II 

115TH CONGRESS 

1ST SESSION S. 1113 

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

of cosmetics. 

IN THE SENATE OF THE UNITED STATES 

MAY 11, 2017 

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; safety of finished products. 

Sec. 103. Good manufacturing practices for cosmetics. 

Sec. 104. Adverse event reports. 

Sec. 105. Records inspection; mandatory recall authority. 

Sec. 106. Labeling. 

Sec. 107. Coal tar chemicals. 

Sec. 108. Animal testing alternatives. 

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 cosmetic comprised of a specified 

15 set of ingredients, which may come in a range of 


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1 possible amounts for each ingredient and which may 

2 include a variety of fragrances, flavors, and colors. 

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, processes, packs, or holds 

7 cosmetic products or cosmetic formulations, or any 

8 other entity whose name and address appear on the 

9 label of a cosmetic product. Such term does not in10 clude— 

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

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

14 ‘‘(B) cosmetic product retailers, including 

15 individual sales representatives, retail distribu16 tion facilities, and pharmacies, that do not oth17 erwise manufacture, process, or package cos18 metics at that location; 

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

20 health care clinics; 

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

23 the consumer; 

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

25 complimentary cosmetics to guests; 


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

2 cosmetic product samples are provided free of 

3 charge; or 

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. 

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

19 packs, or holds, a cosmetic formulation or cosmetic 

20 product that is exported to the United States with21 out further processing or packaging inside the 

22 United States. A cosmetic is not considered to have 

23 undergone further processing or packaging for pur24 poses of this definition solely on the basis that label25 ing was added or that any similar activity of a de 


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1 minimis nature was carried out with respect to the 

2 cosmetic. 

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

4 term ‘non-functional constituent’ means any sub5 stance that is an incidental component of an ingre6 dient, a breakdown product of an ingredient or a by7 product of the manufacturing process that has not 

8 been intentionally added as a separate substance and 

9 serves no technical function in the cosmetic. 

10 ‘‘(6) RESPONSIBLE PERSON.—The term ‘re11 sponsible person’ means— 

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

13 or foreign manufacturer, packer, or entity 

14 whose name appears on a cosmetic product 

15 label of a cosmetic product distributed in the 

16 United States, except for entities described in 

17 subparagraphs (A) through (G) of paragraph 

18 (3); or 

19 ‘‘(B) a contract manufacturer who provides 

20 cosmetic products to the entities described in 

21 subparagraphs (A) through (G) of paragraph 

22 (3).’’. 

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

24 ‘‘(a) REGISTRATION AND FEES FOR EXISTING MAN25 UFACTURING OR PROCESSING OF COSMETICS.— 


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

2 than December 1, 2017, and at a similar time in 

3 each subsequent year, as determined by the Food 

4 and Drug Administration, each responsible person 

5 engaged in manufacturing or processing a cosmetic 

6 product or a cosmetic formulation distributed in the 

7 United States shall register all of the responsible 

8 person’s facilities with the Food and Drug Adminis9 tration. 

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

11 in the United States of cosmetic products of all of 

12 the responsible person’s facilities registered under 

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

14 greater than $2,000,000, a registration shall not be 

15 complete under this subsection until the responsible 

16 person has paid any registration fee required under 

17 section 744L. 

18 ‘‘(b) REGISTRATION FOR EXISTING PACKING OR

19 HOLDING OF COSMETICS.—Not later than December 1, 

20 2017, and at a similar time once every 3 years thereafter, 

21 as determined by the Food and Drug Administration, each 

22 person who owns or operates a cosmetic facility or facili23 ties engaged in packing or holding a cosmetic product dis24 tributed in the United States shall register each such facil25 ity with the Food and Drug Administration. 


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1 ‘‘(c) REGISTRATION BY NEW FACILITIES.—Any facil2 ity first engaging after the date of enactment of the Per3 sonal Care Products Safety Act in an activity that would 

4 require it to register under subsection (a) or (b) shall reg5 ister with the Food and Drug Administration within 60 

6 days of first engaging in such activity, and thereafter in 

7 accordance with subsection (a) or (b). 

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

9 has submitted a registration under this section shall notify 

10 the Food and Drug Administration of any change to the 

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

12 than 60 days after the date of such change, unless other13 wise specified by the Food and Drug Administration. 

14 ‘‘(e) FORMAT; CONTENTS.— 

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

16 shall be submitted using an electronic format, as 

17 specified in a registration form provided by the Food 

18 and Drug Administration. 

19 ‘‘(2) CONTENTS.— 

20 ‘‘(A) IN GENERAL.—The registration shall 

21 contain the following information: 

22 ‘‘(i) Each facility’s name and full ad23 dress, identifying the precise physical loca24 tion of the facility. 


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1 ‘‘(ii) The identity of the facility, in2 cluding the unique facility identifier, if 

3 any, previously assigned by the Food and 

4 Drug Administration to the facility under 

5 subsection (g). 

6 ‘‘(iii) All business trading names used 

7 by the facility. 

8 ‘‘(iv) The product category or cat9 egories of each cosmetic product or cos10 metic formulation manufactured, proc11 essed, packed, or held at the facility or on 

12 whose label the facility’s name and address 

13 appear. 

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

15 the facility (such as manufacturing, proc16 essing, packing, or holding). 

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

18 telephone number, and electronic contact 

19 information of the emergency contact for 

20 the facility. 

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

22 the name, street address, telephone num23 ber, emergency contact information for the 

24 facility, the name of the United States 

25 agent for the facility, and, if available, the 


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1 electronic contact information of the 

2 United States agent. 

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

4 telephone number, and electronic contact 

5 information of the individual submitting 

6 the registration. 

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

8 Drug Administration will be permitted to 

9 inspect such facility at the times and in 

10 the manner permitted by this Act. 

11 ‘‘(x) Additional information pertaining 

12 to the facility or to the cosmetic products 

13 or cosmetic formulations manufactured, 

14 processed, packed, or held at the facility, 

15 or on whose label the facility’s name and 

16 address appear, including all brand names 

17 known to consumers, as the Food and 

18 Drug Administration may require by regu19 lation. 

20 ‘‘(B) SMALL BUSINESSES.— 

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

22 a registrant described in clause (ii), the 

23 registration shall contain the following in24 formation: 


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

2 address, identifying the precise phys3 ical location of the facility. 

4 ‘‘(II) The name, title, street ad5 dress, telephone number, and elec6 tronic contact information of the 

7 emergency contact for the facility. 

8 ‘‘(III) The consumer product cat9 egory or categories of each cosmetic 

10 product or cosmetic formulation man11 ufactured, processed, packed, or held 

12 at the facility or on whose label the 

13 facility’s name and address appear. 

14 ‘‘(ii) SMALL BUSINESS REG15 ISTRANTS.—A registrant described in this 

16 clause is a domestic registrant— 

17 ‘‘(I) whose average gross annual 

18 sales in the United States of cosmetic 

19 products for the previous 3-year pe20 riod is between $500,000 and 

21 $2,000,000 (or between $1,000,000 

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

23 cosmetic products produced in a pri24 vate residence); and 

25 ‘‘(II) who does not produce— 


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1 ‘‘(aa) products that are in2 tended to go on the eye area; 

3 ‘‘(bb) lip products with 

4 color; 

5 ‘‘(cc) products that are in6 jected; 

7 ‘‘(dd) products that are in8 tended for internal use; and 

9 ‘‘(ee) products that are 

10 meant to alter appearance for 

11 more than 24 hours. 

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

13 and Drug Administration shall provide for an abbre14 viated registration renewal process for any registrant 

15 that has not had any changes to the required infor16 mation with respect to the facility or facilities in17 volved since the registrant submitted the preceding 

18 registration. 

19 ‘‘(f) INCOMPLETE OR INACCURATE REGISTRATION.— 

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

21 after providing notice of the intent to cancel a reg22 istration and the basis for such cancellation, the 

23 Food and Drug Administration may cancel a reg24 istration under this section if the Food and Drug 

25 Administration has reasonable grounds to believe 


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1 that the registration was not properly completed or 

2 updated in accordance with this section or otherwise 

3 contains false, incomplete, or inaccurate information. 

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

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

6 to cancel, the sponsor corrects the registration in ac7 cordance with the basis for the cancellation, and the 

8 required registration fee, if any, is paid, the Food 

9 and Drug Administration shall not cancel such reg10 istration. 

11 ‘‘(g) UNIQUE IDENTIFIER.—At the time of the initial 

12 registration of any cosmetic facility under this section, the 

13 Food and Drug Administration shall assign a unique iden14 tifier to the facility. 

15 ‘‘(h) REGISTRY OF FACILITIES.— 

16 ‘‘(1) IN GENERAL.—The Food and Drug Ad17 ministration shall compile, maintain, and update a 

18 registry of facilities that are registered under this 

19 section, and shall remove from such registry the 

20 name of any facility whose registration under this 

21 section is cancelled. The registry shall be publicly 

22 available. 

23 ‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In24 formation derived from the registry or registration 

25 documents that discloses the residential address of a 


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1 registrant or that discloses specific facilities where 

2 specific cosmetic products are manufactured or proc3 essed shall not be subject to disclosure under section 

4 552 of title 5, United States Code. 

5 ‘‘SEC. 606. COSMETIC INGREDIENT STATEMENTS. 

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

7 responsible person shall submit to the Food and Drug Ad8 ministration a cosmetic ingredient statement, at such time 

9 and in such manner as the Food and Drug Administration 

10 may prescribe. The cosmetic ingredient statement shall 

11 not become effective until the responsible person pays any 

12 applicable fee required under section 744L. 

13 ‘‘(b) SUBMISSION OF A COSMETIC INGREDIENT

14 STATEMENT.— 

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

16 case of a cosmetic product that is marketed on the 

17 date of enactment of the Personal Care Products 

18 Safety Act, the responsible person shall submit a 

19 cosmetic ingredient statement not later than Decem20 ber 1, 2017. The responsible person shall submit to 

21 the Food and Drug Administration a renewal of 

22 such statement on a yearly basis. 

23 ‘‘(2) COSMETIC INGREDIENT STATEMENT FOR

24 NEW COSMETIC PRODUCTS.— 


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

2 under subparagraph (B), in the case of a cos3 metic product that is first marketed after the 

4 date of enactment of the Personal Care Prod5 ucts Safety Act or a cosmetic product that is 

6 reformulated after such date of enactment, the 

7 responsible person shall submit a cosmetic in8 gredient statement to the Food and Drug Ad9 ministration within 60 days of first marketing 

10 the new cosmetic product or the reformulated 

11 cosmetic product, and annually thereafter. 

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

13 Drug Administration shall allow a responsible 

14 person that is a business that meets the appli15 cable industry-based small business size stand16 ard established by the Administrator of the 

17 Small Business Administration under section 3 

18 of the Small Business Act to have a period 

19 longer than 60 days to submit an initial new 

20 cosmetic ingredient statement under subpara21 graph (A). Such responsible person shall submit 

22 a cosmetic ingredient statement annually there23 after. 

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

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1 mulated after the date of enactment under sub2 paragraph (A) if the only change in such prod3 uct is in— 

4 ‘‘(i) the amount of an existing ingre5 dient if it is within the range previously re6 ported under subsection (c)(2)(E); or 

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

8 fragrance, flavor, or color, or such other 

9 interchangeable ingredients specified by 

10 the Food and Drug Administration in reg11 ulations or guidance, previously reported 

12 as a potential ingredient under subsection 

13 (c)(2)(E), if, in the case of such an addi14 tion, the amount is within the range pre15 viously reported. 

