I 

116TH CONGRESS 

1ST SESSION H. R. 5279 

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

safety, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 3, 2019 

Mr. PALLONE 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 

improve cosmetic safety, 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; TABLE OF CONTENTS. 

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

5 ‘‘Cosmetic Safety Enhancement Act of 2019’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—COSMETIC SAFETY 

Sec. 101. Registration of cosmetics facilities and cosmetic ingredient statements. 


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Sec. 102. Review of ingredients and nonfunctional constituents; safety of finished products. 

Sec. 103. Good manufacturing practices for cosmetics. 

Sec. 104. Adverse event reports. 

Sec. 105. Records inspection; mandatory recall authority. 

Sec. 106. Labeling and internet sales. 

Sec. 107. Consumer information. 

Sec. 108. Small businesses. 

Sec. 109. Animal testing restrictions. 

Sec. 110. Counterfeit cosmetics. 

Sec. 111. Foreign supplier verification. 

Sec. 112. Applicability with respect to certain cosmetics. 

Sec. 113. Saving clause. 

Sec. 114. Enforcement. 

TITLE II—FEES RELATED TO COSMETIC PRODUCTS 

Sec. 201. Findings. 

Sec. 202. Authority to assess and use cosmetic product fees. 

Sec. 203. Direct hiring authority to support activities related to cosmetics. 

Sec. 204. Sunset dates. 

1 TITLE I—COSMETIC SAFETY 

2 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 

3 COSMETIC INGREDIENT STATEMENTS. 

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

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

6 end the following: 

7 ‘‘SEC. 604. DEFINITIONS. 

8 ‘‘In this chapter: 

9 ‘‘(1) ANIMAL TEST.—The term ‘animal test’ 

10 means the internal or external application or expo11 sure of a cosmetic product, cosmetic formulation, or 

12 cosmetic ingredient to the skin, eyes, or other body 

13 part of a live non-human vertebrate for the purpose 

14 of evaluating the safety of a cosmetic product, cos15 metic formulation, or cosmetic ingredient. 


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1 ‘‘(2) CONTRACT MANUFACTURER.—The term 

2 ‘contract manufacturer’ means a manufacturer (in3 cluding the owner, operator, or agent in charge (or 

4 any affiliate thereof)) of a cosmetic ingredient, cos5 metic formulation, or cosmetic product that does not 

6 sell any such cosmetic ingredient, cosmetic formula7 tion, or cosmetic product unless there is a specific 

8 contractual agreement in place with respect to that 

9 sale. 

10 ‘‘(3) COSMETIC FORMULATION.—The term ‘cos11 metic formulation’ means a preparation of cosmetic 

12 raw materials with a qualitatively and quantitatively 

13 set composition. 

14 ‘‘(4) COSMETIC INGREDIENT.—The term ‘cos15 metic ingredient’ means any single chemical entity 

16 or mixture used as a component in the manufacture 

17 of a finished cosmetic product or cosmetic formula18 tion. 

19 ‘‘(5) COSMETIC PRODUCT.—(A) The term ‘cos20 metic product’ means a finished cosmetic comprised 

21 of a specified set of cosmetic ingredients, which may 

22 come in a range of possible amounts for each cos23 metic ingredient and which may include a variety of 

24 fragrances and colors, and in some specific cosmetic 

25 applications, flavors. 


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1 ‘‘(B) Such term shall include tattoo ink whether 

2 or not labeled as a finished cosmetic. 

3 ‘‘(6) FACILITY.—The term ‘facility’ includes 

4 any factory, warehouse, or establishment (including 

5 a factory, warehouse, or establishment of an im6 porter or of any other entity whose name and ad7 dress appear on the label of a cosmetic product) that 

8 manufactures, processes, packs, or holds cosmetic 

9 products or cosmetic formulations. Such term does 

10 not include— 

11 ‘‘(A) beauty shops and salons that do not 

12 otherwise manufacture, process, or package cos13 metic products or cosmetic formulations at that 

14 location, including beauty stores or counters 

15 that offer customized or personalized cosmetic 

16 products or cosmetic formulations tailored to 

17 individual consumers for sale solely in-person; 

18 ‘‘(B) cosmetic product retailers, including 

19 individual sales representatives, direct sellers 

20 (as defined in section 3508 of the Internal Rev21 enue Code of 1986), retail distribution facilities, 

22 retail franchises, retail warehouses, and phar23 macies, that do not otherwise manufacture, 

24 process, or package cosmetic products or cos25 metic formulations at that location; 


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1 ‘‘(C) entities that manufacture or com2 pound cosmetic products solely for use in re3 search, teaching, or pilot plant production and 

4 not for sale; 

5 ‘‘(D) hospitals, physicians’ offices, and 

6 health care clinics; 

7 ‘‘(E) hotels, airlines, and other entities 

8 that provide complimentary cosmetic products 

9 to guests; 

10 ‘‘(F) public health agencies and other non11 profit entities that provide cosmetic products or 

12 cosmetic formulations directly to the consumer; 

13 or 

14 ‘‘(G) trade shows and other venues where 

15 cosmetic product samples are provided free of 

16 charge. 

17 ‘‘(7) FOREIGN FACILITY.—The term ‘foreign fa18 cility’ means a facility that manufactures, processes, 

19 packs, or holds, cosmetic products or cosmetic for20 mulations that are exported to the United States 

21 without further processing or packaging inside the 

22 United States. A cosmetic product or cosmetic for23 mulation is not considered to have undergone fur24 ther processing or packaging for purposes of this 

25 definition solely on the basis that labeling was added 


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1 or that any similar activity of a de minimis nature 

2 was carried out with respect to the cosmetic product 

3 or cosmetic formulation. 

4 ‘‘(8) NONFUNCTIONAL CONSTITUENT.—The 

5 term ‘nonfunctional constituent’ means any sub6 stance that is an incidental component of an ingre7 dient, a breakdown product of an ingredient, or a 

8 byproduct of the manufacturing process that has not 

9 been intentionally added as a separate substance and 

10 serves no technical function in the cosmetic product. 

11 ‘‘(9) PROFESSIONAL.—With respect to a cos12 metic product, the term ‘professional’ means— 

13 ‘‘(A) a dermatologist or other health care 

14 professional that administers or provides cos15 metic products to patients; or 

16 ‘‘(B) a cosmetologist, nail technician, bar17 ber, or esthetician who administers or provides 

18 cosmetics within the scope of their business 

19 practices. 

20 ‘‘(10) PROFESSIONAL USE.—With respect to a 

21 cosmetic product, the term ‘professional use’ means 

22 a preparation of a cosmetic formulation intended 

23 only for use by professionals in settings such as cos24 metology, nail care, barbering, esthetics, health care, 


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1 and other professions as determined by the Sec2 retary through regulation. 

3 ‘‘(11) RESPONSIBLE PERSON.—The term ‘re4 sponsible person’ means the brand owner, operator, 

5 or agent in charge who is the domestic or foreign 

6 manufacturer, processor, or entity whose name ap7 pears on the label of a cosmetic product or a cos8 metic formulation distributed in the United States. 

9 ‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES. 

10 ‘‘(a) REGISTRATION FOR MANUFACTURING AND

11 PROCESSING FACILITIES.— 

12 ‘‘(1) IN GENERAL.—The owner, operator, or 

13 agent in charge of (or an affiliate thereof) a facility 

14 engaged in manufacturing, or processing, of a cos15 metic product or a cosmetic formulation distributed 

16 in the United States shall register with the Sec17 retary. 

18 ‘‘(2) ELECTRONIC REGISTRATION SYSTEM.— 

19 The Secretary shall— 

20 ‘‘(A) maintain an electronic registration 

21 system for purposes of this section; and 

22 ‘‘(B) not later than one year after the date 

23 of enactment of the Cosmetic Safety Enhance24 ment Act of 2019, announce that such system 

25 is operational. 


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1 ‘‘(3) INITIAL REGISTRATION OF EXISTING FA2 CILITIES.—Not later than the date that is 6 months 

3 after the date of the announcement required by 

4 paragraph (2)(B), each facility engaged in an activ5 ity described in paragraph (1) shall be registered 

6 under such paragraph. 

7 ‘‘(4) INITIAL REGISTRATION OF NEW FACILI8 TIES.—In the case of a facility that first engages in 

9 an activity described in paragraph (1) on or after 

10 the date that is 18 months after the date of enact11 ment of the Cosmetic Safety Enhancement Act of 

12 2019, such a facility shall register with the Sec13 retary immediately upon engaging in such activity. 

14 ‘‘(5) SINGLE REGISTRATION.—The Secretary 

15 shall require only a single registration per registra16 tion period for a facility required to be registered 

17 under paragraph (1), regardless of whether such fa18 cility is manufacturing or processing— 

19 ‘‘(A) its own cosmetic products or cosmetic 

20 formulations; or 

21 ‘‘(B) cosmetic products or cosmetic formu22 lations on behalf of more than one owner, oper23 ator, or agent in charge (or affiliate thereof). 

24 ‘‘(b) REGISTRATION FOR PACKING OR HOLDING FA25 CILITIES.—Each facility engaged in packing or holding a 


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1 cosmetic product or cosmetic formulation distributed in 

2 the United States shall register with the Food and Drug 

3 Administration. Each such facility shall, not later than 6 

4 months after the Secretary announces the establishment 

5 of an electronic registration system for purposes of this 

6 section, submit a registration utilizing such system. 

7 ‘‘(c) ANNUAL REGISTRATION RENEWAL.—A facility 

8 that continues to engage in any activity that would require 

9 registration under subsection (a) or (b) shall submit to 

10 the Secretary an annual registration during the first quar11 ter of the fiscal year for which such renewed registration 

12 shall be effective. 

13 ‘‘(d) FEES.—If the average gross annual sales of cos14 metic products in the United States of all of the facilities 

15 of the responsible person registered under subsection 

16 (a)(1) for the previous 3-fiscal-year period is greater than 

17 $1,000,000, a registration shall not be complete under this 

18 subsection until the responsible person has paid any reg19 istration fee required under section 744M. 

20 ‘‘(e) CHANGES TO INFORMATION.—A facility that 

21 submitted a registration under this section shall notify the 

22 Secretary of any change to the information required under 

23 subsection (a) or (b) not later than 30 days after the date 

24 of such change, unless otherwise specified by the Sec25 retary. 


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1 ‘‘(f) FORMAT; CONTENTS.— 

2 ‘‘(1) ELECTRONIC FORMAT.—Each registration 

3 shall be submitted using an electronic format, as 

4 specified in a registration form provided by the Sec5 retary. 

6 ‘‘(2) CONTENTS.—The registration shall con7 tain the following information: 

8 ‘‘(A) Each facility’s name (including any 

9 parent company of the facility) and full ad10 dress, identifying the precise physical location 

11 of the facility. 

12 ‘‘(B) The identity of the facility, including 

13 the unique facility identifier, if any, previously 

14 assigned by the Secretary to the facility under 

15 subsection (i). 

16 ‘‘(C) All business trading names used by 

17 the facility. 

18 ‘‘(D) The product category (as identified 

19 under section 720.4(c) of title 21, Code of Fed20 eral Regulations (or any successor regulation)), 

21 or other cosmetic categories as determined ap22 propriate by the Secretary (including by guid23 ance) of each cosmetic product or cosmetic for24 mulation manufactured, processed, packed, or 


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1 held at the facility or on whose label the facili2 ty’s name and address appear. 

3 ‘‘(E) The type or types of activities con4 ducted at the facility (such as manufacturing, 

5 processing, packing, or holding). 

6 ‘‘(F) The name, title, street address, tele7 phone number, and electronic contact informa8 tion of the emergency contact for the facility. 

9 ‘‘(G) In the case of a foreign facility, the 

10 name, street address, telephone number, emer11 gency contact information for the facility, the 

12 name of the United States agent for the facil13 ity, and the phone number and electronic con14 tact information of the United States agent. 

15 ‘‘(H) The name, title, street address, tele16 phone number, and electronic contact informa17 tion of the individual submitting the registra18 tion. 

19 ‘‘(I) An assurance that the Secretary will 

20 be permitted to inspect such facility at the 

21 times and in the manner permitted by this Act. 

22 ‘‘(J) Additional information pertaining to 

23 the facility or to the cosmetic products or cos24 metic formulations manufactured, processed, 

25 packed, or held at the facility, or on whose label 


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1 the facility’s name and address appear, includ2 ing all brand names known to consumers, as 

3 the Secretary may require by regulation. 

4 ‘‘(3) ABBREVIATED REGISTRATION.—The Sec5 retary shall provide for an abbreviated registration 

6 renewal process for any facility that has not had any 

7 changes to the information submitted by the facility 

8 for the preceding registration. 

9 ‘‘(g) INCOMPLETE OR INACCURATE REGISTRA10 TION.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

12 the Secretary may cancel a registration of a facility 

13 under this section if— 

14 ‘‘(A) the Secretary has reasonable grounds 

15 to believe that the registration was not properly 

16 completed or updated in accordance with this 

17 section; 

18 ‘‘(B) a required registration fee has not 

19 been paid within 30 days; or 

20 ‘‘(C) the registration otherwise contains 

21 false, incomplete, or inaccurate information. 

22 ‘‘(2) NOTIFICATION.—The Secretary shall, at 

23 least 10 days before canceling a registration pursu24 ant to paragraph (1), provide notice to the facility 

25 of the intent of the Secretary to cancel such regVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 istration that contains the Secretary’s basis for the 

2 determination to so cancel the registration. 

3 ‘‘(3) TIMELY UPDATE OR CORRECTION.—If, not 

4 later than 7 days after receipt of a notice of intent 

5 to cancel under paragraph (2), the facility corrects 

6 the registration in accordance with the basis for the 

7 cancellation, and the required registration fee, if 

8 any, is paid, the Secretary shall not cancel such reg9 istration. 

10 ‘‘(h) UNIQUE IDENTIFIER.—At the time of the initial 

11 registration of any cosmetic facility under this section, the 

12 Secretary shall assign a unique identifier to the facility 

13 and provide such identifier to such facility in writing. 

14 ‘‘(i) REGISTRY OF FACILITIES.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall com16 pile, maintain, and update a registry of facilities 

17 that are registered under this section, and shall re18 move from such registry the name of any facility 

19 whose registration under this section is cancelled. 

20 The registry shall be publicly available. 

21 ‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In22 formation derived from the registry or registration 

23 documents that discloses the residential address of 

24 an owner, operator, or agent in charge of (or an af25 filiate thereof) a facility engaged in manufacturing, 


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1 processing, packing, or holding a cosmetic product 

2 or formulation, or a facility owned by such person, 

3 or that discloses specific facilities where specific 

4 brands of cosmetic products are manufactured or 

5 processed shall not be subject to disclosure under 

6 section 552 of title 5, United States Code. 

7 ‘‘SEC. 606. COSMETIC INGREDIENT STATEMENTS. 

8 ‘‘(a) IN GENERAL.—For each cosmetic product, the 

9 responsible person shall submit to the Secretary a cos10 metic ingredient statement, at such time and in such man11 ner as the Secretary may prescribe. The cosmetic ingre12 dient statement shall not become effective until the re13 sponsible person pays any applicable fee required under 

14 section 744M. 

15 ‘‘(b) SUBMISSION OF A COSMETIC INGREDIENT

16 STATEMENT.— 

17 ‘‘(1) EXISTING COSMETIC PRODUCTS.—In the 

18 case of a cosmetic product or cosmetic formulation 

19 that is marketed on the date of enactment of the 

20 Cosmetic Safety Enhancement Act of 2019, the re21 sponsible person shall— 

22 ‘‘(A) not later than the date that is 6 

23 months after the date of the announcement of 

24 an electronic registration system required by 

25 section 605, submit to the Secretary a cosmetic 


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1 ingredient statement in accordance with this 

2 section; and 

3 ‘‘(B) beginning one year after the ingre4 dient statement is submitted under subpara5 graph (A) and each year thereafter, submit to 

6 the Secretary a renewal of such statement, con7 sistent with the requirements in subsection (e), 

8 during the first quarter of the fiscal year for 

9 which such renewed statement is applicable. 

