[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4075 Introduced in House (IH)]

<DOC>






114th CONGRESS
  1st Session
                                H. R. 4075

  To amend the Federal Food, Drug, and Cosmetic Act to establish new 
     procedures and requirements for the registration of cosmetic 
manufacturing establishments, the submission of cosmetic and ingredient 
 statements, and the reporting of serious cosmetic adverse events, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 18, 2015

 Mr. Sessions 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 
manufacturing establishments, the submission of cosmetic and ingredient 
 statements, and the reporting of serious cosmetic 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 
Modernization Amendments of 2015''.
    (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.

    The table of contents for this Act is as follows:

Sec. 1. Short title and references.
Sec. 2. Table of contents.
Sec. 3. Definitions.
Sec. 4. Registration of cosmetic manufacturing establishments.
Sec. 5. Cosmetic and ingredient statement.
Sec. 6. Serious and unexpected adverse event reporting for cosmetics.
Sec. 7. Good manufacturing practice.
Sec. 8. Safety substantiation for cosmetic ingredients and 
                            nonfunctional constituents.
Sec. 9. National Cosmetic Regulatory Databank.
Sec. 10. Special rules.
Sec. 11. Prohibited acts.
Sec. 12. National uniformity for cosmetics.
Sec. 13. Importation.
Sec. 14. Effective dates.

SEC. 3. DEFINITIONS.

    Chapter VI (21 U.S.C. 361 et seq.) is amended by adding at the end 
the following:

``SEC. 604. DEFINITIONS.

    ``In this chapter:
            ``(1) Cosmetic.--Notwithstanding section 201(i), for 
        purposes of this section and sections 601(f), 605, 606, 607, 
        608, and 801(a), the term `cosmetic' includes only articles 
        described in section 201(i)(1).
            ``(2) Establishment.--
                    ``(A) The term `establishment' means a place of 
                business where a cosmetic is manufactured, without 
                further processing outside or within the United States.
                    ``(B) A cosmetic shall not be considered to have 
                undergone further processing for purposes of 
                subparagraph (A) solely on the basis that packaging or 
                other labeling was added or changed or that any similar 
                activity of a de minimis nature was carried out with 
                respect to the cosmetic.
                    ``(C) The term `domestic establishment' means an 
                establishment location in any State.
                    ``(D) The term `foreign establishment' means an 
                establishment location outside the United States.
            ``(3) Safe; safety.--
                    ``(A) The terms `safe' and `safety', with respect 
                to a cosmetic, mean the cosmetic does not present a 
                significant risk of serious illness or injury to humans 
                under the conditions of use recommended or suggested in 
                the labeling of the cosmetic, including the limitation 
                of `for professional use' only.
                    ``(B) For purposes of subparagraph (A), the term 
                `professional' means an individual who--
                            ``(i) is licensed by an official State 
                        authority to practice in the field of 
                        cosmetology, nail care, barbering, and or 
                        esthetics; and
                            ``(ii) is in compliance with all 
                        requirements of the State for such 
                        licensing.''.

SEC. 4. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.

    Chapter VI (21 U.S.C. 361 et seq.), as amended by section 3, is 
further amended by adding at the end the following:

``SEC. 605. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.

