I 
116TH CONGRESS 
1ST SESSION H. R. 5279 
To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic 
safety, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 3, 2019 
Mr. PALLONE 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 
improve cosmetic safety, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Cosmetic Safety Enhancement Act of 2019’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
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 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
Sec. 102. Review of ingredients and nonfunctional constituents; safety of fin-
ished products. 
Sec. 103. Good manufacturing practices for cosmetics. 
Sec. 104. Adverse event reports. 
Sec. 105. Records inspection; mandatory recall authority. 
Sec. 106. Labeling and internet sales. 
Sec. 107. Consumer information. 
Sec. 108. Small businesses. 
Sec. 109. Animal testing restrictions. 
Sec. 110. Counterfeit cosmetics. 
Sec. 111. Foreign supplier verification. 
Sec. 112. Applicability with respect to certain cosmetics. 
Sec. 113. Saving clause. 
Sec. 114. Enforcement. 
TITLE II—FEES RELATED TO COSMETIC PRODUCTS 
Sec. 201. Findings. 
Sec. 202. Authority to assess and use cosmetic product fees. 
Sec. 203. Direct hiring authority to support activities related to cosmetics. 
Sec. 204. Sunset dates. 
TITLE I—COSMETIC SAFETY 
SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 
COSMETIC INGREDIENT STATEMENTS. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 604. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ANIMAL
TEST.—The term ‘animal test’ 
means the internal or external application or expo-
sure of a cosmetic product, cosmetic formulation, or 
cosmetic ingredient to the skin, eyes, or other body 
part of a live non-human vertebrate for the purpose 
of evaluating the safety of a cosmetic product, cos-
metic formulation, or cosmetic ingredient. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(B) Such term shall include tattoo ink whether 
or not labeled as a finished cosmetic. 
‘‘(6) FACILITY.—The term ‘facility’ includes 
any factory, warehouse, or establishment (including 
a factory, warehouse, or establishment of an im-
porter or of any other entity whose name and ad-
dress appear on the label of a cosmetic product) that 
manufactures, processes, packs, or holds cosmetic 
products or cosmetic formulations. Such term does 
not include— 
‘‘(A) beauty shops and salons that do not 
otherwise manufacture, process, or package cos-
metic products or cosmetic formulations at that 
location, including beauty stores or counters 
that offer customized or personalized cosmetic 
products or cosmetic formulations tailored to 
individual consumers for sale solely in-person; 
‘‘(B) cosmetic product retailers, including 
individual sales representatives, direct sellers 
(as defined in section 3508 of the Internal Rev-
enue Code of 1986), retail distribution facilities, 
retail franchises, retail warehouses, and phar-
macies, that do not otherwise manufacture, 
process, or package cosmetic products or cos-
metic formulations at that location; 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(C) entities that manufacture or com-
pound cosmetic products solely for use in re-
search, teaching, or pilot plant production and 
not for sale; 
‘‘(D) hospitals, physicians’ offices, and 
health care clinics; 
‘‘(E) hotels, airlines, and other entities 
that provide complimentary cosmetic products 
to guests; 
‘‘(F) public health agencies and other non-
profit entities that provide cosmetic products or 
cosmetic formulations directly to the consumer; 
or 
‘‘(G) trade shows and other venues where 
cosmetic product samples are provided free of 
charge. 
‘‘(7) FOREIGN FACILITY.—The term ‘foreign fa-
cility’ means a facility that manufactures, processes, 
packs, or holds, cosmetic products or cosmetic for-
mulations that are exported to the United States 
without further processing or packaging inside the 
United States. A cosmetic product or cosmetic for-
mulation is not considered to have undergone fur-
ther processing or packaging for purposes of this 
definition solely on the basis that labeling was added 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
or that any similar activity of a de minimis nature 
was carried out with respect to the cosmetic product 
or cosmetic formulation. 
‘‘(8) 
NONFUNCTIONAL
CONSTITUENT.—The 
term ‘nonfunctional constituent’ means any sub-
stance that is an incidental component of an ingre-
dient, a breakdown product of an ingredient, or a 
byproduct of the manufacturing process that has not 
been intentionally added as a separate substance and 
serves no technical function in the cosmetic product. 
‘‘(9) PROFESSIONAL.—With respect to a cos-
metic product, the term ‘professional’ means— 
‘‘(A) a dermatologist or other health care 
professional that administers or provides cos-
metic products to patients; or 
‘‘(B) a cosmetologist, nail technician, bar-
ber, or esthetician who administers or provides 
cosmetics within the scope of their business 
practices. 
‘‘(10) PROFESSIONAL USE.—With respect to a 
cosmetic product, the term ‘professional use’ means 
a preparation of a cosmetic formulation intended 
only for use by professionals in settings such as cos-
metology, nail care, barbering, esthetics, health care, 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
and other professions as determined by the Sec-
retary through regulation. 
‘‘(11) RESPONSIBLE
PERSON.—The term ‘re-
sponsible person’ means the brand owner, operator, 
or agent in charge who is the domestic or foreign 
manufacturer, processor, or entity whose name ap-
pears on the label of a cosmetic product or a cos-
metic formulation distributed in the United States. 
‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES. 
‘‘(a) REGISTRATION
FOR
MANUFACTURING
AND 
PROCESSING FACILITIES.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent in charge of (or an affiliate thereof) a facility 
engaged in manufacturing, or processing, of a cos-
metic product or a cosmetic formulation distributed 
in the United States shall register with the Sec-
retary. 
‘‘(2) ELECTRONIC
REGISTRATION
SYSTEM.— 
The Secretary shall— 
‘‘(A) maintain an electronic registration 
system for purposes of this section; and 
‘‘(B) not later than one year after the date 
of enactment of the Cosmetic Safety Enhance-
ment Act of 2019, announce that such system 
is operational. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(3) INITIAL REGISTRATION OF EXISTING FA-
CILITIES.—Not later than the date that is 6 months 
after the date of the announcement required by 
paragraph (2)(B), each facility engaged in an activ-
ity described in paragraph (1) shall be registered 
under such paragraph. 
‘‘(4) INITIAL REGISTRATION OF NEW FACILI-
TIES.—In the case of a facility that first engages in 
an activity described in paragraph (1) on or after 
the date that is 18 months after the date of enact-
ment of the Cosmetic Safety Enhancement Act of 
2019, such a facility shall register with the Sec-
retary immediately upon engaging in such activity. 
‘‘(5) SINGLE
REGISTRATION.—The Secretary 
shall require only a single registration per registra-
tion period for a facility required to be registered 
under paragraph (1), regardless of whether such fa-
cility is manufacturing or processing— 
‘‘(A) its own cosmetic products or cosmetic 
formulations; or 
‘‘(B) cosmetic products or cosmetic formu-
lations on behalf of more than one owner, oper-
ator, or agent in charge (or affiliate thereof). 
‘‘(b) REGISTRATION FOR PACKING OR HOLDING FA-
CILITIES.—Each facility engaged in packing or holding a 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
cosmetic product or cosmetic formulation distributed in 
the United States shall register with the Food and Drug 
Administration. Each such facility shall, not later than 6 
months after the Secretary announces the establishment 
of an electronic registration system for purposes of this 
section, submit a registration utilizing such system. 
‘‘(c) ANNUAL REGISTRATION RENEWAL.—A facility 
that continues to engage in any activity that would require 
registration under subsection (a) or (b) shall submit to 
the Secretary an annual registration during the first quar-
ter of the fiscal year for which such renewed registration 
shall be effective. 
‘‘(d) FEES.—If the average gross annual sales of cos-
metic products in the United States of all of the facilities 
of the responsible person registered under subsection 
(a)(1) for the previous 3-fiscal-year period is greater than 
$1,000,000, a registration shall not be complete under this 
subsection until the responsible person has paid any reg-
istration fee required under section 744M. 
‘‘(e) CHANGES TO INFORMATION.—A facility that 
submitted a registration under this section shall notify the 
Secretary of any change to the information required under 
subsection (a) or (b) not later than 30 days after the date 
of such change, unless otherwise specified by the Sec-
retary. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(f) FORMAT; CONTENTS.— 
‘‘(1) ELECTRONIC FORMAT.—Each registration 
shall be submitted using an electronic format, as 
specified in a registration form provided by the Sec-
retary. 
‘‘(2) CONTENTS.—The registration shall con-
tain the following information: 
‘‘(A) Each facility’s name (including any 
parent company of the facility) and full ad-
dress, identifying the precise physical location 
of the facility. 
‘‘(B) The identity of the facility, including 
the unique facility identifier, if any, previously 
assigned by the Secretary to the facility under 
subsection (i). 
‘‘(C) All business trading names used by 
the facility. 
‘‘(D) The product category (as identified 
under section 720.4(c) of title 21, Code of Fed-
eral Regulations (or any successor regulation)), 
or other cosmetic categories as determined ap-
propriate by the Secretary (including by guid-
ance) of each cosmetic product or cosmetic for-
mulation manufactured, processed, packed, or 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
held at the facility or on whose label the facili-
ty’s name and address appear. 
‘‘(E) The type or types of activities con-
ducted at the facility (such as manufacturing, 
processing, packing, or holding). 
‘‘(F) The name, title, street address, tele-
phone number, and electronic contact informa-
tion of the emergency contact for the facility. 
‘‘(G) In the case of a foreign facility, the 
name, street address, telephone number, emer-
gency contact information for the facility, the 
name of the United States agent for the facil-
ity, and the phone number and electronic con-
tact information of the United States agent. 
‘‘(H) The name, title, street address, tele-
phone number, and electronic contact informa-
tion of the individual submitting the registra-
tion. 
‘‘(I) An assurance that the Secretary will 
be permitted to inspect such facility at the 
times and in the manner permitted by this Act. 
‘‘(J) Additional information pertaining to 
the facility or to the cosmetic products or cos-
metic formulations manufactured, processed, 
packed, or held at the facility, or on whose label 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
the facility’s name and address appear, includ-
ing all brand names known to consumers, as 
the Secretary may require by regulation. 
‘‘(3) ABBREVIATED REGISTRATION.—The Sec-
retary shall provide for an abbreviated registration 
renewal process for any facility that has not had any 
changes to the information submitted by the facility 
for the preceding registration. 
‘‘(g) INCOMPLETE
OR
INACCURATE
REGISTRA-
TION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary may cancel a registration of a facility 
under this section if— 
‘‘(A) the Secretary has reasonable grounds 
to believe that the registration was not properly 
completed or updated in accordance with this 
section; 
‘‘(B) a required registration fee has not 
been paid within 30 days; or 
‘‘(C) the registration otherwise contains 
false, incomplete, or inaccurate information. 
‘‘(2) NOTIFICATION.—The Secretary shall, at 
least 10 days before canceling a registration pursu-
ant to paragraph (1), provide notice to the facility 
of the intent of the Secretary to cancel such reg-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
istration that contains the Secretary’s basis for the 
determination to so cancel the registration. 
‘‘(3) TIMELY UPDATE OR CORRECTION.—If, not 
later than 7 days after receipt of a notice of intent 
to cancel under paragraph (2), the facility corrects 
the registration in accordance with the basis for the 
cancellation, and the required registration fee, if 
any, is paid, the Secretary shall not cancel such reg-
istration. 
‘‘(h) UNIQUE IDENTIFIER.—At the time of the initial 
registration of any cosmetic facility under this section, the 
Secretary shall assign a unique identifier to the facility 
and provide such identifier to such facility in writing. 
‘‘(i) REGISTRY OF FACILITIES.— 
‘‘(1) IN GENERAL.—The Secretary shall com-
pile, maintain, and update a registry of facilities 
that are registered under this section, and shall re-
move from such registry the name of any facility 
whose registration under this section is cancelled. 
The registry shall be publicly available. 
‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In-
formation derived from the registry or registration 
documents that discloses the residential address of 
an owner, operator, or agent in charge of (or an af-
filiate thereof) a facility engaged in manufacturing, 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
processing, packing, or holding a cosmetic product 
or formulation, or a facility owned by such person, 
or that discloses specific facilities where specific 
brands of cosmetic products are manufactured or 
processed shall not be subject to disclosure under 
section 552 of title 5, United States Code. 
‘‘SEC. 606. COSMETIC INGREDIENT STATEMENTS. 
‘‘(a) IN GENERAL.—For each cosmetic product, the 
responsible person shall submit to the Secretary a cos-
metic ingredient statement, at such time and in such man-
ner as the Secretary may prescribe. The cosmetic ingre-
dient statement shall not become effective until the re-
sponsible person pays any applicable fee required under 
section 744M. 
‘‘(b) SUBMISSION
OF
A
COSMETIC
INGREDIENT 
STATEMENT.— 
‘‘(1) EXISTING COSMETIC PRODUCTS.—In the 
case of a cosmetic product or cosmetic formulation 
that is marketed on the date of enactment of the 
Cosmetic Safety Enhancement Act of 2019, the re-
sponsible person shall— 
‘‘(A) not later than the date that is 6 
months after the date of the announcement of 
an electronic registration system required by 
section 605, submit to the Secretary a cosmetic 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
ingredient statement in accordance with this 
section; and 
‘‘(B) beginning one year after the ingre-
dient statement is submitted under subpara-
graph (A) and each year thereafter, submit to 
the Secretary a renewal of such statement, con-
sistent with the requirements in subsection (e), 
during the first quarter of the fiscal year for 
which such renewed statement is applicable. 
‘‘(2) COSMETIC INGREDIENT STATEMENT FOR 
NEW COSMETIC PRODUCTS.— 
‘‘(A) IN
GENERAL.—Except as provided 
under subparagraph (B), in the case of a cos-
metic product or cosmetic formulation that is 
first marketed after the date of enactment of 
the Cosmetic Safety Enhancement Act of 2019 
or a cosmetic product or cosmetic formulation 
that is reformulated after such date of enact-
ment, the responsible person shall— 
‘‘(i) submit to the Secretary a cos-
metic ingredient statement prior to first 
marketing the new cosmetic product, new 
cosmetic formulation, or the reformulated 
cosmetic product or reformulated cosmetic 
formulation; and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(ii) beginning one year after the in-
gredient statement is submitted under 
clause (i), submit to the Secretary annually 
thereafter a renewal of such statement 
during the first quarter of the fiscal year 
for which the cosmetic ingredient state-
ment is applicable, consistent with the re-
quirements in subsection (e). 
‘‘(B) SMALL BUSINESSES.—In the case of 
a responsible person that is a small business, 
the Secretary shall allow such responsible per-
son to have an additional time period, of a du-
ration to be determined by the Secretary, in 
which to submit the first cosmetic ingredient 
statement under subparagraph (A). Such re-
sponsible person shall, consistent with the re-
quirements in subsection (e), submit a cosmetic 
ingredient statement annually thereafter during 
the first quarter of the applicable fiscal year. 
‘‘(C) APPLICABILITY.—In applying sub-
paragraph (A), a cosmetic product or cosmetic 
formulation shall not be considered to be first 
marketed or reformulated after the date of en-
actment of the Cosmetic Safety Enhancement 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
Act of 2019 if the only change in such product 
or formulation is— 
‘‘(i) a change in the amount of an ex-
isting ingredient that is previously reported 
under subsection (c)(2)(E); or 
‘‘(ii) the addition or subtraction of a 
fragrance, flavor, or color, or such other 
interchangeable ingredients specified by 
the Secretary in regulations or guidance, 
previously reported as a potential ingre-
dient under subsection (c)(2). 
‘‘(3) ABBREVIATED RENEWAL.—The Secretary 
shall provide for an abbreviated process for the re-
newal of any cosmetic ingredient statement under 
this subsection with respect to which there has been 
no change since the responsible person submitted the 
previous statement. 
‘‘(c) FORMAT; CONTENTS.— 
‘‘(1) FORM.—For each cosmetic ingredient 
statement submitted with respect to a cosmetic prod-
uct or cosmetic formulation under this section, such 
statement shall be submitted using an electronic for-
mat, in a form specified by the Secretary. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(2) CONTENTS.—Each such cosmetic ingre-
dient statement shall include the following informa-
tion: 
‘‘(A) The unique identifier, assigned under 
section 605(h), as applicable, of— 
‘‘(i) the facility or facilities where the 
cosmetic product or cosmetic formulation 
is manufactured, processed, packed, or 
held or, if the same cosmetic product or 
cosmetic formulation is manufactured, 
processed, packed, or held in more than 
one facility, the unique facility identifier of 
each facility where it is manufactured, 
processed, packed, or held; and 
‘‘(ii) the facility whose name and ad-
dress appear on the label, unless the state-
ment is filed by a contract manufacturer, 
described in section 604(6)(B). 
‘‘(B) The brand name and the full name 
for the cosmetic product or cosmetic formula-
tion as it appears on the label. 
‘‘(C) The listing number, if any, previously 
assigned by the Secretary under subsection (f) 
to the cosmetic product or cosmetic formula-
tion. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(D) The applicable cosmetic category for 
the cosmetic product or cosmetic formulation. 
‘‘(E) A list of ingredients in the cosmetic 
product or cosmetic formulation that— 
‘‘(i) with respect to each such ingre-
dient, the name adopted in regulations pro-
mulgated by the Secretary, if any, or by 
the common or usual name of the ingre-
dient; 
‘‘(ii) is consistent with the regulations 
promulgated by the Food and Drug Ad-
ministration related to cosmetic labeling 
requirements; and 
‘‘(iii) contains a list of fragrances, fla-
vors, and colors that may be included in 
the product, interchangeably, which shall 
include— 
‘‘(I) in the case of fragrances, 
each fragrance allergen contained in 
the cosmetic product as described in 
section 615, and for fragrances that 
are purchased from a fragrance sup-
plier, the fragrances shall be identified 
by the name or code provided by the 
supplier, and include the name and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
contact information for the fragrance 
supplier; and 
‘‘(II) in the case of flavors that 
are purchased from a flavor supplier, 
the flavors shall be identified by the 
name or code provided by the sup-
plier, and include the name and con-
tact information for the flavor sup-
plier; 
‘‘(iv) other appropriate interchange-
able ingredients as the Secretary may 
specify in regulations or guidance that may 
be included in the product; and 
‘‘(v) in the case of an ingredient 
(other than a fragrance, flavor, or color) 
that has been designated for review under 
section 608, includes potential ranges and 
amounts of such ingredient. 
‘‘(F) The title and full contact information 
of each individual submitting the statement. 
‘‘(G) If applicable, information on labeling 
required under section 614. 
‘‘(H) Such additional information per-
taining to the cosmetic product as the Secretary 
may require by regulation. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(3) CONFIDENTIALITY.—Fragrance ingredi-
ents included in a cosmetic ingredient statement 
under paragraph (2)(E), other than fragrance aller-
gens, shall be treated as confidential commercial or 
trade secret information. 
‘‘(4) CONTRACT
MANUFACTURING
ORGANIZA-
TION
FACILITIES.—If a facility manufactures or 
processes cosmetic products or cosmetic formulations 
on behalf of an owner, operator, or agent in charge 
whose name appears on the label of such products 
or formulations, the Secretary shall require only a 
single cosmetic ingredient statement for such cos-
metic product. Such single cosmetic ingredient state-
ment shall be submitted to the Secretary by the re-
sponsible person. 
‘‘(5) COSMETIC INGREDIENT STATEMENT FOR 
CERTAIN SMALL BUSINESSES.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
other provision of this subsection, in the case of 
a responsible person that has had an average of 
less than $1,000,000 in annual domestic cos-
metic sales over the previous 3 years, the Sec-
retary may allow such responsible person— 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(i) to submit a simplified cosmetic 
ingredient statement under this section; 
and 
‘‘(ii) an additional time period, of a 
duration to be determined by the Sec-
retary, in which to submit such simplified 
cosmetic ingredient statement. 
‘‘(B) CONTENTS.—A responsible person 
described in subparagraph (A) shall include in 
each cosmetic ingredient statement submitted 
under this section, at a minimum— 
‘‘(i) a list of ingredients in the cos-
metic product or cosmetic formulation, in-
cluding any fragrance allergens as de-
scribed in section 615; 
‘‘(ii) the applicable cosmetic category 
for the cosmetic product or cosmetic for-
mulation; and 
‘‘(iii) in the case of a cosmetic product 
or cosmetic formulation that includes a 
fragrance or flavor purchased from a fra-
grance or flavor supplier, the contact infor-
mation for the fragrance or flavor supplier, 
including the supplier’s name, street ad-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
dress, telephone number, and electronic 
contact information. 
‘‘(d) INCOMPLETE OR INACCURATE COSMETIC IN-
GREDIENT STATEMENT.— 
‘‘(1) IN GENERAL.—Not earlier than 30 days 
after providing notice under paragraph (2) and sub-
ject to paragraph (3), the Secretary may nullify a 
cosmetic ingredient statement submitted under this 
section if the Secretary has reasonable grounds to 
believe that, except for minor or immaterial errors, 
the cosmetic ingredient statement was not completed 
or updated in accordance with this section or other-
wise contains false, incomplete, or inaccurate infor-
mation. 
‘‘(2) NOTICE OF NULLIFICATION.—If the Sec-
retary nullifies a cosmetic ingredient statement 
under paragraph (1), the Secretary shall provide to 
the responsible person submitting such cosmetic in-
gredient statement under this section notice of any 
such nullification, including the basis for such nul-
lification. 
‘‘(3) TIMELY UPDATE OR CORRECTION.—In the 
case of a cosmetic ingredient statement with respect 
to which the Secretary has provided notice under 
paragraph (2), the Secretary shall not nullify such 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
cosmetic ingredient statement if the cosmetic ingre-
dient statement is appropriately updated or cor-
rected not later than 10 days after the date on 
which such notice is provided. 
‘‘(4) EFFECT OF NULLIFICATION.—No person 
shall import, export, or otherwise distribute any cos-
metic product or cosmetic formulation that is the 
subject of a cosmetic ingredient statement that is 
nullified under this subsection. 
‘‘(e) ADDITIONAL REQUIREMENTS.— 
‘‘(1) SAFETY REQUIREMENTS.—In submitting a 
cosmetic ingredient statement for each cosmetic 
product or cosmetic formulation under this section, 
a responsible person shall include an attestation that 
the safety of the product or formulation, including 
the individual ingredients of such product or formu-
lation, has been substantiated in accordance with 
section 609. 
‘‘(2) CHANGES
TO
INFORMATION.—Not later 
than 90 days after any change to the information re-
quired to be in a cosmetic ingredient statement 
under this section, the responsible person shall no-
tify the Secretary of such change, including the dis-
continuation of the manufacture of a cosmetic prod-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
uct. Such notification is not required for a change 
described in subsection (b)(2)(C). 
‘‘(f) COSMETIC PRODUCTS LIST.— 
‘‘(1) LISTING NUMBER.—At the time of the ini-
tial submission of any cosmetic ingredient statement 
under this section, the Secretary shall— 
‘‘(A) assign a unique cosmetic product list-
ing number to the cosmetic ingredient state-
ment; and 
‘‘(B) provide such number to the respon-
sible person who submitted such statement in 
writing. 
‘‘(2) COSMETIC
PRODUCTS
LIST.—Using cos-
metic ingredient statements submitted under this 
section, the Secretary shall— 
‘‘(A) compile and maintain a list of cos-
metic products or cosmetic formulations distrib-
uted in the United States, including the ingre-
dients of each such product or formulation; and 
‘‘(B) upon request of any State, shall make 
such list available to such State. 