10 ‘‘(2) COSMETIC INGREDIENT STATEMENT FOR

11 NEW COSMETIC PRODUCTS.— 

12 ‘‘(A) IN GENERAL.—Except as provided 

13 under subparagraph (B), in the case of a cos14 metic product or cosmetic formulation that is 

15 first marketed after the date of enactment of 

16 the Cosmetic Safety Enhancement Act of 2019 

17 or a cosmetic product or cosmetic formulation 

18 that is reformulated after such date of enact19 ment, the responsible person shall— 

20 ‘‘(i) submit to the Secretary a cos21 metic ingredient statement prior to first 

22 marketing the new cosmetic product, new 

23 cosmetic formulation, or the reformulated 

24 cosmetic product or reformulated cosmetic 

25 formulation; and 


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1 ‘‘(ii) beginning one year after the in2 gredient statement is submitted under 

3 clause (i), submit to the Secretary annually 

4 thereafter a renewal of such statement 

5 during the first quarter of the fiscal year 

6 for which the cosmetic ingredient state7 ment is applicable, consistent with the re8 quirements in subsection (e). 

9 ‘‘(B) SMALL BUSINESSES.—In the case of 

10 a responsible person that is a small business, 

11 the Secretary shall allow such responsible per12 son to have an additional time period, of a du13 ration to be determined by the Secretary, in 

14 which to submit the first cosmetic ingredient 

15 statement under subparagraph (A). Such re16 sponsible person shall, consistent with the re17 quirements in subsection (e), submit a cosmetic 

18 ingredient statement annually thereafter during 

19 the first quarter of the applicable fiscal year. 

20 ‘‘(C) APPLICABILITY.—In applying sub21 paragraph (A), a cosmetic product or cosmetic 

22 formulation shall not be considered to be first 

23 marketed or reformulated after the date of en24 actment of the Cosmetic Safety Enhancement 


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1 Act of 2019 if the only change in such product 

2 or formulation is— 

3 ‘‘(i) a change in the amount of an ex4 isting ingredient that is previously reported 

5 under subsection (c)(2)(E); or 

6 ‘‘(ii) the addition or subtraction of a 

7 fragrance, flavor, or color, or such other 

8 interchangeable ingredients specified by 

9 the Secretary in regulations or guidance, 

10 previously reported as a potential ingre11 dient under subsection (c)(2). 

12 ‘‘(3) ABBREVIATED RENEWAL.—The Secretary 

13 shall provide for an abbreviated process for the re14 newal of any cosmetic ingredient statement under 

15 this subsection with respect to which there has been 

16 no change since the responsible person submitted the 

17 previous statement. 

18 ‘‘(c) FORMAT; CONTENTS.— 

19 ‘‘(1) FORM.—For each cosmetic ingredient 

20 statement submitted with respect to a cosmetic prod21 uct or cosmetic formulation under this section, such 

22 statement shall be submitted using an electronic for23 mat, in a form specified by the Secretary. 


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1 ‘‘(2) CONTENTS.—Each such cosmetic ingre2 dient statement shall include the following informa3 tion: 

4 ‘‘(A) The unique identifier, assigned under 

5 section 605(h), as applicable, of— 

6 ‘‘(i) the facility or facilities where the 

7 cosmetic product or cosmetic formulation 

8 is manufactured, processed, packed, or 

9 held or, if the same cosmetic product or 

10 cosmetic formulation is manufactured, 

11 processed, packed, or held in more than 

12 one facility, the unique facility identifier of 

13 each facility where it is manufactured, 

14 processed, packed, or held; and 

15 ‘‘(ii) the facility whose name and ad16 dress appear on the label, unless the state17 ment is filed by a contract manufacturer, 

18 described in section 604(6)(B). 

19 ‘‘(B) The brand name and the full name 

20 for the cosmetic product or cosmetic formula21 tion as it appears on the label. 

22 ‘‘(C) The listing number, if any, previously 

23 assigned by the Secretary under subsection (f) 

24 to the cosmetic product or cosmetic formula25 tion. 


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1 ‘‘(D) The applicable cosmetic category for 

2 the cosmetic product or cosmetic formulation. 

3 ‘‘(E) A list of ingredients in the cosmetic 

4 product or cosmetic formulation that— 

5 ‘‘(i) with respect to each such ingre6 dient, the name adopted in regulations pro7 mulgated by the Secretary, if any, or by 

8 the common or usual name of the ingre9 dient; 

10 ‘‘(ii) is consistent with the regulations 

11 promulgated by the Food and Drug Ad12 ministration related to cosmetic labeling 

13 requirements; and 

14 ‘‘(iii) contains a list of fragrances, fla15 vors, and colors that may be included in 

16 the product, interchangeably, which shall 

17 include— 

18 ‘‘(I) in the case of fragrances, 

19 each fragrance allergen contained in 

20 the cosmetic product as described in 

21 section 615, and for fragrances that 

22 are purchased from a fragrance sup23 plier, the fragrances shall be identified 

24 by the name or code provided by the 

25 supplier, and include the name and 


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1 contact information for the fragrance 

2 supplier; and 

3 ‘‘(II) in the case of flavors that 

4 are purchased from a flavor supplier, 

5 the flavors shall be identified by the 

6 name or code provided by the sup7 plier, and include the name and con8 tact information for the flavor sup9 plier; 

10 ‘‘(iv) other appropriate interchange11 able ingredients as the Secretary may 

12 specify in regulations or guidance that may 

13 be included in the product; and 

14 ‘‘(v) in the case of an ingredient 

15 (other than a fragrance, flavor, or color) 

16 that has been designated for review under 

17 section 608, includes potential ranges and 

18 amounts of such ingredient. 

19 ‘‘(F) The title and full contact information 

20 of each individual submitting the statement. 

21 ‘‘(G) If applicable, information on labeling 

22 required under section 614. 

23 ‘‘(H) Such additional information per24 taining to the cosmetic product as the Secretary 

25 may require by regulation. 


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1 ‘‘(3) CONFIDENTIALITY.—Fragrance ingredi2 ents included in a cosmetic ingredient statement 

3 under paragraph (2)(E), other than fragrance aller4 gens, shall be treated as confidential commercial or 

5 trade secret information. 

6 ‘‘(4) CONTRACT MANUFACTURING ORGANIZA7 TION FACILITIES.—If a facility manufactures or 

8 processes cosmetic products or cosmetic formulations 

9 on behalf of an owner, operator, or agent in charge 

10 whose name appears on the label of such products 

11 or formulations, the Secretary shall require only a 

12 single cosmetic ingredient statement for such cos13 metic product. Such single cosmetic ingredient state14 ment shall be submitted to the Secretary by the re15 sponsible person. 

16 ‘‘(5) COSMETIC INGREDIENT STATEMENT FOR

17 CERTAIN SMALL BUSINESSES.— 

18 ‘‘(A) IN GENERAL.—Notwithstanding any 

19 other provision of this subsection, in the case of 

20 a responsible person that has had an average of 

21 less than $1,000,000 in annual domestic cos22 metic sales over the previous 3 years, the Sec23 retary may allow such responsible person— 


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1 ‘‘(i) to submit a simplified cosmetic 

2 ingredient statement under this section; 

3 and 

4 ‘‘(ii) an additional time period, of a 

5 duration to be determined by the Sec6 retary, in which to submit such simplified 

7 cosmetic ingredient statement. 

8 ‘‘(B) CONTENTS.—A responsible person 

9 described in subparagraph (A) shall include in 

10 each cosmetic ingredient statement submitted 

11 under this section, at a minimum— 

12 ‘‘(i) a list of ingredients in the cos13 metic product or cosmetic formulation, in14 cluding any fragrance allergens as de15 scribed in section 615; 

16 ‘‘(ii) the applicable cosmetic category 

17 for the cosmetic product or cosmetic for18 mulation; and 

19 ‘‘(iii) in the case of a cosmetic product 

20 or cosmetic formulation that includes a 

21 fragrance or flavor purchased from a fra22 grance or flavor supplier, the contact infor23 mation for the fragrance or flavor supplier, 

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1 dress, telephone number, and electronic 

2 contact information. 

3 ‘‘(d) INCOMPLETE OR INACCURATE COSMETIC IN4 GREDIENT STATEMENT.— 

5 ‘‘(1) IN GENERAL.—Not earlier than 30 days 

6 after providing notice under paragraph (2) and sub7 ject to paragraph (3), the Secretary may nullify a 

8 cosmetic ingredient statement submitted under this 

9 section if the Secretary has reasonable grounds to 

10 believe that, except for minor or immaterial errors, 

11 the cosmetic ingredient statement was not completed 

12 or updated in accordance with this section or other13 wise contains false, incomplete, or inaccurate infor14 mation. 

15 ‘‘(2) NOTICE OF NULLIFICATION.—If the Sec16 retary nullifies a cosmetic ingredient statement 

17 under paragraph (1), the Secretary shall provide to 

18 the responsible person submitting such cosmetic in19 gredient statement under this section notice of any 

20 such nullification, including the basis for such nul21 lification. 

22 ‘‘(3) TIMELY UPDATE OR CORRECTION.—In the 

23 case of a cosmetic ingredient statement with respect 

24 to which the Secretary has provided notice under 

25 paragraph (2), the Secretary shall not nullify such 


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1 cosmetic ingredient statement if the cosmetic ingre2 dient statement is appropriately updated or cor3 rected not later than 10 days after the date on 

4 which such notice is provided. 

5 ‘‘(4) EFFECT OF NULLIFICATION.—No person 

6 shall import, export, or otherwise distribute any cos7 metic product or cosmetic formulation that is the 

8 subject of a cosmetic ingredient statement that is 

9 nullified under this subsection. 

10 ‘‘(e) ADDITIONAL REQUIREMENTS.— 

11 ‘‘(1) SAFETY REQUIREMENTS.—In submitting a 

12 cosmetic ingredient statement for each cosmetic 

13 product or cosmetic formulation under this section, 

14 a responsible person shall include an attestation that 

15 the safety of the product or formulation, including 

16 the individual ingredients of such product or formu17 lation, has been substantiated in accordance with 

18 section 609. 

19 ‘‘(2) CHANGES TO INFORMATION.—Not later 

20 than 90 days after any change to the information re21 quired to be in a cosmetic ingredient statement 

22 under this section, the responsible person shall no23 tify the Secretary of such change, including the dis24 continuation of the manufacture of a cosmetic prodVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 uct. Such notification is not required for a change 

2 described in subsection (b)(2)(C). 

3 ‘‘(f) COSMETIC PRODUCTS LIST.— 

4 ‘‘(1) LISTING NUMBER.—At the time of the ini5 tial submission of any cosmetic ingredient statement 

6 under this section, the Secretary shall— 

7 ‘‘(A) assign a unique cosmetic product list8 ing number to the cosmetic ingredient state9 ment; and 

10 ‘‘(B) provide such number to the respon11 sible person who submitted such statement in 

12 writing. 

13 ‘‘(2) COSMETIC PRODUCTS LIST.—Using cos14 metic ingredient statements submitted under this 

15 section, the Secretary shall— 

16 ‘‘(A) compile and maintain a list of cos17 metic products or cosmetic formulations distrib18 uted in the United States, including the ingre19 dients of each such product or formulation; and 

20 ‘‘(B) upon request of any State, shall make 

21 such list available to such State. 

22 ‘‘(3) CONFIDENTIALITY.—Information disclosed 

23 to a State that is exempt from disclosure under sec24 tion 552(b)(4) of title 5, United States Code, shall 

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1 mation by the State. Such State and its employees 

2 in possession of such information shall be subject to 

3 the same laws governing information disclosure as 

4 employees of the Food and Drug Administration. 

5 ‘‘(g) EXEMPTION.—A responsible person shall be ex6 empt from the requirements of this section if such person 

7 has had an average of less than $500,000 in annual do8 mestic cosmetic product sales over the previous three 

9 years. Such exemption shall not apply to cosmetic prod10 ucts that are intended to be injected under the skin or 

11 into the eye, including tattoo ink, or ingredients selected 

12 by the Food and Drug Administration for review under 

13 section 608 if such ingredient is included in a cosmetic 

14 product or cosmetic formulation distributed by such per15 son described. 

16 ‘‘SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC 

17 INGREDIENT STATEMENT. 

18 ‘‘(a) SUSPENSION OF REGISTRATION OF A FACIL19 ITY.—If the Secretary determines that a cosmetic product 

20 or cosmetic formulation manufactured, processed, packed, 

21 or held by a facility registered under section 605 has a 

22 reasonable probability of causing serious adverse health 

23 consequences or death to humans, the Secretary may sus24 pend the registration of such facility. 


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1 ‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATE2 MENT.—If the Secretary determines that a cosmetic prod3 uct or cosmetic formulation manufactured in a registered 

4 facility has a reasonable probability of causing serious ad5 verse health consequences or death to humans, the Sec6 retary may suspend the cosmetic ingredient statement of 

7 that product or formulation. 

8 ‘‘(c) NOTICE OF SUSPENSION.—Before suspending 

9 the registration of a facility or a cosmetic ingredient state10 ment under this section, the Secretary shall provide— 

11 ‘‘(1) notice to the facility or responsible person, 

12 as appropriate, of the intent to suspend such reg13 istration or the cosmetic ingredient statement, which 

14 shall specify the basis of the determination by the 

15 Secretary for that suspension; and 

16 ‘‘(2) an opportunity, within 2 business days of 

17 the notice provided under paragraph (1), for the fa18 cility or responsible person that is the subject of 

19 such notice, as appropriate, to address the reasons 

20 for possible suspension of the registration of the fa21 cility or cosmetic ingredient statement. 

22 ‘‘(d) REINSTATEMENT.—Upon a determination by 

23 the Secretary that adequate grounds do not exist to con24 tinue the suspension actions under subsection (a) or (b), 

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1 instate the registration of the facility or the cosmetic in2 gredient statement. 

3 ‘‘(e) EFFECT OF SUSPENSION.—If the registration of 

4 a facility is suspended under this section, no person shall 

5 import or export cosmetics or otherwise distribute cos6 metic products or cosmetic formulations from such facil7 ity. 

8 ‘‘(f) NO DELEGATION.—The authority conferred by 

9 this section to issue an order to suspend a registration 

10 or vacate an order of suspension shall not be delegated 

11 to any officer or employee other than the Commissioner.’’. 

12 SEC. 102. REVIEW OF INGREDIENTS AND NONFUNCTIONAL 

13 CONSTITUENTS; SAFETY OF FINISHED PROD14 UCTS. 

15 (a) AMENDMENTS.—Chapter VI of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

17 amended by section 101, is further amended by adding 

18 at the end the following: 

19 ‘‘SEC. 608. REVIEW OF INGREDIENTS AND NONFUNCTIONAL 

20 CONSTITUENTS. 

21 ‘‘(a) INGREDIENTS AND NONFUNCTIONAL CONSTITU22 ENTS SUBJECT TO REVIEW.— 

23 ‘‘(1) IN GENERAL.—Not later than 3 years 

24 after the date of the enactment of the Cosmetic 

25 Safety Enhancement Act of 2019, the Secretary 


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1 shall review the safety of cosmetic ingredients or 

2 nonfunctional constituents (or categories thereof). 

3 Upon the completion of such review, the Secretary 

4 shall issue an order under subsection (d) with re5 spect to the use of each such ingredient (or a cat6 egory thereof) and presence of each such nonfunc7 tional constituent in cosmetic products or cosmetic 

8 formulations (or a category thereof). 

9 ‘‘(2) INGREDIENTS AND NONFUNCTIONAL CON10 STITUENTS TO BE REVIEWED.—The Secretary shall 

11 select and complete a review, on an ongoing basis, 

12 of cosmetic ingredients or nonfunctional constituents 

13 that were not reviewed in the prior 3 years. Such in14 gredients or nonfunctional constituents, including 

15 any classes of ingredients or nonfunctional constitu16 ents, should be selected after consultation with 

17 stakeholders, including industry and consumer 

18 groups. 

