not suspend or revoke a cosmetic and ingredient state-
ment. 
‘‘(g) LIST.—The Secretary shall compile and main-
tain an up-to-date and publicly available electronic list of 
cosmetics and ingredients for which statements are sub-
mitted under this section. A statement submitted pursuant 
to this section shall not be subject to disclosure under sec-
tion 552 of title 5, United States Code. The Secretary may 
make publicly available information derived from such 
statements that discloses the names of ingredients used 
in cosmetics and the number of cosmetics in which a spe-
cific ingredient is used, but may not make publicly avail-
able any information that relates to any ingredient that 
is exempt from public disclosure under section 720.8 of 
title 21, Code of Federal Regulations (as in effect on the 
date of enactment of the Cosmetic Modernization Amend-
ments of 2017 and including any successor regulations), 
or that discloses at what establishment a cosmetic is man-
ufactured. At the written request of the director of a State 
agency responsible for regulating the safety of cosmetics 
stating good cause therefor, the Secretary may disclose to 
such official confidential business and trade secret infor-
mation contained in a statement and such official and 
other State employees who have access to such informa-
tion shall then be subject to the provisions of section 
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301(j) of this Act, section 552(b) of title 5, United States 
Code, and section 1905 of title 18, United States Code, 
with respect to such information. 
‘‘(h) EXEMPTIONS.—Submission of a statement 
under subsection (a) shall not be required— 
‘‘(1) for a cosmetic for which as of the date of 
enactment of this section a cosmetic ingredient 
statement has been submitted to the Secretary 
under part 710 of title 21, Code of Federal Regula-
tions (as in effect on the date of enactment of the 
Cosmetic Modernization Amendments of 2017); 
‘‘(2) for a cosmetic ingredient exempt from 
public disclosure under section 720.8 of title 21, 
Code of Federal Regulations (as in effect on the 
date of enactment of the Cosmetic Modernization 
Amendments of 2017 and including any successor 
regulations); or 
‘‘(3) by an entity to the extent such entity is 
exempted by section 605(e) from registration under 
section 605.’’. 
SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTING FOR COSMETICS. 
(a) IN GENERAL.—Chapter VI (21 U.S.C. 361 et 
seq.), as amended by sections 3, 4, and 5, is further 
amended by adding at the end the following: 
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‘‘SEC. 607. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTING FOR COSMETICS. 
‘‘(a) IN GENERAL.—The Secretary shall by regula-
tion require that a domestic or foreign manufacturer, 
packer, or distributor whose name appears on the label 
pursuant to section 602(b)(1) of a cosmetic marketed in 
the United States submit to the Secretary under sub-
section (b) a report containing— 
‘‘(1) information received concerning any seri-
ous and unexpected adverse event in the United 
States allegedly associated with the use of the cos-
metic for which it is reasonably likely that the ad-
verse event was caused by the cosmetic when used 
as recommended or suggested in the labeling; and 
‘‘(2) a copy of the label for the cosmetic. 
‘‘(b) SUBMISSION OF REPORTS.—A report on an ad-
verse event under subsection (a) shall be submitted to the 
Secretary not later than 15 business days after informa-
tion concerning the adverse event is received at the place 
of business labeled on the cosmetic pursuant to section 
602(b)(1). 
‘‘(c) REQUIRED CONTENTS.—A report under sub-
section (a) shall include all of the following information: 
‘‘(1) An identifiable patient. 
‘‘(2) An identifiable reporter. 
‘‘(3) A suspect cosmetic or component thereof. 
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‘‘(4) A serious adverse event. 
‘‘(d) ADDITIONAL CONTENTS; SUPPLEMENTAL RE-
PORTING.—The person submitting a report under sub-
section (a) may— 
‘‘(1) include pertinent information in addition 
to the information listed in subsection (c); and 
‘‘(2) after submitting the initial report, supple-
ment the report with additional information. 
