II 

116TH CONGRESS 

1ST SESSION S. 726 

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

of cosmetics. 

IN THE SENATE OF THE UNITED STATES 

MARCH 7, 2019 

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. Sense of the Senate on animal testing. 

Sec. 109. Preemption. 

Sec. 110. Reporting. 

Sec. 111. Small businesses. 

Sec. 112. Applicability with respect to certain cosmetics. 

Sec. 113. Enforcement. 

Sec. 114. Consumer information. 

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 

16 amounts for each ingredient, for purposes of introVerDate Sep 11 2014 22:05 Mar 18, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S726.IS S726

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1 duction into interstate commerce as a finished prod2 uct. 

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

4 any factory, warehouse, or establishment (including 

5 a factory, warehouse, or establishment of an im6 porter) that manufactures or processes cosmetic 

7 products or cosmetic formulations, or any other enti8 ty whose name and address appear on the label of 

9 a cosmetic product. Such term does not include— 

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

11 otherwise manufacture, process, or package cos12 metics at that location; 

13 ‘‘(B) cosmetic product retailers, including 

14 individual sales representatives, direct sellers, 

15 retail distribution facilities, and pharmacies, 

16 that do not otherwise manufacture, process, or 

17 package cosmetics at that location; 

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

19 health care clinics; 

20 ‘‘(D) public health agencies and other non21 profit entities that provide cosmetics directly to 

22 the consumer; 

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

24 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 December 1, 2019, and at a similar time in 

6 each subsequent year, as determined by the Food 

7 and Drug Administration, each responsible person 

8 engaged in manufacturing or processing a cosmetic 

9 product or a cosmetic formulation distributed in the 

10 United States shall register all of the responsible 

11 person’s facilities with the Food and Drug Adminis12 tration. 

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

14 in the United States of cosmetic products of all of 

15 the responsible person’s facilities registered under 

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

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

18 complete under this subsection until the responsible 

19 person has paid any registration fee required under 

20 section 744L. 

21 ‘‘(b) REGISTRATION BY NEW FACILITIES.—Any fa22 cility first engaging after the date of enactment of the Per23 sonal Care Products Safety Act in an activity that would 

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

25 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.—Beginning in fiscal year 

22 2020, the Food and Drug Administration shall re23 view the safety of the cosmetic ingredients and non24 functional constituents listed under paragraph (3), 

25 as modified under subsection (c), if applicable, and 


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1 issue an order under subsection (d) with respect to 

2 the use of each such ingredient and presence of each 

3 such non-functional 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) INGREDIENTS TO BE CONSIDERED IN

14 FIRST YEAR.—During fiscal year 2020, the 

15 Food and Drug Administration shall initiate the 

16 review for safety of the following cosmetic in17 gredients: 

18 ‘‘(i) Diazolidinyl urea. 

19 ‘‘(ii) Diethyl phthalate. 

20 ‘‘(iii) Methylene glycol/methanediol/ 

21 formaldehyde. 

22 ‘‘(iv) Propyl paraben. 

23 ‘‘(v) Quaternium-15. 

24 ‘‘(B) INGREDIENTS TO BE CONSIDERED IN

25 SUBSEQUENT YEARS.— 


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1 ‘‘(i) IN GENERAL.—Beginning in fis2 cal year 2021, the Food and Drug Admin3 istration shall annually select and complete 

4 a safety review of at least 5 cosmetic ingre5 dients or non-functional constituents that 

6 were not reviewed in the prior 3 years, 

7 from a list determined in consultation with 

8 the cosmetic industry and consumer and 

9 health groups. The Food and Drug Admin10 istration may combine selected cosmetics 

11 ingredients or non-functional constituents 

12 into categories for purposes of such review. 

13 The Food and Drug Administration may 

14 modify such list under subsection (c). 

15 ‘‘(ii) CONSIDERATIONS.—The deter16 mination of which ingredients or functional 

17 ingredients will be reviewed in a given year 

18 shall be publicized in annual reports to 

19 Congress and the public, in accordance 

20 with section 616. The review of any cos21 metic ingredient or non-functional con22 stituent shall commence with a public an23 nouncement by the Food and Drug Admin24 istration and the opening of a docket as re25 quired under paragraph (2). 


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

2 reporting to Congress and the public under section 

3 616, the Food and Drug Administration shall solicit 

4 public comment on which cosmetic ingredients or 

5 non-functional constituents on the list are of great6 est interest to be reviewed next for early review and 

7 which additional cosmetic ingredients or non-func8 tional constituents should be added to the list. The 

9 public may submit comments to the Food and Drug 

10 Administration at any time during the year regard11 ing which cosmetic ingredients or non-functional 

12 constituents of interest the Food and Drug Adminis13 tration may consider during that year or subsequent 

14 years. 

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

16 shall maintain a list, posted on the Internet website of the 

17 Food and Drug Administration, of the cosmetic ingredi18 ents and non-functional constituents for which final orders 

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

20 made for each such ingredient or non-functional con21 stituent under subsection (d)(4), as modified by any order 

22 under subsection (f), if applicable, and, if applicable, com23 pliance dates that are the subject of a final order under 

24 subsection (e). 


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

2 Administration may at any time propose the issuance of 

3 an order on the safety of a cosmetic ingredient or non4 functional constituent that was not previously listed in 

5 subsection (a) or under section 616(a)(3). The Food and 

6 Drug Administration shall follow the same procedures and 

7 policies for review of any cosmetic ingredient or non-func8 tional constituent so proposed as for the ingredients and 

9 constituents reviewed pursuant to subsection (a). 

10 ‘‘(d) DETERMINATION ON SAFETY.— 

11 ‘‘(1) INITIAL PROPOSED ADMINISTRATIVE

12 ORDER.—Following consideration of data and com13 ments to the public docket and any other informa14 tion before the Food and Drug Administration, the 

15 Food and Drug Administration shall determine 

16 whether there is adequate evidence to make an ini17 tial finding on the safety of the ingredient or non18 functional constituent. If the Food and Drug Ad19 ministration determines that there is adequate evi20 dence, the Food and Drug Administration shall issue 

21 a proposed administrative order and shall post such 

22 order on the Internet website of the Food and Drug 

23 Administration, notwithstanding subchapter II of 

24 chapter 5 of title 5, United States Code. 


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

2 the proposed administrative order described in para3 graph (1), the Food and Drug Administration shall 

4 open a docket for the submission of public comment. 

5 The Food and Drug Administration shall provide 30 

6 days for public comment following publication of the 

7 proposed administrative order. 

8 ‘‘(3) FINAL ADMINISTRATIVE ORDER.—Fol9 lowing the public comment period described in para10 graph (2) and consideration of comments to the pub11 lic docket and any other information before the Food 

12 and Drug Administration, the Food and Drug Ad13 ministration shall determine whether there is ade14 quate evidence to make a final finding on the safety 

15 of the ingredient or non-functional constituent. If 

16 the Food and Drug Administration determines that 

17 there is adequate evidence, the Food and Drug Ad18 ministration shall issue a final administrative order 

19 and shall post such order on the Internet website of 

20 the Food and Drug Administration, notwithstanding 

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

22 Code. 

23 ‘‘(4) DETERMINATIONS.—In the proposed ad24 ministrative order or the final administrative order, 

25 as applicable, the Food and Drug Administration 


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1 shall make a determination that the ingredient or 

2 non-functional constituent is— 

3 ‘‘(A) safe in cosmetic products under speci4 fied conditions of use or tolerances; 

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

6 need for specified conditions of use or toler7 ances; or 

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

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

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

11 conditions on the use of an ingredient or such toler12 ances on the presence of a non-functional con13 stituent as are necessary for the safety of cosmetic 

14 products containing such ingredient or non-func15 tional constituent, including— 

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

17 of the ingredient or non-functional constituent 

18 that may be present in a cosmetic product, in19 cluding limits in products intended for children 

20 and other vulnerable populations, and limits on 

21 use near the eye or mucosal membranes; 

22 ‘‘(B) warnings that are necessary or appro23 priate under section 612, including warnings re24 lated to use by children, pregnant women, popu25 lations with high exposure to the ingredient 


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

3 or other vulnerable populations, to help ensure 

4 safe use of cosmetic products containing the in5 gredient or non-functional constituent; and 

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

7 or other similar conditions as are necessary for 

8 the safety of cosmetic products containing such 

9 ingredient or non-functional constituent. 