19 ‘‘(3) PROCESS FOR REVIEW.—The Secretary 

20 shall— 

21 ‘‘(A) publish in the Federal Register a list 

22 of the ingredients, nonfunctional constituents 

23 (or categories thereof) identified for review 

24 under paragraph (2); and 


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1 ‘‘(B) open a public docket to solicit public 

2 input and data relevant to the safety of the in3 gredients, nonfunctional constituents (or classes 

4 or categories thereof) so listed for a period of 

5 not less than 60 days. 

6 ‘‘(4) PUBLIC COMMENT.—Comments may be 

7 submitted to the Secretary at any time with respect 

8 to the safety of cosmetic ingredients or nonfunc9 tional constituents (or categories thereof), regardless 

10 of whether such ingredients or constituents (or cat11 egories thereof) have been selected for review under 

12 this subsection. 

13 ‘‘(b) REVIEWED INGREDIENTS AND NONFUNCTIONAL

14 CONSTITUENTS.—The Secretary shall maintain a list, 

15 posted on the internet website of the Food and Drug Ad16 ministration, of each cosmetic ingredient, nonfunctional 

17 constituent, and category of ingredients or nonfunctional 

18 constituents for which final orders have been issued under 

19 subsection (d)(3), and with respect to each such ingredient 

20 or nonfunctional constituent— 

21 ‘‘(1) the finding made for each such ingredient, 

22 nonfunctional constituent, or category under sub23 section (d)(4), as modified by any order under sub24 section (e); and 


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1 ‘‘(2) if applicable, compliance dates that are the 

2 subject of a final order under subsection (d)(3). 

3 ‘‘(c) INITIATIVE OF THE FDA.—The Secretary may, 

4 at any time, propose the issuance of an order on the safety 

5 of a cosmetic ingredient or nonfunctional constituent (or 

6 category thereof) that was not previously listed pursuant 

7 to subsection (a). 

8 ‘‘(d) DETERMINATION ON SAFETY.— 

9 ‘‘(1) PROPOSED ADMINISTRATIVE ORDER.—Fol10 lowing consideration of data and comments to the 

11 public docket opened under subsection (a)(3) and 

12 any other information before the Secretary with re13 spect to the safety of a cosmetic ingredient or non14 functional constituent (or category thereof), the Sec15 retary shall— 

16 ‘‘(A) determine whether there is adequate 

17 evidence to make an initial finding for purposes 

18 of making a determination described in para19 graph (4); 

20 ‘‘(B) if the Secretary determines that there 

21 is adequate evidence to make such a finding, 

22 issue a proposed administrative order con23 taining the Secretary’s initial determination on 

24 the safety of such ingredient or nonfunctional 

25 constituent (or category thereof) as described in 


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1 paragraph (4) and shall post such order on the 

2 internet website of the Food and Drug Admin3 istration, notwithstanding subchapter II of 

4 chapter 5 of title 5, United States Code; and 

5 ‘‘(C) in the case of a proposed administra6 tive order in which the Secretary makes a de7 termination described in subparagraph (B) or 

8 (C) of paragraph (4), include in such order a 

9 compliance date. 

10 ‘‘(2) PUBLIC COMMENT.—The Secretary shall 

11 open a public docket for the submission of public 

12 comments (including comments on whether any pro13 posed compliance date included in such order is fea14 sible)— 

15 ‘‘(A) in the case of a proposed administra16 tive order under paragraph (1), for a period of 

17 not less than 60 days, beginning on the date of 

18 the issuance of the order; or 

19 ‘‘(B) in the case of a final administrative 

20 order under paragraph (3), for a period of not 

21 less than 60 days, beginning on the date that 

22 is at least 60 days before the effective date of 

23 the order. 

24 ‘‘(3) FINAL ADMINISTRATIVE ORDER.—Fol25 lowing the public comment period under paragraph 


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1 (2) and consideration of comments to the public 

2 docket under such paragraph and any other infor3 mation before the Secretary, the Secretary shall— 

4 ‘‘(A) determine whether there is adequate 

5 evidence to make an initial finding for purposes 

6 of making a determination described in para7 graph (4); 

8 ‘‘(B) if the Secretary determines that there 

9 is adequate evidence to make such a final find10 ing, the Secretary shall issue a final administra11 tive order and shall post such order on the 

12 internet website of the Food and Drug Admin13 istration, notwithstanding subchapter II of 

14 chapter 5 of title 5, United States Code; and 

15 ‘‘(C) in the case of a final administrative 

16 order in which the Secretary makes the deter17 mination described in subparagraph (B) or (C) 

18 of paragraph (4), include in such order a com19 pliance date. 

20 ‘‘(4) DETERMINATIONS.—In a proposed admin21 istrative order issued under paragraph (1) or a final 

22 administrative order issued under paragraph (3), as 

23 applicable, the Secretary shall make a determination 

24 that the ingredient or nonfunctional constituent is— 


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1 ‘‘(A) safe in cosmetic products without the 

2 need for specified conditions of use or toler3 ances; 

4 ‘‘(B) safe in cosmetic products under spec5 ified conditions of use or tolerances; or 

6 ‘‘(C) not safe in cosmetic products. 

7 ‘‘(5) CONDITIONS OF USE AND TOLERANCES.— 

8 An order under paragraph (4)(B) shall include such 

9 conditions on the use of an ingredient or such toler10 ances on the presence of a nonfunctional constituent 

11 (or category thereof) as are necessary for the safety 

12 of cosmetic products containing such ingredient or 

13 nonfunctional constituent (or category thereof), in14 cluding— 

15 ‘‘(A) limits on the amount or concentration 

16 of the ingredient or nonfunctional constituent 

17 (or category thereof) that may be present in a 

18 cosmetic product, including limits in products 

19 intended for children, pregnant women, and 

20 other vulnerable populations, and limits on use 

21 near the eye or mucosal membranes; 

22 ‘‘(B) warnings that are necessary or appro23 priate under section 614, including warnings re24 lated to use by children, pregnant women, popu25 lations with high exposure to the ingredient 


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1 (such as workers who are exposed through pro2 duction practices or handling of final products), 

3 or other vulnerable populations, to help ensure 

4 safe use of cosmetic products containing the in5 gredient or nonfunctional constituent (or a cat6 egory thereof); and 

7 ‘‘(C) such other conditions as are nec8 essary for the safety of cosmetic products con9 taining such ingredient or nonfunctional con10 stituent (or category thereof). 

11 ‘‘(6) CONTENTS OF ORDER.—A final adminis12 trative order under this subsection shall— 

13 ‘‘(A) set forth the determination of the 

14 Secretary on safety; 

15 ‘‘(B) include a summary of the valid sci16 entific evidence supporting the determination; 

17 ‘‘(C) include any conditions of use or toler18 ances under paragraph (4)(B); and 

19 ‘‘(D) be effective upon its publication on 

20 the internet website of the Food and Drug Ad21 ministration and shall be considered final agen22 cy action unless a later compliance date is oth23 erwise specified. 

24 ‘‘(e) MODIFICATION OF AN ORDER.—An order issued 

25 under subsection (d) may be modified or revoked by the 


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1 Secretary on the initiative of the Secretary or in response 

2 to a petition. 

3 ‘‘(f) INADEQUATE EVIDENCE.— 

4 ‘‘(1) NOTICE; EXTENSION.—If the Secretary de5 termines that available data and information are not 

6 adequate to make a proposed or final determination 

7 under subsection (d), with respect to the safety of a 

8 cosmetic ingredient or nonfunctional constituent (or 

9 a category thereof), the Secretary shall— 

10 ‘‘(A) publish such determination on the 

11 internet website of the Food and Drug Admin12 istration not later than 180 days after the close 

13 of the relevant comment period for the ingre14 dient or nonfunctional constituent (or category 

15 thereof) under paragraph (2) or (3) of sub16 section (d), as applicable; and 

17 ‘‘(B) include in such publication a notice 

18 providing interested persons an additional 30 

19 days from the date on which the notice is pub20 lished to provide additional data and informa21 tion and an opportunity for a meeting pursuant 

22 to paragraph (2). 

23 ‘‘(2) MEETINGS.—The Secretary may offer a 

24 responsible person of such cosmetic ingredient or 

25 nonfunctional constituent (or category thereof) a 


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1 confidential meeting with respect to a finding under 

2 paragraph (1), to discuss matters relating to the 

3 data and information requirements to support a de4 termination of safety of such ingredient or nonfunc5 tional constituent (or category thereof), which may 

6 involve confidential information. Such meeting 

7 should be convened in a reasonable time period 

8 agreed upon between the responsible person and the 

9 Secretary. 

10 ‘‘(3) DETERMINATION; ORDER.— 

11 ‘‘(A) INADEQUATE DATA AND INFORMA12 TION.—If the Secretary determines that the 

13 available data and information are not adequate 

14 to make a proposed or final determination 

15 under subsection (d) with respect to the safety 

16 of a cosmetic ingredient or nonfunctional con17 stituent (or category thereof), the Secretary 

18 shall— 

19 ‘‘(i) publish such finding on the inter20 net website of the Food and Drug Admin21 istration not later than 180 days after the 

22 close of the relevant comment period for 

23 the ingredient or nonfunctional constituent 

24 (or category thereof) under paragraph (2) 

25 or (3) of subsection (d), as applicable; and 


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1 ‘‘(ii) include in such publication a no2 tice providing interested persons an addi3 tional 30 days from the date on which the 

4 notice is published to provide additional 

5 data and information and an opportunity 

6 for a meeting pursuant to paragraph (2). 

7 ‘‘(B) ADEQUATE DATA AND INFORMA8 TION.—If the Secretary determines, after con9 sidering any additional data and information 

10 submitted pursuant to paragraph (1)(B), that 

11 the available data and information are adequate 

12 to make a determination with respect to the 

13 safety of a cosmetic ingredient or nonfunctional 

14 constituent (or category thereof), the Secretary 

15 shall— 

16 ‘‘(i) in the case of a determination de17 scribed in subparagraph (A) of subsection 

18 (d)(4), within 180 days of the close of the 

19 applicable comment period under sub20 section (d)(2), issue a final administrative 

21 order, with respect to such cosmetic ingre22 dient or nonfunctional constituent (or cat23 egory thereof), in accordance with sub24 section (d)(3); 


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1 ‘‘(ii) in the case of a determination 

2 described in subparagraph (B) of sub3 section (d)(4), within 180 days of the close 

4 of the applicable comment period under 

5 subsection (d)(2), issue a proposed admin6 istrative order, followed by a final adminis7 trative order, with respect to such cosmetic 

8 ingredient or nonfunctional constituent (or 

9 category thereof), in accordance with sub10 section (d)(3); and 

11 ‘‘(iii) in the case of a determination 

12 described in subparagraph (C) of sub13 section (d)(4), within 180 days of the close 

14 of the applicable comment period under 

15 subsection (d)(2), issue a final administra16 tive order, with respect to such cosmetic 

17 ingredient or nonfunctional constituent (or 

18 category thereof), in accordance with sub19 section (d)(3) specifying the date by which 

20 sale of such ingredient or nonfunctional 

21 constituent must cease. 

22 ‘‘(g) SAFETY ASSESSMENT STANDARDS.— 

23 ‘‘(1) IN GENERAL.—In assessing the safety of 

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1 egory thereof) under this section, the Secretary shall 

2 consider— 

3 ‘‘(A) whether there is adequate evidence to 

4 support a reasonable certainty among com5 petent scientists that— 

6 ‘‘(i) in the case of a cosmetic ingre7 dient, the ingredient is not harmful under 

8 the recommended or suggested conditions 

9 of use or customary or usual use; or 

10 ‘‘(ii) in the case of a nonfunctional 

11 constituent, that the nonfunctional con12 stituent is not harmful under the rec13 ommended or suggested tolerance levels or 

14 the level at which it is customarily or usu15 ally present; 

16 ‘‘(B) the probable human exposure to the 

17 ingredient or nonfunctional constituent (or cat18 egory thereof) from expected use in cosmetic 

19 products and cosmetic formulations; 

20 ‘‘(C) the probable cumulative and aggre21 gate effect in humans of relevant exposure to 

22 the ingredient or nonfunctional constituent (or 

23 category thereof) or to any chemically or phar24 macologically related substances from use in 

25 cosmetics or other products with similar routes 


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1 of exposure under recommended or suggested 

2 conditions of use or their customary use, to the 

3 extent adequate data are available for analysis, 

4 and if appropriate, available information on the 

5 total exposure to a cosmetic ingredient or non6 functional constituent from all sources; and 

7 ‘‘(D) whether warnings or recommenda8 tions in a cosmetic product label, as part of any 

9 conditions of use or tolerances imposed by the 

10 Secretary in a determination described in sub11 paragraph (B) of subsection (d)(4), would be 

12 necessary and appropriate to help ensure the 

13 safety of the ingredient or nonfunctional con14 stituent (or category thereof). 

15 ‘‘(2) MINOR ADVERSE REACTIONS.—The Sec16 retary may not consider a cosmetic ingredient or 

17 nonfunctional constituent (or category thereof) 

18 harmful under paragraph (1) solely because it can 

19 cause minor adverse health reactions, such as minor 

20 transient allergic reactions or minor transient skin 

21 irritations, in some users. 

22 ‘‘(3) DATA AND INFORMATION.— 

23 ‘‘(A) REQUIRED INFORMATION.—A deter24 mination that a cosmetic ingredient or nonfunc25 tional constituent (or category thereof) is safe 


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1 in cosmetics under this section shall be based 

2 upon adequate evidence submitted or otherwise 

3 known to the Secretary, which shall include full 

4 reports of all available studies, published or un5 published, that are adequately designed to show 

6 whether the ingredient or nonfunctional con7 stituent is safe. Such studies may include in 

8 vitro and in silico studies and epidemiological 

9 studies, biomonitoring studies, and studies fo10 cused on various points during the lifespan of 

11 the subject, that use scientifically valid method12 ology. 

13 ‘‘(B) ADDITIONAL RELEVANT INFORMA14 TION.—The Secretary shall consider any other 

15 relevant information related to the safety of a 

16 cosmetic ingredient or nonfunctional constituent 

17 (or category thereof), including— 

18 ‘‘(i) adverse event reports; 

19 ‘‘(ii) findings and information from 

20 State, Federal, national, and international 

21 entities and other bodies composed of sci22 entific and medical experts; 

23 ‘‘(iii) if the ingredient or nonfunc24 tional constituent (or category thereof) is 

25 lawfully used or present in other products 


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1 regulated by the Secretary, the scientific 

2 basis for such use; and 

3 ‘‘(iv) experience with the ingredient or 

4 nonfunctional constituent (or category 

5 thereof) in products that are distributed in 

6 the United States or in other countries, if 

7 such experience is well-documented and 

8 has resulted in substantial human exposure 

9 to the ingredient or nonfunctional con10 stituent over time. 

11 ‘‘(h) COAL TAR HAIR DYE.—In assessing for pur12 poses of this section the safety of coal tar hair dye or any 

13 ingredient or nonfunctional constituent therein, the Sec14 retary shall not make a determination that the dye, ingre15 dient, or nonfunctional constituent is not safe for use in 

16 cosmetic products solely because the dye, ingredient, or 

17 nonfunctional constituent can cause allergic reactions. 

18 ‘‘SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS. 

19 ‘‘(a) DETERMINATION.— 

20 ‘‘(1) IN GENERAL.—Each responsible person 

21 for a finished cosmetic product shall, before first dis22 tributing the product for sale, make a written deter23 mination that the product is safe under the condi24 tions of use recommended in the labeling of the 


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1 product. Such determination shall be based on ade2 quate evidence that— 

3 ‘‘(A) each ingredient in the finished prod4 uct is safe for the use recommended or sug5 gested in the labeling of the product and for the 

6 customary or usual use of the product; and 

7 ‘‘(B) the finished product is safe. 

8 ‘‘(2) NEW INFORMATION.—If new information 

9 relevant to the determination becomes available, the 

10 responsible person shall promptly update the deter11 mination to address that information. 

