II 

117TH CONGRESS 

1ST SESSION S. 2100 

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

of cosmetics. 

IN THE SENATE OF THE UNITED STATES 

JUNE 17, 2021 

Mrs. FEINSTEIN (for herself and Ms. COLLINS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

ensure the safety of cosmetics. 

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Personal Care Products Safety Act’’. 

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 non-functional constituents. 

Sec. 103. Good manufacturing practices for cosmetics. 

Sec. 104. Adverse event reports. 

Sec. 105. Records inspection; mandatory recall authority. 

Sec. 106. Labeling. 

Sec. 107. Coal tar chemicals. 

Sec. 108. Fragrance allergen disclosure. 

Sec. 109. Sense of the Senate on animal testing. 

Sec. 110. Preemption. 

Sec. 111. Reporting. 

Sec. 112. Small businesses. 

Sec. 113. Applicability with respect to certain cosmetics. 

Sec. 114. Enforcement. 

Sec. 115. Consumer information. 

Sec. 116. Ban on perfluoroalkyl or polyfluoroalkyl substances. 

Sec. 117. Counterfeit cosmetics. 

TITLE II—FEES RELATED TO COSMETIC SAFETY 

Sec. 201. Findings. 

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

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

1 TITLE I—COSMETIC SAFETY 

2 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 

3 COSMETIC INGREDIENT STATEMENTS. 

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

5 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend6 ed by adding at the end the following: 

7 ‘‘SEC. 604. DEFINITIONS. 

8 ‘‘In this chapter: 

9 ‘‘(1) COSMETIC FORMULATION.—The term ‘cos10 metic formulation’ means a preparation of cosmetic 

11 raw materials with a qualitatively and quantitatively 

12 set composition. 

13 ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 

14 product’ means a preparation of cosmetic raw ingre15 dients, which may come in a range of possible 


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1 amounts for each ingredient, for purposes of intro2 duction into interstate commerce as a finished prod3 uct. 

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

5 any factory, warehouse, or establishment (including 

6 a factory, warehouse, or establishment of an im7 porter) that manufactures or processes cosmetic 

8 products or cosmetic formulations, or any other enti9 ty whose name and address appear on the label of 

10 a cosmetic product. Such term does not include— 

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

12 otherwise manufacture, process, or package cos13 metics at that location; 

14 ‘‘(B) cosmetic product retailers, including 

15 individual sales representatives, direct sellers, 

16 retail distribution facilities, and pharmacies, 

17 that do not otherwise manufacture, process, or 

18 package cosmetics at that location; 

19 ‘‘(C) hospitals, physicians’ offices, and 

20 health care clinics; 

21 ‘‘(D) public health agencies and other non22 profit entities that provide cosmetics directly to 

23 the consumer; 

24 ‘‘(E) hotels and other entities that provide 

25 complimentary cosmetics to guests; 


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1 ‘‘(F) trade shows and other venues where 

2 cosmetic product samples are provided free of 

3 charge; 

4 ‘‘(G) a factory, warehouse, or establish5 ment of— 

6 ‘‘(i) domestic manufacturers with less 

7 than $500,000 in average gross annual 

8 sales of cosmetic products in the United 

9 States for the previous 3-year period, or 

10 less than $1,000,000 in such sales of cos11 metic products produced in a private resi12 dence; or 

13 ‘‘(ii) entities that manufacture or 

14 compound cosmetic products solely for use 

15 in research, teaching, or pilot plant pro16 duction and not for sale; or 

17 ‘‘(H) an establishment that solely performs 

18 one or more of the following with respect to cos19 metic products: labeling, relabeling, packaging, 

20 repackaging, holding, or distributing. 

21 ‘‘(4) FOREIGN FACILITY.—The term ‘foreign fa22 cility’ means a facility that manufactures or proc23 esses a cosmetic formulation or cosmetic product 

24 that is exported to the United States without further 

25 processing or packaging inside the United States. A 


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1 cosmetic is not considered to have undergone further 

2 processing or packaging for purposes of this defini3 tion solely on the basis that labeling was added or 

4 that any similar activity of a de minimis nature was 

5 carried out with respect to the cosmetic. 

6 ‘‘(5) NON-FUNCTIONAL CONSTITUENT.—The 

7 term ‘non-functional constituent’ means any sub8 stance that is an incidental component of an ingre9 dient, a breakdown product of an ingredient or a by10 product of the manufacturing process that has not 

11 been intentionally added as a separate substance and 

12 serves no technical function in the cosmetic. 

13 ‘‘(6) RESPONSIBLE PERSON.—The term ‘re14 sponsible person’ means— 

15 ‘‘(A) the brand owner who is the domestic 

16 or foreign manufacturer or entity whose name 

17 appears on a cosmetic product label of a cos18 metic product distributed in the United States, 

19 except for entities described in subparagraphs 

20 (A) through (H) of paragraph (3); or 

21 ‘‘(B) a contract manufacturer who provides 

22 cosmetic products to the entities described in 

23 subparagraphs (A) through (H) of paragraph 

24 (3).’’. 


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

2 ‘‘(a) REGISTRATION AND FEES FOR EXISTING MAN3 UFACTURING OR PROCESSING OF COSMETICS.— 

4 ‘‘(1) REGISTRATION, IN GENERAL.—Not later 

5 than 1 year after the date of enactment of the Per6 sonal Care Products Safety Act, and at a similar 

7 time in each subsequent year, as determined by the 

8 Food and Drug Administration, each responsible 

9 person engaged in manufacturing or processing a 

10 cosmetic product or a cosmetic formulation distrib11 uted in the United States shall register all of the re12 sponsible person’s facilities with the Food and Drug 

13 Administration. 

14 ‘‘(2) FEES.—If the average gross annual sales 

15 in the United States of cosmetic products of all of 

16 the responsible person’s facilities registered under 

17 paragraph (1) for the previous 3-year period is 

18 greater than $10,000,000, a registration shall not be 

19 complete under this subsection until the responsible 

20 person has paid any registration fee required under 

21 section 744O. 

22 ‘‘(b) REGISTRATION BY NEW FACILITIES.—Any fa23 cility first engaging after the date of enactment of the Per24 sonal Care Products Safety Act in an activity that would 

25 require it to register under subsection (a) shall register 

26 with the Food and Drug Administration within 60 days 


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1 of first engaging in such activity, and thereafter in accord2 ance with subsection (a). 

3 ‘‘(c) CONTRACT MANUFACTURERS.—If a facility 

4 manufactures or processes cosmetic products on behalf of 

5 a responsible person, the Food and Drug Administration 

6 shall require only a single registration for such facility 

7 even if such facility is manufacturing or processing its own 

8 cosmetic products or cosmetic products on behalf of more 

9 than 1 responsible person. Such single registration may 

10 be submitted to the Food and Drug Administration by 

11 such facility or any responsible person whose products are 

12 manufactured or processed at such facility. 

13 ‘‘(d) CHANGES TO INFORMATION.—A registrant who 

14 has submitted a registration under this section shall notify 

15 the Food and Drug Administration of any change to the 

16 information required under subsection (a) or (b) not later 

17 than 60 days after the date of such change, unless other18 wise specified by the Food and Drug Administration. 

19 ‘‘(e) FORMAT; CONTENTS.— 

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

21 shall be submitted using an electronic format, as 

22 specified in a registration form provided by the Food 

23 and Drug Administration. 

24 ‘‘(2) CONTENTS.— 


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1 ‘‘(A) IN GENERAL.—Except as provided in 

2 subparagraph (B), the registration shall contain 

3 the following information: 

4 ‘‘(i) Each facility’s name and full ad5 dress, identifying the precise physical loca6 tion of the facility. 

7 ‘‘(ii) The identity of the facility, in8 cluding the unique facility identifier, if 

9 any, previously assigned by the Food and 

10 Drug Administration to the facility under 

11 subsection (h). 

12 ‘‘(iii) All business trading names used 

13 by the facility. 

14 ‘‘(iv) The product category or cat15 egories of each cosmetic product or cos16 metic formulation manufactured or proc17 essed at the facility or on whose label the 

18 facility’s name and address appear. 

19 ‘‘(v) The type of activity conducted at 

20 the facility (such as manufacturing or 

21 processing). 

22 ‘‘(vi) The name, title, street address, 

23 telephone number, and electronic contact 

24 information of the emergency contact for 

25 the facility. 


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1 ‘‘(vii) In the case of a foreign facility, 

2 the name, street address, telephone num3 ber, emergency contact information, and 

4 name of the United States agent for the 

5 facility, and, if available, the electronic 

6 contact information of the United States 

7 agent. 

8 ‘‘(viii) The name, title, street address, 

9 telephone number, and electronic contact 

10 information of the individual submitting 

11 the registration. 

12 ‘‘(ix) An assurance that the Food and 

13 Drug Administration will be permitted to 

14 inspect such facility at the times and in 

15 the manner permitted by this Act. 

16 ‘‘(x) Additional information pertaining 

17 to the facility or to the cosmetic products 

18 or cosmetic formulations manufactured or 

19 processed at the facility, or on whose label 

20 the facility’s name and address appear, in21 cluding all brand names known to con22 sumers, as the Food and Drug Administra23 tion may require by regulation. 

24 ‘‘(xi) An ingredient listing for all cos25 metic products manufactured or processed 


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1 in such facility, in accordance with sub2 section (f), which, for each relevant cos3 metic product, may be submitted to the 

4 Food and Drug Administration as part of 

5 such registration or separately. 

6 ‘‘(xii) A written assurance that each 

7 cosmetic product manufactured or proc8 essed in such facility has been substan9 tiated for safety or carries the warning re10 quired under section 740.10 of title 21, 

11 Code of Federal Regulations (or any suc12 cessor regulations). The responsible person 

13 shall maintain records documenting any 

14 such substantiation of safety and the infor15 mation on which such determination is 

16 based until 5 years after the finished prod17 uct is no longer marketed, except that a 

18 responsible person for a domestic company 

19 whose sales are under $2,000,000 per year 

20 shall maintain such records for at least 2 

21 years after the finished product is no 

22 longer marketed. 

23 ‘‘(B) SMALL BUSINESSES.— 

24 ‘‘(i) REQUIREMENTS.—In the case of 

25 a registrant described in clause (ii), the 


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1 registration shall contain the following in2 formation: 

3 ‘‘(I) Each facility’s name and full 

4 address, identifying the precise phys5 ical location of the facility. 

6 ‘‘(II) The name, title, street ad7 dress, telephone number, and elec8 tronic contact information of the 

9 emergency contact for the facility. 

10 ‘‘(III) The consumer product cat11 egory or categories of each cosmetic 

12 product or cosmetic formulation man13 ufactured, processed, packed, or held 

14 at the facility or on whose label the 

15 facility’s name and address appear. 

16 ‘‘(ii) SMALL BUSINESS REG17 ISTRANTS.—A registrant described in this 

18 clause is a domestic registrant— 

19 ‘‘(I) whose average gross annual 

20 sales in the United States of cosmetic 

21 products for the previous 3-year pe22 riod is between $500,000 and 

23 $2,000,000 (or between $1,000,000 

24 and $2,000,000 in the case of sales of 


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1 cosmetic products produced in a pri2 vate residence); and 

3 ‘‘(II) who does not produce— 

4 ‘‘(aa) products that are in5 tended to go on the eye area; 

6 ‘‘(bb) lip products with 

7 color; 

8 ‘‘(cc) products that are in9 jected; 

10 ‘‘(dd) products that are in11 tended for internal use; or 

12 ‘‘(ee) products that are 

13 meant to alter appearance for 

14 more than 24 hours. 

15 ‘‘(iii) GUIDANCE.—The Food and 

16 Drug Administration shall, after consulta17 tion with the Small Business Administra18 tion and small businesses that manufac19 ture cosmetics, provide additional guidance 

20 for small businesses on compliance with 

21 the requirements of this section that would 

22 apply to small business registrants. Such 

23 guidance shall include specific examples of 

24 options for compliance that do not place an 

25 undue burden on small businesses. 


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1 ‘‘(3) ABBREVIATED REGISTRATION.—The Food 

2 and Drug Administration shall provide for an abbre3 viated registration renewal process for any registrant 

4 that has not had any changes to the required infor5 mation with respect to the facility or facilities in6 volved since the registrant submitted the preceding 

7 registration. 

