I 
112TH CONGRESS 
2D SESSION 
H. R. 4262 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
of cosmetics. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 26, 2012 
Mr. PALLONE (for himself and Mr. DINGELL) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of cosmetics. 
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 
‘‘Cosmetics Safety Enhancement Act of 2012’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Registration of cosmetic facilities; listing of cosmetic products; fees. 
Sec. 3. Cosmetic product safety substantiation. 
Sec. 4. Serious adverse event reports for cosmetics. 
Sec. 5. Maintenance and access to records. 
Sec. 6. Good manufacturing practices for cosmetics. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
Sec. 7. Mandatory recall authority. 
Sec. 8. Effective dates. 
SEC. 2. REGISTRATION OF COSMETIC FACILITIES; LISTING 
OF COSMETIC PRODUCTS; FEES. 
(a) PROHIBITED ACT.—Section 301(dd) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(dd)) 
is amended by striking the period at the end and adding 
‘‘, the failure to register in accordance with section 604(a), 
or the failure to list a cosmetic product in accordance with 
section 604(b)’’. 
(b) ADULTERATION.—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 it was manufactured, packed, or held in a fa-
cility that is not duly registered under section 604(a), or 
if it is a cosmetic product that is not listed in accordance 
with section 604(b).’’. 
(c) ANNUAL REGISTRATION.—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. REGISTRATION OF COSMETIC FACILITIES AND 
COSMETIC PRODUCT LISTING. 
‘‘(a) REGISTRATION.— 
‘‘(1) IN GENERAL.—The Secretary shall by reg-
ulation require that any facility engaged in manufac-
turing, packing, or holding a cosmetic product or a 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
cosmetic formulation be registered annually with the 
Secretary. To be so registered, any such facility shall 
pay the registration fee required under section 744. 
‘‘(2) REGISTRATION.— 
‘‘(A) TIMING.—A registration under para-
graph (1) shall be submitted to the Secretary 
not later than December 31 of each year. 
‘‘(B) FORMAT; CONTENTS.—Each registra-
tion under paragraph (1) shall be submitted 
using an electronic format, as specified in regu-
lations or guidance issued by the Secretary, and 
shall include the following information: 
‘‘(i) The facility’s name and full ad-
dress, which address shall identify the pre-
cise physical location of the facility. 
‘‘(ii) The identity of the facility, in-
cluding the unique facility identifier, if 
any, previously assigned by the Secretary 
to the facility under paragraph (3). 
‘‘(iii) All business trading names used 
by the facility. 
‘‘(iv) The product category or cat-
egories of each cosmetic product or cos-
metic formulation manufactured, packed, 
or held at the facility. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(v) The type of activity conducted at 
the facility (such as manufacturing, pack-
ing, or holding). 
‘‘(vi) The name, title, street address, 
telephone number, and, if available, the 
email address of the emergency contact for 
the facility. 
‘‘(vii) In the case of a foreign facility, 
the name, street address, telephone num-
ber, emergency contact information, and, if 
available, the email address of the United 
States agent for the facility. 
‘‘(viii) The name, title, street address, 
telephone number, and, if available, email 
address of the individual submitting the 
registration. 
‘‘(ix) 
Additional 
information 
per-
taining to the facility or to the cosmetic 
products or cosmetic formulations manu-
factured, packed, or held at the facility, as 
the Secretary may require by regulation. 
‘‘(C) CHANGES
TO
INFORMATION.—The 
registrant shall notify the Secretary of any 
change to the information described in clauses 
(i) through (ix) of subparagraph (B) not later 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
than 30 days after the date of such change un-
less otherwise specified by the Secretary. 
‘‘(3) PROCEDURE.—Upon receipt of a com-
pleted registration under paragraph (1), the Sec-
retary shall notify the registrant of the receipt of 
such registration. At the time of the initial registra-
tion of any cosmetic facility under this section, the 
Secretary shall assign a unique facility identifier to 
the facility. 