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

11 subsection shall set forth the determination of the 

12 Food and Drug Administration on safety, any condi13 tions of use or tolerances under subparagraph (A) or 

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

15 scientific evidence supporting the finding. The order 

16 shall be effective upon its publication on the Internet 

17 website of the Food and Drug Administration and 

18 shall be considered final agency action. 

19 ‘‘(e) ORDER.— 

20 ‘‘(1) IN GENERAL.—If the Food and Drug Ad21 ministration issues a final administrative order 

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

23 the Food and Drug Administration shall, at the 

24 same time as publication of the notice under sub25 section (d)(6), publish a proposed order identifying 


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1 dates by which use of the ingredient or non-func2 tional constituent in cosmetic products shall comply 

3 with the final administrative order, and provide 60 

4 days for public comment, including comment on 

5 whether compliance is feasible within the proposed 

6 dates. After considering comments on the proposed 

7 order, the Food and Drug Administration shall pub8 lish in the Federal Register a final order. 

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

10 regarding the final order under paragraph (1) shall 

11 include a summary that is written in plain and un12 derstandable language that is comprehensible and 

13 meaningful for consumers. The summary shall in14 clude information on any conditions of use or warn15 ings required under section 612, including the appli16 cation to vulnerable populations, the types of safety 

17 studies evaluated, and any additional relevant infor18 mation that was part of the review process. 

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

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

21 by the Food and Drug Administration on the initiative of 

22 the Food and Drug Administration or in response to a 

23 petition. 

24 ‘‘(g) INADEQUATE EVIDENCE.— 


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

2 Drug Administration determines that the available 

3 data and information are not adequate to make a 

4 proposed or final determination regarding safety 

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

6 ingredient or non-functional constituent, the Food 

7 and Drug Administration shall— 

8 ‘‘(A) publish such finding on the Internet 

9 website of the Food and Drug Administration 

10 not later than 90 days after the close of the rel11 evant comment period for the ingredient or 

12 non-functional constituent under subsection 

13 (a)(2), in the case of a proposed order, or sub14 section (d)(2), in the case of a final order; and 

15 ‘‘(B)(i) include a notice providing inter16 ested persons an additional 30 days from the 

17 notice date to provide additional data and infor18 mation; and 

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

20 clause (i), the Food and Drug Administration 

21 determines that additional safety substantiation 

22 with respect to such ingredient or non-func23 tional constituent is necessary to make a safety 

24 determination— 


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1 ‘‘(I) include a notice specifying an ad2 ditional time period, not to exceed 18 

3 months from the notice date, during which 

4 time the assurance made by a responsible 

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

6 respect to the safety of such cosmetic in7 gredient or non-functional constituent shall 

8 be deemed to be in compliance with the re9 quirements of this Act, but shall not affect 

10 final determinations of safety under sub11 section (d); and 

12 ‘‘(II) plan to obtain such data and in13 formation. 

14 ‘‘(2) DETERMINATION; ORDER.— 

15 ‘‘(A) INADEQUATE DATA AND INFORMA16 TION.—If the Food and Drug Administration 

17 determines, after considering any additional 

18 data and information submitted under para19 graph (1)(B), that the available data and infor20 mation still are not adequate to make a deter21 mination regarding safety under subsection 

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

23 shall, within 90 days of the close of the addi24 tional time period provided under paragraph 


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1 (1)(B), issue a proposed order or a final admin2 istrative order— 

3 ‘‘(i) making a determination that the 

4 ingredient or non-functional constituent 

5 has not been shown to be safe in cosmetic 

6 products; and 

7 ‘‘(ii) explaining why the available data 

8 and information are not adequate to assess 

9 the safety of the ingredient or non-func10 tional constituent. 

11 ‘‘(B) ADEQUATE DATA AND INFORMA12 TION.—If the Food and Drug Administration 

13 determines, after considering any additional 

14 data and information submitted under para15 graph (1)(B), that the available data and infor16 mation are adequate to make a determination 

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

18 Food and Drug Administration shall, within 

19 180 days of the close of the comment period, 

20 issue a proposed order, followed by a final 

21 order, on such cosmetic ingredient or non-func22 tional constituent, in accordance with such sub23 section. 

24 ‘‘(h) SAFETY ASSESSMENT.— 


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

2 an ingredient or non-functional constituent, the 

3 Food and Drug Administration shall consider wheth4 er there is adequate evidence to support a reasonable 

5 certainty among competent scientists that the ingre6 dient is not harmful under the recommended or sug7 gested conditions of use or customary or usual use, 

8 or that a non-functional constituent is not harmful 

9 under the recommended or suggested tolerance levels 

10 or the level at which it is customarily or usually 

11 present. The Food and Drug Administration may 

12 not consider an ingredient or non-functional con13 stituent harmful solely because it can cause minor 

14 adverse health reactions, such as minor transient al15 lergic reactions or minor transient skin irritations, 

16 in some users. 

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

18 ingredient or non-functional constituent, the Food 

19 and Drug Administration shall consider, among 

20 other relevant factors, the following: 

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

22 ingredient or non-functional constituent from 

23 expected use in cosmetics. 

24 ‘‘(B) The probable cumulative and aggre25 gate effect in humans of relevant exposure to 


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1 the ingredient or non-functional constituent or 

2 to any chemically or pharmacologically related 

3 substances from use in cosmetics or other prod4 ucts with similar routes of exposure under rec5 ommended or suggested conditions of use or 

6 their customary use, to the extent adequate 

7 data is available for analysis. In appropriate 

8 cases, the Food and Drug Administration may 

9 consider available information on the total expo10 sure to an ingredient or non-functional con11 stituent from all sources. 

12 ‘‘(C) Whether warnings or recommenda13 tions in a product label required under section 

14 612, as part of any conditions of use or toler15 ances imposed by the Food and Drug Adminis16 tration, would be necessary and appropriate to 

17 help ensure the safety of the ingredient or non18 functional constituent. 

19 ‘‘(3) DATA AND INFORMATION.— 

20 ‘‘(A) REQUIRED INFORMATION.—A deter21 mination that an ingredient or non-functional 

22 constituent is safe in cosmetics shall be based 

23 upon adequate evidence submitted or otherwise 

24 known to the Food and Drug Administration, 

25 which shall include full reports of all available 


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1 studies, published or unpublished, that are ade2 quately designed to show whether the ingredient 

3 or non-functional constituent is safe. Such stud4 ies may include in vitro and in silico studies 

5 and epidemiological studies, biomonitoring stud6 ies, and studies focused on various points dur7 ing the lifespan of the subject, that use scientif8 ically valid methodology. 

9 ‘‘(B) ADDITIONAL RELEVANT INFORMA10 TION.—The Food and Drug Administration 

11 shall consider any other relevant information 

12 related to the safety of the ingredient or non13 functional constituent, including— 

14 ‘‘(i) adverse event reports; 

15 ‘‘(ii) findings and information from 

16 State, Federal, national, and international 

17 entities and other bodies composed of sci18 entific and medical experts; 

19 ‘‘(iii) if the ingredient or non-func20 tional constituent is lawfully used or 

21 present in other products regulated by the 

22 Food and Drug Administration, the sci23 entific basis for such use; and 

24 ‘‘(iv) experience with the ingredient or 

25 non-functional constituent in products that 


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1 are distributed in the United States or in 

2 other countries, if such experience is well3 documented and has resulted in substantial 

4 human exposure to the ingredient or non5 functional constituent over time. 

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

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

8 Food and Drug Administration has issued a final deter9 mination for a coal-tar hair dye ingredient under sub10 section (d)(4)(C).’’. 

