[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4262 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 4262

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
                             of cosmetics.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 26, 2012

  Mr. Pallone (for himself and Mr. Dingell) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
                             of cosmetics.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Cosmetics Safety 
Enhancement Act of 2012''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Registration of cosmetic facilities; listing of cosmetic 
                            products; fees.
Sec. 3. Cosmetic product safety substantiation.
Sec. 4. Serious adverse event reports for cosmetics.
Sec. 5. Maintenance and access to records.
Sec. 6. Good manufacturing practices for cosmetics.
Sec. 7. Mandatory recall authority.
Sec. 8. Effective dates.

SEC. 2. REGISTRATION OF COSMETIC FACILITIES; LISTING OF COSMETIC 
              PRODUCTS; FEES.

    (a) Prohibited Act.--Section 301(dd) of the 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) Adulteration.--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) Annual Registration.--Chapter VI of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361 et seq) is amended by adding at the end the 
following:

``SEC. 604. REGISTRATION OF COSMETIC FACILITIES AND COSMETIC PRODUCT 
              LISTING.

    ``(a) Registration.--
            ``(1) In general.--The Secretary shall by 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) Registration.--
                    ``(A) Timing.--A registration under paragraph (1) 
                shall be submitted to the Secretary not later than 
                December 31 of each year.
                    ``(B) Format; contents.--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) Changes to information.--The registrant shall 
                notify the Secretary of any change to the information 
                described in clauses (i) through (ix) of subparagraph 
                (B) not later than 30 days after the date of such 
                change unless otherwise specified by the Secretary.
            ``(3) Procedure.--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) List.--
                    ``(A) In general.--The Secretary shall compile and 
                maintain an up-to-date list of facilities that are 
                registered under this section.
                    ``(B) Removal.--The Secretary shall--
                            ``(i) remove from such list the name of any 
                        facility whose registration under this section 
                        is suspended or cancelled; and
                            ``(ii) initiate proceedings in 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) Public availability.--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) In general.--The Secretary may suspend the 
                registration of any facility under this section for a 
                violation of this Act that could result in serious 
                adverse health consequences or death to humans or 
                animals.
                    ``(B) Notice of suspension.--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) Reinstatement.--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) In general.--Not earlier than 10 days after 
                providing notice under subparagraph (B), the Secretary 
                may cancel a registration under this section if the 
                Secretary determines that--
                            ``(i) the registration was not updated in 
                        accordance with this section or 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) Notice of cancellation.--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 correction.--If the 
                registration for the facility is updated or corrected 
                and the required registration fee is paid no later than 
                7 days after notice is provided under subparagraph (B), 
                the Secretary shall not cancel such registration.
    ``(b) Cosmetic Product Listing.--
            ``(1) In general.--Not later than March 31 of each year, 
        every responsible person shall file with the Secretary a list, 
        in such form as the Secretary may prescribe, of each cosmetic 
        product owned by such person and distributed in the United 
        States.
            ``(2) Contents.--For each cosmetic product, the list 
        required by paragraph (1) shall include the following 
        information:
                    ``(A) The unique facility identifier (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) Additional requirements.--
                    ``(A) Certification.--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) Changes to information.--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 
        number.--Upon 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) Up-to-date list.--The Secretary shall compile and 
        maintain an up-to-date list of cosmetic products distributed in 
        the United States, including the ingredients of each such 
        product.
    ``(c) Definitions.--For purposes of this section:
            ``(1) Cosmetic formulation.--The term `cosmetic 
        formulation' means a preparation of cosmetic raw materials with 
        a qualitatively and quantitatively set composition.
            ``(2) Cosmetic product.--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) Facility.--
                    ``(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) Responsible person.--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) Registration Fee.--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:

                  ``PART 7--FEES RELATING TO COSMETICS

``SEC. 744. FACILITY REGISTRATION FEE.

    ``(a) In General.--
            ``(1) Assessment and collection.--Beginning in fiscal year 
        2013, the Secretary shall assess and collect an annual fee for 
        the registration of a facility under section 604(a).
            ``(2) Payable date.--A fee under this section shall be 
        payable--
                    ``(A) for a facility that was not registered under 
                section 604 for the preceding fiscal year, on the date 
                of registration; and
                    ``(B) for any other facility--
                            ``(i) for fiscal year 2013, not later than 
                        the sooner of--
                                    ``(I) 90 days after the date of the 
                                enactment of this part; or
                                    ``(II) the date of re-registration; 
                                and
                            ``(ii) for a subsequent fiscal year, on the 
                        date of re-registration.
    ``(b) Fee Amounts.--
            ``(1) In general.--The registration fee under subsection 
        (a) shall be--
                    ``(A) for fiscal year 2013, $500; and
                    ``(B) for fiscal year 2014 and each subsequent 
                fiscal year, the fee for fiscal year 2013 as adjusted 
                under subsection (c).
            ``(2) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of 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) Inflation Adjustment.--For fiscal year 2014 and subsequent 
fiscal years, the revenues established in subsection (b) shall be 
adjusted by the Secretary by notice, published in the Federal Register, 
for a fiscal year to 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) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2013 
        unless appropriations for salaries and expenses of the cosmetic 
        products programs of the Food and Drug Administration for such 
        fiscal year (excluding the amount of fees appropriated for such 
        fiscal year) are equal to or greater than the amount of 
        appropriations for the salaries and 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) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of paragraph (1) and if at a later date in such fiscal 
        year the Secretary may 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) Adjustment factor.--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) In general.--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 acts.--The fees 
        authorized by this section--
                    ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made 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 appropriations.--For each of fiscal 
        years 2013 through 2017, there are authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary.
    ``(f) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee 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) Construction.--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) Annual Fiscal Reports.--Beginning with fiscal year 2014, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this section, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the 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) Definitions.--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) Transitional Provisions.--
            (1) Fees.--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) Sunset date.--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.