‘‘(4) LIST.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
compile and maintain an up-to-date list of fa-
cilities that are registered under this section. 
‘‘(B) REMOVAL.—The Secretary shall— 
‘‘(i) remove from such list the name 
of any facility whose registration under 
this section is suspended or cancelled; and 
‘‘(ii) initiate proceedings in accord-
ance with paragraph (6) to cancel the reg-
istration of any facility that— 
‘‘(I) fails to re-register under this 
section; or 
‘‘(II) fails to pay the registration 
fee required under section 744. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(C) PUBLIC AVAILABILITY.—The list of 
registered facilities maintained pursuant to sub-
paragraph (A) and any registration documents 
submitted pursuant to this subsection shall not 
be subject to disclosure under section 552 of 
title 5, United States Code. Information derived 
from such list or registration documents shall 
not be subject to disclosure under section 552 
of title 5, United States Code, to the extent 
that such information discloses the identity or 
location of a specific registered facility. 
‘‘(5) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN
GENERAL.—The Secretary may 
suspend the registration of any facility under 
this section for a violation of this Act that could 
result in serious adverse health consequences or 
death to humans or animals. 
‘‘(B) NOTICE
OF
SUSPENSION.—Suspen-
sion of a registration under this section shall be 
preceded by— 
‘‘(i) notice, as defined in guidance or 
regulations issued by the Secretary, to the 
facility of the intent to suspend the reg-
istration; and 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(ii) an opportunity for an informal 
hearing concerning the suspension of the 
such registration for such facility. 
‘‘(C) 
REINSTATEMENT.—A 
registration 
that is suspended under this section may be re-
instated pursuant to criteria published by the 
Secretary in the Federal Register and on a pub-
lic Web site of the Food and Drug Administra-
tion. 
‘‘(6) CANCELLATION OF REGISTRATION.— 
‘‘(A) IN GENERAL.—Not earlier than 10 
days after providing notice under subparagraph 
(B), the Secretary may cancel a registration 
under this section if the Secretary determines 
that— 
‘‘(i) the registration was not updated 
in accordance with this section or other-
wise contains false, incomplete, or inac-
curate information; or 
‘‘(ii) the required registration fee 
under section 744 has not been paid within 
30 days after the date due. 
‘‘(B) NOTICE
OF
CANCELLATION.—Can-
cellation shall be preceded by notice to the facil-
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
ity of the intent to cancel the registration and 
the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the facility is updated or 
corrected and the required registration fee is 
paid no later than 7 days after notice is pro-
vided under subparagraph (B), the Secretary 
shall not cancel such registration. 
‘‘(b) COSMETIC PRODUCT LISTING.— 
‘‘(1) IN GENERAL.—Not later than March 31 of 
each year, every responsible person shall file with 
the Secretary a list, in such form as the Secretary 
may prescribe, of each cosmetic product owned by 
such person and distributed in the United States. 
‘‘(2) CONTENTS.—For each cosmetic product, 
the list required by paragraph (1) shall include the 
following information: 
‘‘(A) The unique facility identifier (as-
signed under subsection (a)(3)) of the facility 
where the cosmetic product is manufactured or 
packed, or, if the same cosmetic product is 
manufactured or packed in more than one facil-
ity, unique facility identifier of each facility 
where it is manufactured or packed. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(B) The brand name and the full name 
for the cosmetic product as it appears on the 
label. 
‘‘(C) The cosmetic product listing number, 
if any, previously assigned by the Secretary 
under paragraph (4) to the cosmetic product. 
‘‘(D) The applicable cosmetic category for 
the cosmetic product. 
‘‘(E) The ingredients in the cosmetic prod-
uct in descending order of predominance by 
weight, with each ingredient identified by the 
name adopted in regulations promulgated by 
the Secretary, if any, or by the common or 
usual name of the ingredient. 
‘‘(F) The title and full contact information 
of each individual submitting the list. 
‘‘(G) Such additional information per-
taining to the cosmetic product as the Secretary 
may require by regulation. 