11 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS12 METICS. 

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

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

15 amended by section 102, is further amended by adding 

16 at the end the following: 

17 ‘‘SEC. 608. GOOD MANUFACTURING PRACTICES FOR COS18 METICS. 

19 ‘‘(a) IN GENERAL.—The Food and Drug Administra20 tion shall review national and international standards for 

21 cosmetic good manufacturing practices that are in exist22 ence on the date of enactment of the Personal Care Prod23 ucts Safety Act and shall develop and implement, through 

24 regulations, standards consistent, to the extent the Food 

25 and Drug Administration determines practicable and apVerDate Sep 11 2014 22:05 Mar 18, 2019 Jkt 089200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\S726.IS S726

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1 propriate, with such national and international standards 

2 for cosmetic good manufacturing practices to ensure that 

3 requirements of this chapter with respect to the manufac4 ture of cosmetic products are in harmony. 

5 ‘‘(b) CONSULTATION.—The standards under sub6 section (a) shall include simplified good manufacturing 

7 practices for small businesses that take into account the 

8 size and scope of the business, developed in consultation 

9 with the Small Business Administration. 

10 ‘‘(c) TIMEFRAME.—The Food and Drug Administra11 tion shall publish a proposed rule described in subsection 

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

13 of the Personal Care Products Safety Act and shall pub14 lish a final such rule not later than 3 years after such 

15 date of enactment.’’. 

16 (b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR17 ERS.— 

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

19 size greater than the Small Business Administra20 tion’s standard for a small business, section 608 of 

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

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

23 180 days after the date on which the Food and 

24 Drug Administration makes effective cosmetic good 

25 manufacturing practices. 


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

2 size that meets the Small Business Administration’s 

3 standard for a small business, section 608 of the 

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

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

6 after the date the Food and Drug Administration 

7 makes effective cosmetic good manufacturing prac8 tices. 

9 SEC. 104. ADVERSE EVENT REPORTS. 

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

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

12 103(a), is further amended by adding at the end the fol13 lowing: 

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

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

16 product distributed in the United States, the responsible 

17 person shall submit to the Food and Drug Administration 

18 a report of any serious adverse event associated with such 

19 cosmetic product, when used in the United States, accom20 panied by a copy of the label on or with the retail pack21 aging of the cosmetic, any new medical information, re22 lated to a submitted serious adverse event report that is 

23 received by the responsible person, and an annual report 

24 for all adverse events received by the responsible person. 

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


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

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

3 this product that is adverse. 

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

5 product is an adverse event that— 

6 ‘‘(A) results in— 

7 ‘‘(i) death; 

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

9 ‘‘(iii) inpatient hospitalization; 

10 ‘‘(iv) a persistent or significant dis11 ability or incapacity; 

12 ‘‘(v) congenital anomaly or birth de13 fect; or 

14 ‘‘(vi) significant disfigurement, includ15 ing serious and persistent rashes or infec16 tions and significant hair loss; or 

17 ‘‘(B) requires, based on appropriate med18 ical judgment, a medical or surgical interven19 tion to prevent an outcome described in sub20 paragraph (A). 

21 ‘‘(c) SUBMISSION OF REPORTS.— 

22 ‘‘(1) SERIOUS ADVERSE EVENT REPORTS.—Ex23 cept as provided in paragraph (2), with respect to a 

24 cosmetic product distributed in the United States, 

25 the responsible person shall submit a serious adverse 


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1 event report to the Food and Drug Administration 

2 not later than 15 business days after information 

3 concerning the adverse event is received. If a serious 

4 adverse event report for a cosmetic with drug prop5 erties is filed using Form FDA 3500A (or any suc6 cessor form developed for such purpose) or its elec7 tronic equivalent for over-the-counter drugs, the re8 sponsible person shall not have to submit a duplica9 tive serious adverse event report under this section. 

10 ‘‘(2) NEW MEDICAL INFORMATION.—The re11 sponsible person shall submit to the Food and Drug 

12 Administration any new medical information, related 

13 to a submitted serious adverse event report that is 

14 received by the responsible person within 1 year of 

15 the initial report, and shall submit such information 

16 not later than 15 business days after the new infor17 mation is received by the responsible person. 

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

19 and Drug Administration shall provide for systems 

20 to enable the responsible person to submit a single 

21 report that includes duplicate reports of, or new 

22 medical information related to, a serious adverse 

23 event. 

24 ‘‘(4) ANNUAL REPORT.— 


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

2 1 of each year, except as provided under sub3 paragraph (C), the responsible person shall sub4 mit an electronic report for the prior calendar 

5 year for each cosmetic product marketed during 

6 that year. 

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

8 paragraph shall contain a summary of all ad9 verse events received during the reporting pe10 riod, a complete list of individual reports, and 

11 an estimate of the total number of product 

12 units estimated to have been distributed to con13 sumers in the United States during such period. 

14 The report shall not include consumer com15 plaints that are solely regarding efficacy and do 

16 not contain any information about an adverse 

17 event. The Food and Drug Administration shall 

18 further specify the contents of the annual elec19 tronic report by regulation or guidance. 

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

21 the case of a domestic facility for which the av22 erage gross annual sales in cosmetic products in 

23 the United States over the previous 3-year pe24 riod is not more than $2,000,000, the responVerDate Sep 11 2014 22:05 Mar 18, 2019 Jkt 089200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6201 E:\BILLS\S726.IS S726

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1 sible person is not required to submit an annual 

2 report under this paragraph. 

3 ‘‘(5) EXEMPTION.—The Food and Drug Ad4 ministration may establish by regulation an exemp5 tion to any of the requirements under this sub6 section if the Food and Drug Administration deter7 mines that such exemption is supported by adequate 

8 evidence and would have no adverse effect on public 

9 health. 

10 ‘‘(d) REQUIREMENTS.— 

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

12 report under this section shall be submitted to the 

13 Food and Drug Administration using an electronic 

14 system of the Food and Drug Administration. The 

15 Food and Drug Administration shall make such elec16 tronic system available not later than 1 year after 

17 the date of enactment of the Personal Care Products 

18 Safety Act. 

19 ‘‘(2) MODIFICATION.—The format of the re20 porting system may be modified by the Food and 

21 Drug Administration and the reports may include 

22 additional information. The Food and Drug Admin23 istration may, in guidance, further specify the for24 mat and contents of required reports. 


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1 ‘‘(3) SCOPE OF SERIOUS ADVERSE EVENT RE2 PORT.—A serious adverse event report (including all 

3 information submitted in the initial report or added 

4 later) submitted to the Food and Drug Administra5 tion under subsection (a) includes— 

6 ‘‘(A) a report under section 756 with re7 spect to safety and related to a specific cos8 metic product; 

9 ‘‘(B) a record about an individual who suf10 fered the serious adverse event under section 

11 552a of title 5, United States Code; 

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

13 the serious adverse event, the disclosure of 

14 which would constitute a violation of section 

15 552(b)(6) of such title 5, and shall not be pub16 licly disclosed unless all personally identifiable 

17 information is redacted; and 

18 ‘‘(D) contact information for the individual 

19 reporting the serious adverse event. 

20 ‘‘(4) RESPONSIBILITY TO GATHER INFORMA21 TION.—After an individual initiates the reporting of 

22 a serious adverse event, the responsible person for 

23 the cosmetic product shall actively gather all of the 

24 information to complete and file the report with the 

25 Food and Drug Administration. 


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

2 Food and Drug Administration shall provide an op3 tion as part of the electronic registration process for 

4 the responsible person to indicate if such responsible 

5 person had no adverse events to report over the pre6 vious year. With respect to a responsible person who 

7 received no adverse event reports for a year, the an8 nual adverse event report requirement may be met 

9 by indicating no such events on the annual registra10 tion form. 

11 ‘‘(e) LIMITATION WITH RESPECT TO ADVERSE

12 EVENT REPORTS.—The submission of an adverse event 

13 report in compliance with subsection (a) shall not con14 stitute an admission that the cosmetic involved caused or 

15 contributed to the adverse event. 