    ``(a) In General.--
            ``(1) Registration.--The Secretary shall by regulation 
        require that every domestic and foreign establishment engaged 
        in the manufacture of a cosmetic intended to be sold in the 
        United States that is not exempt under subsection (e) be 
        registered with the Secretary within 60 business days after the 
        first commercial sale of a cosmetic in the United States. If a 
        cosmetic is processed in more than one establishment, 
        registration shall be required under this section only for the 
        establishment that performs the final portion of the 
        manufacturing operation. The single registration shall cover 
        all such cosmetics manufactured by the establishment. The 
        registration shall state only the name of the company or other 
        organization name of the establishment, 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. For a foreign establishment, the 
        registration shall include the contact information for the 
        initial United States agent of the establishment.
            ``(2) Unique number.--The Secretary shall establish and 
        provide to each registrant under this section a unique cosmetic 
        establishment registration number within 15 business days after 
        receiving the registration. If the Secretary does not provide a 
        unique cosmetic establishment registration number within such 
        15 business days, any requirement under this Act for such 
        number shall be deemed to be inapplicable until 30 business 
        days after such number is received by the person who submitted 
        the registration. Where more than one person registers the same 
        establishment, the Secretary shall provide only one unique 
        establishment registration number for the establishment. The 
        unique cosmetic establishment number shall not be required to 
        be included in cosmetic labeling.
    ``(b) Maintenance.--The information required in a registration 
under subsection (a) or in an existing registration under subsection 
(e)(1)(A) shall be maintained as current and accurate by the registrant 
by withdrawing or amending the registration within 60 business days 
after the information becomes no longer current and accurate.
    ``(c) Enforcement.--The Secretary shall enforce this section under 
section 301(ddd) and shall not suspend or revoke a registration under 
this section.
    ``(d) List.--The Secretary shall compile and maintain an up-to-date 
and publicly available electronic list of establishments that are 
registered under this section.
    ``(e) Exemptions.--
            ``(1) In general.--Registration under subsection (a) shall 
        not be required for any entity based on such entity operating 
        as--
                    ``(A) an 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 (as in effect on such date);
                    ``(B) a beauty shop or salon or spa;
                    ``(C) a cosmetic retailer, including any such 
                retailer that is--
                            ``(i) an individual sales representative;
                            ``(ii) a wholesale or retail distribution 
                        or sales facility; or
                            ``(iii) a pharmacy or other person or 
                        organization that--
                                    ``(I) compounds cosmetics at a 
                                single location and administers, 
                                dispenses, or distributes such 
                                cosmetics at retail from that location; 
                                and
                                    ``(II) does not otherwise 
                                manufacture or package cosmetics from 
                                that location;
                    ``(D) a health care provider, including a hospital 
                or clinic;
                    ``(E) a public health agency or other nonprofit 
                entity;
                    ``(F) a hotel or other entity that provides 
                complimentary cosmetics;
                    ``(G) a trade show or other venue where cosmetic 
                samples are provided;
                    ``(H) an establishment that manufactures, prepares, 
                compounds, or processes cosmetics for use in research, 
                teaching, or chemical analysis or pilot plant 
                production;
                    ``(I) a handcrafted soap or cosmetic made in a 
                home, a community facility, or a similar establishment; 
                or
                    ``(J) a business with less than $1,000,000 annual 
                net sales of cosmetics.
            ``(2) Additional exemptions.--The Secretary may supplement 
        the list of exemptions under paragraph (1) with additional 
        exemptions for persons and activities where the cost of 
        compliance exceeds the safety benefit to the public.''.

SEC. 5. COSMETIC AND INGREDIENT STATEMENT.

    Chapter VI (21 U.S.C. 361 et seq.), as amended by sections 3 and 4, 
is further amended by adding at the end the following:

``SEC. 606. COSMETIC AND INGREDIENT STATEMENT.