16 ‘‘(c) FORMAT; CONTENTS.— 

17 ‘‘(1) FORM.—For each cosmetic product, the 

18 cosmetic ingredient statement shall be submitted 

19 using an electronic format, as specified in a cosmetic 

20 and ingredient form provided by the Food and Drug 

21 Administration. 

22 ‘‘(2) CONTENTS.—The cosmetic ingredient 

23 statement shall include the following information: 

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

25 section 605(g), as applicable, of— 


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1 ‘‘(i) each facility where the cosmetic 

2 product is manufactured, processed, 

3 packed, or held; and 

4 ‘‘(ii) the facility whose name and ad5 dress appear on the label, unless the state6 ment is filed by a contract manufacturer, 

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

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

9 for the cosmetic product as it appears on the 

10 label. 

11 ‘‘(C) The cosmetic product listing number, 

12 if any, previously assigned by the Food and 

13 Drug Administration under subsection (f) to 

14 the cosmetic product. 

15 ‘‘(D) The applicable cosmetic category for 

16 the cosmetic product. 

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

18 product, including a range of possible amounts 

19 of each ingredient, and with each ingredient 

20 identified by the name adopted in regulations 

21 promulgated by the Food and Drug Adminis22 tration, if any, or by the common or usual 

23 name of the ingredient. The cosmetic ingredient 

24 statement shall contain— 


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

2 colors that may be included in the product, 

3 interchangeably, with ranges of possible 

4 amounts, which shall include— 

5 ‘‘(I) in the case of fragrances 

6 that are purchased from a fragrance 

7 supplier, identification of the fra8 grances by the name or code provided 

9 by the supplier, including the name 

10 and contact information for the fra11 grance supplier; and 

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

13 are purchased from a flavor supplier, 

14 identification of the flavors by the 

15 name or code provided by the sup16 plier, including the name and contact 

17 information for the flavor supplier; 

18 and 

19 ‘‘(ii) other appropriate interchange20 able ingredients as the Food and Drug Ad21 ministration may specify in regulations or 

22 guidance that may be included in the prod23 uct, with ranges of possible amounts. 

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

25 of each individual submitting the statement. 


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1 ‘‘(G) If applicable, information on the la2 beling required under section 614. 

3 ‘‘(H) Such additional information per4 taining to the cosmetic product as the Food and 

5 Drug Administration may require. 

6 ‘‘(3) ADDITIONAL INFORMATION.—In the case 

7 of a cosmetic ingredient statement that includes a 

8 list of fragrances or flavors that are purchased from 

9 a fragrance or flavor supplier as described in para10 graph (2)(E)(i), upon request by the Food and Drug 

11 Administration, the fragrance or flavor supplier shall 

12 submit to the Food and Drug Administration the 

13 complete list of ingredients in specific fragrances, or 

14 flavors not later than 30 days after receiving such 

15 request. 

16 ‘‘(d) INCOMPLETE OR INACCURATE COSMETIC IN17 GREDIENT STATEMENT.— 

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

19 after providing notice to the responsible person of 

20 the intent to cancel the cosmetic ingredient state21 ment and the basis for such cancellation, the Food 

22 and Drug Administration may nullify a cosmetic in23 gredient statement filed under this section if the 

24 Food and Drug Administration has reasonable 

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1 ment was not completed or updated in accordance 

2 with this section or otherwise contains false, incom3 plete, or inaccurate information. 

4 ‘‘(2) TIMELY UPDATE OR CORRECTION.—If the 

5 cosmetic ingredient statement is appropriately up6 dated or corrected not later than 7 days after notice 

7 is provided under paragraph (1), the Food and Drug 

8 Administration shall not nullify such cosmetic ingre9 dient statement. 

10 ‘‘(e) ADDITIONAL REQUIREMENTS.— 

11 ‘‘(1) SAFETY REQUIREMENTS.—In filing each 

12 cosmetic ingredient statement cosmetic product, the 

13 responsible person shall include an attestation that 

14 the safety of the product, including the individual in15 gredients of such product and the product as a 

16 whole, has been substantiated in accordance with 

17 section 609. In the case of a cosmetic ingredient 

18 statement that includes a range of possible amounts 

19 (as described in subsection (c)(2)(E)), the respon20 sible person shall include an attestation that such 

21 person has substantiated the safety of the product 

22 and its ingredients in accordance with the require23 ments of section 609. 

24 ‘‘(2) ABBREVIATED FILING.—The Food and 

25 Drug Administration shall provide for an abbreVerDate Sep 11 2014 22:08 May 15, 2017 Jkt 069200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S1113.IS S1113

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1 viated renewal process for any such filing with re2 spect to which there has been no change since the 

3 responsible person submitted the previous filing. 

4 ‘‘(3) CHANGES TO INFORMATION.— 

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

6 subparagraph (B), the responsible person shall 

7 notify the Food and Drug Administration with8 in 60 days of any change to the information re9 quired to be in a cosmetic ingredient statement, 

10 including discontinuation of the manufacture of 

11 a cosmetic product, except that notification 

12 under this paragraph is not required for a 

13 change in— 

14 ‘‘(i) the amount of an existing ingre15 dient if it is within the range previously re16 ported under subsection (c)(2)(E); or 

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

18 fragrance, flavor or color, or such other 

19 interchangeable ingredients specified by 

20 the Food and Drug Administration in reg21 ulations or guidance, previously reported 

22 as a potential ingredient under subsection 

23 (c)(2)(E), if, in the case of an addition of 

24 such an ingredient, the amount is within 

25 the range previously reported. 


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1 ‘‘(B) EXCEPTIONS.— 

2 ‘‘(i) SMALL BUSINESSES.—The Food 

3 and Drug Administration shall allow a re4 sponsible person that is a business that 

5 meets the applicable industry-based small 

6 business size standard established by the 

7 Administrator of the Small Business Ad8 ministration under section 3 of the Small 

9 Business Act to have a period longer than 

10 60 days, but not longer than the next an11 nual registration deadline under section 

12 605(a)(1), to submit any change to the in13 formation required to be in a cosmetic in14 gredient statement as described in sub15 paragraph (A). 

16 ‘‘(ii) OTHER BUSINESSES.—Any busi17 ness that has an average of not more than 

18 $2,000,000 in annual domestic cosmetic 

19 sales over the previous 3 years is not re20 quired to report the discontinuation of the 

21 manufacture of a cosmetic product or cos22 metic product category as described in sub23 paragraph (A) until the next annual reg24 istration period under section 605. 


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1 ‘‘(f) COSMETIC PRODUCTS LIST.—At the time of the 

2 initial submission of any cosmetic ingredient statement 

3 under this section, the Food and Drug Administration 

4 shall assign a unique cosmetic product listing number to 

5 the cosmetic ingredient statement. Based on such cosmetic 

6 ingredient statements, the Food and Drug Administration 

7 shall compile and maintain a list of cosmetic products dis8 tributed in the United States, including the ingredients 

9 of each such product, and shall make available such list 

10 to any State, upon request. Information disclosed to a 

11 State that is exempt from disclosure under section 

12 552(b)(4) of title 5, United States Code, shall be treated 

13 as a trade secret and confidential information by the 

14 State. 

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

16 INGREDIENT STATEMENT. 

17 ‘‘(a) SUSPENSION OF REGISTRATION OF A FACIL18 ITY.—If the Food and Drug Administration determines 

19 that a cosmetic formulation or cosmetic product manufac20 tured, processed, packed, or held by a registered facility 

21 and distributed in the United States has a reasonable 

22 probability of causing serious adverse health consequences 

23 or death to humans, and the Food and Drug Administra24 tion has a reasonable belief that other products manufac25 tured or processed by the facility may be similarly affected 


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1 because of a failure that cannot be isolated to a single 

2 product or products or is sufficiently pervasive to raise 

3 concerns about other products manufactured in the facil4 ity, the Food and Drug Administration may suspend the 

5 registration of a facility. 

6 ‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATE7 MENT.—If the Food and Drug Administration determines 

8 that a cosmetic product manufactured in a registered fa9 cility has a reasonable probability of causing serious ad10 verse health consequences or death to humans, the Food 

11 and Drug Administration may suspend the cosmetic ingre12 dient statement of that product. 

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

14 facility registration or a cosmetic ingredient statement 

15 under this section, the Food and Drug Administration 

16 shall provide— 

17 ‘‘(1) notice to the facility registrant of the cos18 metic product or formulation or other responsible 

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

20 facility registration or the cosmetic ingredient state21 ment, which shall specify the basis of the determina22 tion by the Food and Drug Administration that the 

23 facility or the cosmetic ingredient should be sus24 pended and recommendations for specific actions to 

25 avoid suspension; and 


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

2 the notice provided under paragraph (1), for the re3 sponsible person to address the reasons for possible 

4 suspension of the facility registration or cosmetic in5 gredient statement. 

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

7 the Food and Drug Administration that adequate grounds 

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

9 and Drug Administration shall promptly vacate the sus10 pension and reinstate the registration of the facility or the 

11 cosmetic ingredient statement. 

12 ‘‘(e) EFFECT OF SUSPENSION.— 

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

14 facility is suspended under this section, no person 

15 shall introduce or deliver for introduction into inter16 state commerce cosmetics or cosmetic products from 

17 such facility. 

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

19 the cosmetic ingredient statement for a cosmetic 

20 product is suspended under this section, no person 

21 shall introduce or deliver for introduction into inter22 state commerce any cosmetic product that is the 

23 subject of such statement. 

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

25 this section to issue an order to suspend a registration 


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1 or vacate an order of suspension shall not be delegated 

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

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

4 CONSTITUENTS; SAFETY OF FINISHED PROD5 UCTS. 

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

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

8 amended by section 101, is further amended by adding 

9 at the end the following: 

10 ‘‘SEC. 608. REVIEW OF INGREDIENTS AND NON-FUNC11 TIONAL CONSTITUENTS. 

12 ‘‘(a) INGREDIENTS AND NON-FUNCTIONAL CON13 STITUENTS SUBJECT TO REVIEW.— 

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

15 2018, the Food and Drug Administration shall re16 view the safety of the cosmetic ingredients and non17 functional constituents under paragraph (3), as 

18 modified under subsection (c), if applicable, and 

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

20 the use of each such ingredient and presence of each 

21 such non-functional constituent. 

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

23 initiation of the review of each cosmetic ingredient 

24 or non-functional constituent, the Food and Drug 

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1 sion of public comment and additional data relevant 

2 to the safety of the ingredient or non-functional con3 stituent. The Food and Drug Administration shall 

4 provide 60 days for public comment. 

5 ‘‘(3) COSMETIC INGREDIENTS.— 

6 ‘‘(A) INGREDIENTS TO BE CONSIDERED IN

7 FIRST YEAR.—During fiscal year 2018, the 

8 Food and Drug Administration shall initiate the 

9 review for safety of the following cosmetic in10 gredients: 

11 ‘‘(i) Diazolidinyl urea. 

12 ‘‘(ii) Lead acetate. 

13 ‘‘(iii) Methylene glycol/methanediol/ 

14 formaldehyde. 

15 ‘‘(iv) Propyl paraben. 

16 ‘‘(v) Quaternium-15. 