8 ‘‘(f) COSMETIC PRODUCT INGREDIENT LISTING.— 

9 ‘‘(1) IN GENERAL.—The ingredient listing re10 quired pursuant to subsection (e)(2)(A)(xi) shall in11 clude— 

12 ‘‘(A) the unique identifier assigned under 

13 section (h), as applicable, of— 

14 ‘‘(i) each facility where the cosmetic 

15 product is manufactured or processed; and 

16 ‘‘(ii) the facility whose name and ad17 dress appear on the label, unless the state18 ment is filed by a contract manufacturer 

19 described in section 604(6)(B); 

20 ‘‘(B) the brand name and the full name for 

21 the cosmetic product as it appears on the label; 

22 ‘‘(C) the cosmetic product listing number, 

23 if any, previously assigned to the cosmetic prod24 uct by the Food and Drug Administration 

25 under paragraph (4); 


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1 ‘‘(D) the applicable cosmetic category for 

2 the cosmetic product; 

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

4 product, including a range of possible amounts 

5 of each ingredient, identified by the name 

6 adopted in regulations promulgated by the Food 

7 and Drug Administration, if any, or by the 

8 common or usual name of the ingredient, which 

9 shall include— 

10 ‘‘(i) a list of fragrances, flavors, and 

11 colors that may be included in the product, 

12 interchangeably, with ranges of possible 

13 amounts, which shall include— 

14 ‘‘(I) in the case of fragrances 

15 that are purchased from a fragrance 

16 supplier, identification of the fra17 grances by the name or code provided 

18 by the supplier, including the name 

19 and contact information for the fra20 grance supplier; and 

21 ‘‘(II) in the case of flavors that 

22 are purchased from a flavor supplier, 

23 identification of the flavors by the 

24 name or code provided by the sup25 plier, including the name and contact 


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1 information for the flavor supplier; 

2 and 

3 ‘‘(ii) other appropriate interchange4 able ingredients as the Food and Drug Ad5 ministration may specify in regulations or 

6 guidance that may be included in the prod7 uct, with ranges of possible amounts; 

8 ‘‘(F) the title and full contact information 

9 of each individual submitting the statement; 

10 ‘‘(G) if applicable, information on the la11 beling required under section 612; and 

12 ‘‘(H) if applicable, information showing 

13 that the cosmetic ingredient or ingredients in 

14 the product meet any specified conditions of use 

15 or tolerances required following a final deter16 mination of safety under section 607(d). 

17 ‘‘(2) ADDITIONAL INFORMATION.—In the case 

18 of a cosmetic ingredient statement that includes a 

19 list of fragrances or flavors that are purchased from 

20 a fragrance or flavor supplier as described in para21 graph (1)(E)(i), upon request by the Food and Drug 

22 Administration, the fragrance or flavor supplier shall 

23 submit to the Food and Drug Administration the 

24 complete list of ingredients in specific fragrances or 


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1 flavors, not later than 30 days after receiving such 

2 request. 

3 ‘‘(3) COSMETIC PRODUCT INGREDIENT STATE4 MENT FOR NEW OR REFORMULATED COSMETIC

5 PRODUCTS.— 

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

7 under subparagraph (B), in the case of a cos8 metic product that is first marketed after the 

9 date of enactment of the Personal Care Prod10 ucts Safety Act or a cosmetic product that is 

11 reformulated after such date of enactment, the 

12 responsible person shall submit a cosmetic in13 gredient statement to the Food and Drug Ad14 ministration within 60 days of first marketing 

15 the new cosmetic product or reformulated cos16 metic product, and annually thereafter. 

17 ‘‘(B) SMALL BUSINESSES.—The Food and 

18 Drug Administration shall allow a responsible 

19 person that is a business that meets the appli20 cable industry-based small business size stand21 ard established by the Administrator of the 

22 Small Business Administration under section 3 

23 of the Small Business Act to have a period 

24 longer than 60 days to submit an initial new 


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1 cosmetic ingredient statement under subpara2 graph (A). 

3 ‘‘(C) DEFINITION.—A cosmetic product 

4 shall not be considered first marketed or refor5 mulated after the date of enactment under sub6 paragraph (A) if the only change in such prod7 uct is in— 

8 ‘‘(i) the amount of an existing ingre9 dient if it is within the range previously re10 ported under paragraph (1)(E); or 

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

12 fragrance, flavor, or color, or such other 

13 interchangeable ingredients specified by 

14 the Food and Drug Administration in reg15 ulations or guidance, previously reported 

16 as a potential ingredient under paragraph 

17 (1)(E), if, in the case of such an addition, 

18 the amount is within the range previously 

19 reported. 

20 ‘‘(4) COSMETIC PRODUCTS LIST.—At the time 

21 of the initial submission of any cosmetic ingredient 

22 statement under this section, the Food and Drug 

23 Administration shall assign a unique cosmetic prod24 uct listing number to the cosmetic ingredient state25 ment. Based on such cosmetic ingredient statements, 


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1 the Food and Drug Administration shall compile 

2 and maintain a list of cosmetic products distributed 

3 in the United States, including the ingredients of 

4 each such product, and shall make available such list 

5 to any State, upon request. Information disclosed to 

6 a State that is exempt from disclosure under section 

7 552(b)(4) of title 5, United States Code, shall be 

8 treated as a trade secret and confidential informa9 tion by the State. 

10 ‘‘(g) INCOMPLETE OR INACCURATE REGISTRA11 TION.— 

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

13 after providing notice of the intent to cancel a reg14 istration and the basis for such cancellation, the 

15 Food and Drug Administration may cancel a reg16 istration under this section if the Food and Drug 

17 Administration has reasonable grounds to believe 

18 that the registration was not properly completed or 

19 updated in accordance with this section or otherwise 

20 contains false, incomplete, or inaccurate information. 

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

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

23 to cancel, the responsible person corrects the reg24 istration in accordance with the basis for the can25 cellation, and the required registration fee, if any, is 


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1 paid, the Food and Drug Administration shall not 

2 cancel such registration. 

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

4 registration of any cosmetic facility under this section, the 

5 Food and Drug Administration shall assign a unique iden6 tifier to the facility. 

7 ‘‘(i) REGISTRY OF FACILITIES.— 

8 ‘‘(1) IN GENERAL.—The Food and Drug Ad9 ministration shall compile, maintain, and update a 

10 registry of facilities that are registered under this 

11 section, and shall remove from such registry the 

12 name of any facility whose registration under this 

13 section is cancelled. The registry shall be publicly 

14 available. 

15 ‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In16 formation derived from the registry or registration 

17 documents that discloses the residential address of a 

18 registrant or that discloses specific facilities where 

19 specific cosmetic products are manufactured or proc20 essed shall not be subject to disclosure under section 

21 552 of title 5, United States Code. 

22 ‘‘SEC. 606. SUSPENSION OF REGISTRATION OR COSMETIC 

23 INGREDIENT STATEMENT. 

24 ‘‘(a) SUSPENSION OF REGISTRATION OF A FACIL25 ITY.—If the Food and Drug Administration determines 


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1 that a cosmetic formulation or cosmetic product manufac2 tured or processed by a registered facility and distributed 

3 in the United States has a reasonable probability of caus4 ing serious adverse health consequences or death to hu5 mans, and the Food and Drug Administration has a rea6 sonable belief that other products manufactured or proc7 essed by the facility may be similarly affected because of 

8 a failure that cannot be isolated to a single product or 

9 products or is sufficiently pervasive to raise concerns 

10 about other products manufactured in the facility, the 

11 Food and Drug Administration may suspend the registra12 tion of a facility. 

13 ‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATE14 MENT.—If the Food and Drug Administration determines 

15 that a cosmetic product manufactured in a registered fa16 cility has a reasonable probability of causing serious ad17 verse health consequences or death to humans, the Food 

18 and Drug Administration may suspend the cosmetic ingre19 dient statement of that product. 

20 ‘‘(c) NOTICE OF SUSPENSION.—Before suspending a 

21 facility registration or a cosmetic ingredient statement 

22 under this section, the Food and Drug Administration 

23 shall provide— 

24 ‘‘(1) notice to the facility registrant of the cos25 metic product or formulation or other responsible 


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1 person, as appropriate, of the intent to suspend the 

2 facility registration or the cosmetic ingredient state3 ment, which shall specify the basis of the determina4 tion by the Food and Drug Administration that the 

5 facility or the cosmetic ingredient should be sus6 pended and recommendations for specific actions to 

7 avoid suspension; and 

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

9 the notice provided under paragraph (1), for the re10 sponsible person to address the reasons for possible 

11 suspension of the facility registration or cosmetic in12 gredient statement. 

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

14 the Food and Drug Administration that adequate grounds 

15 do not exist to continue the suspension actions, the Food 

16 and Drug Administration shall promptly vacate the sus17 pension and reinstate the registration of the facility or the 

18 cosmetic ingredient statement. 

19 ‘‘(e) EFFECT OF SUSPENSION.— 

20 ‘‘(1) REGISTRATION.—If the registration of a 

21 facility is suspended under this section, no person 

22 shall introduce or deliver for introduction into inter23 state commerce cosmetics or cosmetic products from 

24 such facility. 


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1 ‘‘(2) COSMETIC INGREDIENT STATEMENT.—If 

2 the cosmetic ingredient statement for a cosmetic 

3 product is suspended under this section, no person 

4 shall introduce or deliver for introduction into inter5 state commerce any cosmetic product that is the 

6 subject of such statement. 

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

8 this section to issue an order to suspend a registration 

9 or vacate an order of suspension shall not be delegated 

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

11 SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL 

12 CONSTITUENTS. 

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

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

15 amended by section 101, is further amended by adding 

16 at the end the following: 

17 ‘‘SEC. 607. REVIEW OF INGREDIENTS AND NON-FUNC18 TIONAL CONSTITUENTS. 

19 ‘‘(a) INGREDIENTS AND NON-FUNCTIONAL CON20 STITUENTS SUBJECT TO REVIEW.— 

21 ‘‘(1) IN GENERAL.—The Food and Drug Ad22 ministration shall review the safety of the cosmetic 

23 ingredients and non-functional constituents listed 

24 under paragraph (3), as modified under subsection 

25 (c), if applicable, and issue an order under subVerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100

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1 section (d) with respect to the use of each such in2 gredient and presence of each such non-functional 

3 constituent. 

4 ‘‘(2) PUBLIC NOTICE AND COMMENT.—At the 

5 initiation of the review of each cosmetic ingredient 

6 or non-functional constituent, the Food and Drug 

7 Administration shall open a docket for the submis8 sion of public comment and additional data relevant 

9 to the safety of the ingredient or non-functional con10 stituent. The Food and Drug Administration shall 

11 provide 60 days for public comment. 

12 ‘‘(3) COSMETIC INGREDIENTS.— 

13 ‘‘(A) IN GENERAL.—Beginning in fiscal 

14 year 2022, the Food and Drug Administration 

15 shall annually select and complete a safety re16 view of at least 5 cosmetic ingredients or non17 functional constituents that were not reviewed 

18 in the prior 3 years, from a list determined in 

19 consultation with the cosmetic industry and 

20 consumer and health groups. The Food and 

21 Drug Administration may combine selected cos22 metics ingredients or non-functional constitu23 ents into categories for purposes of such review. 

24 The Food and Drug Administration may modify 

25 such list under subsection (c). 


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1 ‘‘(B) CONSIDERATIONS.—The determina2 tion of which ingredients or functional ingredi3 ents will be reviewed in a given year shall be 

4 publicized in annual reports to Congress and 

5 the public, in accordance with section 617. The 

6 review of any cosmetic ingredient or non-func7 tional constituent shall commence with a public 

8 announcement by the Food and Drug Adminis9 tration and the opening of a docket as required 

10 under paragraph (2). 

11 ‘‘(4) COMMENT PERIOD.—As part of the annual 

12 reporting to Congress and the public under section 

13 617, the Food and Drug Administration shall solicit 

14 public comment on which cosmetic ingredients or 

15 non-functional constituents on the list are of great16 est interest to be reviewed next for early review and 

17 which additional cosmetic ingredients or non-func18 tional constituents should be added to the list. The 

19 public may submit comments to the Food and Drug 

20 Administration at any time during the year regard21 ing which cosmetic ingredients or non-functional 

22 constituents of interest the Food and Drug Adminis23 tration may consider during that year or subsequent 

24 years. 


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1 ‘‘(b) LIST.—The Food and Drug Administration 

2 shall maintain a list, posted on the internet website of the 

3 Food and Drug Administration, of the cosmetic ingredi4 ents and non-functional constituents for which final orders 

5 have been issued under subsection (d)(3), the finding 

6 made for each such ingredient or non-functional con7 stituent under subsection (d)(4), as modified by any order 

8 under subsection (f), if applicable, and, if applicable, com9 pliance dates that are the subject of a final order under 

10 subsection (e). 

11 ‘‘(c) INITIATIVE OF THE FDA.—The Food and Drug 

12 Administration may at any time propose the issuance of 

13 an order on the safety of a cosmetic ingredient or non14 functional constituent that was not previously listed in 

15 subsection (a) or under section 617(a)(3). The Food and 

16 Drug Administration shall follow the same procedures and 

17 policies for review of any cosmetic ingredient or non-func18 tional constituent so proposed as for the ingredients and 

19 constituents reviewed pursuant to subsection (a). 

