Personal Care Products Safety Act

II 117TH CONGRESS 1ST SESSION S. 2100 To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. IN THE SENATE OF THE UNITED STATES JUNE 17, 2021 Mrs. FEINSTEIN (for herself and Ms. COLLINS) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. 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 ‘‘Personal Care Products Safety Act’’. 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 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 2100 IS Sec. 102. Review of ingredients and non-functional constituents. Sec. 103. Good manufacturing practices for cosmetics. Sec. 104. Adverse event reports. Sec. 105. Records inspection; mandatory recall authority. Sec. 106. Labeling. Sec. 107. Coal tar chemicals. Sec. 108. Fragrance allergen disclosure. Sec. 109. Sense of the Senate on animal testing. Sec. 110. Preemption. Sec. 111. Reporting. Sec. 112. Small businesses. Sec. 113. Applicability with respect to certain cosmetics. Sec. 114. Enforcement. Sec. 115. Consumer information. Sec. 116. Ban on perfluoroalkyl or polyfluoroalkyl substances. Sec. 117. Counterfeit cosmetics. TITLE II—FEES RELATED TO COSMETIC SAFETY Sec. 201. Findings. Sec. 202. Authority to assess and use cosmetic safety fees. Sec. 203. Direct hiring authority to support activities related to cosmetics. TITLE I—COSMETIC SAFETY 1 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 2 COSMETIC INGREDIENT STATEMENTS. 3 (a) AMENDMENTS.—Chapter VI of the Federal Food, 4 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend- 5 ed by adding at the end the following: 6 ‘‘SEC. 604. DEFINITIONS. 7 ‘‘In this chapter: 8 ‘‘(1) COSMETIC FORMULATION.—The term ‘cos- 9 metic formulation’ means a preparation of cosmetic 10 raw materials with a qualitatively and quantitatively 11 set composition. 12 ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 13 product’ means a preparation of cosmetic raw ingre- 14 dients, which may come in a range of possible 15 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 2100 IS amounts for each ingredient, for purposes of intro- 1 duction into interstate commerce as a finished prod- 2 uct. 3 ‘‘(3) FACILITY.—The term ‘facility’ includes 4 any factory, warehouse, or establishment (including 5 a factory, warehouse, or establishment of an im- 6 porter) that manufactures or processes cosmetic 7 products or cosmetic formulations, or any other enti- 8 ty whose name and address appear on the label of 9 a cosmetic product. Such term does not include— 10 ‘‘(A) beauty shops and salons that do not 11 otherwise manufacture, process, or package cos- 12 metics at that location; 13 ‘‘(B) cosmetic product retailers, including 14 individual sales representatives, direct sellers, 15 retail distribution facilities, and pharmacies, 16 that do not otherwise manufacture, process, or 17 package cosmetics at that location; 18 ‘‘(C) hospitals, physicians’ offices, and 19 health care clinics; 20 ‘‘(D) public health agencies and other non- 21 profit entities that provide cosmetics directly to 22 the consumer; 23 ‘‘(E) hotels and other entities that provide 24 complimentary cosmetics to guests; 25 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 2100 IS ‘‘(F) trade shows and other venues where 1 cosmetic product samples are provided free of 2 charge; 3 ‘‘(G) a factory, warehouse, or establish- 4 ment of— 5 ‘‘(i) domestic manufacturers with less 6 than $500,000 in average gross annual 7 sales of cosmetic products in the United 8 States for the previous 3-year period, or 9 less than $1,000,000 in such sales of cos- 10 metic products produced in a private resi- 11 dence; or 12 ‘‘(ii) entities that manufacture or 13 compound cosmetic products solely for use 14 in research, teaching, or pilot plant pro- 15 duction and not for sale; or 16 ‘‘(H) an establishment that solely performs 17 one or more of the following with respect to cos- 18 metic products: labeling, relabeling, packaging, 19 repackaging, holding, or distributing. 20 ‘‘(4) FOREIGN FACILITY.—The term ‘foreign fa- 21 cility’ means a facility that manufactures or proc- 22 esses a cosmetic formulation or cosmetic product 23 that is exported to the United States without further 24 processing or packaging inside the United States. A 25 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 2100 IS cosmetic is not considered to have undergone further 1 processing or packaging for purposes of this defini- 2 tion solely on the basis that labeling was added or 3 that any similar activity of a de minimis nature was 4 carried out with respect to the cosmetic. 