Cosmetic Safety Enhancement Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 5279 To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes. IN THE HOUSE OF REPRESENTATIVES DECEMBER 3, 2019 Mr. PALLONE introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Cosmetic Safety Enhancement Act of 2019’’. 5 (b) TABLE OF CONTENTS.—The table of contents for 6 this Act is as follows: 7 Sec. 1. Short title; table of contents. TITLE I—COSMETIC SAFETY Sec. 101. Registration of cosmetics facilities and cosmetic ingredient state- ments. VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 2 •HR 5279 IH Sec. 102. Review of ingredients and nonfunctional constituents; safety of fin- ished products. Sec. 103. Good manufacturing practices for cosmetics. Sec. 104. Adverse event reports. Sec. 105. Records inspection; mandatory recall authority. Sec. 106. Labeling and internet sales. Sec. 107. Consumer information. Sec. 108. Small businesses. Sec. 109. Animal testing restrictions. Sec. 110. Counterfeit cosmetics. Sec. 111. Foreign supplier verification. Sec. 112. Applicability with respect to certain cosmetics. Sec. 113. Saving clause. Sec. 114. Enforcement. TITLE II—FEES RELATED TO COSMETIC PRODUCTS Sec. 201. Findings. Sec. 202. Authority to assess and use cosmetic product fees. Sec. 203. Direct hiring authority to support activities related to cosmetics. Sec. 204. Sunset dates. TITLE I—COSMETIC SAFETY 1 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 2 COSMETIC INGREDIENT STATEMENTS. 3 Chapter VI of the Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 361 et seq.) is amended by adding at the 5 end the following: 6 ‘‘SEC. 604. DEFINITIONS. 7 ‘‘In this chapter: 8 ‘‘(1) ANIMAL TEST.—The term ‘animal test’ 9 means the internal or external application or expo- 10 sure of a cosmetic product, cosmetic formulation, or 11 cosmetic ingredient to the skin, eyes, or other body 12 part of a live non-human vertebrate for the purpose 13 of evaluating the safety of a cosmetic product, cos- 14 metic formulation, or cosmetic ingredient. 15 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 3 •HR 5279 IH ‘‘(2) CONTRACT MANUFACTURER.—The term 1 ‘contract manufacturer’ means a manufacturer (in- 2 cluding the owner, operator, or agent in charge (or 3 any affiliate thereof)) of a cosmetic ingredient, cos- 4 metic formulation, or cosmetic product that does not 5 sell any such cosmetic ingredient, cosmetic formula- 6 tion, or cosmetic product unless there is a specific 7 contractual agreement in place with respect to that 8 sale. 9 ‘‘(3) COSMETIC FORMULATION.—The term ‘cos- 10 metic formulation’ means a preparation of cosmetic 11 raw materials with a qualitatively and quantitatively 12 set composition. 13 ‘‘(4) COSMETIC INGREDIENT.—The term ‘cos- 14 metic ingredient’ means any single chemical entity 15 or mixture used as a component in the manufacture 16 of a finished cosmetic product or cosmetic formula- 17 tion. 18 ‘‘(5) COSMETIC PRODUCT.—(A) The term ‘cos- 19 metic product’ means a finished cosmetic comprised 20 of a specified set of cosmetic ingredients, which may 21 come in a range of possible amounts for each cos- 22 metic ingredient and which may include a variety of 23 fragrances and colors, and in some specific cosmetic 24 applications, flavors. 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 4 •HR 5279 IH ‘‘(B) Such term shall include tattoo ink whether 1 or not labeled as a finished cosmetic. 2 ‘‘(6) FACILITY.—The term ‘facility’ includes 3 any factory, warehouse, or establishment (including 4 a factory, warehouse, or establishment of an im- 5 porter or of any other entity whose name and ad- 6 dress appear on the label of a cosmetic product) that 7 manufactures, processes, packs, or holds cosmetic 8 products or cosmetic formulations. Such term does 9 not include— 10 ‘‘(A) beauty shops and salons that do not 11 otherwise manufacture, process, or package cos- 12 metic products or cosmetic formulations at that 13 location, including beauty stores or counters 14 that offer customized or personalized cosmetic 15 products or cosmetic formulations tailored to 16 individual consumers for sale solely in-person; 17 ‘‘(B) cosmetic product retailers, including 18 individual sales representatives, direct sellers 19 (as defined in section 3508 of the Internal Rev- 20 enue Code of 1986), retail distribution facilities, 21 retail franchises, retail warehouses, and phar- 22 macies, that do not otherwise manufacture, 23 process, or package cosmetic products or