‘‘(3) ADDITIONAL REQUIREMENTS.— 
‘‘(A) CERTIFICATION.—The filing for a 
cosmetic product under paragraph (1) shall in-
clude a certification, submitted by the respon-
sible person, that such list includes all cosmetic 
products owned by such person. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(B) CHANGES
TO
INFORMATION.—The 
responsible person shall notify the Secretary 
within 60 days of— 
‘‘(i) any change to the information re-
quired to be in such product list; or 
‘‘(ii) the discontinuation of the manu-
facture of a cosmetic product. 
‘‘(4) NOTIFICATION
TO
OWNER; ASSIGNMENT 
OF COSMETIC PRODUCT NUMBER.—Upon receipt of 
a list for a cosmetic product under paragraph (1), 
the Secretary shall— 
‘‘(A) notify the responsible person identi-
fied in such list that the list has been received; 
and 
‘‘(B) assign a cosmetic product number to 
any listed product not previously assigned a 
cosmetic product listing number. 
‘‘(5) UP-TO-DATE
LIST.—The Secretary shall 
compile and maintain an up-to-date list of cosmetic 
products distributed in the United States, including 
the ingredients of each such product. 
‘‘(c) DEFINITIONS.—For purposes of this section: 
‘‘(1) COSMETIC FORMULATION.—The term ‘cos-
metic formulation’ means a preparation of cosmetic 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
raw materials with a qualitatively and quantitatively 
set composition. 
‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 
product’ means a finished cosmetic that has under-
gone all stages of production, including packaging in 
its final container for shipment and application of a 
product label. 
‘‘(3) FACILITY.— 
‘‘(A)(i) The term ‘facility’ includes any fac-
tory, warehouse, or establishment facility (in-
cluding a factory, warehouse, or establishment 
of an importer) that manufactures, packs, or 
holds cosmetic products or cosmetic formula-
tions. 
‘‘(ii) Such term does not include— 
‘‘(I) beauty shops and salons; 
‘‘(II) pharmacies and other cosmetic 
product retailers, including individual sales 
representatives and retail distribution fa-
cilities; 
‘‘(III) hospitals, physicians’ offices, 
and health care clinics; 
‘‘(IV) public health agencies and other 
nonprofit entities that provide cosmetics 
directly to the consumer; 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(V) hotels and other entities that 
provide complimentary cosmetics to guests; 
‘‘(VI) trade shows and other venues 
where cosmetic product samples are pro-
vided free of charge; and 
‘‘(VII) entities that manufacture or 
compound cosmetic products solely for use 
in research, teaching, or pilot plant pro-
duction and not for sale. 
‘‘(B) The term ‘domestic facility’ means a 
facility located in any State. 
‘‘(C)(i) The term ‘foreign facility’ means a 
facility that manufactures, packs, or holds cos-
metics that are exported to the United States 
without further processing or packaging outside 
the United States. 
‘‘(ii) A cosmetic may not be considered to 
have undergone further processing or packaging 
for purposes of clause (i) solely on the basis 
that labeling was added or that any similar ac-
tivity of a de minimis nature was carried out 
with respect to the cosmetic. 
‘‘(4) RESPONSIBLE
PERSON.—The term ‘re-
sponsible person’ means a person (as defined in sec-
tion 201(e)) that is the owner of a cosmetic product 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
intended for introduction into United States com-
merce.’’. 
(d) REGISTRATION FEE.—Chapter VII of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 371 et 
seq.) is amended by adding at the end of subchapter C 
the following: 
‘‘PART 7—FEES RELATING TO COSMETICS 
‘‘SEC. 744. FACILITY REGISTRATION FEE. 
‘‘(a) IN GENERAL.— 
‘‘(1) ASSESSMENT
AND
COLLECTION.—Begin-
ning in fiscal year 2013, the Secretary shall assess 
and collect an annual fee for the registration of a fa-
cility under section 604(a). 