17 ‘‘(B) INGREDIENTS TO BE CONSIDERED IN

18 SUBSEQUENT YEARS.— 

19 ‘‘(i) IN GENERAL.—Beginning in fis20 cal year 2019, the Food and Drug Admin21 istration shall annually select and complete 

22 a review of at least 5 cosmetic ingredients 

23 or non-functional constituents that were 

24 not reviewed in the prior 3 years from a 

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1 try and consumer groups for review of 

2 safety. The Food and Drug Administration 

3 may combine selected cosmetics ingredients 

4 or non-functional constituents into cat5 egories for purposes of such review. The 

6 Food and Drug Administration may mod7 ify such list under subsection (c). 

8 ‘‘(ii) CONSIDERATIONS.—The deter9 mination of which ingredients or functional 

10 ingredients will be reviewed in a given year 

11 shall be publicized in annual reports to 

12 Congress and the public, in accordance 

13 with section 618, and subject to consulta14 tion as provided for in clause (iii). The re15 view of any cosmetic ingredient or non16 functional constituent shall commence with 

17 a public announcement by the Food and 

18 Drug Administration and the opening of a 

19 docket as required under paragraph (2). 

20 ‘‘(iii) CONSULTATION.—The Food and 

21 Drug Administration shall establish a Cos22 metics Safety Advisory Committee, which 

23 shall include equal numbers of individuals 

24 from the cosmetics industry and consumer 

25 groups, and other individuals, as the Food 


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1 and Drug Administration determines ap2 propriate, including medical practitioners. 

3 Such advisory committee shall advise the 

4 Food and Drug Administration on cos5 metic ingredients and non-functional con6 stituents to be considered for review, sum7 marize public comments received pursuant 

8 to paragraph (4), and recommend 5 cos9 metic ingredients or non-functional con10 stituents to be reviewed for safety each 

11 year, as described in clause (i). The Food 

12 and Drug Administration may consult with 

13 the Cosmetics Safety Advisory Committee 

14 on other matters pertaining to cosmetic 

15 safety. 

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

17 reporting to Congress and the public under section 

18 618, the Food and Drug Administration shall solicit 

19 public comment on which cosmetic ingredients or 

20 non-functional constituents on the list are of great21 est interest to be reviewed next for early review and 

22 which additional cosmetic ingredients or non-func23 tional constituents should be added to the list. The 

24 public may submit comments to the Food and Drug 

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1 ing which cosmetic ingredients or non-functional 

2 constituents of interest the Food and Drug Adminis3 tration may consider during that year or subsequent 

4 years. 

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

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

7 Food and Drug Administration, of the cosmetic ingredi8 ents and non-functional constituents for which final orders 

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

10 made for each such ingredient or non-functional con11 stituent under subsection (d)(4), as modified by any order 

12 under subsection (f), if applicable, and, if applicable, com13 pliance dates that are the subject of a final order under 

14 subsection (e). 

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

16 Administration may at any time, after consultation with 

17 the Cosmetics Safety Advisory Committee, propose the 

18 issuance of an order on the safety of a cosmetic ingredient 

19 or non-functional constituent that was not previously list20 ed in subsection (a) or under section 618(a)(3). The Food 

21 and Drug Administration shall follow the same procedures 

22 and policies for review of any cosmetic ingredient or non23 functional constituent so proposed as for the ingredients 

24 and constituents reviewed pursuant to subsection (a). 

25 ‘‘(d) DETERMINATION ON SAFETY.— 


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1 ‘‘(1) INITIAL PROPOSED ADMINISTRATIVE

2 ORDER.—Following consideration of data and com3 ments to the public docket and any other informa4 tion before the Food and Drug Administration, the 

5 Food and Drug Administration shall determine 

6 whether there is adequate evidence to make an ini7 tial finding on the safety of the ingredient or non8 functional constituent. If the Food and Drug Ad9 ministration determines that there is adequate evi10 dence, the Food and Drug Administration shall issue 

11 a proposed administrative order and shall post such 

12 order on the Internet website of the Food and Drug 

13 Administration, notwithstanding subchapter II of 

14 chapter 5 of title 5, United States Code. 

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

16 the proposed administrative order described in para17 graph (1), the Food and Drug Administration shall 

18 open a docket for the submission of public comment. 

19 The Food and Drug Administration shall provide 30 

20 days for public comment following publication of the 

21 proposed administrative order. 

22 ‘‘(3) FINAL ADMINISTRATIVE ORDER.—Fol23 lowing the public comment period described in para24 graph (2) and consideration of comments to the pub25 lic docket and any other information before the Food 


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1 and Drug Administration, the Food and Drug Ad2 ministration shall determine whether there is ade3 quate evidence to make a final finding on the safety 

4 of the ingredient or non-functional constituent. If 

5 the Food and Drug Administration determines that 

6 there is adequate evidence, the Food and Drug Ad7 ministration shall issue a final administrative order 

8 and shall post such order on the Internet website of 

9 the Food and Drug Administration, notwithstanding 

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

11 Code. 

12 ‘‘(4) DETERMINATIONS.—In the proposed ad13 ministrative order or the final administrative order, 

14 as applicable, the Food and Drug Administration 

15 shall make a determination that the ingredient or 

16 non-functional constituent is— 

17 ‘‘(A) safe in cosmetic products under speci18 fied conditions of use or tolerances; 

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

20 need for specified conditions of use or toler21 ances; or 

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

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

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

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1 ances on the presence of a non-functional con2 stituent as are necessary for the safety of cosmetic 

3 products containing such ingredient or non-func4 tional constituent, including— 

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

6 of the ingredient or non-functional constituent 

7 that may be present in a cosmetic product, in8 cluding limits in products intended for children 

9 and other vulnerable populations, and limits on 

10 use near the eye or mucosal membranes; 

11 ‘‘(B) warnings that are necessary or appro12 priate under section 614, including warnings re13 lated to use by children, pregnant women, popu14 lations with high exposure to the ingredient 

15 (such as workers who are exposed through pro16 duction practices or handling of final products), 

17 or other vulnerable populations, to help ensure 

18 safe use of cosmetic products containing the in19 gredient or non-functional constituent; and 

20 ‘‘(C) such other conditions as are nec21 essary for the safety of cosmetic products con22 taining such ingredient or non-functional con23 stituent. 

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

25 subsection shall set forth the determination of the 


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1 Food and Drug Administration on safety, any condi2 tions of use or tolerances under subparagraph (A) or 

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

4 scientific evidence supporting the finding. The order 

5 shall be effective upon its publication on the Internet 

6 website of the Food and Drug Administration and 

7 shall be considered final agency action. 

8 ‘‘(e) ORDER.— 

9 ‘‘(1) IN GENERAL.—If the Food and Drug Ad10 ministration issues a final administrative order 

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

12 the Food and Drug Administration shall, at the 

13 same time as publication of the notice under sub14 section (d)(6), publish a proposed order identifying 

15 dates by which use of the ingredient or non-func16 tional constituent in cosmetic products shall comply 

17 with the final administrative order, and provide 60 

18 days for public comment, including comment on 

19 whether compliance is feasible within the proposed 

20 dates. After considering comments on the proposed 

21 order, the Food and Drug Administration shall pub22 lish in the Federal Register a final order. 

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

24 regarding the final order under paragraph (1) shall 

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1 derstandable language that is comprehensible and 

2 meaningful for consumers. The summary shall in3 clude information on any conditions of use or warn4 ings required under section 614, including the appli5 cation to vulnerable populations, the types of safety 

6 studies evaluated, and any additional relevant infor7 mation that was part of the review process. 

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

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

10 by the Food and Drug Administration on the initiative of 

11 the Food and Drug Administration or in response to a 

12 petition. 

13 ‘‘(g) INADEQUATE EVIDENCE.— 

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

15 Drug Administration determines that the available 

16 data and information are not adequate to make a 

17 proposed or final determination regarding safety 

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

19 ingredient or non-functional constituent, the Food 

20 and Drug Administration shall— 

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

22 website of the Food and Drug Administration 

23 not later than 90 days after the close of the rel24 evant comment period for the ingredient or 

25 non-functional constituent under subsection 


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1 (a)(2), in the case of a proposed order, or sub2 section (d)(2), in the case of a final order; and 

3 ‘‘(B)(i) include a notice providing inter4 ested persons an additional 30 days from the 

5 notice date to provide additional data and infor6 mation; and 

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

8 clause (i), the Food and Drug Administration 

9 determines that additional safety substantiation 

10 with respect to such ingredient or non-func11 tional constituent is necessary to make a safety 

12 determination— 

13 ‘‘(I) include a notice specifying an ad14 ditional time period, not to exceed 18 

15 months from the notice date, during which 

16 time the determination made by a respon17 sible person under subsection (a) or (b) of 

18 section 609 with respect to the safety of 

19 such cosmetic ingredient or non-functional 

20 constituent shall be deemed to be in com21 pliance with the requirements of this Act, 

22 but shall not affect final determinations of 

23 safety under subsection (d); and 

24 ‘‘(II) plan to obtain such data and in25 formation. 


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1 ‘‘(2) DETERMINATION; ORDER.— 

2 ‘‘(A) INADEQUATE DATA AND INFORMA3 TION.—If the Food and Drug Administration 

4 determines, after considering any additional 

5 data and information submitted under para6 graph (1)(B), that the available data and infor7 mation still are not adequate to make a deter8 mination regarding safety under subsection 

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

10 shall, within 90 days of the close of the addi11 tional time period provided under paragraph 

12 (1)(B), issue a proposed order or a final admin13 istrative order— 

14 ‘‘(i) making a determination that the 

15 ingredient or non-functional constituent 

16 has not been shown to be safe in cosmetic 

17 products; and 

18 ‘‘(ii) explaining why the available data 

19 and information are not adequate to assess 

20 the safety of the ingredient or non-func21 tional constituent. 

22 ‘‘(B) ADEQUATE DATA AND INFORMA23 TION.—If the Food and Drug Administration 

24 determines, after considering any additional 

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1 graph (1)(B), that the available data and infor2 mation are adequate to make a determination 

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

4 Food and Drug Administration shall, within 

5 180 days of the close of the comment period, 

6 issue a proposed order, followed by a final 

7 order, on such cosmetic ingredient or non-func8 tional constituent, in accordance with such sub9 section. 

10 ‘‘(h) SAFETY ASSESSMENT.— 

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

12 an ingredient or non-functional constituent, the 

13 Food and Drug Administration shall consider wheth14 er there is adequate evidence to support a reasonable 

15 certainty among competent scientists that the ingre16 dient is not harmful under the recommended or sug17 gested conditions of use or customary or usual use, 

18 or that a non-functional constituent is not harmful 

19 under the recommended or suggested tolerance levels 

20 or the level at which it is customarily or usually 

21 present. The Food and Drug Administration may 

22 not consider an ingredient or non-functional con23 stituent harmful solely because it can cause minor 

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1 lergic reactions or minor transient skin irritations, 

2 in some users. 

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

4 ingredient or non-functional constituent, the Food 

5 and Drug Administration shall consider, among 

6 other relevant factors, the following: 

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

8 ingredient or non-functional constituent from 

9 expected use in cosmetics. 

10 ‘‘(B) The probable cumulative and aggre11 gate effect in humans of relevant exposure to 

12 the ingredient or non-functional constituent or 

13 to any chemically or pharmacologically related 

14 substances from use in cosmetics or other prod15 ucts with similar routes of exposure under rec16 ommended or suggested conditions of use or 

17 their customary use, to the extent adequate 

18 data is available for analysis. In appropriate 

19 cases, the Food and Drug Administration may 

20 consider available information on the total expo21 sure to an ingredient or non-functional con22 stituent from all sources. 