‘‘(e) SPECIAL RULES.— 
‘‘(1) PROTECTED
INFORMATION.—A serious 
and unexpected adverse event report (including all 
information submitted in the initial report or added 
later) submitted under subsection (a)— 
‘‘(A) shall be considered to be a safety re-
port under section 756 that is subject to the 
provisions of that section; and 
‘‘(B) shall be considered to be a record 
about an individual under section 552a of title 
5, United States Code, and a medical or similar 
file the disclosure of which would constitute a 
violation of section 552 of such title 5, and 
shall not be publicly disclosed unless all person-
ally identifiable information is redacted. 
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‘‘(2) NO TREATMENT AS ADMISSION.—The sub-
mission of a serious and unexpected adverse event 
report in compliance with subsection (a)— 
‘‘(A) shall not be construed as an admis-
sion that the cosmetic involved caused or con-
tributed to the adverse event; and 
‘‘(B) may be accompanied by a statement 
that denies that the report constitutes an ad-
mission that the cosmetic involved caused or 
contributed to the adverse event. 
‘‘(3) INCLUSION OF STATEMENT IN PUBLIC DIS-
CLOSURE.—In releasing any report under subsection 
(a) or portion thereof for public disclosure, the Sec-
retary shall include any statement under paragraph 
(2)(B). 
‘‘(f) LABELING.—The label of a cosmetic shall bear 
the domestic telephone number, email address, or mailing 
address through which the person whose name and place 
of business appear on the label may receive a report of 
a serious adverse event. 
‘‘(g) EXEMPTION.—The Secretary may, by regula-
tion, establish an exemption to the requirements under 
subsections (b) and (d) if the Secretary determines that 
such exemption would have no adverse effect on public 
health. 
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‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) The term ‘serious’, with respect to an ad-
verse event, means— 
‘‘(A) resulting in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a persistent and significant dis-
ability or incapacity; 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(vi) permanent disfiguration; or 
‘‘(B) requiring, based on reasonable med-
ical judgment, a medical or surgical interven-
tion to prevent an outcome described under 
subparagraph (A). 
‘‘(2) The term ‘unexpected’, with respect to an 
adverse event, means not identified on the cosmetic 
label.’’. 
(b) 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 a cosmetic that is marketed in the United 
States, unless the label of such cosmetic includes a domes-
tic address or domestic phone number through which a 
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report of a serious and unexpected adverse event (as such 
term is used in section 607) associated with the use of 
such cosmetic may be submitted to the person described 
in section 607(f).’’. 
SEC. 7. GOOD MANUFACTURING PRACTICE. 
(a) PROHIBITION.—Section 601 (21 U.S.C. 361) is 
amended by adding at the end the following: 
‘‘(f) If it has been manufactured under conditions 
that do not satisfy the principles and standards for good 
manufacturing practice established under section 608 and 
as a result presents a significant risk of serious adverse 
health consequences or death to humans.’’. 
(b) PRINCIPLES AND STANDARDS.—Chapter VI (21 
U.S.C. 361 et seq.), as amended by sections 3, 4, 5, and 
6, is further amended by adding at the end the following: 
‘‘SEC. 608. GOOD MANUFACTURING PRACTICE. 
‘‘(a) IN GENERAL.—The Secretary may by regulation 
establish principles and standards for good manufacturing 
practice for the manufacture of cosmetics in accordance 
with paragraphs (a) and (d) of section 601. 
‘‘(b) NOTICE AND COMMENT.—A regulation under 
subsection (a) shall be promulgated only after providing 
notice and an opportunity for comment in accordance with 
chapter 5 of title 5, United States Code. 
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‘‘(c) GOOD MANUFACTURING PRACTICES OF OTHER 
PARTIES.—A manufacturer shall not be responsible under 
section 601(f) or this section for the good manufacturing 
practice of its suppliers. A distributor shall not be respon-
sible under section 601(f) or this section for the good man-
ufacturing practice of its manufacturers.’’. 