16 ‘‘(f) CONTACT INFORMATION.—The label of a cos17 metic shall bear the domestic telephone number or elec18 tronic contact information, and it is encouraged that the 

19 label include both the telephone number and electronic 

20 contact information, through which the responsible person 

21 may receive a report of an adverse event. 

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

23 person shall maintain records related to each report of an 

24 adverse event received by the responsible person for a pe25 riod of 6 years. 


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

2 Drug Administration shall make available records sub3 mitted under this section to any State, upon request. In4 formation disclosed to a State that is exempt from disclo5 sure under section 552(b)(4) of title 5, United States 

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

7 information by the State. 

8 ‘‘(i) EFFECTIVE DATE OF REQUIREMENT WITH RE9 SPECT TO SERIOUS ADVERSE EVENTS.—The requirement 

10 under this section to report serious adverse events shall 

11 become effective on the date that the Food and Drug Ad12 ministration publicizes the availability of the electronic 

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

14 SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU15 THORITY. 

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

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

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

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

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

21 or processor of a cosmetic shall, at the request of an offi22 cer or employee duly designated by the Food and Drug 

23 Administration, permit such officer or employee, upon 

24 presentation of appropriate credentials and written notice 

25 to such person, at reasonable times and within reasonable 


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

2 copy— 

3 ‘‘(1) all records maintained under section 

4 605(e)(2)(A)(xii) or 609 and in accordance with the 

5 rules promulgated by the Food and Drug Adminis6 tration under section 608, as applicable; and 

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

8 other records, if the Food and Drug Administra9 tion— 

10 ‘‘(A) has a reasonable belief that the cos11 metic— 

12 ‘‘(i) is adulterated; 

13 ‘‘(ii) has caused a reportable serious 

14 adverse event; or 

15 ‘‘(iii) contains an ingredient that sub16 stantial new scientific information shows 

17 may be unsafe when present in a cosmetic; 

18 and 

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

20 for the Food and Drug Administration’s rea21 sonable belief described in subparagraph (A). 

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

23 section shall extend to financial data, pricing data, per24 sonnel data (other than data as to qualification of tech25 nical and professional personnel performing functions subVerDate Sep 11 2014 22:05 Mar 18, 2019 Jkt 089200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\S726.IS S726

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1 ject to this Act), research data (other than safety data), 

2 or sales data other than shipment data. 

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

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

5 in any format (including paper and electronic formats) 

6 and at any location. 

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

8 The Food and Drug Administration shall take appropriate 

9 measures to ensure that there are effective procedures to 

10 prevent the unauthorized disclosure of any trade secret or 

11 confidential information that is obtained by the Food and 

12 Drug Administration pursuant to this section. Information 

13 disclosed to a State that is exempt from disclosure under 

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

15 treated as a trade secret and confidential information by 

16 the State. 

17 ‘‘(e) LIMITATIONS.—This section shall not be con18 strued— 

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

20 Drug Administration to inspect records or to require 

21 establishment and maintenance of records under any 

22 other provision of this Act; or 

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

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

25 18, United States Code. 


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1 ‘‘(f) SUBMISSION OF RECORDS.— 

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

3 maintained by a responsible person under section 

4 605(e)(2)(A)(xii) shall, upon the written request of 

5 the Food and Drug Administration to the respon6 sible person, be provided to the Food and Drug Ad7 ministration within a reasonable timeframe not to 

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

9 ‘‘(2) CRITERIA.—The Food and Drug Adminis10 tration may require records under paragraph (1) 

11 if— 

12 ‘‘(A) the Food and Drug Administration 

13 has a reasonable belief, described in written no14 tice, that— 

15 ‘‘(i) the finished product may be 

16 harmful based on adverse event reports or 

17 other scientific information; or 

18 ‘‘(ii) scientific information raises cred19 ible and relevant questions about the safe20 ty of the product or any of its ingredients; 

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

22 an expert regulatory body, or an expert body 

23 composed of scientific and medical experts finds 

24 an ingredient in the product to be unsafe under 

25 the conditions of use of the product; or 


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1 ‘‘(C) the Food and Drug Administration 

2 concludes that submission of the records will 

3 serve the public health or otherwise enable the 

4 Food and Drug Administration to fulfill the 

5 cosmetic safety purposes of this section.’’. 

6 ‘‘SEC. 611. MANDATORY RECALL AUTHORITY. 

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

8 Drug Administration determines that there is a reasonable 

9 probability that a cosmetic is adulterated under section 

10 601 or misbranded under section 602 and the use of or 

11 exposure to such cosmetic is likely to cause serious adverse 

12 health consequences or death, the Food and Drug Admin13 istration shall provide the responsible person with an op14 portunity to voluntarily cease distribution and recall such 

15 article. 

16 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE

17 DISTRIBUTION AND GIVE NOTICE.— 

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

19 refuses to or does not voluntarily cease distribution 

20 or recall such cosmetic within the time and in the 

21 manner prescribed by the Food and Drug Adminis22 tration, the Food and Drug Administration may 

23 order such person to— 

24 ‘‘(A) immediately cease distribution of 

25 such cosmetic; and 


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

2 persons— 

3 ‘‘(i) manufacturing, processing, pack4 ing, transporting, holding, receiving, dis5 tributing, or importing and selling such 

6 cosmetic; and 

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

8 distributed, transported, or sold (except 

9 consumers), 

10 to immediately cease distribution of such cos11 metic. 

12 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 

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

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

15 has been distributed to a warehouse-based 

16 third-party logistics provider without providing 

17 such provider sufficient information to know or 

18 reasonably determine the precise identity of 

19 such cosmetic covered by a recall order that is 

20 in its possession, the notice provided by the re21 sponsible person subject to the order issued 

22 under paragraph (1)(B) shall include such in23 formation as is necessary for the warehouse24 based third-party logistics provider to identify 

25 the cosmetic. 


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

2 in this paragraph shall be construed— 

3 ‘‘(i) to exempt a warehouse-based 

4 third-party logistics provider from the re5 quirements of this chapter, including the 

6 requirements of this section and section 

7 610; or 

8 ‘‘(ii) to exempt a warehouse-based 

9 third-party logistics provider from being 

10 the subject of a mandatory recall order. 

11 ‘‘(3) DETERMINATION TO LIMIT AREAS AF12 FECTED.—If the Food and Drug Administration re13 quires a responsible person to cease distribution 

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

15 Drug Administration may limit the size of the geo16 graphic area and the markets affected by such ces17 sation if such limitation would not compromise the 

18 public health. 

19 ‘‘(c) HEARING ON ORDER.—The Food and Drug Ad20 ministration shall provide the responsible party subject to 

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

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

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

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

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


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1 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA2 TION OF ORDER.— 

3 ‘‘(1) AMENDMENT OF ORDER.—If, after pro4 viding opportunity for an informal hearing under 

5 subsection (c), the Food and Drug Administration 

6 determines that removal of the cosmetic from com7 merce is necessary, the Food and Drug Administra8 tion shall, as appropriate— 

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

10 such cosmetic or other appropriate action; 

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

12 shall occur; 

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

14 and Drug Administration describing the 

15 progress of the recall; and 

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

17 such cosmetic was, or may have been, distrib18 uted. 

19 ‘‘(2) VACATING OF ORDER.—If, after such hear20 ing, the Food and Drug Administration determines 

21 that adequate grounds do not exist to continue the 

22 actions required by the order, or that such actions 

23 should be modified, the Food and Drug Administra24 tion shall vacate the order or modify the order. 


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

2 and Drug Administration shall work with State and local 

3 public health officials in carrying out this section, as ap4 propriate. 