‘‘(2) PAYABLE DATE.—A fee under this section 
shall be payable— 
‘‘(A) for a facility that was not registered 
under section 604 for the preceding fiscal year, 
on the date of registration; and 
‘‘(B) for any other facility— 
‘‘(i) for fiscal year 2013, not later 
than the sooner of— 
‘‘(I) 90 days after the date of the 
enactment of this part; or 
‘‘(II) the date of re-registration; 
and 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(ii) for a subsequent fiscal year, on 
the date of re-registration. 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—The registration fee under 
subsection (a) shall be— 
‘‘(A) for fiscal year 2013, $500; and 
‘‘(B) for fiscal year 2014 and each subse-
quent fiscal year, the fee for fiscal year 2013 as 
adjusted under subsection (c). 
‘‘(2) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of fis-
cal year 2014 and each subsequent fiscal year, es-
tablish, for the next fiscal year, registration fees 
under subsection (a), as described in paragraph (1). 
‘‘(c) INFLATION ADJUSTMENT.—For fiscal year 2014 
and subsequent fiscal years, the revenues established in 
subsection (b) shall be adjusted by the Secretary by notice, 
published in the Federal Register, for a fiscal year to re-
flect the sum of one plus— 
‘‘(1) the average annual change in the cost, per 
full-time equivalent position of the Food and Drug 
Administration, of all personnel compensation and 
benefits paid with respect to such positions for the 
first 3 years of the preceding 4 fiscal years multi-
plied by the proportion of personnel compensation 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
and benefits costs to total costs of cosmetic safety 
activities for the first 3 years of the preceding 4 
years; and 
‘‘(2) the average annual change that occurred 
in the Consumer Price Index for urban consumers 
(Washington-Baltimore, DC–MD–VA–WV; Not Sea-
sonally Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 4 years of available 
data multiplied by the proportion of all costs other 
than personnel compensation and benefits costs to 
total costs of cosmetic safety activities for the first 
3 years of the preceding 4 fiscal years. 
The adjustment made each fiscal year under this sub-
section will be added on a compounded basis to the sum 
of all adjustments made each fiscal year after fiscal year 
2013 under this subsection. 
‘‘(d) LIMITATIONS.— 
‘‘(1) IN GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after 
fiscal year 2013 unless appropriations for salaries 
and expenses of the cosmetic products programs of 
the Food and Drug Administration for such fiscal 
year (excluding the amount of fees appropriated for 
such fiscal year) are equal to or greater than the 
amount of appropriations for the salaries and ex-
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
penses of the cosmetic products programs of the 
Food and Drug Administration for fiscal year 2012 
(excluding the amount of fees appropriated for such 
fiscal year) multiplied by the adjustment factor ap-
plicable to the fiscal year involved. 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate, for 
registration under section 604 at any time in such 
fiscal year. 
‘‘(3) ADJUSTMENT
FACTOR.—In this sub-
section, the term ‘adjustment factor’ applicable to a 
fiscal year is the Consumer Price Index for all urban 
consumers (all items; United States city average) for 
October of the preceding fiscal year divided by such 
Index for October 2011. 
‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified 
in appropriation Acts, or otherwise made avail-
able for obligation, for such fiscal year; and 
‘‘(B) shall only be collected and available 
to defray the costs of cosmetic safety activities. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of fiscal years 2013 through 2017, there 
are authorized to be appropriated for fees under this 
section such sums as may be necessary. 
‘‘(f) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
‘‘(g) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
positions in the Department of Health and Human Serv-
ices, for officers, employees, and advisory committees not 
engaged in cosmetic safety activities, be reduced to offset 
the number of officers, employees, and advisory commit-
tees so engaged. 
‘‘(h) ANNUAL FISCAL REPORTS.—Beginning with 
fiscal year 2014, not later than 120 days after the end 
of each fiscal year for which fees are collected under this 
section, the Secretary shall prepare and 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 on the imple-
mentation of the authority for such fees during such fiscal 
year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year. 