SEC. 8. SAFETY SUBSTANTIATION FOR COSMETIC INGREDI-
ENTS AND NONFUNCTIONAL CONSTITUENTS. 
Chapter VI (21 U.S.C. 361 et seq.), as amended by 
sections 3, 4, 5, 6, and 7, is further amended by adding 
at the end the following: 
‘‘SEC. 609. COSMETIC INGREDIENTS AND NONFUNCTIONAL 
CONSTITUENTS THAT ARE SAFE FOR USE IN 
COSMETICS. 
‘‘(a) IN GENERAL.—A manufacturer or distributor of 
a cosmetic may rely on this section to substantiate the 
safety of such cosmetic. 
‘‘(b) SAFE INGREDIENTS.—Unless and until prohib-
ited or limited by the Secretary by regulation, the fol-
lowing ingredients are deemed to be adequately substan-
tiated for safe use in cosmetics subject to the requirements 
of good manufacturing practice: 
‘‘(1) Color additives approved by the Secretary 
for use in cosmetics, within any limits established in 
such approval. 
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‘‘(2) Food additives approved by the Secretary 
for direct addition to food for human consumption, 
within any limits established in such approval. 
‘‘(3) Food ingredients that have been deter-
mined by the Secretary to be generally recognized as 
safe for direct addition to food for human consump-
tion, within any limits established in such deter-
mination. 
‘‘(4) Food ingredients for which monographs 
have been included in the Food Chemicals Codex for 
direct addition to food for human consumption, 
within any limits established in such monographs. 
‘‘(5) Pharmaceutical excipients and inactive in-
gredients approved or permitted by the Secretary, 
listed on a Food and Drug Administration website 
for use in drugs for human consumption or for 
which monographs have been included in the Hand-
book of Pharmaceutical Excipients, within any limits 
established in such lists or monographs. 
‘‘(6) Cosmetic ingredients that have been re-
viewed for safety by a qualified nongovernmental or 
governmental expert scientific body, including the 
Cosmetic Ingredient Review Expert Panel, and that 
are the subject of a monograph published in a peer- 
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reviewed scientific journal, within any limits estab-
lished in such monographs. 
‘‘(7) Fragrance ingredients that have been re-
viewed for safety by a qualified nongovernmental or 
governmental expert scientific body, including the 
Research Institute of Fragrance Materials Expert 
Panel, and that are the subject of a monograph pub-
lished in a peer-reviewed scientific journal, within 
any limits established in such monographs. 
‘‘(8) Cosmetic ingredients approved or per-
mitted for use in cosmetics by any of the countries 
listed in section 802(b)(1)(A) as having an adequate 
regulatory authority, within any limits established by 
such regulatory authority. 
‘‘(c) SAFE NONFUNCTIONAL CONSTITUENTS.— 
‘‘(1) DEFINITION.—A nonfunctional constituent 
in a cosmetic is any substance that— 
‘‘(A) has not been intentionally added as a 
separate substance; and 
‘‘(B) serves no technical or cosmetic func-
tion in the cosmetic. 
‘‘(2) ADEQUATE
SUBSTANTIATION.—The fol-
lowing nonfunctional constituents are deemed to be 
adequately substantiated for safe use in cosmetics, 
subject to the requirements of good manufacturing 
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practice and any limits or bans established by the 
Secretary by regulation: 
‘‘(A) The levels approved or permitted for 
nonfunctional constituents by the Secretary for 
color additives for cosmetic use and for food ad-
ditives and generally recognized as safe food in-
gredients for direct human consumption. 
‘‘(B) The levels approved or permitted for 
nonfunctional constituents by the Secretary for 
cosmetics and for food and food ingredients for 
direct human consumption in compliance policy 
guides, guidance, and website statements. 
