section (b)(1), a brand owner of a cosmetic shall, with re-
spect to each ingredient that the brand owner uses in a 
cosmetic— 
‘‘(1) obtain, from each supplier or manufac-
turer of the ingredient, specifications for the ingre-
dient that include— 
‘‘(A) the level of each contaminant present 
in the ingredient; and 
‘‘(B) the detection limits of the analytical 
test used to detect the contaminant; or 
‘‘(2) comply with the requirements under para-
graphs (1) and (2) of subsection (c) for the ingre-
dient, in the same manner as if the brand owner 
were a supplier. 
‘‘SEC. 619. COSMETIC AND INGREDIENT STATEMENTS. 
‘‘(a) IN GENERAL.—Beginning 1 year after the date 
of the enactment of this subchapter, each brand owner of 
a cosmetic intended to be marketed in the United States 
shall submit electronically to the Secretary, for each cos-
metic that is intended to be marketed in the United 
States, a statement containing— 
‘‘(1) the registration number of the brand 
owner; 
‘‘(2) the brand name and the product name for 
the cosmetic; 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00038
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(3) the applicable use for the cosmetic; 
‘‘(4) the ingredient list as it appears on the cos-
metic label or insert, including the particle size 
range of any nanoscale cosmetic ingredients; 
‘‘(5) any warnings and directions for use from 
the cosmetic label or insert; and 
‘‘(6) the title and full contact information for 
the individual responsible for submitting and main-
taining such statement. 
‘‘(b) NEW COSMETICS.—Any brand owner that be-
gins to market a cosmetic after the date of the enactment 
of this subchapter shall comply with the requirements of 
subsection (a) beginning on the later of the following: 
‘‘(1) The end of the 18-month period beginning 
on the date of the enactment of this subchapter. 
‘‘(2) The 6-month period after the date on 
which the establishment begins to manufacture such 
cosmetic. 
‘‘(c) NOTIFICATION OF CHANGES.—The brand owner 
shall notify the Secretary annually of any change to the 
information required under subsection (a). 
‘‘(d) PROCEDURE.—Upon receipt of a completed 
statement described under subsection (a), the Secretary 
shall notify the brand owner of the receipt of such state-
ment and assign a cosmetic statement number. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00039
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(e) LIST.—The Secretary shall compile, maintain, 
and update as appropriate, a list of cosmetics for which 
statements are submitted under this section. 
‘‘(f) ACCESS TO SAFETY INFORMATION.—The cos-
metic and ingredient statements collected under this sec-
tion shall be added to the publicly accessible database cre-
ated by the Secretary under section 615(b). 
‘‘SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED COS-
METICS. 
‘‘(a) NOTIFICATION
OF ADULTERATED
OR MIS-
BRANDED COSMETICS.— 
‘‘(1) IN GENERAL.—A responsible party that 
has reason to believe that a cosmetic, when intro-
duced into or while in interstate commerce, or while 
held for sale (regardless of whether such sale is the 
first sale of such cosmetic) after shipment in inter-
state commerce, is adulterated or misbranded in a 
manner that presents a reasonable probability that 
the use or exposure to the cosmetic (or an ingredient 
or component used in any such cosmetic) will cause 
a threat of serious adverse event shall notify the 
Secretary of the identity and location of the cos-
metic. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00040
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation or guidance. 
‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur-
poses of this subsection, the term ‘responsible party’ 
means a brand owner, manufacturer, packager, re-
tailer, or distributor of the cosmetic. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a cosmetic that the 
Secretary has reason to believe is adulterated, misbranded, 
or otherwise in violation of this Act voluntarily— 
‘‘(1) recall such cosmetic; and 
‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
‘‘(c) ORDER TO CEASE DISTRIBUTION.— 
‘‘(1) IN GENERAL.—If the Secretary has reason 
to believe that— 
‘‘(A) the use of, or exposure to, a cosmetic 
may cause serious adverse event; 
‘‘(B) the cosmetic is misbranded; or 
‘‘(C) the cosmetic is marketed, manufac-
tured, packaged, or distributed by an unregis-
tered brand owner; 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00041
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
the Secretary shall have the authority to issue an 
order requiring any person who distributes such cos-
metic to immediately cease distribution of such cos-
metic. 
‘‘(2) CEASE DISTRIBUTION AND NOTICE.—Any 
person who is subject to an order under paragraph 
(1) shall immediately cease distribution of such cos-
metic and provide notification as required by such 
order. 
