Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Services (HHS). Requires such manufacturers to submit to the Secretary: (1) a cosmetic and ingredient statement for each manufactured cosmetic containing a unique registration number for the manufacturing establishment where the cosmetic is manufactured, the brand name for the cosmetic, the ingredients in the cosmetic, and contact information for individuals responsible for filing and maintaining the cosmetic and ingredient statement; and (2) a report on any serious and unexpected adverse event allegedly associated with the use of a cosmetic product.
Requires the Secretary to: (1) establish good manufacturing practices for the manufacture, processing, filling, or packaging of cosmetics; and (2) establish and maintain in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) an electronic National Cosmetic Regulatory Databank to hold information pertaining to the regulation of cosmetics.
Grants the Secretary authority to review the findings of the Cosmetic Ingredient Review Expert Panel with respect to any cosmetic products.
Authorizes the Secretary to: (1) establish a tolerance level for a nonfunctional constituent in a cosmetic product, (2) evaluate the safety of any ingredient in a cosmetic product, and (3) obtain access to and copy records for determining whether a cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans.
Denies entry into the United States of a cosmetic product if: (1) the importer does not present the unique cosmetic establishment registration number and the unique cosmetic and ingredient statement number, or (2) either of such numbers is not correct.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4395 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 4395
To amend the Federal Food, Drug, and Cosmetic Act to establish new
procedures and requirements for the registration of cosmetic product
manufacturing establishments, the submission of cosmetic product and
ingredient statements, and the reporting of serious and unexpected
cosmetic product adverse events, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 18, 2012
Mr. Lance 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 establish new
procedures and requirements for the registration of cosmetic product
manufacturing establishments, the submission of cosmetic product and
ingredient statements, and the reporting of serious and unexpected
cosmetic product adverse events, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE AND REFERENCES.
(a) Short Title.--This Act may be cited as the ``Cosmetic Safety
Amendments Act of 2012''.
(b) References to the Federal Food, Drug, and Cosmetic Act.--Except
as otherwise specified, whenever in this Act an amendment is expressed
in terms of an amendment to a section or other provision, the reference
shall be considered to be made to a section or other provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 2. TABLE OF CONTENTS.
Sec. 1. Short title and references.
Sec. 2. Table of contents.
Sec. 3. Registration of cosmetic manufacturing establishments.
Sec. 4. Cosmetic and ingredient statement.
Sec. 5. Serious and unexpected adverse event reporting for cosmetics.
Sec. 6. Good manufacturing practice for cosmetics.
Sec. 7. Tolerances for nonfunctional constituents in cosmetics.
Sec. 8. Cosmetic ingredient review.
Sec. 9. Cosmetic ingredient safety.
Sec. 10. National cosmetic regulatory databank.
Sec. 11. Cosmetic records inspection.
Sec. 12. Rules of construction.
Sec. 13. Conforming amendments.
Sec. 14. National uniformity for cosmetics.
Sec. 15. Importation.
Sec. 16. Authorization of appropriations.
Sec. 17. Effective dates.
SEC. 3. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.
Chapter VI is amended by adding at the end the following:
``SEC. 604. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.
``(a) In General.--
``(1) The Secretary shall by regulation require that every
domestic and foreign establishment engaged in the manufacture
of a cosmetic intended to be marketed in the United States be
registered with the Secretary within 60 days after beginning
such manufacture. If a cosmetic is processed in more than one
establishment, registration shall be required only for the
establishment that performs the final portion of the
manufacturing operation. The registration shall state the name
of the company or other organization, the city, street address,
State, and country of the establishment, and the title, email
address, and telephone number for the office within the
establishment that is responsible for submitting and
maintaining the registration.
``(2) The Secretary shall establish and provide to the
registrant a unique cosmetic establishment registration number
within 15 business days after receiving the registration. Where
more than one person registers the same manufacturing
establishment, the Secretary shall provide only one unique
establishment registration number for the establishment.
``(b) Maintenance.--The information required in a registration
under subsection (a) or in an existing registration under subsection
(e) shall be maintained as current and accurate by the registrant by
withdrawing or amending the registration within 60 days after the
information becomes no longer current and accurate.
``(c) List.--The Secretary shall compile and maintain an up-to-date
and publicly available electronic list of establishments that are
registered under this section.
``(d) Definitions.--For purposes of this chapter the following
definitions apply:
``(1) The term `establishment' is a place of business where
a cosmetic is manufactured, without further processing outside
or within the United States.