‘‘(C) The levels approved or permitted for 
nonfunctional constituents by the Secretary or 
the United States Pharmacopeia for oral non-
prescription drugs. 
‘‘(D) The levels approved or permitted for 
nonfunctional constituents by the Environ-
mental Protection Agency for direct human 
consumption in drinking water. 
‘‘(E) The levels for nonfunctional constitu-
ents approved or permitted in cosmetics and 
human food and food ingredients by any of the 
countries listed in section 802(b)(1)(A) as hav-
ing an adequate regulatory authority. 
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‘‘(d) CENTER.—The Secretary shall establish a pro-
gram within the center of the Food and Drug Administra-
tion with primary responsibility for regulating cosmetics 
to evaluate and make determinations, by regulation, on 
the safe use of cosmetics and ingredients and nonfunc-
tional constituents thereof. 
‘‘(e) APPLICATION; PREEMPTION.—A safety deter-
mination accepted or made by the Secretary or established 
under this section shall apply in every State. No State may 
establish or enforce a safety determination for a cosmetic 
or an ingredient or nonfunctional constituent of a cos-
metic. 
‘‘(f) EFFECTIVE DATE OF REGULATIONS.—Any reg-
ulation or guidance by the Secretary pursuant to this sec-
tion concerning the safety of a cosmetic or an ingredient 
or nonfunctional constituent of a cosmetic shall apply be-
ginning no earlier than the date that is 2 years after the 
date on which such regulation or guidance is issued as 
final, unless the Secretary determines, after public notice 
and an opportunity for public comment, that an earlier 
date of applicability is required to prevent serious adverse 
health consequences or death to humans.’’. 
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SEC. 9. NATIONAL COSMETIC REGULATORY DATABANK. 
Chapter VI (21 U.S.C. 361 et seq.), as amended by 
sections 3, 4, 5, 6, 7, and 8, is further amended by adding 
at the end the following: 
‘‘SEC. 610. NATIONAL COSMETIC REGULATORY DATABANK. 
‘‘(a) IN GENERAL.—For the purpose of consolidating 
information pertaining to the regulation of cosmetic safe-
ty, the Secretary shall establish and maintain in the center 
of the Food and Drug Administration with primary re-
sponsibility for regulating cosmetics a database, to be 
known as the National Cosmetic Regulatory Databank, 
containing— 
‘‘(1) the information submitted to the Secretary 
under sections 605, 606, 607, and 609; and 
‘‘(2) such other information pertaining to the 
regulation of cosmetics as the Secretary deems ap-
propriate. 
‘‘(b) AVAILABILITY.—In the case of information in 
the National Cosmetic Regulatory Databank that is not 
subject to public disclosure under section 552 of title 5, 
United States Code, the Secretary may nonetheless dis-
close such information to the director of a State agency 
on written request by such director demonstrating good 
cause for the disclosure. A director receiving information 
pursuant to the preceding sentence shall agree to limit to 
the disclosure of such information by State officials and 
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employees to the same extent such disclosure is limited 
with respect to Federal officials and employees under sec-
tion 301(j) of this Act, section 552(b) of title 5, United 
States Code, and section 1905 of title 18, United States 
Code, with respect to such information. 
‘‘(c) PREEMPTION.—No State or political subdivision 
thereof may require submission of information that is 
available in the National Cosmetic Regulatory Databank, 
whether in the same or a different format.’’. 
SEC. 10. SPECIAL RULES. 
(a) CERTAIN RULES.—Chapter VI (21 U.S.C. 361 et 
seq.), as amended by sections 3, 4, 5, 6, 7, 8, and 9, is 
further amended by adding at the end the following: 
‘‘SEC. 611. SPECIAL RULES. 
