I 

112TH CONGRESS 

2D SESSION H. R. 4262 

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

of cosmetics. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 26, 2012 

Mr. PALLONE (for himself and Mr. DINGELL) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

improve the safety of cosmetics. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Cosmetics Safety Enhancement Act of 2012’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 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. 


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Sec. 7. Mandatory recall authority. 

Sec. 8. Effective dates. 

1 SEC. 2. REGISTRATION OF COSMETIC FACILITIES; LISTING 

2 OF COSMETIC PRODUCTS; FEES. 

3 (a) PROHIBITED ACT.—Section 301(dd) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(dd)) 

5 is amended by striking the period at the end and adding 

6 ‘‘, the failure to register in accordance with section 604(a), 

7 or the failure to list a cosmetic product in accordance with 

8 section 604(b)’’. 

9 (b) ADULTERATION.—Section 601 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amend11 ed by adding at the end the following: 

12 ‘‘(f) If it was manufactured, packed, or held in a fa13 cility that is not duly registered under section 604(a), or 

14 if it is a cosmetic product that is not listed in accordance 

15 with section 604(b).’’. 

16 (c) ANNUAL REGISTRATION.—Chapter VI of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 

18 et seq) is amended by adding at the end the following: 

19 ‘‘SEC. 604. REGISTRATION OF COSMETIC FACILITIES AND 

20 COSMETIC PRODUCT LISTING. 

21 ‘‘(a) REGISTRATION.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall by reg23 ulation require that any facility engaged in manufac24 turing, packing, or holding a cosmetic product or a 


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1 cosmetic formulation be registered annually with the 

2 Secretary. To be so registered, any such facility shall 

3 pay the registration fee required under section 744. 

4 ‘‘(2) REGISTRATION.— 

5 ‘‘(A) TIMING.—A registration under para6 graph (1) shall be submitted to the Secretary 

7 not later than December 31 of each year. 

8 ‘‘(B) FORMAT; CONTENTS.—Each registra9 tion under paragraph (1) shall be submitted 

10 using an electronic format, as specified in regu11 lations or guidance issued by the Secretary, and 

12 shall include the following information: 

13 ‘‘(i) The facility’s name and full ad14 dress, which address shall identify the pre15 cise physical location of the facility. 

16 ‘‘(ii) The identity of the facility, in17 cluding the unique facility identifier, if 

18 any, previously assigned by the Secretary 

19 to the facility under paragraph (3). 

20 ‘‘(iii) All business trading names used 

21 by the facility. 

22 ‘‘(iv) The product category or cat23 egories of each cosmetic product or cos24 metic formulation manufactured, packed, 

25 or held at the facility. 


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1 ‘‘(v) The type of activity conducted at 

2 the facility (such as manufacturing, pack3 ing, or holding). 

4 ‘‘(vi) The name, title, street address, 

5 telephone number, and, if available, the 

6 email address of the emergency contact for 

7 the facility. 

8 ‘‘(vii) In the case of a foreign facility, 

9 the name, street address, telephone num10 ber, emergency contact information, and, if 

11 available, the email address of the United 

12 States agent for the facility. 

13 ‘‘(viii) The name, title, street address, 

14 telephone number, and, if available, email 

15 address of the individual submitting the 

16 registration. 

17 ‘‘(ix) Additional information per18 taining to the facility or to the cosmetic 

19 products or cosmetic formulations manu20 factured, packed, or held at the facility, as 

21 the Secretary may require by regulation. 

22 ‘‘(C) CHANGES TO INFORMATION.—The 

23 registrant shall notify the Secretary of any 

24 change to the information described in clauses 

25 (i) through (ix) of subparagraph (B) not later 


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1 than 30 days after the date of such change un2 less otherwise specified by the Secretary. 

3 ‘‘(3) PROCEDURE.—Upon receipt of a com4 pleted registration under paragraph (1), the Sec5 retary shall notify the registrant of the receipt of 

6 such registration. At the time of the initial registra7 tion of any cosmetic facility under this section, the 

8 Secretary shall assign a unique facility identifier to 

9 the facility. 

10 ‘‘(4) LIST.— 

11 ‘‘(A) IN GENERAL.—The Secretary shall 

12 compile and maintain an up-to-date list of fa13 cilities that are registered under this section. 

14 ‘‘(B) REMOVAL.—The Secretary shall— 

15 ‘‘(i) remove from such list the name 

16 of any facility whose registration under 

17 this section is suspended or cancelled; and 

18 ‘‘(ii) initiate proceedings in accord19 ance with paragraph (6) to cancel the reg20 istration of any facility that— 

21 ‘‘(I) fails to re-register under this 

22 section; or 

23 ‘‘(II) fails to pay the registration 

24 fee required under section 744. 