12 ‘‘(b) PRESUMPTION OF ADEQUATE EVIDENCE.— 

13 ‘‘(1) IN GENERAL.—Except as provided in sub14 section (c), a determination made under subsection 

15 (a) with respect to a finished cosmetic product shall 

16 be presumed to be based on adequate evidence if it 

17 is supported by— 

18 ‘‘(A) with respect to each ingredient in the 

19 finished cosmetic product— 

20 ‘‘(i) references to an official statement 

21 by one or more expert medical or scientific 

22 bodies that the ingredient is safe under the 

23 conditions of use recommended or sug24 gested in the product’s labeling or under 


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1 such conditions of use as are customary or 

2 usual; or 

3 ‘‘(ii) appropriate safety testing of the 

4 ingredient; and 

5 ‘‘(B) appropriate safety substantiation of 

6 the finished cosmetic product beyond the safety 

7 substantiation of individual ingredients and 

8 consideration of the combination of ingredients. 

9 ‘‘(2) STATEMENT OF AN EXPERT MEDICAL OR

10 SCIENTIFIC BODY.—For purposes of applying para11 graph (1)(A)(i), a statement of an expert medical or 

12 scientific body is an official statement of that body, 

13 if— 

14 ‘‘(A) the medical or scientific body is a 

15 Federal, State, national, or international entity 

16 with recognized expertise in chemical or cos17 metic safety, or other similarly recognized body 

18 composed of scientific and medical experts; 

19 ‘‘(B) the statement is based upon adequate 

20 data to support the finding of safety, and such 

21 data are available to the Secretary; and 

22 ‘‘(C) the statement is published and en23 dorsed by the medical or scientific body and is 

24 not a statement of an employee of such body 

25 made in the individual capacity of the employee. 


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1 ‘‘(c) REBUTTAL OF PRESUMPTION.—Notwithstand2 ing subsection (b), a determination under subsection (a) 

3 will not be presumed to be based on adequate evidence 

4 if— 

5 ‘‘(1) the Secretary issues an order under section 

6 608 that an ingredient or nonfunctional constituent 

7 in the finished product is not safe under the prod8 uct’s conditions of use or customary or usual use; or 

9 ‘‘(2) the Secretary has provided the manufac10 turer with notice that— 

11 ‘‘(A) the manufacturer has not met the cri12 teria under subsection (b); or 

13 ‘‘(B) the Secretary has information that 

14 raises significant questions about the safety of 

15 the product or any of its ingredients. 

16 ‘‘(d) TIMELY UPDATE.—Upon notice of inadequate 

17 evidence under subsection (c), the responsible person shall 

18 have 10 days to submit additional evidence to the Sec19 retary regarding the safety of an ingredient, nonfunctional 

20 constituent, or the entire cosmetic product, and the Sec21 retary shall have 30 days from the date of receipt of such 

22 additional evidence to provide the responsible person with 

23 notice that the criteria under subsection (b) have been met 

24 or not met. 


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1 ‘‘(e) RECORDS MAINTENANCE.—The responsible per2 son shall maintain records documenting the determination 

3 required under this section and the information on which 

4 it is based until 5 years after the finished product is no 

5 longer marketed. 

6 ‘‘(f) SUBMISSION OF RECORDS.— 

7 ‘‘(1) IN GENERAL.—The records required under 

8 subsection (e) shall, upon the written request of the 

9 Secretary to the responsible person, be provided to 

10 the Secretary within a reasonable timeframe not to 

11 exceed 30 days, in electronic form. 

12 ‘‘(2) CRITERIA.—The Secretary may require 

13 records under paragraph (1) if— 

14 ‘‘(A) the Secretary has a reasonable belief, 

15 described in written notice, that— 

16 ‘‘(i) the finished product may be 

17 harmful based on adverse event reports or 

18 other scientific information; 

19 ‘‘(ii) scientific information raises cred20 ible and relevant questions about the safe21 ty of the product or any of its ingredients; 

22 ‘‘(iii) the determination required 

23 under subsection (a) is not supported by 

24 adequate evidence; or 


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1 ‘‘(iv) one or more of the criteria to es2 tablish a presumption of adequate evidence 

3 of safety in subsection (b) has not been 

4 satisfied; 

5 ‘‘(B) the Secretary, an expert regulatory 

6 body, or an expert body composed of scientific 

7 and medical experts finds an ingredient in the 

8 product to be unsafe under the conditions of 

9 use of the product; or 

10 ‘‘(C) the Secretary concludes that submis11 sion of the records will serve the public health 

12 or otherwise enable the Secretary to fulfill the 

13 cosmetic safety purposes of this section. 

14 ‘‘(g) GUIDANCE AND REGULATIONS.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall issue 

16 guidance describing the evidence necessary to sup17 port a determination under subsection (a), and may, 

18 by regulation, establish exemptions to the require19 ments of this section, if the Secretary determines 

20 that such exemptions are supported by adequate evi21 dence and would have no adverse effect on public 

22 health. 

23 ‘‘(2) SMALL BUSINESSES.—The Secretary shall, 

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1 metics, provide additional guidance for small busi2 nesses on compliance with the requirements of this 

3 section. Such guidance shall include specific exam4 ples of options for compliance that do not place an 

5 undue burden on small businesses.’’. 

6 (b) EFFECTIVE DATE.—Section 609 of the Federal 

7 Food, Drug, and Cosmetic Act, as added by subsection 

8 (a), shall take effect 180 days after the date of enactment 

9 of this Act. 

10 (c) PUBLIC MEETING AND GUIDANCE.— 

11 (1) PUBLIC MEETING.—Not later than 12 

12 months after the date of the enactment of this Act, 

13 the Secretary of Health and Human Services (in this 

14 subsection referred to as the ‘‘Secretary’’) shall con15 vene a public meeting to describe and solicit public 

16 input regarding the ingredient review process under 

17 section 608 of the Federal Food, Drug, and Cos18 metic Act (as added by subsection (a)). Such meet19 ing shall include representatives from the cosmetics 

20 industry, medical practitioners and scientific experts 

21 with cosmetic expertise, and consumer and public 

22 health advocacy organizations. 

23 (2) GUIDANCE.—Not less than one year after 

24 the public meeting conducted under paragraph (1), 

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1 ments to implement section 608 of the Federal 

2 Food, Drug, and Cosmetic Act (as added by sub3 section (a)). Such guidance documents shall include 

4 information regarding— 

5 (A) the types of scientific evidence, clinical 

6 studies, data, or other information needed to 

7 support the review of cosmetic ingredients or 

8 nonfunctional constituents (or categories there9 of) selected for review under such section; 

10 (B) the recommended format in which to 

11 submit to the Secretary such data and informa12 tion, including any applicable foreign data and 

13 information, related to a cosmetic ingredient or 

14 nonfunctional constituent (or category thereof) 

15 that has been selected for such review; 

16 (C) the manner and the number of days by 

17 which the Secretary intends to review and re18 spond to such data and information, including 

19 with respect to providing a scientific rationale 

20 for any additional data and information; 

21 (D) the process for communication be22 tween the Secretary and industry related to an 

23 ingredient or nonfunctional constituent (or a 

24 category thereof) that has been selected for re25 view; and 


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1 (E) includes such other information as the 

2 Secretary determines appropriate. 

3 (3) TIMING.—Not later than 24 months after 

4 the date of the enactment of this Act, the Secretary 

5 shall issue draft guidance under paragraph (1) on 

6 the implementation of section 608 of the Federal 

7 Food, Drug, and Cosmetic Act (as added by sub8 section (a)). The Secretary shall issue final guidance 

9 on the implementation of such section not later than 

10 6 months after the date on which the comment pe11 riod for the draft guidance closes. 

12 (d) GAO STUDY.—Not later than 6 years after the 

13 date of the enactment of this Act, the Comptroller General 

14 of the United States shall submit to the Committee on 

15 Energy and Commerce of the House of Representatives 

16 and the Committee on Health, Education, Labor, and 

17 Pensions of the Senate a report addressing the effective18 ness and overall impact of the ingredient review program 

19 established under section 608 of the Federal Food, Drug, 

20 and Cosmetic Act (as added by subsection (a)), including 

21 with respect to its impact on the safety of cosmetic ingre22 dients— 

23 (1) for each ingredient or nonfunctional con24 stituent (or category thereof) selected for review— 


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1 (A) whether the ingredient or nonfunc2 tional constituent (or category thereof) was de3 termined— 

4 (i) to be safe in cosmetic products 

5 without the need for specified conditions of 

6 use or tolerances; 

7 (ii) to be safe in cosmetic products 

8 under specified conditions of use of toler9 ances; or 

10 (iii) to be not safe in cosmetic prod11 ucts; 

12 (B) the timeline for such review; 

13 (C) the types of scientific evidence, clinical 

14 studies, data, or other information used to 

15 make such a determination; 

16 (D) whether, and to what extent, the re17 view of the ingredient or nonfunctional con18 stituent (or category thereof) resulted in cos19 metic products being reformulated or removed 

20 from the market; and 

21 (E) the impact the review and determina22 tion had on consumer use and access to such 

23 product; and 


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1 (2) an analysis of the ingredient, nonfunctional 

2 constituent (or category thereof) review conducted 

3 under such section 608, including— 

4 (A) the resources used by the Secretary in 

5 reviewing ingredients and nonfunctional con6 stituents (or categories thereof), including the 

7 effects of the program on other cosmetic safety 

8 activities of the Secretary; 

9 (B) the impact of such section on innova10 tion and consumer access to cosmetic products; 

11 and 

12 (C) whether any improvements to the pro13 gram under such section 608 are necessary for 

14 increasing the efficiency and effectiveness of the 

15 review of cosmetic ingredients, nonfunctional 

16 constituents, or categories thereof. 

17 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS18 METICS. 

19 (a) IN GENERAL.—Chapter VI of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

21 amended by section 102, is further amended by adding 

22 at the end the following: 

23 ‘‘SEC. 610. GOOD MANUFACTURING PRACTICES FOR COS24 METICS. 

25 ‘‘(a) IN GENERAL.—The Secretary shall— 


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1 ‘‘(1) review national and international stand2 ards for cosmetic good manufacturing practices that 

3 are in effect on the date of enactment of the Cos4 metic Safety Enhancement Act of 2019; and 

5 ‘‘(2) issue a rule establishing current good man6 ufacturing standards consistent, to the extent the 

7 Secretary determines practicable and appropriate, 

8 with such national and international standards. 

9 ‘‘(b) CONTENT OF REGULATIONS.—The regulations 

10 issued pursuant to subsection (a)(2)— 

11 ‘‘(1) may specify requirements for the use of 

12 certain analytical or recordkeeping methods by a 

13 manufacturer as may be necessary to ensure that a 

14 cosmetic product or cosmetic formulation is not inju15 rious to health under the recommended or suggested 

16 conditions of use, or customary or usual use of the 

17 product or formulation; and 

18 ‘‘(2) shall not— 

19 ‘‘(A) impose standards for which there is 

20 no current and generally available analytic 

21 method; or 

22 ‘‘(B) apply to facilities meeting the criteria 

23 to be considered a facility under section 604(6), 

24 including retail stores or counters offering cus25 tomized or personalized cosmetics to consumers, 


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1 or to entities that are in compliance with the 

2 good manufacturing practice regulations speci3 fied in parts 210 and 211 of title 21, Code of 

4 Federal Regulations (or any successor regula5 tions). 

6 ‘‘(c) TIMEFRAME.—The Secretary shall publish a 

7 proposed rule described in subsection (a) not later than 

8 24 months after the date of enactment of the Cosmetic 

9 Safety Enhancement Act of 2019 and shall publish a final 

10 such rule not later than 36 months after such date of en11 actment.’’. 

12 (b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR13 ERS.—Regulations issued pursuant to section 610 of the 

14 Federal Food, Drug, and Cosmetic Act (as added by sub15 section (a)) shall apply with respect to— 

16 (1) large manufacturers (as defined in section 

17 744L of such Act (as added by section 202 of this 

18 Act)), beginning 180 days after the date on which 

19 the final rule described in subsection (a) is effective; 

20 (2) midsize manufacturers (as defined in sec21 tion 744L of such Act (as added by section 202 of 

22 this Act)), beginning 210 days after such date; and 

23 (3) small manufacturers (as defined in section 

24 744L of such Act (as added by section 202 of this 

25 Act)), beginning 2 years after such date. 


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1 (c) ENFORCEMENT.—Section 601 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amend3 ed by adding at the end the following: 

4 ‘‘(f) If the methods used in, or the facilities or con5 trols used for, its manufacture, processing, packing, or 

6 holding do not conform to current good manufacturing 

7 practice, as prescribed by the Secretary.’’. 

8 SEC. 104. ADVERSE EVENT REPORTS. 

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

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

11 103(a), is further amended by adding at the end the fol12 lowing: 

13 ‘‘SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS. 

14 ‘‘(a) SUBMISSION OF SERIOUS ADVERSE EVENT RE15 PORTS.— 

16 ‘‘(1) IN GENERAL.—With respect to any cos17 metic product distributed in the United States, the 

18 responsible person shall submit, not later than 15 

19 days after the receipt by the responsible person, 

20 using an electronic system developed under sub21 section (b), to the Secretary any report of a serious 

22 adverse event associated with the use of the cosmetic 

23 product, accompanied by a copy of the label on or 

24 with the retail packaging of the cosmetic product. 


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1 ‘‘(2) NEW MEDICAL INFORMATION.—During the 

2 12-month period following the submission of a seri3 ous adverse event report under paragraph (1), with 

4 respect to any cosmetic product distributed in the 

5 United States, the responsible person shall submit, 

6 not later than 15 days after the receipt by the re7 sponsible person, using an electronic system devel8 oped under subsection (b), to the Secretary any new 

9 medical information related to such serious adverse 

10 event report that is received by the responsible per11 son. 

12 ‘‘(3) PUBLICATION.—The Secretary shall make 

13 publicly available on the internet website of the Food 

14 and Drug Administration reports submitted under 

15 paragraph (1). 

16 ‘‘(4) NO DUPLICATION.—In the case of cos17 metic product that is also a drug for which a serious 

18 adverse event report is filed using Form FDA 

19 3500A (or any successor form developed for such 

20 purpose) or its electronic equivalent for over-the21 counter drugs, the responsible person shall not be 

22 required to submit a serious adverse event report 

23 under paragraph (1) with respect to that cosmetic 

24 product. 


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1 ‘‘(b) REQUIREMENTS FOR SERIOUS ADVERSE EVENT

2 REPORTS.— 

3 ‘‘(1) ELECTRONIC SYSTEM.— 

4 ‘‘(A) IN GENERAL.—The Secretary shall, 

5 not later than 1 year after the date of enact6 ment of the Cosmetic Safety Enhancement Act 

7 of 2019, develop and implement an electronic 

8 system for use for the submission of serious ad9 verse event reports under this section. 

10 ‘‘(B) MODIFICATION.—The format of the 

11 electronic system developed and implemented 

12 under paragraph (1) may be modified by the 

13 Secretary and the reports may include addi14 tional information. The Secretary may, in guid15 ance, further specify the format and contents of 

16 required reports. 

17 ‘‘(2) CONTENT OF REPORTS.—A serious ad18 verse event report submitted under paragraph (1) of 

19 subsection (a) shall include all information sub20 mitted with the initial report and any information 

21 subsequently added to such report pursuant to para22 graph (2) of such subsection and— 

23 ‘‘(A) any report by the responsible person 

24 under section 756 with respect to the safety of 


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1 the cosmetic product that is the subject of the 

2 report; 

3 ‘‘(B) information on the individual or indi4 viduals with respect to whom the adverse event 

5 report is submitted, in accordance with the dis6 closure requirements of section 552a of title 5, 

7 United States Code; 

8 ‘‘(C) notwithstanding section 552(b)(6) of 

9 title 5, United States Code, medical (or similar) 

10 documentation of the serious adverse event that 

11 is the subject of the report, with all personally 

12 identifiable information redacted; and 

13 ‘‘(D) contact information for the individual 

14 or individuals reporting the serious adverse 

15 event. 