‘‘(i) DEFINITIONS.—In this section: 
‘‘(1) The term ‘costs of cosmetic safety activi-
ties’ means the expenses incurred in connection with 
cosmetic safety activities for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees and to contracts with 
such contractors; 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(B) laboratory capacity; 
‘‘(C) management of information, and the 
acquisition, maintenance, and repair of tech-
nology resources; 
‘‘(D) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(E) collecting fees under this section and 
accounting for resources allocated for cosmetic 
safety activities. 
‘‘(2) The term ‘cosmetic safety activities’ means 
activities of the Food and Drug Administration re-
lated to ensuring the safety of cosmetics sold for use 
in the United States, as authorized by this Act.’’. 
(e) TRANSITIONAL PROVISIONS.— 
(1) FEES.—The Secretary of Health and 
Human Services shall first impose the fee estab-
lished under section 744 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (d), for 
fiscal years beginning with fiscal year 2013. 
(2) SUNSET DATE.—Section 744 of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (d), does not authorize the assessment or col-
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
lection of a fee for registration under section 604 of 
such Act occurring after fiscal year 2017. 
SEC. 3. COSMETIC PRODUCT SAFETY SUBSTANTIATION. 
(a) ADULTERATION.—Section 601 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 361), as 
amended by section 2(b), is further amended by adding 
at the end the following: 
‘‘(g) If it is a cosmetic product for which any require-
ment of section 605 (relating to safety substantiation) is 
not met.’’. 
(b) SUBSTANTIATION.—Chapter VI of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), 
as amended, is further amended by adding at the end the 
following: 
‘‘SEC. 605. COSMETIC PRODUCT SAFETY SUBSTANTIATION. 
‘‘(a) IN GENERAL.—The responsible person shall— 
‘‘(1) before introduction or delivery for intro-
duction into interstate commerce of a cosmetic prod-
uct, establish a file containing scientific evidence 
pertaining to such product’s safety; and 
‘‘(2) maintain such file for no less than 5 years 
after the date on which such person ceases to intro-
duce such article into interstate commerce. 
‘‘(b) SCIENTIFIC EVIDENCE.—The scientific evidence 
required by subsection (a)(1) shall— 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(1) consist of studies, tests, data, or other in-
formation known to the responsible person that re-
lates to the cosmetic product’s safety; and 
‘‘(2) demonstrate that such cosmetic product is 
safe. 
‘‘(c) 
REQUESTS
BY
SECRETARY; 
ACCESS
TO 
RECORDS.—In response to a request by the Secretary, the 
responsible person shall promptly supply to the Secretary 
a copy of the file required under subsection (a). Such per-
son shall also permit an officer or employee duly des-
ignated by the Secretary, upon presentation of appropriate 
credentials, to have access at reasonable times to records 
required to be maintained under this section for the pur-
pose of inspection and copying. 
‘‘(d) DEFINITIONS.—For the purposes of this section: 
‘‘(1) The term ‘cosmetic product’ has the mean-
ing given to such term in section 604(c). 
‘‘(2) The term ‘safe’, with respect to a cosmetic 
product, means that evidence in the file established 
under subsection (a)(1) demonstrates that there is a 
reasonable certainty that no harm will result from 
the use of the cosmetic product under the intended 
conditions of use for such cosmetic product. 
‘‘(3) The term ‘responsible person’ has the 
meaning given to such term in section 604(c).’’. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
SEC. 4. SERIOUS ADVERSE EVENT REPORTS FOR COS-
METICS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed— 
(1) in subsection (e)— 
(A) by striking ‘‘or 761’’ and inserting 
‘‘761, or 606’’; and 
(B) by inserting ‘‘606,’’ before ‘‘909,’’; and 
(2) in subsection (ii)— 
(A) by striking ‘‘760 or 761’’ and inserting 
‘‘760, 761, or 606’’; 
(B) by striking ‘‘or the’’ and inserting ‘‘, 
the’’; and 
(C) by striking the period at the end and 
inserting ‘‘, or the falsification of a report sub-
mitted under section 606 to the Secretary.’’. 