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1 ‘‘(C) PUBLIC AVAILABILITY.—The list of 

2 registered facilities maintained pursuant to sub3 paragraph (A) and any registration documents 

4 submitted pursuant to this subsection shall not 

5 be subject to disclosure under section 552 of 

6 title 5, United States Code. Information derived 

7 from such list or registration documents shall 

8 not be subject to disclosure under section 552 

9 of title 5, United States Code, to the extent 

10 that such information discloses the identity or 

11 location of a specific registered facility. 

12 ‘‘(5) SUSPENSION OF REGISTRATION.— 

13 ‘‘(A) IN GENERAL.—The Secretary may 

14 suspend the registration of any facility under 

15 this section for a violation of this Act that could 

16 result in serious adverse health consequences or 

17 death to humans or animals. 

18 ‘‘(B) NOTICE OF SUSPENSION.—Suspen19 sion of a registration under this section shall be 

20 preceded by— 

21 ‘‘(i) notice, as defined in guidance or 

22 regulations issued by the Secretary, to the 

23 facility of the intent to suspend the reg24 istration; and 


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1 ‘‘(ii) an opportunity for an informal 

2 hearing concerning the suspension of the 

3 such registration for such facility. 

4 ‘‘(C) REINSTATEMENT.—A registration 

5 that is suspended under this section may be re6 instated pursuant to criteria published by the 

7 Secretary in the Federal Register and on a pub8 lic Web site of the Food and Drug Administra9 tion. 

10 ‘‘(6) CANCELLATION OF REGISTRATION.— 

11 ‘‘(A) IN GENERAL.—Not earlier than 10 

12 days after providing notice under subparagraph 

13 (B), the Secretary may cancel a registration 

14 under this section if the Secretary determines 

15 that— 

16 ‘‘(i) the registration was not updated 

17 in accordance with this section or other18 wise contains false, incomplete, or inac19 curate information; or 

20 ‘‘(ii) the required registration fee 

21 under section 744 has not been paid within 

22 30 days after the date due. 

23 ‘‘(B) NOTICE OF CANCELLATION.—Can24 cellation shall be preceded by notice to the facilVerDate Mar 15 2010 03:22 Mar 27, 2012 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4262.IH H4262

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1 ity of the intent to cancel the registration and 

2 the basis for such cancellation. 

3 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

4 If the registration for the facility is updated or 

5 corrected and the required registration fee is 

6 paid no later than 7 days after notice is pro7 vided under subparagraph (B), the Secretary 

8 shall not cancel such registration. 

9 ‘‘(b) COSMETIC PRODUCT LISTING.— 

10 ‘‘(1) IN GENERAL.—Not later than March 31 of 

11 each year, every responsible person shall file with 

12 the Secretary a list, in such form as the Secretary 

13 may prescribe, of each cosmetic product owned by 

14 such person and distributed in the United States. 

15 ‘‘(2) CONTENTS.—For each cosmetic product, 

16 the list required by paragraph (1) shall include the 

17 following information: 

18 ‘‘(A) The unique facility identifier (as19 signed under subsection (a)(3)) of the facility 

20 where the cosmetic product is manufactured or 

21 packed, or, if the same cosmetic product is 

22 manufactured or packed in more than one facil23 ity, unique facility identifier of each facility 

24 where it is manufactured or packed. 


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1 ‘‘(B) The brand name and the full name 

2 for the cosmetic product as it appears on the 

3 label. 

4 ‘‘(C) The cosmetic product listing number, 

5 if any, previously assigned by the Secretary 

6 under paragraph (4) to the cosmetic product. 

7 ‘‘(D) The applicable cosmetic category for 

8 the cosmetic product. 

9 ‘‘(E) The ingredients in the cosmetic prod10 uct in descending order of predominance by 

11 weight, with each ingredient identified by the 

12 name adopted in regulations promulgated by 

13 the Secretary, if any, or by the common or 

14 usual name of the ingredient. 

15 ‘‘(F) The title and full contact information 

16 of each individual submitting the list. 

17 ‘‘(G) Such additional information per18 taining to the cosmetic product as the Secretary 

19 may require by regulation. 

20 ‘‘(3) ADDITIONAL REQUIREMENTS.— 

21 ‘‘(A) CERTIFICATION.—The filing for a 

22 cosmetic product under paragraph (1) shall in23 clude a certification, submitted by the respon24 sible person, that such list includes all cosmetic 

25 products owned by such person. 


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1 ‘‘(B) CHANGES TO INFORMATION.—The 

2 responsible person shall notify the Secretary 

3 within 60 days of— 

4 ‘‘(i) any change to the information re5 quired to be in such product list; or 

6 ‘‘(ii) the discontinuation of the manu7 facture of a cosmetic product. 

8 ‘‘(4) NOTIFICATION TO OWNER; ASSIGNMENT

9 OF COSMETIC PRODUCT NUMBER.—Upon receipt of 

10 a list for a cosmetic product under paragraph (1), 

11 the Secretary shall— 

12 ‘‘(A) notify the responsible person identi13 fied in such list that the list has been received; 

14 and 

15 ‘‘(B) assign a cosmetic product number to 

16 any listed product not previously assigned a 

17 cosmetic product listing number. 