20 ‘‘(d) DETERMINATION ON SAFETY.— 

21 ‘‘(1) INITIAL PROPOSED ADMINISTRATIVE

22 ORDER.—Following consideration of data and com23 ments to the public docket and any other informa24 tion before the Food and Drug Administration, the 

25 Food and Drug Administration shall determine 


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1 whether there is adequate evidence to make an ini2 tial finding on the safety of the ingredient or non3 functional constituent. If the Food and Drug Ad4 ministration determines that there is adequate evi5 dence, the Food and Drug Administration shall issue 

6 a proposed administrative order and shall post such 

7 order on the internet website of the Food and Drug 

8 Administration, notwithstanding subchapter II of 

9 chapter 5 of title 5, United States Code. 

10 ‘‘(2) PUBLIC COMMENT.—Upon publication of 

11 the proposed administrative order described in para12 graph (1), the Food and Drug Administration shall 

13 open a docket for the submission of public comment. 

14 The Food and Drug Administration shall provide 30 

15 days for public comment following publication of the 

16 proposed administrative order. 

17 ‘‘(3) FINAL ADMINISTRATIVE ORDER.—Fol18 lowing the public comment period described in para19 graph (2) and consideration of comments to the pub20 lic docket and any other information before the Food 

21 and Drug Administration, the Food and Drug Ad22 ministration shall determine whether there is ade23 quate evidence to make a final finding on the safety 

24 of the ingredient or non-functional constituent. If 

25 the Food and Drug Administration determines that 


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1 there is adequate evidence, the Food and Drug Ad2 ministration shall issue a final administrative order 

3 and shall post such order on the internet website of 

4 the Food and Drug Administration, notwithstanding 

5 subchapter II of chapter 5 of title 5, United States 

6 Code. 

7 ‘‘(4) DETERMINATIONS.—In the proposed ad8 ministrative order or the final administrative order, 

9 as applicable, the Food and Drug Administration 

10 shall make a determination that the ingredient or 

11 non-functional constituent is— 

12 ‘‘(A) safe in cosmetic products under speci13 fied conditions of use or tolerances; 

14 ‘‘(B) safe in cosmetic products without the 

15 need for specified conditions of use or toler16 ances; or 

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

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

19 An order under paragraph (4)(A) shall include such 

20 conditions on the use of an ingredient or such toler21 ances on the presence of a non-functional con22 stituent as are necessary for the safety of cosmetic 

23 products containing such ingredient or non-func24 tional constituent, including— 


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

2 of the ingredient or non-functional constituent 

3 that may be present in a cosmetic product, in4 cluding limits in products intended for children 

5 and other vulnerable populations, and limits on 

6 use near the eye or mucosal membranes; 

7 ‘‘(B) warnings that are necessary or appro8 priate under section 612, including warnings re9 lated to use by children, pregnant women, popu10 lations with high exposure to the ingredient 

11 (such as workers who are exposed through pro12 duction practices or handling of final products), 

13 or other vulnerable populations, to help ensure 

14 safe use of cosmetic products containing the in15 gredient or non-functional constituent; and 

16 ‘‘(C) such other screening, safety protocol, 

17 or other similar conditions as are necessary for 

18 the safety of cosmetic products containing such 

19 ingredient or non-functional constituent. 

20 ‘‘(6) PUBLIC NOTICE.—A final order under this 

21 subsection shall set forth the determination of the 

22 Food and Drug Administration on safety, any condi23 tions of use or tolerances under subparagraph (A) or 

24 (B) of paragraph (4) and a summary of the valid 

25 scientific evidence supporting the finding. The order 


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1 shall be effective upon its publication on the internet 

2 website of the Food and Drug Administration and 

3 shall be considered final agency action. 

4 ‘‘(e) ORDER.— 

5 ‘‘(1) IN GENERAL.—If the Food and Drug Ad6 ministration issues a final administrative order 

7 under subparagraph (A) or (C) of subsection (d)(4), 

8 the Food and Drug Administration shall, at the 

9 same time as publication of the notice under sub10 section (d)(6), publish a proposed order identifying 

11 dates by which use of the ingredient or non-func12 tional constituent in cosmetic products shall comply 

13 with the final administrative order, and provide 60 

14 days for public comment, including comment on 

15 whether compliance is feasible within the proposed 

16 dates. After considering comments on the proposed 

17 order, the Food and Drug Administration shall pub18 lish in the Federal Register a final order. 

19 ‘‘(2) CONTENT.—The public notice information 

20 regarding the final order under paragraph (1) shall 

21 include a summary that is written in plain and un22 derstandable language that is comprehensible and 

23 meaningful for consumers. The summary shall in24 clude information on any conditions of use or warn25 ings required under section 612, including the appliVerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100

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1 cation to vulnerable populations, the types of safety 

2 studies evaluated, and any additional relevant infor3 mation that was part of the review process. 

4 ‘‘(f) MODIFICATION OF AN ORDER.—An order issued 

5 under subsection (d) or (e) may be modified or revoked 

6 by the Food and Drug Administration on the initiative of 

7 the Food and Drug Administration or in response to a 

8 petition. 

9 ‘‘(g) INADEQUATE EVIDENCE.— 

10 ‘‘(1) NOTICE; EXTENSION.—If the Food and 

11 Drug Administration determines that the available 

12 data and information are not adequate to make a 

13 proposed or final determination regarding safety 

14 under subsection (d)(4), with respect to a cosmetic 

15 ingredient or non-functional constituent, the Food 

16 and Drug Administration shall— 

17 ‘‘(A) publish such finding on the internet 

18 website of the Food and Drug Administration 

19 not later than 90 days after the close of the rel20 evant comment period for the ingredient or 

21 non-functional constituent under subsection 

22 (a)(2), in the case of a proposed order, or sub23 section (d)(2), in the case of a final order; and 

24 ‘‘(B)(i) include a notice providing inter25 ested persons an additional 30 days from the 


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1 notice date to provide additional data and infor2 mation; and 

3 ‘‘(ii) if, after the 30-day period under 

4 clause (i), the Food and Drug Administration 

5 determines that additional safety substantiation 

6 with respect to such ingredient or non-func7 tional constituent is necessary to make a safety 

8 determination— 

9 ‘‘(I) include a notice specifying an ad10 ditional time period, not to exceed 18 

11 months from the notice date, during which 

12 time the assurance made by a responsible 

13 person under section 605(e)(2)(A)(xii) with 

14 respect to the safety of such cosmetic in15 gredient or non-functional constituent shall 

16 be deemed to be in compliance with the re17 quirements of this Act, but shall not affect 

18 final determinations of safety under sub19 section (d); and 

20 ‘‘(II) plan to obtain such data and in21 formation. 

22 ‘‘(2) DETERMINATION; ORDER.— 

23 ‘‘(A) INADEQUATE DATA AND INFORMA24 TION.—If the Food and Drug Administration 

25 determines, after considering any additional 


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1 data and information submitted under para2 graph (1)(B), that the available data and infor3 mation still are not adequate to make a deter4 mination regarding safety under subsection 

5 (d)(4), the Food and Drug Administration 

6 shall, within 90 days of the close of the addi7 tional time period provided under paragraph 

8 (1)(B), issue a proposed order or a final admin9 istrative order— 

10 ‘‘(i) making a determination that the 

11 ingredient or non-functional constituent 

12 has not been shown to be safe in cosmetic 

13 products; and 

14 ‘‘(ii) explaining why the available data 

15 and information are not adequate to assess 

16 the safety of the ingredient or non-func17 tional constituent. 

18 ‘‘(B) ADEQUATE DATA AND INFORMA19 TION.—If the Food and Drug Administration 

20 determines, after considering any additional 

21 data and information submitted under para22 graph (1)(B), that the available data and infor23 mation are adequate to make a determination 

24 regarding safety under subsection (d)(4), the 

25 Food and Drug Administration shall, within 


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1 180 days of the close of the comment period, 

2 issue a proposed order, followed by a final 

3 order, on such cosmetic ingredient or non-func4 tional constituent, in accordance with such sub5 section. 

6 ‘‘(h) SAFETY ASSESSMENT.— 

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

8 an ingredient or non-functional constituent, the 

9 Food and Drug Administration shall consider wheth10 er there is adequate evidence to support a reasonable 

11 certainty among competent scientists that the ingre12 dient is not harmful under the recommended or sug13 gested conditions of use or customary or usual use, 

14 or that a non-functional constituent is not harmful 

15 under the recommended or suggested tolerance levels 

16 or the level at which it is customarily or usually 

17 present. The Food and Drug Administration may 

18 not consider an ingredient or non-functional con19 stituent harmful solely because it can cause minor 

20 adverse health reactions, such as minor transient al21 lergic reactions or minor transient skin irritations, 

22 in some users. 

23 ‘‘(2) FACTORS.—In assessing the safety of an 

24 ingredient or non-functional constituent, the Food 


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1 and Drug Administration shall consider, among 

2 other relevant factors, the following: 

3 ‘‘(A) The probable human exposure to the 

4 ingredient or non-functional constituent from 

5 expected use in cosmetics. 

6 ‘‘(B) The probable cumulative and aggre7 gate effect in humans of relevant exposure to 

8 the ingredient or non-functional constituent or 

9 to any chemically or pharmacologically related 

10 substances from use in cosmetics or other prod11 ucts with similar routes of exposure under rec12 ommended or suggested conditions of use or 

13 their customary use, to the extent adequate 

14 data is available for analysis. In appropriate 

15 cases, the Food and Drug Administration may 

16 consider available information on the total expo17 sure to an ingredient or non-functional con18 stituent from all sources. 

19 ‘‘(C) Whether warnings or recommenda20 tions in a product label required under section 

21 612, as part of any conditions of use or toler22 ances imposed by the Food and Drug Adminis23 tration, would be necessary and appropriate to 

24 help ensure the safety of the ingredient or non25 functional constituent. 


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1 ‘‘(3) DATA AND INFORMATION.— 

2 ‘‘(A) REQUIRED INFORMATION.—A deter3 mination that an ingredient or non-functional 

4 constituent is safe in cosmetics shall be based 

5 upon adequate evidence submitted or otherwise 

6 known to the Food and Drug Administration, 

7 which shall include full reports of all available 

8 studies, published or unpublished, that are ade9 quately designed to show whether the ingredient 

10 or non-functional constituent is safe. Such stud11 ies may include in vitro and in silico studies 

12 and epidemiological studies, biomonitoring stud13 ies, and studies focused on various points dur14 ing the lifespan of the subject, that use scientif15 ically valid methodology. 

16 ‘‘(B) ADDITIONAL RELEVANT INFORMA17 TION.—The Food and Drug Administration 

18 shall consider any other relevant information 

19 related to the safety of the ingredient or non20 functional constituent, including— 

21 ‘‘(i) adverse event reports; 

22 ‘‘(ii) findings and information from 

23 State, Federal, national, and international 

24 entities and other bodies composed of sci25 entific and medical experts; 


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1 ‘‘(iii) if the ingredient or non-func2 tional constituent is lawfully used or 

3 present in other products regulated by the 

4 Food and Drug Administration, the sci5 entific basis for such use; and 

6 ‘‘(iv) experience with the ingredient or 

7 non-functional constituent in products that 

8 are distributed in the United States or in 

9 other countries, if such experience is well10 documented and has resulted in substantial 

11 human exposure to the ingredient or non12 functional constituent over time. 

13 ‘‘(i) COAL-TAR HAIR DYE.—Coal-tar hair dye shall 

14 be subject to the conditions of section 601(a) unless the 

15 Food and Drug Administration has issued a final deter16 mination for a coal-tar hair dye ingredient under sub17 section (d)(4)(C). 

18 ‘‘(j) CERTAIN INGREDIENTS IMPARTING PIGMENT.— 

19 Ingredients imparting pigment to cosmetic products that 

20 are subject to review and approval pursuant to section 

21 721(b) shall not be subject to review under this section.’’. 

22 (b) GAO REPORT.—The Comptroller General of the 

23 United States shall conduct a review of the program of 

24 review of cosmetic ingredients and non-functional con25 stituents under section 607 of the Federal Food, Drug, 


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1 and Cosmetic Act, as added by subsection (a), and, not 

2 later than 5 years after the date of enactment of this Act, 

3 issue a report on such review. 

4 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS5 METICS. 

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

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

8 amended by section 102, is further amended by adding 

9 at the end the following: 

10 ‘‘SEC. 608. GOOD MANUFACTURING PRACTICES FOR COS11 METICS. 

12 ‘‘(a) IN GENERAL.—The Food and Drug Administra13 tion shall review national and international standards for 

14 cosmetic good manufacturing practices that are in exist15 ence on the date of enactment of the Personal Care Prod16 ucts Safety Act and shall develop and implement, through 

17 regulations, standards consistent, to the extent the Food 

18 and Drug Administration determines practicable and ap19 propriate, with such national and international standards 

20 for cosmetic good manufacturing practices to ensure that 

21 requirements of this chapter with respect to the manufac22 ture of cosmetic products are in harmony. 

23 ‘‘(b) CONSULTATION.—The standards under sub24 section (a) shall include simplified good manufacturing 

25 practices for small businesses that take into account the 


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1 size and scope of the business, developed in consultation 

2 with the Small Business Administration. 