``(2)(A) The term `domestic establishment' means an
establishment location in any State.
``(B) The term `foreign establishment' means an
establishment location outside the States from which a cosmetic
is exported to the United States.
``(3) A cosmetic shall not be considered to have undergone
further processing for purposes of paragraph (1) solely on the
basis that packaging or other labeling was added or that any
similar activity of a de minimis nature was carried out with
respect to the cosmetic.
``(e) Exemptions.--Registration under subsection (a) shall not be
required for any establishment that as of the date of enactment of this
section is registered as a cosmetic establishment under part 710 of
title 21, Code of Federal Regulations.
``(f) Suspension of Registration.--
``(1) In general.--The Secretary may suspend the
registration of any facility under this section for a violation
of this Act that presents a significant risk of serious adverse
health consequences or death to humans.
``(2) Notice of suspension.--Suspension of a registration
under this section shall be preceded by--
``(A) notice to the establishment of the intent to
suspend the registration; and
``(B) an opportunity for an informal hearing
concerning the suspension.
``(3) Reinstatement.--A registration that is suspended
under this section may be reinstated by the Secretary.
``(4) Procedures.--The Secretary shall by regulations
establish procedures for the implementation of this subsection.
``(g) Cancellation of Registration.--
``(1) In general.--Not earlier than 10 days after providing
notice under paragraph (2), the Secretary may cancel a
registration under this section if the Secretary determines
that the registration was not updated in accordance with this
section or otherwise is not current and accurate.
``(2) Notice of cancellation.--Cancellation shall be
preceded by notice to the establishment of the intent to cancel
the registration and the basis for such cancellation.
``(3) Timely update or correction.--If the registration for
the establishment is updated or corrected no later than 7 days
after notice is provided under paragraph (2), the Secretary
shall not cancel the registration.''.
SEC. 4. COSMETIC AND INGREDIENT STATEMENT.
Chapter VI, as amended by section 3, is amended by adding at the
end the following:
``SEC. 605. COSMETIC AND INGREDIENT STATEMENT.
``(a) In General.--The Secretary shall by regulation require that
every domestic and foreign establishment engaged in the manufacture of
a cosmetic intended to be marketed in the United States submit to the
Secretary, for each cosmetic manufactured in the establishment, within
60 days after beginning manufacture of the product, a cosmetic and
ingredient statement containing--
``(1) the unique establishment registration number of the
manufacturing establishment where the cosmetic is manufactured
or, if the same cosmetic product is manufactured in more than
one establishment, the unique establishment registration number
of each establishment where it is manufactured;
``(2) the brand name or names for the cosmetic;
``(3) the applicable cosmetic category or categories for
the cosmetic;
``(4) the ingredients in the cosmetic (in accordance with
section 701.3 of title 21, Code of Federal Regulations, and
using the name of each ingredient established under subsection
(b), if any), in descending order of predominance by weight,
except that--
``(A) flavors and fragrances may be designated as
such; and
``(B) all variations in color, flavor, or fragrance
may be included in one statement; and
``(5) the title, email address, and telephone number for
the office within the establishment that is responsible for
filing and maintaining the statement.
The Secretary shall establish and provide to the person submitting the
statement a unique cosmetic and ingredient statement number within 15
business days after receiving the statement.
``(b) Name of Ingredient.--For purposes of this section and
cosmetic ingredient labeling under section 701.3 of title 21, Code of
Federal Regulations, the name of a cosmetic ingredient shall be the
name, if any, in the most recent edition of the International Cosmetic
Ingredient Dictionary, unless the Secretary, after public notice and an
opportunity for public comment, by regulation or guidance establishes a
different name for the ingredient.
``(c) Maintenance.--The information required in a statement
submitted to the Secretary under subsection (a) or in an existing
statement under subsection (e)(1) shall be maintained as current and
accurate by the person who filed the statement by withdrawing or
amending the statement within 60 days after the information becomes no
longer current and accurate, except that no amendment shall be required
for a change in the order of predominance of the ingredients or for any
other type or category of change for which the Secretary determines
that the costs of amending the statement exceed the benefits.