23 ‘‘(C) Whether warnings or recommenda24 tions in a product label required under section 

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1 ances imposed by the Food and Drug Adminis2 tration, would be necessary and appropriate to 

3 help ensure the safety of the ingredient or non4 functional constituent. 

5 ‘‘(3) DATA AND INFORMATION.— 

6 ‘‘(A) REQUIRED INFORMATION.—A deter7 mination that an ingredient or non-functional 

8 constituent is safe in cosmetics shall be based 

9 upon adequate evidence submitted or otherwise 

10 known to the Food and Drug Administration, 

11 which shall include full reports of all available 

12 studies, published or unpublished, that are ade13 quately designed to show whether the ingredient 

14 or non-functional constituent is safe. Such stud15 ies may include in vitro and in silico studies 

16 and epidemiological studies, biomonitoring stud17 ies, and studies focused on various points dur18 ing the lifespan of the subject, that use scientif19 ically valid methodology. 

20 ‘‘(B) ADDITIONAL RELEVANT INFORMA21 TION.—The Food and Drug Administration 

22 shall consider any other relevant information 

23 related to the safety of the ingredient or non24 functional constituent, including— 

25 ‘‘(i) adverse event reports; 


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1 ‘‘(ii) findings and information from 

2 State, Federal, national, and international 

3 entities and other bodies composed of sci4 entific and medical experts; 

5 ‘‘(iii) if the ingredient or non-func6 tional constituent is lawfully used or 

7 present in other products regulated by the 

8 Food and Drug Administration, the sci9 entific basis for such use; and 

10 ‘‘(iv) experience with the ingredient or 

11 non-functional constituent in products that 

12 are distributed in the United States or in 

13 other countries, if such experience is well14 documented and has resulted in substantial 

15 human exposure to the ingredient or non16 functional constituent over time.’’. 

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

18 ‘‘(a) DETERMINATION.— 

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

20 for a finished cosmetic product, before first intro21 ducing or delivering for introduction into interstate 

22 commerce, or, in the case of such a product in inter23 state commerce on the date of enactment of the Per24 sonal Care Products Safety Act, not later than the 

25 date on which registration is first required under 


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1 subsection 605(b), shall make a written determina2 tion that the product is safe under the conditions of 

3 use recommended in the labeling of the product. 

4 Such determination shall be based on adequate evi5 dence that each ingredient in the finished product is 

6 safe for the use recommended or suggested in the la7 beling of the product and that the finished product 

8 is safe. 

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

10 relevant to the determination becomes available, the 

11 responsible person shall promptly update the deter12 mination to address that information. 

13 ‘‘(3) SAFETY WITH RESPECT TO RANGES OF

14 POSSIBLE AMOUNTS.—In the case of a cosmetic 

15 product for which there is a range of possible 

16 amounts of cosmetic ingredients included in the cos17 metic ingredient statement, as described in section 

18 606(c)(2)(E), the safety determination under para19 graph (1) shall include substantiation of the safety 

20 of the full range in the finished product. 

21 ‘‘(4) SMALL BUSINESSES.—A small business 

22 registrant (as defined in section 605(e)(2)(B)(ii)) 

23 may satisfy the requirements of this section by using 

24 the ingredients in concentrations recommended by 

25 available medical or scientific guidelines, or cosmetic 


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1 manufacturing reference, and following any other 

2 specific instructions for use recommended by the in3 gredient manufacturer. 

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

5 ‘‘(1) IN GENERAL.—Except as provided in sub6 section (c), a determination made under subsection 

7 (a) shall be presumed to be based on adequate evi8 dence if it is supported by— 

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

10 finished product— 

11 ‘‘(i) references to an official statement 

12 by one or more expert medical or scientific 

13 bodies that the ingredient is safe under the 

14 conditions of use recommended or sug15 gested in the product’s labeling; or 

16 ‘‘(ii) appropriate safety testing of the 

17 ingredient; and 

18 ‘‘(B) appropriate safety substantiation of 

19 the finished product beyond the safety substan20 tiation of individual ingredients and consider21 ation of the combination of ingredients. 

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

23 SCIENTIFIC BODY.—For purposes of this section, a 

24 statement of an expert medical or scientific body is 

25 an official statement of that body, if— 


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

2 Federal, State, national, or international entity 

3 with recognized expertise in chemical or cos4 metic safety, or other similarly recognized body 

5 composed of scientific and medical experts; 

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

7 data to support the finding of safety, and such 

8 data are available to the Food and Drug Ad9 ministration; and 

10 ‘‘(C) the statement is published and en11 dorsed by the medical or scientific body and is 

12 not a statement of an employee of such body 

13 made in the individual capacity of the employee. 

14 ‘‘(c) REBUTTAL OF PRESUMPTION.—Notwith15 standing subsection (b), a determination under subsection 

16 (a) will not be presumed to be based on adequate evidence 

17 if— 

18 ‘‘(1) the Food and Drug Administration issues 

19 an order under section 608 that an ingredient or 

20 non-functional constituent in the finished product is 

21 not safe under the product’s conditions of use or 

22 customary or usual use; or 

23 ‘‘(2) the Food and Drug Administration has 

24 provided the manufacturer with notice that— 


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1 ‘‘(A) the manufacturer has not met the cri2 teria for a presumption of adequate information 

3 under subsection (b); or 

4 ‘‘(B) the Food and Drug Administration 

5 has information that raises significant questions 

6 about the safety of the product or any of its in7 gredients. 

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

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

10 have 10 days to submit additional evidence to the Food 

11 and Drug Administration regarding the safety of an ingre12 dient, non-functional constituent, or the entire cosmetic 

13 product, and the Food and Drug Administration shall 

14 have 30 days from the date of receipt of such additional 

15 evidence to provide the responsible person with notice that 

16 the criteria under subsection (b) have been met or not met. 

17 ‘‘(e) RECORDS MAINTENANCE.—The responsible per18 son shall maintain records documenting the determination 

19 required under this section and the information on which 

20 such determination is based until 5 years after the fin21 ished product is no longer marketed, except that a respon22 sible person for a domestic company whose sales are under 

23 $2,000,000 per year shall maintain such records for at 

24 least 2 years after the finished product is no longer mar25 keted. 


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1 ‘‘(f) SUBMISSION OF RECORDS.— 

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

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

4 Food and Drug Administration to the responsible 

5 person, be provided to the Food and Drug Adminis6 tration within a reasonable timeframe not to exceed 

7 60 days, in either electronic or paper form. 

8 ‘‘(2) CRITERIA.—The Food and Drug Adminis9 tration may require records under paragraph (1) 

10 if— 

11 ‘‘(A) the Food and Drug Administration 

12 has a reasonable belief, described in written no13 tice, that— 

14 ‘‘(i) the finished product may be 

15 harmful based on adverse event reports or 

16 other scientific information; 

17 ‘‘(ii) scientific information raises cred18 ible and relevant questions about the safe19 ty of the product or any of its ingredients; 

20 ‘‘(iii) the responsible person has not 

21 made the determination required under 

22 subsection (a), or such determination is 

23 not supported by adequate evidence; or 

24 ‘‘(iv) one or more of the criteria to es25 tablish a presumption of adequate evidence 


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1 of safety in subsection (b) has not been 

2 satisfied; 

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

4 an expert regulatory body, or an expert body 

5 composed of scientific and medical experts finds 

6 an ingredient in the product to be unsafe under 

7 the conditions of use of the product; or 

8 ‘‘(C) the Food and Drug Administration 

9 concludes that submission of the records will 

10 serve the public health or otherwise enable the 

11 Food and Drug Administration to fulfill the 

12 cosmetic safety purposes of this section. 

13 ‘‘(g) GUIDANCE AND REGULATIONS.— 

14 ‘‘(1) IN GENERAL.—The Food and Drug Ad15 ministration shall issue guidance describing the evi16 dence necessary to support a determination under 

17 subsection (a), and may, by regulation, establish ex18 emptions to the requirements of this section, if the 

19 Food and Drug Administration determines that such 

20 exemptions are supported by adequate evidence and 

21 would have no adverse effect on public health. 

22 ‘‘(2) SMALL BUSINESSES.—The Food and Drug 

23 Administration shall, after consultation with the 

24 Small Business Administration and small businesses 

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1 ance for small businesses on compliance with the re2 quirements of this section that would apply to small 

3 business registrants. Such guidance shall include 

4 specific examples of options for compliance that do 

5 not place an undue burden on small businesses.’’. 

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

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

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

9 of this Act. 

10 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS11 METICS. 

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

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

14 amended by section 102, is further amended by adding 

15 at the end the following: 

16 ‘‘SEC. 610. GOOD MANUFACTURING PRACTICES FOR COS17 METICS. 

18 ‘‘(a) IN GENERAL.—The Food and Drug Administra19 tion shall review national and international standards for 

20 cosmetic good manufacturing practices that are in exist21 ence on the date of enactment of the Personal Care Prod22 ucts Safety Act and shall develop and implement, through 

23 regulations, standards consistent, to the extent the Food 

24 and Drug Administration determines practicable and ap25 propriate, with such national and international standards 


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1 for cosmetic good manufacturing practices to ensure that 

2 requirements of this chapter with respect to the manufac3 ture of cosmetic products are in harmony. 

4 ‘‘(b) CONSULTATION.—The standards under sub5 section (a) shall include simplified good manufacturing 

6 practices for small businesses that take into account the 

7 size and scope of the business, developed in consultation 

8 with the Small Business Administration. 

9 ‘‘(c) TIMEFRAME.—The Food and Drug Administra10 tion shall publish a proposed rule described in subsection 

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

12 of the Personal Care Products Safety Act and shall pub13 lish a final such rule not later than 3 years after such 

14 date of enactment.’’. 

15 (b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR16 ERS.— 

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

18 size greater than the Small Business Administra19 tion’s standard for a small business, section 610 of 

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

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

22 180 days after the date on which the Food and 

23 Drug Administration makes effective cosmetic good 

24 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 610 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. 611. 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) ANNUAL REPORT.— 

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

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

23 year for each cosmetic product marketed during 

24 that year. 


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

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

5 an estimate of the total number of product 

6 units estimated to have been distributed to con7 sumers during such period. The report shall not 

8 include consumer complaints that are solely re9 garding efficacy and do not contain any infor10 mation about an adverse event. The Food and 

11 Drug Administration shall further specify the 

12 contents of the annual electronic report by reg13 ulation or guidance. 

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

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

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

20 report under this paragraph. 

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


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1 evidence and would have no adverse effect on public 

2 health. 

3 ‘‘(d) REQUIREMENTS.— 

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

5 report under this section shall be submitted to the 

6 Food and Drug Administration using an electronic 

7 system of the Food and Drug Administration. The 

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

10 the date of enactment of the Personal Care Products 

11 Safety Act. 

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

14 Drug Administration and the reports may include 

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

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

20 information submitted in the initial report or added 

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

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


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

3 552a of title 5, United States Code; 

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

5 the serious adverse event, the disclosure of 

6 which would constitute a violation of section 

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

9 information is redacted; and 

10 ‘‘(D) contact information for the individual 

11 reporting the serious adverse event. 

