1.Short title; table of
contents
(a)This Act may be cited
as the Cosmetics Safety Enhancement
Act of 2012
.
(b)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.
Sec. 7. Mandatory recall authority.
Sec. 8. Effective dates.
2.Registration of
cosmetic facilities; listing of cosmetic products; fees
(a)Section 301(dd) of the
Federal 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)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 it was
manufactured, packed, or held in a facility 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)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:
604.Registration of
cosmetic facilities and cosmetic product listing
(a)
(1)The Secretary shall
by regulation require that any facility engaged in manufacturing, packing, or
holding a cosmetic product or a 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)
(A)A
registration under paragraph (1) shall be submitted to the Secretary not later
than December 31 of each year.
(B)Each registration under paragraph (1) shall be submitted
using an electronic format, as specified in regulations or guidance issued by
the Secretary, and shall include the following information:
(i)The facility’s
name and full address, which address shall identify the precise physical
location of the facility.
(ii)The identity of
the facility, including 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 categories of each cosmetic product or cosmetic formulation
manufactured, packed, or held at the facility.
(v)The type of
activity conducted at the facility (such as manufacturing, packing, 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 number, 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 pertaining to the facility or to the cosmetic products or cosmetic
formulations manufactured, packed, or held at the facility, as the Secretary
may require by regulation.
(C)The registrant
shall notify the Secretary of any change to the information described in
clauses (i) through (ix) of subparagraph (B) not later than 30 days after the
date of such change unless otherwise specified by the Secretary.
(3)Upon
receipt of a completed registration under paragraph (1), the Secretary shall
notify the registrant of the receipt of such registration. At the time of the
initial registration of any cosmetic facility under this section, the Secretary
shall assign a unique facility identifier to the facility.
(4)
(A)The Secretary shall
compile and maintain an up-to-date list of facilities that are registered under
this section.
(B)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 accordance with paragraph (6) to cancel the registration of any
facility that—
(I)fails to
re-register under this section; or
(II)fails to pay the
registration fee required under section 744.
(C)The list of registered facilities maintained
pursuant to subparagraph (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)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)Suspension 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 registration; and
(ii)an opportunity
for an informal hearing concerning the suspension of the such registration for
such facility.
(C)A
registration that is suspended under this section may be reinstated pursuant to
criteria published by the Secretary in the Federal Register and on a public Web
site of the Food and Drug Administration.
(6)Cancellation of
registration
(A)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 otherwise contains false,
incomplete, or inaccurate information; or
(ii)the required
registration fee under section 744 has not been paid within 30 days after the
date due.
(B)Cancellation shall be preceded by notice to the
facility of the intent to cancel the registration and the basis for such
cancellation.
(C)Timely update or
correctionIf the registration for the facility is updated or
corrected and the required registration fee is paid no later than 7 days after
notice is provided under subparagraph (B), the Secretary shall not cancel such
registration.
(b)
(1)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)For
each cosmetic product, the list required by paragraph (1) shall include the
following information:
(A)The unique facility identifier (assigned
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 facility, unique facility identifier of each facility
where it is manufactured or packed.
(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 product 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 pertaining to
the cosmetic product as the Secretary may require by regulation.
(3)
(A)The
filing for a cosmetic product under paragraph (1) shall include a
certification, submitted by the responsible person, that such list includes all
cosmetic products owned by such person.
(B)The responsible person shall notify the Secretary
within 60 days of—
(i)any change to the
information required to be in such product list; or
(ii)the
discontinuation of the manufacture of a cosmetic product.
(4)Notification to
owner; assignment of cosmetic product numberUpon receipt of a list for a cosmetic
product under paragraph (1), the Secretary shall—
(A)notify the
responsible person identified 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)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)For
purposes of this section:
(1)The term
cosmetic formulation means a preparation of cosmetic raw materials
with a qualitatively and quantitatively set composition.
(2)The term
cosmetic product means a finished cosmetic that has undergone all
stages of production, including packaging in its final container for shipment
and application of a product label.