‘‘(3) CONFIDENTIALITY.—Information disclosed 
to a State that is exempt from disclosure under sec-
tion 552(b)(4) of title 5, United States Code, shall 
be treated as a trade secret and confidential infor-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
mation by the State. Such State and its employees 
in possession of such information shall be subject to 
the same laws governing information disclosure as 
employees of the Food and Drug Administration. 
‘‘(g) EXEMPTION.—A responsible person shall be ex-
empt from the requirements of this section if such person 
has had an average of less than $500,000 in annual do-
mestic cosmetic product sales over the previous three 
years. Such exemption shall not apply to cosmetic prod-
ucts that are intended to be injected under the skin or 
into the eye, including tattoo ink, or ingredients selected 
by the Food and Drug Administration for review under 
section 608 if such ingredient is included in a cosmetic 
product or cosmetic formulation distributed by such per-
son described. 
‘‘SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC 
INGREDIENT STATEMENT. 
‘‘(a) SUSPENSION OF REGISTRATION OF A FACIL-
ITY.—If the Secretary determines that a cosmetic product 
or cosmetic formulation manufactured, processed, packed, 
or held by a facility registered under section 605 has a 
reasonable probability of causing serious adverse health 
consequences or death to humans, the Secretary may sus-
pend the registration of such facility. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATE-
MENT.—If the Secretary determines that a cosmetic prod-
uct or cosmetic formulation manufactured in a registered 
facility has a reasonable probability of causing serious ad-
verse health consequences or death to humans, the Sec-
retary may suspend the cosmetic ingredient statement of 
that product or formulation. 
‘‘(c) NOTICE OF SUSPENSION.—Before suspending 
the registration of a facility or a cosmetic ingredient state-
ment under this section, the Secretary shall provide— 
‘‘(1) notice to the facility or responsible person, 
as appropriate, of the intent to suspend such reg-
istration or the cosmetic ingredient statement, which 
shall specify the basis of the determination by the 
Secretary for that suspension; and 
‘‘(2) an opportunity, within 2 business days of 
the notice provided under paragraph (1), for the fa-
cility or responsible person that is the subject of 
such notice, as appropriate, to address the reasons 
for possible suspension of the registration of the fa-
cility or cosmetic ingredient statement. 
‘‘(d) REINSTATEMENT.—Upon a determination by 
the Secretary that adequate grounds do not exist to con-
tinue the suspension actions under subsection (a) or (b), 
the Secretary shall promptly vacate the suspension and re-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
instate the registration of the facility or the cosmetic in-
gredient statement. 
‘‘(e) EFFECT OF SUSPENSION.—If the registration of 
a facility is suspended under this section, no person shall 
import or export cosmetics or otherwise distribute cos-
metic products or cosmetic formulations from such facil-
ity. 
‘‘(f) NO DELEGATION.—The authority conferred by 
this section to issue an order to suspend a registration 
or vacate an order of suspension shall not be delegated 
to any officer or employee other than the Commissioner.’’. 
SEC. 102. REVIEW OF INGREDIENTS AND NONFUNCTIONAL 
CONSTITUENTS; SAFETY OF FINISHED PROD-
UCTS. 
(a) AMENDMENTS.—Chapter VI of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 
amended by section 101, is further amended by adding 
at the end the following: 
‘‘SEC. 608. REVIEW OF INGREDIENTS AND NONFUNCTIONAL 
CONSTITUENTS. 
‘‘(a) INGREDIENTS AND NONFUNCTIONAL CONSTITU-
ENTS SUBJECT TO REVIEW.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of the enactment of the Cosmetic 
Safety Enhancement Act of 2019, the Secretary 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
shall review the safety of cosmetic ingredients or 
nonfunctional constituents (or categories thereof). 
Upon the completion of such review, the Secretary 
shall issue an order under subsection (d) with re-
spect to the use of each such ingredient (or a cat-
egory thereof) and presence of each such nonfunc-
tional constituent in cosmetic products or cosmetic 
formulations (or a category thereof). 
‘‘(2) INGREDIENTS AND NONFUNCTIONAL CON-
STITUENTS TO BE REVIEWED.—The Secretary shall 
select and complete a review, on an ongoing basis, 
of cosmetic ingredients or nonfunctional constituents 
that were not reviewed in the prior 3 years. Such in-
gredients or nonfunctional constituents, including 
any classes of ingredients or nonfunctional constitu-
ents, should be selected after consultation with 
stakeholders, including industry and consumer 
groups. 
‘‘(3) PROCESS
FOR
REVIEW.—The Secretary 
shall— 
‘‘(A) publish in the Federal Register a list 
of the ingredients, nonfunctional constituents 
(or categories thereof) identified for review 
under paragraph (2); and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(B) open a public docket to solicit public 
input and data relevant to the safety of the in-
gredients, nonfunctional constituents (or classes 
or categories thereof) so listed for a period of 
not less than 60 days. 
‘‘(4) PUBLIC
COMMENT.—Comments may be 
submitted to the Secretary at any time with respect 
to the safety of cosmetic ingredients or nonfunc-
tional constituents (or categories thereof), regardless 
of whether such ingredients or constituents (or cat-
egories thereof) have been selected for review under 
this subsection. 
‘‘(b) REVIEWED INGREDIENTS AND NONFUNCTIONAL 
CONSTITUENTS.—The Secretary shall maintain a list, 
posted on the internet website of the Food and Drug Ad-
ministration, of each cosmetic ingredient, nonfunctional 
constituent, and category of ingredients or nonfunctional 
constituents for which final orders have been issued under 
subsection (d)(3), and with respect to each such ingredient 
or nonfunctional constituent— 
‘‘(1) the finding made for each such ingredient, 
nonfunctional constituent, or category under sub-
section (d)(4), as modified by any order under sub-
section (e); and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(2) if applicable, compliance dates that are the 
subject of a final order under subsection (d)(3). 
‘‘(c) INITIATIVE OF THE FDA.—The Secretary may, 
at any time, propose the issuance of an order on the safety 
of a cosmetic ingredient or nonfunctional constituent (or 
category thereof) that was not previously listed pursuant 
to subsection (a). 
‘‘(d) DETERMINATION ON SAFETY.— 
‘‘(1) PROPOSED ADMINISTRATIVE ORDER.—Fol-
lowing consideration of data and comments to the 
public docket opened under subsection (a)(3) and 
any other information before the Secretary with re-
spect to the safety of a cosmetic ingredient or non-
functional constituent (or category thereof), the Sec-
retary shall— 
‘‘(A) determine whether there is adequate 
evidence to make an initial finding for purposes 
of making a determination described in para-
graph (4); 
‘‘(B) if the Secretary determines that there 
is adequate evidence to make such a finding, 
issue a proposed administrative order con-
taining the Secretary’s initial determination on 
the safety of such ingredient or nonfunctional 
constituent (or category thereof) as described in 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
paragraph (4) and shall post such order on the 
internet website of the Food and Drug Admin-
istration, notwithstanding subchapter II of 
chapter 5 of title 5, United States Code; and 
‘‘(C) in the case of a proposed administra-
tive order in which the Secretary makes a de-
termination described in subparagraph (B) or 
(C) of paragraph (4), include in such order a 
compliance date. 
‘‘(2) PUBLIC COMMENT.—The Secretary shall 
open a public docket for the submission of public 
comments (including comments on whether any pro-
posed compliance date included in such order is fea-
sible)— 
‘‘(A) in the case of a proposed administra-
tive order under paragraph (1), for a period of 
not less than 60 days, beginning on the date of 
the issuance of the order; or 
‘‘(B) in the case of a final administrative 
order under paragraph (3), for a period of not 
less than 60 days, beginning on the date that 
is at least 60 days before the effective date of 
the order. 
‘‘(3) FINAL
ADMINISTRATIVE
ORDER.—Fol-
lowing the public comment period under paragraph 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(2) and consideration of comments to the public 
docket under such paragraph and any other infor-
mation before the Secretary, the Secretary shall— 
‘‘(A) determine whether there is adequate 
evidence to make an initial finding for purposes 
of making a determination described in para-
graph (4); 
‘‘(B) if the Secretary determines that there 
is adequate evidence to make such a final find-
ing, the Secretary shall issue a final administra-
tive order and shall post such order on the 
internet website of the Food and Drug Admin-
istration, notwithstanding subchapter II of 
chapter 5 of title 5, United States Code; and 
‘‘(C) in the case of a final administrative 
order in which the Secretary makes the deter-
mination described in subparagraph (B) or (C) 
of paragraph (4), include in such order a com-
pliance date. 
‘‘(4) DETERMINATIONS.—In a proposed admin-
istrative order issued under paragraph (1) or a final 
administrative order issued under paragraph (3), as 
applicable, the Secretary shall make a determination 
that the ingredient or nonfunctional constituent is— 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(A) safe in cosmetic products without the 
need for specified conditions of use or toler-
ances; 
‘‘(B) safe in cosmetic products under spec-
ified conditions of use or tolerances; or 
‘‘(C) not safe in cosmetic products. 
‘‘(5) CONDITIONS OF USE AND TOLERANCES.— 
An order under paragraph (4)(B) shall include such 
conditions on the use of an ingredient or such toler-
ances on the presence of a nonfunctional constituent 
(or category thereof) as are necessary for the safety 
of cosmetic products containing such ingredient or 
nonfunctional constituent (or category thereof), in-
cluding— 
‘‘(A) limits on the amount or concentration 
of the ingredient or nonfunctional constituent 
(or category thereof) that may be present in a 
cosmetic product, including limits in products 
intended for children, pregnant women, and 
other vulnerable populations, and limits on use 
near the eye or mucosal membranes; 
‘‘(B) warnings that are necessary or appro-
priate under section 614, including warnings re-
lated to use by children, pregnant women, popu-
lations with high exposure to the ingredient 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00034
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(such as workers who are exposed through pro-
duction practices or handling of final products), 
or other vulnerable populations, to help ensure 
safe use of cosmetic products containing the in-
gredient or nonfunctional constituent (or a cat-
egory thereof); and 
‘‘(C) such other conditions as are nec-
essary for the safety of cosmetic products con-
taining such ingredient or nonfunctional con-
stituent (or category thereof). 
‘‘(6) CONTENTS OF ORDER.—A final adminis-
trative order under this subsection shall— 
‘‘(A) set forth the determination of the 
Secretary on safety; 
‘‘(B) include a summary of the valid sci-
entific evidence supporting the determination; 
‘‘(C) include any conditions of use or toler-
ances under paragraph (4)(B); and 
‘‘(D) be effective upon its publication on 
the internet website of the Food and Drug Ad-
ministration and shall be considered final agen-
cy action unless a later compliance date is oth-
erwise specified. 
‘‘(e) MODIFICATION OF AN ORDER.—An order issued 
under subsection (d) may be modified or revoked by the 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00035
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
Secretary on the initiative of the Secretary or in response 
to a petition. 
‘‘(f) INADEQUATE EVIDENCE.— 
‘‘(1) NOTICE; EXTENSION.—If the Secretary de-
termines that available data and information are not 
adequate to make a proposed or final determination 
under subsection (d), with respect to the safety of a 
cosmetic ingredient or nonfunctional constituent (or 
a category thereof), the Secretary shall— 
‘‘(A) publish such determination on the 
internet website of the Food and Drug Admin-
istration not later than 180 days after the close 
of the relevant comment period for the ingre-
dient or nonfunctional constituent (or category 
thereof) under paragraph (2) or (3) of sub-
section (d), as applicable; and 
‘‘(B) include in such publication a notice 
providing interested persons an additional 30 
days from the date on which the notice is pub-
lished to provide additional data and informa-
tion and an opportunity for a meeting pursuant 
to paragraph (2). 