18 ‘‘(5) UP-TO-DATE LIST.—The Secretary shall 

19 compile and maintain an up-to-date list of cosmetic 

20 products distributed in the United States, including 

21 the ingredients of each such product. 

22 ‘‘(c) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) COSMETIC FORMULATION.—The term ‘cos24 metic formulation’ means a preparation of cosmetic 


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1 raw materials with a qualitatively and quantitatively 

2 set composition. 

3 ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 

4 product’ means a finished cosmetic that has under5 gone all stages of production, including packaging in 

6 its final container for shipment and application of a 

7 product label. 

8 ‘‘(3) FACILITY.— 

9 ‘‘(A)(i) The term ‘facility’ includes any fac10 tory, warehouse, or establishment facility (in11 cluding a factory, warehouse, or establishment 

12 of an importer) that manufactures, packs, or 

13 holds cosmetic products or cosmetic formula14 tions. 

15 ‘‘(ii) Such term does not include— 

16 ‘‘(I) beauty shops and salons; 

17 ‘‘(II) pharmacies and other cosmetic 

18 product retailers, including individual sales 

19 representatives and retail distribution fa20 cilities; 

21 ‘‘(III) hospitals, physicians’ offices, 

22 and health care clinics; 

23 ‘‘(IV) public health agencies and other 

24 nonprofit entities that provide cosmetics 

25 directly to the consumer; 


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1 ‘‘(V) hotels and other entities that 

2 provide complimentary cosmetics to guests; 

3 ‘‘(VI) trade shows and other venues 

4 where cosmetic product samples are pro5 vided free of charge; and 

6 ‘‘(VII) entities that manufacture or 

7 compound cosmetic products solely for use 

8 in research, teaching, or pilot plant pro9 duction and not for sale. 

10 ‘‘(B) The term ‘domestic facility’ means a 

11 facility located in any State. 

12 ‘‘(C)(i) The term ‘foreign facility’ means a 

13 facility that manufactures, packs, or holds cos14 metics that are exported to the United States 

15 without further processing or packaging outside 

16 the United States. 

17 ‘‘(ii) A cosmetic may not be considered to 

18 have undergone further processing or packaging 

19 for purposes of clause (i) solely on the basis 

20 that labeling was added or that any similar ac21 tivity of a de minimis nature was carried out 

22 with respect to the cosmetic. 

23 ‘‘(4) RESPONSIBLE PERSON.—The term ‘re24 sponsible person’ means a person (as defined in sec25 tion 201(e)) that is the owner of a cosmetic product 


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1 intended for introduction into United States com2 merce.’’. 

3 (d) REGISTRATION FEE.—Chapter VII of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 371 et 

5 seq.) is amended by adding at the end of subchapter C 

6 the following: 

7 ‘‘PART 7—FEES RELATING TO COSMETICS 

8 ‘‘SEC. 744. FACILITY REGISTRATION FEE. 

9 ‘‘(a) IN GENERAL.— 

10 ‘‘(1) ASSESSMENT AND COLLECTION.—Begin11 ning in fiscal year 2013, the Secretary shall assess 

12 and collect an annual fee for the registration of a fa13 cility under section 604(a). 

14 ‘‘(2) PAYABLE DATE.—A fee under this section 

15 shall be payable— 

16 ‘‘(A) for a facility that was not registered 

17 under section 604 for the preceding fiscal year, 

18 on the date of registration; and 

19 ‘‘(B) for any other facility— 

20 ‘‘(i) for fiscal year 2013, not later 

21 than the sooner of— 

22 ‘‘(I) 90 days after the date of the 

23 enactment of this part; or 

24 ‘‘(II) the date of re-registration; 

25 and 


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1 ‘‘(ii) for a subsequent fiscal year, on 

2 the date of re-registration. 

3 ‘‘(b) FEE AMOUNTS.— 

4 ‘‘(1) IN GENERAL.—The registration fee under 

5 subsection (a) shall be— 

6 ‘‘(A) for fiscal year 2013, $500; and 

7 ‘‘(B) for fiscal year 2014 and each subse8 quent fiscal year, the fee for fiscal year 2013 as 

9 adjusted under subsection (c). 

10 ‘‘(2) ANNUAL FEE SETTING.—The Secretary 

11 shall, not later than 60 days before the start of fis12 cal year 2014 and each subsequent fiscal year, es13 tablish, for the next fiscal year, registration fees 

14 under subsection (a), as described in paragraph (1). 