5 ‘‘(5) NON-FUNCTIONAL CONSTITUENT.—The 6 term ‘non-functional constituent’ means any sub- 7 stance that is an incidental component of an ingre- 8 dient, a breakdown product of an ingredient or a by- 9 product of the manufacturing process that has not 10 been intentionally added as a separate substance and 11 serves no technical function in the cosmetic. 12 ‘‘(6) RESPONSIBLE PERSON.—The term ‘re- 13 sponsible person’ means— 14 ‘‘(A) the brand owner who is the domestic 15 or foreign manufacturer or entity whose name 16 appears on a cosmetic product label of a cos- 17 metic product distributed in the United States, 18 except for entities described in subparagraphs 19 (A) through (H) of paragraph (3); or 20 ‘‘(B) a contract manufacturer who provides 21 cosmetic products to the entities described in 22 subparagraphs (A) through (H) of paragraph 23 (3).’’. 24 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 2100 IS ‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES. 1 ‘‘(a) REGISTRATION AND FEES FOR EXISTING MAN- 2 UFACTURING OR PROCESSING OF COSMETICS.— 3 ‘‘(1) REGISTRATION, IN GENERAL.—Not later 4 than 1 year after the date of enactment of the Per- 5 sonal Care Products Safety Act, and at a similar 6 time in each subsequent year, as determined by the 7 Food and Drug Administration, each responsible 8 person engaged in manufacturing or processing a 9 cosmetic product or a cosmetic formulation distrib- 10 uted in the United States shall register all of the re- 11 sponsible person’s facilities with the Food and Drug 12 Administration. 13 ‘‘(2) FEES.—If the average gross annual sales 14 in the United States of cosmetic products of all of 15 the responsible person’s facilities registered under 16 paragraph (1) for the previous 3-year period is 17 greater than $10,000,000, a registration shall not be 18 complete under this subsection until the responsible 19 person has paid any registration fee required under 20 section 744O. 21 ‘‘(b) REGISTRATION BY NEW FACILITIES.—Any fa- 22 cility first engaging after the date of enactment of the Per- 23 sonal Care Products Safety Act in an activity that would 24 require it to register under subsection (a) shall register 25 with the Food and Drug Administration within 60 days 26 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 2100 IS of first engaging in such activity, and thereafter in accord- 1 ance with subsection (a). 2 ‘‘(c) CONTRACT MANUFACTURERS.—If a facility 3 manufactures or processes cosmetic products on behalf of 4 a responsible person, the Food and Drug Administration 5 shall require only a single registration for such facility 6 even if such facility is manufacturing or processing its own 7 cosmetic products or cosmetic products on behalf of more 8 than 1 responsible person. Such single registration may 9 be submitted to the Food and Drug Administration by 10 such facility or any responsible person whose products are 11 manufactured or processed at such facility. 12 ‘‘(d) CHANGES TO INFORMATION.—A registrant who 13 has submitted a registration under this section shall notify 14 the Food and Drug Administration of any change to the 15 information required under subsection (a) or (b) not later 16 than 60 days after the date of such change, unless other- 17 wise specified by the Food and Drug Administration. 18 ‘‘(e) FORMAT; CONTENTS.— 19 ‘‘(1) ELECTRONIC FORMAT.—Each registration 20 shall be submitted using an electronic format, as 21 specified in a registration form provided by the Food 22 and Drug Administration. 23 ‘‘(2) CONTENTS.— 24 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 2100 IS ‘‘(A) IN GENERAL.—Except as provided in 1 subparagraph (B), the registration shall contain 2 the following information: 3 ‘‘(i) Each facility’s name and full ad- 4 dress, identifying the precise physical loca- 5 tion of the facility. 6 ‘‘(ii) The identity of the facility, in- 7 cluding the unique facility identifier, if 8 any, previously assigned by the Food and 9 Drug Administration to the facility under 10 subsection (h). 11 ‘‘(iii) All business trading names used 12 by the facility. 13 ‘‘(iv) The product category or cat- 14 egories of each cosmetic product or cos- 15 metic formulation manufactured or proc- 16 essed at the facility or on whose label the 17 facility’s name and address appear. 