16 ‘‘(3) RESPONSIBILITY TO GATHER INFORMA17 TION.—After an individual initiates the reporting of 

18 a serious adverse event, the responsible person for 

19 the cosmetic product shall actively gather all of the 

20 information reasonably available to such person to 

21 complete and file the report with the Secretary 

22 under subsection (a)(1). 

23 ‘‘(4) NO ADVERSE EVENTS TO REPORT.—The 

24 Secretary shall provide an option as part of the elec25 tronic registration process for the responsible person 


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1 to indicate if such responsible person had no adverse 

2 events to report over the previous year. With respect 

3 to a responsible person who received no adverse 

4 event reports for a year, the annual adverse event 

5 report requirement may be met by indicating no 

6 such events on the annual registration form. 

7 ‘‘(5) EXEMPTION.—The Secretary may estab8 lish by regulation an exemption to any of the re9 quirements under this section if the Secretary deter10 mines that such exemption is supported by adequate 

11 evidence and would have no adverse effect on public 

12 health. 

13 ‘‘(c) REQUIREMENTS FOR OTHER ADVERSE EVENT

14 REPORTS.— 

15 ‘‘(1) IN GENERAL.—Each responsible person 

16 shall maintain records related to each report of an 

17 adverse event (including serious adverse events) as18 sociated with each cosmetic product marketed by 

19 such responsible person and received by such respon20 sible person for a period of 6 years. Such records 

21 shall be made available to an officer or an employee 

22 duly designated by the Secretary upon request, at 

23 reasonable times and within reasonable limits and in 

24 a reasonable manner, including allowing electronic 

25 access and to copy such records. 


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1 ‘‘(2) CONTENT.—Records required to be main2 tained under this paragraph shall contain all infor3 mation reasonably available, including— 

4 ‘‘(A) a summary of all adverse events re5 ceived during the calendar year for each cos6 metic product marketed; 

7 ‘‘(B) a complete list of individual reports 

8 of adverse events for each cosmetic product 

9 marketed and with respect to each such event, 

10 the same information required to be included in 

11 a report with respect to a serious adverse event 

12 under subsection (b)(2), subject to the same 

13 conditions with respect to the disclosure of such 

14 information; 

15 ‘‘(C) an estimate of the total number of 

16 product units estimated to have been distrib17 uted to consumers during the period specified 

18 in paragraph (1); and 

19 ‘‘(D) such other information as may be 

20 specified in regulation or guidance issued by the 

21 Secretary. 

22 ‘‘(3) RULE OF CONSTRUCTION.—This section 

23 shall not be construed to require the inclusion in any 

24 report under this section any consumer complaint 


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1 that concerns solely efficacy and does not contain 

2 any information about an adverse event. 

3 ‘‘(d) LIMITATION WITH RESPECT TO ADVERSE

4 EVENT REPORTS.— Section 756 shall apply with respect 

5 to the submission of an adverse event report in compliance 

6 with subsection (a). 

7 ‘‘(e) CONTACT INFORMATION.—The label of a cos8 metic product shall bear the domestic address, and either 

9 the domestic telephone number or electronic contact infor10 mation, through which the responsible person may receive 

11 a report of an adverse event. 

12 ‘‘(f) AVAILABILITY TO STATES.—The Secretary shall 

13 make records submitted under this section available to any 

14 State, upon request, to the extent permissible under the 

15 laws governing disclosure of information by the Secretary. 

16 Information disclosed to a State that is exempt from dis17 closure under section 552(b)(4) of title 5, United States 

18 Code, shall be treated as a trade secret and confidential 

19 information by the State. Such State and its employees 

20 in possession of such information shall be subject to the 

21 same laws governing information disclosure as employees 

22 of the Food and Drug Administration. 

23 ‘‘(g) PROTECTION OF INFORMATION.—A serious ad24 verse event report submitted to the Secretary under sub25 section (a), including any new medical information subVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 mitted under paragraph (2) of such subsection, or an ad2 verse event report voluntarily submitted to the Secretary, 

3 shall be considered to be a safety report under section 756 

4 and may be accompanied by a statement, which shall be 

5 a part of any report that is released for public disclosure, 

6 that denies that the report or the records constitute an 

7 admission that the product involved caused or contributed 

8 to the adverse event. 

9 ‘‘(h) EFFECTIVE DATES.— 

10 ‘‘(1) SERIOUS ADVERSE EVENTS.—The require11 ment under this section to report serious adverse 

12 events shall become effective on the date that the 

13 Secretary publicizes the availability of the electronic 

14 system described in subsection (b)(1). 

15 ‘‘(2) OTHER ADVERSE EVENTS.—The require16 ment under this section to maintain records relating 

17 to adverse events which are not serious adverse 

18 events shall become effective 18 months after the 

19 date of the enactment of the Cosmetic Safety En20 hancement Act of 2019. 

21 ‘‘(i) DEFINITIONS.—In this section: 

22 ‘‘(1) ADVERSE EVENT.—The term ‘adverse 

23 event’ means, with respect to a cosmetic product, a 

24 health-related or medical event associated with the 

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1 jury. Such term does not include any instance of a 

2 consumer complaint that such product did not work 

3 as advertised or marketed. 

4 ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘se5 rious adverse event’ means, with respect to a cos6 metic product, an adverse event that— 

7 ‘‘(A) results in— 

8 ‘‘(i) death; 

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

10 ‘‘(iii) inpatient hospitalization; 

11 ‘‘(iv) a persistent or significant ad12 verse health condition, disability, or inca13 pacity; 

14 ‘‘(v) congenital anomaly or birth de15 fect; or 

16 ‘‘(vi) significant disfigurement, includ17 ing serious or persistent rashes and infec18 tions, burns, or significant hair loss; or 

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

20 judgment, a medical or surgical intervention to 

21 prevent an outcome described in subparagraph 

22 (A).’’. 


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1 SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU2 THORITY. 

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

4 Act (21 U.S.C. 361 et seq.), as amended by section 104, 

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

6 ‘‘SEC. 612. INSPECTION OF COSMETIC RECORDS. 

7 ‘‘(a) INSPECTION OF RECORDS.—Each facility, in8 cluding a facility owned or operated by a responsible per9 son for a cosmetic product shall, at the request of an offi10 cer or employee duly designated by the Secretary, permit 

11 such officer or employee, upon presentation of appropriate 

12 credentials and written notice to such person, at reason13 able times and within reasonable limits and in a reason14 able manner, to have access to and copy, or receive elec15 tronically records maintained by or on behalf of such per16 son in any format (including paper and electronic formats) 

17 and at any location, including— 

18 ‘‘(1) all records maintained under section 611 

19 and in accordance with the rules promulgated by the 

20 Secretary under section 610, as applicable; 

21 ‘‘(2) all records maintained under section 609; 

22 ‘‘(3) any records relating to the list of ingredi23 ents in specific fragrances or flavors of a cosmetic 

24 product or cosmetic formulation, if requested by the 

25 Secretary by means of a written notification; and 


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1 ‘‘(4) except as provided in subsection (b), all 

2 other records relating to the cosmetic product or 

3 cosmetic formulation and to any other cosmetic 

4 product or cosmetic formulation the Secretary rea5 sonably believes is likely to be affected in a similar 

6 manner, if the Secretary— 

7 ‘‘(A) has a reasonable belief that the cos8 metic product or cosmetic formulation— 

9 ‘‘(i) is adulterated; 

10 ‘‘(ii) has caused a reportable serious 

11 adverse event; or 

12 ‘‘(iii) contains an ingredient for which 

13 new scientific information shows may be 

14 unsafe when present in a cosmetic product 

15 or cosmetic formulation; and 

16 ‘‘(B) provides written notice to the respon17 sible person of the basis for the Secretary’s rea18 sonable belief described in subparagraph (A), as 

19 applicable. 

20 ‘‘(b) EXCLUSIONS.— 

21 ‘‘(1) IN GENERAL.—No inspection authorized 

22 by this section shall extend to— 

23 ‘‘(A) recipes, financial data, pricing data, 

24 personnel data (other than data as to qualifica25 tion of technical and professional personnel perVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 forming functions subject to this Act), research 

2 data (other than safety data) or sales data 

3 other than shipment and distribution data; or 

4 ‘‘(B) except as provided in paragraph (2), 

5 information related to ingredients in fragrances 

6 or flavors of a cosmetic product or cosmetic for7 mulation. 

8 ‘‘(2) EXCEPTION.—The Secretary may obtain 

9 information related to the ingredients in fragrances 

10 or flavors in an identified cosmetic product or cos11 metic formulation only by a request in a written no12 tification provided to the manufacturer pursuant to 

13 a for-cause inspection. In response to such written 

14 notification, the manufacturer of such fragrance or 

15 flavor shall provide information about the ingredi16 ents in the specified fragrance or flavor that the 

17 Secretary determines is necessary to assist its inves18 tigation, in the manufacturer’s preferred electronic 

19 or written format, to the Secretary upon receipt of 

20 such notification. Any information provided in re21 sponse to such written notification shall be consid22 ered a trade secret under section 301(j) and, not23 withstanding such section, shall only be disclosed if 

24 the Secretary determines such disclosure is nec25 essary to protect the public health. The authority to 


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1 determine such disclosure is necessary to protect the 

2 public health shall not be delegated to any officer or 

3 employee other than the director of the applicable 

4 office. 

5 ‘‘(c) PROTECTION OF SENSITIVE INFORMATION.— 

6 The Secretary shall take appropriate measures to ensure 

7 that there are effective procedures to prevent the unau8 thorized disclosure of any trade secret or confidential in9 formation that is obtained by the Secretary pursuant to 

10 this section. Information disclosed to a State shall be pur11 suant to the laws governing disclosure of information. 

12 Confidential information disclosed to the State that is ex13 empt from disclosure under section 552(b)(4) of title 5, 

14 United States Code, shall be treated as confidential infor15 mation by the State. Such State and its employees in pos16 session of such information under this section shall be sub17 ject to the same laws governing information disclosure as 

18 employees of the Food and Drug Administration. 

19 ‘‘(d) LIMITATIONS.—This section shall not be con20 strued— 

21 ‘‘(1) to limit the authority of the Secretary to 

22 inspect records or to require establishment and 

23 maintenance of records under any other provision of 

24 this Act; or 


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1 ‘‘(2) to require the Secretary to publicly disclose 

2 any information that is exempt from disclosure 

3 under section 522 of title 5, United States Code, or 

4 section 1905 of title 18, United States Code. 

5 ‘‘SEC. 613. MANDATORY RECALL AUTHORITY. 

6 ‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 

7 determines that there is a reasonable probability that a 

8 cosmetic product is adulterated under section 601 or mis9 branded under section 602 and the use of, and exposure 

10 to, such cosmetic product is likely to cause serious adverse 

11 health consequences or death, the Secretary shall provide 

12 the responsible person with an opportunity to voluntarily 

13 cease distribution and recall such article. 

14 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE

15 DISTRIBUTION AND GIVE NOTICE.— 

16 ‘‘(1) IN GENERAL.—If the domestic responsible 

17 person refuses to or does not voluntarily cease dis18 tribution or recall such cosmetic product within the 

19 time and in the manner prescribed by the Secretary, 

20 the Secretary may order such person to— 

21 ‘‘(A) immediately cease distribution of 

22 such cosmetic product; and 

23 ‘‘(B) as applicable, immediately order all 

24 facilities— 


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1 ‘‘(i) manufacturing, processing, pack2 ing, transporting, holding, receiving, dis3 tributing, or importing and selling such 

4 cosmetic product; and 

5 ‘‘(ii) to which such cosmetic product 

6 has been distributed, transported, or sold, 

7 to immediately cease distribution of such cos8 metic product. 

9 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 

10 ‘‘(A) IN GENERAL.—In the case of a cos11 metic product that is subject to a recall order 

12 issued under paragraph (1)(B) with respect to 

13 which the responsible person, before the 

14 issuance of such order, distributed to a ware15 house-based, third-party logistics provider with16 out providing such logistics provider with suffi17 cient information to know or reasonably deter18 mine the precise identity of such cosmetic prod19 uct, the notice provided by the domestic respon20 sible person pursuant to such order shall in21 clude such information as is necessary for the 

22 logistics provider to identify the cosmetic prod23 uct. 

24 ‘‘(B) RULES OF CONSTRUCTION.—Nothing 

25 in this paragraph shall be construed to exempt 


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1 a warehouse-based, third-party logistics pro2 vider from— 

3 ‘‘(i) the requirements of this chapter, 

4 including the requirements of this section 

5 and section 612; or 

6 ‘‘(ii) being the subject of a mandatory 

7 recall order under this section. 

8 ‘‘(3) DETERMINATION TO LIMIT AREAS AF9 FECTED.—If the Secretary requires a domestic re10 sponsible person to cease distribution under para11 graph (1)(A) of a cosmetic product, the Secretary 

12 may limit the size of the geographic area and the 

13 markets affected by such cessation if such limitation 

14 would not compromise the public health. 

15 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro16 vide the responsible person subject to an order under sub17 section (b) with an opportunity for an informal hearing, 

18 to be held as soon as possible, but not later than 2 days 

19 after the issuance of the order, on the actions required 

20 by the order and on why the cosmetic product that is the 

21 subject of the order should not be recalled. 

22 ‘‘(d) POSTHEARING RECALL ORDER AND MODIFICA23 TION OF ORDER.— 

24 ‘‘(1) AMENDMENT OF ORDER.—If, after pro25 viding opportunity for an informal hearing under 


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1 subsection (c), the Secretary determines that re2 moval of the cosmetic product from commerce is 

3 necessary, the Secretary shall, as appropriate— 

4 ‘‘(A) amend the order to require recall of 

5 such cosmetic product or other appropriate ac6 tion; 

7 ‘‘(B) specify a timetable in which the recall 

8 shall occur; 

9 ‘‘(C) require periodic reports to the Sec10 retary describing the progress of the recall; and 

11 ‘‘(D) provide notice to consumers to whom 

12 such cosmetic product was, or may have been, 

13 distributed. 

14 ‘‘(2) VACATING OF ORDER.—If, after such hear15 ing, the Secretary determines that adequate grounds 

16 do not exist to continue the actions required by the 

17 order, or that such actions should be modified, the 

18 Secretary shall vacate the order or modify the order. 

19 ‘‘(e) COOPERATION AND CONSULTATION.—The Sec20 retary shall work with State and local public health offi21 cials in carrying out this section, as appropriate. 

22 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 

23 under this section, the Secretary shall— 

24 ‘‘(1) ensure that a press release is published re25 garding the recall, and that alerts and public notices 


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1 are issued, as appropriate, in order to provide notifi2 cation— 

3 ‘‘(A) of the recall to consumers and retail4 ers to whom such cosmetic product was, or may 

5 have been, distributed; and 

6 ‘‘(B) that includes, at a minimum— 

7 ‘‘(i) the name of the cosmetic product 

8 subject to the recall; 

9 ‘‘(ii) a description of the risk associ10 ated with the use of such cosmetic product; 

11 and 

12 ‘‘(iii) to the extent practicable, infor13 mation for consumers about similar cos14 metic products that are not affected by the 

15 recall; and 

16 ‘‘(2) ensure publication on the internet website 

17 of the Food and Drug Administration of an image 

18 of the cosmetic product that is the subject of the 

19 press release described in paragraph (1), if available. 

20 ‘‘(g) NO DELEGATION.—The authority conferred by 

21 this section to order a recall or vacate a recall order shall 

22 not be delegated to any officer or employee other than the 

23 Commissioner of Food and Drugs. 

24 ‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec25 tion shall affect the authority of the Secretary to request 


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1 or participate in a voluntary recall, or to issue an order 

2 to cease distribution or to recall any article under any 

3 other provision of this Act or under the Public Health 

4 Service Act. 

5 ‘‘(i) DEFINITION.—In this section, the term ‘domestic 

6 responsible person’ means a person who is the domestic 

7 contact for a responsible person.’’. 