``(d) List.--The Secretary shall compile and maintain an up-to-date
and publicly available electronic list of cosmetics and ingredients for
which statements are submitted under this section. A statement
submitted pursuant to this section shall not be subject to disclosure
under section 552 of title 5, United States Code. The Secretary may
make publicly available information derived from such statements that
discloses the names of ingredients used in cosmetic products and the
number of cosmetic products in which a specific ingredient is used but
may not make publicly available any information that relates to any
ingredient that is exempt from public disclosure under section 720.8 of
title 21, Code of Federal Regulations, or that discloses at what
establishment a cosmetic is manufactured. At the request of the
director of a State agency responsible for regulating the safety of
cosmetics, the Secretary may disclose to such official confidential
business and trade secret information contained in a statement and such
official and other State employees who have access to such information
shall then be subject to the provisions of section 301(j), subsection
552(b) of title 5, United States Code, and section 1905 of title 18,
United States Code, with respect to such information.
``(e) Exemptions.--Submission of a statement under subsection (a)
shall not be required for--
``(1) a cosmetic for which as of the date of enactment of
this section a cosmetic ingredient statement has been submitted
to the Secretary under part 710 of title 21, Code of Federal
Regulations; or
``(2) a cosmetic ingredient exempt from public disclosure
under section 720.8 of title 21, Code of Federal
Regulations.''.
SEC. 5. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.
Chapter VI, as amended by sections 3 and 4, is amended by adding at
the end the following:
``SEC. 606. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR
COSMETICS.
``(a) In General.--The Secretary shall by regulation require that a
domestic or foreign manufacturer, packer, or distributor whose name
appears on the label pursuant to section 602(b)(1) of a cosmetic
marketed in the United States submit to the Secretary under subsection
(b) a report containing information received concerning a serious and
unexpected adverse event in the United States allegedly associated with
the use of the product.
``(b) Submission of Reports.--A serious and unexpected adverse
event report 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 labeled on the product under section
602(b)(1).
``(c) Contents.--No such report shall be submitted unless the
person submitting the report has been able to verify--
``(1) an identifiable patient;
``(2) an identifiable reporter;
``(3) a suspect cosmetic product; and
``(4) a serious and unexpected adverse event.
The person submitting the report may include in the submission any
additional pertinent information and may supplement the report with
additional information at a later time.
``(d) Definitions.--
``(1) A `serious' adverse event is one that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent and significant
disability or incapacity; or
``(v) congenital anomaly or birth defect;
or
``(B) requires, based on reasonable medical
judgment, a medical or surgical intervention to prevent
an outcome described under subparagraph (A).
``(2) An `unexpected' adverse event is one that is not
identified in the current labeling for the cosmetic.
``(e) Rules of Construction.--
``(1) A serious and unexpected adverse event report
(including all information submitted in the initial report or
added later) submitted to the Secretary under subsection (a)
is--
``(A) a safety report under section 756 that is
subject to the provisions of that section;
``(B)(i) a record about an individual under section
552a of title 5, United States Code; and
``(ii) a medical or similar file the disclosure of
which would constitute a violation of section 552(b)(6)
of such title 5, and shall not be publicly disclosed.
``(2) The submission of a serious and unexpected adverse
event report in compliance with subsection (a) shall not
constitute an admission that the cosmetic involved caused or
contributed to the adverse event.
``(f) The label of a cosmetic shall bear the domestic telephone
number through which the person whose name and place of business appear
on the label may receive a report of a serious and unexpected adverse
event.''.
SEC. 6. GOOD MANUFACTURING PRACTICE FOR COSMETICS.
Chapter VI, as amended by sections 3, 4, and 5, is amended by
adding at the end the following:
``SEC. 607. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
``The Secretary shall, after public notice and an opportunity for
public comment, by regulation establish good manufacturing practices
for the methods used in, or the facilities or controls used for, the
manufacture, processing, filling, or packaging of cosmetics. In issuing
such regulations or guidance, the Secretary shall review international
standards for cosmetic good manufacturing practices to ensure that such
regulations or guidance are consistent, to the extent the Secretary
determines practicable and appropriate, with such standards.''.
SEC. 7. TOLERANCES FOR NONFUNCTIONAL CONSTITUENTS IN COSMETICS.
Chapter VI, as amended by sections 3, 4, 5, and 6, is amended by
adding at the end the following:
``SEC. 608. TOLERANCES FOR NONFUNCTIONAL CONSTITUENTS IN COSMETICS.