‘‘(2) MEETINGS.—The Secretary may offer a 
responsible person of such cosmetic ingredient or 
nonfunctional constituent (or category thereof) a 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00036
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
confidential meeting with respect to a finding under 
paragraph (1), to discuss matters relating to the 
data and information requirements to support a de-
termination of safety of such ingredient or nonfunc-
tional constituent (or category thereof), which may 
involve confidential information. Such meeting 
should be convened in a reasonable time period 
agreed upon between the responsible person and the 
Secretary. 
‘‘(3) DETERMINATION; ORDER.— 
‘‘(A) INADEQUATE
DATA
AND
INFORMA-
TION.—If the Secretary determines that the 
available data and information are not adequate 
to make a proposed or final determination 
under subsection (d) with respect to the safety 
of a cosmetic ingredient or nonfunctional con-
stituent (or category thereof), the Secretary 
shall— 
‘‘(i) publish such finding on the inter-
net website of the Food and Drug Admin-
istration not later than 180 days after the 
close of the relevant comment period for 
the ingredient or nonfunctional constituent 
(or category thereof) under paragraph (2) 
or (3) of subsection (d), as applicable; and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00037
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(ii) include in such publication a no-
tice providing interested persons an addi-
tional 30 days from the date on which the 
notice is published to provide additional 
data and information and an opportunity 
for a meeting pursuant to paragraph (2). 
‘‘(B) ADEQUATE
DATA
AND
INFORMA-
TION.—If the Secretary determines, after con-
sidering any additional data and information 
submitted pursuant to paragraph (1)(B), that 
the available data and information are adequate 
to make a determination with respect to the 
safety of a cosmetic ingredient or nonfunctional 
constituent (or category thereof), the Secretary 
shall— 
‘‘(i) in the case of a determination de-
scribed in subparagraph (A) of subsection 
(d)(4), within 180 days of the close of the 
applicable comment period under sub-
section (d)(2), issue a final administrative 
order, with respect to such cosmetic ingre-
dient or nonfunctional constituent (or cat-
egory thereof), in accordance with sub-
section (d)(3); 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00038
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(ii) in the case of a determination 
described in subparagraph (B) of sub-
section (d)(4), within 180 days of the close 
of the applicable comment period under 
subsection (d)(2), issue a proposed admin-
istrative order, followed by a final adminis-
trative order, with respect to such cosmetic 
ingredient or nonfunctional constituent (or 
category thereof), in accordance with sub-
section (d)(3); and 
‘‘(iii) in the case of a determination 
described in subparagraph (C) of sub-
section (d)(4), within 180 days of the close 
of the applicable comment period under 
subsection (d)(2), issue a final administra-
tive order, with respect to such cosmetic 
ingredient or nonfunctional constituent (or 
category thereof), in accordance with sub-
section (d)(3) specifying the date by which 
sale of such ingredient or nonfunctional 
constituent must cease. 
‘‘(g) SAFETY ASSESSMENT STANDARDS.— 
‘‘(1) IN GENERAL.—In assessing the safety of 
an ingredient or nonfunctional constituent (or cat-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00039
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
egory thereof) under this section, the Secretary shall 
consider— 
‘‘(A) whether there is adequate evidence to 
support a reasonable certainty among com-
petent scientists that— 
‘‘(i) in the case of a cosmetic ingre-
dient, the ingredient is not harmful under 
the recommended or suggested conditions 
of use or customary or usual use; or 
‘‘(ii) in the case of a nonfunctional 
constituent, that the nonfunctional con-
stituent is not harmful under the rec-
ommended or suggested tolerance levels or 
the level at which it is customarily or usu-
ally present; 
‘‘(B) the probable human exposure to the 
ingredient or nonfunctional constituent (or cat-
egory thereof) from expected use in cosmetic 
products and cosmetic formulations; 
‘‘(C) the probable cumulative and aggre-
gate effect in humans of relevant exposure to 
the ingredient or nonfunctional constituent (or 
category thereof) or to any chemically or phar-
macologically related substances from use in 
cosmetics or other products with similar routes 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00040
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
of exposure under recommended or suggested 
conditions of use or their customary use, to the 
extent adequate data are available for analysis, 
and if appropriate, available information on the 
total exposure to a cosmetic ingredient or non-
functional constituent from all sources; and 
‘‘(D) whether warnings or recommenda-
tions in a cosmetic product label, as part of any 
conditions of use or tolerances imposed by the 
Secretary in a determination described in sub-
paragraph (B) of subsection (d)(4), would be 
necessary and appropriate to help ensure the 
safety of the ingredient or nonfunctional con-
stituent (or category thereof). 
‘‘(2) MINOR ADVERSE REACTIONS.—The Sec-
retary may not consider a cosmetic ingredient or 
nonfunctional constituent (or category thereof) 
harmful under paragraph (1) solely because it can 
cause minor adverse health reactions, such as minor 
transient allergic reactions or minor transient skin 
irritations, in some users. 
‘‘(3) DATA AND INFORMATION.— 
‘‘(A) REQUIRED INFORMATION.—A deter-
mination that a cosmetic ingredient or nonfunc-
tional constituent (or category thereof) is safe 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00041
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
in cosmetics under this section shall be based 
upon adequate evidence submitted or otherwise 
known to the Secretary, which shall include full 
reports of all available studies, published or un-
published, that are adequately designed to show 
whether the ingredient or nonfunctional con-
stituent is safe. Such studies may include in 
vitro and in silico studies and epidemiological 
studies, biomonitoring studies, and studies fo-
cused on various points during the lifespan of 
the subject, that use scientifically valid method-
ology. 
‘‘(B) ADDITIONAL
RELEVANT
INFORMA-
TION.—The Secretary shall consider any other 
relevant information related to the safety of a 
cosmetic ingredient or nonfunctional constituent 
(or category thereof), including— 
‘‘(i) adverse event reports; 
‘‘(ii) findings and information from 
State, Federal, national, and international 
entities and other bodies composed of sci-
entific and medical experts; 
‘‘(iii) if the ingredient or nonfunc-
tional constituent (or category thereof) is 
lawfully used or present in other products 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00042
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
regulated by the Secretary, the scientific 
basis for such use; and 
‘‘(iv) experience with the ingredient or 
nonfunctional 
constituent 
(or 
category 
thereof) in products that are distributed in 
the United States or in other countries, if 
such experience is well-documented and 
has resulted in substantial human exposure 
to the ingredient or nonfunctional con-
stituent over time. 
‘‘(h) COAL TAR HAIR DYE.—In assessing for pur-
poses of this section the safety of coal tar hair dye or any 
ingredient or nonfunctional constituent therein, the Sec-
retary shall not make a determination that the dye, ingre-
dient, or nonfunctional constituent is not safe for use in 
cosmetic products solely because the dye, ingredient, or 
nonfunctional constituent can cause allergic reactions. 
‘‘SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS. 
‘‘(a) DETERMINATION.— 
‘‘(1) IN
GENERAL.—Each responsible person 
for a finished cosmetic product shall, before first dis-
tributing the product for sale, make a written deter-
mination that the product is safe under the condi-
tions of use recommended in the labeling of the 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00043
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
product. Such determination shall be based on ade-
quate evidence that— 
‘‘(A) each ingredient in the finished prod-
uct is safe for the use recommended or sug-
gested in the labeling of the product and for the 
customary or usual use of the product; and 
‘‘(B) the finished product is safe. 
‘‘(2) NEW INFORMATION.—If new information 
relevant to the determination becomes available, the 
responsible person shall promptly update the deter-
mination to address that information. 
‘‘(b) PRESUMPTION OF ADEQUATE EVIDENCE.— 
‘‘(1) IN GENERAL.—Except as provided in sub-
section (c), a determination made under subsection 
(a) with respect to a finished cosmetic product shall 
be presumed to be based on adequate evidence if it 
is supported by— 
‘‘(A) with respect to each ingredient in the 
finished cosmetic product— 
‘‘(i) references to an official statement 
by one or more expert medical or scientific 
bodies that the ingredient is safe under the 
conditions of use recommended or sug-
gested in the product’s labeling or under 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00044
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
such conditions of use as are customary or 
usual; or 
‘‘(ii) appropriate safety testing of the 
ingredient; and 
‘‘(B) appropriate safety substantiation of 
the finished cosmetic product beyond the safety 
substantiation of individual ingredients and 
consideration of the combination of ingredients. 
‘‘(2) STATEMENT OF AN EXPERT MEDICAL OR 
SCIENTIFIC BODY.—For purposes of applying para-
graph (1)(A)(i), a statement of an expert medical or 
scientific body is an official statement of that body, 
if— 
‘‘(A) the medical or scientific body is a 
Federal, State, national, or international entity 
with recognized expertise in chemical or cos-
metic safety, or other similarly recognized body 
composed of scientific and medical experts; 
‘‘(B) the statement is based upon adequate 
data to support the finding of safety, and such 
data are available to the Secretary; and 
‘‘(C) the statement is published and en-
dorsed by the medical or scientific body and is 
not a statement of an employee of such body 
made in the individual capacity of the employee. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00045
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(c) REBUTTAL OF PRESUMPTION.—Notwithstand-
ing subsection (b), a determination under subsection (a) 
will not be presumed to be based on adequate evidence 
if— 
‘‘(1) the Secretary issues an order under section 
608 that an ingredient or nonfunctional constituent 
in the finished product is not safe under the prod-
uct’s conditions of use or customary or usual use; or 
‘‘(2) the Secretary has provided the manufac-
turer with notice that— 
‘‘(A) the manufacturer has not met the cri-
teria under subsection (b); or 
‘‘(B) the Secretary has information that 
raises significant questions about the safety of 
the product or any of its ingredients. 
‘‘(d) TIMELY UPDATE.—Upon notice of inadequate 
evidence under subsection (c), the responsible person shall 
have 10 days to submit additional evidence to the Sec-
retary regarding the safety of an ingredient, nonfunctional 
constituent, or the entire cosmetic product, and the Sec-
retary shall have 30 days from the date of receipt of such 
additional evidence to provide the responsible person with 
notice that the criteria under subsection (b) have been met 
or not met. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00046
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(e) RECORDS MAINTENANCE.—The responsible per-
son shall maintain records documenting the determination 
required under this section and the information on which 
it is based until 5 years after the finished product is no 
longer marketed. 
‘‘(f) SUBMISSION OF RECORDS.— 
‘‘(1) IN GENERAL.—The records required under 
subsection (e) shall, upon the written request of the 
Secretary to the responsible person, be provided to 
the Secretary within a reasonable timeframe not to 
exceed 30 days, in electronic form. 
‘‘(2) CRITERIA.—The Secretary may require 
records under paragraph (1) if— 
‘‘(A) the Secretary has a reasonable belief, 
described in written notice, that— 
‘‘(i) the finished product may be 
harmful based on adverse event reports or 
other scientific information; 
‘‘(ii) scientific information raises cred-
ible and relevant questions about the safe-
ty of the product or any of its ingredients; 
‘‘(iii) 
the 
determination 
required 
under subsection (a) is not supported by 
adequate evidence; or 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00047
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(iv) one or more of the criteria to es-
tablish a presumption of adequate evidence 
of safety in subsection (b) has not been 
satisfied; 
‘‘(B) the Secretary, an expert regulatory 
body, or an expert body composed of scientific 
and medical experts finds an ingredient in the 
product to be unsafe under the conditions of 
use of the product; or 
‘‘(C) the Secretary concludes that submis-
sion of the records will serve the public health 
or otherwise enable the Secretary to fulfill the 
cosmetic safety purposes of this section. 