(b) MISBRANDING.—Section 602 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend-
ed by adding at the end the following: 
‘‘(f) If it is a cosmetic product that is marketed in 
the United States, unless the label of such cosmetic prod-
uct includes a domestic address, including the street ad-
dress or P.O. box, city, State, and zip code, or a domestic 
telephone number, including the area code, through which 
the responsible person (as described in section 606(a)(1)) 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
may receive a report of a serious adverse event associated 
with the use of such cosmetic product.’’. 
(c) ADVERSE EVENT REPORTING.—Chapter VI of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 
et seq.), as amended, is further amended by adding at the 
end the following: 
‘‘SEC. 606. SERIOUS ADVERSE EVENT REPORTS FOR COS-
METICS. 
‘‘(a)(1) IN GENERAL.—The manufacturer, packer, or 
distributor of a cosmetic product distributed in the United 
States (referred to in this section as the ‘responsible per-
son’) shall submit to the Secretary under subsection (b) 
a report containing any information that such responsible 
person received concerning any serious adverse event that 
occurs in the United States and that is associated with 
the use of the cosmetic product in the United States, ac-
companied by a copy of the label on or within the retail 
packaging of such cosmetic product. 
‘‘(2) RETAILER.—A retailer whose name appears on 
the label of a cosmetic product and who is also a dis-
tributor of such product may agree in writing that the 
manufacturer of the cosmetic product shall submit the re-
ports required by paragraph (1) for any cosmetic product 
so long as the retailer directs to the manufacturer all in-
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
formation relating to each adverse event associated with 
such cosmetic product that is provided to the retailer. 
‘‘(b) SUBMISSION OF REPORTS.— 
‘‘(1) IN GENERAL.—A report under subsection 
(a) shall be submitted to the Secretary no later than 
15 business days after information concerning the 
adverse event is received at the place of business 
that is indicated on the label of the cosmetic, as re-
quired under section 602(b)(1). 
‘‘(2) CONTENTS.—A report under subsection 
(a) shall be submitted to the Secretary in a format, 
and shall contain the information, defined by the 
Secretary in guidance or by regulation, including the 
following information, to the extent to which such 
information has been provided to the responsible 
person: 
‘‘(A) The identity of the individual experi-
encing the adverse event. 
‘‘(B) The identity of the individual report-
ing the adverse event to the responsible person. 
‘‘(C) The identity of the cosmetic product 
associated with the adverse event. 
‘‘(D) A detailed description of the adverse 
event. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(3) ADDITIONAL INFORMATION.—The respon-
sible person submitting a report under subsection 
(a) may include any additional information and 
shall, within 15 business days of receiving any new 
information related to the serious adverse event re-
port, submit such new information to the Secretary. 
‘‘(c) 
MAINTENANCE
AND
INSPECTION
OF 
RECORDS.— 
‘‘(1) MAINTENANCE.—The responsible person 
shall maintain records of all information received by 
such person relating to each serious adverse event 
for a period of 6 years from initial receipt of such 
information. 
‘‘(2) RECORDS
INSPECTION.—The responsible 
person shall permit an officer or employee duly des-
ignated by the Secretary, upon presentation of ap-
propriate credentials, to have access, at reasonable 
times, to records required to be maintained under 
this subsection for the purpose of inspection and 
copying. 
‘‘(d) RELATION TO OTHER PROVISIONS.—A report 
under subsection (a) (including all information submitted 
in the initial report or added later) shall be considered 
to be— 
‘‘(1) a safety report under section 756; 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(2) a record about an individual under section 
552a of title 5, United States Code; and 
‘‘(3) a medical or similar file, the disclosure of 
which would constitute a violation of section 
552(b)(6) of such title 5, United States Code, and 
which shall not be disclosed under section 552 of 
such title. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) The term ‘serious’, with respect to an ad-
verse event associated with a cosmetic product, 
means— 
‘‘(A) resulting in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a disability, disfigurement, or in-
capacity; or 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(B) requiring, based on reasonable med-
ical judgment, a medical or surgical interven-
tion to prevent an outcome described in sub-
paragraph (A). 