3 ‘‘(c) TIMEFRAME.—The Food and Drug Administra4 tion shall publish a proposed rule described in subsection 

5 (a) not later than 18 months after the date of enactment 

6 of the Personal Care Products Safety Act and shall pub7 lish a final such rule not later than 3 years after such 

8 date of enactment.’’. 

9 (b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR10 ERS.— 

11 (1) LARGE BUSINESSES.—For businesses of a 

12 size greater than the Small Business Administra13 tion’s standard for a small business, section 608 of 

14 the Federal Food, Drug, and Cosmetic Act (as 

15 added by subsection (a)) shall take effect beginning 

16 180 days after the date on which the Food and 

17 Drug Administration makes effective cosmetic good 

18 manufacturing practices. 

19 (2) SMALL BUSINESSES.—For businesses of a 

20 size that meets the Small Business Administration’s 

21 standard for a small business, section 608 of the 

22 Federal Food, Drug, and Cosmetic Act (as added by 

23 subsection (a)) shall take effect beginning 2 years 

24 after the date the Food and Drug Administration 


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1 makes effective cosmetic good manufacturing prac2 tices. 

3 SEC. 104. ADVERSE EVENT REPORTS. 

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

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

6 103(a), is further amended by adding at the end the fol7 lowing: 

8 ‘‘SEC. 609. ADVERSE EVENT REPORTING FOR COSMETICS. 

9 ‘‘(a) IN GENERAL.—With respect to any cosmetic 

10 product distributed in the United States, the responsible 

11 person shall submit to the Food and Drug Administration 

12 a report of any serious adverse event associated with such 

13 cosmetic product, when used in the United States, accom14 panied by a copy of the label on or with the retail pack15 aging of the cosmetic, any new medical information, re16 lated to a submitted serious adverse event report that is 

17 received by the responsible person, and an annual report 

18 for all adverse events received by the responsible person. 

19 ‘‘(b) DEFINITIONS.—In this section: 

20 ‘‘(1) An ‘adverse event’ for a cosmetic product 

21 is a health-related event associated with the use of 

22 this product that is adverse. 

23 ‘‘(2) A ‘serious adverse event’ for a cosmetic 

24 product is an adverse event that— 

25 ‘‘(A) results in— 


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1 ‘‘(i) death; 

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

3 ‘‘(iii) inpatient hospitalization; 

4 ‘‘(iv) a persistent or significant dis5 ability or incapacity; 

6 ‘‘(v) congenital anomaly or birth de7 fect; or 

8 ‘‘(vi) significant disfigurement, includ9 ing serious and persistent rashes or infec10 tions and significant hair loss; or 

11 ‘‘(B) requires, based on appropriate med12 ical judgment, a medical or surgical interven13 tion to prevent an outcome described in sub14 paragraph (A). 

15 ‘‘(c) SUBMISSION OF REPORTS.— 

16 ‘‘(1) SERIOUS ADVERSE EVENT REPORTS.—Ex17 cept as provided in paragraph (2), with respect to a 

18 cosmetic product distributed in the United States, 

19 the responsible person shall submit a serious adverse 

20 event report to the Food and Drug Administration 

21 not later than 15 business days after information 

22 concerning the adverse event is received. If a serious 

23 adverse event report for a cosmetic with drug prop24 erties is filed using Form FDA 3500A (or any suc25 cessor form developed for such purpose) or its elecVerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100

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1 tronic equivalent for over-the-counter drugs, the re2 sponsible person shall not have to submit a duplica3 tive serious adverse event report under this section. 

4 ‘‘(2) NEW MEDICAL INFORMATION.—The re5 sponsible person shall submit to the Food and Drug 

6 Administration any new medical information, related 

7 to a submitted serious adverse event report that is 

8 received by the responsible person within 1 year of 

9 the initial report, and shall submit such information 

10 not later than 15 business days after the new infor11 mation is received by the responsible person. 

12 ‘‘(3) CONSOLIDATION OF REPORTS.—The Food 

13 and Drug Administration shall provide for systems 

14 to enable the responsible person to submit a single 

15 report that includes duplicate reports of, or new 

16 medical information related to, a serious adverse 

17 event. 

18 ‘‘(4) ANNUAL REPORT.— 

19 ‘‘(A) IN GENERAL.—Not later than March 

20 1 of each year, except as provided under sub21 paragraph (C), the responsible person shall sub22 mit an electronic report for the prior calendar 

23 year for each cosmetic product marketed during 

24 that year. 


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1 ‘‘(B) CONTENTS.—Each report under this 

2 paragraph shall contain a summary of all ad3 verse events received during the reporting pe4 riod, a complete list of individual reports, and 

5 an estimate of the total number of product 

6 units estimated to have been distributed to con7 sumers in the United States during such period. 

8 The report shall not include consumer com9 plaints that are solely regarding efficacy and do 

10 not contain any information about an adverse 

11 event. The Food and Drug Administration shall 

12 further specify the contents of the annual elec13 tronic report by regulation or guidance. 

14 ‘‘(C) SMALL BUSINESS EXCEPTION.—In 

15 the case of a domestic facility for which the av16 erage gross annual sales in cosmetic products in 

17 the United States over the previous 3-year pe18 riod is not more than $2,000,000, the respon19 sible person is not required to submit an annual 

20 report under this paragraph. 

21 ‘‘(5) EXEMPTION.—The Food and Drug Ad22 ministration may establish by regulation an exemp23 tion to any of the requirements under this sub24 section if the Food and Drug Administration deter25 mines that such exemption is supported by adequate 


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1 evidence and would have no adverse effect on public 

2 health. 

3 ‘‘(d) REQUIREMENTS.— 

4 ‘‘(1) IN GENERAL.—Each serious adverse event 

5 report under this section shall be submitted to the 

6 Food and Drug Administration using an electronic 

7 system of the Food and Drug Administration. The 

8 Food and Drug Administration shall make such elec9 tronic system available not later than 1 year after 

10 the date of enactment of the Personal Care Products 

11 Safety Act. 

12 ‘‘(2) MODIFICATION.—The format of the re13 porting system may be modified by the Food and 

14 Drug Administration and the reports may include 

15 additional information. The Food and Drug Admin16 istration may, in guidance, further specify the for17 mat and contents of required reports. 

18 ‘‘(3) SCOPE OF SERIOUS ADVERSE EVENT RE19 PORT.—A serious adverse event report (including all 

20 information submitted in the initial report or added 

21 later) submitted to the Food and Drug Administra22 tion under subsection (a) includes— 

23 ‘‘(A) a report under section 756 with re24 spect to safety and related to a specific cos25 metic product; 


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1 ‘‘(B) a record about an individual who suf2 fered the serious adverse event under section 

3 552a of title 5, United States Code; 

4 ‘‘(C) a medical or similar file documenting 

5 the serious adverse event, the disclosure of 

6 which would constitute a violation of section 

7 552(b)(6) of such title 5, and shall not be pub8 licly disclosed unless all personally identifiable 

9 information is redacted; and 

10 ‘‘(D) contact information for the individual 

11 reporting the serious adverse event. 

12 ‘‘(4) RESPONSIBILITY TO GATHER INFORMA13 TION.—After an individual initiates the reporting of 

14 a serious adverse event, the responsible person for 

15 the cosmetic product shall actively gather all of the 

16 information to complete and file the report with the 

17 Food and Drug Administration. 

18 ‘‘(5) NO ADVERSE EVENTS TO REPORT.—The 

19 Food and Drug Administration shall provide an op20 tion as part of the electronic registration process for 

21 the responsible person to indicate if such responsible 

22 person had no adverse events to report over the pre23 vious year. With respect to a responsible person who 

24 received no adverse event reports for a year, the an25 nual adverse event report requirement may be met 


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1 by indicating no such events on the annual registra2 tion form. 

3 ‘‘(e) LIMITATION WITH RESPECT TO ADVERSE

4 EVENT REPORTS.—The submission of an adverse event 

5 report in compliance with subsection (a) shall not con6 stitute an admission that the cosmetic involved caused or 

7 contributed to the adverse event. 

8 ‘‘(f) CONTACT INFORMATION.—The label of a cos9 metic shall bear the domestic telephone number or elec10 tronic contact information, and it is encouraged that the 

11 label include both the telephone number and electronic 

12 contact information, through which the responsible person 

13 may receive a report of an adverse event. 

14 ‘‘(g) MAINTENANCE OF RECORDS.—The responsible 

15 person shall maintain records related to each report of an 

16 adverse event received by the responsible person for a pe17 riod of 6 years. 

18 ‘‘(h) AVAILABILITY TO STATES.—The Food and 

19 Drug Administration shall make available records sub20 mitted under this section to any State, upon request. In21 formation disclosed to a State that is exempt from disclo22 sure under section 552(b)(4) of title 5, United States 

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

24 information by the State. 


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1 ‘‘(i) EFFECTIVE DATE OF REQUIREMENT WITH RE2 SPECT TO SERIOUS ADVERSE EVENTS.—The requirement 

3 under this section to report serious adverse events shall 

4 become effective on the date that the Food and Drug Ad5 ministration publicizes the availability of the electronic 

6 system described in subsection (d)(1).’’. 

7 SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU8 THORITY. 

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

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

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

12 ‘‘SEC. 610. INSPECTION OF COSMETIC RECORDS. 

13 ‘‘(a) INSPECTION OF RECORDS.—Each manufacturer 

14 or processor of a cosmetic shall, at the request of an offi15 cer or employee duly designated by the Food and Drug 

16 Administration, permit such officer or employee, upon 

17 presentation of appropriate credentials and written notice 

18 to such person, at reasonable times and within reasonable 

19 limits and in a reasonable manner, to have access to and 

20 copy— 

21 ‘‘(1) all records maintained under section 

22 605(e)(2)(A)(xii) or 609 and in accordance with the 

23 rules promulgated by the Food and Drug Adminis24 tration under section 608, as applicable; and 


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

2 other records, if the Food and Drug Administra3 tion— 

4 ‘‘(A) has a reasonable belief that the cos5 metic— 

6 ‘‘(i) is adulterated; 

7 ‘‘(ii) has caused a reportable serious 

8 adverse event; or 

9 ‘‘(iii) contains an ingredient that sub10 stantial new scientific information shows 

11 may be unsafe when present in a cosmetic; 

12 and 

13 ‘‘(B) provides written notice of the basis 

14 for the Food and Drug Administration’s rea15 sonable belief described in subparagraph (A). 

16 ‘‘(b) EXCLUSIONS.—No inspection authorized by this 

17 section shall extend to financial data, pricing data, per18 sonnel data (other than data as to qualification of tech19 nical and professional personnel performing functions sub20 ject to this Act), research data (other than safety data), 

21 or sales data other than shipment data. 

22 ‘‘(c) SCOPE.—The requirements under subsection (a) 

23 apply to records maintained by or on behalf of such person 

24 in any format (including paper and electronic formats) 

25 and at any location. 


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1 ‘‘(d) PROTECTION OF SENSITIVE INFORMATION.— 

2 The Food and Drug Administration shall take appropriate 

3 measures to ensure that there are effective procedures to 

4 prevent the unauthorized disclosure of any trade secret or 

5 confidential information that is obtained by the Food and 

6 Drug Administration pursuant to this section. Information 

7 disclosed to a State that is exempt from disclosure under 

8 section 552(b)(4) of title 5, United States Code, shall be 

9 treated as a trade secret and confidential information by 

10 the State. 

11 ‘‘(e) LIMITATIONS.—This section shall not be con12 strued— 

13 ‘‘(1) to limit the authority of the Food and 

14 Drug Administration to inspect records or to require 

15 establishment and maintenance of records under any 

16 other provision of this Act; or 

17 ‘‘(2) to have any legal effect on section 552 of 

18 title 5, United States Code, or section 1905 of title 

19 18, United States Code. 

20 ‘‘(f) SUBMISSION OF RECORDS.— 

21 ‘‘(1) IN GENERAL.—Any records required to be 

22 maintained by a responsible person under section 

23 605(e)(2)(A)(xii) shall, upon the written request of 

24 the Food and Drug Administration to the respon25 sible person, be provided to the Food and Drug AdVerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100

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1 ministration within a reasonable timeframe not to 

2 exceed 60 days, in either electronic or paper form. 

3 ‘‘(2) CRITERIA.—The Food and Drug Adminis4 tration may require records under paragraph (1) 

5 if— 

6 ‘‘(A) the Food and Drug Administration 

7 has a reasonable belief, described in written no8 tice, that— 

9 ‘‘(i) the finished product may be 

10 harmful based on adverse event reports or 

11 other scientific information; or 

12 ‘‘(ii) scientific information raises cred13 ible and relevant questions about the safe14 ty of the product or any of its ingredients; 

15 ‘‘(B) the Food and Drug Administration, 

16 an expert regulatory body, or an expert body 

17 composed of scientific and medical experts finds 

18 an ingredient in the product to be unsafe under 

19 the conditions of use of the product; or 

20 ‘‘(C) the Food and Drug Administration 

21 concludes that submission of the records will 

22 serve the public health or otherwise enable the 

23 Food and Drug Administration to fulfill the 

24 cosmetic safety purposes of this section.’’. 