cos- 24 metic formulations at that location; 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 5 •HR 5279 IH ‘‘(C) entities that manufacture or com- 1 pound cosmetic products solely for use in re- 2 search, teaching, or pilot plant production and 3 not for sale; 4 ‘‘(D) hospitals, physicians’ offices, and 5 health care clinics; 6 ‘‘(E) hotels, airlines, and other entities 7 that provide complimentary cosmetic products 8 to guests; 9 ‘‘(F) public health agencies and other non- 10 profit entities that provide cosmetic products or 11 cosmetic formulations directly to the consumer; 12 or 13 ‘‘(G) trade shows and other venues where 14 cosmetic product samples are provided free of 15 charge. 16 ‘‘(7) FOREIGN FACILITY.—The term ‘foreign fa- 17 cility’ means a facility that manufactures, processes, 18 packs, or holds, cosmetic products or cosmetic for- 19 mulations that are exported to the United States 20 without further processing or packaging inside the 21 United States. A cosmetic product or cosmetic for- 22 mulation is not considered to have undergone fur- 23 ther processing or packaging for purposes of this 24 definition solely on the basis that labeling was added 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 6 •HR 5279 IH or that any similar activity of a de minimis nature 1 was carried out with respect to the cosmetic product 2 or cosmetic formulation. 3 ‘‘(8) NONFUNCTIONAL CONSTITUENT.—The 4 term ‘nonfunctional constituent’ means any sub- 5 stance that is an incidental component of an ingre- 6 dient, a breakdown product of an ingredient, or a 7 byproduct of the manufacturing process that has not 8 been intentionally added as a separate substance and 9 serves no technical function in the cosmetic product. 10 ‘‘(9) PROFESSIONAL.—With respect to a cos- 11 metic product, the term ‘professional’ means— 12 ‘‘(A) a dermatologist or other health care 13 professional that administers or provides cos- 14 metic products to patients; or 15 ‘‘(B) a cosmetologist, nail technician, bar- 16 ber, or esthetician who administers or provides 17 cosmetics within the scope of their business 18 practices. 19 ‘‘(10) PROFESSIONAL USE.—With respect to a 20 cosmetic product, the term ‘professional use’ means 21 a preparation of a cosmetic formulation intended 22 only for use by professionals in settings such as cos- 23 metology, nail care, barbering, esthetics, health care, 24 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 7 •HR 5279 IH and other professions as determined by the Sec- 1 retary through regulation. 2 ‘‘(11) RESPONSIBLE PERSON.—The term ‘re- 3 sponsible person’ means the brand owner, operator, 4 or agent in charge who is the domestic or foreign 5 manufacturer, processor, or entity whose name ap- 6 pears on the label of a cosmetic product or a cos- 7 metic formulation distributed in the United States. 8 ‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES. 9 ‘‘(a) REGISTRATION FOR MANUFACTURING AND 10 PROCESSING FACILITIES.— 11 ‘‘(1) IN GENERAL.—The owner, operator, or 12 agent in charge of (or an affiliate thereof) a facility 13 engaged in manufacturing, or processing, of a cos- 14 metic product or a cosmetic formulation distributed 15 in the United States shall register with the Sec- 16 retary. 17 ‘‘(2) ELECTRONIC REGISTRATION SYSTEM.— 18 The Secretary shall— 19 ‘‘(A) maintain an electronic registration 20 system for purposes of this section; and 21 ‘‘(B) not later than one year after the date 22 of enactment of the Cosmetic Safety Enhance- 23 ment Act of 2019, announce that such system 24 is operational. 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 8 •HR 5279 IH ‘‘(3) INITIAL REGISTRATION OF EXISTING FA- 1 CILITIES.—Not later than the date that is 6 months 2 after the date of the announcement required by 3 paragraph (2)(B), each facility engaged in an activ- 4 ity described in paragraph (1) shall be registered 5 under such paragraph. 6 ‘‘(4) INITIAL REGISTRATION OF NEW FACILI- 7 TIES.—In the case of a facility that first engages in 8 an activity described in paragraph (1) on or after 9 the date that is 18 months after the date of enact- 10 ment of the Cosmetic Safety Enhancement Act of 11 2019, such a facility shall register with the Sec- 12 retary immediately upon engaging in such activity. 13 ‘‘(5) SINGLE REGISTRATION.