15 ‘‘(c) INFLATION ADJUSTMENT.—For fiscal year 2014 

16 and subsequent fiscal years, the revenues established in 

17 subsection (b) shall be adjusted by the Secretary by notice, 

18 published in the Federal Register, for a fiscal year to re19 flect the sum of one plus— 

20 ‘‘(1) the average annual change in the cost, per 

21 full-time equivalent position of the Food and Drug 

22 Administration, of all personnel compensation and 

23 benefits paid with respect to such positions for the 

24 first 3 years of the preceding 4 fiscal years multi25 plied by the proportion of personnel compensation 


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1 and benefits costs to total costs of cosmetic safety 

2 activities for the first 3 years of the preceding 4 

3 years; and 

4 ‘‘(2) the average annual change that occurred 

5 in the Consumer Price Index for urban consumers 

6 (Washington-Baltimore, DC–MD–VA–WV; Not Sea7 sonally Adjusted; All items; Annual Index) for the 

8 first 3 years of the preceding 4 years of available 

9 data multiplied by the proportion of all costs other 

10 than personnel compensation and benefits costs to 

11 total costs of cosmetic safety activities for the first 

12 3 years of the preceding 4 fiscal years. 

13 The adjustment made each fiscal year under this sub14 section will be added on a compounded basis to the sum 

15 of all adjustments made each fiscal year after fiscal year 

16 2013 under this subsection. 

17 ‘‘(d) LIMITATIONS.— 

18 ‘‘(1) IN GENERAL.—Fees under subsection (a) 

19 shall be refunded for a fiscal year beginning after 

20 fiscal year 2013 unless appropriations for salaries 

21 and expenses of the cosmetic products programs of 

22 the Food and Drug Administration for such fiscal 

23 year (excluding the amount of fees appropriated for 

24 such fiscal year) are equal to or greater than the 

25 amount of appropriations for the salaries and exVerDate Mar 15 2010 03:22 Mar 27, 2012 Jkt 019200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H4262.IH H4262

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1 penses of the cosmetic products programs of the 

2 Food and Drug Administration for fiscal year 2012 

3 (excluding the amount of fees appropriated for such 

4 fiscal year) multiplied by the adjustment factor ap5 plicable to the fiscal year involved. 

6 ‘‘(2) AUTHORITY.—If the Secretary does not 

7 assess fees under subsection (a) during any portion 

8 of a fiscal year because of paragraph (1) and if at 

9 a later date in such fiscal year the Secretary may as10 sess such fees, the Secretary may assess and collect 

11 such fees, without any modification in the rate, for 

12 registration under section 604 at any time in such 

13 fiscal year. 

14 ‘‘(3) ADJUSTMENT FACTOR.—In this sub15 section, the term ‘adjustment factor’ applicable to a 

16 fiscal year is the Consumer Price Index for all urban 

17 consumers (all items; United States city average) for 

18 October of the preceding fiscal year divided by such 

19 Index for October 2011. 

20 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

21 ‘‘(1) IN GENERAL.—Fees authorized under sub22 section (a) shall be collected and available for obliga23 tion only to the extent and in the amount provided 

24 in advance in appropriations Acts. Such fees are au25 thorized to remain available until expended. Such 


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1 sums as may be necessary may be transferred from 

2 the Food and Drug Administration salaries and ex3 penses appropriation account without fiscal year lim4 itation to such appropriation account for salaries 

5 and expenses with such fiscal year limitation. 

6 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

7 ACTS.—The fees authorized by this section— 

8 ‘‘(A) shall be retained in each fiscal year in 

9 an amount not to exceed the amount specified 

10 in appropriation Acts, or otherwise made avail11 able for obligation, for such fiscal year; and 

12 ‘‘(B) shall only be collected and available 

13 to defray the costs of cosmetic safety activities. 

14 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

15 For each of fiscal years 2013 through 2017, there 

16 are authorized to be appropriated for fees under this 

17 section such sums as may be necessary. 

18 ‘‘(f) COLLECTION OF UNPAID FEES.—In any case 

19 where the Secretary does not receive payment of a fee as20 sessed under subsection (a) within 30 days after it is due, 

21 such fee shall be treated as a claim of the United States 

22 Government subject to subchapter II of chapter 37 of title 

23 31, United States Code. 

24 ‘‘(g) CONSTRUCTION.—This section may not be con25 strued to require that the number of full-time equivalent 


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1 positions in the Department of Health and Human Serv2 ices, for officers, employees, and advisory committees not 

3 engaged in cosmetic safety activities, be reduced to offset 

4 the number of officers, employees, and advisory commit5 tees so engaged. 

6 ‘‘(h) ANNUAL FISCAL REPORTS.—Beginning with 

7 fiscal year 2014, not later than 120 days after the end 

8 of each fiscal year for which fees are collected under this 

9 section, the Secretary shall prepare and submit to the 

10 Committee on Energy and Commerce of the House of 

11 Representatives and the Committee on Health, Education, 

12 Labor, and Pensions of the Senate a report on the imple13 mentation of the authority for such fees during such fiscal 

14 year and the use, by the Food and Drug Administration, 

15 of the fees collected for such fiscal year. 