‘‘(g) GUIDANCE AND REGULATIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall issue 
guidance describing the evidence necessary to sup-
port a determination under subsection (a), and may, 
by regulation, establish exemptions to the require-
ments of this section, if the Secretary determines 
that such exemptions are supported by adequate evi-
dence and would have no adverse effect on public 
health. 
‘‘(2) SMALL BUSINESSES.—The Secretary shall, 
after consultation with the Small Business Adminis-
tration and small businesses that manufacture cos-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00048
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
metics, provide additional guidance for small busi-
nesses on compliance with the requirements of this 
section. Such guidance shall include specific exam-
ples of options for compliance that do not place an 
undue burden on small businesses.’’. 
(b) EFFECTIVE DATE.—Section 609 of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), shall take effect 180 days after the date of enactment 
of this Act. 
(c) PUBLIC MEETING AND GUIDANCE.— 
(1) PUBLIC
MEETING.—Not later than 12 
months after the date of the enactment of this Act, 
the Secretary of Health and Human Services (in this 
subsection referred to as the ‘‘Secretary’’) shall con-
vene a public meeting to describe and solicit public 
input regarding the ingredient review process under 
section 608 of the Federal Food, Drug, and Cos-
metic Act (as added by subsection (a)). Such meet-
ing shall include representatives from the cosmetics 
industry, medical practitioners and scientific experts 
with cosmetic expertise, and consumer and public 
health advocacy organizations. 
(2) GUIDANCE.—Not less than one year after 
the public meeting conducted under paragraph (1), 
the Secretary shall issue one or more guidance docu-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00049
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
ments to implement section 608 of the Federal 
Food, Drug, and Cosmetic Act (as added by sub-
section (a)). Such guidance documents shall include 
information regarding— 
(A) the types of scientific evidence, clinical 
studies, data, or other information needed to 
support the review of cosmetic ingredients or 
nonfunctional constituents (or categories there-
of) selected for review under such section; 
(B) the recommended format in which to 
submit to the Secretary such data and informa-
tion, including any applicable foreign data and 
information, related to a cosmetic ingredient or 
nonfunctional constituent (or category thereof) 
that has been selected for such review; 
(C) the manner and the number of days by 
which the Secretary intends to review and re-
spond to such data and information, including 
with respect to providing a scientific rationale 
for any additional data and information; 
(D) the process for communication be-
tween the Secretary and industry related to an 
ingredient or nonfunctional constituent (or a 
category thereof) that has been selected for re-
view; and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00050
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(E) includes such other information as the 
Secretary determines appropriate. 
(3) TIMING.—Not later than 24 months after 
the date of the enactment of this Act, the Secretary 
shall issue draft guidance under paragraph (1) on 
the implementation of section 608 of the Federal 
Food, Drug, and Cosmetic Act (as added by sub-
section (a)). The Secretary shall issue final guidance 
on the implementation of such section not later than 
6 months after the date on which the comment pe-
riod for the draft guidance closes. 
(d) GAO STUDY.—Not later than 6 years after the 
date of the enactment of this Act, the Comptroller General 
of the United States shall submit to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report addressing the effective-
ness and overall impact of the ingredient review program 
established under section 608 of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a)), including 
with respect to its impact on the safety of cosmetic ingre-
dients— 
(1) for each ingredient or nonfunctional con-
stituent (or category thereof) selected for review— 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(A) whether the ingredient or nonfunc-
tional constituent (or category thereof) was de-
termined— 
(i) to be safe in cosmetic products 
without the need for specified conditions of 
use or tolerances; 
(ii) to be safe in cosmetic products 
under specified conditions of use of toler-
ances; or 
(iii) to be not safe in cosmetic prod-
ucts; 
(B) the timeline for such review; 
(C) the types of scientific evidence, clinical 
studies, data, or other information used to 
make such a determination; 
(D) whether, and to what extent, the re-
view of the ingredient or nonfunctional con-
stituent (or category thereof) resulted in cos-
metic products being reformulated or removed 
from the market; and 
(E) the impact the review and determina-
tion had on consumer use and access to such 
product; and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(2) an analysis of the ingredient, nonfunctional 
constituent (or category thereof) review conducted 
under such section 608, including— 
(A) the resources used by the Secretary in 
reviewing ingredients and nonfunctional con-
stituents (or categories thereof), including the 
effects of the program on other cosmetic safety 
activities of the Secretary; 
(B) the impact of such section on innova-
tion and consumer access to cosmetic products; 
and 
(C) whether any improvements to the pro-
gram under such section 608 are necessary for 
increasing the efficiency and effectiveness of the 
review of cosmetic ingredients, nonfunctional 
constituents, or categories thereof. 
SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS-
METICS. 
(a) IN GENERAL.—Chapter VI of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 
amended by section 102, is further amended by adding 
at the end the following: 
‘‘SEC. 610. GOOD MANUFACTURING PRACTICES FOR COS-
METICS. 
‘‘(a) IN GENERAL.—The Secretary shall— 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(1) review national and international stand-
ards for cosmetic good manufacturing practices that 
are in effect on the date of enactment of the Cos-
metic Safety Enhancement Act of 2019; and 
‘‘(2) issue a rule establishing current good man-
ufacturing standards consistent, to the extent the 
Secretary determines practicable and appropriate, 
with such national and international standards. 
‘‘(b) CONTENT OF REGULATIONS.—The regulations 
issued pursuant to subsection (a)(2)— 
‘‘(1) may specify requirements for the use of 
certain analytical or recordkeeping methods by a 
manufacturer as may be necessary to ensure that a 
cosmetic product or cosmetic formulation is not inju-
rious to health under the recommended or suggested 
conditions of use, or customary or usual use of the 
product or formulation; and 
‘‘(2) shall not— 
‘‘(A) impose standards for which there is 
no current and generally available analytic 
method; or 
‘‘(B) apply to facilities meeting the criteria 
to be considered a facility under section 604(6), 
including retail stores or counters offering cus-
tomized or personalized cosmetics to consumers, 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
or to entities that are in compliance with the 
good manufacturing practice regulations speci-
fied in parts 210 and 211 of title 21, Code of 
Federal Regulations (or any successor regula-
tions). 
‘‘(c) TIMEFRAME.—The Secretary shall publish a 
proposed rule described in subsection (a) not later than 
24 months after the date of enactment of the Cosmetic 
Safety Enhancement Act of 2019 and shall publish a final 
such rule not later than 36 months after such date of en-
actment.’’. 
(b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR-
ERS.—Regulations issued pursuant to section 610 of the 
Federal Food, Drug, and Cosmetic Act (as added by sub-
section (a)) shall apply with respect to— 
(1) large manufacturers (as defined in section 
744L of such Act (as added by section 202 of this 
Act)), beginning 180 days after the date on which 
the final rule described in subsection (a) is effective; 
(2) midsize manufacturers (as defined in sec-
tion 744L of such Act (as added by section 202 of 
this Act)), beginning 210 days after such date; and 
(3) small manufacturers (as defined in section 
744L of such Act (as added by section 202 of this 
Act)), beginning 2 years after such date. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(c) ENFORCEMENT.—Section 601 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amend-
ed by adding at the end the following: 
‘‘(f) If the methods used in, or the facilities or con-
trols used for, its manufacture, processing, packing, or 
holding do not conform to current good manufacturing 
practice, as prescribed by the Secretary.’’. 
SEC. 104. ADVERSE EVENT REPORTS. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 
103(a), is further amended by adding at the end the fol-
lowing: 
‘‘SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS. 
‘‘(a) SUBMISSION OF SERIOUS ADVERSE EVENT RE-
PORTS.— 
‘‘(1) IN GENERAL.—With respect to any cos-
metic product distributed in the United States, the 
responsible person shall submit, not later than 15 
days after the receipt by the responsible person, 
using an electronic system developed under sub-
section (b), to the Secretary any report of a serious 
adverse event associated with the use of the cosmetic 
product, accompanied by a copy of the label on or 
with the retail packaging of the cosmetic product. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(2) NEW MEDICAL INFORMATION.—During the 
12-month period following the submission of a seri-
ous adverse event report under paragraph (1), with 
respect to any cosmetic product distributed in the 
United States, the responsible person shall submit, 
not later than 15 days after the receipt by the re-
sponsible person, using an electronic system devel-
oped under subsection (b), to the Secretary any new 
medical information related to such serious adverse 
event report that is received by the responsible per-
son. 
‘‘(3) PUBLICATION.—The Secretary shall make 
publicly available on the internet website of the Food 
and Drug Administration reports submitted under 
paragraph (1). 
‘‘(4) NO
DUPLICATION.—In the case of cos-
metic product that is also a drug for which a serious 
adverse event report is filed using Form FDA 
3500A (or any successor form developed for such 
purpose) or its electronic equivalent for over-the- 
counter drugs, the responsible person shall not be 
required to submit a serious adverse event report 
under paragraph (1) with respect to that cosmetic 
product. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(b) REQUIREMENTS FOR SERIOUS ADVERSE EVENT 
REPORTS.— 
‘‘(1) ELECTRONIC SYSTEM.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
not later than 1 year after the date of enact-
ment of the Cosmetic Safety Enhancement Act 
of 2019, develop and implement an electronic 
system for use for the submission of serious ad-
verse event reports under this section. 
‘‘(B) MODIFICATION.—The format of the 
electronic system developed and implemented 
under paragraph (1) may be modified by the 
Secretary and the reports may include addi-
tional information. The Secretary may, in guid-
ance, further specify the format and contents of 
required reports. 
‘‘(2) CONTENT
OF
REPORTS.—A serious ad-
verse event report submitted under paragraph (1) of 
subsection (a) shall include all information sub-
mitted with the initial report and any information 
subsequently added to such report pursuant to para-
graph (2) of such subsection and— 
‘‘(A) any report by the responsible person 
under section 756 with respect to the safety of 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
the cosmetic product that is the subject of the 
report; 
‘‘(B) information on the individual or indi-
viduals with respect to whom the adverse event 
report is submitted, in accordance with the dis-
closure requirements of section 552a of title 5, 
United States Code; 
‘‘(C) notwithstanding section 552(b)(6) of 
title 5, United States Code, medical (or similar) 
documentation of the serious adverse event that 
is the subject of the report, with all personally 
identifiable information redacted; and 
‘‘(D) contact information for the individual 
or individuals reporting the serious adverse 
event. 
‘‘(3) RESPONSIBILITY
TO
GATHER
INFORMA-
TION.—After an individual initiates the reporting of 
a serious adverse event, the responsible person for 
the cosmetic product shall actively gather all of the 
information reasonably available to such person to 
complete and file the report with the Secretary 
under subsection (a)(1). 
‘‘(4) NO ADVERSE EVENTS TO REPORT.—The 
Secretary shall provide an option as part of the elec-
tronic registration process for the responsible person 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
to indicate if such responsible person had no adverse 
events to report over the previous year. With respect 
to a responsible person who received no adverse 
event reports for a year, the annual adverse event 
report requirement may be met by indicating no 
such events on the annual registration form. 
‘‘(5) EXEMPTION.—The Secretary may estab-
lish by regulation an exemption to any of the re-
quirements under this section if the Secretary deter-
mines that such exemption is supported by adequate 
evidence and would have no adverse effect on public 
health. 