‘‘(2) The term ‘cosmetic product’ has the mean-
ing given to such term in section 604(c). 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
‘‘(3) The term ‘retailer’ means a person that 
sells or otherwise provides a cosmetic product di-
rectly to a consumer.’’. 
(d) IMPORTED COSMETIC PRODUCTS.—Section 801 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381) is amended— 
(1) in subsection (a), by striking ‘‘760 or 761’’ 
each place it appears and inserting ‘‘760, 761, or 
606’’; and 
(2) in subsection (b), by striking ‘‘760 or 761’’ 
each place it appears and inserting ‘‘760, 761, or 
606’’. 
SEC. 5. MAINTENANCE AND ACCESS TO RECORDS. 
(a) IN GENERAL.—Chapter VI of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 
amended, is further amended by adding at the end the 
following: 
‘‘SEC. 607. MAINTENANCE AND ACCESS TO RECORDS. 
‘‘(a) RECORDS ACCESS.— 
‘‘(1) RECORDS
ACCESS
DURING
AN
INSPEC-
TION.— 
‘‘(A) IN
GENERAL.—Each person who 
manufactures, packs, or holds a cosmetic prod-
uct in the United States or for import into the 
United States shall, at the request of an officer 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
or employee duly designated by the Secretary, 
permit such officer or employee, upon presen-
tation of appropriate credentials, at reasonable 
times, within reasonable limits, and in a reason-
able manner, to have access to and copy all 
records relating to whether the cosmetic may be 
adulterated, misbranded, or otherwise in viola-
tion of this Act, including all records collected 
or developed to comply with section 605 (relat-
ing to cosmetic product safety substantiation) 
or 606 (relating to serious adverse event re-
ports). 
‘‘(B) SCOPE OF RECORDS.—The require-
ment under subparagraph (A) applies to all 
records relating to the manufacture, packing, or 
holding of such cosmetic product maintained by 
or on behalf of such person in any format and 
at any location. 
‘‘(C) IMMEDIATE AVAILABILITY WITH NO-
TICE.—Records not required to be made avail-
able immediately on commencement of an in-
spection under subparagraph (A) shall nonethe-
less be made available immediately on com-
mencement of such an inspection if, a reason-
able time before such inspection, the Secretary 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
by letter provides written notice to the person 
and identifies the records to be made available 
during such inspection. Nothing in this sub-
paragraph shall be construed as permitting a 
person to refuse to produce records required 
under and in accordance with subparagraph (A) 
due to failure of the Secretary to provide notice 
under this paragraph. 
‘‘(2) ADDITIONAL
AUTHORITIES
TO
ACCESS 
RECORDS REMOTELY; SUBMISSION OF RECORDS TO 
THE SECRETARY.— 
‘‘(A) REMOTE ACCESS IN EMERGENCIES.— 
If the Secretary has a reasonable belief that a 
cosmetic product has caused one or more seri-
ous adverse events (as such term is used in sec-
tion 606), the Secretary may require each per-
son who manufactures, packs, or holds such 
cosmetic product, or any cosmetic product that 
the Secretary determines may be affected in a 
similar manner, to submit to the Secretary all 
records reasonably related to such cosmetic 
product as soon as is reasonably practicable, 
after receiving written notice (including by no-
tice served personally and outside normal busi-
ness hours to an agent identified under clause 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
(vi) or (vii) of section 604(a)(2)(B) of such re-
quirement). 
‘‘(B) ELECTRONIC
SUBMISSION.—If the 
records required to be submitted to the Sec-
retary under subparagraph (A) are available in 
electronic format, such records shall be sub-
mitted electronically unless the Secretary speci-
fies otherwise in the notice under such subpara-
graph. 