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

6 under this section, the Food and Drug Administration 

7 shall— 

8 ‘‘(1) ensure that a press release is published re9 garding the recall, and that alerts and public notices 

10 are issued, as appropriate, in order to provide notifi11 cation— 

12 ‘‘(A) of the recall to consumers and retail13 ers to whom such cosmetic was, or may have 

14 been, distributed; and 

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

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

17 to the recall; 

18 ‘‘(ii) a description of the risk associ19 ated with such article; and 

20 ‘‘(iii) to the extent practicable, infor21 mation for consumers about similar cos22 metics that are not affected by the recall; 

23 and 

24 ‘‘(2) ensure publication on the Internet website 

25 of the Food and Drug Administration of an image 


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1 of the cosmetic that is the subject of the press re2 lease described in paragraph (1), if available. 

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

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

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

6 Commissioner. 

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

8 the authority of the Food and Drug Administration to re9 quest or participate in a voluntary recall, or to issue an 

10 order to cease distribution or to recall under any other 

11 provision of this chapter or under the Public Health Serv12 ice Act.’’. 

13 SEC. 106. LABELING. 

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

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

16 amended by section 105, is further amended by adding 

17 at the end the following: 

18 ‘‘SEC. 612. LABELING. 

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

20 review of cosmetic ingredients that determines that warn21 ings are required to help ensure safe use of cosmetic prod22 ucts under section 607(d)(5), the Food and Drug Admin23 istration shall require labeling of cosmetics that are not 

24 appropriate for use in the entire population, including 


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1 warnings that vulnerable populations, such as children or 

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

3 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL

4 USE.— 

5 ‘‘(1) DEFINITION OF PROFESSIONAL.—For pur6 poses of this section, with respect to cosmetics, the 

7 term ‘professional’ means an individual who— 

8 ‘‘(A) is licensed by an official State author9 ity to practice in the field of cosmetology, nail 

10 care, barbering, or esthetics; 

11 ‘‘(B) has complied with all requirements 

12 set forth by the State for such licensing; and 

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

14 board or legal agency or legal authority. 

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

16 products used and sold by professionals shall list all 

17 ingredients and warnings, as required for other cos18 metic products under this chapter. 

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

20 case of a cosmetic product intended to be used only 

21 by a professional on account of a specific ingredient 

22 or increased concentration of an ingredient that re23 quires safe handling by trained professionals, the 

24 product shall bear a statement as follows: ‘To be Ad25 ministered Only by Licensed Professionals’. 


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1 ‘‘(c) REQUIREMENTS.— 

2 ‘‘(1) DISPLAY.—A warning required under sub3 section (a) and a statement required under sub4 section (b)(3) shall be prominently displayed— 

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

6 label; and 

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

8 contrast by typography, layout, or color with 

9 other material printed or displayed on the label. 

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

11 responsible person may include on the labeling any 

12 additional warnings in addition to the minimum 

13 warnings required under subsection (a). 

14 ‘‘(d) INTERNET SALES.—In the case of Internet sales 

15 of cosmetics, each Internet website offering a cosmetic 

16 product for sale to consumers shall provide the same infor17 mation that is included on the packaging of the cosmetic 

18 product as regularly available through in-person sales, ex19 cept information that is unique to a single cosmetic prod20 uct sold in a retail facility, such as a lot number or expira21 tion date, and the warnings and statements described in 

22 subsection (c) shall be prominently and conspicuously dis23 played on the website. 

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

25 cosmetic shall bear the domestic telephone number or elecVerDate Sep 11 2014 22:05 Mar 18, 2019 Jkt 089200 PO 00000 Frm 00057 Fmt 6652 Sfmt 6201 E:\BILLS\S726.IS S726

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1 tronic contact information, and it is encouraged that the 

2 label include both the telephone number and electronic 

3 contact information, that consumers may use to contact 

4 the responsible person with respect to adverse events. The 

5 contact number shall provide a means for consumers to 

6 obtain additional information about ingredients in a cos7 metic, including the ability to ask if a specific ingredient 

8 may be present that is not listed on the label, including 

9 whether a specific ingredient may be contained in the fra10 grance or flavor used in the cosmetic. The manufacturer 

11 of the cosmetic is responsible for providing such informa12 tion, including obtaining the information from suppliers 

13 if it is not readily available. Suppliers are required to re14 lease such information upon request of the cosmetic manu15 facturer.’’. 

16 (b) EFFECTIVE DATE.—Section 612 of the Federal 

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

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

19 date of enactment of this Act. 

20 SEC. 107. COAL TAR CHEMICALS. 

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

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

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


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1 ‘‘SEC. 613. COAL TAR CHEMICALS. 

2 ‘‘Specific ingredients in coal tar hair dyes may be se3 lected and reviewed under section 607. If the Food and 

4 Drug Administration reviews a coal-tar ingredient found 

5 in hair dye and makes a safety determination under sec6 tion 607(d) for such ingredient, such determination shall 

7 include consideration for the safe use of such ingredient 

8 through appropriate conditions of use, which may include 

9 a specific label requirement, specified limits of concentra10 tions, or other such conditions of use as the Food and 

11 Drug Administration determines appropriate, including a 

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

13 SEC. 108. SENSE OF THE SENATE ON ANIMAL TESTING. 

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

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

16 as amended by section 107, is further amended by adding 

17 the following: 

18 ‘‘SEC. 614. ANIMAL TESTING. 

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

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

21 cosmetic products and should be phased out with the ex22 ception of appropriate allowances.’’. 

23 SEC. 109. PREEMPTION. 

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

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

26 is further amended by adding the following: 


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1 ‘‘SEC. 615. PREEMPTION. 

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

3 of a State may establish or continue in effect any require4 ment for cosmetics, other than a requirement that is in 

5 full effect and implemented on the date of enactment of 

6 the Personal Care Products Safety Act— 

7 ‘‘(1) with respect to registration, good manufac8 turing practices, mandatory recalls, or adverse event 

9 reporting; or 

10 ‘‘(2) with respect to the safety of a cosmetic in11 gredient or non-functional constituent that is the 

12 subject of a final order on a determination of safety 

13 under this chapter, unless the requirement of the 

14 State or political subdivision is more restrictive than 

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

16 ‘‘(b) SAFETY OF COSMETIC INGREDIENTS AND NON17 FUNCTIONAL CONSTITUENTS.— 

18 ‘‘(1) DELAYED EFFECT OF NEW STATE RE19 QUIREMENTS.— 

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

21 the Food and Drug Administration has made 

22 public the final selection of a cosmetic ingre23 dient or non-functional constituent to be re24 viewed in the coming year under section 

25 607(a)(3)(B) and opened the public comment 

26 period under section 607(a)(2), until the date 


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1 that is one year after the Food and Drug Ad2 ministration has made public such selection, no 

3 State or political subdivision of a State may es4 tablish any new requirement related to such 

5 cosmetic ingredient or non-functional con6 stituent. 

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

8 the cosmetic ingredients to be reviewed in the 

9 first year, in accordance with section 

10 607(a)(3)(A), for the 1-year period beginning 

11 on the date that is 6 months after the date of 

12 enactment of the Personal Care Products Safe13 ty Act, no State or political subdivision of a 

14 State may establish any new requirement re15 lated to such cosmetic ingredient or non-func16 tional constituent. 

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

18 construed to affect the authority of a State or polit19 ical subdivision of a State with respect to any re20 quirement for the safety of a cosmetic ingredient or 

21 non-functional constituent that is unrelated to the 

22 scope of the safety assessment under section 607. 

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

24 Congress that a State or political subdivision that 

25 regulates the safety of cosmetics with respect to the 


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1 health of humans beyond the scope of section 607 

2 should utilize the safety assessment criteria de3 scribed in section 607(h). 

4 ‘‘(c) STATE REQUIREMENT THAT IS IN FULL EF5 FECT AND IMPLEMENTED.—For purposes of this section: 

6 ‘‘(1) STATE REQUIREMENT.—A State require7 ment includes a State requirement that is adopted 

8 by a State public initiative or referendum. 

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

10 term ‘full effect and implemented’ includes require11 ments of States that are implemented after the date 

12 of enactment of the Personal Care Products Safety 

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

14 in effect, or a lawful program that was established 

15 and functioning, prior to the date of enactment of 

16 the Personal Care Products Safety Act. 