16 ‘‘(i) DEFINITIONS.—In this section: 

17 ‘‘(1) The term ‘costs of cosmetic safety activi18 ties’ means the expenses incurred in connection with 

19 cosmetic safety activities for— 

20 ‘‘(A) officers and employees of the Food 

21 and Drug Administration, contractors of the 

22 Food and Drug Administration, advisory com23 mittees, and costs related to such officers, em24 ployees, and committees and to contracts with 

25 such contractors; 


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1 ‘‘(B) laboratory capacity; 

2 ‘‘(C) management of information, and the 

3 acquisition, maintenance, and repair of tech4 nology resources; 

5 ‘‘(D) leasing, maintenance, renovation, and 

6 repair of facilities and acquisition, maintenance, 

7 and repair of fixtures, furniture, scientific 

8 equipment, and other necessary materials and 

9 supplies; and 

10 ‘‘(E) collecting fees under this section and 

11 accounting for resources allocated for cosmetic 

12 safety activities. 

13 ‘‘(2) The term ‘cosmetic safety activities’ means 

14 activities of the Food and Drug Administration re15 lated to ensuring the safety of cosmetics sold for use 

16 in the United States, as authorized by this Act.’’. 

17 (e) TRANSITIONAL PROVISIONS.— 

18 (1) FEES.—The Secretary of Health and 

19 Human Services shall first impose the fee estab20 lished under section 744 of the Federal Food, Drug, 

21 and Cosmetic Act, as added by subsection (d), for 

22 fiscal years beginning with fiscal year 2013. 

23 (2) SUNSET DATE.—Section 744 of the Federal 

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1 lection of a fee for registration under section 604 of 

2 such Act occurring after fiscal year 2017. 

3 SEC. 3. COSMETIC PRODUCT SAFETY SUBSTANTIATION. 

4 (a) ADULTERATION.—Section 601 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 361), as 

6 amended by section 2(b), is further amended by adding 

7 at the end the following: 

8 ‘‘(g) If it is a cosmetic product for which any require9 ment of section 605 (relating to safety substantiation) is 

10 not met.’’. 

11 (b) SUBSTANTIATION.—Chapter VI of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), 

13 as amended, is further amended by adding at the end the 

14 following: 

15 ‘‘SEC. 605. COSMETIC PRODUCT SAFETY SUBSTANTIATION. 

16 ‘‘(a) IN GENERAL.—The responsible person shall— 

17 ‘‘(1) before introduction or delivery for intro18 duction into interstate commerce of a cosmetic prod19 uct, establish a file containing scientific evidence 

20 pertaining to such product’s safety; and 

21 ‘‘(2) maintain such file for no less than 5 years 

22 after the date on which such person ceases to intro23 duce such article into interstate commerce. 

24 ‘‘(b) SCIENTIFIC EVIDENCE.—The scientific evidence 

25 required by subsection (a)(1) shall— 


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1 ‘‘(1) consist of studies, tests, data, or other in2 formation known to the responsible person that re3 lates to the cosmetic product’s safety; and 

4 ‘‘(2) demonstrate that such cosmetic product is 

5 safe. 

6 ‘‘(c) REQUESTS BY SECRETARY; ACCESS TO

7 RECORDS.—In response to a request by the Secretary, the 

8 responsible person shall promptly supply to the Secretary 

9 a copy of the file required under subsection (a). Such per10 son shall also permit an officer or employee duly des11 ignated by the Secretary, upon presentation of appropriate 

12 credentials, to have access at reasonable times to records 

13 required to be maintained under this section for the pur14 pose of inspection and copying. 

15 ‘‘(d) DEFINITIONS.—For the purposes of this section: 

16 ‘‘(1) The term ‘cosmetic product’ has the mean17 ing given to such term in section 604(c). 

18 ‘‘(2) The term ‘safe’, with respect to a cosmetic 

19 product, means that evidence in the file established 

20 under subsection (a)(1) demonstrates that there is a 

21 reasonable certainty that no harm will result from 

22 the use of the cosmetic product under the intended 

23 conditions of use for such cosmetic product. 

24 ‘‘(3) The term ‘responsible person’ has the 

25 meaning given to such term in section 604(c).’’. 


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1 SEC. 4. SERIOUS ADVERSE EVENT REPORTS FOR COS2 METICS. 

3 (a) PROHIBITED ACTS.—Section 301 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend5 ed— 

6 (1) in subsection (e)— 

7 (A) by striking ‘‘or 761’’ and inserting 

8 ‘‘761, or 606’’; and 

9 (B) by inserting ‘‘606,’’ before ‘‘909,’’; and 

10 (2) in subsection (ii)— 

11 (A) by striking ‘‘760 or 761’’ and inserting 

12 ‘‘760, 761, or 606’’; 

13 (B) by striking ‘‘or the’’ and inserting ‘‘, 

14 the’’; and 

15 (C) by striking the period at the end and 

16 inserting ‘‘, or the falsification of a report sub17 mitted under section 606 to the Secretary.’’. 