8 SEC. 106. LABELING AND INTERNET SALES. 

9 (a) IN GENERAL.—Chapter VI of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

11 amended by section 105, is further amended by adding 

12 at the end the following: 

13 ‘‘SEC. 614. LABELING AND INTERNET SALES. 

14 ‘‘(a) SAFETY REVIEW AND LABELING.—If a warning 

15 or condition of use is required pursuant to section 

16 608(d)(4) to ensure the safe use of a cosmetic ingredient, 

17 the Secretary shall require appropriate labeling of any cos18 metic product that contains such ingredient, including if 

19 such ingredient— 

20 ‘‘(1) is not appropriate for use in the entire 

21 population; or 

22 ‘‘(2) requires warnings that children, pregnant 

23 women, and other vulnerable populations should 

24 limit or avoid using the product. 


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1 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL

2 USE.— 

3 ‘‘(1) LISTING OF INGREDIENTS.—The labeling 

4 of cosmetic products used and sold by professionals 

5 shall list all ingredients, as required for other cos6 metic products pursuant to section 602(g). 

7 ‘‘(2) PROFESSIONAL USE LABELING.—In the 

8 case of a cosmetic product that is intended to be 

9 used only by a professional on account of a specific 

10 ingredient or increased concentration of an ingre11 dient and requires safe handling by trained profes12 sionals, the product shall bear a statement as fol13 lows: ‘For Professional Use Only’. 

14 ‘‘(c) DISPLAY.—A warning required under subsection 

15 (a) and any statement required under subsection (b)(2) 

16 shall be prominently displayed— 

17 ‘‘(1) in the primary language used on the label 

18 or on packaging; and 

19 ‘‘(2) in conspicuous and legible type in contrast 

20 by typography, layout, or color with other material 

21 printed or displayed on the label. 

22 ‘‘(d) INTERNET SALES.— 

23 ‘‘(1) IN GENERAL.—In the case of internet 

24 sales of cosmetic products, each primary seller offer25 ing a cosmetic product for sale to consumers on an 


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1 internet website shall prominently and conspicuously 

2 display on such internet website— 

3 ‘‘(A) the same information that is included 

4 on the packaging of the cosmetic product as 

5 regularly available, such as any warnings, ingre6 dient list, and contact information; and 

7 ‘‘(B) the warnings and statements de8 scribed in subsection (c). 

9 ‘‘(2) DEFINITION.—For purposes of this sub10 section, the term ‘primary seller’ refers to the entity 

11 who offers a cosmetic product for sale on an internet 

12 website, including the responsible person. 

13 ‘‘SEC. 615. FRAGRANCE INGREDIENTS. 

14 ‘‘(a) FRAGRANCE INGREDIENTS.—Not later than 2 

15 years after the date of enactment of the Cosmetic Safety 

16 Enhancement Act of 2019, the responsible person shall 

17 include on the label of any cosmetic products containing 

18 one or more fragrance allergens, a list of each such fra19 grance allergen included in such cosmetic product that is 

20 consistent with national and international regulations for 

21 fragrance allergens labeling. 

22 ‘‘(b) CONTACT INFORMATION.— 

23 ‘‘(1) IN GENERAL.—The contact information on 

24 the label on a cosmetic product for consumers to re25 port adverse events shall also provide a means for 


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1 consumers to obtain additional information about 

2 the inclusion of any recognized fragrance allergen 

3 required to be included on such label under sub4 section (a). 

5 ‘‘(2) RESPONSE.— 

6 ‘‘(A) IN GENERAL.—The responsible per7 son shall— 

8 ‘‘(i) upon receipt of a request for in9 formation under paragraph (1), promptly 

10 obtain and provide such information to the 

11 requesting consumer; and 

12 ‘‘(ii) in the case of information in the 

13 possession of a supplier, promptly obtain 

14 such information from such supplier, if 

15 reasonably available. 

16 ‘‘(B) SUPPLIER.—A supplier shall prompt17 ly provide information requested pursuant to 

18 subparagraph (A)(ii).’’. 

19 (b) INGREDIENT STATEMENT.—Section 602 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) 

21 is amended by adding at the end the following: 

22 ‘‘(g) If its labeling or packaging does not contain a 

23 listing of ingredients that meets the requirements of part 

24 701 of title 21, Code of Federal Regulations (as in effect 


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1 on date of enactment of the Cosmetic Safety Enhancement 

2 Act of 2019) (or any successor regulations).’’. 

3 (c) EFFECTIVE DATE.—The amendments made by 

4 this section shall apply with respect to products introduced 

5 or delivered for introduction into interstate commerce on 

6 or after the date that is 2 years after the date of enact7 ment of this Act. 

8 SEC. 107. CONSUMER INFORMATION. 

9 The Secretary of Health and Human Services, acting 

10 through the Commissioner of Food and Drugs, shall post 

11 on its internet website information for consumers regard12 ing— 

13 (1) final orders regarding the safety of a cos14 metic ingredient or nonfunctional constituent under 

15 section 608(d)(3); 

16 (2) cosmetic product recalls (including vol17 untary and mandatory recalls); and 

18 (3) identified counterfeit cosmetic products. 

19 SEC. 108. SMALL BUSINESSES. 

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

21 Act (21 U.S.C. 361 et seq.), as amended by section 106, 

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

23 ‘‘SEC. 616. SMALL BUSINESSES. 

24 ‘‘(a) IN GENERAL.—The Commissioner, in coordina25 tion with the Administrator of the Small Business AdminVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 istration, shall provide technical assistance, such as guid2 ance and expertise, to small businesses regarding compli3 ance with the Cosmetic Safety Enhancement Act of 2019, 

4 including the amendments made by such Act. 

5 ‘‘(b) COMPLIANCE GUIDE.—Not later than 180 days 

6 after the date of the enactment of Cosmetic Safety En7 hancement Act of 2019, the Secretary shall issue a small 

8 business guide setting forth in plain language the require9 ments of sections 605 and 606 in order to assist small 

10 businesses in complying with such requirements.’’. 

11 SEC. 109. ANIMAL TESTING RESTRICTIONS. 

12 (a) IN GENERAL.—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 the cosmetic product, cosmetic formulation, or 

16 cosmetic ingredient was developed or manufactured using 

17 an animal test that was conducted or contracted by the 

18 manufacturer, or any affiliate or supplier of the manufac19 turer, unless one of the following applies: 

20 ‘‘(1) With respect to a cosmetic ingredient of 

21 the cosmetic product or cosmetic formulation, an 

22 animal test is required by the Secretary to evaluate 

23 the safety of such ingredient or formulation. 

24 ‘‘(2) With respect to a cosmetic ingredient of 

25 the cosmetic product or cosmetic formulation, the 


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1 cosmetic ingredient or cosmetic formulation is in 

2 wide use and cannot be replaced by another ingre3 dient that is capable of performing a similar func4 tion without posing a potentially greater risk to 

5 human health and there is not an alternative method 

6 for testing the cosmetic ingredient that is accepted 

7 by the Secretary and the Interagency Coordinating 

8 Committee on Validation of Alternative Methods. 

9 ‘‘(3) The animal test was conducted to comply 

10 with a requirement of another Federal agency or a 

11 State or foreign regulatory authority. 

12 ‘‘(4) In the case of a cosmetic product, cosmetic 

13 formulation, or cosmetic ingredient that is also a 

14 drug, the animal test was conducted with respect to 

15 the approval under chapter V of the application sub16 mitted with respect to such product, formulation, or 

17 ingredient. 

18 ‘‘(5) The animal test was conducted for pur19 poses not related to developing or manufacturing the 

20 cosmetic product, cosmetic formulation, or cosmetic 

21 ingredient, and in response to a requirement of a 

22 Federal, State, or foreign regulatory authority.’’. 

23 (b) APPLICABILITY.—The amendment made by sub24 section (a) shall apply with respect to cosmetic products 

25 or cosmetic formulations introduced or delivered for introVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 duction into interstate commerce on or after the date that 

2 is two years after the date of enactment of this Act. 

3 (c) GUIDANCE.—Not later than 1 year after the date 

4 of enactment of this Act, the Secretary shall issue guid5 ance on the acceptability of scientifically reliable and rel6 evant alternatives to animal testing for the safety of cos7 metic products, cosmetic formulations, and cosmetic ingre8 dients, and encouraging the use of such methods. 

9 (d) RESOURCES REGARDING ANIMAL TESTING AL10 TERNATIVES.—Not later than 180 days after the date of 

11 enactment of this Act, the Secretary shall publish informa12 tion on the internet website of the Food and Drug Admin13 istration regarding resources available for information 

14 about non-animal methods, and methods that reduce ani15 mal usage, in testing for the safety of cosmetic products, 

16 cosmetic formulations, and cosmetic ingredients. 

17 (e) RULES OF CONSTRUCTION.— 

18 (1) USE OF EVIDENCE.—Nothing in this sec19 tion, or the amendment made by this section, shall 

20 be construed to prohibit any entity from reviewing, 

21 assessing, or retaining evidence generated from ani22 mal testing. 

23 (2) ACCEPTANCE OF DATA BY SECRETARY.— 

24 Nothing in this section, or the amendment made by 

25 this section, shall be construed to prohibit the SecVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 retary from accepting data from animal testing con2 ducted— 

3 (A) prior to the date specified in sub4 section (b); or 

5 (B) on or after such date— 

6 (i) in the case of a cosmetic product, 

7 cosmetic formulation, or cosmetic ingre8 dient that is also a drug, with respect to 

9 the approval under chapter V of the Fed10 eral Food, Drug, and Cosmetic Act (21 

11 U.S.C. 351 et seq.) of the application sub12 mitted with respect to such product, for13 mulation, or ingredient; or 

14 (ii) pursuant to requirements of a 

15 Federal, State, or foreign regulatory au16 thority. 

17 SEC. 110. COUNTERFEIT COSMETICS. 

18 (a) COUNTERFEIT COSMETICS DEFINED.—Section 

19 201(i) of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 321(i)) is amended— 

21 (1) by striking ‘‘(i) The term’’ inserting ‘‘(i)(1) 

22 The term’’; 

23 (2) by striking ‘‘(1) articles intended to be’’ and 

24 inserting ‘‘(A) articles intended to be’’; 


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1 (3) by striking ‘‘(2) articles intended for use’’ 

2 and inserting ‘‘(B) articles intended for use’’; and 

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

4 ‘‘(2) The term ‘counterfeit cosmetic’ means a cos5 metic which, or the container or labeling of which, without 

6 authorization— 

7 ‘‘(A) bears the trademark, trade name, or other 

8 identifying mark, imprint, or device, or any likeness 

9 thereof, of a cosmetic manufacturer, processor, pack10 er, or distributor other than the person or persons 

11 who in fact manufactured, processed, packed, or dis12 tributed such cosmetic; and 

13 ‘‘(B) thereby falsely purports or is represented 

14 to be the product of, or to have been packed or dis15 tributed by, such other cosmetic manufacturer, proc16 essor, packer, or distributor.’’. 

17 (b) PROHIBITED ACT.—Section 301(i) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 331(i)) is 

19 amended— 

20 (1) in subparagraph (2)— 

21 (A) by inserting ‘‘digital printer,’’ after 

22 ‘‘stone,’’; 

23 (B) by inserting ‘‘cosmetic’’ after ‘‘drug 

24 or’’; and 


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1 (C) by inserting before the period at the 

2 end the following: ‘‘or such cosmetic a counter3 feit cosmetic’’; and 

4 (2) in subparagraph (3)— 

5 (A) by inserting ‘‘or a cosmetic to be a 

6 counterfeit cosmetic’’ after ‘‘to be a counterfeit 

7 drug’’; and 

8 (B) by inserting ‘‘or counterfeit cosmetic’’ 

9 before the period at the end. 

10 (c) PENALTIES.—Section 303(c)(5) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 333(c)(5)) is 

12 amended— 

13 (1) by inserting ‘‘digital printer’’ after ‘‘stone,’’; 

14 (2) by inserting ‘‘or a cosmetic being a counter15 feit cosmetic’’ after ‘‘drug being a counterfeit drug’’; 

16 and 

17 (3) by inserting before the period at the end the 

18 following: ‘‘or the cosmetic was a counterfeit cos19 metic’’. 

20 (d) SEIZURE.—Section 304(a)(2) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 334(a)(2)) is 

22 amended— 

23 (1) by striking ‘‘(B) Any container’’ and all 

24 that follows through ‘‘(D) Any adulterated’’ and in25 serting ‘‘(B) Any cosmetic that is a counterfeit cosVerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279

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1 metic, (C) Any container of a counterfeit drug or 

2 counterfeit cosmetic, (D) Any punch, die, plate, 

3 stone, labeling, container, digital printer, or other 

4 thing used or designed for use in making a counter5 feit drug or drugs or a counterfeit cosmetic or cos6 metics, (E) Any adulterated’’; and 

7 (2) by striking ‘‘(E)’’ and inserting ‘‘(F)’’ be8 fore ‘‘Any adulterated or misbranded tobacco prod9 uct’’. 

10 (e) EXAMINATIONS AND INVESTIGATIONS.—Section 

11 702(e) of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 372(e)) is amended— 

13 (1) in the matter preceding paragraph (1), by 

14 inserting ‘‘or counterfeit cosmetics’’ after ‘‘counter15 feit drugs’’; 

16 (2) in paragraph (4), by inserting ‘‘or cos17 metics’’ after ‘‘such drugs’’; and 

18 (3) in paragraph (5)— 

19 (A) by striking ‘‘drugs or containers’’ and 

20 inserting ‘‘drugs, cosmetics, or containers’’; and 

21 (B) by inserting ‘‘digital printers,’’ after 

22 ‘‘labeling,’’. 


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1 SEC. 111. FOREIGN SUPPLIER VERIFICATION. 

2 (a) IN GENERAL.—Chapter VIII of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 

4 is amended by adding at the end the following: 

5 ‘‘SEC. 810. COSMETICS FOREIGN SUPPLIER VERIFICATION 

6 PROGRAM. 

7 ‘‘(a) IN GENERAL.— 

8 ‘‘(1) VERIFICATION REQUIREMENT.—Except as 

9 provided under subsection (e), each importer shall 

10 perform risk-based foreign supplier verification ac11 tivities for the purpose of verifying that the cosmetic 

12 product or cosmetic ingredient imported by the im13 porter (or agent thereof)— 

14 ‘‘(A) has been manufactured according to 

15 the cosmetic product good manufacturing prac16 tices established under section 610; and 

17 ‘‘(B) is not adulterated under section 601 

18 or misbranded under section 602. 

19 ‘‘(2) IMPORTER DEFINED.—For purposes of 

20 this section, the term ‘importer’ means, with respect 

21 to a cosmetic product or cosmetic ingredient— 

22 ‘‘(A) the United States owner or consignee 

23 of the cosmetic product or cosmetic ingredient 

24 at the time of entry of such cosmetic product 

25 or cosmetic ingredient into the United States; 

26 or 


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1 ‘‘(B) in the case when there is no United 

2 States owner or consignee as described in sub3 paragraph (A), the United States agent or rep4 resentative of a foreign owner or consignee of 

5 the cosmetic product or cosmetic ingredient at 

6 the time of entry of such article into the United 

7 States. 

8 ‘‘(b) GUIDANCE.—Not later than 1 year after the 

9 date of enactment of the Cosmetic Safety Enhancement 

10 Act of 2019, the Secretary shall issue guidance to assist 

11 importers in developing foreign supplier verification pro12 grams. 

13 ‘‘(c) REGULATIONS.— 

14 ‘‘(1) IN GENERAL.—Not later than 1 year after 

15 the date of enactment of Cosmetic Safety Enhance16 ment Act of 2019, the Secretary shall promulgate 

17 regulations to provide for the content of the foreign 

18 supplier verification program established under sub19 section (a). 

