.—Section 601 (21 U.S.C. 361) is 

7 amended by adding at the end the following: 

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

9 that do not satisfy the principles and standards for good 

10 manufacturing practice established under section 608 and 

11 as a result presents a significant risk of serious adverse 

12 health consequences or death to humans.’’. 

13 (b) PRINCIPLES AND STANDARDS.—Chapter VI (21 

14 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, and 

15 6, is further amended by adding at the end the following: 

16 ‘‘SEC. 608. GOOD MANUFACTURING PRACTICE. 

17 ‘‘(a) IN GENERAL.—The Secretary may by regulation 

18 establish principles and standards for good manufacturing 

19 practice for the manufacture of cosmetics in accordance 

20 with paragraphs (a) and (d) of section 601. 

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

22 subsection (a) shall be promulgated only after providing 

23 notice and an opportunity for comment in accordance with 

24 chapter 5 of title 5, United States Code. 


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1 ‘‘(c) GOOD MANUFACTURING PRACTICES OF OTHER

2 PARTIES.—A manufacturer shall not be responsible under 

3 section 601(f) or this section for the good manufacturing 

4 practice of its suppliers. A distributor shall not be respon5 sible under section 601(f) or this section for the good man6 ufacturing practice of its manufacturers.’’. 

7 SEC. 8. SAFETY SUBSTANTIATION FOR COSMETIC INGREDI8 ENTS AND NONFUNCTIONAL CONSTITUENTS. 

9 Chapter VI (21 U.S.C. 361 et seq.), as amended by 

10 sections 3, 4, 5, 6, and 7, is further amended by adding 

11 at the end the following: 

12 ‘‘SEC. 609. COSMETIC INGREDIENTS AND NONFUNCTIONAL 

13 CONSTITUENTS THAT ARE SAFE FOR USE IN 

14 COSMETICS. 

15 ‘‘(a) IN GENERAL.—A manufacturer or distributor of 

16 a cosmetic may rely on this section to substantiate the 

17 safety of such cosmetic. 

18 ‘‘(b) SAFE INGREDIENTS.—Unless and until prohib19 ited or limited by the Secretary by regulation, the fol20 lowing ingredients are deemed to be adequately substan21 tiated for safe use in cosmetics subject to the requirements 

22 of good manufacturing practice: 

23 ‘‘(1) Color additives approved by the Secretary 

24 for use in cosmetics, within any limits established in 

25 such approval. 


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1 ‘‘(2) Food additives approved by the Secretary 

2 for direct addition to food for human consumption, 

3 within any limits established in such approval. 

4 ‘‘(3) Food ingredients that have been deter5 mined by the Secretary to be generally recognized as 

6 safe for direct addition to food for human consump7 tion, within any limits established in such deter8 mination. 

9 ‘‘(4) Food ingredients for which monographs 

10 have been included in the Food Chemicals Codex for 

11 direct addition to food for human consumption, 

12 within any limits established in such monographs. 

13 ‘‘(5) Pharmaceutical excipients and inactive in14 gredients approved or permitted by the Secretary, 

15 listed on a Food and Drug Administration website 

16 for use in drugs for human consumption or for 

17 which monographs have been included in the Hand18 book of Pharmaceutical Excipients, within any limits 

19 established in such lists or monographs. 

20 ‘‘(6) Cosmetic ingredients that have been re21 viewed for safety by a qualified nongovernmental or 

22 governmental expert scientific body, including the 

23 Cosmetic Ingredient Review Expert Panel, and that 

24 are the subject of a monograph published in a peerVerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075

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1 reviewed scientific journal, within any limits estab2 lished in such monographs. 

3 ‘‘(7) Fragrance ingredients that have been re4 viewed for safety by a qualified nongovernmental or 

5 governmental expert scientific body, including the 

6 Research Institute of Fragrance Materials Expert 

7 Panel, and that are the subject of a monograph pub8 lished in a peer-reviewed scientific journal, within 

9 any limits established in such monographs. 

10 ‘‘(8) Cosmetic ingredients approved or per11 mitted for use in cosmetics by any of the countries 

12 listed in section 802(b)(1)(A) as having an adequate 

13 regulatory authority, within any limits established by 

14 such regulatory authority. 