    ``(a) In General.--The Secretary shall by regulation require that 
every domestic establishment and foreign establishment engaged in the 
manufacture of a cosmetic intended to be sold in the United States 
submit to the Secretary, for each cosmetic so manufactured in the 
establishment, except such cosmetics manufactured by entities exempted 
by section 605(e) from registration under section 605, within 60 
business days after the first commercial sale of the cosmetic, a 
cosmetic and ingredient statement. The Secretary shall require the 
statement to contain only--
            ``(1) the unique establishment registration number of the 
        manufacturing establishment where the cosmetic is manufactured 
        or, if the same cosmetic 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 (as in 
        effect on the date of enactment of the Cosmetic Modernization 
        Amendments of 2015 and including any successor regulations), 
        and using the name of each ingredient established under 
        subsection (d), 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 
        submitting and maintaining the statement.
    ``(b) Unique Number.--The Secretary shall establish and provide to 
the office submitting a statement required by subsection (a) a unique 
cosmetic and ingredient statement number within 15 business days after 
receiving the statement. If the Secretary does not provide a unique 
cosmetic and ingredient statement number within such 15-business-day 
period, any requirement under this Act for such number shall be deemed 
to be inapplicable until the date that is 30 business days after such 
number is received by the office that submitted the statement. The 
unique cosmetic and ingredient statement number shall not be required 
to be included in cosmetic labeling.
    ``(c) Change in Labeling.--An establishment shall not be required 
to submit a new or revised statement under subsection (a) because of a 
change in labeling except to the extent necessary to maintain the 
accuracy of the information included in a statement under subsection 
(a).
    ``(d) Name of Ingredient.--For purposes of this section and 
cosmetic ingredient labeling under section 701.3 of title 21, Code of 
Federal Regulations (as in effect on the date of enactment of the 
Cosmetic Modernization Amendments of 2015 and including any successor 
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 by regulation establishes a 
different name for the ingredient.
    ``(e) Maintenance.--The information required in a statement 
submitted to the Secretary under subsection (a) or in an existing 
statement under subsection (g)(1) shall be maintained as current and 
accurate by the office that filed the statement by withdrawing or 
amending the statement within 60 business 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 
costs of amending the statement exceed the safety benefit to the 
public.
    ``(f) Enforcement.--The Secretary shall enforce subsections (a) and 
(e) under section 301(eee) and shall not suspend or revoke a cosmetic 
and ingredient statement.
    ``(g) 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 cosmetics and the number of 
cosmetics 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 (as in effect on the date of enactment of the 
Cosmetic Modernization Amendments of 2015 and including any successor 
regulations), or that discloses at what establishment a cosmetic is 
manufactured. At the written request of the director of a State agency 
responsible for regulating the safety of cosmetics stating good cause 
therefor, 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) of this Act, 
section 552(b) of title 5, United States Code, and section 1905 of 
title 18, United States Code, with respect to such information.
    ``(h) Exemptions.--Submission of a statement under subsection (a) 
shall not be required--
            ``(1) for 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 (as in effect on the date of enactment of 
        the Cosmetic Modernization Amendments of 2015);
            ``(2) for a cosmetic ingredient exempt from public 
        disclosure under section 720.8 of title 21, Code of Federal 
        Regulations (as in effect on the date of enactment of the 
        Cosmetic Modernization Amendments of 2015 and including any 
        successor regulations); or
            ``(3) by an entity to the extent such entity is exempted by 
        section 605(e) from registration under section 605.''.

SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.

    (a) In General.--Chapter VI (21 U.S.C. 361 et seq.), as amended by 
sections 3, 4, and 5, is further amended by adding at the end the 
following:

``SEC. 607. 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--
            ``(1) information received concerning any serious and 
        unexpected adverse event in the United States allegedly 
        associated with the use of the cosmetic for which it is 
        reasonably likely that the adverse event was caused by the 
        cosmetic when used as recommended or suggested in the labeling; 
        and
            ``(2) a copy of the label for the cosmetic.
    ``(b) Submission of Reports.--A report on an adverse event under 
subsection (a) shall be submitted to the Secretary not later than 15 
business days after information concerning the adverse event is 
received at the place of business labeled on the cosmetic pursuant to 
section 602(b)(1).
    ``(c) Required Contents.--A report under subsection (a) shall 
include all of the following information:
            ``(1) An identifiable patient.
            ``(2) An identifiable reporter.
            ``(3) A suspect cosmetic or component thereof.
            ``(4) A serious adverse event.
    ``(d) Additional Contents; Supplemental Reporting.--The person 
submitting a report under subsection (a) may--
            ``(1) include pertinent information in addition to the 
        information listed in subsection (c); and
            ``(2) after submitting the initial report, supplement the 
        report with additional information.
    ``(e) Special Rules.--
            ``(1) Protected information.--A serious and unexpected 
        adverse event report (including all information submitted in 
        the initial report or added later) submitted under subsection 
        (a)--
                    ``(A) shall be considered to be a safety report 
                under section 756 that is subject to the provisions of 
                that section; and
                    ``(B) shall be considered to be a record about an 
                individual under section 552a of title 5, United States 
                Code, and a medical or similar file the disclosure of 
                which would constitute a violation of section 552 of 
                such title 5, and shall not be publicly disclosed 
                unless all personally identifiable information is 
                redacted.
            ``(2) No treatment as admission.--The submission of a 
        serious and unexpected adverse event report in compliance with 
        subsection (a)--
                    ``(A) shall not be construed as an admission that 
                the cosmetic involved caused or contributed to the 
                adverse event; and
                    ``(B) may be accompanied by a statement that denies 
                that the report constitutes an admission that the 
                cosmetic involved caused or contributed to the adverse 
                event.
            ``(3) Inclusion of statement in public disclosure.--In 
        releasing any report under subsection (a) or portion thereof 
        for public disclosure, the Secretary shall include any 
        statement under paragraph (2)(B).
    ``(f) Labeling.--The label of a cosmetic shall bear the domestic 
telephone number, email address, or mailing address through which the 
person whose name and place of business appear on the label may receive 
a report of a serious adverse event.
    ``(g) Exemption.--The Secretary may, by regulation, establish an 
exemption to the requirements under subsections (b) and (d) if the 
Secretary determines that such exemption would have no adverse effect 
on public health.
    ``(h) Definitions.--In this section:
            ``(1) The term `serious', with respect to an adverse event, 
        means--
                    ``(A) resulting in--
                            ``(i) death;
                            ``(ii) a life-threatening experience;
                            ``(iii) inpatient hospitalization;
                            ``(iv) a persistent and significant 
                        disability or incapacity;
                            ``(v) a congenital anomaly or birth defect; 
                        or
                            ``(vi) permanent disfiguration; or
                    ``(B) requiring, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described under subparagraph (A).
            ``(2) The term `unexpected', with respect to an adverse 
        event, means not identified on the cosmetic label.''.
    (b) Misbranding.--Section 602 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 362) is amended by adding at the end the 
following:
    ``(g) If it is a cosmetic that is marketed in the United States, 
unless the label of such cosmetic includes a domestic address or 
domestic phone number through which a report of a serious and 
unexpected adverse event (as such term is used in section 607) 
associated with the use of such cosmetic may be submitted to the person 
described in section 607(f).''.

SEC. 7. GOOD MANUFACTURING PRACTICE.

    (a) Prohibition.--Section 601 (21 U.S.C. 361) is amended by adding 
at the end the following:
    ``(f) If it has been manufactured under conditions that do not 
satisfy the principles and standards for good manufacturing practice 
established under section 608 and as a result presents a significant 
risk of serious adverse health consequences or death to humans.''.
    (b) Principles and Standards.--Chapter VI (21 U.S.C. 361 et seq.), 
as amended by sections 3, 4, 5, and 6, is further amended by adding at 
the end the following:

``SEC. 608. GOOD MANUFACTURING PRACTICE.

    ``(a) In General.--The Secretary may by regulation establish 
principles and standards for good manufacturing practice for the 
manufacture of cosmetics in accordance with paragraphs (a) and (d) of 
section 601.
    ``(b) Notice and Comment.--A regulation under subsection (a) shall 
be promulgated only after providing notice and an opportunity for 
comment in accordance with chapter 5 of title 5, United States Code.
    ``(c) Good Manufacturing Practices of Other Parties.--A 
manufacturer shall not be responsible under section 601(f) or this 
section for the good manufacturing practice of its suppliers. A 
distributor shall not be responsible under section 601(f) or this 
section for the good manufacturing practice of its manufacturers.''.

SEC. 8. SAFETY SUBSTANTIATION FOR COSMETIC INGREDIENTS AND 
              NONFUNCTIONAL CONSTITUENTS.

    Chapter VI (21 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, 
6, and 7, is further amended by adding at the end the following:

``SEC. 609. COSMETIC INGREDIENTS AND NONFUNCTIONAL CONSTITUENTS THAT 
              ARE SAFE FOR USE IN COSMETICS.