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

14 a serious adverse event, the responsible person for 

15 the cosmetic product shall actively gather all of the 

16 information to complete and file the report with the 

17 Food and Drug Administration. 

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

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

21 the responsible person to indicate if such responsible 

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

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


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

3 ‘‘(e) LIMITATION WITH RESPECT TO ADVERSE

4 EVENT REPORTS.—The submission of an adverse event 

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

7 contributed to the adverse event. 

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

11 label include both the telephone number and electronic 

12 contact information, through which the responsible person 

13 may receive a report of an adverse event. 

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

15 person shall maintain records related to each report of an 

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

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

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

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

24 information by the State. 


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

3 under this section to report serious adverse events shall 

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

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

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

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

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

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

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

13 ‘‘(a) INSPECTION OF RECORDS.—Each manufac14 turer, processor, packer, or holder of a cosmetic shall, at 

15 the request of an officer or employee duly designated by 

16 the Food and Drug Administration, permit such officer 

17 or employee, upon presentation of appropriate credentials 

18 and written notice to such person, at reasonable times and 

19 within reasonable limits and in a reasonable manner, to 

20 have access to and copy— 

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

22 and in accordance with the rules promulgated by the 

23 Food and Drug Administration under section 610, 

24 as applicable; and 


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

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

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

6 ‘‘(i) is adulterated; 

7 ‘‘(ii) has caused a reportable serious 

8 adverse event; or 

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

11 may be unsafe when present in a cosmetic; 

12 and 

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

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

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

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

21 or sales data other than shipment data. 

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

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

24 in any format (including paper and electronic formats) 

25 and at any location. 


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

2 The Food and Drug Administration shall take appropriate 

3 measures to ensure that there are effective procedures to 

4 prevent the unauthorized disclosure of any trade secret or 

5 confidential information that is obtained by the Food and 

6 Drug Administration pursuant to this section. Information 

7 disclosed to a State that is exempt from disclosure under 

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

9 treated as a trade secret and confidential information by 

10 the State. 

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

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

14 Drug Administration to inspect records or to require 

15 establishment and maintenance of records under any 

16 other provision of this Act; or 

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

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

19 18, United States Code.’’. 

20 ‘‘SEC. 613. MANDATORY RECALL AUTHORITY. 

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

22 Drug Administration determines that there is a reasonable 

23 probability that a cosmetic is adulterated under section 

24 601 or misbranded under section 602 and the use of or 

25 exposure to such cosmetic is likely to cause serious adverse 


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1 health consequences or death, the Food and Drug Admin2 istration shall provide the responsible person with an op3 portunity to voluntarily cease distribution and recall such 

4 article. 

5 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE

6 DISTRIBUTION AND GIVE NOTICE.— 

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

8 refuses to or does not voluntarily cease distribution 

9 or recall such cosmetic within the time and in the 

10 manner prescribed by the Food and Drug Adminis11 tration, the Food and Drug Administration may 

12 order such person to— 

13 ‘‘(A) immediately cease distribution of 

14 such cosmetic; and 

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

16 persons— 

17 ‘‘(i) manufacturing, processing, pack18 ing, transporting, holding, receiving, dis19 tributing, or importing and selling such 

20 cosmetic; and 

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

22 distributed, transported, or sold, 

23 to immediately cease distribution of such cos24 metic. 

25 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 


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

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

3 has been distributed to a warehouse-based 

4 third-party logistics provider without providing 

5 such provider sufficient information to know or 

6 reasonably determine the precise identity of 

7 such cosmetic covered by a recall order that is 

8 in its possession, the notice provided by the re9 sponsible person subject to the order issued 

10 under paragraph (1)(B) shall include such in11 formation as is necessary for the warehouse12 based third-party logistics provider to identify 

13 the cosmetic. 

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

15 in this paragraph shall be construed— 

16 ‘‘(i) to exempt a warehouse-based 

17 third-party logistics provider from the re18 quirements of this chapter, including the 

19 requirements of this section and section 

20 612; or 

21 ‘‘(ii) to exempt a warehouse-based 

22 third-party logistics provider from being 

23 the subject of a mandatory recall order. 

24 ‘‘(3) DETERMINATION TO LIMIT AREAS AF25 FECTED.—If the Food and Drug Administration reVerDate Sep 11 2014 22:08 May 15, 2017 Jkt 069200 PO 00000 Frm 00060 Fmt 6652 Sfmt 6201 E:\BILLS\S1113.IS S1113

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1 quires a responsible person to cease distribution 

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

3 Drug Administration may limit the size of the geo4 graphic area and the markets affected by such ces5 sation if such limitation would not compromise the 

6 public health. 

7 ‘‘(c) HEARING ON ORDER.—The Food and Drug Ad8 ministration shall provide the responsible party subject to 

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

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

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

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

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

14 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA15 TION OF ORDER.— 

16 ‘‘(1) AMENDMENT OF ORDER.—If, after pro17 viding opportunity for an informal hearing under 

18 subsection (c), the Food and Drug Administration 

19 determines that removal of the cosmetic from com20 merce is necessary, the Food and Drug Administra21 tion shall, as appropriate— 

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

23 such cosmetic or other appropriate action; 

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

25 shall occur; 


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

2 and Drug Administration describing the 

3 progress of the recall; and 

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

5 such cosmetic was, or may have been, distrib6 uted. 

7 ‘‘(2) VACATING OF ORDER.—If, after such hear8 ing, the Food and Drug Administration determines 

9 that adequate grounds do not exist to continue the 

10 actions required by the order, or that such actions 

11 should be modified, the Food and Drug Administra12 tion shall vacate the order or modify the order. 

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

14 and Drug Administration shall work with State and local 

15 public health officials in carrying out this section, as ap16 propriate. 

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

18 under this section, the Food and Drug Administration 

19 shall— 

20 ‘‘(1) ensure that a press release is published re21 garding the recall, and that alerts and public notices 

22 are issued, as appropriate, in order to provide notifi23 cation— 


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1 ‘‘(A) of the recall to consumers and retail2 ers to whom such cosmetic was, or may have 

3 been, distributed; and 

4 ‘‘(B) that includes, at a minimum— 

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

6 to the recall; 

7 ‘‘(ii) a description of the risk associ8 ated with such article; and 

9 ‘‘(iii) to the extent practicable, infor10 mation for consumers about similar cos11 metics that are not affected by the recall; 

12 and 

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

14 of the Food and Drug Administration an image of 

15 the cosmetic that is the subject of the press release 

16 described in paragraph (1), if available. 

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

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

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

20 Commissioner. 

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

22 the authority of the Food and Drug Administration to re23 quest or participate in a voluntary recall, or to issue an 

24 order to cease distribution or to recall under any other 


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1 provision of this chapter or under the Public Health Serv2 ice Act.’’. 

3 SEC. 106. LABELING. 

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

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

6 amended by section 105, is further amended by adding 

7 at the end the following: 

8 ‘‘SEC. 614. LABELING. 

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

10 review of cosmetic ingredients that determines that warn11 ings are required to help ensure safe use of cosmetic prod12 ucts under section 608(d)(5), the Food and Drug Admin13 istration shall require labeling of cosmetics that are not 

14 appropriate for use in the entire population, including 

15 warnings that vulnerable populations, such as children or 

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

17 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL

18 USE.— 

19 ‘‘(1) DEFINITION OF PROFESSIONAL.—With re20 spect to cosmetics, the term ‘professional’ means an 

21 individual who— 

22 ‘‘(A) is licensed by an official State author23 ity to practice in the field of cosmetology, nail 

24 care, barbering, or esthetics; 


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1 ‘‘(B) has complied with all requirements 

2 set forth by the State for such licensing; and 

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

4 board or legal agency or legal authority. 

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

6 products used and sold by professionals shall list all 

7 ingredients and warnings, as required for other cos8 metic products under this chapter. 

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

10 case of a cosmetic product intended to be used only 

11 by a professional on account of a specific ingredient 

12 or increased concentration of an ingredient that re13 quires safe handling by trained professionals, the 

14 product shall bear a statement as follows: ‘To be Ad15 ministered Only by Licensed Professionals’. 

16 ‘‘(c) REQUIREMENTS.— 

17 ‘‘(1) DISPLAY.—A warning required under sub18 section (a) and a statement required under sub19 section (b)(3) shall be prominently displayed— 

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

21 label; and 

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

23 contrast by typography, layout, or color with 

24 other material printed or displayed on the label. 


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

2 responsible person may include on the labeling any 

3 additional warnings in addition to the minimum 

4 warnings required under subsection (a). 

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

6 of cosmetics, each Internet website offering a cosmetic 

7 product for sale to consumers shall provide the same infor8 mation that is included on the packaging of the cosmetic 

9 product as regularly available through in-person sales, ex10 cept information that is unique to a single cosmetic prod11 uct sold in a retail facility, such as a lot number or expira12 tion date, and the warnings and statements described in 

13 subsection (c) shall be prominently and conspicuously dis14 played on the website. 

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

16 cosmetic shall bear the domestic telephone number or elec17 tronic contact information, and it is encouraged that the 

18 label include both the telephone number and electronic 

19 contact information, that consumers may use to contact 

20 the responsible person with respect to adverse events. The 

21 contact number shall provide a means for consumers to 

22 obtain additional information about ingredients in a cos23 metic, including the ability to ask if a specific ingredient 

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

25 whether a specific ingredient may be contained in the fraVerDate Sep 11 2014 22:08 May 15, 2017 Jkt 069200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\S1113.IS S1113

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1 grance or flavor used in the cosmetic. The manufacturer 

2 of the cosmetic is responsible for providing such informa3 tion, including obtaining the information from suppliers 

4 if it is not readily available. Suppliers are required to re5 lease such information upon request of the cosmetic manu6 facturer.’’. 

7 (b) EFFECTIVE DATE.—Section 614 of the Federal 

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

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

10 date of enactment of this Act. 

11 SEC. 107. COAL TAR CHEMICALS. 

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

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

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

15 ‘‘SEC. 615. COAL TAR CHEMICALS. 

16 ‘‘Specific chemicals in coal tar hair dyes may be se17 lected and reviewed under section 608.’’. 

18 SEC. 108. ANIMAL TESTING ALTERNATIVES. 

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

20 Act (21 U.S.C. 361 et seq.), as amended by section 107, 

21 is further amended by adding the following: 

22 ‘‘SEC. 616. ANIMAL TESTING ALTERNATIVES. 

23 ‘‘(a) IN GENERAL.—To minimize the use of animal 

24 testing for safety of cosmetic ingredients, non-functional 


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1 constituents, and finished cosmetic products, the Food 

2 and Drug Administration shall— 

3 ‘‘(1) encourage the use of alternative testing 

4 methods that provide information that is equivalent 

5 or superior in scientific quality to the animal testing 

6 method to— 

7 ‘‘(A) not involve the use of an animal to 

8 test a chemical substance for safe use in cos9 metics; or 

10 ‘‘(B) use fewer animals than conventional 

11 animal-based tests for safe use in cosmetics 

12 when non-animal methods are impracticable; 

13 and 

14 ‘‘(2) encourage— 

15 ‘‘(A) the sharing of data across companies 

16 and organizations that are testing for safety in 

17 cosmetics, so as to avoid duplication of animal 

18 tests; and 

19 ‘‘(B) funding for research and validation of 

20 alternative testing methods. 