‘‘(c) REQUIREMENTS FOR OTHER ADVERSE EVENT 
REPORTS.— 
‘‘(1) IN
GENERAL.—Each responsible person 
shall maintain records related to each report of an 
adverse event (including serious adverse events) as-
sociated with each cosmetic product marketed by 
such responsible person and received by such respon-
sible person for a period of 6 years. Such records 
shall be made available to an officer or an employee 
duly designated by the Secretary upon request, at 
reasonable times and within reasonable limits and in 
a reasonable manner, including allowing electronic 
access and to copy such records. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(2) CONTENT.—Records required to be main-
tained under this paragraph shall contain all infor-
mation reasonably available, including— 
‘‘(A) a summary of all adverse events re-
ceived during the calendar year for each cos-
metic product marketed; 
‘‘(B) a complete list of individual reports 
of adverse events for each cosmetic product 
marketed and with respect to each such event, 
the same information required to be included in 
a report with respect to a serious adverse event 
under subsection (b)(2), subject to the same 
conditions with respect to the disclosure of such 
information; 
‘‘(C) an estimate of the total number of 
product units estimated to have been distrib-
uted to consumers during the period specified 
in paragraph (1); and 
‘‘(D) such other information as may be 
specified in regulation or guidance issued by the 
Secretary. 
‘‘(3) RULE
OF
CONSTRUCTION.—This section 
shall not be construed to require the inclusion in any 
report under this section any consumer complaint 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00061
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
that concerns solely efficacy and does not contain 
any information about an adverse event. 
‘‘(d) LIMITATION
WITH
RESPECT
TO
ADVERSE 
EVENT REPORTS.— Section 756 shall apply with respect 
to the submission of an adverse event report in compliance 
with subsection (a). 
‘‘(e) CONTACT INFORMATION.—The label of a cos-
metic product shall bear the domestic address, and either 
the domestic telephone number or electronic contact infor-
mation, through which the responsible person may receive 
a report of an adverse event. 
‘‘(f) AVAILABILITY TO STATES.—The Secretary shall 
make records submitted under this section available to any 
State, upon request, to the extent permissible under the 
laws governing disclosure of information by the Secretary. 
Information disclosed to a State that is exempt from dis-
closure under section 552(b)(4) of title 5, United States 
Code, shall be treated as a trade secret and confidential 
information by the State. Such State and its employees 
in possession of such information shall be subject to the 
same laws governing information disclosure as employees 
of the Food and Drug Administration. 
‘‘(g) PROTECTION OF INFORMATION.—A serious ad-
verse event report submitted to the Secretary under sub-
section (a), including any new medical information sub-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00062
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
mitted under paragraph (2) of such subsection, or an ad-
verse event report voluntarily submitted to the Secretary, 
shall be considered to be a safety report under section 756 
and may be accompanied by a statement, which shall be 
a part of any report that is released for public disclosure, 
that denies that the report or the records constitute an 
admission that the product involved caused or contributed 
to the adverse event. 
‘‘(h) EFFECTIVE DATES.— 
‘‘(1) SERIOUS ADVERSE EVENTS.—The require-
ment under this section to report serious adverse 
events shall become effective on the date that the 
Secretary publicizes the availability of the electronic 
system described in subsection (b)(1). 
‘‘(2) OTHER ADVERSE EVENTS.—The require-
ment under this section to maintain records relating 
to adverse events which are not serious adverse 
events shall become effective 18 months after the 
date of the enactment of the Cosmetic Safety En-
hancement Act of 2019. 
‘‘(i) DEFINITIONS.—In this section: 
‘‘(1) ADVERSE
EVENT.—The term ‘adverse 
event’ means, with respect to a cosmetic product, a 
health-related or medical event associated with the 
use of such product, including a risk of illness or in-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00063
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
jury. Such term does not include any instance of a 
consumer complaint that such product did not work 
as advertised or marketed. 
‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘se-
rious adverse event’ means, with respect to a cos-
metic product, an adverse event that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a persistent or significant ad-
verse health condition, disability, or inca-
pacity; 
‘‘(v) congenital anomaly or birth de-
fect; or 
‘‘(vi) significant disfigurement, includ-
ing serious or persistent rashes and infec-
tions, burns, or significant hair loss; or 
‘‘(B) requires, based on reasonable medical 
judgment, a medical or surgical intervention to 
prevent an outcome described in subparagraph 
(A).’’. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00064
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU-
THORITY. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 104, 
is further amended by adding at the end the following: 
‘‘SEC. 612. INSPECTION OF COSMETIC RECORDS. 
‘‘(a) INSPECTION OF RECORDS.—Each facility, in-
cluding a facility owned or operated by a responsible per-
son for a cosmetic product shall, at the request of an offi-
cer or employee duly designated by the Secretary, permit 
such officer or employee, upon presentation of appropriate 
credentials and written notice to such person, at reason-
able times and within reasonable limits and in a reason-
able manner, to have access to and copy, or receive elec-
tronically records maintained by or on behalf of such per-
son in any format (including paper and electronic formats) 
and at any location, including— 
‘‘(1) all records maintained under section 611 
and in accordance with the rules promulgated by the 
Secretary under section 610, as applicable; 
‘‘(2) all records maintained under section 609; 
‘‘(3) any records relating to the list of ingredi-
ents in specific fragrances or flavors of a cosmetic 
product or cosmetic formulation, if requested by the 
Secretary by means of a written notification; and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00065
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(4) except as provided in subsection (b), all 
other records relating to the cosmetic product or 
cosmetic formulation and to any other cosmetic 
product or cosmetic formulation the Secretary rea-
sonably believes is likely to be affected in a similar 
manner, if the Secretary— 
‘‘(A) has a reasonable belief that the cos-
metic product or cosmetic formulation— 
‘‘(i) is adulterated; 
‘‘(ii) has caused a reportable serious 
adverse event; or 
‘‘(iii) contains an ingredient for which 
new scientific information shows may be 
unsafe when present in a cosmetic product 
or cosmetic formulation; and 
‘‘(B) provides written notice to the respon-
sible person of the basis for the Secretary’s rea-
sonable belief described in subparagraph (A), as 
applicable. 
‘‘(b) EXCLUSIONS.— 
‘‘(1) IN
GENERAL.—No inspection authorized 
by this section shall extend to— 
‘‘(A) recipes, financial data, pricing data, 
personnel data (other than data as to qualifica-
tion of technical and professional personnel per-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00066
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
forming functions subject to this Act), research 
data (other than safety data) or sales data 
other than shipment and distribution data; or 
‘‘(B) except as provided in paragraph (2), 
information related to ingredients in fragrances 
or flavors of a cosmetic product or cosmetic for-
mulation. 
‘‘(2) EXCEPTION.—The Secretary may obtain 
information related to the ingredients in fragrances 
or flavors in an identified cosmetic product or cos-
metic formulation only by a request in a written no-
tification provided to the manufacturer pursuant to 
a for-cause inspection. In response to such written 
notification, the manufacturer of such fragrance or 
flavor shall provide information about the ingredi-
ents in the specified fragrance or flavor that the 
Secretary determines is necessary to assist its inves-
tigation, in the manufacturer’s preferred electronic 
or written format, to the Secretary upon receipt of 
such notification. Any information provided in re-
sponse to such written notification shall be consid-
ered a trade secret under section 301(j) and, not-
withstanding such section, shall only be disclosed if 
the Secretary determines such disclosure is nec-
essary to protect the public health. The authority to 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00067
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
determine such disclosure is necessary to protect the 
public health shall not be delegated to any officer or 
employee other than the director of the applicable 
office. 
‘‘(c) PROTECTION OF SENSITIVE INFORMATION.— 
The Secretary shall take appropriate measures to ensure 
that there are effective procedures to prevent the unau-
thorized disclosure of any trade secret or confidential in-
formation that is obtained by the Secretary pursuant to 
this section. Information disclosed to a State shall be pur-
suant to the laws governing disclosure of information. 
Confidential information disclosed to the State that is ex-
empt from disclosure under section 552(b)(4) of title 5, 
United States Code, shall be treated as confidential infor-
mation by the State. Such State and its employees in pos-
session of such information under this section shall be sub-
ject to the same laws governing information disclosure as 
employees of the Food and Drug Administration. 
‘‘(d) LIMITATIONS.—This section shall not be con-
strued— 
‘‘(1) to limit the authority of the Secretary to 
inspect records or to require establishment and 
maintenance of records under any other provision of 
this Act; or 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00068
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(2) to require the Secretary to publicly disclose 
any information that is exempt from disclosure 
under section 522 of title 5, United States Code, or 
section 1905 of title 18, United States Code. 
‘‘SEC. 613. MANDATORY RECALL AUTHORITY. 
‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 
determines that there is a reasonable probability that a 
cosmetic product is adulterated under section 601 or mis-
branded under section 602 and the use of, and exposure 
to, such cosmetic product is likely to cause serious adverse 
health consequences or death, the Secretary shall provide 
the responsible person with an opportunity to voluntarily 
cease distribution and recall such article. 
‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE 
DISTRIBUTION AND GIVE NOTICE.— 
‘‘(1) IN GENERAL.—If the domestic responsible 
person refuses to or does not voluntarily cease dis-
tribution or recall such cosmetic product within the 
time and in the manner prescribed by the Secretary, 
the Secretary may order such person to— 
‘‘(A) immediately cease distribution of 
such cosmetic product; and 
‘‘(B) as applicable, immediately order all 
facilities— 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00069
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(i) manufacturing, processing, pack-
ing, transporting, holding, receiving, dis-
tributing, or importing and selling such 
cosmetic product; and 
‘‘(ii) to which such cosmetic product 
has been distributed, transported, or sold, 
to immediately cease distribution of such cos-
metic product. 
‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 
‘‘(A) IN GENERAL.—In the case of a cos-
metic product that is subject to a recall order 
issued under paragraph (1)(B) with respect to 
which the responsible person, before the 
issuance of such order, distributed to a ware-
house-based, third-party logistics provider with-
out providing such logistics provider with suffi-
cient information to know or reasonably deter-
mine the precise identity of such cosmetic prod-
uct, the notice provided by the domestic respon-
sible person pursuant to such order shall in-
clude such information as is necessary for the 
logistics provider to identify the cosmetic prod-
uct. 
‘‘(B) RULES OF CONSTRUCTION.—Nothing 
in this paragraph shall be construed to exempt 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00070
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
a warehouse-based, third-party logistics pro-
vider from— 
‘‘(i) the requirements of this chapter, 
including the requirements of this section 
and section 612; or 
‘‘(ii) being the subject of a mandatory 
recall order under this section. 
‘‘(3) DETERMINATION
TO
LIMIT
AREAS
AF-
FECTED.—If the Secretary requires a domestic re-
sponsible person to cease distribution under para-
graph (1)(A) of a cosmetic product, the Secretary 
may limit the size of the geographic area and the 
markets affected by such cessation if such limitation 
would not compromise the public health. 
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide the responsible person subject to an order under sub-
section (b) with an opportunity for an informal hearing, 
to be held as soon as possible, but not later than 2 days 
after the issuance of the order, on the actions required 
by the order and on why the cosmetic product that is the 
subject of the order should not be recalled. 
‘‘(d) POSTHEARING RECALL ORDER AND MODIFICA-
TION OF ORDER.— 
‘‘(1) AMENDMENT OF ORDER.—If, after pro-
viding opportunity for an informal hearing under 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00071
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
subsection (c), the Secretary determines that re-
moval of the cosmetic product from commerce is 
necessary, the Secretary shall, as appropriate— 
‘‘(A) amend the order to require recall of 
such cosmetic product or other appropriate ac-
tion; 
‘‘(B) specify a timetable in which the recall 
shall occur; 
‘‘(C) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(D) provide notice to consumers to whom 
such cosmetic product was, or may have been, 
distributed. 
‘‘(2) VACATING OF ORDER.—If, after such hear-
ing, the Secretary determines that adequate grounds 
do not exist to continue the actions required by the 
order, or that such actions should be modified, the 
Secretary shall vacate the order or modify the order. 
‘‘(e) COOPERATION AND CONSULTATION.—The Sec-
retary shall work with State and local public health offi-
cials in carrying out this section, as appropriate. 
‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 
under this section, the Secretary shall— 
‘‘(1) ensure that a press release is published re-
garding the recall, and that alerts and public notices 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00072
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
are issued, as appropriate, in order to provide notifi-
cation— 
‘‘(A) of the recall to consumers and retail-
ers to whom such cosmetic product was, or may 
have been, distributed; and 
‘‘(B) that includes, at a minimum— 
‘‘(i) the name of the cosmetic product 
subject to the recall; 
‘‘(ii) a description of the risk associ-
ated with the use of such cosmetic product; 
and 
‘‘(iii) to the extent practicable, infor-
mation for consumers about similar cos-
metic products that are not affected by the 
recall; and 
‘‘(2) ensure publication on the internet website 
of the Food and Drug Administration of an image 
of the cosmetic product that is the subject of the 
press release described in paragraph (1), if available. 
‘‘(g) NO DELEGATION.—The authority conferred by 
this section to order a recall or vacate a recall order shall 
not be delegated to any officer or employee other than the 
Commissioner of Food and Drugs. 
‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall affect the authority of the Secretary to request 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00073
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
or participate in a voluntary recall, or to issue an order 
to cease distribution or to recall any article under any 
other provision of this Act or under the Public Health 
Service Act. 
‘‘(i) DEFINITION.—In this section, the term ‘domestic 
responsible person’ means a person who is the domestic 
contact for a responsible person.’’. 
SEC. 106. LABELING AND INTERNET SALES. 
(a) IN GENERAL.—Chapter VI of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 
amended by section 105, is further amended by adding 
at the end the following: 
‘‘SEC. 614. LABELING AND INTERNET SALES. 
‘‘(a) SAFETY REVIEW AND LABELING.—If a warning 
or condition of use is required pursuant to section 
608(d)(4) to ensure the safe use of a cosmetic ingredient, 
the Secretary shall require appropriate labeling of any cos-
metic product that contains such ingredient, including if 
such ingredient— 
‘‘(1) is not appropriate for use in the entire 
population; or 
‘‘(2) requires warnings that children, pregnant 
women, and other vulnerable populations should 
limit or avoid using the product. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00074
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(b) COSMETIC
PRODUCTS
FOR
PROFESSIONAL 
USE.— 
‘‘(1) LISTING OF INGREDIENTS.—The labeling 
of cosmetic products used and sold by professionals 
shall list all ingredients, as required for other cos-
metic products pursuant to section 602(g). 
‘‘(2) PROFESSIONAL
USE
LABELING.—In the 
case of a cosmetic product that is intended to be 
used only by a professional on account of a specific 
ingredient or increased concentration of an ingre-
dient and requires safe handling by trained profes-
sionals, the product shall bear a statement as fol-
lows: ‘For Professional Use Only’. 
‘‘(c) DISPLAY.—A warning required under subsection 
(a) and any statement required under subsection (b)(2) 
shall be prominently displayed— 
‘‘(1) in the primary language used on the label 
or on packaging; and 
‘‘(2) in conspicuous and legible type in contrast 
by typography, layout, or color with other material 
printed or displayed on the label. 
‘‘(d) INTERNET SALES.— 
‘‘(1) IN
GENERAL.—In the case of internet 
sales of cosmetic products, each primary seller offer-
ing a cosmetic product for sale to consumers on an 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00075
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
internet website shall prominently and conspicuously 
display on such internet website— 
‘‘(A) the same information that is included 
on the packaging of the cosmetic product as 
regularly available, such as any warnings, ingre-
dient list, and contact information; and 
‘‘(B) the warnings and statements de-
scribed in subsection (c). 
‘‘(2) DEFINITION.—For purposes of this sub-
section, the term ‘primary seller’ refers to the entity 
who offers a cosmetic product for sale on an internet 
website, including the responsible person. 
‘‘SEC. 615. FRAGRANCE INGREDIENTS. 
‘‘(a) FRAGRANCE INGREDIENTS.—Not later than 2 
years after the date of enactment of the Cosmetic Safety 
Enhancement Act of 2019, the responsible person shall 
include on the label of any cosmetic products containing 
one or more fragrance allergens, a list of each such fra-
grance allergen included in such cosmetic product that is 
consistent with national and international regulations for 
fragrance allergens labeling. 
‘‘(b) CONTACT INFORMATION.— 
‘‘(1) IN GENERAL.—The contact information on 
the label on a cosmetic product for consumers to re-
port adverse events shall also provide a means for 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00076
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
consumers to obtain additional information about 
the inclusion of any recognized fragrance allergen 
required to be included on such label under sub-
section (a). 
‘‘(2) RESPONSE.— 
‘‘(A) IN GENERAL.—The responsible per-
son shall— 
‘‘(i) upon receipt of a request for in-
formation under paragraph (1), promptly 
obtain and provide such information to the 
requesting consumer; and 
‘‘(ii) in the case of information in the 
possession of a supplier, promptly obtain 
such information from such supplier, if 
reasonably available. 
‘‘(B) SUPPLIER.—A supplier shall prompt-
ly provide information requested pursuant to 
subparagraph (A)(ii).’’. 
(b) INGREDIENT STATEMENT.—Section 602 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) 
is amended by adding at the end the following: 
‘‘(g) If its labeling or packaging does not contain a 
listing of ingredients that meets the requirements of part 
701 of title 21, Code of Federal Regulations (as in effect 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00077
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
on date of enactment of the Cosmetic Safety Enhancement 
Act of 2019) (or any successor regulations).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to products introduced 
or delivered for introduction into interstate commerce on 
or after the date that is 2 years after the date of enact-
ment of this Act. 
SEC. 107. CONSUMER INFORMATION. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall post 
on its internet website information for consumers regard-
ing— 
(1) final orders regarding the safety of a cos-
metic ingredient or nonfunctional constituent under 
section 608(d)(3); 
(2) cosmetic product recalls (including vol-
untary and mandatory recalls); and 
(3) identified counterfeit cosmetic products. 
SEC. 108. SMALL BUSINESSES. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 106, 
is further amended by adding at the end the following: 
‘‘SEC. 616. SMALL BUSINESSES. 
‘‘(a) IN GENERAL.—The Commissioner, in coordina-
tion with the Administrator of the Small Business Admin-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00078
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
istration, shall provide technical assistance, such as guid-
ance and expertise, to small businesses regarding compli-
ance with the Cosmetic Safety Enhancement Act of 2019, 
including the amendments made by such Act. 
‘‘(b) COMPLIANCE GUIDE.—Not later than 180 days 
after the date of the enactment of Cosmetic Safety En-
hancement Act of 2019, the Secretary shall issue a small 
business guide setting forth in plain language the require-
ments of sections 605 and 606 in order to assist small 
businesses in complying with such requirements.’’. 
SEC. 109. ANIMAL TESTING RESTRICTIONS. 
(a) IN GENERAL.—Section 601 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361) is amended by 
adding at the end the following: 
‘‘(f) If the cosmetic product, cosmetic formulation, or 
cosmetic ingredient was developed or manufactured using 
an animal test that was conducted or contracted by the 
manufacturer, or any affiliate or supplier of the manufac-
turer, unless one of the following applies: 
‘‘(1) With respect to a cosmetic ingredient of 
the cosmetic product or cosmetic formulation, an 
animal test is required by the Secretary to evaluate 
the safety of such ingredient or formulation. 
‘‘(2) With respect to a cosmetic ingredient of 
the cosmetic product or cosmetic formulation, the 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00079
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
cosmetic ingredient or cosmetic formulation is in 
wide use and cannot be replaced by another ingre-
dient that is capable of performing a similar func-
tion without posing a potentially greater risk to 
human health and there is not an alternative method 
for testing the cosmetic ingredient that is accepted 
by the Secretary and the Interagency Coordinating 
Committee on Validation of Alternative Methods. 
‘‘(3) The animal test was conducted to comply 
with a requirement of another Federal agency or a 
State or foreign regulatory authority. 
‘‘(4) In the case of a cosmetic product, cosmetic 
formulation, or cosmetic ingredient that is also a 
drug, the animal test was conducted with respect to 
the approval under chapter V of the application sub-
mitted with respect to such product, formulation, or 
ingredient. 
‘‘(5) The animal test was conducted for pur-
poses not related to developing or manufacturing the 
cosmetic product, cosmetic formulation, or cosmetic 
ingredient, and in response to a requirement of a 
Federal, State, or foreign regulatory authority.’’. 
(b) APPLICABILITY.—The amendment made by sub-
section (a) shall apply with respect to cosmetic products 
or cosmetic formulations introduced or delivered for intro-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00080
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
duction into interstate commerce on or after the date that 
is two years after the date of enactment of this Act. 
(c) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Secretary shall issue guid-
ance on the acceptability of scientifically reliable and rel-
evant alternatives to animal testing for the safety of cos-
metic products, cosmetic formulations, and cosmetic ingre-
dients, and encouraging the use of such methods. 
(d) RESOURCES REGARDING ANIMAL TESTING AL-
TERNATIVES.—Not later than 180 days after the date of 
enactment of this Act, the Secretary shall publish informa-
tion on the internet website of the Food and Drug Admin-
istration regarding resources available for information 
about non-animal methods, and methods that reduce ani-
mal usage, in testing for the safety of cosmetic products, 
cosmetic formulations, and cosmetic ingredients. 
(e) RULES OF CONSTRUCTION.— 
(1) USE OF EVIDENCE.—Nothing in this sec-
tion, or the amendment made by this section, shall 
be construed to prohibit any entity from reviewing, 
assessing, or retaining evidence generated from ani-
mal testing. 
(2) ACCEPTANCE OF DATA BY SECRETARY.— 
Nothing in this section, or the amendment made by 
this section, shall be construed to prohibit the Sec-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00081
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
retary from accepting data from animal testing con-
ducted— 
(A) prior to the date specified in sub-
section (b); or 
(B) on or after such date— 
(i) in the case of a cosmetic product, 
cosmetic formulation, or cosmetic ingre-
dient that is also a drug, with respect to 
the approval under chapter V of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) of the application sub-
mitted with respect to such product, for-
mulation, or ingredient; or 
(ii) pursuant to requirements of a 
Federal, State, or foreign regulatory au-
thority. 
SEC. 110. COUNTERFEIT COSMETICS. 
(a) COUNTERFEIT COSMETICS DEFINED.—Section 
201(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(i)) is amended— 
(1) by striking ‘‘(i) The term’’ inserting ‘‘(i)(1) 
The term’’; 
(2) by striking ‘‘(1) articles intended to be’’ and 
inserting ‘‘(A) articles intended to be’’; 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00082
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(3) by striking ‘‘(2) articles intended for use’’ 
and inserting ‘‘(B) articles intended for use’’; and 
(4) by adding at the end the following: 
‘‘(2) The term ‘counterfeit cosmetic’ means a cos-
metic which, or the container or labeling of which, without 
authorization— 
‘‘(A) bears the trademark, trade name, or other 
identifying mark, imprint, or device, or any likeness 
thereof, of a cosmetic manufacturer, processor, pack-
er, or distributor other than the person or persons 
who in fact manufactured, processed, packed, or dis-
tributed such cosmetic; and 
‘‘(B) thereby falsely purports or is represented 
to be the product of, or to have been packed or dis-
tributed by, such other cosmetic manufacturer, proc-
essor, packer, or distributor.’’. 
(b) PROHIBITED ACT.—Section 301(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(i)) is 
amended— 
(1) in subparagraph (2)— 
(A) by inserting ‘‘digital printer,’’ after 
‘‘stone,’’; 
(B) by inserting ‘‘cosmetic’’ after ‘‘drug 
or’’; and 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00083
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(C) by inserting before the period at the 
end the following: ‘‘or such cosmetic a counter-
feit cosmetic’’; and 
(2) in subparagraph (3)— 
(A) by inserting ‘‘or a cosmetic to be a 
counterfeit cosmetic’’ after ‘‘to be a counterfeit 
drug’’; and 
(B) by inserting ‘‘or counterfeit cosmetic’’ 
before the period at the end. 