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

18 this Act made by the Personal Care Products Safety Act 

19 shall be construed to preempt any State statute, public 

20 initiative, referendum, or other State action, except as ex21 pressly provided in this section. 

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

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

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

25 report, safety assessment, safety determination, scientific 


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1 assessment, or order issued or implemented pursuant to 

2 such amendments, shall be construed to modify or other3 wise affect, preempt, or displace any cause of action or 

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

5 criminal cause of action, whether statutory or based in 

6 common law. 

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

8 Senate that subsection (e) does not negate the other provi9 sions of this section.’’. 

10 SEC. 110. REPORTING. 

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

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

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

14 ‘‘SEC. 616. REPORTING. 

15 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

16 year 2020, and not later than 60 days prior to the end 

17 of each fiscal year for which fees are collected under sec18 tion 744L, the Food and Drug Administration shall pre19 pare and submit to Congress a report concerning the 

20 progress of the Food and Drug Administration in achiev21 ing the objectives of the Personal Care Products Safety 

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

23 Food and Drug Administration for meeting the objectives. 

24 The annual report for a fiscal year shall include— 


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1 ‘‘(1) the number of registered facilities and cos2 metic ingredient statements on file with the Food 

3 and Drug Administration; 

4 ‘‘(2) identification of the cosmetic ingredients 

5 and non-functional constituents that have been fully 

6 reviewed for safety by the Food and Drug Adminis7 tration in the prior fiscal year and for which a final 

8 administrative order has been released; 

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

10 ingredients and non-functional constituents that will 

11 be reviewed by the Food and Drug Administration 

12 in the next fiscal year; 

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

14 mandatory recalls that transpired during that fiscal 

15 year; 

16 ‘‘(5) the number of serious adverse event re17 ports received by the Food and Drug Administration 

18 during that fiscal year; and 

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

20 Drug Administration about adverse event reports re21 lated to specific cosmetic ingredients or non-func22 tional constituents. 

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

24 Administration shall make the reports required under sub25 section (a) available to the public on the Internet website 


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1 of the Food and Drug Administration on the date of sub2 mission of such reports to Congress. 

3 ‘‘(c) PUBLIC INPUT ON SAFETY REVIEW.—Upon re4 lease of the report described in subsection (a), the Food 

5 and Drug Administration shall provide the public with an 

6 opportunity to provide feedback, at any time during the 

7 year, on the identification of ingredients under subsection 

8 (a)(3) by— 

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

10 of the report, enabling the public to— 

11 ‘‘(A) comment on the cosmetic ingredients 

12 or non-functional constituents under review for 

13 the current year; 

14 ‘‘(B) recommend additional cosmetic ingre15 dients and non-functional constituents to be 

16 considered for review for safety in future years; 

17 and 

18 ‘‘(C) comment on the priorities for the spe19 cific cosmetic ingredients and non-functional 

20 constituents that the Food and Drug Adminis21 tration anticipates will be reviewed in the next 

22 fiscal year; 

23 ‘‘(2) announcing on the Internet website of the 

24 Food and Drug Administration, within the first 30 

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


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1 list of cosmetic ingredients and non-functional con2 stituents submitted pursuant to subsection (a)(3) 

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

4 and 

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

6 least 5 specific cosmetic ingredients and non-func7 tional constituents that will be reviewed in the com8 ing year under section 607, providing a comment pe9 riod for further public input, pursuant to section 

10 607(a)(2).’’. 

11 SEC. 111. SMALL BUSINESSES. 

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

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

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

15 ‘‘SEC. 617. SMALL BUSINESSES. 

16 ‘‘The Commissioner, in coordination with the Admin17 istrator of the Small Business Administration, shall pro18 vide technical assistance, such as guidance and expertise, 

19 to small businesses regarding compliance with the Per20 sonal Care Products Safety Act, including the amend21 ments made by such Act.’’. 


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1 SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS2 METICS. 

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

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

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

6 ‘‘SEC. 618. APPLICABILITY WITH RESPECT TO CERTAIN 

7 COSMETICS. 

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

9 is subject to the requirements under this chapter and 

10 chapter V, if any requirement under chapter V with re11 spect to such cosmetic or facility is substantially similar 

12 to a requirement under this chapter, the cosmetic product 

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

14 applicable requirement under this chapter if such product 

15 or facility is in compliance with such substantially similar 

16 requirement under chapter V, provided that the product 

17 or facility has not obtained a waiver from the requirement 

18 under chapter V. In the case of a cosmetic product or fa19 cility that is subject to, and in compliance with, a fee 

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

21 part 10 of such subchapter, any fee under such part 10 

22 shall be waived with respect to such cosmetic product or 

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


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1 SEC. 113. ENFORCEMENT. 

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

3 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend4 ed— 

5 (1) in paragraph (e)— 

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

7 ‘‘504, 564, 609, 610,’’; and 

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

9 ‘‘519, 564, 609,’’; 

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

11 608,’’ before ‘‘704’’; 

12 (3) in paragraph (ii)— 

13 (A) by striking ‘‘760 or 761) or’’ and in14 serting ‘‘604, 760, or 761) or’’; and 

15 (B) by striking ‘‘761) submitted’’ and in16 serting ‘‘761 or as described in section 609) 

17 submitted’’; 

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

19 after ‘‘423’’; and 

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

21 ‘‘(fff) The failure to register in accordance with sec22 tion 605, the failure to provide any information required 

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

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


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

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

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

6 holding do not conform to current good manufacturing 

7 practice, as prescribed by the Food and Drug Administra8 tion in accordance with section 608. 

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

10 section 607(e), an ingredient that the Food and Drug Ad11 ministration has determined under section 607(d)(4) to be 

12 not safe, or not safe under the conditions of use rec13 ommended or suggested in the label or a non-functional 

14 constituent that the Food and Drug Administration has 

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

16 safe in the amount present in the cosmetic. 

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

18 regarding safety substantiation have not been supplied 

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

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

21 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend22 ed— 

23 (1) in paragraph (b)— 

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

25 ‘‘(2)’’; and 


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1 (B) by inserting ‘‘; and (3) a domestic ad2 dress or a domestic telephone number, and it is 

3 encouraged that the label include both a domes4 tic address and a domestic telephone number, 

5 through which the responsible person may re6 ceive a report of an adverse event associated 

7 with the use of such cosmetic product’’ after 

8 ‘‘numerical count’’; and 

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

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

11 factory, warehouse, or establishment and the responsible 

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

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

14 refuses to permit entry or inspection. 

15 ‘‘(h) If its labeling does not conform with a require16 ment under section 612.’’. 

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

18 of enactment of this Act, the Food and Drug Administra19 tion shall issue guidance that defines the circumstances 

20 that would constitute delaying, denying, or limiting inspec21 tion, or refusing to permit entry or inspection, for pur22 poses of section 602(g) of the Federal Food, Drug, and 

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

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

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


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

2 third, and fourth place such term appears and in3 serting ‘‘section 609, 760, or 761’’; and 

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

5 ‘‘604, 760, or 761)’’. 

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

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

8 374(a)(1)) is amended by inserting after the third sen9 tence the following: ‘‘In the case of any person who manu10 factures, processes, distributes, or imports a cosmetic 

11 product, or distributes a cosmetic product and affixes its 

12 name on the cosmetic label, the inspection shall extend 

13 to all records and other information described in section 

14 610 (regarding inspection of cosmetic records), when the 

15 standard for records inspections under paragraph (1) or 

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

17 the limitations under subsections (d) and (e) of such sec18 tion.’’. 

19 SEC. 114. CONSUMER INFORMATION. 

20 The Food and Drug Administration shall post on its 

21 Internet website information for consumers regarding— 

22 (1) final orders regarding the safety of a cos23 metic ingredient or non-functional constituent under 

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

25 Cosmetic Act; 


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1 (2) cosmetic product recalls (including vol2 untary and mandatory recalls); and 

3 (3) identified counterfeit cosmetic products. 