15 ‘‘(c) SAFE NONFUNCTIONAL CONSTITUENTS.— 

16 ‘‘(1) DEFINITION.—A nonfunctional constituent 

17 in a cosmetic is any substance that— 

18 ‘‘(A) has not been intentionally added as a 

19 separate substance; and 

20 ‘‘(B) serves no technical or cosmetic func21 tion in the cosmetic. 

22 ‘‘(2) ADEQUATE SUBSTANTIATION.—The fol23 lowing nonfunctional constituents are deemed to be 

24 adequately substantiated for safe use in cosmetics, 

25 subject to the requirements of good manufacturing 


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1 practice and any limits or bans established by the 

2 Secretary by regulation: 

3 ‘‘(A) The levels approved or permitted for 

4 nonfunctional constituents by the Secretary for 

5 color additives for cosmetic use and for food ad6 ditives and generally recognized as safe food in7 gredients for direct human consumption. 

8 ‘‘(B) The levels approved or permitted for 

9 nonfunctional constituents by the Secretary for 

10 cosmetics and for food and food ingredients for 

11 direct human consumption in compliance policy 

12 guides, guidance, and website statements. 

13 ‘‘(C) The levels approved or permitted for 

14 nonfunctional constituents by the Secretary or 

15 the United States Pharmacopeia for oral non16 prescription drugs. 

17 ‘‘(D) The levels approved or permitted for 

18 nonfunctional constituents by the Environ19 mental Protection Agency for direct human 

20 consumption in drinking water. 

21 ‘‘(E) The levels for nonfunctional constitu22 ents approved or permitted in cosmetics and 

23 human food and food ingredients by any of the 

24 countries listed in section 802(b)(1)(A) as hav25 ing an adequate regulatory authority. 


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1 ‘‘(d) CENTER.—The Secretary shall establish a pro2 gram within the center of the Food and Drug Administra3 tion with primary responsibility for regulating cosmetics 

4 to evaluate and make determinations, by regulation, on 

5 the safe use of cosmetics and ingredients and nonfunc6 tional constituents thereof. 

7 ‘‘(e) APPLICATION; PREEMPTION.—A safety deter8 mination accepted or made by the Secretary or established 

9 under this section shall apply in every State. No State may 

10 establish or enforce a safety determination for a cosmetic 

11 or an ingredient or nonfunctional constituent of a cosmetic 

12 ‘‘(f) EFFECTIVE DATE OF REGULATIONS.—Any reg13 ulation or guidance by the Secretary pursuant to this sec14 tion concerning the safety of a cosmetic or an ingredient 

15 or nonfunctional constituent of a cosmetic shall apply be16 ginning no earlier than the date that is 2 years after the 

17 date on which such regulation or guidance is issued as 

18 final, unless the Secretary determines, after public notice 

19 and an opportunity for public comment, that an earlier 

20 date of applicability is required to prevent serious adverse 

21 health consequences or death to humans.’’. 

22 SEC. 9. NATIONAL COSMETIC REGULATORY DATABANK. 

23 Chapter VI (21 U.S.C. 361 et seq.), as amended by 

24 sections 3, 4, 5, 6, 7, and 8, is further amended by adding 

25 at the end the following: 


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1 ‘‘SEC. 610. NATIONAL COSMETIC REGULATORY DATABANK. 

2 ‘‘(a) IN GENERAL.—For the purpose of consolidating 

3 information pertaining to the regulation of cosmetic safe4 ty, the Secretary shall establish and maintain in the center 

5 of the Food and Drug Administration with primary re6 sponsibility for regulating cosmetics a database, to be 

7 known as the National Cosmetic Regulatory Databank, 

8 containing— 

9 ‘‘(1) the information submitted to the Secretary 

10 under sections 605, 606, 607, and 609; and 

11 ‘‘(2) such other information pertaining to the 

12 regulation of cosmetics as the Secretary deems ap13 propriate. 