``(a) In General.--The Secretary may on the Secretary's own
initiative, and shall in response to a petition submitted by an
interested person, including a State, under subsection (b) or in
accordance with the provisions under subsection (c), after public
notice and an opportunity for public comment, establish by regulation
or guidance a tolerance level for a nonfunctional constituent in
cosmetics. For purposes of this section, a `nonfunctional constituent'
in a cosmetic is any substance that is an ancillary part of an
ingredient or the manufacturing process, has not been added as a
separate substance, and serves no cosmetic function in the cosmetic.
The Secretary shall establish such a tolerance at a level that is
necessary for the protection of the public health using generally
recognized principles of scientific risk assessment. In issuing such a
regulation or guidance, the Secretary shall take into consideration the
level that is reasonably achievable through good manufacturing
practices and shall review tolerance levels for such nonfunctional
constituent established by authoritative scientific or regulatory
organizations to ensure that such regulation or guidance is consistent,
to the extent the Secretary determines practicable and appropriate,
with such other tolerance levels.
``(b) Procedure.--
``(1)(A)(i) If the review of a nonfunctional constituent is
being conducted on the Secretary's own initiative or under
subsection (c), the Secretary shall initiate the proceeding by
publishing in the Federal Register a proposed regulation or
guidance. The Secretary shall provide 180 days for public
comment.
``(ii) Not later than 180 days after the end of the period
for public comment, the Secretary shall publish in the Federal
Register a final regulation or guidance.
``(B)(i) If the review of a nonfunctional constituent is
being conducted in response to a petition submitted by an
interested person, the Secretary shall publish the petition in
the Federal Register for public comment not later than 60 days
after receipt of the petition. All appendices to the petition
shall be made available on the Secretary's website. The
Secretary shall provide 180 days for public comment.
``(ii) Any such petition shall specify the nonfunctional
constituent, the proposed tolerance level, and the scientific
data and information on which the proposed tolerance level is
based.
``(iii) Not later than 180 days after the end of the period
for public comment, the Secretary shall publish in the Federal
Register a proposed regulation or guidance for public comment.
The Secretary shall provide 90 days for public comment.
``(iv) Not later than 90 days after the end of the period
for public comment, the Secretary shall publish in the Federal
Register a final regulation or guidance.
``(C) The Secretary may on the Secretary's own initiative,
and shall in response to a petition submitted by an interested
person, reconsider any tolerance level established under
subparagraph (A) or (B), using the same procedure established
in this paragraph (1).
``(D) Any regulation or guidance, including any revised
regulation or guidance, shall apply to cosmetics first shipped
in interstate commerce beginning two years after the date of
issue of the regulation or guidance, unless the Secretary
determines, after public notice and an opportunity for public
comment, that an earlier effective date is required to prevent
serious adverse health consequences or death.
``(2) The failure of the Secretary to comply with any
applicable time period requirement under paragraph (1) shall
constitute final agency action for purposes of judicial review.
If the court conducting such review determines that the
Secretary has failed to comply with the requirement, the court
shall order the Secretary to comply within a time period
determined by the court to be appropriate, but in no event
later than 90 days following the court's order.
``(c) Priority List.--Within 180 days after the date of enactment,
the Secretary shall establish a publicly available electronic priority
list of nonfunctional constituents in cosmetics for review under this
section. The Secretary shall begin and complete a review of at least
one such priority nonfunctional constituent every 365 days.
``(d) Application.--A tolerance level established by the Secretary
under this section shall apply in every State.''.
SEC. 8. COSMETIC INGREDIENT REVIEW.
Chapter VI, as amended by sections 3, 4, 5, 6, and 7, is amended by
adding at the end the following:
``SEC. 609. COSMETIC INGREDIENT REVIEW.
``(a) Panel's Recommendation.--The Cosmetic Ingredient Review
Expert Panel determination in an approved final report that a cosmetic
ingredient--
``(1) is safe for use in cosmetic products without the need
for specified conditions of use;
``(2) is safe for use in cosmetic products under specified
conditions for use;
``(3) is not safe for use in a cosmetic product under any
conditions of use;
``(4) requires more information in order to make a
determination whether the ingredient is safe for use in a
cosmetic product under any conditions of use; or
``(5) is the subject of any other type of determination by
the Cosmetic Ingredient Review Expert Panel, shall be deemed to
constitute a recommendation that the Secretary accept that
determination for purposes of implementing and enforcing this
chapter in accordance with the effective dates established
under subsection (d).