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1 ‘‘SEC. 611. MANDATORY RECALL AUTHORITY. 

2 ‘‘(a) VOLUNTARY PROCEDURES.—If the Food and 

3 Drug Administration determines that there is a reasonable 

4 probability that a cosmetic is adulterated under section 

5 601 or misbranded under section 602 and the use of or 

6 exposure to such cosmetic is likely to cause serious adverse 

7 health consequences or death, the Food and Drug Admin8 istration shall provide the responsible person with an op9 portunity to voluntarily cease distribution and recall such 

10 article. 

11 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE

12 DISTRIBUTION AND GIVE NOTICE.— 

13 ‘‘(1) IN GENERAL.—If the responsible person 

14 refuses to or does not voluntarily cease distribution 

15 or recall such cosmetic within the time and in the 

16 manner prescribed by the Food and Drug Adminis17 tration, the Food and Drug Administration may 

18 order such person to— 

19 ‘‘(A) immediately cease distribution of 

20 such cosmetic; and 

21 ‘‘(B) as applicable, immediately notify all 

22 persons— 

23 ‘‘(i) manufacturing, processing, pack24 ing, transporting, holding, receiving, dis25 tributing, or importing and selling such 

26 cosmetic; and 


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1 ‘‘(ii) to which such cosmetic has been 

2 distributed, transported, or sold (except 

3 consumers), 

4 to immediately cease distribution of such cos5 metic. 

6 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 

7 ‘‘(A) IN GENERAL.—If a cosmetic covered 

8 by a recall order issued under paragraph (1)(B) 

9 has been distributed to a warehouse-based 

10 third-party logistics provider without providing 

11 such provider sufficient information to know or 

12 reasonably determine the precise identity of 

13 such cosmetic covered by a recall order that is 

14 in its possession, the notice provided by the re15 sponsible person subject to the order issued 

16 under paragraph (1)(B) shall include such in17 formation as is necessary for the warehouse18 based third-party logistics provider to identify 

19 the cosmetic. 

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

21 in this paragraph shall be construed— 

22 ‘‘(i) to exempt a warehouse-based 

23 third-party logistics provider from the re24 quirements of this chapter, including the 


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1 requirements of this section and section 

2 610; or 

3 ‘‘(ii) to exempt a warehouse-based 

4 third-party logistics provider from being 

5 the subject of a mandatory recall order. 

6 ‘‘(3) DETERMINATION TO LIMIT AREAS AF7 FECTED.—If the Food and Drug Administration re8 quires a responsible person to cease distribution 

9 under paragraph (1)(A) of a cosmetic, the Food and 

10 Drug Administration may limit the size of the geo11 graphic area and the markets affected by such ces12 sation if such limitation would not compromise the 

13 public health. 

14 ‘‘(c) HEARING ON ORDER.—The Food and Drug Ad15 ministration shall provide the responsible party subject to 

16 an order under subsection (b) with an opportunity for an 

17 informal hearing, to be held as soon as possible, but not 

18 later than 2 days after the issuance of the order, on the 

19 actions required by the order and on why the cosmetic that 

20 is the subject of the order should not be recalled. 

21 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA22 TION OF ORDER.— 

23 ‘‘(1) AMENDMENT OF ORDER.—If, after pro24 viding opportunity for an informal hearing under 

25 subsection (c), the Food and Drug Administration 


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1 determines that removal of the cosmetic from com2 merce is necessary, the Food and Drug Administra3 tion shall, as appropriate— 

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

5 such cosmetic or other appropriate action; 

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

7 shall occur; 

8 ‘‘(C) require periodic reports to the Food 

9 and Drug Administration describing the 

10 progress of the recall; and 

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

12 such cosmetic was, or may have been, distrib13 uted. 

14 ‘‘(2) VACATING OF ORDER.—If, after such hear15 ing, the Food and Drug Administration determines 

16 that adequate grounds do not exist to continue the 

17 actions required by the order, or that such actions 

18 should be modified, the Food and Drug Administra19 tion shall vacate the order or modify the order. 

20 ‘‘(e) COOPERATION AND CONSULTATION.—The Food 

21 and Drug Administration shall work with State and local 

22 public health officials in carrying out this section, as ap23 propriate. 


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

2 under this section, the Food and Drug Administration 

3 shall— 

4 ‘‘(1) ensure that a press release is published re5 garding the recall, and that alerts and public notices 

6 are issued, as appropriate, in order to provide notifi7 cation— 

8 ‘‘(A) of the recall to consumers and retail9 ers to whom such cosmetic was, or may have 

10 been, distributed; and 

11 ‘‘(B) that includes, at a minimum— 

12 ‘‘(i) the name of the cosmetic subject 

13 to the recall; 

14 ‘‘(ii) a description of the risk associ15 ated with such article; and 

16 ‘‘(iii) to the extent practicable, infor17 mation for consumers about similar cos18 metics that are not affected by the recall; 

19 and 

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

21 of the Food and Drug Administration of an image 

22 of the cosmetic that is the subject of the press re23 lease described in paragraph (1), if available. 

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

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


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

2 Commissioner. 

3 ‘‘(h) EFFECT.—Nothing in this section shall affect 

4 the authority of the Food and Drug Administration to re5 quest or participate in a voluntary recall, or to issue an 

6 order to cease distribution or to recall under any other 

7 provision of this chapter or under the Public Health Serv8 ice Act.’’. 

9 SEC. 106. LABELING. 

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

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

12 amended by section 105, is further amended by adding 

13 at the end the following: 

14 ‘‘SEC. 612. LABELING. 

15 ‘‘(a) SAFETY REVIEW AND LABELING.—Following a 

16 review of cosmetic ingredients that determines that warn17 ings are required to help ensure safe use of cosmetic prod18 ucts under section 607(d)(5), the Food and Drug Admin19 istration shall require labeling of cosmetics that are not 

20 appropriate for use in the entire population, including 

21 warnings that vulnerable populations, such as children or 

22 pregnant women, should limit or avoid using the product. 

23 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL

24 USE.— 


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1 ‘‘(1) DEFINITION OF PROFESSIONAL.—For pur2 poses of this section, with respect to cosmetics, the 

3 term ‘professional’ means an individual who— 

4 ‘‘(A) is licensed by an official State author5 ity to practice in the field of cosmetology, nail 

6 care, barbering, or esthetics; 

7 ‘‘(B) has complied with all requirements 

8 set forth by the State for such licensing; and 

9 ‘‘(C) has been granted a license by a State 

10 board or legal agency or legal authority. 

11 ‘‘(2) LISTING OF INGREDIENTS.—Cosmetic 

12 products used and sold by professionals shall list all 

13 ingredients and warnings, as required for other cos14 metic products under this chapter. 

15 ‘‘(3) PROFESSIONAL USE LABELING.—In the 

16 case of a cosmetic product intended to be used only 

17 by a professional on account of a specific ingredient 

18 or increased concentration of an ingredient that re19 quires safe handling by trained professionals, the 

20 product shall bear a statement as follows: ‘To be Ad21 ministered Only by Licensed Professionals’. 

22 ‘‘(c) REQUIREMENTS.— 

23 ‘‘(1) DISPLAY.—A warning required under sub24 section (a) and a statement required under sub25 section (b)(3) shall be prominently displayed— 


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1 ‘‘(A) in the primary language used on the 

2 label; and 

3 ‘‘(B) in conspicuous and legible type in 

4 contrast by typography, layout, or color with 

5 other material printed or displayed on the label. 

6 ‘‘(2) MINIMUM WARNING REQUIREMENTS.—A 

7 responsible person may include on the labeling any 

8 additional warnings in addition to the minimum 

9 warnings required under subsection (a). 

10 ‘‘(d) INTERNET SALES.—In the case of internet sales 

11 of cosmetics, each internet website offering a cosmetic 

12 product for sale to consumers shall provide the same infor13 mation, in an electronically readable format, that is in14 cluded on the packaging of the cosmetic product as regu15 larly available through in-person sales, except information 

16 that is unique to a single cosmetic product sold in a retail 

17 facility, such as a lot number or expiration date, and the 

18 warnings and statements described in subsection (c) shall 

19 be prominently and conspicuously displayed on the 

20 website. 

21 ‘‘(e) CONTACT INFORMATION.—The label on each 

22 cosmetic shall bear the manufacturer’s toll-free domestic 

23 telephone number and electronic contact information, and 

24 it is encouraged that the label include both the telephone 

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1 sumers may use to contact the responsible person with re2 spect to adverse events. The contact number shall provide 

3 a means for consumers to obtain additional information 

4 about ingredients in the designated cosmetic, including the 

5 ability to ask if a specific ingredient may be present that 

6 is not listed on the label and whether a specific ingredient 

7 may be contained in the fragrance or flavor used in the 

8 cosmetic. The manufacturer of the cosmetic is responsible 

9 for providing such information, including obtaining the in10 formation from suppliers if it is not readily available. Sup11 pliers are required to release such information upon re12 quest of the cosmetic manufacturer.’’. 

13 (b) USE OF THE TERM ‘‘NATURAL’’ IN LABELING.— 

14 The Food and Drug Administration— 

15 (1) in consultation with consumer protection 

16 stakeholders and the scientific community, shall es17 tablish a definition of the term ‘‘natural’’ with re18 spect to the use of such term in the labeling of cos19 metics; 

20 (2) not later than 1 year after the date of en21 actment of this Act, shall issue proposed regulations 

22 setting forth such definition; and 

23 (3) not later than 2 years after such date of en24 actment, issue final regulations setting forth such 

25 definition. 


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1 (c) EFFECTIVE DATE.—Section 612 of the Federal 

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

3 (a), shall take effect on the date that is 1 year after the 

4 date of enactment of this Act. 

5 SEC. 107. COAL TAR CHEMICALS. 

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

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

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

9 ‘‘SEC. 613. COAL TAR CHEMICALS. 

10 ‘‘Specific ingredients in coal tar hair dyes may be se11 lected and reviewed under section 607. If the Food and 

12 Drug Administration reviews a coal-tar ingredient found 

13 in hair dye and makes a safety determination under sec14 tion 607(d) for such ingredient, such determination shall 

15 include consideration for the safe use of such ingredient 

16 through appropriate conditions of use, which may include 

17 a specific label requirement, specified limits of concentra18 tions, or other such conditions of use as the Food and 

19 Drug Administration determines appropriate, including a 

20 finding of not safe under any conditions if appropriate.’’. 

21 SEC. 108. FRAGRANCE ALLERGEN DISCLOSURE. 

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

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

24 amended by section 107, is further amended by adding 

25 at the end the following: 


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1 ‘‘SEC. 614. FRAGRANCE ALLERGENS. 

2 ‘‘(a) FRAGRANCE ALLERGENS.—Not later than 2 

3 years after the date of enactment of the Personal Care 

4 Products Safety Act, the responsible person shall include 

5 on the label of any cosmetic product containing one or 

6 more fragrance allergens, a list of each such fragrance al7 lergen present in a rinse-off cosmetic at a concentration 

8 above 0.01 percent (100 ppm) or present in a leave-on 

9 cosmetic product at a concentration above .001 percent 

10 (10 ppm), in a form and manner as specified by the Food 

11 and Drug Administration.’’. 

12 ‘‘(b) IDENTIFIED FRAGRANCE ALLERGENS.—The 

13 fragrance allergens required to be identified on a label of 

14 a cosmetic product pursuant to subsection (a) include— 

15 ‘‘(1) alpha-Isomethyl ionone; 

16 ‘‘(2) amyl cinnamal; 

17 ‘‘(3) amylcinnamyl alcohol; 

18 ‘‘(4) anise alcohol; 

19 ‘‘(5) benzyl alcohol; 

20 ‘‘(6) benzyl benzoate; 

21 ‘‘(7) benzyl cinnamate; 

22 ‘‘(8) benzyl salicylate; 

23 ‘‘(9) butylphenyl methylpropional; 

24 ‘‘(10) cinnamal; 

25 ‘‘(11) cinnamyl alcohol; 

26 ‘‘(12) citral; 


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1 ‘‘(13) citronellol; 

2 ‘‘(14) coumarin; 

3 ‘‘(15) eugenol; 

4 ‘‘(16) evernia prunastri (oak moss); 

5 ‘‘(17) evernia furfuracea (tree moss); 

6 ‘‘(18) farnesol; 

7 ‘‘(19) geraniol; 

8 ‘‘(20) hexyl cinnamal; 

9 ‘‘(21) hydroxycitronellal; 

10 ‘‘(22) hydroxyisohexyl 3-cyclohexene 

11 carboxaldehyde; 

12 ‘‘(23) isoeugenol; 

13 ‘‘(24) limonene; 

14 ‘‘(25) linalool; 

15 ‘‘(26) methyl 2-octynoate; and 

16 ‘‘(27) other substances as identified by the 

17 Food and Drug Administration in guidance issued 

18 pursuant to this section. 

