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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Children’s Product 
Warning Label Act of 2019’’. 
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SEC. 2. LABELING OF TALC IN CHILDREN’S COSMETICS. 
(a) MISBRANDING.—Section 602 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend-
ed by adding at the end the following: 
‘‘(g) If it is marketed for use in children (meaning 
individuals under the age of 18) and contains talc (as de-
fined in section 604) unless— 
‘‘(1) its label includes the following statement 
printed in conspicuous text: ‘WARNING: Talc in 
this product has not been evaluated for asbestos con-
tamination. Asbestos may be present. Asbestos at 
any level is known to the FDA to cause cancer, in-
cluding lung cancer and mesothelioma. This product 
is not suitable for use by children.’; or 
‘‘(2) a waiver is in effect with respect to the 
cosmetic pursuant to section 604.’’. 
(b) PREMARKET SAFETY VERIFICATION
OF TALC 
CONTENT.—Chapter VI of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361 et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 604. PREMARKET SAFETY VERIFICATION OF TALC 
CONTENT. 
‘‘(a) IN GENERAL.—The Secretary shall waive the 
applicability of section 602(g)(1) with respect to a cos-
metic containing talc if the manufacturer of the cos-
metic— 
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‘‘(1) attests in writing to the Secretary that the 
source of the talc is an asbestos-free mine; and 
‘‘(2) demonstrates to the Secretary that the talc 
is asbestos-free using the transmission electron mi-
croscopy method. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) The term ‘asbestos’ means the asbestiform 
varieties of chrysotile (serpentine), crocidolite (rie-
beckite), amosite (cummingtonitegrunerite), antho-
phyllite, tremolite, and actinolite. 
‘‘(2) The term ‘asbestos-free’ means containing 
no traceable asbestos fibers. 
‘‘(3) The term ‘talc’— 
‘‘(A) means a basic silicate of magnesium; 
and 
‘‘(B) includes talcum powder, hydrous 
magnesium silicate, non-fibrous talc, non-as-
bestiform talc, steatite talc, and fibrous non- 
tremolite talc. 
‘‘(4) The term ‘transmission electron micros-
copy’ refers to the asbestos analysis method used by 
laboratories that— 
‘‘(A) are accredited by the National Bu-
reau of Standards; and 
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‘‘(B) use the protocol described in appen-
dix A to subpart E of part 763 of title 40, Code 
of Federal Regulations (or any successor regu-
lations).’’. 
(c) APPLICABILITY.—Sections 602(g) and 604 of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
sections (a) and (b), apply beginning on the date that is 
180 days after the date of enactment of this Act. 
(d) REGULATIONS.—Not later than 180 days after 
the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall promulgate final regulations to im-
plement such sections 602(g) and 604. 
Æ 
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