    ``(a) In General.--A manufacturer or distributor of a cosmetic may 
rely on this section to substantiate the safety of such cosmetic.
    ``(b) Safe Ingredients.--Unless and until prohibited or limited by 
the Secretary by regulation, the following ingredients are deemed to be 
adequately substantiated for safe use in cosmetics subject to the 
requirements of good manufacturing practice:
            ``(1) Color additives approved by the Secretary for use in 
        cosmetics, within any limits established in such approval.
            ``(2) Food additives approved by the Secretary for direct 
        addition to food for human consumption, within any limits 
        established in such approval.
            ``(3) Food ingredients that have been determined by the 
        Secretary to be generally recognized as safe for direct 
        addition to food for human consumption, within any limits 
        established in such determination.
            ``(4) Food ingredients for which monographs have been 
        included in the Food Chemicals Codex for direct addition to 
        food for human consumption, within any limits established in 
        such monographs.
            ``(5) Pharmaceutical excipients and inactive ingredients 
        approved or permitted by the Secretary, listed on a Food and 
        Drug Administration website for use in drugs for human 
        consumption or for which monographs have been included in the 
        Handbook of Pharmaceutical Excipients, within any limits 
        established in such lists or monographs.
            ``(6) Cosmetic ingredients that have been reviewed for 
        safety by a qualified nongovernmental or governmental expert 
        scientific body, including the Cosmetic Ingredient Review 
        Expert Panel, and that are the subject of a monograph published 
        in a peer-reviewed scientific journal, within any limits 
        established in such monographs.
            ``(7) Fragrance ingredients that have been reviewed for 
        safety by a qualified nongovernmental or governmental expert 
        scientific body, including the Research Institute of Fragrance 
        Materials Expert Panel, and that are the subject of a monograph 
        published in a peer-reviewed scientific journal, within any 
        limits established in such monographs.
            ``(8) Cosmetic ingredients approved or permitted for use in 
        cosmetics by any of the countries listed in section 
        802(b)(1)(A) as having an adequate regulatory authority, within 
        any limits established by such regulatory authority.
    ``(c) Safe Nonfunctional Constituents.--
            ``(1) Definition.--A nonfunctional constituent in a 
        cosmetic is any substance that--
                    ``(A) has not been intentionally added as a 
                separate substance; and
                    ``(B) serves no technical or cosmetic function in 
                the cosmetic.
            ``(2) Adequate substantiation.--The following nonfunctional 
        constituents are deemed to be adequately substantiated for safe 
        use in cosmetics, subject to the requirements of good 
        manufacturing practice and any limits or bans established by 
        the Secretary by regulation:
                    ``(A) The levels approved or permitted for 
                nonfunctional constituents by the Secretary for color 
                additives for cosmetic use and for food additives and 
                generally recognized as safe food ingredients for 
                direct human consumption.
                    ``(B) The levels approved or permitted for 
                nonfunctional constituents by the Secretary for 
                cosmetics and for food and food ingredients for direct 
                human consumption in compliance policy guides, 
                guidance, and website statements.
                    ``(C) The levels approved or permitted for 
                nonfunctional constituents by the Secretary or the 
                United States Pharmacopeia for oral nonprescription 
                drugs.
                    ``(D) The levels approved or permitted for 
                nonfunctional constituents by the Environmental 
                Protection Agency for direct human consumption in 
                drinking water.
                    ``(E) The levels for nonfunctional constituents 
                approved or permitted in cosmetics and human food and 
                food ingredients by any of the countries listed in 
                section 802(b)(1)(A) as having an adequate regulatory 
                authority.
    ``(d) Center.--The Secretary shall establish a program within the 
center of the Food and Drug Administration with primary responsibility 
for regulating cosmetics to evaluate and make determinations, by 
regulation, on the safe use of cosmetics and ingredients and 
nonfunctional constituents thereof.
    ``(e) Application; Preemption.--A safety determination accepted or 
made by the Secretary or established under this section shall apply in 
every State. No State may establish or enforce a safety determination 
for a cosmetic or an ingredient or nonfunctional constituent of a 
cosmetic
    ``(f) Effective Date of Regulations.--Any regulation or guidance by 
the Secretary pursuant to this section concerning the safety of a 
cosmetic or an ingredient or nonfunctional constituent of a cosmetic 
shall apply beginning no earlier than the date that is 2 years after 
the date on which such regulation or guidance is issued as final, 
unless the Secretary determines, after public notice and an opportunity 
for public comment, that an earlier date of applicability is required 
to prevent serious adverse health consequences or death to humans.''.

SEC. 9. NATIONAL COSMETIC REGULATORY DATABANK.