18 ‘‘(v) The type of activity conducted at 19 the facility (such as manufacturing or 20 processing). 21 ‘‘(vi) The name, title, street address, 22 telephone number, and electronic contact 23 information of the emergency contact for 24 the facility. 25 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 2100 IS ‘‘(vii) In the case of a foreign facility, 1 the name, street address, telephone num- 2 ber, emergency contact information, and 3 name of the United States agent for the 4 facility, and, if available, the electronic 5 contact information of the United States 6 agent. 7 ‘‘(viii) The name, title, street address, 8 telephone number, and electronic contact 9 information of the individual submitting 10 the registration. 11 ‘‘(ix) An assurance that the Food and 12 Drug Administration will be permitted to 13 inspect such facility at the times and in 14 the manner permitted by this Act. 15 ‘‘(x) Additional information pertaining 16 to the facility or to the cosmetic products 17 or cosmetic formulations manufactured or 18 processed at the facility, or on whose label 19 the facility’s name and address appear, in- 20 cluding all brand names known to con- 21 sumers, as the Food and Drug Administra- 22 tion may require by regulation. 23 ‘‘(xi) An ingredient listing for all cos- 24 metic products manufactured or processed 25 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 10 •S 2100 IS in such facility, in accordance with sub- 1 section (f), which, for each relevant cos- 2 metic product, may be submitted to the 3 Food and Drug Administration as part of 4 such registration or separately. 5 ‘‘(xii) A written assurance that each 6 cosmetic product manufactured or proc- 7 essed in such facility has been substan- 8 tiated for safety or carries the warning re- 9 quired under section 740.10 of title 21, 10 Code of Federal Regulations (or any suc- 11 cessor regulations). The responsible person 12 shall maintain records documenting any 13 such substantiation of safety and the infor- 14 mation on which such determination is 15 based until 5 years after the finished prod- 16 uct is no longer marketed, except that a 17 responsible person for a domestic company 18 whose sales are under $2,000,000 per year 19 shall maintain such records for at least 2 20 years after the finished product is no 21 longer marketed. 22 ‘‘(B) SMALL BUSINESSES.— 23 ‘‘(i) REQUIREMENTS.—In the case of 24 a registrant described in clause (ii), the 25 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 11 •S 2100 IS registration shall contain the following in- 1 formation: 2 ‘‘(I) Each facility’s name and full 3 address, identifying the precise phys- 4 ical location of the facility. 5 ‘‘(II) The name, title, street ad- 6 dress, telephone number, and elec- 7 tronic contact information of the 8 emergency contact for the facility. 9 ‘‘(III) The consumer product cat- 10 egory or categories of each cosmetic 11 product or cosmetic formulation man- 12 ufactured, processed, packed, or held 13 at the facility or on whose label the 14 facility’s name and address appear. 15 ‘‘(ii) SMALL BUSINESS REG- 16 ISTRANTS.—A registrant described in this 17 clause is a domestic registrant— 18 ‘‘(I) whose average gross annual 19 sales in the United States of cosmetic 20 products for the previous 3-year pe- 21 riod is between $500,000 and 22 $2,000,000 (or between $1,000,000 23 and $2,000,000 in the case of sales of 24 VerDate Sep 11 2014 04:41 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2100.IS S2100 pbinns on DSKJLVW7X2PROD with BILLS 12 •S 2100 IS cosmetic products produced in a pri- 1 vate residence); and 2 ‘‘(II) who does not produce— 3 ‘‘(aa) products that are in- 4 tended to go on the eye area; 5 ‘‘(bb) lip products with 6 color; 7 ‘‘(cc) products that are in- 8 jected; 9 ‘‘(dd) products that are in- 10 tended for internal use; or 11 ‘‘(ee) products that are 12 meant to alter appearance for 13 more than 24 hours. 14 ‘‘(iii) GUIDANCE.—The Food and 15 Drug Administration shall, after consulta- 16 tion with the Small Business Administra- 17 tion and small businesses that manufac- 18 ture cosmetics, provide additional guidance 19 for small businesses on compliance with 20 the requirements of this section that would 21 apply to small business registrants. Such 22 guidance shall include specific examples of 23 options for complian [Text truncated for display. Full text available on Congress.gov.]