‘‘(a) CONTRACTORS.—The person described in sec-
tion 607(f) with respect to a cosmetic (referred to in this 
section as the ‘responsible party’) may, by agreement, au-
thorize a manufacturer, distributor, or packer of the cos-
metic or a third-party contractor to submit any required 
report of a serious and unexpected adverse event (as such 
term is used in section 607) so long as the responsible 
party directs to the manufacturer, distributor, packer, or 
third-party contractor all such adverse events associated 
with such cosmetic that are reported to the responsible 
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party through the address or telephone number described 
in section 607(f). 
‘‘(b) EXEMPTIONS.—The Secretary, on the Sec-
retary’s own initiative or in response to a petition, may 
establish exemptions from the requirements of sections 
601(f), 605, 606, 607, and 608— 
‘‘(1) for the efficient and cost-effective imple-
mentation of such requirements; or 
‘‘(2) where the cost of compliance exceeds the 
safety benefit to the public.’’. 
(b) COSMETIC
DEFINITION.—Section 201(i) (21 
U.S.C. 321(i)) is amended by adding at the end the fol-
lowing: ‘‘An article described in subparagraph (1) that is 
intended only for topical external use to alter the appear-
ance by temporarily affecting the structure or any function 
of the human skin, and that is not the subject of an ap-
proved new drug application under section 505, shall, for 
purposes of this Act, be treated only as a cosmetic and 
not a drug.’’. 
(c) COLOR ADDITIVES.—Section 721(f) (21 U.S.C. 
379e(f)) is amended— 
(1) by striking ‘‘(f) The Secretary shall’’ and 
inserting ‘‘(f)(1) The Secretary shall’’; and 
(2) by adding at the end the following: 
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‘‘(2) A color additive, including mixtures thereof, in-
tended for use in externally applied cosmetics and not in 
the area of the eye is exempt from the requirements of 
this section if it is generally recognized, among experts 
qualified by scientific training and experience to evaluate 
its safety, as having been shown through scientific proce-
dures to be safe under the conditions of its intended use. 
Notwithstanding the preceding sentence, the Secretary 
may by regulation require certification of batches under 
subsection (c) for any such color additive.’’. 
SEC. 11. PROHIBITED ACTS. 
(a) IN GENERAL.—Section 301 (21 U.S.C. 331) is 
amended by adding at the end the following: 
‘‘(eee) The failure to register a cosmetic establish-
ment as required under section 605 or to maintain the 
registration current and accurate. 
‘‘(fff) The failure to submit a cosmetic and ingredient 
statement as required under section 606 or to maintain 
the statement current and accurate. 
‘‘(ggg) The failure to submit a serious and unex-
pected adverse event report, or to include on the label of 
a cosmetic the domestic telephone number, email address, 
or mailing address through which a report of a serious 
adverse event may be received, as required under section 
607.’’. 
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(b) INFORMATION SECURITY.—Section 301(j) (21 
U.S.C. 331(j)) is amended by inserting ‘‘605, 606, 609,’’ 
after ‘‘573,’’. 
SEC. 12. NATIONAL UNIFORMITY FOR COSMETICS. 
Section 752 (21 U.S.C. 379s) is amended— 
(1) by amending the section heading to read as 
follows: ‘‘NATIONAL
UNIFORMITY
FOR
COS-
METICS’’; 
(2) by amending subsection (a) to read as fol-
lows: 
‘‘(a) IN GENERAL.—Except as provided in subsection 
(b) or (d) of this section, no State or political subdivision 
of a State may establish or continue in effect any require-
ment for labeling or packaging of a cosmetic.’’; 
(3) by amending subsection (c) to read as fol-
lows: 
‘‘(c) COSMETIC SAFETY.—No State or political sub-
division of a State may establish or continue in effect any 
law, regulation, order, or other requirement— 
‘‘(1) relating directly or indirectly to, or relying 
upon, a human health or safety evaluation of a non-
functional cosmetic constituent, cosmetic ingredient, 
or cosmetic (as defined in section 201(i)(1)), or re-
lating in any way to the safety standard and the 
human health-based requirements, evaluations, and 
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