    Chapter VI (21 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, 
6, 7, and 8, is further amended by adding at the end the following:

``SEC. 610. NATIONAL COSMETIC REGULATORY DATABANK.

    ``(a) In General.--For the purpose of consolidating information 
pertaining to the regulation of cosmetic safety, the Secretary shall 
establish and maintain in the center of the Food and Drug 
Administration with primary responsibility for regulating cosmetics a 
database, to be known as the National Cosmetic Regulatory Databank, 
containing--
            ``(1) the information submitted to the Secretary under 
        sections 605, 606, 607, and 609; and
            ``(2) such other information pertaining to the regulation 
        of cosmetics as the Secretary deems appropriate.
    ``(b) Availability.--In the case of information in the National 
Cosmetic Regulatory Databank that is not subject to public disclosure 
under section 552 of title 5, United States Code, the Secretary may 
nonetheless disclose such information to the director of a State agency 
on written request by such director demonstrating good cause for the 
disclosure. A director receiving information pursuant to the preceding 
sentence shall agree to limit to the disclosure of such information by 
State officials and employees to the same extent such disclosure is 
limited with respect to Federal officials and employees under section 
301(j) of this Act, section 552(b) of title 5, United States Code, and 
section 1905 of title 18, United States Code, with respect to such 
information.
    ``(c) Preemption.--No State or political subdivision thereof may 
require submission of information that is available in the National 
Cosmetic Regulatory Databank, whether in the same or a different 
format.''.

SEC. 10. SPECIAL RULES.

    (a) Certain Rules.--Chapter VI (21 U.S.C. 361 et seq.), as amended 
by sections 3, 4, 5, 6, 7, 8, and 9, is further amended by adding at 
the end the following:

``SEC. 611. SPECIAL RULES.

    ``(a) Contractors.--The person described in section 607(f) with 
respect to a cosmetic (referred to in this section as the `responsible 
party') may, by agreement, authorize a manufacturer, distributor, or 
packer of the cosmetic or a third-party contractor to submit any 
required report of a serious and unexpected adverse event (as such term 
is used in section 607) so long as the responsible party directs to the 
manufacturer, distributor, packer, or third-party contractor all such 
adverse events associated with such cosmetic that are reported to the 
responsible party through the address or telephone number described in 
section 607(f).
    ``(b) Exemptions.--The Secretary, on the Secretary's own initiative 
or in response to a petition, may establish exemptions from the 
requirements of sections 601(f), 605, 606, 607, and 608--
            ``(1) for the efficient and cost-effective implementation 
        of such requirements; or
            ``(2) where the cost of compliance exceeds the safety 
        benefit to the public.''.
    (b) Cosmetic Definition.--Section 201(i) (21 U.S.C. 321(i)) is 
amended by adding at the end the following: ``An article described in 
subparagraph (1) that is intended only for topical external use to 
alter the appearance by temporarily affecting the structure or any 
function of the human skin, and that is not the subject of an approved 
new drug application under section 505, shall, for purposes of this 
Act, be treated only as a cosmetic and not a drug.''.
    (c) Color Additives.--Section 721(f) (21 U.S.C. 379e(f)) is 
amended--
            (1) by striking ``(f) The Secretary shall'' and inserting 
        ``(f)(1) The Secretary shall''; and
            (2) by adding at the end the following:
    ``(2) A color additive, including mixtures thereof, intended for 
use in externally applied cosmetics and not in the area of the eye is 
exempt from the requirements of this section if it is generally 
recognized, among experts qualified by scientific training and 
experience to evaluate its safety, as having been shown through 
scientific procedures to be safe under the conditions of its intended 
use. Notwithstanding the preceding sentence, the Secretary may by 
regulation require certification of batches under subsection (c) for 
any such color additive.''.

SEC. 11. PROHIBITED ACTS.

    (a) In General.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(ddd) The failure to register a cosmetic establishment as 
required under section 605 or to maintain the registration current and 
accurate.
    ``(eee) The failure to submit a cosmetic and ingredient statement 
as required under section 606 or to maintain the statement current and 
accurate.
    ``(fff) The failure to submit a serious and unexpected adverse 
event report, or to include on the label of a cosmetic the domestic 
telephone number, email address, or mailing address through which a 
report of a serious adverse event may be received, as required under 
section 607.''.
    (b) Information Security.--Section 301(j) (21 U.S.C. 331(j)) is 
amended by inserting ``605, 606, 609,'' after ``573,''.