‘‘(b) 
REGULATIONS
CONCERNING
RECORD-
KEEPING.—The Secretary shall, by regulation, establish 
requirements regarding the establishment and mainte-
nance, for not longer than 2 years, of records by persons 
who manufacture, pack, or hold cosmetics in the United 
States or for import into the United States, which records 
are needed by the Secretary for inspection to allow the 
Secretary to determine that the cosmetic is in compliance 
with applicable laws and regulations; to identify the pre-
vious sources and the subsequent recipients of a cosmetic, 
including its packaging; or for other purposes the Sec-
retary deems necessary to protect public health. The Sec-
retary shall take into account the size of a business in 
promulgating regulations under this subsection.’’. 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
(b) CONFORMING AMENDMENTS.—Section 704(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)) is amended— 
(1) in paragraph (1)— 
(A) by inserting after the second sentence 
the following: ‘‘In the case of any person who 
manufactures, packs, or holds cosmetics, the in-
spection shall extend to all records and other 
information described in or required under sec-
tion 607 bearing on whether a cosmetic is adul-
terated, misbranded, or otherwise in violation of 
this Act.’’; and 
(B) in the fourth sentence— 
(i) by striking ‘‘the preceding sen-
tence’’ and inserting ‘‘either of the pre-
ceding two sentences’’; 
(ii) by striking ‘‘and’’ after ‘‘or chap-
ter IX’’; and 
(iii) 
by 
inserting 
after 
‘‘section 
505(j))’’ the following: ‘‘, and formulas for 
a cosmetic, financial data, pricing data, 
personnel data, research data, or sales 
data (other than shipment data regarding 
sales) related to a cosmetic’’; and 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
(2) in paragraph (2), by striking ‘‘third sen-
tence’’ and inserting ‘‘fourth sentence’’. 
(c) NO EFFECT ON OTHER PROVISIONS.—This sec-
tion shall not be construed to limit the authority of the 
Secretary to require the establishment and maintenance 
of records under any other provision of this Act. 
SEC. 6. GOOD MANUFACTURING PRACTICES FOR COS-
METICS. 
(a) IN GENERAL.—Section 601 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361), as amended by 
section 3(a), is further amended by adding at the end the 
following: 
‘‘(h) If the methods used in, or the facilities or con-
trols used for, its manufacture, packing, or holding do not 
conform to current good manufacturing practice, as pre-
scribed by the Secretary in regulations, to ensure that the 
cosmetic is safe and otherwise in compliance with this 
Act.’’. 
(b) REGULATIONS.— 
(1) PROMULGATION.—The Secretary of Health 
and Human Services, acting through the Commis-
sioner of Food and Drugs, shall promulgate regula-
tions to carry out section 601(h) of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (a). 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS
(2) INTERNATIONAL STANDARDS.—In promul-
gating such regulations, the Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall review international stand-
ards for cosmetic product good manufacturing prac-
tice that are in existence on the date of enactment 
of this Act to ensure that such regulations are con-
sistent, to the extent the Secretary determines prac-
ticable and appropriate, with such standards. 
SEC. 7. MANDATORY RECALL AUTHORITY. 
(a) PROHIBITED ACT.—Section 301(xx) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(xx)) 
is amended by inserting ‘‘or 608’’ after ‘‘The refusal or 
failure to follow an order under section 423’’. 
(b) RECALL AUTHORITY.—Chapter VI of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), 
as amended, is further amended by adding at the end the 
following: 
‘‘SEC. 608. MANDATORY RECALL AUTHORITY. 
‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 
determines that there is a reasonable probability that a 
cosmetic is adulterated under section 601 and the use of, 
or exposure to, such cosmetic will cause serious adverse 
health consequences or death to humans, the Secretary 
VerDate Mar 15 2010 
03:22 Mar 27, 2012
Jkt 019200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6201
E:\BILLS\H4262.IH
H4262
tjames on DSK6SPTVN1PROD with BILLS