19 ‘‘(c) GUIDANCE.— 

20 ‘‘(1) ISSUANCE.—Not later than one year after 

21 the date of enactment of the Personal Care Products 

22 Safety Act, the Food and Drug Administration shall 

23 issue guidance specifying the form and manner of 

24 fragrance allergen listing on the label of cosmetic 

25 products pursuant to subsection (a). 


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1 ‘‘(2) CONTENT.—The guidance described in 

2 paragraph (1) shall— 

3 ‘‘(A) specify the form and manner of fra4 grance allergen listing for cosmetic products 

5 where the package or label is too small or oth6 erwise is unable to accommodate a label with 

7 sufficient space to bear the information re8 quired for compliance with this section; and 

9 ‘‘(B) take into consideration requirements 

10 under international regulations for fragrance al11 lergen labeling, as appropriate. 

12 ‘‘(3) UPDATES.—The Food and Drug Adminis13 tration may, as appropriate, update the list of fra14 grance allergens to include additional substances 

15 pursuant to guidance issued under this subsection 

16 and taking into consideration international regula17 tions, as appropriate. 

18 ‘‘(d) CONTACT INFORMATION.— 

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

20 the label on a cosmetic product for consumers to re21 port adverse events shall also provide a means for 

22 consumers to obtain additional information about 

23 the inclusion of any recognized fragrance allergen 

24 required to be included on such label under sub25 section (a). 


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1 ‘‘(2) RESPONSE.— 

2 ‘‘(A) IN GENERAL.—The responsible per3 son shall— 

4 ‘‘(i) upon receipt of a request for in5 formation under paragraph (1), promptly 

6 obtain and provide such information to the 

7 requesting consumer; and 

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

9 possession of a supplier, promptly obtain 

10 such information from such supplier, if 

11 reasonably available. 

12 ‘‘(B) SUPPLIER.—A relevant supplier shall 

13 promptly provide information requested to a re14 sponsible person pursuant to subparagraph 

15 (A)(ii).’’. 

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

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

18 as amended by section 114(c), is further amended by add19 ing at the end the following: 

20 ‘‘(i) If its labeling or packaging does not contain a 

21 listing of ingredients that meets the requirements of sec22 tion 614.’’. 

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

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1 merce on or after the date that is 2 years after the date 

2 of enactment of this Act. 

3 SEC. 109. SENSE OF THE SENATE ON ANIMAL TESTING. 

4 (a) ANIMAL TESTING.—Chapter VI of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), 

6 as amended by section 108, is further amended by adding 

7 the following: 

8 ‘‘SEC. 615. ANIMAL TESTING. 

9 ‘‘It is the sense of the Senate that animal testing 

10 should not be used for the purposes of safety testing on 

11 cosmetic products and should be phased out with the ex12 ception of appropriate allowances.’’. 

13 SEC. 110. PREEMPTION. 

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

15 Act (21 U.S.C. 361 et seq.), as amended by section 109, 

16 is further amended by adding the following: 

17 ‘‘SEC. 616. PREEMPTION. 

18 ‘‘(a) IN GENERAL.—No State or political subdivision 

19 of a State may establish or continue in effect any require20 ment for cosmetics, other than a requirement that is in 

21 full effect and implemented on the date of enactment of 

22 the Personal Care Products Safety Act— 

23 ‘‘(1) with respect to registration, good manufac24 turing practices, mandatory recalls, or adverse event 

25 reporting; or 


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1 ‘‘(2) with respect to the safety of a cosmetic in2 gredient or non-functional constituent that is the 

3 subject of a final order on a determination of safety 

4 under this chapter, unless the requirement of the 

5 State or political subdivision is more restrictive than 

6 the final order under section 607(d)(3). 

7 ‘‘(b) SAFETY OF COSMETIC INGREDIENTS AND NON8 FUNCTIONAL CONSTITUENTS.— 

9 ‘‘(1) DELAYED EFFECT OF NEW STATE RE10 QUIREMENTS.— 

11 ‘‘(A) IN GENERAL.—From the date that 

12 the Food and Drug Administration has made 

13 public the final selection of a cosmetic ingre14 dient or non-functional constituent to be re15 viewed in the coming year under section 

16 607(a)(3) and opened the public comment pe17 riod under section 607(a)(2), until the date that 

18 is one year after the Food and Drug Adminis19 tration has made public such selection, no State 

20 or political subdivision of a State may establish 

21 any new requirement related to such cosmetic 

22 ingredient or non-functional constituent. 

23 ‘‘(B) INITIAL REVIEW.—With respect to 

24 the cosmetic ingredients to be reviewed in the 

25 first year, in accordance with section 607(a)(3), 


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1 for the 1-year period beginning on the date that 

2 is 6 months after the date of enactment of the 

3 Personal Care Products Safety Act, no State or 

4 political subdivision of a State may establish 

5 any new requirement related to such cosmetic 

6 ingredient or non-functional constituent. 

7 ‘‘(2) SCOPE.—Subsection (a)(2) shall not be 

8 construed to affect the authority of a State or polit9 ical subdivision of a State with respect to any re10 quirement for the safety of a cosmetic ingredient or 

11 non-functional constituent that is unrelated to the 

12 scope of the safety assessment under section 607. 

13 ‘‘(3) SENSE OF CONGRESS.—It is the sense of 

14 Congress that a State or political subdivision that 

15 regulates the safety of cosmetics with respect to the 

16 health of humans beyond the scope of section 607 

17 should utilize the safety assessment criteria de18 scribed in section 607(h). 

19 ‘‘(c) STATE REQUIREMENT THAT IS IN FULL EF20 FECT AND IMPLEMENTED.—For purposes of this section: 

21 ‘‘(1) STATE REQUIREMENT.—A State require22 ment includes a State requirement that is adopted 

23 by a State public initiative or referendum. 

24 ‘‘(2) FULL EFFECT AND IMPLEMENTED.—The 

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1 ments of States that are implemented after the date 

2 of enactment of the Personal Care Products Safety 

3 Act, if such requirements are under a law that was 

4 in effect, or a lawful program that was established 

5 and functioning, prior to the date of enactment of 

6 the Personal Care Products Safety Act. 

7 ‘‘(d) LIMITATION.—Nothing in the amendments to 

8 this Act made by the Personal Care Products Safety Act 

9 shall be construed to preempt any State statute, public 

10 initiative, referendum, or other State action, except as ex11 pressly provided in this section. 

12 ‘‘(e) SAVINGS.—Nothing in the amendments to this 

13 Act made by the Personal Care Products Safety Act, nor 

14 any standard, rule, requirement, regulation, adverse event 

15 report, safety assessment, safety determination, scientific 

16 assessment, or order issued or implemented pursuant to 

17 such amendments, shall be construed to modify or other18 wise affect, preempt, or displace any cause of action or 

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

20 criminal cause of action, whether statutory or based in 

21 common law. 

22 ‘‘(f) SENSE OF THE SENATE.—It is the sense of the 

23 Senate that subsection (e) does not negate the other provi24 sions of this section.’’. 


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1 SEC. 111. REPORTING. 

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

3 Act (21 U.S.C. 361 et seq.), as amended by section 110, 

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

5 ‘‘SEC. 617. REPORTING. 

6 ‘‘(a) PERFORMANCE REPORT.—Not later than 1 year 

7 after the date of enactment of the Personal Care Products 

8 Safety Act, and not later than 60 days prior to the end 

9 of each fiscal year for which fees are collected under sec10 tion 744O, the Food and Drug Administration shall pre11 pare and submit to Congress a report concerning the 

12 progress of the Food and Drug Administration in achiev13 ing the objectives of the Personal Care Products Safety 

14 Act during such fiscal year and the future plans of the 

15 Food and Drug Administration for meeting the objectives. 

16 The annual report for a fiscal year shall include— 

17 ‘‘(1) the number of registered facilities and cos18 metic ingredient statements on file with the Food 

19 and Drug Administration; 

20 ‘‘(2) identification of the cosmetic ingredients 

21 and non-functional constituents that have been fully 

22 reviewed for safety by the Food and Drug Adminis23 tration in the prior fiscal year and for which a final 

24 administrative order has been released; 

25 ‘‘(3) identification of at least 5 specific cosmetic 

26 ingredients and non-functional constituents that will 


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1 be reviewed by the Food and Drug Administration 

2 in the next fiscal year; 

3 ‘‘(4) the number of facilities inspected and 

4 mandatory recalls that transpired during that fiscal 

5 year; 

6 ‘‘(5) the number of serious adverse event re7 ports received by the Food and Drug Administration 

8 during that fiscal year; and 

9 ‘‘(6) any trends identified by the Food and 

10 Drug Administration about adverse event reports re11 lated to specific cosmetic ingredients or non-func12 tional constituents. 

13 ‘‘(b) PUBLIC AVAILABILITY.—The Food and Drug 

14 Administration shall make the reports required under sub15 section (a) available to the public on the internet website 

16 of the Food and Drug Administration on the date of sub17 mission of such reports to Congress. 

18 ‘‘(c) PUBLIC INPUT ON SAFETY REVIEW.—Upon re19 lease of the report described in subsection (a), the Food 

20 and Drug Administration shall provide the public with an 

21 opportunity to provide feedback, at any time during the 

22 year, on the identification of ingredients under subsection 

23 (a)(3) by— 

24 ‘‘(1) providing an electronic portal, upon release 

25 of the report, enabling the public to— 


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1 ‘‘(A) comment on the cosmetic ingredients 

2 or non-functional constituents under review for 

3 the current year; 

4 ‘‘(B) recommend additional cosmetic ingre5 dients and non-functional constituents to be 

6 considered for review for safety in future years; 

7 and 

8 ‘‘(C) comment on the priorities for the spe9 cific cosmetic ingredients and non-functional 

10 constituents that the Food and Drug Adminis11 tration anticipates will be reviewed in the next 

12 fiscal year; 

13 ‘‘(2) announcing on the internet website of the 

14 Food and Drug Administration, within the first 30 

15 days of the new fiscal year, any amendments to the 

16 list of cosmetic ingredients and non-functional con17 stituents submitted pursuant to subsection (a)(3) 

18 based on public input, pursuant to paragraph (1); 

19 and 

20 ‘‘(3) together with the final announcement of at 

21 least 5 specific cosmetic ingredients and non-func22 tional constituents that will be reviewed in the com23 ing year under section 607, providing a comment pe24 riod for further public input, pursuant to section 

25 607(a)(2).’’. 


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1 SEC. 112. SMALL BUSINESSES. 

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

3 Act (21 U.S.C. 361 et seq.), as amended by section 111, 

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

5 ‘‘SEC. 618. SMALL BUSINESSES. 

6 ‘‘The Commissioner, in coordination with the Admin7 istrator of the Small Business Administration, shall pro8 vide technical assistance, such as guidance and expertise, 

9 to small businesses regarding compliance with the Per10 sonal Care Products Safety Act, including the amend11 ments made by such Act.’’. 

12 SEC. 113. APPLICABILITY WITH RESPECT TO CERTAIN COS13 METICS. 

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

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

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

17 ‘‘SEC. 619. APPLICABILITY WITH RESPECT TO CERTAIN 

18 COSMETICS. 

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

20 is subject to the requirements under this chapter and 

21 chapter V, if any requirement under chapter V with re22 spect to such cosmetic or facility is substantially similar 

23 to a requirement under this chapter, the cosmetic product 

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

25 applicable requirement under this chapter if such product 

26 or facility is in compliance with such substantially similar 


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1 requirement under chapter V, provided that the product 

2 or facility has not obtained a waiver from the requirement 

3 under chapter V. In the case of a cosmetic product or fa4 cility that is subject to, and in compliance with, a fee 

5 under subchapter C of chapter VII, other than a fee under 

6 part 11 of such subchapter, any fee under such part 11 

7 shall be waived with respect to such cosmetic product or 

8 facility (with respect to cosmetic products).’’. 

9 SEC. 114. ENFORCEMENT. 

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

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend12 ed— 

13 (1) in paragraph (e)— 

14 (A) by striking ‘‘504, 564,’’ and inserting 

15 ‘‘504, 564, 609, 610,’’; and 

16 (B) by striking ‘‘519, 564,’’ and inserting 

17 ‘‘519, 564, 609,’’; 

18 (2) in paragraph (j), by inserting ‘‘606, 607, 

19 608,’’ before ‘‘704’’; 

20 (3) in paragraph (ii)— 

21 (A) by striking ‘‘760 or 761) or’’ and in22 serting ‘‘604, 760, or 761) or’’; and 

23 (B) by striking ‘‘761) submitted’’ and in24 serting ‘‘761 or as described in section 609) 

25 submitted’’; 


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1 (4) in paragraph (xx) by inserting ‘‘or 611’’ 

2 after ‘‘423’’; and 

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

4 ‘‘(fff) The failure to register in accordance with sec5 tion 605, the failure to provide any information required 

6 by section 605, or the failure to update the information 

7 required by section 605, as required.’’. 