18 (b) MISBRANDING.—Section 602 of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend20 ed by adding at the end the following: 

21 ‘‘(f) If it is a cosmetic product that is marketed in 

22 the United States, unless the label of such cosmetic prod23 uct includes a domestic address, including the street ad24 dress or P.O. box, city, State, and zip code, or a domestic 

25 telephone number, including the area code, through which 

26 the responsible person (as described in section 606(a)(1)) 


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1 may receive a report of a serious adverse event associated 

2 with the use of such cosmetic product.’’. 

3 (c) ADVERSE EVENT REPORTING.—Chapter VI of 

4 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 

5 et seq.), as amended, is further amended by adding at the 

6 end the following: 

7 ‘‘SEC. 606. SERIOUS ADVERSE EVENT REPORTS FOR COS8 METICS. 

9 ‘‘(a)(1) IN GENERAL.—The manufacturer, packer, or 

10 distributor of a cosmetic product distributed in the United 

11 States (referred to in this section as the ‘responsible per12 son’) shall submit to the Secretary under subsection (b) 

13 a report containing any information that such responsible 

14 person received concerning any serious adverse event that 

15 occurs in the United States and that is associated with 

16 the use of the cosmetic product in the United States, ac17 companied by a copy of the label on or within the retail 

18 packaging of such cosmetic product. 

19 ‘‘(2) RETAILER.—A retailer whose name appears on 

20 the label of a cosmetic product and who is also a dis21 tributor of such product may agree in writing that the 

22 manufacturer of the cosmetic product shall submit the re23 ports required by paragraph (1) for any cosmetic product 

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1 formation relating to each adverse event associated with 

2 such cosmetic product that is provided to the retailer. 

3 ‘‘(b) SUBMISSION OF REPORTS.— 

4 ‘‘(1) IN GENERAL.—A report under subsection 

5 (a) shall be submitted to the Secretary no later than 

6 15 business days after information concerning the 

7 adverse event is received at the place of business 

8 that is indicated on the label of the cosmetic, as re9 quired under section 602(b)(1). 

10 ‘‘(2) CONTENTS.—A report under subsection 

11 (a) shall be submitted to the Secretary in a format, 

12 and shall contain the information, defined by the 

13 Secretary in guidance or by regulation, including the 

14 following information, to the extent to which such 

15 information has been provided to the responsible 

16 person: 

17 ‘‘(A) The identity of the individual experi18 encing the adverse event. 

19 ‘‘(B) The identity of the individual report20 ing the adverse event to the responsible person. 

21 ‘‘(C) The identity of the cosmetic product 

22 associated with the adverse event. 

23 ‘‘(D) A detailed description of the adverse 

24 event. 


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1 ‘‘(3) ADDITIONAL INFORMATION.—The respon2 sible person submitting a report under subsection 

3 (a) may include any additional information and 

4 shall, within 15 business days of receiving any new 

5 information related to the serious adverse event re6 port, submit such new information to the Secretary. 

7 ‘‘(c) MAINTENANCE AND INSPECTION OF

8 RECORDS.— 

9 ‘‘(1) MAINTENANCE.—The responsible person 

10 shall maintain records of all information received by 

11 such person relating to each serious adverse event 

12 for a period of 6 years from initial receipt of such 

13 information. 

14 ‘‘(2) RECORDS INSPECTION.—The responsible 

15 person shall permit an officer or employee duly des16 ignated by the Secretary, upon presentation of ap17 propriate credentials, to have access, at reasonable 

18 times, to records required to be maintained under 

19 this subsection for the purpose of inspection and 

20 copying. 

21 ‘‘(d) RELATION TO OTHER PROVISIONS.—A report 

22 under subsection (a) (including all information submitted 

23 in the initial report or added later) shall be considered 

24 to be— 

25 ‘‘(1) a safety report under section 756; 


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1 ‘‘(2) a record about an individual under section 

2 552a of title 5, United States Code; and 

3 ‘‘(3) a medical or similar file, the disclosure of 

4 which would constitute a violation of section 

5 552(b)(6) of such title 5, United States Code, and 

6 which shall not be disclosed under section 552 of 

7 such title. 

8 ‘‘(e) DEFINITIONS.—In this section: 

9 ‘‘(1) The term ‘serious’, with respect to an ad10 verse event associated with a cosmetic product, 

11 means— 

12 ‘‘(A) resulting in— 

13 ‘‘(i) death; 

14 ‘‘(ii) a life-threatening experience; 

15 ‘‘(iii) inpatient hospitalization; 

16 ‘‘(iv) a disability, disfigurement, or in17 capacity; or 

18 ‘‘(v) a congenital anomaly or birth de19 fect; or 

20 ‘‘(B) requiring, based on reasonable med21 ical judgment, a medical or surgical interven22 tion to prevent an outcome described in sub23 paragraph (A). 

24 ‘‘(2) The term ‘cosmetic product’ has the mean25 ing given to such term in section 604(c). 


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1 ‘‘(3) The term ‘retailer’ means a person that 

2 sells or otherwise provides a cosmetic product di3 rectly to a consumer.’’. 