‘‘(3) APPEAL.— 
‘‘(A) 24 HOURS.—A person subject to an 
order under paragraph (1) may appeal such 
order to the Secretary within 24 hours of the 
issuance of such order. 
‘‘(B) CONTENTS OF APPEAL.—Such appeal 
may include a request for an informal hearing 
and a description of any efforts to recall such 
cosmetic undertaken voluntarily by the person, 
including after a request under subsection (b). 
‘‘(C) INFORMAL HEARING.—Except as pro-
vided in subsection (e), an informal hearing 
shall be held as soon as practicable, but not 
later than 5 calendar days (or less as deter-
mined by the Secretary) after such an appeal is 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00042
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
filed, unless the parties jointly agree to an ex-
tension. 
‘‘(D) IMPACT ON RECALL.—If an appeal is 
filed under subparagraph (A), the Secretary 
may not amend the order to require a recall 
under subsection (d) until after the conclusion 
of the hearing under subparagraph (C). 
‘‘(4) VACATION OF ORDER.—If the Secretary 
determines that inadequate grounds exist to support 
the actions required by the order under paragraph 
(1), the Secretary shall vacate the order. 
‘‘(d) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (e) and subject to subsection (c)(3)(D), if 
the Secretary determines that a recall of a cosmetic 
subject to an order under subsection (c) is appro-
priate, the Secretary shall amend the order to re-
quire a recall. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
‘‘(A) specify a timetable in which the recall 
will occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; and 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00043
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(C) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
In providing for such notice, the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(3) NONDELEGATION.—An amended order 
under this subsection may only be issued by the Sec-
retary or an official designated by the Secretary, and 
may not be delegated to another official or employee. 
‘‘(4) DETERMINATION.—If the Secretary deter-
mines that inadequate grounds exist to support the 
amendment made to the order under paragraph (1), 
the Secretary shall remove such amendment from 
such order. 
‘‘(e) EMERGENCY RECALL ORDER.— 
‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that a cosmetic subject 
to an order under subsection (c) presents an immi-
nent threat of serious adverse event, the Secretary 
may issue an order requiring any person who dis-
tributes such cosmetic— 
‘‘(A) to immediately recall such cosmetic; 
and 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00044
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) RECALL AND NOTICE.—Any person who is 
subject to an emergency recall order under this sub-
section shall immediately recall such cosmetic and 
provide notification as required by such order. 
‘‘(3) APPEAL.— 
‘‘(A) 24 HOURS.—Any person subject to 
such an order may appeal such order to the 
Secretary within 24 hours of the issuance of 
such order. 
‘‘(B) CONTENTS OF APPEAL.—Such appeal 
may include a request for an informal hearing 
and a description of any efforts to recall such 
cosmetic undertaken voluntarily by the person, 
including after a request under subsection (b). 
‘‘(C) INFORMAL
HEARING.—An informal 
hearing shall be held as soon as practicable 
after the appeal is filed under subparagraph 
(A), but not later than 5 calendar days after 
such an appeal is filed, or fewer days (as deter-
mined by the Secretary), unless the parties 
jointly agree to an extension. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00045
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(4) VACATION OF ORDER.—If the Secretary 
determines that inadequate grounds exist to support 
the actions required by the order under paragraph 
(1), the Secretary shall vacate the order. 
‘‘(5) NONDELEGATION.—An order under this 
subsection may only be issued by the Secretary or an 
official designated by the Secretary, and may not be 
delegated to another official or employee. 
‘‘(f) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to consumers to whom the cosmetic was, or may 
have been, distributed and to appropriate State and local 
health officials. 
‘‘(g) SUPPLY CHAIN INFORMATION.— 
‘‘(1) IN GENERAL.—In the case of a cosmetic 
that the Secretary has reason to believe is adulter-
ated, misbranded, or otherwise in violation of this 
Act, the Secretary shall request that the brand 
owner named on the label of such cosmetic (as re-
quired under section 602(b)(1)) submit all of the fol-
lowing information: 
‘‘(A) The name and place of business of 
the manufacturer, packager, supplier, or dis-
tributor from which such entity received the 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00046
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
cosmetic or ingredients for manufacturing such 
cosmetic. 
‘‘(B) The name and place of business of 
any entity (including any retailer) that was pro-
vided with such cosmetic by the entity named 
on the label. 
