I 

115TH CONGRESS 

2D SESSION H. R. 4964 

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 demonstrated to be asbestos-free, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 7, 2018 

Mrs. DINGELL 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 demonstrated to be asbestos-free, and for other purposes. 

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. 

4 This Act may be cited as the ‘‘Children’s Product 

5 Warning Label Act of 2018’’. 


dlhill on DSK3GLQ082PROD with BILLS
2 

•HR 4964 IH

1 SEC. 2. LABELING OF TALC IN CHILDREN’S COSMETICS. 

2 (a) MISBRANDING.—Section 602 of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend4 ed by adding at the end the following: 

5 ‘‘(g) If it is marketed for use in children (meaning 

6 individuals under the age of 18) and contains talc (as de7 fined in section 604) unless— 

8 ‘‘(1) its label includes the following statement 

9 printed in conspicuous text: ‘WARNING: Talc has 

10 not been evaluated for asbestos contamination. As11 bestos at any level is known to the FDA to cause 

12 cancer, including lung cancer and mesothelioma and 

13 may be present in this product. This product is not 

14 suitable for use by children.’; or 

15 ‘‘(2) a waiver is in effect with respect to the 

16 cosmetic pursuant to section 604.’’. 

17 (b) PREMARKET SAFETY VERIFICATION OF TALC

18 CONTENT.—Chapter VI of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 361 et seq.) is amended by add20 ing at the end the following: 

21 ‘‘SEC. 604. PREMARKET SAFETY VERIFICATION OF TALC 

22 CONTENT. 

23 ‘‘(a) IN GENERAL.—The Secretary shall waive the 

24 applicability of section 602(g)(1) with respect to a cos25 metic containing talc if the manufacturer of the cos26 metic— 


dlhill on DSK3GLQ082PROD with BILLS
3 

•HR 4964 IH

1 ‘‘(1) attests in writing to the Secretary that the 

2 source of the talc is an asbestos-free mine; and 

3 ‘‘(2) demonstrates to the Secretary that the talc 

4 is asbestos-free using the transmission electron mi5 croscopy method. 

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

7 ‘‘(1) The term ‘asbestos’ means the asbestiform 

8 varieties of chrysotile (serpentine), crocidolite (rie9 beckite), amosite (cummingtonitegrunerite), antho10 phyllite, tremolite, and actinolite. 

11 ‘‘(2) The term ‘asbestos-free’ means containing 

12 no traceable asbestos fibers. 

13 ‘‘(3) The term ‘talc’— 

14 ‘‘(A) means a basic silicate of magnesium; 

15 and 

16 ‘‘(B) includes talcum powder, hydrous 

17 magnesium silicate, non-fibrous talc, non18 asbestiform talc, steatite talc, and fibrous non19 tremolite talc. 

20 ‘‘(4) The term ‘transmission electron micros21 copy’ refers to the asbestos analysis method used by 

22 laboratories that— 

23 ‘‘(A) are accredited by the National Bu24 reau of Standards; and 


dlhill on DSK3GLQ082PROD with BILLS
4 

•HR 4964 IH

1 ‘‘(B) use the protocol described in appen2 dix A to subpart E of part 763 of title 40, Code 

3 of Federal Regulations (or any successor regu4 lations).’’. 

5 (c) APPLICABILITY.—Sections 602(g) and 604 of the 

6 Federal Food, Drug, and Cosmetic Act, as added by sub7 sections (a) and (b), apply beginning on the date that is 

8 180 days after the date of enactment of this Act. 

9 (d) REGULATIONS.—Not later than 180 days after 

10 the date of enactment of this Act, the Secretary of Health 

11 and Human Services, acting through the Commissioner of 

12 Food and Drugs, shall promulgate final regulations to im13 plement such sections 602(g) and 604. 

Æ 


dlhill on DSK3GLQ082PROD with BILLS