4 (d) IMPORTED COSMETIC PRODUCTS.—Section 801 

5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 381) is amended— 

7 (1) in subsection (a), by striking ‘‘760 or 761’’ 

8 each place it appears and inserting ‘‘760, 761, or 

9 606’’; and 

10 (2) in subsection (b), by striking ‘‘760 or 761’’ 

11 each place it appears and inserting ‘‘760, 761, or 

12 606’’. 

13 SEC. 5. MAINTENANCE AND ACCESS TO RECORDS. 

14 (a) IN GENERAL.—Chapter VI of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

16 amended, is further amended by adding at the end the 

17 following: 

18 ‘‘SEC. 607. MAINTENANCE AND ACCESS TO RECORDS. 

19 ‘‘(a) RECORDS ACCESS.— 

20 ‘‘(1) RECORDS ACCESS DURING AN INSPEC21 TION.— 

22 ‘‘(A) IN GENERAL.—Each person who 

23 manufactures, packs, or holds a cosmetic prod24 uct in the United States or for import into the 

25 United States shall, at the request of an officer 


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1 or employee duly designated by the Secretary, 

2 permit such officer or employee, upon presen3 tation of appropriate credentials, at reasonable 

4 times, within reasonable limits, and in a reason5 able manner, to have access to and copy all 

6 records relating to whether the cosmetic may be 

7 adulterated, misbranded, or otherwise in viola8 tion of this Act, including all records collected 

9 or developed to comply with section 605 (relat10 ing to cosmetic product safety substantiation) 

11 or 606 (relating to serious adverse event re12 ports). 

13 ‘‘(B) SCOPE OF RECORDS.—The require14 ment under subparagraph (A) applies to all 

15 records relating to the manufacture, packing, or 

16 holding of such cosmetic product maintained by 

17 or on behalf of such person in any format and 

18 at any location. 

19 ‘‘(C) IMMEDIATE AVAILABILITY WITH NO20 TICE.—Records not required to be made avail21 able immediately on commencement of an in22 spection under subparagraph (A) shall nonethe23 less be made available immediately on com24 mencement of such an inspection if, a reason25 able time before such inspection, the Secretary 


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1 by letter provides written notice to the person 

2 and identifies the records to be made available 

3 during such inspection. Nothing in this sub4 paragraph shall be construed as permitting a 

5 person to refuse to produce records required 

6 under and in accordance with subparagraph (A) 

7 due to failure of the Secretary to provide notice 

8 under this paragraph. 

9 ‘‘(2) ADDITIONAL AUTHORITIES TO ACCESS

10 RECORDS REMOTELY; SUBMISSION OF RECORDS TO

11 THE SECRETARY.— 

12 ‘‘(A) REMOTE ACCESS IN EMERGENCIES.— 

13 If the Secretary has a reasonable belief that a 

14 cosmetic product has caused one or more seri15 ous adverse events (as such term is used in sec16 tion 606), the Secretary may require each per17 son who manufactures, packs, or holds such 

18 cosmetic product, or any cosmetic product that 

19 the Secretary determines may be affected in a 

20 similar manner, to submit to the Secretary all 

21 records reasonably related to such cosmetic 

22 product as soon as is reasonably practicable, 

23 after receiving written notice (including by no24 tice served personally and outside normal busi25 ness hours to an agent identified under clause 


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1 (vi) or (vii) of section 604(a)(2)(B) of such re2 quirement). 

3 ‘‘(B) ELECTRONIC SUBMISSION.—If the 

4 records required to be submitted to the Sec5 retary under subparagraph (A) are available in 

6 electronic format, such records shall be sub7 mitted electronically unless the Secretary speci8 fies otherwise in the notice under such subpara9 graph. 

10 ‘‘(b) REGULATIONS CONCERNING RECORD11 KEEPING.—The Secretary shall, by regulation, establish 

12 requirements regarding the establishment and mainte13 nance, for not longer than 2 years, of records by persons 

14 who manufacture, pack, or hold cosmetics in the United 

15 States or for import into the United States, which records 

16 are needed by the Secretary for inspection to allow the 

17 Secretary to determine that the cosmetic is in compliance 

18 with applicable laws and regulations; to identify the pre19 vious sources and the subsequent recipients of a cosmetic, 

20 including its packaging; or for other purposes the Sec21 retary deems necessary to protect public health. The Sec22 retary shall take into account the size of a business in 

23 promulgating regulations under this subsection.’’. 


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1 (b) CONFORMING AMENDMENTS.—Section 704(a) of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 374(a)) is amended— 

4 (1) in paragraph (1)— 

5 (A) by inserting after the second sentence 

6 the following: ‘‘In the case of any person who 

7 manufactures, packs, or holds cosmetics, the in8 spection shall extend to all records and other 

9 information described in or required under sec10 tion 607 bearing on whether a cosmetic is adul11 terated, misbranded, or otherwise in violation of 

12 this Act.’’; and 

13 (B) in the fourth sentence— 

14 (i) by striking ‘‘the preceding sen15 tence’’ and inserting ‘‘either of the pre16 ceding two sentences’’; 

17 (ii) by striking ‘‘and’’ after ‘‘or chap18 ter IX’’; and 

19 (iii) by inserting after ‘‘section 

20 505(j))’’ the following: ‘‘, and formulas for 

21 a cosmetic, financial data, pricing data, 

22 personnel data, research data, or sales 

23 data (other than shipment data regarding 

24 sales) related to a cosmetic’’; and 


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1 (2) in paragraph (2), by striking ‘‘third sen2 tence’’ and inserting ‘‘fourth sentence’’. 