8 (b) ADULTERATION.—Section 601 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amend10 ed by adding at the end the following: 

11 ‘‘(f) If the methods used in, or the facilities or con12 trols used for, its manufacture, processing, packing, or 

13 holding do not conform to current good manufacturing 

14 practice, as prescribed by the Food and Drug Administra15 tion in accordance with section 608. 

16 ‘‘(g) If it contains, after the date prescribed under 

17 section 607(e), an ingredient that the Food and Drug Ad18 ministration has determined under section 607(d)(4) to be 

19 not safe, or not safe under the conditions of use rec20 ommended or suggested in the label or a non-functional 

21 constituent that the Food and Drug Administration has 

22 determined under section 607(d)(4) to be not safe or not 

23 safe in the amount present in the cosmetic. 


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1 ‘‘(h) If it is a cosmetic product for which assurances 

2 regarding safety substantiation have not been supplied 

3 under section 605(e)(2)(A)(xii).’’. 

4 (c) MISBRANDING.—Section 602 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend6 ed— 

7 (1) in paragraph (b)— 

8 (A) by striking ‘‘and (2)’’ and inserting 

9 ‘‘(2)’’; and 

10 (B) by inserting ‘‘; and (3) a domestic ad11 dress or a domestic telephone number, and it is 

12 encouraged that the label include both a domes13 tic address and a domestic telephone number, 

14 through which the responsible person may re15 ceive a report of an adverse event associated 

16 with the use of such cosmetic product’’ after 

17 ‘‘numerical count’’; and 

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

19 ‘‘(g) If it has been manufactured or processed in any 

20 factory, warehouse, or establishment and the responsible 

21 person, operator, or agent of such factory, warehouse, or 

22 establishment delays, denies, or limits an inspection, or 

23 refuses to permit entry or inspection. 

24 ‘‘(h) If its labeling does not conform with a require25 ment under section 612.’’. 


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

2 of enactment of this Act, the Food and Drug Administra3 tion shall issue guidance that defines the circumstances 

4 that would constitute delaying, denying, or limiting inspec5 tion, or refusing to permit entry or inspection, for pur6 poses of section 602(g) of the Federal Food, Drug, and 

7 Cosmetic Act, as added by subsection (c)(2). 

8 (e) IMPORTS.—Section 801(a) of the Federal Food, 

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

10 (1) by striking ‘‘section 760 or 761’’ the first, 

11 third, and fourth place such term appears and in12 serting ‘‘section 609, 760, or 761’’; and 

13 (2) by striking ‘‘760 or 761)’’ and inserting 

14 ‘‘604, 760, or 761)’’. 

15 (f) FACTORY INSPECTION.—Section 704(a)(1) of the 

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

17 374(a)(1)) is amended by inserting after the third sen18 tence the following: ‘‘In the case of any person who manu19 factures, processes, distributes, or imports a cosmetic 

20 product, or distributes a cosmetic product and affixes its 

21 name on the cosmetic label, the inspection shall extend 

22 to all records and other information described in section 

23 610 (regarding inspection of cosmetic records), when the 

24 standard for records inspections under paragraph (1) or 

25 (2) of subsection (a) of such section applies, subject to 


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1 the limitations under subsections (d) and (e) of such sec2 tion.’’. 

3 SEC. 115. CONSUMER INFORMATION. 

4 The Food and Drug Administration shall post on its 

5 internet website information for consumers regarding— 

6 (1) final orders regarding the safety of a cos7 metic ingredient or non-functional constituent under 

8 section 607(d)(3) of the Federal Food, Drug, and 

9 Cosmetic Act; 

10 (2) cosmetic product recalls (including vol11 untary and mandatory recalls); and 

12 (3) identified counterfeit cosmetic products. 

13 SEC. 116. BAN ON PERFLUOROALKYL OR 

14 POLYFLUOROALKYL SUBSTANCES. 

15 Not later than 6 months after the date of enactment 

16 of this Act, the Food and Drug Administration shall issue 

17 a proposed rule to ban the use of intentionally added 

18 perfluoroalkyl or polyfluoroalkyl substances in cosmetics. 

19 SEC. 117. COUNTERFEIT COSMETICS. 

20 (a) COUNTERFEIT COSMETICS DEFINED.—Section 

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

22 U.S.C. 321(i)) is amended— 

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

24 The term’’; 


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

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

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

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

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

6 ‘‘(2) The term ‘counterfeit cosmetic’ means a cos7 metic which, or the container or labeling of which, without 

8 authorization— 

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

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

11 thereof, of a cosmetic manufacturer, processor, pack12 er, or distributor other than the person or persons 

13 who in fact manufactured, processed, packed, or dis14 tributed such cosmetic; and 

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

16 to be the product of, or to have been packed or dis17 tributed by, such other cosmetic manufacturer, proc18 essor, packer, or distributor.’’. 

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

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

21 amended— 

22 (1) in subparagraph (2)— 

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

24 ‘‘stone,’’; 


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

2 or’’; and 

3 (C) by inserting before the period at the 

4 end the following: ‘‘or such cosmetic a counter5 feit cosmetic’’; and 

6 (2) in subparagraph (3)— 

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

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

9 drug’’; and 

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

11 before the period at the end. 

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

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

14 amended— 

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

16 (2) by inserting ‘‘or a cosmetic being a counter17 feit cosmetic’’ after ‘‘drug being a counterfeit drug’’; 

18 and 

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

20 following: ‘‘or the cosmetic was a counterfeit cos21 metic’’. 

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

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

24 amended— 


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

2 that follows through ‘‘(D) Any adulterated’’ and in3 serting ‘‘(B) Any cosmetic that is a counterfeit cos4 metic, (C) Any container of a counterfeit drug or 

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

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

7 thing used or designed for use in making a counter8 feit drug or drugs or a counterfeit cosmetic or cos9 metics, (E) Any adulterated’’; and 

10 (2) by striking ‘‘(E)’’ and inserting ‘‘(F)’’ be11 fore ‘‘Any adulterated or misbranded tobacco prod12 uct’’. 

13 (e) EXAMINATIONS AND INVESTIGATIONS.—Section 

14 702(e) of the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 372(e)) is amended— 

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

17 inserting ‘‘or counterfeit cosmetics’’ after ‘‘counter18 feit drugs’’; 

19 (2) in paragraph (4), by inserting ‘‘or cos20 metics’’ after ‘‘such drugs’’; and 

21 (3) in paragraph (5)— 

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

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

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

25 ‘‘labeling,’’. 


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1 TITLE II—FEES RELATED TO 

2 COSMETIC SAFETY 

3 SEC. 201. FINDINGS. 

4 Congress finds that the fees authorized by the 

5 amendments made by this title will be dedicated to cos6 metic safety activities, as set forth in the goals identified 

7 for purposes of part 11 of subchapter C of chapter VII 

8 of the Federal Food, Drug, and Cosmetic Act, in the let9 ters from the Secretary of Health and Human Services 

10 to the Chairman of the Committee on Health, Education, 

11 Labor, and Pensions of the Senate and the Chairman of 

12 the Committee on Energy and Commerce of the House 

13 of Representatives, as set forth in the Congressional 

14 Record. 

15 SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFE16 TY FEES. 

17 Subchapter C of chapter VII of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 

19 amended by adding at the end the following: 

20 ‘‘PART 11—FEES RELATING TO COSMETICS 

21 ‘‘SEC. 744O. REGISTRATION FEE. 

22 ‘‘(a) ASSESSMENT AND COLLECTION.— 

23 ‘‘(1) IN GENERAL.—Beginning in fiscal year 

24 2022, the Food and Drug Administration shall as25 sess and collect an annual fee from every responsible 


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1 person (referred to in this section as a ‘registrant’) 

2 who owns or operates any facility (as defined in sec3 tion 604(3)) engaged in manufacturing or proc4 essing, or whose name and address appear on the 

5 label of a cosmetic product distributed in the United 

6 States, except that this subsection shall not apply to 

7 contract manufacturers if a responsible person has 

8 already paid the appropriate fee with respect to the 

9 cosmetic product, to ensure no double fees are paid. 

10 ‘‘(2) PAYABLE DATE.—A fee under this section 

11 shall be payable during the period of initial registra12 tion and on the date of registration each year there13 after as prescribed in section 605(a)(1). 

14 ‘‘(b) DEFINITIONS.—In this section: 

15 ‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust16 ment factor’ applicable to a fiscal year means the 

17 Consumer Price Index for all urban consumers (all 

18 items; United States city average) for October of the 

19 preceding fiscal year divided by such index for Octo20 ber 2021. 

21 ‘‘(2) AFFILIATE.—The term ‘affiliate’ means 

22 any business entity that has a relationship with a 

23 second business entity if, directly or indirectly— 

24 ‘‘(A) one business entity controls, or has 

25 power to control, the other business entity; or 


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1 ‘‘(B) a third party controls, or has the 

2 power to control, both of the business entities. 

3 ‘‘(3) COSMETIC PRODUCT.—The term ‘cosmetic 

4 product’ has the meaning given such term in section 

5 604(2). 

6 ‘‘(4) COSMETIC SAFETY ACTIVITIES.—The term 

7 ‘cosmetic safety activities’— 

8 ‘‘(A) means activities related to compliance 

9 by registrants under section 605 with the re10 quirements of this Act with respect to cos11 metics, including— 

12 ‘‘(i) administrative activities, such as 

13 information technology support, human re14 sources, financial management, the admin15 istration and maintenance of the cosmetic 

16 registration system and the cosmetic ingre17 dient statement system under section 605, 

18 and fee assessment and collection under 

19 this section; and 

20 ‘‘(ii) implementation and enforcement 

21 activities, such as the establishment of 

22 good manufacturing practices, the review 

23 of adverse event reports, inspection plan24 ning and inspections, and use of enforce25 ment tools; and 


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1 ‘‘(B) includes activities related to imple2 mentation of section 607, regarding the review 

3 of cosmetic ingredients and non-functional con4 stituents. 

5 ‘‘(5) GROSS ANNUAL SALES.—The term ‘gross 

6 annual sales’ means the average United States gross 

7 annual sales for the previous 3-year period of cos8 metics for a registrant, including the sales of all of 

9 its affiliates, as reported in the registration under 

10 section 605. 

11 ‘‘(c) FEE SETTING AND AMOUNTS.— 

12 ‘‘(1) IN GENERAL.—Subject to subsection (d), 

13 the Food and Drug Administration shall establish 

14 the fees to be collected under this section for each 

15 fiscal year after fiscal year 2022, based on the meth16 odology described in paragraph (3), and shall pub17 lish such fees in a Federal Register notice not later 

18 than 60 days before the beginning of each such fis19 cal year. 

20 ‘‘(2) FEE EXEMPTION.—Any registrant whose 

21 gross annual sales of cosmetic products in the 3-year 

22 period immediately preceding the fiscal year for 

23 which the annual fee will be paid was not more than 

24 $10,000,000, shall be exempt from registration fees 

25 under this section for that fiscal year. 


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1 ‘‘(3) ANNUAL FEE SETTING.—For fiscal years 

2 2022 through 2027, to generate a total estimated 

3 annual revenue amount of $20,600,000, the amount 

4 of the registration fee under subsection (a) shall be 

5 as follows: 

6 ‘‘(A) TIER I–A.—For a registrant that has 

7 gross annual sales of $5,000,000,000 or more 

8 in 2020, $1,350,000. 

9 ‘‘(B) TIER I–B.—For a registrant that has 

10 gross annual sales of at least $4,000,000,000 

11 per annum but less than $5,000,000,000 in 

12 2020, $850,000. 

13 ‘‘(C) TIER II–A.—For a registrant that has 

14 gross annual sales of at least $3,000,000,000 

15 per annum but less than $4,000,000,000 in 

16 2020, $730,000. 

17 ‘‘(D) TIER II–B.—For a registrant that 

18 has gross annual sales of at least 

19 $2,000,000,000 per annum but less than 

20 $3,000,000,000 in 2020, $610,000. 

21 ‘‘(E) TIER III–A.—For a registrant that 

22 has gross annual sales of at least 

23 $1,000,000,000 per annum but less than 

24 $2,000,000,000 in 2020, $500,000. 


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1 ‘‘(F) TIER III–B.—For a registrant that 

2 has gross annual sales of at least $500,000,000 

3 per annum but less than $1,000,000,000 in 

4 2020, $395,000. 

5 ‘‘(G) TIER IV–A.—For a registrant that 

6 has gross annual sales of at least $200,000,000 

7 per annum but less than $500,000,000 in 2020, 

8 $325,000. 

9 ‘‘(H) TIER IV–B.—For a registrant that 

10 has gross annual sales of at least $100,000,000 

11 per annum but less than $200,000,000 in 2020, 

12 $275,000. 