21 ‘‘(b) GUIDANCE.—Not later than 3 years after the 

22 date of enactment of the Personal Care Products Safety 

23 Act, the Food and Drug Administration shall issue guid24 ance on the acceptability of scientifically reliable and rel25 evant alternatives to animal testing for the safety of cosVerDate Sep 11 2014 22:08 May 15, 2017 Jkt 069200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\S1113.IS S1113

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1 metic ingredients, non-functional constituents, and fin2 ished cosmetic products, and encouraging the use of such 

3 methods. The Food and Drug Administration shall update 

4 such guidance on an annual basis. 

5 ‘‘(c) RESOURCES REGARDING ANIMAL TESTING AL6 TERNATIVES.—Not later than 180 days after the date of 

7 enactment of the Personal Care Products Safety Act, the 

8 Food and Drug Administration shall provide information 

9 on the Internet website of the Food and Drug Administra10 tion regarding resources available for information about 

11 non-animal methods, and methods that reduce animal 

12 usage, in testing for the safety of cosmetic ingredients, 

13 non-functional constituents, and finished cosmetic prod14 ucts.’’. 

15 SEC. 109. PREEMPTION. 

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

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

18 is further amended by adding the following: 

19 ‘‘SEC. 617. PREEMPTION. 

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

21 of a State may establish or continue in effect any require22 ment for cosmetics, other than a requirement that is in 

23 full effect and implemented on the date of enactment of 

24 the Personal Care Products Safety Act— 


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1 ‘‘(1) with respect to registration, good manufac2 turing practices, mandatory recalls, or adverse event 

3 reporting; or 

4 ‘‘(2) with respect to the safety of a cosmetic in5 gredient or non-functional constituent that is the 

6 subject of a final order on a determination of safety 

7 under this chapter, unless the requirement of the 

8 State or political subdivision is more restrictive than 

9 the final order under section 608(d)(3). 

10 ‘‘(b) SAFETY OF COSMETIC INGREDIENTS AND NON11 FUNCTIONAL CONSTITUENTS.— 

12 ‘‘(1) DELAYED EFFECT OF NEW STATE RE13 QUIREMENTS.— 

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

15 the Food and Drug Administration has made 

16 public the final selection of a cosmetic ingre17 dient or non-functional constituent to be re18 viewed in the coming year under section 

19 608(a)(3)(B) and opened the public comment 

20 period under section 608(a)(2), until the date 

21 that is one year after the Food and Drug Ad22 ministration has made public such selection, no 

23 State or political subdivision of a State may es24 tablish any new requirement related to such 


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1 cosmetic ingredient or non-functional con2 stituent. 

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

4 the cosmetic ingredients to be reviewed in the 

5 first year, in accordance with section 

6 608(a)(3)(A), for the 1-year period beginning 

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

8 enactment of the Personal Care Products Safe9 ty Act, no State or political subdivision of a 

10 State may establish any new requirement re11 lated to such cosmetic ingredient or non-func12 tional constituent. 

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

14 construed to affect the authority of a State or polit15 ical subdivision of a State with respect to any re16 quirement for the safety of a cosmetic ingredient or 

17 non-functional constituent that is unrelated to the 

18 scope of the safety assessment under section 608. 

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

20 Congress that a State or political subdivision that 

21 regulates the safety of cosmetics with respect to the 

22 health of humans beyond the scope of section 608 

23 should utilize the safety assessment criteria de24 scribed in section 608(h). 


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1 ‘‘(c) STATE REQUIREMENT THAT IS IN FULL EF2 FECT AND IMPLEMENTED.—For purposes of this section: 

3 ‘‘(1) STATE REQUIREMENT.—A State require4 ment includes a State requirement that is adopted 

5 by a State public initiative or referendum. 

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

7 term ‘full effect and implemented’ includes require8 ments of States that are implemented after the date 

9 of enactment of the Personal Care Products Safety 

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

11 in effect, or a lawful program that was established 

12 and functioning, prior to the date of enactment of 

13 the Personal Care Products Safety Act. 

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

15 this Act made by the Personal Care Products Safety Act 

16 shall be construed to preempt any State statute, public 

17 initiative, referendum, or other State action, except as ex18 pressly provided in this section. 

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

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

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

22 report, safety assessment, safety determination, scientific 

23 assessment, or order issued or implemented pursuant to 

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


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

2 criminal cause of action, whether statutory or based in 

3 common law.’’. 

4 SEC. 110. REPORTING. 

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

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

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

8 ‘‘SEC. 618. REPORTING. 

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

10 year 2018, and not later than 60 days prior to the end 

11 of each fiscal year for which fees are collected under sec12 tion 744L, the Food and Drug Administration shall pre13 pare and submit to Congress a report concerning the 

14 progress of the Food and Drug Administration in achiev15 ing the objectives of the Personal Care Products Safety 

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

17 Food and Drug Administration for meeting the objectives. 

18 The annual report for a fiscal year shall include— 

19 ‘‘(1) the number of registered facilities and cos20 metic ingredient statements on file with the Food 

21 and Drug Administration; 

22 ‘‘(2) identification of the cosmetic ingredients 

23 and non-functional constituents that have been fully 

24 reviewed for safety by the Food and Drug AdminisVerDate Sep 11 2014 22:08 May 15, 2017 Jkt 069200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\S1113.IS S1113

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1 tration in the prior fiscal year and for which a final 

2 administrative order has been released; 

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

4 ingredients and non-functional constituents that will 

5 be reviewed by the Food and Drug Administration 

6 in the next fiscal year; 

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

8 mandatory recalls that transpired during that fiscal 

9 year; 

10 ‘‘(5) the number of serious adverse event re11 ports received by the Food and Drug Administration 

12 during that fiscal year; 

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

14 Drug Administration about adverse event reports re15 lated to specific cosmetic ingredients or non-func16 tional constituents; and 

17 ‘‘(7) efforts of the Food and Drug Administra18 tion to reduce animal testing for safety of cosmetic 

19 ingredients, non-functional constituents, and cos20 metic products. 

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

22 Administration shall make the reports required under sub23 section (a) available to the public on the Internet website 

24 of the Food and Drug Administration on the date of sub25 mission of such reports to Congress. 


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1 ‘‘(c) PUBLIC INPUT ON SAFETY REVIEW.—Upon re2 lease of the report described in subsection (a), the Food 

3 and Drug Administration shall provide the public with an 

4 opportunity to provide feedback, at any time during the 

5 year, on subsection (a)(3) by— 

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

7 of the report, enabling the public to— 

8 ‘‘(A) comment on the cosmetic ingredients 

9 or non-functional constituents under review for 

10 the current year; 

11 ‘‘(B) recommend additional cosmetic ingre12 dients and non-functional constituents to be 

13 considered for review for safety in future years; 

14 and 

15 ‘‘(C) comment on the priorities for the spe16 cific cosmetic ingredients and non-functional 

17 constituents that the Food and Drug Adminis18 tration anticipates will be reviewed in the next 

19 fiscal year; 

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

21 Food and Drug Administration, within the first 30 

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

23 list of cosmetic ingredients and non-functional con24 stituents submitted pursuant to subsection (a)(3) 


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

2 and 

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

4 least 5 specific cosmetic ingredients and non-func5 tional constituents that will be reviewed in the com6 ing year under section 608, providing a comment pe7 riod for further public input, pursuant to section 

8 608(a)(2).’’. 

9 SEC. 111. SMALL BUSINESSES. 

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

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

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

13 ‘‘SEC. 619. SMALL BUSINESSES. 

14 ‘‘The Commissioner, in coordination with the Admin15 istrator of the Small Business Administration, shall pro16 vide technical assistance, such as guidance and expertise, 

17 to small businesses regarding compliance with the Per18 sonal Care Products Safety Act, including the amend19 ments made by such Act.’’. 

20 SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS21 METICS. 

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

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

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


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1 ‘‘SEC. 620. APPLICABILITY WITH RESPECT TO CERTAIN 

2 COSMETICS. 

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

4 is subject to the requirements under this chapter and 

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

7 to a requirement under this chapter, the cosmetic product 

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

9 applicable requirement under this chapter if such product 

10 or facility is in compliance with such substantially similar 

11 requirement under chapter V, provided that the product 

12 or facility has not obtained a waiver from the requirement 

13 under chapter V. In the case of a cosmetic product or fa14 cility that is subject to, and in compliance with, a fee 

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

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

17 shall be waived with respect to such cosmetic product or 

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

19 SEC. 113. ENFORCEMENT. 

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

21 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend22 ed— 

23 (1) in subsection (e)— 

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

25 ‘‘504, 564, 611, 612,’’; and 


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

2 ‘‘519, 564, 611,’’; 

3 (2) in subsection (j), by inserting ‘‘607, 608, 

4 610,’’ before ‘‘704’’; 

5 (3) in subsection (ii)— 

6 (A) by striking ‘‘760 or 761) or’’ and in7 serting ‘‘604, 760, or 761) or’’; and 

8 (B) by striking ‘‘760 or 761) submitted’’ 

9 and inserting ‘‘611, 760, or 761) submitted’’; 

10 (4) in subsection (xx) by inserting ‘‘or 613’’ 

11 after ‘‘423’’; and 

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

13 ‘‘(eee) The failure to register in accordance with sec14 tion 605, the failure to submit a cosmetic ingredient state15 ment under section 606, the failure to provide any infor16 mation required by section 605 or 606, or the failure to 

17 update the information required by section 605 or 606, 

18 as required.’’. 

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

20 Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amend21 ed by adding at the end the following: 

22 ‘‘(f) If the methods used in, or the facilities or con23 trols used for, its manufacture, processing, packing, or 

24 holding do not conform to current good manufacturing 


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1 practice, as prescribed by the Food and Drug Administra2 tion in accordance with section 610. 

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

4 section 608(e), an ingredient that the Food and Drug Ad5 ministration has determined under section 608(d)(4) to be 

6 not safe, or not safe under the conditions of use rec7 ommended or suggested in the label or a non-functional 

8 constituent that the Food and Drug Administration has 

9 determined under section 608(d)(4) to be not safe or not 

10 safe in the amount present in the cosmetic. 

11 ‘‘(h) If it is a cosmetic product for which any require12 ment of section 609 (relating to safety substantiation) is 

13 not met.’’. 

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

15 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend16 ed— 

17 (1) in subsection (b)— 

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

19 ‘‘(2)’’; and 

20 (B) by inserting ‘‘; and (3) a domestic ad21 dress or a domestic telephone number, and it is 

22 encouraged that the label include both a domes23 tic address and a domestic telephone number, 

24 through which the responsible person may re25 ceive a report of an adverse event associated 


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1 with the use of such cosmetic product’’ after 

2 ‘‘numerical count’’; and 

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

4 ‘‘(g) If it has been manufactured, processed, packed, 

5 or held in any factory, warehouse, or establishment and 

6 the responsible person, operator, or agent of such factory, 

7 warehouse, or establishment delays, denies, or limits an 

8 inspection, or refuses to permit entry or inspection. 

9 ‘‘(h) If its labeling does not conform with a require10 ment under section 614.’’. 

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

12 of enactment of this Act, the Food and Drug Administra13 tion shall issue guidance that defines the circumstances 

14 that would constitute delaying, denying, or limiting inspec15 tion, or refusing to permit entry or inspection, for pur16 poses of section 602(g) of the Federal Food, Drug, and 

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

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

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

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

21 third, and fourth place such term appears and in22 serting ‘‘section 611, 760, or 761’’; and 

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

24 ‘‘604, 760, or 761)’’. 