‘‘(2) COLLECTION
OF
ADDITIONAL
SUPPLY 
CHAIN
INFORMATION.—In the case of a cosmetic 
that the Secretary has reason to believe is adulter-
ated, misbranded, or otherwise in violation of this 
Act, to the extent necessary to protect the safety of 
the public, the Secretary may request that any entity 
(including a supplier of an ingredient, manufacturer, 
packer, distributor, or retailer) in the supply chain 
of such cosmetic submit to the Secretary information 
that is similar to the information described under 
subparagraphs (A) and (B) of paragraph (1). 
‘‘(3) MAINTENANCE OF RECORDS.—Any entity 
in supply chain of a cosmetic (including the brand 
owner named on the label of a cosmetic) shall— 
‘‘(A) maintain records sufficient to provide 
the information described in subparagraphs (A) 
and (B) of paragraph (1); and 
‘‘(B) provide such information to the Sec-
retary upon the request of the Secretary. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00047
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting the authority of the 
Secretary to issue an order to cease distribution of, or to 
recall, a cosmetic under any other provision of this Act. 
‘‘SEC. 621. PETITIONS. 
‘‘(a) IN GENERAL.—The Secretary shall complete 
and publish a review, and, if appropriate, immediately re-
vise related, relevant information, including ingredient 
lists, ingredient restrictions or prohibitions, or ingredient 
or cosmetic safety determinations, not later than 6 months 
after the date on which the Secretary receives from any 
individual or entity a reasonable petition— 
‘‘(1) to prohibit or restrict an ingredient for use 
in cosmetics and list such ingredient on the list 
under section 616(b); 
‘‘(2) to remove an ingredient from the list of in-
gredients that are safe without limits under section 
616(c); 
‘‘(3) to add an ingredient to the priority assess-
ment list under section 616(d); or 
‘‘(4) to add an ingredient to the list of contami-
nants under section 618. 
‘‘(b) REASONABLE PETITION.—Not later than 1 year 
after the date of the enactment of this Act, the Secretary 
shall issue rules specifying the criteria which the Secretary 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00048
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
will use to determine if a petition submitted under this 
section is a reasonable petition. 
‘‘SEC. 622. MANDATORY REPORTING OF SERIOUS ADVERSE 
EVENTS. 
‘‘(a) SUBMISSION OF REPORT ON SERIOUS ADVERSE 
EVENTS.—The Secretary shall require that the brand 
owner of a cosmetic whose name appears on the label of 
a cosmetic marketed in the United States submit to the 
Secretary a report containing information received con-
cerning any serious adverse event associated with the use 
of the cosmetic. 
‘‘(b) TIMING OF REPORT.—A report under subsection 
(a) shall be submitted to the Secretary not later than 15 
business days after information concerning the serious ad-
verse event is received at the place of business of the brand 
owner. 
‘‘(c) CONTENT OF REPORT.—A report under sub-
section (a) shall include the following information, to the 
extent to which the brand owner submitting the report has 
been able to verify the information: 
‘‘(1) The identity of the individual experiencing 
the adverse health event. 
‘‘(2) An identifiable report of such effect. 
‘‘(3) The name of the cosmetic suspected of 
causing such effect. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00049
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(4) A description of the adverse health event. 
‘‘(d) PUBLIC AVAILABILITY AND PRIVACY.— 
‘‘(1) PUBLIC AVAILABILITY.—Subject to para-
graph (2), the serious adverse event reports collected 
by the Secretary under this section shall be sub-
mitted electronically and shall be made accessible to 
the public. 
‘‘(2) PRIVACY.— 
‘‘(A) PERSONALLY IDENTIFIABLE INFOR-
MATION.—Notwithstanding any other provision 
of law, personally identifiable information in se-
rious adverse event reports provided to the Sec-
retary under this section, shall not— 
‘‘(i) be made publicly available pursu-
ant to any State or other law requiring dis-
closure of information or records; or 
‘‘(ii) otherwise be disclosed or distrib-
uted to any party without the written con-
sent of the Secretary and the person sub-
mitting such information to the Secretary. 
‘‘(B) 
TREATMENT
OF
INFORMATION 
UNDER PRIVACY ACT AND FOIA.—A report sub-
mitted to the Secretary under this section, shall 
be considered to be a record about an individual 
under section 552a of title 5, United States 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00050
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
Code (commonly referred to as the ‘‘Privacy 
Act of 1974’’) and a medical or similar file the 
disclosure of which would constitute a violation 
of section 552 of such title 5 (commonly re-
ferred to as the ‘‘Freedom of Information 
Act’’), and shall not be publicly disclosed unless 
all personally identifiable information is re-
dacted. 