``(b) Secretary's Determination.--The Secretary shall be deemed to
accept that determination and recommendation unless the Secretary at
any time determines, by regulation or guidance, after public notice and
an opportunity for public comment, to make a different determination. A
determination and recommendation described in subsection (a) that is
deemed to be accepted by the Secretary shall be implemented and
enforced by the Secretary by banning any use of any ingredient that
does not conform to the specified safe conditions of use under
subsection (a)(2) and any ingredient described under subsection (a)(3)
or (4).
``(c) Proprietary Data.--The determination described in subsection
(a)(4) shall not apply to a person using the ingredient who has
adequate safety substantiation and provides that substantiation to the
Secretary as confidential business or trade secret information that
shall not be publicly disclosed under section 301(j) of this Act or
sections 552(b)(4) of title 5 or 1905 of title 18, United States Code.
``(d) Effective Dates.--Subsection (b) shall be effective--
``(1) three years after the date of enactment for
ingredients that are the subject of an approved final report as
of the date of enactment of this subsection; and
``(2) two years after the date of approval of the final
report for ingredients that are the subject of an approved
final report after the date of enactment of this subsection.
``(e) Secretary's Representative.--The Secretary shall appoint a
representative who shall be a member of and shall participate in the
deliberations of the Cosmetic Ingredient Review Expert Panel.
``(f) Application.--A safety determination accepted or made by the
Secretary under this section shall apply in every State.''.
SEC. 9. COSMETIC INGREDIENT SAFETY.
Chapter VI, as amended by sections 3, 4, 5, 6, 7, and 8, is amended
by adding at the end the following:
``SEC. 610. COSMETIC INGREDIENT SAFETY.
``(a) In General.--
``(1) The Secretary may on the Secretary's own initiative,
and shall in response to a petition submitted by an interested
person, including a State, under subsection (b) or in
accordance with the provisions under subsection (c), evaluate
the safety of any ingredient intended for use as or in a
cosmetic product and, after public notice and an opportunity
for public comment, establish by regulation or guidance the
conditions, if any, under which the ingredient is safe for
human use.
``(2) In evaluating the safety of any such ingredient, the
Secretary shall apply generally recognized principles of
scientific risk assessment and shall take into account--
``(A) the conditions of use recommended or
suggested in the labeling;
``(B) any relevant safety evaluation conducted by
the Cosmetic Ingredient Review Expert Panel; and
``(C) all relevant unpublished and published safety
data and information, including human exposure during
marketing.
The Secretary shall determine the conditions for the use of the
ingredient that are necessary for safe use, or that the
ingredient is safe for use without the need for specified
conditions of use, or that there are no conditions under which
the ingredient can be safely used.
``(b) Procedure.--
``(1)(A)(i) If the review of an ingredient is being
conducted on the Secretary's own initiative or under subsection
(c), the Secretary shall initiate the proceeding by publishing
in the Federal Register a proposed regulation or guidance. The
Secretary shall provide 180 days for public comment.
``(ii) Not later than 180 days after the end of the period
for public comment, the Secretary shall publish in the Federal
Register a final regulation or guidance.
``(B)(i) If the review of an ingredient is being conducted
in response to a petition submitted by an interested person,
the Secretary shall publish the petition in the Federal
Register for public comment not later than 60 days after
receipt of the petition. All appendices to the petition shall
be made available on the Secretary's website. The Secretary
shall provide 180 days for public comment.
``(ii) Any such petition shall specify the ingredient, the
uses for which the ingredient is intended, any proposed
conditions of safe use, and the scientific data and
information, including human exposure during marketing, on
which the proposed conditions are based.
``(iii) Not later than 180 days after the end of the period
for public comment, the Secretary shall publish in the Federal
Register a proposed regulation or guidance for public comment.
The Secretary shall provide 90 days for public comment.
``(iv) Not later than 90 days after the end of the period
for public comment, the Secretary shall publish in the Federal
Register a final regulation or guidance.
``(C) The Secretary may on the Secretary's own initiative,
and shall in response to a petition submitted by an interested
person, reconsider any conditions for safe use established
under subparagraph (A) or (B), using the same procedure
established in this paragraph (1).
``(D) Any regulation or guidance, including any revised
regulation or guidance, shall apply to cosmetics first shipped
in interstate commerce beginning two years after the date of
issuance of the regulation or guidance, unless the Secretary
determines, after public notice and an opportunity for public
comment, that an earlier effective date is required to prevent
serious adverse health consequences or death.