20 ‘‘(2) REQUIREMENTS.—The regulations promul21 gated under paragraph (1)— 

22 ‘‘(A) shall require that the foreign supplier 

23 verification program of each importer be ade24 quate to provide assurances that each foreign 

25 supplier to the importer produces the imported 


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1 cosmetic product or cosmetic ingredient in com2 pliance with— 

3 ‘‘(i) with cosmetic good manufac4 turing practices established under section 

5 610; and 

6 ‘‘(ii) sections 601 and 602; and 

7 ‘‘(B) shall include such other requirements 

8 as the Secretary deems necessary and appro9 priate to verify that cosmetic products and cos10 metic ingredients imported into the United 

11 States are as safe as cosmetic products and cos12 metic ingredients produced and sold within the 

13 United States. 

14 ‘‘(3) CONSIDERATIONS.—In promulgating regu15 lations under this subsection, the Secretary shall, as 

16 appropriate, take into account differences among im17 porters and types of imported cosmetic products and 

18 cosmetic ingredients, including based on the level of 

19 risk posed by the imported cosmetic product or cos20 metic ingredient. 

21 ‘‘(4) ACTIVITIES.—Verification activities under 

22 a foreign supplier verification program under this 

23 section may include monitoring records for ship24 ments, lot-by-lot certification of compliance, annual 

25 on-site inspections, compliance with cosmetic good 


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1 manufacturing practices and other safety processes, 

2 and periodically testing and sampling shipments. 

3 ‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records 

4 of an importer related to a foreign supplier verification 

5 program shall— 

6 ‘‘(1) be maintained for a period of not less than 

7 2 years; and 

8 ‘‘(2) be made available promptly to a duly au9 thorized representative of the Secretary upon re10 quest. 

11 ‘‘(e) EXEMPTIONS.—The Secretary, by notice pub12 lished in the Federal Register, shall establish an exemp13 tion from the requirements of this section for cosmetic 

14 products or cosmetic ingredients imported in small quan15 tities for research and evaluation purposes or for personal 

16 consumption, provided that such cosmetic products or cos17 metic ingredients are not intended for retail sale and are 

18 not sold or distributed to the public. 

19 ‘‘(f) PUBLICATION OF LIST OF PARTICIPANTS.—The 

20 Secretary shall publish and maintain on the internet 

21 website of the Food and Drug Administration a current 

22 list that includes the name of, location of, and other infor23 mation deemed necessary by the Secretary about, import24 ers participating under this section.’’. 


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1 (b) PROHIBITED ACT.—Section 301 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

3 amended by section 113, is further amended by adding 

4 at the end the following: 

5 ‘‘(ggg) The importation or offering for importation 

6 of a cosmetic product or cosmetic ingredient if the im7 porter (as defined in section 810) does not have in place 

8 a foreign supplier verification program in compliance with 

9 such section 810.’’. 

10 (c) IMPORTS.—Section 801(a) of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended 

12 by striking ‘‘or the importer (as defined in section 805) 

13 is in violation of such section 805’’ and inserting ‘‘, or 

14 being imported or offered for import into the United 

15 States by an importer (as defined in section 805 or 810, 

16 as applicable) that is in violation of section 805 or 810, 

17 respectively’’. 

18 (d) EFFECTIVE DATE.—The amendments made by 

19 this section shall take effect 2 years after the date of en20 actment of this Act. 

21 SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS22 METICS. 

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

24 Act (21 U.S.C. 361 et seq.), as amended by section 108, 

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


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1 ‘‘SEC. 617. APPLICABILITY WITH RESPECT TO CERTAIN 

2 COSMETICS. 

3 ‘‘In the case of a cosmetic product or a facility that 

4 is subject to the requirements under this chapter and 

5 chapter V, if any requirement under chapter V with re6 spect to such cosmetic or facility is substantially similar 

7 to a requirement under this chapter, the cosmetic product 

8 or facility shall be deemed to be in compliance with the 

9 applicable requirement under this chapter if such product 

10 or facility is in compliance with such substantially similar 

11 requirement under chapter V, provided that the product 

12 or facility has not obtained a waiver from the requirement 

13 under chapter V.’’. 

14 SEC. 113. SAVING CLAUSE. 

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

16 Act (21 U.S.C. 361 et seq.), as amended by section 112, 

17 is further amended by adding the following: 

18 ‘‘SEC. 616. SAVINGS CLAUSE. 

19 ‘‘Nothing in the amendments to this Act made by the 

20 Cosmetic Safety Enhancement Act of 2019, nor any 

21 standard, rule, requirement, regulation, adverse event re22 port, safety assessment, safety determination, scientific 

23 assessment, or order issued or implemented pursuant to 

24 such amendments, shall be construed to modify or other25 wise affect, preempt, or displace any cause of action or 

26 State or Federal law creating a remedy for civil relief or 


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1 criminal cause of action, whether statutory or based in 

2 common law.’’. 

3 SEC. 114. ENFORCEMENT. 

4 (a) PROHIBITED ACTS.—Section 301 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend6 ed— 

7 (1) in paragraph (e)— 

8 (A) by striking ‘‘504, 564,’’ and inserting 

9 ‘‘504, 564, 611, 612’’; and 

10 (B) by striking ‘‘519, 564,’’ and inserting 

11 ‘‘519, 564, 609, 611,’’; 

12 (2) in paragraph (j) by inserting ‘‘607, 608, 

13 610, 611’’ before ‘‘704’’; 

14 (3) in paragraph (ii)— 

15 (A) by striking ‘‘760 or 761)’’ and insert16 ing ‘‘604, 760, or 761)’’; and 

17 (B) by striking ‘‘760 or 761) submitted’’ 

18 and inserting ‘‘611, 760, or 761) submitted’’; 

19 (4) in paragraph (xx), by inserting ‘‘or 613’’ 

20 after ‘‘423’’; and 

21 (5) by adding at the end the following: 

22 ‘‘(fff) The failure to register in accordance with sec23 tion 605, the failure to submit a cosmetic ingredient state24 ment under section 606, the failure to provide information 

25 required by section 605 or 606, or the failure to update 


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1 the information required by section 605 or 606, as re2 quired.’’. 

3 (b) ADULTERATION.—Section 601 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 361), as 

5 amended by section 603, is further amended by adding 

6 at the end the following: 

7 ‘‘(g) If it contains, after the date prescribed under 

8 section 608(d)(3), an ingredient that the Secretary has de9 termined under section 608(d)(4) to be not safe, or not 

10 safe under the conditions of use recommended or sug11 gested in the label based on an order issued by the Sec12 retary under section 608(d)(4). 

13 ‘‘(h) If it is a cosmetic product for which any require14 ment of section 609 is not met.’’. 

15 (c) MISBRANDING.—Section 602 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 362), as 

17 amended by section 106, is further amended— 

18 (1) in paragraph (b)— 

19 (A) by striking ‘‘and (2)’’ and inserting 

20 ‘‘(2)’’; and 

21 (B) by inserting ‘‘; and (3) a domestic ad22 dress or a domestic telephone number, or elec23 tronic contact information, through which the 

24 responsible person may receive a report of an 


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1 adverse event associated with the use of such 

2 cosmetic product’’ after ‘‘numerical count’’; and 

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

4 ‘‘(h) If it is a cosmetic product and it has been manu5 factured, processed, packed, or held in any factory, ware6 house, or establishment and the responsible person delays, 

7 denies, or limits an inspection, or refuses to permit entry 

8 or inspection. 

9 ‘‘(i) If a fragrance ingredient described in section 615 

10 is not disclosed to consumers through a method identified 

11 by the Food and Drug Administration in the guidance doc12 ument issued under such section. 

13 ‘‘(j) If its labeling does not conform with a require14 ment under section 614.’’. 

15 (d) GUIDANCE.—Not later than 1 year after the date 

16 of enactment of this Act, the Secretary of Health and 

17 Human Services, acting through the Commissioner of 

18 Food and Drugs, shall issue guidance that defines the cir19 cumstances that would constitute delaying, denying, or 

20 limiting inspection, or refusing to permit entry or inspec21 tion, for purposes of section 602(g) of the Federal Food, 

22 Drug, and Cosmetic Act, as added by subsection (c)(2). 

23 (e) IMPORTS.—Section 801(a) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— 


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1 (1) by striking ‘‘section 760 or 761’’ the first, 

2 third, and fourth place such term appears and in3 serting ‘‘section 611, 760, or 761’’; and 

4 (2) by striking ‘‘760 or 761)’’ and inserting 

5 ‘‘604, 760, or 761)’’. 

6 (f) FACILITY INSPECTION.—Section 704(a)(1) of the 

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

8 374(a)(1)) is amended by inserting after the third sen9 tence the following: ‘‘In the case of any person who manu10 factures, processes, packs, holds, distributes, or imports 

11 a cosmetic product, or distributes a cosmetic product and 

12 affixes its name on the cosmetic label, the inspection shall 

13 extend to all records and other information described in 

14 section 612 (regarding inspection of cosmetic records), 

15 subject to the limitations under of such section.’’. 

16 TITLE II—FEES RELATED TO 

17 COSMETIC PRODUCTS 

18 SEC. 201. FINDINGS. 

19 The Congress finds that the fees authorized by the 

20 amendment made by section 202 of this Act will be dedi21 cated to cosmetic safety activities, as defined in section 

22 744L of the Federal Food, Drug, and Cosmetic Act, as 

23 added by such section 202. Such fees should supplement, 

24 not supplant, funding dedicated to cosmetic safety activi25 ties of the Food and Drug Administration. Future fees 


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1 authorized by the reauthorization of part 10 of subchapter 

2 C of chapter VII of the Federal Food, Drug, and Cosmetic 

3 Act to be collected by the Secretary of Health and Human 

4 Services should be dedicated to cosmetic safety activities 

5 as set forth in the goals identified for purposes of such 

6 part 10, in the letters from the Secretary of Health and 

7 Human Services to the Chairman of the Committee on 

8 Health, Education, Labor, and Pensions of the Senate and 

9 the Chairman of the Committee on Energy and Commerce 

10 of the House of Representatives, as set forth in the Con11 gressional Record. 

12 SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC 

13 PRODUCT FEES. 

14 Subchapter C of chapter VII of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 

16 amended by adding at the end the following: 

17 ‘‘PART 10—FEES RELATING TO COSMETIC 

18 PRODUCTS 

19 ‘‘SEC. 744L. DEFINITIONS. 

20 ‘‘For the purposes of this part: 

21 ‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust22 ment factor’ applicable to a fiscal year means the 

23 Consumer Price Index for all urban consumers (all 

24 items; United States city average) for October of the 


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1 preceding fiscal year divided by such index for Octo2 ber 2018. 

3 ‘‘(2) COSMETIC FORMULATION.—The term ‘cos4 metic formulation’ has the meaning given to such 

5 term in section 604. 

6 ‘‘(3) CONTRACT MANUFACTURER.—The term 

7 ‘contract manufacturer’ means a cosmetic manufac8 turer where neither the owner, operator, or agent in 

9 charge of such entity nor any affiliate of such owner, 

10 operator, or agent in charge sells the cosmetic ingre11 dient, cosmetic formulation, or cosmetic product un12 less there is a specific contractual agreement in 

13 place. 

14 ‘‘(4) COSMETIC PRODUCT.—The term ‘cosmetic 

15 product’ has the meaning given to such term in sec16 tion 604. 

17 ‘‘(5) COSMETIC SAFETY ACTIVITIES.—The term 

18 ‘cosmetic safety activities’— 

19 ‘‘(A) means activities of the Secretary re20 lated to compliance by responsible persons re21 quired to register under section 605 with re22 spect to cosmetics, including administrative ac23 tivities, such as— 


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1 ‘‘(i) information technology acquisi2 tion, management, maintenance, and sup3 port; 

4 ‘‘(ii) the acquisition, administration, 

5 and maintenance of the cosmetic registra6 tion system under section 605 and the cos7 metic ingredient statement system under 

8 section 606; 

9 ‘‘(iii) fee assessment and collection 

10 under this part; and 

11 ‘‘(iv) the acquisition, leasing, mainte12 nance, renovation, and repair of facilities, 

13 fixtures, furniture, scientific equipment, 

14 and other necessary materials and supplies 

15 for purposes of clauses (i) through (iii); 

16 ‘‘(B) includes activities of the Secretary re17 lated to implementation of section 608, regard18 ing the review of cosmetic ingredients and non19 functional constituents; 

20 ‘‘(C) includes activities of the Secretary re21 lated to implementation of section 606; 

22 ‘‘(D) includes activities of the Secretary re23 lated to implementation and enforcement, such 

24 as the establishment of good manufacturing 

25 practices, the review of adverse event reports, 


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1 inspection planning and inspections, and use of 

2 enforcement tools; and 

3 ‘‘(E) includes activities of the Secretary re4 lated to meetings with regulated industry re5 garding determinations under section 608. 

6 ‘‘(6) GROSS ANNUAL SALES.—The term ‘gross 

7 annual sales’ means the average United States gross 

8 annual sales for the previous 3 fiscal years of cos9 metic products for a responsible person, including 

10 the sales of cosmetic products of all of its affiliates, 

11 as reported in the registration under section 605. 

12 ‘‘(7) LARGE MANUFACTURER.—The term ‘large 

13 manufacturer’ means any entity that manufactures 

14 cosmetic products or cosmetic formulations for sale 

15 or distribution in the United States and has gross 

16 annual sales of over $500,000,000. 

17 ‘‘(8) MIDSIZE MANUFACTURER.—The term 

18 ‘midsize manufacturer’ means any entity that manu19 factures cosmetic products or cosmetic formulations 

20 for sale or distribution in the United States and has 

21 gross annual sales that are not more than 

22 $500,000,000 and over $30,000,000. 

23 ‘‘(9) SMALL MANUFACTURER.—The term ‘small 

24 manufacturer’ means any entity that manufactures 

25 cosmetic products or cosmetic formulations for sale 


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1 or distribution in the United States and has gross 

2 annual sales that are not more than $30,000,000 

3 and over $1,000,000. 

4 ‘‘(10) RESPONSIBLE PERSON.—The term ‘re5 sponsible person’ means the owner, operator, agent 

6 in charge, or affiliate that owns the brand under 

7 which a cosmetic product is sold. 

8 ‘‘SEC. 744M. REGISTRATION FEE. 

9 ‘‘(a) ASSESSMENT AND COLLECTION.— 

10 ‘‘(1) IN GENERAL.—Beginning in fiscal year 

11 2020, the Secretary shall in accordance with this 

12 section assess and collect an annual fee from every 

13 responsible person that manufactures or distributes 

14 cosmetic products or cosmetic formulations in the 

15 United States. 

16 ‘‘(2) PAYABLE DATE.—Fees under this section 

17 shall be due and payable— 

18 ‘‘(A) for fiscal year 2020, with respect to 

19 responsible persons as described in paragraph 

20 (1) for such first program year, on the date 

21 that is 180 days after the identification in sub22 section (b); and 

23 ‘‘(B) for fiscal year 2021 and each subse24 quent fiscal year, on the later of— 


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1 ‘‘(i) the date of registration or reg2 istration renewal, as applicable, under sec3 tion 605; or 

4 ‘‘(ii) the date of enactment of an ap5 propriations Act providing for the collec6 tion and obligation of fees under this sec7 tion for the fiscal year involved. 

8 ‘‘(b) ONE-TIME IDENTIFICATION OF RESPONSIBLE

9 PERSONS FOR PURPOSES OF APPORTIONING FEES.— 

10 ‘‘(1) REQUIRED IDENTIFICATION OF RESPON11 SIBLE PERSONS.—Not later than 120 days after en12 actment of the Cosmetic Safety Enhancement Act of 

13 2019, each responsible person that markets or sells 

14 a cosmetic product shall submit to the Secretary the 

15 information required under this subsection. 