—The Secretary 14 shall require only a single registration per registra- 15 tion period for a facility required to be registered 16 under paragraph (1), regardless of whether such fa- 17 cility is manufacturing or processing— 18 ‘‘(A) its own cosmetic products or cosmetic 19 formulations; or 20 ‘‘(B) cosmetic products or cosmetic formu- 21 lations on behalf of more than one owner, oper- 22 ator, or agent in charge (or affiliate thereof). 23 ‘‘(b) REGISTRATION FOR PACKING OR HOLDING FA- 24 CILITIES.—Each facility engaged in packing or holding a 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 9 •HR 5279 IH cosmetic product or cosmetic formulation distributed in 1 the United States shall register with the Food and Drug 2 Administration. Each such facility shall, not later than 6 3 months after the Secretary announces the establishment 4 of an electronic registration system for purposes of this 5 section, submit a registration utilizing such system. 6 ‘‘(c) ANNUAL REGISTRATION RENEWAL.—A facility 7 that continues to engage in any activity that would require 8 registration under subsection (a) or (b) shall submit to 9 the Secretary an annual registration during the first quar- 10 ter of the fiscal year for which such renewed registration 11 shall be effective. 12 ‘‘(d) FEES.—If the average gross annual sales of cos- 13 metic products in the United States of all of the facilities 14 of the responsible person registered under subsection 15 (a)(1) for the previous 3-fiscal-year period is greater than 16 $1,000,000, a registration shall not be complete under this 17 subsection until the responsible person has paid any reg- 18 istration fee required under section 744M. 19 ‘‘(e) CHANGES TO INFORMATION.—A facility that 20 submitted a registration under this section shall notify the 21 Secretary of any change to the information required under 22 subsection (a) or (b) not later than 30 days after the date 23 of such change, unless otherwise specified by the Sec- 24 retary. 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 10 •HR 5279 IH ‘‘(f) FORMAT; CONTENTS.— 1 ‘‘(1) ELECTRONIC FORMAT.—Each registration 2 shall be submitted using an electronic format, as 3 specified in a registration form provided by the Sec- 4 retary. 5 ‘‘(2) CONTENTS.—The registration shall con- 6 tain the following information: 7 ‘‘(A) Each facility’s name (including any 8 parent company of the facility) and full ad- 9 dress, identifying the precise physical location 10 of the facility. 11 ‘‘(B) The identity of the facility, including 12 the unique facility identifier, if any, previously 13 assigned by the Secretary to the facility under 14 subsection (i). 15 ‘‘(C) All business trading names used by 16 the facility. 17 ‘‘(D) The product category (as identified 18 under section 720.4(c) of title 21, Code of Fed- 19 eral Regulations (or any successor regulation)), 20 or other cosmetic categories as determined ap- 21 propriate by the Secretary (including by guid- 22 ance) of each cosmetic product or cosmetic for- 23 mulation manufactured, processed, packed, or 24 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 11 •HR 5279 IH held at the facility or on whose label the facili- 1 ty’s name and address appear. 2 ‘‘(E) The type or types of activities con- 3 ducted at the facility (such as manufacturing, 4 processing, packing, or holding). 5 ‘‘(F) The name, title, street address, tele- 6 phone number, and electronic contact informa- 7 tion of the emergency contact for the facility. 8 ‘‘(G) In the case of a foreign facility, the 9 name, street address, telephone number, emer- 10 gency contact information for the facility, the 11 name of the United States agent for the facil- 12 ity, and the phone number and electronic con- 13 tact information of the United States agent. 14 ‘‘(H) The name, title, street address, tele- 15 phone number, and electronic contact informa- 16 tion of the individual submitting the registra- 17 tion. 18 ‘‘(I) An assurance that the Secretary will 19 be permitted to inspect such facility at the 20 times and in the manner permitted by this Act. 21 ‘‘(J) Additional information pertaining to 22 the facility or to the cosmetic products or cos- 23 metic formulations manufactured, processed, 24 packed, or held at the facility, or on whose label 25 VerDate Sep 11 2014 02:40 Dec 07, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5279.IH H5279 kjohnson on DSK79L0C42 with BILLS 12 •HR 5279 IH the facility’s name and address appear, includ- 1 ing all brand names known to consumers, as 2 the Secretary may require by regulation. 3 ‘‘(3) ABBREVIATED REGISTRATION.—The Sec- 4 ret [Text truncated for display. 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