``(2) The failure of the Secretary to comply with any
applicable time period requirement under paragraph (1) shall
constitute final agency action for purposes of judicial review.
If the court conducting such review determines that the
Secretary has failed to comply with the requirement, the court
shall order the Secretary to comply within a time period
determined by the court to be appropriate, but in no event
later than 90 days following the court's order.
``(c) Priority List.--Within 180 days after the date of enactment,
the Secretary shall establish a publicly available electronic priority
list of cosmetic ingredients. The Secretary shall begin and complete a
review of at least one such priority cosmetic ingredient every 365
days.
``(d) Application.--A safety determination accepted or made by the
Secretary under this section shall apply in every State.''.
SEC. 10. NATIONAL COSMETIC REGULATORY DATABANK.
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, and 9, is
amended by adding at the end the following:
``SEC. 613. NATIONAL COSMETIC REGULATORY DATABANK.
``In order to consolidate all information pertaining to regulation
of the safety of cosmetics in one place for use by State officials
responsible for the regulation of cosmetics and by the general public,
the Secretary shall establish and maintain in the Center for Food
Safety and Applied Nutrition (or any successor organization of such
Center) of the Food and Drug Administration an electronic National
Cosmetic Regulatory Databank that shall contain the information
submitted to the Secretary under sections 604, 605, and 606, and such
other information pertaining to the regulation of cosmetics as the
Secretary shall deem appropriate. Information in the National Cosmetic
Regulatory Databank that is not subject to public disclosure under
section 552 of title 5, United States Code, may be disclosed on request
to the director of a State agency responsible for regulating the safety
of cosmetics, and such official and other State employees who have
access to such information shall then be subject to the provisions of
section 301(j), subsection 552(b) of title 5, United States Code, and
section 1905 of title 18, United States Code, with respect to such
information. Information available in the National Cosmetic Regulatory
Databank shall not be subject to State laws on submission of that
information, whether in the same or a different format.''.
SEC. 11. COSMETIC RECORDS INSPECTION.
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, and 10, is
amended by adding at the end the following:
``SEC. 614. COSMETIC RECORDS INSPECTION.
``If the Secretary has a reasonable belief that a cosmetic product,
and any other related cosmetic product that the Secretary reasonably
believes is affected in the same manner, is adulterated and presents a
threat of serious adverse health consequences or death to humans, each
person who manufactures, processes, packs, distributes, receives,
holds, or imports such article shall, at the request of an officer or
employee duly designated by the Secretary, permit such officer or
employee, upon presentation of appropriate credentials and a written
notice to such person setting forth the basis for the Secretary's
belief, at reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy records that are needed
to assist the Secretary in determining whether the cosmetic product is
adulterated and presents a threat of serious adverse health
consequences or death to humans. The Secretary shall prevent the
disclosure of trade secret or confidential information obtained by the
Secretary pursuant to this section. This section does not extend to
cosmetic product formulas, financial data, pricing data, personnel
data, research data, or sales data other than shipment data.''.
SEC. 12. RULES OF CONSTRUCTION.
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, 10, and 11,
is amended by adding at the end the following:
``SEC. 615. RULES OF CONSTRUCTION.
``(a) Cosmetic Products.--Whenever the term cosmetic or cosmetics
is used in sections 604, 605, 606, or 607, it shall be deemed to refer
only to a cosmetic product or cosmetic products. A cosmetic product
that is subject to the caution legend in section 601(a) shall not be
subject to the provisions of sections 608, 609, or 610.
``(b) Contractors.--A requirement for registration of a cosmetic
establishment under section 604, submission of a cosmetic and
ingredient statement under section 605, or submission of a serious and
unexpected adverse event report for a cosmetic under section 606, may
be satisfied by a person who contracts to perform that function for the
person who is required to register or make the submission.
``(c) Exemptions.--The Secretary may, in the Secretary's
discretion, establish exemptions from the requirements in this title
for the efficient and cost-effective implementation of these
provisions.
``(d) Safety.--For purposes of chapter VI, a cosmetic shall be
deemed to be safe if it does not present a risk of significant illness
or injury to humans under the conditions of use recommended or
suggested in the labeling.''.
SEC. 13. CONFORMING AMENDMENTS.
(a) Section 301 is amended by adding at the end the following:
``(aaa) The failure to
register a cosmetic
establishment required to be
registered under section 604 or
to maintain the registration
current and accurate.