4 TITLE II—FEES RELATED TO 

5 COSMETIC SAFETY 

6 SEC. 201. FINDINGS. 

7 Congress finds that the fees authorized by the 

8 amendments made by this title will be dedicated to cos9 metic safety activities, as set forth in the goals identified 

10 for purposes of part 10 of subchapter C of chapter VII 

11 of the Federal Food, Drug, and Cosmetic Act, in the let12 ters from the Secretary of Health and Human Services 

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

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

15 the Committee on Energy and Commerce of the House 

16 of Representatives, as set forth in the Congressional 

17 Record. 

18 SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFE19 TY FEES. 

20 Subchapter C of chapter VII of the Federal Food, 

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

22 amended by adding at the end the following: 

23 ‘‘PART 10—FEES RELATING TO COSMETICS 

24 ‘‘SEC. 744L. REGISTRATION FEE. 

25 ‘‘(a) ASSESSMENT AND COLLECTION.— 


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

2 2020, the Food and Drug Administration shall as3 sess and collect an annual fee from every responsible 

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

5 who owns or operates any facility (as defined in sec6 tion 604(3)) engaged in manufacturing or proc7 essing, or whose name and address appear on the 

8 label of a cosmetic product distributed in the United 

9 States, except that this subsection shall not apply to 

10 contract manufacturers if a responsible person has 

11 already paid the appropriate fee with respect to the 

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

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

14 shall be payable during the period of initial registra15 tion and on the date of registration each year there16 after as prescribed in section 605(a)(1). 

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

18 ‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust19 ment factor’ applicable to a fiscal year means the 

20 Consumer Price Index for all urban consumers (all 

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

22 preceding fiscal year divided by such index for Octo23 ber 2019. 


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

2 any business entity that has a relationship with a 

3 second business entity if, directly or indirectly— 

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

5 power to control, the other business entity; or 

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

7 power to control, both of the business entities. 

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

9 product’ has the meaning given such term in section 

10 604(2). 

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

12 ‘cosmetic safety activities’— 

13 ‘‘(A) means activities related to compliance 

14 by registrants under section 605 with the re15 quirements of this Act with respect to cos16 metics, including— 

17 ‘‘(i) administrative activities, such as 

18 information technology support, human re19 sources, financial management, the admin20 istration and maintenance of the cosmetic 

21 registration system and the cosmetic ingre22 dient statement system under section 605, 

23 and fee assessment and collection under 

24 this section; and 


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1 ‘‘(ii) implementation and enforcement 

2 activities, such as the establishment of 

3 good manufacturing practices, the review 

4 of adverse event reports, inspection plan5 ning and inspections, and use of enforce6 ment tools; and 

7 ‘‘(B) includes activities related to imple8 mentation of section 607, regarding the review 

9 of cosmetic ingredients and non-functional con10 stituents. 

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

12 annual sales’ means the average United States gross 

13 annual sales for the previous 3-year period of cos14 metics for a registrant, including the sales of all of 

15 its affiliates, as reported in the registration under 

16 section 605. 

17 ‘‘(c) FEE SETTING AND AMOUNTS.— 

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

19 the Food and Drug Administration shall establish 

20 the fees to be collected under this section for each 

21 fiscal year after fiscal year 2020, based on the meth22 odology described in paragraph (3), and shall pub23 lish such fees in a Federal Register notice not later 

24 than 60 days before the beginning of each such fis25 cal year. 


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

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

3 period immediately preceding the fiscal year for 

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

5 $10,000,000, shall be exempt from registration fees 

6 under this section for that fiscal year. 

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

8 2020 through 2025, to generate a total estimated 

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

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

11 as follows: 

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

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

14 in 2018, $1,350,000. 

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

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

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

18 2018, $850,000. 

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

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

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

22 2018, $730,000. 

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

24 has gross annual sales of at least 


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1 $2,000,000,000 per annum but less than 

2 $3,000,000,000 in 2018, $610,000. 

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

4 has gross annual sales of at least 

5 $1,000,000,000 per annum but less than 

6 $2,000,000,000 in 2018, $500,000. 

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

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

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

10 2018, $395,000. 

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

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

13 per annum but less than $500,000,000 in 2018, 

14 $325,000. 

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

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

17 per annum but less than $200,000,000 in 2018, 

18 $275,000. 

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

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

21 annum but less than $100,000,000 in 2018, 

22 $185,000. 

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

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


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1 annum but less than $80,000,000 in 2018, 

2 $95,000. 

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

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

5 per annum but less than $60,000,000 in 2018, 

6 $15,000. 

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

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

9 per annum but less than $40,000,000 in 2018, 

10 $12,000. 

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

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

13 per annum but less than $20,000,000 in 2018, 

14 $500. 

15 ‘‘(d) ADJUSTMENTS.— 

16 ‘‘(1) INFLATION ADJUSTMENT.— 

17 ‘‘(A) IN GENERAL.—For fiscal year 2021 

18 and each subsequent fiscal year, the revenues 

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

20 be adjusted by the Food and Drug Administra21 tion in the annual Federal Register notice es22 tablishing fees in subsection (c)(1), by an 

23 amount equal to the sum of— 

24 ‘‘(i) one; 


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1 ‘‘(ii) the average annual percent 

2 change in the cost, per full-time equivalent 

3 position of the Food and Drug Administra4 tion, of all personnel compensation and 

5 benefits paid with respect to such positions 

6 for the first 3 of the preceding 4 fiscal 

7 years for which data are available, multi8 plied by the average proportion of per9 sonnel compensation and benefits costs to 

10 total Food and Drug Administration costs 

11 for the first 3 years of the preceding 4 fis12 cal years for which data are available; and 

13 ‘‘(iii) the average annual percent 

14 change that occurred in the Consumer 

15 Price Index for urban consumers (Wash16 ington-Baltimore, DC6 MD–VA–WV; not 

17 seasonally adjusted; all items less food and 

18 energy; annual index) for the first 3 years 

19 of the preceding 4 years for which data are 

20 available multiplied by the average propor21 tion of all costs other than personnel com22 pensation and benefits costs to total Food 

23 and Drug Administration costs for the 

24 first 3 years of the preceding 4 fiscal years 

25 for which data are available. 


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1 ‘‘(B) COMPOUNDED BASIS.—The adjust2 ment made each fiscal year under this sub3 section shall be added on a compounded basis 

4 to the sum of all adjustments made each fiscal 

5 year after fiscal year 2020 under this sub6 section. 

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

8 year 2025, the Food and Drug Administration may, 

9 in addition to adjustments under paragraph (1), fur10 ther increase the fee revenues and fees established in 

11 subsection (c) if such an adjustment is necessary to 

12 provide for not more than 3 months of operating re13 serves of carryover fees for cosmetic safety activities 

14 for the first 3 months of fiscal year 2026. If such 

15 an adjustment is necessary, the rationale for the in16 crease, shall be contained in the annual Federal 

17 Register notice establishing fees, in subsection 

18 (c)(1), for fiscal year 2025. If the Food and Drug 

19 Administration has carryover balances for such ac20 tivities in excess of 3 months of such operating re21 serves, the adjustment under this subparagraph 

22 shall not be made. 

23 ‘‘(3) WORKLOAD ADJUSTMENT.— 

24 ‘‘(A) IN GENERAL.—For fiscal year 2021 

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1 nues established in subsection (c)(3) are ad2 justed for a fiscal year for inflation in accord3 ance with paragraph (1), the fee revenues shall 

4 be adjusted further for each fiscal year to re5 flect changes in the workload of the Food and 

6 Drug Administration for actual changes in 

7 workload volume due to the process of reviewing 

8 cosmetic ingredients or non-functional constitu9 ents not listed under section 607(b). 

10 ‘‘(B) DETERMINATION OF ADJUSTMENT.— 

11 The adjustment shall be determined by the 

12 Food and Drug Administration based on the 

13 workload in the most recent 1-year period for 

14 which workload data is available. The Food and 

15 Drug Administration shall publish in the Fed16 eral Register the fee revenues and fees resulting 

17 from the adjustment and the supporting meth18 odologies. 