14 ‘‘(b) AVAILABILITY.—In the case of information in 

15 the National Cosmetic Regulatory Databank that is not 

16 subject to public disclosure under section 552 of title 5, 

17 United States Code, the Secretary may nonetheless dis18 close such information to the director of a State agency 

19 on written request by such director demonstrating good 

20 cause for the disclosure. A director receiving information 

21 pursuant to the preceding sentence shall agree to limit to 

22 the disclosure of such information by State officials and 

23 employees to the same extent such disclosure is limited 

24 with respect to Federal officials and employees under sec25 tion 301(j) of this Act, section 552(b) of title 5, United 


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

2 Code, with respect to such information. 

3 ‘‘(c) PREEMPTION.—No State or political subdivision 

4 thereof may require submission of information that is 

5 available in the National Cosmetic Regulatory Databank, 

6 whether in the same or a different format.’’. 

7 SEC. 10. SPECIAL RULES. 

8 (a) CERTAIN RULES.—Chapter VI (21 U.S.C. 361 et 

9 seq.), as amended by sections 3, 4, 5, 6, 7, 8, and 9, is 

10 further amended by adding at the end the following: 

11 ‘‘SEC. 611. SPECIAL RULES. 

12 ‘‘(a) CONTRACTORS.—The person described in sec13 tion 607(f) with respect to a cosmetic (referred to in this 

14 section as the ‘responsible party’) may, by agreement, au15 thorize a manufacturer, distributor, or packer of the cos16 metic or a third-party contractor to submit any required 

17 report of a serious and unexpected adverse event (as such 

18 term is used in section 607) so long as the responsible 

19 party directs to the manufacturer, distributor, packer, or 

20 third-party contractor all such adverse events associated 

21 with such cosmetic that are reported to the responsible 

22 party through the address or telephone number described 

23 in section 607(f). 

24 ‘‘(b) EXEMPTIONS.—The Secretary, on the Sec25 retary’s own initiative or in response to a petition, may 


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1 establish exemptions from the requirements of sections 

2 601(f), 605, 606, 607, and 608— 

3 ‘‘(1) for the efficient and cost-effective imple4 mentation of such requirements; or 

5 ‘‘(2) where the cost of compliance exceeds the 

6 safety benefit to the public.’’. 

7 (b) COSMETIC DEFINITION.—Section 201(i) (21 

8 U.S.C. 321(i)) is amended by adding at the end the fol9 lowing: ‘‘An article described in subparagraph (1) that is 

10 intended only for topical external use to alter the appear11 ance by temporarily affecting the structure or any function 

12 of the human skin, and that is not the subject of an ap13 proved new drug application under section 505, shall, for 

14 purposes of this Act, be treated only as a cosmetic and 

15 not a drug.’’. 

16 (c) COLOR ADDITIVES.—Section 721(f) (21 U.S.C. 

17 379e(f)) is amended— 

18 (1) by striking ‘‘(f) The Secretary shall’’ and 

19 inserting ‘‘(f)(1) The Secretary shall’’; and 

20 (2) by adding at the end the following: 

21 ‘‘(2) A color additive, including mixtures thereof, in22 tended for use in externally applied cosmetics and not in 

23 the area of the eye is exempt from the requirements of 

24 this section if it is generally recognized, among experts 

25 qualified by scientific training and experience to evaluate 


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1 its safety, as having been shown through scientific proce2 dures to be safe under the conditions of its intended use. 

3 Notwithstanding the preceding sentence, the Secretary 

4 may by regulation require certification of batches under 

5 subsection (c) for any such color additive.’’. 

6 SEC. 11. PROHIBITED ACTS. 

7 (a) IN GENERAL.—Section 301 (21 U.S.C. 331) is 

8 amended by adding at the end the following: 

9 ‘‘(ddd) The failure to register a cosmetic establish10 ment as required under section 605 or to maintain the 

11 registration current and accurate. 

12 ‘‘(eee) The failure to submit a cosmetic and ingre13 dient statement as required under section 606 or to main14 tain the statement current and accurate. 

15 ‘‘(fff) The failure to submit a serious and unexpected 

16 adverse event report, or to include on the label of a cos17 metic the domestic telephone number, email address, or 

18 mailing address through which a report of a serious ad19 verse event may be received, as required under section 

20 607.’’. 

21 (b) INFORMATION SECURITY.—Section 301(j) (21 

22 U.S.C. 331(j)) is amended by inserting ‘‘605, 606, 609,’’ 

23 after ‘‘573,’’. 