(3)
(A)(i)The term
facility includes any factory, warehouse, or establishment
facility (including a factory, warehouse, or establishment of an importer) that
manufactures, packs, or holds cosmetic products or cosmetic
formulations.
(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
facilities;
(III)hospitals, physicians’ offices, and
health care clinics;
(IV)public health agencies and other
nonprofit entities that provide cosmetics directly to the consumer;
(V)hotels and other entities that provide
complimentary cosmetics to guests;
(VI)trade shows and other venues where
cosmetic product samples are provided free of charge; and
(VII)entities that manufacture or compound
cosmetic products solely for use in research, teaching, or pilot plant
production 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 cosmetics
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 activity of a
de minimis nature was carried out with respect to the cosmetic.
(4)The term responsible person means a person
(as defined in section 201(e)) that is the owner of a cosmetic product intended
for introduction into United States
commerce.
.
(d)Chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by
adding at the end of subchapter C the following:
7FEES
RELATING TO COSMETICS
744.Facility
registration fee
(a)
(1)Assessment and
collectionBeginning in fiscal year 2013, the Secretary shall
assess and collect an annual fee for the registration of a facility under
section 604(a).
(2)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
(ii)for a subsequent
fiscal year, on the date of re-registration.
(b)
(1)The registration fee under subsection (a) shall
be—
(A)for fiscal year
2013, $500; and
(B)for fiscal year
2014 and each subsequent fiscal year, the fee for fiscal year 2013 as adjusted
under subsection (c).
(2)The Secretary shall, not later than 60 days before the
start of fiscal year 2014 and each subsequent fiscal year, establish, for the
next fiscal year, registration fees under subsection (a), as described in
paragraph (1).
(c)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 reflect 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 multiplied
by the proportion of personnel compensation 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 Seasonally 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 subsection 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)
(1)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 expenses 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 applicable to the
fiscal year involved.
(2)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 assess 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)In this subsection, 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)Fees authorized under subsection (a) shall be collected
and available for obligation only to the extent and in the amount provided in
advance in appropriations Acts. Such fees are authorized to remain available
until expended. Such sums as may be necessary may be transferred from the Food
and Drug Administration salaries and expenses appropriation account without
fiscal year limitation to such appropriation account for salaries and expenses
with such fiscal year limitation.
(2)Collections and
appropriations actsThe 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 available 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
appropriationsFor 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 feesIn any case where the Secretary does not receive
payment of a fee assessed 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)This
section may not be construed to require that the number of full-time equivalent
positions in the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in cosmetic safety activities,
be reduced to offset the number of officers, employees, and advisory committees
so engaged.
(h)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 implementation 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)In
this section:
(1)The term
costs of cosmetic safety activities 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 committees, and costs related to such officers,
employees, and committees and to contracts with such contractors;
(B)laboratory
capacity;
(C)management of
information, and the acquisition, maintenance, and repair of technology
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 related to ensuring the safety of cosmetics sold for use in the
United States, as authorized by this
Act.
.
(e)
(1)The
Secretary of Health and Human Services shall first impose the fee established
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)Section 744 of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (d), does not authorize the assessment or collection of a
fee for registration under section 604 of such Act occurring after fiscal year
2017.
3.Cosmetic product
safety substantiation
(a)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 requirement of section 605 (relating to safety
substantiation) is not
met.
.
(b)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:
605.Cosmetic
product safety substantiation
(a)The responsible person shall—
(1)before
introduction or delivery for introduction into interstate commerce of a
cosmetic product, 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
introduce such article into interstate commerce.
(b)The scientific
evidence required by subsection (a)(1) shall—
(1)consist of
studies, tests, data, or other information known to the responsible person that
relates to the cosmetic product’s safety; and
(2)demonstrate that
such cosmetic product is safe.
(c)Requests by
Secretary; access to recordsIn 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 person shall also permit an
officer or employee duly designated 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 purpose of inspection and
copying.
(d)For
the purposes of this section:
(1)The term
cosmetic product has the meaning 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).