‘‘SEC. 623. NONCONFIDENTIAL INFORMATION. 
‘‘(a) INFORMATION AVAILABLE TO PUBLIC.—Subject 
to subsection (c) and section 622(d)(2), all nonconfidential 
information submitted pursuant to this subchapter shall 
be made available to the public, including the following 
types of information: 
‘‘(1) The name, identity, and structure of a 
chemical substance, contaminant, or impurity that is 
an ingredient. 
‘‘(2) All information concerning function, expo-
sure, toxicity data, health hazards, and environ-
mental hazards for a cosmetic. 
‘‘(3) The functions of ingredients in cosmetics. 
‘‘(4) Fragrance, flavor, and colorants in a cos-
metic. 
‘‘(b) CONFIDENTIAL INFORMATION.—The concentra-
tion of cosmetic ingredients used in a finished cosmetic 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
shall be considered confidential business information and 
may not be made available to the public under subsection 
(a). 
‘‘(c) PETITION FOR INFORMATION TO REMAIN CON-
FIDENTIAL.— 
‘‘(1) IN GENERAL.—The Secretary shall create 
a process for an entity to petition for nonconfidential 
information described in subsection (a) to remain 
confidential if the entity shows that there would be 
a serious negative impact to the entity’s commercial 
interests if such information were disclosed to the 
public. 
‘‘(2) LIMITATION.—The Secretary may not ap-
prove a petition under paragraph (1) to the extent 
that such petition would prevent the public disclo-
sure of— 
‘‘(A) the name, identity, and structure of 
any chemical substance, contaminant, or impu-
rity that is an ingredient; 
‘‘(B) all health and safety data related to 
that substance, contaminant, or impurity; or 
‘‘(C) any data used to substantiate the 
safety of that substance, contaminant, or impu-
rity. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘SEC. 624. BAN ON USE OF ANIMAL TESTING. 
‘‘(a) BAN.—Beginning on the date of enactment of 
this subchapter, it shall be unlawful for any entity to con-
duct, directly or pursuant to contract, animal testing for 
the purpose of developing a cosmetic for sale in or affect-
ing interstate commerce. 
‘‘(b) LIMITATION ON CONSIDERATION OF DATA.— 
The Secretary shall not take into consideration any animal 
testing on a finished cosmetic product or an ingredient 
that occurs on or after the date of enactment of this sub-
chapter with respect to any determination as to whether 
a cosmetic or ingredient meets the safety standard under 
section 614(a). 
‘‘(c) EXCEPTION.—Subsections (a) and (b) shall not 
apply with respect to animal testing if— 
‘‘(1) the animal testing is for the purpose of de-
termining whether an ingredient, or the relevant cat-
egory of ingredients, meets the safety standard 
under section 614(a); and 
‘‘(2) the Secretary determines that the safety of 
the ingredient, or the relevant category of ingredi-
ents, cannot be established using a non-animal test-
ing method that is validated by the Interagency Co-
ordinating Committee on the Validation of Alter-
native Methods. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(d) VALIDATED, ELIGIBLE NON-ANIMAL TESTING 
METHODS.— 
‘‘(1) LIST.—The Secretary shall develop, main-
tain, and make publicly available a list of non-animal 
testing methods that— 
‘‘(A) are validated by the Interagency Co-
ordinating Committee on the Validation of Al-
ternative Methods; and 
‘‘(B) are eligible for use pursuant to the 
exception described in subsection (c). 
‘‘(2) INITIAL LIST; UPDATES.—The Secretary 
shall— 
‘‘(A) not later than 1 year after the date 
of enactment of this subchapter, publish the ini-
tial list under paragraph (1); and 
‘‘(B) annually thereafter, update such list. 
‘‘(e) GRANTS.—The Secretary shall award grants for 
the development of testing methods that may be used to 
replace animal testing pursuant to the exception described 
in subsection (c). 
‘‘SEC. 625. PRODUCT TESTING AND REVIEW AUDIT. 
‘‘The Secretary shall conduct annual audits of ran-
dom samples of cosmetics to assess or test for acute nega-
tive reactions, pathogen hazards, contaminants, leaching 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
of packaging additives, mislabeling, or other relevant 
issues of concern (as determined by the Secretary). 