24 SEC. 12. NATIONAL UNIFORMITY FOR COSMETICS. 

25 Section 752 (21 U.S.C. 379s) is amended— 


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

2 follows: ‘‘NATIONAL UNIFORMITY FOR COS3 METICS’’; 

4 (2) by amending subsection (a) to read as fol5 lows: 

6 ‘‘(a) IN GENERAL.—Except as provided in subsection 

7 (b) or (d) of this section, no State or political subdivision 

8 of a State may establish or continue in effect any require9 ment for labeling or packaging of a cosmetic.’’; 

10 (3) by amending subsection (c) to read as fol11 lows: 

12 ‘‘(c) COSMETIC SAFETY.—No State or political sub13 division of a State may establish or continue in effect any 

14 law, regulation, order, or other requirement— 

15 ‘‘(1) relating directly or indirectly to, or relying 

16 upon, a human health or safety evaluation of a non17 functional cosmetic constituent, cosmetic ingredient, 

18 or cosmetic (as defined in section 201(i)(1)), or re19 lating in any way to the safety standard and the 

20 human health-based requirements, evaluations, and 

21 determinations under chapter VI, the Poison Preven22 tion Packaging Act of 1970, or the Fair Packaging 

23 and Labeling Act; or 

24 ‘‘(2) relating directly or indirectly to registra25 tion or listing of cosmetic facilities, establishments, 


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1 cosmetics, or cosmetic ingredients, reporting of any 

2 information relating to cosmetics including adverse 

3 event reporting, cosmetic manufacturing processes 

4 or standards including good manufacturing practice, 

5 cosmetic labels or labeling including any general or 

6 health related warnings or public statement, or the 

7 requirement of any fees on cosmetic establishments, 

8 cosmetics, ingredients, or nonfunctional constitu9 ents.’’; and 

10 (4) by repealing subsection (e). 

11 SEC. 13. IMPORTATION. 

12 Section 801(a) (21 U.S.C. 381(a)) is amended by 

13 adding at the end the following: ‘‘If a cosmetic is being 

14 imported or offered for import into the United States and 

15 the importer does not present both the unique cosmetic 

16 establishment registration number required under section 

17 605 for the establishment that performs the final portion 

18 of the manufacturing operation and the unique cosmetic 

19 and ingredient statement number required under section 

20 606 for the cosmetic, or the registration or statement 

21 number is not correct and accurate, the cosmetic shall be 

22 denied entry.’’. 

23 SEC. 14. EFFECTIVE DATES. 

24 (a)(1) The amendments made by sections 4, 5, 6, and 

25 13 of this Act apply beginning on the later date of— 


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1 (A) the date that is one year after the Sec2 retary of Health and Human Services promulgates 

3 final regulations implementing such amendments; or 

4 (B) the date that is one year after the Sec5 retary of Health and Human Services publishes a 

6 notice in the Federal Register determining that an 

7 effective electronic system has been established and 

8 is fully operational for— 

9 (i) the submission of cosmetic manufac10 turing establishment registrations, cosmetic and 

11 ingredient statements, and reports of serious 

12 cosmetic adverse events; and 

13 (ii) the National Cosmetic Regulatory 

14 Databank. 

15 (2) Until the date applicable under paragraph (1), 

16 the voluntary establishment registration and voluntary in17 gredient listing programs established in parts 710 and 720 

18 of title 21, Code of Federal Regulations (as in effect on 

19 the date of enactment of this Act), shall remain effective 

20 and shall be fully implemented by the Secretary of Health 

21 and Human Services. 

22 (b) The amendments made by sections 7 and 8 apply 

23 beginning on the date that is two years after the date of 

24 enactment of this Act. 


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1 (c) Notwithstanding subsections (a) and (b), the 

2 amendments made by sections 5 and 7 shall not apply with 

3 respect to a cosmetic manufacturer with less than 

4 $5,000,000 of annual net sales of cosmetics until the later 

5 of— 

6 (1)(A) with respect to the amendment made by 

7 section 5, the date that is 36 months after the date 

8 otherwise applicable under subsection (a); and 

9 (B) with respect to the amendments made by 

10 section 7, the date that is 36 months after the date 

11 otherwise applicable under subsection (b); and 

12 (2) such later date as may be determined by the 

13 Secretary of Health and Human Services. 

14 (d) Except as provided in subsections (a) through (c), 

15 this Act takes effect on the date of enactment of this Act. 

Æ 


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