SEC. 3. COSMETIC PRODUCT SAFETY SUBSTANTIATION.

    (a) Adulteration.--Section 601 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361), as amended by section 2(b), is further 
amended by adding at the end the following:
    ``(g) If it is a cosmetic product for which any requirement of 
section 605 (relating to safety substantiation) is not met.''.
    (b) Substantiation.--Chapter VI of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361 et seq.), as amended, is further amended by 
adding at the end the following:

``SEC. 605. COSMETIC PRODUCT SAFETY SUBSTANTIATION.

    ``(a) In General.--The responsible person shall--
            ``(1) before introduction or delivery for 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) Scientific Evidence.--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 Records.--In response to a 
request by the Secretary, the responsible person shall promptly supply 
to the Secretary a copy of the file required under subsection (a). Such 
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) Definitions.--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).''.

SEC. 4. SERIOUS ADVERSE EVENT REPORTS FOR COSMETICS.

    (a) Prohibited Acts.--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) 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:
    ``(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) Adverse Event Reporting.--Chapter VI of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 361 et seq.), as amended, is further 
amended by adding at the end the following:

``SEC. 606. SERIOUS ADVERSE EVENT REPORTS FOR COSMETICS.

    ``(a)(1) In General.--The manufacturer, packer, or distributor of a 
cosmetic product distributed in the United States (referred to in this 
section as the `responsible 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) Retailer.--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) Submission of Reports.--
            ``(1) In general.--A report under subsection (a) shall be 
        submitted to the Secretary no later than 15 business days after 
        information concerning the adverse event is received at the 
        place of business that is indicated on the label of the 
        cosmetic, as required under section 602(b)(1).
            ``(2) Contents.--A report under subsection (a) shall be 
        submitted to the Secretary in a format, and shall contain the 
        information, defined by the Secretary in guidance or by 
        regulation, including the following information, to the extent 
        to which such information has been provided to the responsible 
        person:
                    ``(A) The identity of the individual 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) Additional information.--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) Maintenance.--The responsible person shall maintain 
        records of all information received by such person relating to 
        each serious adverse event for a period of 6 years from initial 
        receipt of such information.
            ``(2) Records inspection.--The responsible person shall 
        permit an officer or employee duly 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 Provisions.--A report under subsection (a) 
(including all information submitted in the initial report or added 
later) shall be considered to be--
            ``(1) a safety report under section 756;
            ``(2) a record about an individual under section 552a of 
        title 5, United States Code; and
            ``(3) a medical or similar file, the disclosure of which 
        would constitute a violation of section 552(b)(6) of such title 
        5, United States Code, and which shall not be disclosed under 
        section 552 of such title.
    ``(e) Definitions.--In this section:
            ``(1) The term `serious', with respect to an 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 Products.--Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) in subsection (a), by striking ``760 or 761'' each 
        place it appears and inserting ``760, 761, or 606''; and
            (2) in subsection (b), by striking ``760 or 761'' each 
        place it appears and inserting ``760, 761, or 606''.

SEC. 5. MAINTENANCE AND ACCESS TO RECORDS.

    (a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.), as amended, is further amended by adding 
at the end the following:

``SEC. 607. MAINTENANCE AND ACCESS TO RECORDS.

    ``(a) Records Access.--
            ``(1) Records access during an inspection.--
                    ``(A) In general.--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) Scope of records.--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 notice.--Records 
                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 emergencies.--If 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) Electronic submission.--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 Recordkeeping.--The 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) Conforming Amendments.--Section 704(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting after the second sentence the 
                following: ``In the case of any person who 
                manufactures, packs, or holds cosmetics, the 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 Provisions.--This 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.

SEC. 6. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

    (a) In General.--Section 601 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361), as amended by section 3(a), is further 
amended by adding at the end the following:
    ``(h) If the methods used in, or the facilities or 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) Regulations.--
            (1) Promulgation.--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) International standards.--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.

SEC. 7. MANDATORY RECALL AUTHORITY.

    (a) Prohibited Act.--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) Recall Authority.--Chapter VI of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 361 et seq.), as amended, is further amended by 
adding at the end the following:

``SEC. 608. MANDATORY RECALL AUTHORITY.

    ``(a) Voluntary Procedures.--If the Secretary determines that there 
is a reasonable probability that a cosmetic is adulterated under 
section 601 and the use of, or exposure to, such cosmetic will cause 
serious adverse health consequences or death to humans, the Secretary 
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) In general.--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 affected.--If 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) Hearing on Order.--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) Amendment of order.--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) Vacating of order.--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 Consultation.--The Secretary shall work with 
State and local public health officials in carrying out this section, 
as appropriate.
    ``(f) Public Notification.--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) No Delegation.--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) Effect.--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 Defined.--In this section, the term 
`responsible person' has the meaning given to such term in section 
604(c).''.

SEC. 8. EFFECTIVE DATES.

    (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.
                                 <all>