SEC. 12. NATIONAL UNIFORMITY FOR COSMETICS.

    Section 752 (21 U.S.C. 379s) is amended--
            (1) by amending the section heading to read as follows: 
        ``national uniformity for cosmetics'';
            (2) by amending subsection (a) to read as follows:
    ``(a) In General.--Except as provided in subsection (b) or (d) of 
this section, no State or political subdivision of a State may 
establish or continue in effect any requirement for labeling or 
packaging of a cosmetic.'';
            (3) by amending subsection (c) to read as follows:
    ``(c) Cosmetic Safety.--No State or political subdivision of a 
State may establish or continue in effect any law, regulation, order, 
or other requirement--
            ``(1) relating directly or indirectly to, or relying upon, 
        a human health or safety evaluation of a nonfunctional cosmetic 
        constituent, cosmetic ingredient, or cosmetic (as defined in 
        section 201(i)(1)), or relating in any way to the safety 
        standard and the human health-based requirements, evaluations, 
        and determinations under chapter VI, the Poison Prevention 
        Packaging Act of 1970, or the Fair Packaging and Labeling Act; 
        or
            ``(2) relating directly or indirectly to registration or 
        listing of cosmetic facilities, establishments, cosmetics, or 
        cosmetic ingredients, reporting of any information relating to 
        cosmetics including adverse event reporting, cosmetic 
        manufacturing processes or standards including good 
        manufacturing practice, cosmetic labels or labeling including 
        any general or health related warnings or public statement, or 
        the requirement of any fees on cosmetic establishments, 
        cosmetics, ingredients, or nonfunctional constituents.''; and
            (4) by repealing subsection (e).

SEC. 13. IMPORTATION.

    Section 801(a) (21 U.S.C. 381(a)) is amended by adding at the end 
the following: ``If a cosmetic is being imported or offered for import 
into the United States and the importer does not present both the 
unique cosmetic establishment registration number required under 
section 605 for the establishment that performs the final portion of 
the manufacturing operation and the unique cosmetic and ingredient 
statement number required under section 606 for the cosmetic, or the 
registration or statement number is not correct and accurate, the 
cosmetic shall be denied entry.''.

SEC. 14. EFFECTIVE DATES.

    (a)(1) The amendments made by sections 4, 5, 6, and 13 of this Act 
apply beginning on the later date of--
            (A) the date that is one year after the Secretary of Health 
        and Human Services promulgates final regulations implementing 
        such amendments; or
            (B) the date that is 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 fully operational for--
                    (i) the submission of cosmetic manufacturing 
                establishment registrations, cosmetic and ingredient 
                statements, and reports of serious cosmetic adverse 
                events; and
                    (ii) the National Cosmetic Regulatory Databank.
    (2) Until the date applicable under paragraph (1), the voluntary 
establishment registration and voluntary ingredient listing programs 
established in parts 710 and 720 of title 21, Code of Federal 
Regulations (as in effect on the date of enactment of this Act), shall 
remain effective and shall be fully implemented by the Secretary of 
Health and Human Services.
    (b) The amendments made by sections 7 and 8 apply beginning on the 
date that is two years after the date of enactment of this Act.
    (c) Notwithstanding subsections (a) and (b), the amendments made by 
sections 5 and 7 shall not apply with respect to a cosmetic 
manufacturer with less than $5,000,000 of annual net sales of cosmetics 
until the later of--
            (1)(A) with respect to the amendment made by section 5, the 
        date that is 36 months after the date otherwise applicable 
        under subsection (a); and
            (B) with respect to the amendments made by section 7, the 
        date that is 36 months after the date otherwise applicable 
        under subsection (b); and
            (2) such later date as may be determined by the Secretary 
        of Health and Human Services.
    (d) Except as provided in subsections (a) through (c), this Act 
takes effect on the date of enactment of this Act.
                                 <all>