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

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

3 374(a)(1)) is amended by inserting after the third sen4 tence the following: ‘‘In the case of any person who manu5 factures, processes, packs, holds, distributes, or imports 

6 a cosmetic product, or distributes a cosmetic product and 

7 affixes its name on the cosmetic label, the inspection shall 

8 extend to all records and other information described in 

9 section 612 (regarding inspection of cosmetic records), 

10 when the standard for records inspections under para11 graph (1) or (2) of subsection (a) of such section applies, 

12 subject to the limitations under subsections (d) and (e) 

13 of such section.’’. 

14 SEC. 114. CONSUMER INFORMATION. 

15 The Food and Drug Administration shall post on its 

16 Internet website information for consumers regarding— 

17 (1) final orders regarding the safety of a cos18 metic ingredient or non-functional constituent under 

19 section 608(d)(3) of the Federal Food, Drug, and 

20 Cosmetic Act; 

21 (2) cosmetic product recalls (including vol22 untary and mandatory recalls); and 

23 (3) identified counterfeit cosmetic products. 


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1 TITLE II—FEES RELATED TO 

2 COSMETIC SAFETY 

3 SEC. 201. FINDINGS. 

4 Congress finds that the fees authorized by the 

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

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

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

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

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

12 the Committee on Energy and Commerce of the House 

13 of Representatives, as set forth in the Congressional 

14 Record. 

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

17 Subchapter C of chapter VII of the Federal Food, 

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

19 amended by adding at the end the following: 

20 ‘‘PART 10—FEES RELATING TO COSMETICS 

21 ‘‘SEC. 744L. REGISTRATION FEE. 

22 ‘‘(a) ASSESSMENT AND COLLECTION.— 

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

24 2018, the Food and Drug Administration shall as25 sess and collect an annual fee from every responsible 


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

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

5 label of a cosmetic product distributed in the United 

6 States, except that this subsection shall not apply to 

7 contract manufacturers if a responsible person has 

8 already paid the appropriate fee with respect to the 

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

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

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

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

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

17 Consumer Price Index for all urban consumers (all 

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

19 preceding fiscal year divided by such index for Octo20 ber 2017. 

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

22 any business entity that has a relationship with a 

23 second business entity if, directly or indirectly— 

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

25 power to control, the other business entity; or 


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

2 power to control, both of the business entities. 

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

4 product’ has the meaning given such term in section 

5 604(2). 

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

7 ‘cosmetic safety activities’— 

8 ‘‘(A) means activities related to compliance 

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

12 ‘‘(i) administrative activities, such as 

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

16 registration system and the cosmetic ingre17 dient statement system under sections 605 

18 and 606, and fee assessment and collection 

19 under this section; and 

20 ‘‘(ii) implementation and enforcement 

21 activities, such as the establishment of 

22 good manufacturing practices, the review 

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


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1 ‘‘(B) includes activities related to imple2 mentation of section 608, regarding the review 

3 of cosmetic ingredients and non-functional con4 stituents. 

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

6 annual sales’ means the average United States gross 

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

9 its affiliates, as reported in the registration under 

10 section 605. 

11 ‘‘(c) FEE SETTING AND AMOUNTS.— 

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

13 the Food and Drug Administration shall establish 

14 the fees to be collected under this section for each 

15 fiscal year after fiscal year 2018, based on the meth16 odology described in paragraph (3)(B), and shall 

17 publish such fees in a Federal Register notice not 

18 later than 60 days before the beginning of each such 

19 fiscal year. 

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

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

22 period immediately preceding the fiscal year for 

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

24 $2,000,000, shall be exempt from registration fees 

25 under this section for that fiscal year. 


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1 ‘‘(3) ANNUAL FEE SETTING.— 

2 ‘‘(A) FISCAL YEAR 2018.—For fiscal year 

3 2018, to generate a total estimated revenue 

4 amount of $20,600,000, the amount of the reg5 istration fee under subsection (a) shall be as 

6 follows: 

7 ‘‘(i) TIER I–A.—For a registrant that 

8 has gross annual sales of $5,000,000,000 

9 or more in 2017, $1,350,000. 

10 ‘‘(ii) TIER I–B.—For a registrant that 

11 has gross annual sales of at least 

12 $4,000,000,000 per annum but less than 

13 $5,000,000,000 in 2017, $850,000. 

14 ‘‘(iii) TIER II–A.—For a registrant 

15 that has gross annual sales of at least 

16 $3,000,000,000 per annum but less than 

17 $4,000,000,000 in 2017, $730,000. 

18 ‘‘(iv) TIER II–B.—For a registrant 

19 that has gross annual sales of at least 

20 $2,000,000,000 per annum but less than 

21 $3,000,000,000 in 2017, $610,000. 

22 ‘‘(v) TIER III–A.—For a registrant 

23 that has gross annual sales of at least 

24 $1,000,000,000 per annum but less than 

25 $2,000,000,000 in 2017, $500,000. 


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

2 that has gross annual sales of at least 

3 $500,000,000 per annum but less than 

4 $1,000,000,000 in 2017, $395,000. 

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

6 that has gross annual sales of at least 

7 $200,000,000 per annum but less than 

8 $500,000,000 in 2017, $325,000. 

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

10 that has gross annual sales of at least 

11 $100,000,000 per annum but less than 

12 $200,000,000 in 2017, $275,000. 

13 ‘‘(ix) TIER V–A.—For a registrant 

14 that has gross annual sales of at least 

15 $80,000,000 per annum but less than 

16 $100,000,000 in 2017, $185,000. 

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

18 has gross annual sales of at least 

19 $60,000,000 per annum but less than 

20 $80,000,000 in 2017, $95,000. 

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

22 that has gross annual sales of at least 

23 $40,000,000 per annum but less than 

24 $60,000,000 in 2017, $15,000. 


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

2 that has gross annual sales of at least 

3 $20,000,000 per annum but less than 

4 $40,000,000 in 2017, $12,000. 

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

6 that has gross annual sales of at least 

7 $10,000,000 per annum but less than 

8 $20,000,000 in 2017, $500. 

9 ‘‘(xiv) TIER VII–B.—For a registrant 

10 that has gross annual sales of at least 

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

12 $10,000,000 in 2017, $350. 

13 ‘‘(xv) TIER VIII–A.—For a registrant 

14 that has gross annual sales of at least 

15 $2,000,000 per annum but less than 

16 $5,000,000 in 2017, $250. 

17 ‘‘(B) FISCAL YEARS 2019–2024.—For fiscal 

18 years 2019 through 2024, fees under subsection 

19 (a) shall be established to generate a total esti20 mated revenue amount of $20,600,000, as ad21 justed by subsection (d). Of that amount: 

22 ‘‘(i) TIER I–A.—Registrants that have 

23 gross annual sales of $5,000,000,000 or 

24 more in the fiscal year immediately pre25 ceding the fiscal year in which the annual 


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1 fee will be paid, shall be responsible, collec2 tively, for 10.7 percent. 

3 ‘‘(ii) TIER I–B.—Registrants that 

4 have gross annual sales of at least 

5 $4,000,000,000 per annum but less than 

6 $5,000,000,000 in the fiscal year imme7 diately preceding the fiscal year in which 

8 the annual fee will be paid, shall be re9 sponsible, collectively, for 4.1 percent. 

10 ‘‘(iii) TIER II–A.—Registrants that 

11 have gross annual sales of at least 

12 $3,000,000,000 per annum but less than 

13 $4,000,000,000 in the fiscal year imme14 diately preceding the fiscal year in which 

15 the annual fee will be paid, shall be re16 sponsible, collectively, for 3.5 percent. 

17 ‘‘(iv) TIER II–B.—Registrants that 

18 have gross annual sales of at least 

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

20 $3,000,000,000 in the fiscal year imme21 diately preceding the fiscal year in which 

22 the annual fee will be paid, shall be re23 sponsible, collectively, for 2.9 percent. 

24 ‘‘(v) TIER III–A.—Registrants that 

25 have gross annual sales of at least 


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

2 $2,000,000,000 in the fiscal year imme3 diately preceding the fiscal year in which 

4 the annual fee will be paid, shall be re5 sponsible, collectively, for 7.3 percent. 

6 ‘‘(vi) TIER III–B.—Registrants that 

7 have gross annual sales of at least 

8 $500,000,000 per annum but less than 

9 $1,000,000,000 in the fiscal year imme10 diately preceding the fiscal year in which 

11 the annual fee will be paid, shall be re12 sponsible, collectively, for 13.4 percent. 

13 ‘‘(vii) TIER IV–A.—Registrants that 

14 have gross annual sales of at least 

15 $200,000,000 per annum but less than 

16 $500,000,000 in the fiscal year imme17 diately preceding the fiscal year in which 

18 the annual fee will be paid, shall be re19 sponsible, collectively, for 15.8 percent. 

20 ‘‘(viii) TIER IV–B.—Registrants that 

21 have gross annual sales of at least 

22 $100,000,000 per annum but less than 

23 $200,000,000 in the fiscal year imme24 diately preceding the fiscal year in which 


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1 the annual fee will be paid, shall be re2 sponsible, collectively, for 13.3 percent. 

3 ‘‘(ix) TIER V–A.—Registrants that 

4 have gross annual sales of at least 

5 $80,000,000 per annum but less than 

6 $100,000,000 in the fiscal year imme7 diately preceding the fiscal year in which 

8 the annual fee will be paid, shall be re9 sponsible, collectively, for 9 percent. 

10 ‘‘(x) TIER V–B.—Registrants that 

11 have gross annual sales of at least 

12 $60,000,000 per annum but less than 

13 $80,000,000 in the fiscal year immediately 

14 preceding the fiscal year in which the an15 nual fee will be paid, shall be responsible, 

16 collectively, for 6.9 percent. 

17 ‘‘(xi) TIER VI–A.—Registrants that 

18 have gross annual sales of at least 

19 $40,000,000 per annum but less than 

20 $60,000,000 in the fiscal year immediately 

21 preceding the fiscal year in which the an22 nual fee will be paid, shall be responsible, 

23 collectively, for 5.1 percent. 

24 ‘‘(xii) TIER VI–B.—Registrants that 

25 have gross annual sales of at least 


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1 $20,000,000 per annum but less than 

2 $40,000,000 in the fiscal year immediately 

3 preceding the fiscal year in which the an4 nual fee will be paid, shall be responsible, 

5 collectively, for 4.4 percent. 

6 ‘‘(xiii) TIER VII–A.—Registrants that 

7 have gross annual sales of at least 

8 $10,000,000 per annum but less than 

9 $20,000,000 in the fiscal year immediately 

10 preceding the fiscal year in which the an11 nual fee will be paid, shall be responsible, 

12 collectively, for 1.2 percent. 

13 ‘‘(xiv) TIER VII–B.—Registrants that 

14 have gross annual sales of at least 

15 $5,000,000 per annum but less than 

16 $10,000,000 in the fiscal year immediately 

17 preceding the fiscal year in which the an18 nual fee will be paid, shall be responsible, 

19 collectively, for 1.2 percent, except that no 

20 such registrant shall be responsible for 

21 more than $350 per fiscal year. 

22 ‘‘(xv) TIER VIII–A.—Registrants that 

23 have gross annual sales of at least 

24 $2,000,000 per annum but less than 

25 $5,000,000 in the fiscal year immediately 


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1 preceding the fiscal year in which the an2 nual fee will be paid, shall be responsible, 

3 collectively, for 1.2 percent, except that no 

4 such registrant shall be responsible for 

5 more than $250 per fiscal year. 