.
4.Serious adverse
event reports for cosmetics
(a)Section 301 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended—
(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
submitted under section 606 to the Secretary.
.
(b)Section
602 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amended 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 product includes a domestic address, including the street address
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)) may receive a report of a serious adverse event associated
with the use of such cosmetic
product.
.
(c)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:
606.Serious adverse
event reports for cosmetics
(a)(1)The manufacturer, packer, or distributor of a cosmetic
product distributed in the United States (referred to in this section as the
responsible person
) 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, accompanied by a copy of the label on or within the retail packaging of
such cosmetic product.
(2)A retailer
whose name appears on the label of a cosmetic product and who is also a
distributor of such product may agree in writing that the manufacturer of the
cosmetic product shall submit the reports required by paragraph (1) for any
cosmetic product so long as the retailer directs to the manufacturer all
information relating to each adverse event associated with such cosmetic
product that is provided to the retailer.
(b)
(1)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 required under section 602(b)(1).
(2)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 experiencing the adverse event.
(B)The identity of
the individual reporting 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.
(3)The responsible 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 report, submit such new information to the Secretary.
(c)Maintenance and
inspection of records
(1)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)The responsible person shall permit an officer or
employee duly designated by the Secretary, upon presentation of appropriate
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 provisionsA 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;
(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)In
this section:
(1)The term
serious, with respect to an adverse 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 incapacity; or
(v)a
congenital anomaly or birth defect; or
(B)requiring, based
on reasonable medical judgment, a medical or surgical intervention to prevent
an outcome described in subparagraph (A).
(2)The term
cosmetic product has the meaning given to such term in section
604(c).
(3)The term
retailer means a person that sells or otherwise provides a
cosmetic product directly to a
consumer.
.
(d)Imported
cosmetic productsSection 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
.
5.Maintenance and
access to records
(a)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:
607.Maintenance and
access to records
(a)
(1)Records access
during an inspection
(A)Each person who manufactures, packs, or holds a cosmetic
product in the United States or for import into the United States shall, at the
request of an officer or employee duly designated by the Secretary, permit such
officer or employee, upon presentation of appropriate credentials, at
reasonable times, within reasonable limits, and in a reasonable manner, to have
access to and copy all records relating to whether the cosmetic may be
adulterated, misbranded, or otherwise in violation of this Act, including all
records collected or developed to comply with section 605 (relating to cosmetic
product safety substantiation) or 606 (relating to serious adverse event
reports).
(B)The requirement 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 noticeRecords not required to be made
available immediately on commencement of an inspection under subparagraph (A)
shall nonetheless be made available immediately on commencement of such an
inspection if, a reasonable time before such inspection, the Secretary by
letter provides written notice to the person and identifies the records to be
made available during such inspection. Nothing in this subparagraph 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
emergenciesIf the Secretary has a reasonable belief that a
cosmetic product has caused one or more serious adverse events (as such term is
used in section 606), the Secretary may require each person 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 notice
served personally and outside normal business hours to an agent identified
under clause (vi) or (vii) of section 604(a)(2)(B) of such requirement).
(B)If the records required to be submitted to the
Secretary under subparagraph (A) are available in electronic format, such
records shall be submitted electronically unless the Secretary specifies
otherwise in the notice under such subparagraph.
(b)Regulations
concerning recordkeepingThe Secretary shall, by regulation,
establish requirements regarding the establishment and maintenance, 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 previous sources and the subsequent recipients of
a cosmetic, including its packaging; or for other purposes the Secretary deems
necessary to protect public health. The Secretary shall take into account the
size of a business in promulgating regulations under this
subsection.
.
(b)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 inspection shall extend to all
records and other information described in or required under section 607
bearing on whether a cosmetic is adulterated, misbranded, or otherwise in
violation of this Act.
; and
(B)in the fourth
sentence—
(i)by
striking the preceding sentence
and inserting either of
the preceding two sentences
;
(ii)by
striking and
after or chapter 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
(2)in paragraph (2),
by striking third sentence
and inserting fourth
sentence
.