``(bbb) The failure to
submit a cosmetic and
ingredient statement required
under section 605 or to
maintain the statement current
and accurate.
``(ccc) The failure to
submit a serious and unexpected
adverse event report or to
include on a label the domestic
telephone number through which
a report of a serious and
unexpected adverse event may be
received, as required under
section 606.
``(ddd) The failure to
comply with cosmetic good
manufacturing practices
established under section 607.
``(eee) The failure to
comply with a tolerance for a
nonfunctional constituent in
cosmetics established under
section 608.
``(fff) The failure to
comply with a determination
with respect to the safety of a
cosmetic ingredient under
section 609 or section 610.
``(ggg) For a cosmetic
product that is being imported
or offered for import, the
failure of the importer to
present both the unique
cosmetic establishment
registration number established
by the Secretary under section
604(a) and the unique cosmetic
and ingredient statement number
established by the Secretary
under section 605(a).''.
(b) Section 301(j) is amended by inserting ``605, 609, 613,'' after
``573,''.
SEC. 14. NATIONAL UNIFORMITY FOR COSMETICS.
Section 752 is amended--
(1) by amending the section heading to read as follows:
``national uniformity for cosmetics'';
(2) in subsection (b), by inserting ``or (f)'' after
``subsection (a)''; and
(3) by adding at the end the following:
``(f) Cosmetic Safety.--
``(1) In general.--Subject to paragraphs (2) and (3), no
State or political subdivision of a State may establish or
continue in effect any law, regulation, order, or other
requirement relating to cosmetic constituents, cosmetic
ingredients, or cosmetic products--
``(A) that is different from, in addition to, or
otherwise not identical to, the provisions of chapter
VI and the requirements and determinations established
or accepted by the Secretary thereunder; or
``(B) relating to registration, listing, or fees
for establishments, products, ingredients, or
constituents, or to submission of reports.
``(2) State petitions.--Not later than 180 days after the
date of the enactment of this subsection, a State may petition
the Secretary under section 609 or 610 to establish as a
national standard a tolerance for a nonfunctional constituent
or a safety requirement for a cosmetic ingredient that exists
in a State law or a duly promulgated State regulation that is
effective on the date of enactment of this subsection. Pending
completion of the process established under section 608 or 610,
the State requirement shall remain in effect for that State.
Upon completion of the process established under section 608 or
610, the final regulation or guidance published by the
Secretary in the Federal Register shall be the national safety
standard for the constituent or ingredient.
``(3) Requirements adopted by state public initiative or
referendum.--This subsection shall not apply to a State
requirement adopted by a State public initiative or referendum
enacted prior to the enactment of this subsection.''.
SEC. 15. IMPORTATION.
Section 801(a) is amended by adding at the end the following:
``If a cosmetic product is being imported or offered for import
into the United States and the importer does not present both the
unique cosmetic establishment registration number established under
section 604 and the unique cosmetic and ingredient statement number
established under section 605, or the registration number or statement
number is not correct and accurate, the cosmetic product shall be
denied entry.''.
SEC. 16. AUTHORIZATION OF APPROPRIATIONS.
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, 10, 11, and
12, is amended by adding at the end the following:
``SEC. 616. AUTHORIZATION OF APPROPRIATIONS.
``To carry out this chapter and section 752, there is authorized to
be appropriated $11,700,000 for each of fiscal years 2014 through 2018.
The Secretary shall annually allocate for personnel and functions for
the regulation of cosmetics during the period of such fiscal years at
least $11,700,000 out of the total funds appropriated for the Food and
Drug Administration, 10 full-time equivalent personnel in the Office of
Regulatory Affairs, and 1 full-time equivalent lawyer in the Office of
Chief Counsel.''.
SEC. 17. EFFECTIVE DATES.
(a) Sections 3, 4, 5, 6, and 15 of this Act shall be effective on
the later date of--
(1) one year after the Secretary of Health and Human
Services promulgates final regulations or guidance implementing
these sections; or
(2) one year after the Secretary of Health and Human
Services publishes a notice in the Federal Register determining
that an effective electronic system has been established and is
operational for the submission of cosmetic manufacturing
establishment registrations, cosmetic and ingredient filings,
reports of serious and unexpected cosmetic adverse events, good
manufacturing practices for cosmetics, and the National
Cosmetic Regulatory Databank.
(b) The remaining sections of this Act shall be effective on the
date of the enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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