‘‘SEC. 626. RESOURCES FOR SMALL BUSINESSES. 
‘‘The Secretary shall provide technical support to as-
sist small businesses in carrying out the requirements of 
this subchapter. 
‘‘SEC. 627. INTERAGENCY COOPERATION. 
‘‘(a) INTERAGENCY COUNCIL ON COSMETIC SAFE-
TY.—There is established an Interagency Council on Cos-
metic Safety for the purpose of sharing data and pro-
moting collaboration on cosmetic safety between the Food 
and Drug Administration, the National Institute of Envi-
ronmental Health Sciences, the Centers for Disease Con-
trol and Prevention, the Occupational Safety and Health 
Administration, and the Environmental Protection Agen-
cy. 
‘‘(b) USE OF DATA FROM FEDERAL SOURCES.—For 
purposes of this subchapter, the Secretary, as appropriate, 
shall request and utilize ingredient and cosmetic toxicity, 
use, and exposure data from other Federal agencies. 
‘‘SEC. 628. SAVINGS CLAUSE. 
‘‘Nothing in this Act affects the right of a State or 
a political subdivision of a State to adopt or enforce any 
regulation, requirement, or standard of performance that 
is different from, or in addition to, a regulation, require-
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
ment, liability, or standard for performance established 
pursuant to this Act unless compliance with both this Act 
and the State or political subdivision of a State regulation, 
requirement, or standard of performance is impossible, in 
which case the applicable provisions of this Act shall con-
trol. 
‘‘SEC. 629. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated such sums 
as may be necessary to carry out this subchapter for each 
of the fiscal years 2014 through 2018.’’. 
(b) ADULTERATED AND MISBRANDED COSMETICS.— 
(1) ADULTERATED COSMETICS.—Section 601 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 361) is amended in paragraph (a)— 
(A) by striking ‘‘, except that this provi-
sion shall not apply to coal-tar hair dye’’ and all 
that follows through ‘‘or eyebrow dyes’’; and 
(B) by adding at the end the following: 
‘‘(f) If it is manufactured in a manner that fails 
to comply with section 617(a). 
‘‘(g) If it is imported, distributed, or marketed 
and— 
‘‘(1) it contains an ingredient on the list 
under section 616(b)(1)(A), and the manufac-
turer has not complied with section 616(b)(5) 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
with respect to such ingredient and such cos-
metic; or 
‘‘(2) it contains an ingredient on the list 
under section 616(b)(1)(B), such ingredient is 
being used in a manner that violates the limit 
on use or concentration of such ingredient 
under section 616(b)(3), and the manufacturer 
has not complied with section 616(b)(5) with 
respect to such ingredient and such cosmetic. 
‘‘(h) If it is marketed by a brand owner that, 
with respect to such cosmetic, is required to dem-
onstrate, under section 617(b)(2), that the cosmetic 
meets the safety standard and the brand owner has 
not yet submitted the required data under section 
617(b)(3).’’. 
(2) MISBRANDED COSMETICS.—Section 602 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 362) is amended— 
(A) in paragraph (a), by inserting ‘‘or fails 
to meet the requirements of section 613 or 
618(b)’’ before the period; and 
(B) by adding at the end the following: 
‘‘(g) If it— 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(1) was brought to market by a brand 
owner that failed to register and pay the appli-
cable fee as required under section 612; 
‘‘(2) is brought to market, manufactured, 
packaged, distributed, or sold in retail by a 
brand owner, manufacturer, packager, dis-
tributor, or retailer, respectively, who fails to 
notify the Secretary as required under section 
620(a)(1); 
‘‘(3) is distributed in violation of an order 
under section 620(c); 
‘‘(4) is not recalled as required by an order 
under subsection (d) or (e) of section 620; 
‘‘(5) is manufactured in a manner that 
fails to comply with good manufacturing prac-
tices prescribed by the Secretary under section 
614(b); or 
‘‘(6) is brought to market by a brand 
owner who fails— 
‘‘(A) to submit the statement required 
under section 619; or 
‘‘(B) notify the Secretary of changes 
to information contained in such report, as 
required by such section.’’. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
(3) ADDITIONAL PROHIBITIONS.—Section 301 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331) is amended— 
(A) in paragraph (e), by inserting ‘‘612,’’ 
after ‘‘564,’’ each place it appears; and 
(B) by adding at the end the following: 
‘‘(ccc) The failure of a brand owner, manufac-
turer, or supplier of a cosmetic or an ingredient for 
use in a cosmetic to submit and update data and in-
formation as required under section 615(a). 