(c) PENALTIES.—Section 303(c)(5) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(c)(5)) is 
amended— 
(1) by inserting ‘‘digital printer’’ after ‘‘stone,’’; 
(2) by inserting ‘‘or a cosmetic being a counter-
feit cosmetic’’ after ‘‘drug being a counterfeit drug’’; 
and 
(3) by inserting before the period at the end the 
following: ‘‘or the cosmetic was a counterfeit cos-
metic’’. 
(d) SEIZURE.—Section 304(a)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 334(a)(2)) is 
amended— 
(1) by striking ‘‘(B) Any container’’ and all 
that follows through ‘‘(D) Any adulterated’’ and in-
serting ‘‘(B) Any cosmetic that is a counterfeit cos-
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00084
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
SEC. 111. FOREIGN SUPPLIER VERIFICATION. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 810. COSMETICS FOREIGN SUPPLIER VERIFICATION 
PROGRAM. 
‘‘(a) IN GENERAL.— 
‘‘(1) VERIFICATION REQUIREMENT.—Except as 
provided under subsection (e), each importer shall 
perform risk-based foreign supplier verification ac-
tivities for the purpose of verifying that the cosmetic 
product or cosmetic ingredient imported by the im-
porter (or agent thereof)— 
‘‘(A) has been manufactured according to 
the cosmetic product good manufacturing prac-
tices established under section 610; and 
‘‘(B) is not adulterated under section 601 
or misbranded under section 602. 
‘‘(2) IMPORTER
DEFINED.—For purposes of 
this section, the term ‘importer’ means, with respect 
to a cosmetic product or cosmetic ingredient— 
‘‘(A) the United States owner or consignee 
of the cosmetic product or cosmetic ingredient 
at the time of entry of such cosmetic product 
or cosmetic ingredient into the United States; 
or 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00086
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘(B) in the case when there is no United 
States owner or consignee as described in sub-
paragraph (A), the United States agent or rep-
resentative of a foreign owner or consignee of 
the cosmetic product or cosmetic ingredient at 
the time of entry of such article into the United 
States. 
‘‘(b) GUIDANCE.—Not later than 1 year after the 
date of enactment of the Cosmetic Safety Enhancement 
Act of 2019, the Secretary shall issue guidance to assist 
importers in developing foreign supplier verification pro-
grams. 
‘‘(c) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of Cosmetic Safety Enhance-
ment Act of 2019, the Secretary shall promulgate 
regulations to provide for the content of the foreign 
supplier verification program established under sub-
section (a). 
‘‘(2) REQUIREMENTS.—The regulations promul-
gated under paragraph (1)— 
‘‘(A) shall require that the foreign supplier 
verification program of each importer be ade-
quate to provide assurances that each foreign 
supplier to the importer produces the imported 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00087
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
cosmetic product or cosmetic ingredient in com-
pliance with— 
‘‘(i) with cosmetic good manufac-
turing practices established under section 
610; and 
‘‘(ii) sections 601 and 602; and 
‘‘(B) shall include such other requirements 
as the Secretary deems necessary and appro-
priate to verify that cosmetic products and cos-
metic ingredients imported into the United 
States are as safe as cosmetic products and cos-
metic ingredients produced and sold within the 
United States. 
‘‘(3) CONSIDERATIONS.—In promulgating regu-
lations under this subsection, the Secretary shall, as 
appropriate, take into account differences among im-
porters and types of imported cosmetic products and 
cosmetic ingredients, including based on the level of 
risk posed by the imported cosmetic product or cos-
metic ingredient. 
‘‘(4) ACTIVITIES.—Verification activities under 
a foreign supplier verification program under this 
section may include monitoring records for ship-
ments, lot-by-lot certification of compliance, annual 
on-site inspections, compliance with cosmetic good 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
manufacturing practices and other safety processes, 
and periodically testing and sampling shipments. 
‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records 
of an importer related to a foreign supplier verification 
program shall— 
‘‘(1) be maintained for a period of not less than 
2 years; and 
‘‘(2) be made available promptly to a duly au-
thorized representative of the Secretary upon re-
quest. 
‘‘(e) EXEMPTIONS.—The Secretary, by notice pub-
lished in the Federal Register, shall establish an exemp-
tion from the requirements of this section for cosmetic 
products or cosmetic ingredients imported in small quan-
tities for research and evaluation purposes or for personal 
consumption, provided that such cosmetic products or cos-
metic ingredients are not intended for retail sale and are 
not sold or distributed to the public. 
‘‘(f) PUBLICATION OF LIST OF PARTICIPANTS.—The 
Secretary shall publish and maintain on the internet 
website of the Food and Drug Administration a current 
list that includes the name of, location of, and other infor-
mation deemed necessary by the Secretary about, import-
ers participating under this section.’’. 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00089
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(b) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 
amended by section 113, is further amended by adding 
at the end the following: 
‘‘(ggg) The importation or offering for importation 
of a cosmetic product or cosmetic ingredient if the im-
porter (as defined in section 810) does not have in place 
a foreign supplier verification program in compliance with 
such section 810.’’. 
(c) IMPORTS.—Section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended 
by striking ‘‘or the importer (as defined in section 805) 
is in violation of such section 805’’ and inserting ‘‘, or 
being imported or offered for import into the United 
States by an importer (as defined in section 805 or 810, 
as applicable) that is in violation of section 805 or 810, 
respectively’’. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 2 years after the date of en-
actment of this Act. 
SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS-
METICS. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 108, 
is further amended by adding at the end the following: 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
‘‘SEC. 617. APPLICABILITY WITH RESPECT TO CERTAIN 
COSMETICS. 
‘‘In the case of a cosmetic product or a facility that 
is subject to the requirements under this chapter and 
chapter V, if any requirement under chapter V with re-
spect to such cosmetic or facility is substantially similar 
to a requirement under this chapter, the cosmetic product 
or facility shall be deemed to be in compliance with the 
applicable requirement under this chapter if such product 
or facility is in compliance with such substantially similar 
requirement under chapter V, provided that the product 
or facility has not obtained a waiver from the requirement 
under chapter V.’’. 
SEC. 113. SAVING CLAUSE. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended by section 112, 
is further amended by adding the following: 
‘‘SEC. 616. SAVINGS CLAUSE. 
‘‘Nothing in the amendments to this Act made by the 
Cosmetic Safety Enhancement Act of 2019, nor any 
standard, rule, requirement, regulation, adverse event re-
port, safety assessment, safety determination, scientific 
assessment, or order issued or implemented pursuant to 
such amendments, shall be construed to modify or other-
wise affect, preempt, or displace any cause of action or 
State or Federal law creating a remedy for civil relief or 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00091
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
criminal cause of action, whether statutory or based in 
common law.’’. 
SEC. 114. ENFORCEMENT. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed— 
(1) in paragraph (e)— 
(A) by striking ‘‘504, 564,’’ and inserting 
‘‘504, 564, 611, 612’’; and 
(B) by striking ‘‘519, 564,’’ and inserting 
‘‘519, 564, 609, 611,’’; 
(2) in paragraph (j) by inserting ‘‘607, 608, 
610, 611’’ before ‘‘704’’; 
(3) in paragraph (ii)— 
(A) by striking ‘‘760 or 761)’’ and insert-
ing ‘‘604, 760, or 761)’’; and 
(B) by striking ‘‘760 or 761) submitted’’ 
and inserting ‘‘611, 760, or 761) submitted’’; 
(4) in paragraph (xx), by inserting ‘‘or 613’’ 
after ‘‘423’’; and 
(5) by adding at the end the following: 
‘‘(fff) The failure to register in accordance with sec-
tion 605, the failure to submit a cosmetic ingredient state-
ment under section 606, the failure to provide information 
required by section 605 or 606, or the failure to update 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00092
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
the information required by section 605 or 606, as re-
quired.’’. 
(b) ADULTERATION.—Section 601 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 361), as 
amended by section 603, is further amended by adding 
at the end the following: 
‘‘(g) If it contains, after the date prescribed under 
section 608(d)(3), an ingredient that the Secretary has de-
termined under section 608(d)(4) to be not safe, or not 
safe under the conditions of use recommended or sug-
gested in the label based on an order issued by the Sec-
retary under section 608(d)(4). 
‘‘(h) If it is a cosmetic product for which any require-
ment of section 609 is not met.’’. 
(c) MISBRANDING.—Section 602 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 362), as 
amended by section 106, is further amended— 
(1) in paragraph (b)— 
(A) by striking ‘‘and (2)’’ and inserting 
‘‘(2)’’; and 
(B) by inserting ‘‘; and (3) a domestic ad-
dress or a domestic telephone number, or elec-
tronic contact information, through which the 
responsible person may receive a report of an 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00093
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
adverse event associated with the use of such 
cosmetic product’’ after ‘‘numerical count’’; and 
(2) by adding at the end the following: 
‘‘(h) If it is a cosmetic product and it has been manu-
factured, processed, packed, or held in any factory, ware-
house, or establishment and the responsible person delays, 
denies, or limits an inspection, or refuses to permit entry 
or inspection. 
‘‘(i) If a fragrance ingredient described in section 615 
is not disclosed to consumers through a method identified 
by the Food and Drug Administration in the guidance doc-
ument issued under such section. 
‘‘(j) If its labeling does not conform with a require-
ment under section 614.’’. 
(d) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall issue guidance that defines the cir-
cumstances that would constitute delaying, denying, or 
limiting inspection, or refusing to permit entry or inspec-
tion, for purposes of section 602(g) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (c)(2). 
(e) IMPORTS.—Section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00094
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
(1) by striking ‘‘section 760 or 761’’ the first, 
third, and fourth place such term appears and in-
serting ‘‘section 611, 760, or 761’’; and 
(2) by striking ‘‘760 or 761)’’ and inserting 
‘‘604, 760, or 761)’’. 
(f) FACILITY INSPECTION.—Section 704(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)(1)) is amended by inserting after the third sen-
tence the following: ‘‘In the case of any person who manu-
factures, processes, packs, holds, distributes, or imports 
a cosmetic product, or distributes a cosmetic product and 
affixes its name on the cosmetic label, the inspection shall 
extend to all records and other information described in 
section 612 (regarding inspection of cosmetic records), 
subject to the limitations under of such section.’’. 
TITLE II—FEES RELATED TO 
COSMETIC PRODUCTS 
SEC. 201. FINDINGS. 
The Congress finds that the fees authorized by the 
amendment made by section 202 of this Act will be dedi-
cated to cosmetic safety activities, as defined in section 
744L of the Federal Food, Drug, and Cosmetic Act, as 
added by such section 202. Such fees should supplement, 
not supplant, funding dedicated to cosmetic safety activi-
ties of the Food and Drug Administration. Future fees 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00095
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS
authorized by the reauthorization of part 10 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act to be collected by the Secretary of Health and Human 
Services should be dedicated to cosmetic safety activities 
as set forth in the goals identified for purposes of such 
part 10, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC 
PRODUCT FEES. 
Subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 
amended by adding at the end the following: 
‘‘PART 10—FEES RELATING TO COSMETIC 
PRODUCTS 
‘‘SEC. 744L. DEFINITIONS. 
‘‘For the purposes of this part: 
‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust-
ment factor’ applicable to a fiscal year means the 
Consumer Price Index for all urban consumers (all 
items; United States city average) for October of the 
VerDate Sep 11 2014 
02:40 Dec 07, 2019
Jkt 099200
PO 00000
Frm 00096
Fmt 6652
Sfmt 6201
E:\BILLS\H5279.IH
H5279
kjohnson on DSK79L0C42 with BILLS