19 ‘‘(C) MINIMUM REVENUES.—The adjust20 ment shall not result in fee revenues for a fiscal 

21 year that are less than the sum of the amount 

22 under subsection (c)(3), as adjusted for infla23 tion under subparagraph (1). 

24 ‘‘(e) LIMITATIONS.— 


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1 ‘‘(1) IN GENERAL.—With respect to the amount 

2 that, under the salaries and expenses account of the 

3 Food and Drug Administration, is appropriated for 

4 a fiscal year for the cosmetics program in the Center 

5 for Food Safety and Applied Nutrition and related 

6 field activities, fees may not be assessed under sub7 section (a) for the fiscal year unless the amount so 

8 appropriated for the fiscal year (excluding the 

9 amount of fees appropriated for the fiscal year), is 

10 equal to or greater than that assessed for fiscal year 

11 2019, multiplied by the adjustment factor applicable 

12 to the fiscal year involved. 

13 ‘‘(2) AUTHORITY.—If the Food and Drug Ad14 ministration does not assess fees under subsection 

15 (a) during any portion of a fiscal year because of 

16 paragraph (1) and if at a later date in such fiscal 

17 year the Food and Drug Administration may assess 

18 such fees, the Food and Drug Administration may 

19 assess and collect such fees, without any modifica20 tion in the rate, for registration under section 605 

21 at any time in such fiscal year. 

22 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

23 ‘‘(1) IN GENERAL.—Fees authorized under sub24 section (a) shall be collected and available for obliga25 tion only to the extent and in the amount provided 


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1 in advance in appropriations Acts. Such fees are au2 thorized to remain available until expended. Such 

3 sums as may be necessary may be transferred from 

4 the Food and Drug Administration salaries and ex5 penses appropriation account without fiscal year lim6 itation to such appropriation account for salaries 

7 and expenses with such fiscal year limitation. The 

8 sums transferred shall be available solely for cos9 metic safety activities. 

10 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

11 ACTS.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graphs (C) and (D), the fees authorized by this 

14 section shall be collected and available in each 

15 fiscal year in an amount not to exceed the 

16 amount specified in appropriation Acts, or oth17 erwise made available for obligation for such 

18 fiscal year. 

19 ‘‘(B) USE OF FEES AND LIMITATION.— 

20 The fees authorized by this section shall be col21 lected and available only to defray the costs of 

22 cosmetic safety activities. 

23 ‘‘(C) FEE COLLECTIONS DURING FIRST

24 PROGRAM YEAR.—Until the date of enactment 

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1 tember 30, 2020, for the salaries and expenses 

2 account of the Food and Drug Administration, 

3 fees authorized by this section for fiscal year 

4 2020 may be collected and shall be credited to 

5 such account to remain available until ex6 pended. Fees collected under this subparagraph 

7 shall be considered discretionary for purposes of 

8 the Balanced Budget and Emergency Deficit 

9 Control Act of 1985. 

10 ‘‘(D) REIMBURSEMENT OF START-UP

11 AMOUNTS.—Any amounts allocated to establish 

12 programs under section 605, prior to collection 

13 of fees, may be reimbursed through any appro14 priated fees collected under this section, in such 

15 manner as the Food and Drug Administration 

16 determines appropriate. Any amounts reim17 bursed under this subparagraph shall be avail18 able for the programs and activities for which 

19 funds allocated to establish the programs were 

20 available, prior to such allocation, until the end 

21 of the fiscal year in which the reimbursement 

22 occurs, notwithstanding any otherwise applica23 ble limits on amounts for such program or ac24 tivities for a fiscal year. 


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

2 For each of fiscal years 2020 through 2026, there 

3 are authorized to be appropriated for fees under this 

4 section $20,600,000, as adjusted by subsection (d). 

5 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

6 OF COLLECTION SHORTFALLS.— 

7 ‘‘(A) OFFSET OF OVERCOLLECTIONS.—If 

8 the sum of the cumulative amount of fees col9 lected under this section for the fiscal years 

10 2020 through 2024 exceeds the cumulative 

11 amount appropriated pursuant to paragraph (3) 

12 for fiscal years 2020 through 2025, the excess 

13 amount shall be credited to the appropriation 

14 account of the Food and Drug Administration 

15 as provided in paragraph (1), and shall be sub16 tracted from the amount of fees that would oth17 erwise be authorized to be collected under this 

18 section pursuant to appropriation Acts for fiscal 

19 year 2026. 

20 ‘‘(B) RECOVERY OF COLLECTION SHORT21 FALLS.— 

22 ‘‘(i) 2022.—For fiscal year 2022, 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 2020 falls 

3 below the amount of fees authorized for 

4 fiscal year 2020 under paragraph (3). 

5 ‘‘(ii) 2023.—For fiscal year 2023, the 

6 amount of fees otherwise authorized to be 

7 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 221 falls 

11 below the amount of fees authorized for 

12 fiscal year 2021 under paragraph (3). 

13 ‘‘(iii) 2024.—For fiscal year 2024, 

14 the amount of fees otherwise authorized to 

15 be 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 2022 falls 

19 below the amount of fees authorized for 

20 fiscal year 2022 under paragraph (3). 

21 ‘‘(iv) 2025.—For fiscal year 2025, 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 2023 falls 

2 below the amount of fees authorized for 

3 fiscal year 2023 under paragraph (3). 

4 ‘‘(v) 2026.—For fiscal year 2026, the 

5 amount of fees otherwise authorized to be 

6 collected under this section shall be in7 creased by the amount, if any, by which 

8 the amount collected under this section 

9 and appropriated for fiscal year 2024 falls 

10 below the amount of fees authorized for 

11 fiscal year 2024 under paragraph (3). 

12 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.—The Food 

13 and Drug Administration shall not consider a registration 

14 submitted to be complete until such fee under subsection 

15 (a) is paid. Until the fee is paid, the registration is incom16 plete and the registrant is deemed to have failed to reg17 ister in accordance with section 605. 

18 ‘‘(h) FALSE STATEMENTS.—Any statement or rep19 resentation made to the Food and Drug Administration 

20 shall be subject to section 1001 of title 18, United States 

21 Code. 

22 ‘‘(i) COLLECTION OF UNPAID FEES.—In any case 

23 where the Food and Drug Administration does not receive 

24 payment of a fee assessed under subsection (a), such fee 

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1 ment subject to subchapter II of chapter 37 of title 31, 

2 United States Code. 

3 ‘‘(j) CONSTRUCTION.—This section may not be con4 strued to require that the number of full-time equivalent 

5 positions in the Department of Health and Human Serv6 ices, for officers, employees, and advisory committees not 

7 engaged in cosmetic activities, be reduced to offset the 

8 number of officers, employees, and advisory committees so 

9 engaged. 

10 ‘‘(k) RECORDS.—Each facility shall retain all records 

11 necessary to demonstrate the facility’s gross annual sales 

12 for at least 2 fiscal years after such information is re13 ported in the facility’s registration. Such records shall be 

14 made available to the Food and Drug Administration for 

15 review and duplication upon request of the Food and Drug 

16 Administration.’’. 

17 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI18 TIES RELATED TO COSMETICS. 

19 Part 10 of subchapter C of chapter VII of the Fed20 eral Food, Drug, and Cosmetic Act, as added by section 

21 202, is amended by inserting after section 744L the fol22 lowing: 


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1 ‘‘SEC. 744M. DIRECT HIRING AUTHORITY TO SUPPORT AC2 TIVITIES RELATED TO COSMETICS. 

3 ‘‘(a) IN GENERAL.—The Food and Drug Administra4 tion shall have direct hiring authority with respect to the 

5 appointment of employees into the competitive service or 

6 the excepted service to administer the amendments made 

7 by title I of the Personal Care Products Safety Act. 

8 ‘‘(b) SUNSET.—The authority under subsection (a) 

9 shall terminate on the date that is 3 years after the date 

10 of enactment of such title.’’. 

Æ 


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