‘‘(ddd) The manufacture, importation, distribu-
tion, or marketing of an ingredient for use in a cos-
metic that is on the list under section 616(b)(1)(A). 
‘‘(eee) The failure of a supplier of an ingredient 
for use in a cosmetic— 
‘‘(1) to provide data and information as re-
quired by section 615(a)(4)(B); or 
‘‘(2) comply with the testing requirements 
under section 618(c). 
‘‘(fff) The failure of a manufacturer to comply 
with the requirements of section 618(d). 
‘‘(ggg) The failure of a brand owner of a cos-
metic to comply with the requirement of reporting 
serious adverse events under section 622. 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(hhh) The conduct of animal testing in viola-
tion of section 624.’’. 
SEC. 3. WORKER ISSUES. 
(a) IN GENERAL.—The Secretary of Labor shall pro-
mulgate an occupational safety and health standard under 
section 6 of the Occupational Safety and Health Act of 
1970 (29 U.S.C. 655) that requires the following: 
(1) MANUFACTURERS AND IMPORTERS.—Each 
manufacturer or importer selling any cosmetic for 
professional use shall— 
(A) obtain or develop a material safety 
data sheet described in subsection (b) for each 
such cosmetic or personal care product that— 
(i) the manufacturer or importer pro-
duces or imports; and 
(ii) includes a hazardous chemical, or 
a product ingredient associated with any 
chemical hazard, that is classified as a 
health hazard in accordance with the cri-
teria found in section 1910.1200(d) of title 
29 of the Code of Federal Regulations, and 
any successor regulations; and 
(B) make the material safety data sheet 
available on the manufacturer or importer’s 
Web site (in addition to any other required 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
manner of making such sheet available) to dis-
tributors and employers, including salon own-
ers, in English, Spanish, Vietnamese, and, upon 
request, other languages. 
(2) DISTRIBUTORS.—Each distributor of a cos-
metic or personal care product for professional use 
shall distribute and provide material safety data 
sheets described in subsection (b) in the same man-
ner as a distributor of a chemical hazard is required 
to distribute and provide material safety data sheets 
under section 1910.1200(g) of title 29, Code of Fed-
eral Regulations, or any successor regulations. 
(3) EMPLOYERS.—Each employer, including 
any operator of a salon, shall— 
(A) have a material safety data sheet in 
the workplace for each cosmetic or personal 
care product for professional use that is used in 
the course of the employer’s business; 
(B) make such material safety data sheet 
available to all employees of the employer who 
are exposed or use the product to the same ex-
tent and in the same manner as material safety 
data sheets are required to be made available 
under section 1910.1200(g) of title 29, Code of 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00061
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
Federal Regulations, or any successor regula-
tions; and 
(C) upon request, provide employees with 
translations of such material safety data sheet 
in other languages, including Spanish and Viet-
namese. 
(b) CONTENTS
OF
MATERIAL
SAFETY
DATA 
SHEET.—A material safety data sheet for a cosmetic or 
personal care product for professional use described in this 
section shall— 
(1) contain the information required in a mate-
rial safety data sheet under section 1910.1200(g) of 
title 29, Code of Federal Regulations, or any suc-
cessor regulations, for each hazardous chemical, or 
product ingredient associated with any chemical haz-
ard, described in subsection (a)(1)(A)(ii); and 
(2) include the following statement: ‘‘This ma-
terial safety data sheet is also available in multiple 
languages by contacting the manufacturer, using the 
contact information provided on this sheet.’’. 
(c) PROFESSIONAL USE DEFINED.—In this section, 
the term ‘‘professional use’’ has the meaning given such 
term in section 611(8) of the Federal Food, Drug, and 
Cosmetic Act except to the extent that such term applies 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00062
Fmt 6652
Sfmt 6201
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS
to a product that is sold as a retail product in any of the 
establishments listed under such definition. 
Æ 
VerDate Sep 11 2014 
23:48 Oct 02, 2018
Jkt 079200
PO 00000
Frm 00063
Fmt 6652
Sfmt 6301
E:\BILLS\H6903.IH
H6903
pamtmann on DSKBFK8HB2PROD with BILLS