6 ‘‘(d) ADJUSTMENTS.— 

7 ‘‘(1) INFLATION ADJUSTMENT.— 

8 ‘‘(A) IN GENERAL.—For fiscal year 2019 

9 and each subsequent fiscal year, the revenues 

10 and fee amounts under subsection (c)(3)(B) 

11 shall be adjusted by the Food and Drug Admin12 istration in the annual Federal Register notice 

13 establishing fees in subsection (c)(1), by an 

14 amount equal to the sum of— 

15 ‘‘(i) one; 

16 ‘‘(ii) the average annual percent 

17 change in the cost, per full-time equivalent 

18 position of the Food and Drug Administra19 tion, of all personnel compensation and 

20 benefits paid with respect to such positions 

21 for the first 3 of the preceding 4 fiscal 

22 years for which data are available, multi23 plied by the average proportion of per24 sonnel compensation and benefits costs to 

25 total Food and Drug Administration costs 


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1 for the first 3 years of the preceding 4 fis2 cal years for which data are available; and 

3 ‘‘(iii) the average annual percent 

4 change that occurred in the Consumer 

5 Price Index for urban consumers (Wash6 ington-Baltimore, DC6 MD-VA-WV; not 

7 seasonally adjusted; all items less food and 

8 energy; annual index) for the first 3 years 

9 of the preceding 4 years for which data are 

10 available multiplied by the average propor11 tion of all costs other than personnel com12 pensation and benefits costs to total Food 

13 and Drug Administration costs for the 

14 first 3 years of the preceding 4 fiscal years 

15 for which data are available. 

16 ‘‘(B) COMPOUNDED BASIS.—The adjust17 ment made each fiscal year under this sub18 section shall be added on a compounded basis 

19 to the sum of all adjustments made each fiscal 

20 year after fiscal year 2018 under this sub21 section. 

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

23 year 2024, the Food and Drug Administration may, 

24 in addition to adjustments under paragraph (1), fur25 ther increase the fee revenues and fees established in 


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

2 provide for not more than 3 months of operating re3 serves of carryover fees for cosmetic safety activities 

4 for the first 3 months of fiscal year 2025. If such 

5 an adjustment is necessary, the rationale for the in6 crease, shall be contained in the annual Federal 

7 Register notice establishing fees, in subsection 

8 (c)(1), for fiscal year 2024. If the Food and Drug 

9 Administration has carryover balances for such ac10 tivities in excess of 3 months of such operating re11 serves, the adjustment under this subparagraph 

12 shall not be made. 

13 ‘‘(3) WORKLOAD ADJUSTMENT.— 

14 ‘‘(A) IN GENERAL.—For fiscal year 2019 

15 and each subsequent fiscal year, after fee reve16 nues established in subsection (c)(3)(B) are ad17 justed for a fiscal year for inflation in accord18 ance with paragraph (1), the fee revenues shall 

19 be adjusted further for each fiscal year to re20 flect changes in the workload of the Food and 

21 Drug Administration for actual changes in 

22 workload volume due to the process of reviewing 

23 cosmetic ingredients or non-functional constitu24 ents not listed under section 608(b). 


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1 ‘‘(B) DETERMINATION OF ADJUSTMENT.— 

2 The adjustment shall be determined by the 

3 Food and Drug Administration based on the 

4 workload in the most recent 1-year period for 

5 which workload data is available. The Food and 

6 Drug Administration shall publish in the Fed7 eral Register the fee revenues and fees resulting 

8 from the adjustment and the supporting meth9 odologies. 

10 ‘‘(C) MINIMUM REVENUES.—The adjust11 ment shall not result in fee revenues for a fiscal 

12 year that are less than the sum of the amount 

13 under subsection (c)(3)(B), as adjusted for in14 flation under subparagraph (1). 

15 ‘‘(e) LIMITATIONS.— 

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

17 that, under the salaries and expenses account of the 

18 Food and Drug Administration, is appropriated for 

19 a fiscal year for the cosmetics program in the Center 

20 for Food Safety and Applied Nutrition and related 

21 field activities, fees may not be assessed under sub22 section (a) for the fiscal year unless the amount so 

23 appropriated for the fiscal year (excluding the 

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

25 equal to or greater than that assessed for fiscal year 


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1 2017, multiplied by the adjustment factor applicable 

2 to the fiscal year involved. 

3 ‘‘(2) AUTHORITY.—If the Food and Drug Ad4 ministration does not assess fees under subsection 

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

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

7 year the Food and Drug Administration may assess 

8 such fees, the Food and Drug Administration may 

9 assess and collect such fees, without any modifica10 tion in the rate, for registration under section 605 

11 at any time in such fiscal year. 

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

13 ‘‘(1) IN GENERAL.—Fees authorized under sub14 section (a) shall be collected and available for obliga15 tion only to the extent and in the amount provided 

16 in advance in appropriations Acts. Such fees are au17 thorized to remain available until expended. Such 

18 sums as may be necessary may be transferred from 

19 the Food and Drug Administration salaries and ex20 penses appropriation account without fiscal year lim21 itation to such appropriation account for salaries 

22 and expenses with such fiscal year limitation. The 

23 sums transferred shall be available solely for cos24 metic safety activities. 


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1 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

2 ACTS.— 

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graphs (C) and (D), the fees authorized by this 

5 section shall be collected and available in each 

6 fiscal year in an amount not to exceed the 

7 amount specified in appropriation Acts, or oth8 erwise made available for obligation for such 

9 fiscal year. 

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

11 The fees authorized by this section shall be col12 lected and available only to defray the costs of 

13 cosmetic safety activities. 

14 ‘‘(C) FEE COLLECTIONS DURING FIRST

15 PROGRAM YEAR.—Until the date of enactment 

16 of an Act making appropriations through Sep17 tember 30, 2017, for the salaries and expenses 

18 account of the Food and Drug Administration, 

19 fees authorized by this section for fiscal year 

20 2018 may be collected and shall be credited to 

21 such account to remain available until ex22 pended. Fees collected under this subparagraph 

23 shall be considered discretionary for purposes of 

24 the Balanced Budget and Emergency Deficit 

25 Control Act of 1985. 


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1 ‘‘(D) REIMBURSEMENT OF START-UP

2 AMOUNTS.—Any amounts allocated to establish 

3 programs under sections 605 and 606, prior to 

4 collection of fees, may be reimbursed through 

5 any appropriated fees collected under this sec6 tion, in such manner as the Food and Drug Ad7 ministration determines appropriate. Any 

8 amounts reimbursed under this subparagraph 

9 shall be available for the programs and activi10 ties for which funds allocated to establish the 

11 programs were available, prior to such alloca12 tion, until the end of the fiscal year in which 

13 the reimbursement occurs, notwithstanding any 

14 otherwise applicable limits on amounts for such 

15 program or activities for a fiscal year. 

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

17 For each of fiscal years 2018 through 2024, there 

18 are authorized to be appropriated for fees under this 

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

20 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

21 OF COLLECTION SHORTFALLS.— 

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

23 the sum of the cumulative amount of fees col24 lected under this section for the fiscal years 

25 2018 through 2022 exceeds the cumulative 


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1 amount appropriated pursuant to paragraph (3) 

2 for fiscal years 2018 through 2023, the excess 

3 amount shall be credited to the appropriation 

4 account of the Food and Drug Administration 

5 as provided in paragraph (1), and shall be sub6 tracted from the amount of fees that would oth7 erwise be authorized to be collected under this 

8 section pursuant to appropriation Acts for fiscal 

9 year 2024. 

10 ‘‘(B) RECOVERY OF COLLECTION SHORT11 FALLS.— 

12 ‘‘(i) 2020.—For fiscal year 2020, the 

13 amount of fees otherwise authorized to be 

14 collected under this section shall be in15 creased by the amount, if any, by which 

16 the amount collected under this section 

17 and appropriated for fiscal year 2018 falls 

18 below the amount of fees authorized for 

19 fiscal year 2018 under paragraph (3). 

20 ‘‘(ii) 2021.—For fiscal year 2021, the 

21 amount of fees otherwise authorized to be 

22 collected under this section shall be in23 creased by the amount, if any, by which 

24 the amount collected under this section 

25 and appropriated for fiscal year 2019 falls 


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1 below the amount of fees authorized for 

2 fiscal year 2019 under paragraph (3). 

3 ‘‘(iii) 2022.—For fiscal year 2022, 

4 the amount of fees otherwise authorized to 

5 be collected under this section shall be in6 creased by the amount, if any, by which 

7 the amount collected under this section 

8 and appropriated for fiscal year 2020 falls 

9 below the amount of fees authorized for 

10 fiscal year 2020 under paragraph (3). 

11 ‘‘(iv) 2023.—For fiscal year 2023, the 

12 amount of fees otherwise authorized to be 

13 collected under this section shall be in14 creased by the amount, if any, by which 

15 the amount collected under this section 

16 and appropriated for fiscal year 2021 falls 

17 below the amount of fees authorized for 

18 fiscal year 2021 under paragraph (3). 

19 ‘‘(v) 2024.—For fiscal year 2024, the 

20 amount of fees otherwise authorized to be 

21 collected under this section shall be in22 creased by the amount, if any, by which 

23 the amount collected under this section 

24 and appropriated for fiscal year 2022 falls 


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1 below the amount of fees authorized for 

2 fiscal year 2022 under paragraph (3). 

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

4 and Drug Administration shall not consider a registration 

5 submitted to be complete until such fee under subsection 

6 (a) is paid. Until the fee is paid, the registration is incom7 plete and the registrant is deemed to have failed to reg8 ister in accordance with section 605. 

9 ‘‘(h) FALSE STATEMENTS.—Any statement or rep10 resentation made to the Food and Drug Administration 

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

12 Code. 

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

14 where the Food and Drug Administration does not receive 

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

16 shall be treated as a claim of the United States Govern17 ment subject to subchapter II of chapter 37 of title 31, 

18 United States Code. 

19 ‘‘(j) CONSTRUCTION.—This section may not be con20 strued to require that the number of full-time equivalent 

21 positions in the Department of Health and Human Serv22 ices, for officers, employees, and advisory committees not 

23 engaged in cosmetic activities, be reduced to offset the 

24 number of officers, employees, and advisory committees so 

25 engaged. 


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

2 necessary to demonstrate the facility’s gross annual sales 

3 for at least 2 fiscal years after such information is re4 ported in the facility’s registration. Such records shall be 

5 made available to the Food and Drug Administration for 

6 review and duplication upon request of the Food and Drug 

7 Administration.’’. 

8 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI9 TIES RELATED TO COSMETICS. 

10 Part 10 of subchapter C of chapter VII of the Fed11 eral Food, Drug, and Cosmetic Act, as added by section 

12 202, is amended by inserting after section 744L the fol13 lowing: 

14 ‘‘SEC. 744M. DIRECT HIRING AUTHORITY TO SUPPORT AC15 TIVITIES RELATED TO COSMETICS. 

16 ‘‘(a) IN GENERAL.—The Food and Drug Administra17 tion shall have direct hiring authority with respect to the 

18 appointment of employees into the competitive service or 

19 the excepted service to administer the amendments made 

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

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

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

23 of enactment of such title.’’. 

Æ 


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