(c)No effect on
other provisionsThis section 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.
6.Good manufacturing
practices for cosmetics
(a)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 controls used for, its manufacture, packing, or holding do not conform to
current good manufacturing practice, as prescribed by the Secretary in
regulations, to ensure that the cosmetic is safe and otherwise in compliance
with this
Act.
.
(b)
(1)The
Secretary of Health and Human Services, acting through the Commissioner of Food
and Drugs, shall promulgate regulations to carry out section 601(h) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
(2)In promulgating such regulations, the Secretary of
Health and Human Services, acting through the Commissioner of Food and Drugs,
shall review international standards for cosmetic product good manufacturing
practice that are in existence on the date of enactment of this Act to ensure
that such regulations are consistent, to the extent the Secretary determines
practicable and appropriate, with such standards.
7.Mandatory recall
authority
(a)Section 301(xx) of the Federal 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)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:
608.MANDATORY
RECALL AUTHORITY
(a)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 shall provide each responsible person with an
opportunity to cease distribution and recall such cosmetic.
(b)Prehearing Order
To Cease Distribution and Give Notice
(1)If a responsible person refuses to or does not
voluntarily cease distribution or recall such cosmetic within the time and in
the manner prescribed by the Secretary (if so prescribed), the Secretary may,
by order require, as the Secretary deems necessary, such person to—
(A)immediately cease
distribution of such cosmetic; and
(B)as applicable,
immediately notify all persons—
(i)manufacturing,
packing, or holding such cosmetic, and
(ii)to which such
cosmetic has been distributed, transported, or sold,
to
immediately cease distribution of such cosmetic.(2)Determination to
limit areas affectedIf the Secretary requires a responsible
person to cease distribution under paragraph (1)(A) of a cosmetic identified in
subsection (a), 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)The Secretary shall provide a responsible person subject to
an order under subsection (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 that is
the subject of the order should not be recalled.
(d)Post-Hearing
Recall Order and Modification of Order
(1)If, after providing opportunity for an informal hearing
under subsection (c), the Secretary determines that removal of the cosmetic
from commerce is necessary, the Secretary shall, as appropriate—
(A)amend the order to
require recall of such cosmetic or other appropriate action;
(B)specify a
timetable in which the recall shall occur;
(C)require periodic
reports to the Secretary describing the progress of the recall; and
(D)provide notice to
consumers to whom such cosmetic was, or may have been, distributed.
(2)If, after such hearing, 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
ConsultationThe Secretary shall work with State and local public
health officials in carrying out this section, as appropriate.
(f)In conducting a recall under this section, the
Secretary shall—
(1)ensure that a
press release is published regarding the recall, as well as alerts and public
notices, as appropriate, in order to provide notification—
(A)of the recall to
consumers and retailers to whom such cosmetic was, or may have been,
distributed; and
(B)that includes, at
a minimum—
(i)the name of the
cosmetic subject to the recall;
(ii)a
description of the risk associated with such cosmetic; and
(iii)to the extent
practicable, information for consumers about similar cosmetics that are not
affected by the recall;
(2)shall consider
providing a list to the public of retail consignees receiving products involved
in a Class I recall, as determined appropriate by the Secretary; and
(3)if available,
publish on the Internet Web site of the Food and Drug Administration an image
of the cosmetic that is the subject of the press release described in
(1).
(g)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.
(h)Nothing
in this section shall affect the authority of the Secretary to request or
participate in a voluntary recall, or to issue an order to cease distribution
or to recall under any other provision of this Act or under the Public Health
Service Act.
(i)Responsible
person definedIn this
section, the term responsible person has the meaning given to such
term in section
604(c).
.
8.
(a)The amendments
made by sections 2(a), 3, 4, 5, and 7 shall take effect 18 months after the
date of enactment of this Act.
(b)The amendments
made by sections 2(b) and 6 shall take effect 3 years after the date of
enactment of this Act.