16 ‘‘(2) INFORMATION REQUIRED TO BE SUB17 MITTED.—At a minimum, the submission required 

18 by paragraph (1) shall include for each such respon19 sible person— 

20 ‘‘(A) the gross annual sales of cosmetic 

21 products or cosmetic formulations for the pre22 vious 3 fiscal years as will be reported in the 

23 first registration under section 605 for such re24 sponsible person, and an assessment of whether 

25 such responsible person qualifies as a small, 


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1 midsize, or large manufacturer for the purposes 

2 of subsection (c)(3)(A); 

3 ‘‘(B) identification of facilities where such 

4 responsible person’s cosmetic products or cos5 metic formulations are manufactured, which 

6 cosmetic products or cosmetic formulations are 

7 manufactured there, and any other products 

8 regulated under this Act that the facility manu9 factures; 

10 ‘‘(C) the location of all such facilities iden11 tified in subparagraph (B); and 

12 ‘‘(D) whether the facility is owned and op13 erated by a contract manufacturer. 

14 ‘‘(3) NOTICE.—The Secretary may, by notice 

15 published in the Federal Register, specify the means 

16 and format for submission of the information under 

17 paragraph (2) and may specify, as necessary for 

18 purposes of this section, any additional information 

19 relevant to setting the annual fee under this section 

20 to be submitted. 

21 ‘‘(c) FEE SETTING AND AMOUNTS.— 

22 ‘‘(1) IN GENERAL.—Subject to subsection (d), 

23 the Secretary shall establish the fees to be collected 

24 under this section for each fiscal year beginning in 

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1 scribed in paragraph (3)(A), and shall publish such 

2 fees in each fiscal year after fiscal year 2020 in a 

3 Federal Register notice not later than 60 days be4 fore the beginning of each such fiscal year. For fis5 cal year 2020, the Secretary shall publish the fees 

6 150 days after the date of enactment of the Cos7 metic Safety Enhancement Act of 2019. 

8 ‘‘(2) FEE EXEMPTION.—Any facility required to 

9 register under section 605 whose average gross an10 nual sales of cosmetic products in the 3 fiscal years 

11 immediately preceding the fiscal year for which the 

12 annual fee will be paid was not more than 

13 $1,000,000, shall be exempt from registration fees 

14 under this section for that fiscal year. 

15 ‘‘(3) ANNUAL FEE SETTING.— 

16 ‘‘(A) FEE SETTING.—For fiscal years 

17 2020 to 2027, the amount of the registration 

18 fee under subsection (a) shall be apportioned as 

19 follows: 

20 ‘‘(i) Seventy percent shall be derived 

21 from fees from large manufacturers. 

22 ‘‘(ii) Twenty percent shall be derived 

23 from fees from midsize manufacturers. 

24 ‘‘(iii) Ten percent shall be derived 

25 from fees from small manufacturers. 


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1 ‘‘(B) TOTAL REVENUE.—The Secretary 

2 shall establish the fee amounts for each fiscal 

3 year in accordance with subparagraph (A), in 

4 order to generate a total estimated revenue of— 

5 ‘‘(i) $10,000,000 for fiscal year 2020; 

6 ‘‘(ii) $20,000,000 for fiscal year 2021; 

7 ‘‘(iii) $35,000,000 for fiscal year 

8 2022; and 

9 ‘‘(iv) $46,000,000 for each of fiscal 

10 years 2023 through 2027. 

11 ‘‘(d) ADJUSTMENTS.— 

12 ‘‘(1) INFLATION ADJUSTMENTS.— 

13 ‘‘(A) ADJUSTMENT TO TOTAL REVENUE

14 AMOUNTS.—For fiscal year 2020 and each sub15 sequent fiscal year, the Secretary shall adjust 

16 the total revenue amount specified in subsection 

17 (c)(3) for such fiscal year by multiplying such 

18 amount by the applicable inflation adjustment 

19 under subparagraph (B) for such year. 

20 ‘‘(B) APPLICABLE INFLATION ADJUST21 MENT.—The applicable inflation adjustment for 

22 fiscal year 2022 and each subsequent fiscal 

23 year is the product of— 


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1 ‘‘(i) the base inflation adjustment 

2 under subparagraph (C) for such fiscal 

3 year; and 

4 ‘‘(ii) the product of the base inflation 

5 adjustment under subparagraph (C) for 

6 each of the fiscal years preceding such fis7 cal year, beginning with fiscal year 2020. 

8 ‘‘(C) BASE INFLATION ADJUSTMENT.— 

9 ‘‘(i) IN GENERAL.—Subject to further 

10 adjustment under clause (ii), the base in11 flation adjustment for a fiscal year is the 

12 sum of one plus— 

13 ‘‘(I) the average annual percent 

14 change in the cost, per full-time equiv15 alent position of the Food and Drug 

16 Administration, of all personnel com17 pensation and benefits paid with re18 spect to such positions for the first 3 

19 fiscal years of the preceding 4 fiscal 

20 years, multiplied by 0.60; and 

21 ‘‘(II) the average annual percent 

22 change that occurred in the Consumer 

23 Price Index for urban consumers 

24 (Washington-Arlington-Alexandria; 

25 Not Seasonally Adjusted; All items; 


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1 Annual Index) for the first 3 fiscal 

2 years of the preceding 4 years of 

3 available data multiplied by 0.40. 

4 ‘‘(ii) LIMITATIONS.—For purposes of 

5 subparagraph (B), if the base inflation ad6 justment for a fiscal year under clause 

7 (i)— 

8 ‘‘(I) is less than 1, such adjust9 ment shall be considered to be equal 

10 to 1; or 

11 ‘‘(II) is greater than 1.04, such 

12 adjustment shall be considered to be 

13 equal to 1.04. 

14 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal 

15 year 2027, the Secretary may, in addition to adjust16 ments under paragraph (1), further increase the fee 

17 revenues and fees established in subsection (c) if 

18 such an adjustment is necessary to provide for not 

19 more than 3 months of operating reserves of carry20 over fees for cosmetic safety activities for the first 

21 3 months of fiscal year 2028. If such an adjustment 

22 is necessary, the rationale for the increase shall be 

23 contained in the annual Federal Register notice es24 tablishing fees for fiscal year 2027. If the Food and 

25 Drug Administration has carryover balances for 


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1 such activities in excess of 3 months of such oper2 ating reserves, the adjustment under this paragraph 

3 shall not be made. 

4 ‘‘(e) LIMITATIONS.— 

5 ‘‘(1) IN GENERAL.—With respect to the amount 

6 that is appropriated for a fiscal year for the cos7 metics program of the Center for Food Safety and 

8 Applied Nutrition of the Food and Drug Administra9 tion and related field activities, fees may not be as10 sessed under subsection (a) for the fiscal year unless 

11 the amount so appropriated (excluding the amount 

12 of fees appropriated for the fiscal year), is equal to 

13 or greater than the amount that is appropriated for 

14 such program for fiscal year 2019, multiplied by the 

15 adjustment factor applicable to the fiscal year in16 volved. If the amount so appropriated prevents the 

17 Secretary from assessing fees under subsection (a), 

18 the Secretary is not required to carry out any activi19 ties described in section 608 during that fiscal year. 

20 ‘‘(2) AUTHORITY.—If the Secretary does not 

21 assess fees under subsection (a) during any portion 

22 of a fiscal year because of paragraph (1) and if at 

23 a later date in such fiscal year the Secretary may as24 sess such fees, the Secretary may assess and collect 

25 such fees, without any modification in the rate, for 


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1 registration under section 605 at any time in such 

2 fiscal year. 

3 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

4 ‘‘(1) IN GENERAL.—Fees authorized under sub5 section (a) shall be collected and available for obliga6 tion only to the extent and in the amount provided 

7 in advance in appropriations Acts. Such fees are au8 thorized to remain available until expended. Such 

9 sums as may be necessary may be transferred from 

10 the Food and Drug Administration salaries and ex11 penses appropriation account without fiscal year lim12 itation to such appropriation account for salaries 

13 and expenses with such fiscal year limitation. The 

14 sums transferred shall be available solely for cos15 metic safety activities. 

16 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

17 ACTS.— 

18 ‘‘(A) IN GENERAL.—Subject to subpara19 graphs (C) and (D), the fees authorized by this 

20 section shall be collected and available in each 

21 fiscal year in an amount not to exceed the 

22 amount specified in appropriation Acts, or oth23 erwise made available for obligation, for such 

24 fiscal year. 


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1 ‘‘(B) USE OF FEES AND LIMITATION.— 

2 The fees authorized by this section shall be col3 lected and available only to defray the costs of 

4 cosmetic safety activities. 

5 ‘‘(C) FEE COLLECTIONS DURING FIRST

6 PROGRAM YEAR.—Until the date of enactment 

7 of discretionary appropriations through Sep8 tember 30, 2020, for the ‘Food and Drug Ad9 ministration—Salaries and Expenses’ account, 

10 fees authorized by this section for fiscal year 

11 2020 may be collected, and any fees so collected 

12 shall be credited to such account, to remain 

13 available until expended. 

14 ‘‘(D) STARTUP COSTS.—Until one year 

15 after the Secretary begins collecting user fees 

16 under subsection (a), any amounts available for 

17 the Center for Food Safety and Applied Nutri18 tion and related field activities (excluding user 

19 fees) shall be available and allocated as needed 

20 to pay the costs of any cosmetic safety activities 

21 not authorized before enactment of the Cos22 metic Safety Enhancement Act of 2019. 

23 ‘‘(E) REIMBURSEMENT OF STARTUP

24 AMOUNTS.— 


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1 ‘‘(i) IN GENERAL.—Any amounts allo2 cated for the startup period pursuant to 

3 subparagraph (D) shall be reimbursed 

4 through any appropriated fees collected 

5 under subsection (a), in such manner as 

6 the Secretary determines appropriate to 

7 ensure that such allocation results in no 

8 net change in the total amount of funds 

9 otherwise available, for a period not to ex10 ceed two years after the Secretary begins 

11 collecting user fees under subsection (a), 

12 for the Center for Food Safety and Applied 

13 Nutrition and related field activities (other 

14 than cosmetic safety activities and related 

15 field activities funded through such alloca16 tion) for such period. 

17 ‘‘(ii) TREATMENT OF REIMBURSED

18 AMOUNTS.—Amounts reimbursed under 

19 clause (i) shall be available for the pro20 grams and activities for which funds allo21 cated for the startup period were available, 

22 prior to such allocation, until 1 year after 

23 the Secretary begins collecting user fees 

24 under subsection (a), notwithstanding any 

25 otherwise applicable limits on amounts for 


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1 such programs or activities for a fiscal 

2 year. 

3 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

4 There are authorized to be appropriated for fees 

5 under this section the following: 

6 ‘‘(A) $10,000,000 for fiscal year 2020; 

7 ‘‘(B) $20,000,000 for fiscal year 2021; 

8 ‘‘(C) $35,000,000 for fiscal year 2022; and 

9 ‘‘(D) $46,000,000 for each of fiscal years 

10 2023 through 2027. 

11 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.—The Sec12 retary shall not consider a registration by a responsible 

13 person submitted under section 605 to be complete until 

14 all fees owed by such person under subsection (a) are paid. 

15 Until the fees are paid, the registration is incomplete and 

16 the responsible person is deemed to have failed to register 

17 in accordance with section 605. 

18 ‘‘(h) COLLECTION OF UNPAID FEES.—In any case 

19 where the Secretary does not receive payment of a fee as20 sessed under subsection (a), such fee shall be treated as 

21 a claim of the United States Government subject to sub22 chapter II of chapter 37 of title 31, United States Code. 

23 ‘‘(i) CONSTRUCTION.—This section may not be con24 strued to require that the number of full-time equivalent 

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1 ices, for officers, employees, and advisory committees not 

2 engaged in cosmetic safety activities, be reduced to offset 

3 the number of officers, employees, and advisory commit4 tees so engaged. 

5 ‘‘(j) RECORDS.—Each responsible person that is re6 quired to register under section 605 shall retain all records 

7 necessary to demonstrate gross annual sales for at least 

8 2 fiscal years after such information is reported in its reg9 istration. Such records shall be made available to the Sec10 retary for review and duplication upon request of the Sec11 retary. 

12 ‘‘(k) LIMITATION.—This part does not authorize the 

13 assessment or collection of a fee for registration under sec14 tion 605 occurring after fiscal year 2027.’’. 

15 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI16 TIES RELATED TO COSMETICS. 

17 Part 10 of subchapter C of chapter VII, as added 

18 by section 202, is amended by inserting after section 

19 744M the following: 

20 ‘‘SEC. 744N. DIRECT HIRING AUTHORITY TO SUPPORT AC21 TIVITIES RELATED TO COSMETICS. 

22 ‘‘The Secretary shall have direct hiring authority with 

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1 metic Safety Enhancement Act of 2019 and the amend2 ments made thereby. 

3 ‘‘SEC. 744O. REPORTING REQUIREMENTS; REAUTHORIZA4 TION. 

5 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

6 year 2021, and not later than 120 calendar days after the 

7 end of each fiscal year thereafter for which fees are col8 lected under this part, the Secretary shall prepare and 

9 submit to the Committee on Energy and Commerce of the 

10 House of Representatives and the Committee on Health, 

11 Education, Labor, and Pensions of the Senate a report 

12 concerning the progress of the Food and Drug Adminis13 tration on cosmetic safety activities during such fiscal 

14 year, including the future plans of the Food and Drug Ad15 ministration for such activities. 

16 ‘‘(b) FISCAL REPORT.—Not later than 120 calendar 

17 days after the end of fiscal year 2021 and each subsequent 

18 fiscal year for which fees are collected under this part, 

19 the Secretary shall prepare and submit to the Committee 

20 on Energy and Commerce of the House of Representatives 

21 and the Committee on Health, Education, Labor, and 

22 Pensions of the Senate a report on the implementation 

23 of the authority for such fees during such fiscal year and 

24 the use, by the Food and Drug Administration, of the fees 

25 collected for such fiscal year. 


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1 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

2 make the reports required under subsections (a) and (b) 

3 available to the public on the internet website of the Food 

4 and Drug Administration. 

5 ‘‘(d) REAUTHORIZATION.— 

6 ‘‘(1) CONSULTATION.—In developing recom7 mendations to present to the Congress with respect 

8 to performance goals developed by the Food and 

9 Drug Administration, and plans for meeting the 

10 goals, for cosmetic safety activities for the first 5 fis11 cal years after fiscal year 2027, and for the reau12 thorization of this part for such fiscal years, the Sec13 retary shall consult with— 

14 ‘‘(A) the Committee on Energy and Com15 merce of the House of Representatives; 

16 ‘‘(B) the Committee on Health, Education, 

17 Labor, and Pensions of the Senate; 

18 ‘‘(C) scientific and academic experts; 

19 ‘‘(D) health care professionals; 

20 ‘‘(E) representatives of public health and 

21 consumer advocacy groups; and 

22 ‘‘(F) the regulated industry. 

23 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA24 TIONS.—After negotiations with the regulated indus25 try, the Secretary shall— 


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1 ‘‘(A) present the recommendations devel2 oped under paragraph (1) to the congressional 

3 committees specified in such paragraph; 

4 ‘‘(B) publish such recommendations in the 

5 Federal Register; 

6 ‘‘(C) provide for a period of 30 calendar 

7 days for the public to provide written comments 

8 on such recommendations; 

9 ‘‘(D) hold a meeting at which the public 

10 may present its views on such recommenda11 tions; and 

12 ‘‘(E) after consideration of such public 

13 views and comments, revise such recommenda14 tions as necessary. 

15 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

16 Not later than January 15, 2026, the Secretary 

17 shall transmit to the Congress the revised rec18 ommendations under paragraph (2), a summary of 

19 the views and comments received under such para20 graph, and any changes made to the recommenda21 tions in response to such views and comments.’’. 

22 SEC. 204. SUNSET DATES. 

23 (a) AUTHORIZATION.—Sections 744L, 744M, and 

24 744N of the Federal Food, Drug, and Cosmetic Act, as 


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1 added by section 202, shall cease to be effective October 

2 1, 2027. 

3 (b) REPORTING REQUIREMENTS.—Section 744O of 

4 the Federal Food, Drug, and Cosmetic Act, as added by 

5 section 203, shall cease to be effective January 31, 2028. 

Æ 


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