13 ‘‘(I) TIER V–A.—For a registrant that has 

14 gross annual sales of at least $80,000,000 per 

15 annum but less than $100,000,000 in 2020, 

16 $185,000. 

17 ‘‘(J) TIER V–B.—For a registrant that has 

18 gross annual sales of at least $60,000,000 per 

19 annum but less than $80,000,000 in 2020, 

20 $95,000. 

21 ‘‘(K) TIER VI–A.—For a registrant that 

22 has gross annual sales of at least $40,000,000 

23 per annum but less than $60,000,000 in 2020, 

24 $15,000. 


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1 ‘‘(L) TIER IV–B.—For a registrant that 

2 has gross annual sales of at least $20,000,000 

3 per annum but less than $40,000,000 in 2020, 

4 $12,000. 

5 ‘‘(M) TIER VII–A.—For a registrant that 

6 has gross annual sales of at least $10,000,000 

7 per annum but less than $20,000,000 in 2020, 

8 $500. 

9 ‘‘(d) ADJUSTMENTS.— 

10 ‘‘(1) INFLATION ADJUSTMENT.— 

11 ‘‘(A) IN GENERAL.—For fiscal year 2023 

12 and each subsequent fiscal year, the revenues 

13 and fee amounts under subsection (c)(3) shall 

14 be adjusted by the Food and Drug Administra15 tion in the annual Federal Register notice es16 tablishing fees in subsection (c)(1), by an 

17 amount equal to the sum of— 

18 ‘‘(i) one; 

19 ‘‘(ii) the average annual percent 

20 change in the cost, per full-time equivalent 

21 position of the Food and Drug Administra22 tion, of all personnel compensation and 

23 benefits paid with respect to such positions 

24 for the first 3 of the preceding 4 fiscal 

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1 plied by the average proportion of per2 sonnel compensation and benefits costs to 

3 total Food and Drug Administration costs 

4 for the first 3 years of the preceding 4 fis5 cal years for which data are available; and 

6 ‘‘(iii) the average annual percent 

7 change that occurred in the Consumer 

8 Price Index for urban consumers (Wash9 ington-Baltimore, DC6 MD–VA–WV; not 

10 seasonally adjusted; all items less food and 

11 energy; annual index) for the first 3 years 

12 of the preceding 4 years for which data are 

13 available multiplied by the average propor14 tion of all costs other than personnel com15 pensation and benefits costs to total Food 

16 and Drug Administration costs for the 

17 first 3 years of the preceding 4 fiscal years 

18 for which data are available. 

19 ‘‘(B) COMPOUNDED BASIS.—The adjust20 ment made each fiscal year under this sub21 section shall be added on a compounded basis 

22 to the sum of all adjustments made each fiscal 

23 year after fiscal year 2022 under this sub24 section. 


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1 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal 

2 year 2027, the Food and Drug Administration may, 

3 in addition to adjustments under paragraph (1), fur4 ther increase the fee revenues and fees established in 

5 subsection (c) if such an adjustment is necessary to 

6 provide for not more than 3 months of operating re7 serves of carryover fees for cosmetic safety activities 

8 for the first 3 months of fiscal year 2028. If such 

9 an adjustment is necessary, the rationale for the in10 crease, shall be contained in the annual Federal 

11 Register notice establishing fees, in subsection 

12 (c)(1), for fiscal year 2027. If the Food and Drug 

13 Administration has carryover balances for such ac14 tivities in excess of 3 months of such operating re15 serves, the adjustment under this subparagraph 

16 shall not be made. 

17 ‘‘(3) WORKLOAD ADJUSTMENT.— 

18 ‘‘(A) IN GENERAL.—For fiscal year 2023 

19 and each subsequent fiscal year, after fee reve20 nues established in subsection (c)(3) are ad21 justed for a fiscal year for inflation in accord22 ance with paragraph (1), the fee revenues shall 

23 be adjusted further for each fiscal year to re24 flect changes in the workload of the Food and 

25 Drug Administration for actual changes in 


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1 workload volume due to the process of reviewing 

2 cosmetic ingredients or non-functional constitu3 ents not listed under section 607(b). 

4 ‘‘(B) DETERMINATION OF ADJUSTMENT.— 

5 The adjustment shall be determined by the 

6 Food and Drug Administration based on the 

7 workload in the most recent 1-year period for 

8 which workload data is available. The Food and 

9 Drug Administration shall publish in the Fed10 eral Register the fee revenues and fees resulting 

11 from the adjustment and the supporting meth12 odologies. 

13 ‘‘(C) MINIMUM REVENUES.—The adjust14 ment shall not result in fee revenues for a fiscal 

15 year that are less than the sum of the amount 

16 under subsection (c)(3), as adjusted for infla17 tion under subparagraph (1). 

18 ‘‘(e) LIMITATIONS.— 

19 ‘‘(1) IN GENERAL.—With respect to the amount 

20 that, under the salaries and expenses account of the 

21 Food and Drug Administration, is appropriated for 

22 a fiscal year for the cosmetics program in the Center 

23 for Food Safety and Applied Nutrition and related 

24 field activities, fees may not be assessed under sub25 section (a) for the fiscal year unless the amount so 


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1 appropriated for the fiscal year (excluding the 

2 amount of fees appropriated for the fiscal year), is 

3 equal to or greater than that assessed for fiscal year 

4 2021, multiplied by the adjustment factor applicable 

5 to the fiscal year involved. 

6 ‘‘(2) AUTHORITY.—If the Food and Drug Ad7 ministration does not assess fees under subsection 

8 (a) during any portion of a fiscal year because of 

9 paragraph (1) and if at a later date in such fiscal 

10 year the Food and Drug Administration may assess 

11 such fees, the Food and Drug Administration may 

12 assess and collect such fees, without any modifica13 tion in the rate, for registration under section 605 

14 at any time in such fiscal year. 

15 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

16 ‘‘(1) IN GENERAL.—Fees authorized under sub17 section (a) shall be collected and available for obliga18 tion only to the extent and in the amount provided 

19 in advance in appropriations Acts. Such fees are au20 thorized to remain available until expended. Such 

21 sums as may be necessary may be transferred from 

22 the Food and Drug Administration salaries and ex23 penses appropriation account without fiscal year lim24 itation to such appropriation account for salaries 

25 and expenses with such fiscal year limitation. The 


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1 sums transferred shall be available solely for cos2 metic safety activities. 

3 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

4 ACTS.— 

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graphs (C) and (D), the fees authorized by this 

7 section shall be collected and available in each 

8 fiscal year in an amount not to exceed the 

9 amount specified in appropriation Acts, or oth10 erwise made available for obligation for such 

11 fiscal year. 

12 ‘‘(B) USE OF FEES AND LIMITATION.— 

13 The fees authorized by this section shall be col14 lected and available only to defray the costs of 

15 cosmetic safety activities. 

16 ‘‘(C) FEE COLLECTIONS DURING FIRST

17 PROGRAM YEAR.—Until the date of enactment 

18 of an Act making appropriations through Sep19 tember 30, 2020, for the salaries and expenses 

20 account of the Food and Drug Administration, 

21 fees authorized by this section for fiscal year 

22 2022 may be collected and shall be credited to 

23 such account to remain available until ex24 pended. Fees collected under this subparagraph 

25 shall be considered discretionary for purposes of 


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1 the Balanced Budget and Emergency Deficit 

2 Control Act of 1985. 

3 ‘‘(D) REIMBURSEMENT OF START-UP

4 AMOUNTS.—Any amounts allocated to establish 

5 programs under section 605, prior to collection 

6 of fees, may be reimbursed through any appro7 priated fees collected under this section, in such 

8 manner as the Food and Drug Administration 

9 determines appropriate. Any amounts reim10 bursed under this subparagraph shall be avail11 able for the programs and activities for which 

12 funds allocated to establish the programs were 

13 available, prior to such allocation, until the end 

14 of the fiscal year in which the reimbursement 

15 occurs, notwithstanding any otherwise applica16 ble limits on amounts for such program or ac17 tivities for a fiscal year. 

18 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

19 For each of fiscal years 2022 through 2028, there 

20 are authorized to be appropriated for fees under this 

21 section $20,600,000, as adjusted by subsection (d). 

22 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

23 OF COLLECTION SHORTFALLS.— 

24 ‘‘(A) OFFSET OF OVERCOLLECTIONS.—If 

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1 lected under this section for the fiscal years 

2 2022 through 2026 exceeds the cumulative 

3 amount appropriated pursuant to paragraph (3) 

4 for fiscal years 2022 through 2027, the excess 

5 amount shall be credited to the appropriation 

6 account of the Food and Drug Administration 

7 as provided in paragraph (1), and shall be sub8 tracted from the amount of fees that would oth9 erwise be authorized to be collected under this 

10 section pursuant to appropriation Acts for fiscal 

11 year 2028. 

12 ‘‘(B) RECOVERY OF COLLECTION SHORT13 FALLS.— 

14 ‘‘(i) 2024.—For fiscal year 2024, the 

15 amount of fees otherwise authorized to be 

16 collected under this section shall be in17 creased by the amount, if any, by which 

18 the amount collected under this section 

19 and appropriated for fiscal year 2022 falls 

20 below the amount of fees authorized for 

21 fiscal year 2022 under paragraph (3). 

22 ‘‘(ii) 2025.—For fiscal year 2025, the 

23 amount of fees otherwise authorized to be 

24 collected under this section shall be in25 creased by the amount, if any, by which 


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1 the amount collected under this section 

2 and appropriated for fiscal year 221 falls 

3 below the amount of fees authorized for 

4 fiscal year 2023 under paragraph (3). 

5 ‘‘(iii) 2026.—For fiscal year 2026, 

6 the amount of fees otherwise authorized to 

7 be collected under this section shall be in8 creased by the amount, if any, by which 

9 the amount collected under this section 

10 and appropriated for fiscal year 2024 falls 

11 below the amount of fees authorized for 

12 fiscal year 2024 under paragraph (3). 

13 ‘‘(iv) 2027.—For fiscal year 2027, the 

14 amount of fees otherwise authorized to be 

15 collected under this section shall be in16 creased by the amount, if any, by which 

17 the amount collected under this section 

18 and appropriated for fiscal year 2025 falls 

19 below the amount of fees authorized for 

20 fiscal year 2025 under paragraph (3). 

21 ‘‘(v) 2028.—For fiscal year 2028, the 

22 amount of fees otherwise authorized to be 

23 collected under this section shall be in24 creased by the amount, if any, by which 

25 the amount collected under this section 


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1 and appropriated for fiscal year 2026 falls 

2 below the amount of fees authorized for 

3 fiscal year 2026 under paragraph (3). 

4 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.—The Food 

5 and Drug Administration shall not consider a registration 

6 submitted to be complete until such fee under subsection 

7 (a) is paid. Until the fee is paid, the registration is incom8 plete and the registrant is deemed to have failed to reg9 ister in accordance with section 605. 

10 ‘‘(h) FALSE STATEMENTS.—Any statement or rep11 resentation made to the Food and Drug Administration 

12 shall be subject to section 1001 of title 18, United States 

13 Code. 

14 ‘‘(i) COLLECTION OF UNPAID FEES.—In any case 

15 where the Food and Drug Administration does not receive 

16 payment of a fee assessed under subsection (a), such fee 

17 shall be treated as a claim of the United States Govern18 ment subject to subchapter II of chapter 37 of title 31, 

19 United States Code. 

20 ‘‘(j) CONSTRUCTION.—This section may not be con21 strued to require that the number of full-time equivalent 

22 positions in the Department of Health and Human Serv23 ices, for officers, employees, and advisory committees not 

24 engaged in cosmetic activities, be reduced to offset the 


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1 number of officers, employees, and advisory committees so 

2 engaged. 

3 ‘‘(k) RECORDS.—Each facility shall retain all records 

4 necessary to demonstrate the facility’s gross annual sales 

5 for at least 2 fiscal years after such information is re6 ported in the facility’s registration. Such records shall be 

7 made available to the Food and Drug Administration for 

8 review and duplication upon request of the Food and Drug 

9 Administration.’’. 

10 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI11 TIES RELATED TO COSMETICS. 

12 Part 11 of subchapter C of chapter VII of the Fed13 eral Food, Drug, and Cosmetic Act, as added by section 

14 202, is amended by inserting after section 744O the fol15 lowing: 

16 ‘‘SEC. 744P. DIRECT HIRING AUTHORITY TO SUPPORT AC17 TIVITIES RELATED TO COSMETICS. 

18 ‘‘(a) IN GENERAL.—The Food and Drug Administra19 tion shall have direct hiring authority with respect to the 

20 appointment of employees into the competitive service or 

21 the excepted service to administer the amendments made 

22 by title I of the Personal Care Products Safety Act. 


pbinns on DSKJLVW7X2PROD with BILLS
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1 ‘‘(b) SUNSET.—The authority under subsection (a) 

2 shall terminate on the date that is 3 years after the date 

3 of enactment of such title.’’. 

Æ 


pbinns on DSKJLVW7X2PROD with BILLS