Children’s Product Warning Label Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1816 To amend the Federal Food, Drug, and Cosmetic Act to require that chil- dren’s cosmetics containing talc include an appropriate warning unless the cosmetics are demonstrated to be asbestos-free, and for other pur- poses. IN THE HOUSE OF REPRESENTATIVES MARCH 18, 2019 Mrs. DINGELL (for herself and Ms. SCHAKOWSKY) 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 require that children’s cosmetics containing talc include an appropriate warning unless the cosmetics are dem- onstrated to be asbestos-free, 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. 3 This Act may be cited as the ‘‘Children’s Product 4 Warning Label Act of 2019’’. 5 VerDate Sep 11 2014 00:45 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1816.IH H1816 kjohnson on DSK79L0C42 with BILLS 2 •HR 1816 IH SEC. 2. LABELING OF TALC IN CHILDREN’S COSMETICS. 1 (a) MISBRANDING.—Section 602 of the Federal 2 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend- 3 ed by adding at the end the following: 4 ‘‘(g) If it is marketed for use in children (meaning 5 individuals under the age of 18) and contains talc (as de- 6 fined in section 604) unless— 7 ‘‘(1) its label includes the following statement 8 printed in conspicuous text: ‘WARNING: Talc in 9 this product has not been evaluated for asbestos con- 10 tamination. Asbestos may be present. Asbestos at 11 any level is known to the FDA to cause cancer, in- 12 cluding lung cancer and mesothelioma. This product 13 is not suitable for use by children.’; or 14 ‘‘(2) a waiver is in effect with respect to the 15 cosmetic pursuant to section 604.’’. 16 (b) PREMARKET SAFETY VERIFICATION OF TALC 17 CONTENT.—Chapter VI of the Federal Food, Drug, and 18 Cosmetic Act (21 U.S.C. 361 et seq.) is amended by add- 19 ing at the end the following: 20 ‘‘SEC. 604. PREMARKET SAFETY VERIFICATION OF TALC 21 CONTENT. 22 ‘‘(a) IN GENERAL.—The Secretary shall waive the 23 applicability of section 602(g)(1) with respect to a cos- 24 metic containing talc if the manufacturer of the cos- 25 metic— 26 VerDate Sep 11 2014 00:45 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1816.IH H1816 kjohnson on DSK79L0C42 with BILLS 3 •HR 1816 IH ‘‘(1) attests in writing to the Secretary that the 1 source of the talc is an asbestos-free mine; and 2 ‘‘(2) demonstrates to the Secretary that the talc 3 is asbestos-free using the transmission electron mi- 4 croscopy method. 5 ‘‘(b) DEFINITIONS.—In this section: 6 ‘‘(1) The term ‘asbestos’ means the asbestiform 7 varieties of chrysotile (serpentine), crocidolite (rie- 8 beckite), amosite (cummingtonitegrunerite), antho- 9 phyllite, tremolite, and actinolite. 10 ‘‘(2) The term ‘asbestos-free’ means containing 11 no traceable asbestos fibers. 12 ‘‘(3) The term ‘talc’— 13 ‘‘(A) means a basic silicate of magnesium; 14 and 15 ‘‘(B) includes talcum powder, hydrous 16 magnesium silicate, non-fibrous talc, non-as- 17 bestiform talc, steatite talc, and fibrous non- 18 tremolite talc. 19 ‘‘(4) The term ‘transmission electron micros- 20 copy’ refers to the asbestos analysis method used by 21 laboratories that— 22 ‘‘(A) are accredited by the National Bu- 23 reau of Standards; and 24 VerDate Sep 11 2014 00:45 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1816.IH H1816 kjohnson on DSK79L0C42 with BILLS 4 •HR 1816 IH ‘‘(B) use the protocol described in appen- 1 dix A to subpart E of part 763 of title 40, Code 2 of Federal Regulations (or any successor regu- 3 lations).’’. 4 (c) APPLICABILITY.—Sections 602(g) and 604 of the 5 Federal Food, Drug, and Cosmetic Act, as added by sub- 6 sections (a) and (b), apply beginning on the date that is 7 180 days after the date of enactment of this Act. 8 (d) REGULATIONS.—Not later than 180 days after 9 the date of enactment of this Act, the Secretary of Health 10 and Human Services, acting through the Commissioner of 11 Food and Drugs, shall promulgate final regulations to im- 12 plement such sections 602(g) and 604. 13 Æ VerDate Sep 11 2014 00:45 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1816.IH H1816 kjohnson on DSK79L0C42 with BILLS