3 (c) NO EFFECT ON OTHER PROVISIONS.—This sec4 tion shall not be construed to limit the authority of the 

5 Secretary to require the establishment and maintenance 

6 of records under any other provision of this Act. 

7 SEC. 6. GOOD MANUFACTURING PRACTICES FOR COS8 METICS. 

9 (a) IN GENERAL.—Section 601 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 361), as amended by 

11 section 3(a), is further amended by adding at the end the 

12 following: 

13 ‘‘(h) If the methods used in, or the facilities or con14 trols used for, its manufacture, packing, or holding do not 

15 conform to current good manufacturing practice, as pre16 scribed by the Secretary in regulations, to ensure that the 

17 cosmetic is safe and otherwise in compliance with this 

18 Act.’’. 

19 (b) REGULATIONS.— 

20 (1) PROMULGATION.—The Secretary of Health 

21 and Human Services, acting through the Commis22 sioner of Food and Drugs, shall promulgate regula23 tions to carry out section 601(h) of the Federal 

24 Food, Drug, and Cosmetic Act, as added by sub25 section (a). 


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1 (2) INTERNATIONAL STANDARDS.—In promul2 gating such regulations, the Secretary of Health and 

3 Human Services, acting through the Commissioner 

4 of Food and Drugs, shall review international stand5 ards for cosmetic product good manufacturing prac6 tice that are in existence on the date of enactment 

7 of this Act to ensure that such regulations are con8 sistent, to the extent the Secretary determines prac9 ticable and appropriate, with such standards. 

10 SEC. 7. MANDATORY RECALL AUTHORITY. 

11 (a) PROHIBITED ACT.—Section 301(xx) of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(xx)) 

13 is amended by inserting ‘‘or 608’’ after ‘‘The refusal or 

14 failure to follow an order under section 423’’. 

15 (b) RECALL AUTHORITY.—Chapter VI of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), 

17 as amended, is further amended by adding at the end the 

18 following: 

19 ‘‘SEC. 608. MANDATORY RECALL AUTHORITY. 

20 ‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 

21 determines that there is a reasonable probability that a 

22 cosmetic is adulterated under section 601 and the use of, 

23 or exposure to, such cosmetic will cause serious adverse 

24 health consequences or death to humans, the Secretary 


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1 shall provide each responsible person with an opportunity 

2 to cease distribution and recall such cosmetic. 

3 ‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION

4 AND GIVE NOTICE.— 

5 ‘‘(1) IN GENERAL.—If a responsible person re6 fuses to or does not voluntarily cease distribution or 

7 recall such cosmetic within the time and in the man8 ner prescribed by the Secretary (if so prescribed), 

9 the Secretary may, by order require, as the Sec10 retary deems necessary, such person to— 

11 ‘‘(A) immediately cease distribution of 

12 such cosmetic; and 

13 ‘‘(B) as applicable, immediately notify all 

14 persons— 

15 ‘‘(i) manufacturing, packing, or hold16 ing such cosmetic, and 

17 ‘‘(ii) to which such cosmetic has been 

18 distributed, transported, or sold, 

19 to immediately cease distribution of such cos20 metic. 

21 ‘‘(2) DETERMINATION TO LIMIT AREAS AF22 FECTED.—If the Secretary requires a responsible 

23 person to cease distribution under paragraph (1)(A) 

24 of a cosmetic identified in subsection (a), the Sec25 retary may limit the size of the geographic area and 


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1 the markets affected by such cessation if such limi2 tation would not compromise the public health. 

3 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro4 vide a responsible person subject to an order under sub5 section (b) with an opportunity for an informal hearing, 

6 to be held as soon as possible, but not later than 2 days 

7 after the issuance of the order, on the actions required 

8 by the order and on why the cosmetic that is the subject 

9 of the order should not be recalled. 

10 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA11 TION OF ORDER.— 

12 ‘‘(1) AMENDMENT OF ORDER.—If, after pro13 viding opportunity for an informal hearing under 

14 subsection (c), the Secretary determines that re15 moval of the cosmetic from commerce is necessary, 

16 the Secretary shall, as appropriate— 

17 ‘‘(A) amend the order to require recall of 

18 such cosmetic or other appropriate action; 

19 ‘‘(B) specify a timetable in which the recall 

20 shall occur; 

21 ‘‘(C) require periodic reports to the Sec22 retary describing the progress of the recall; and 

23 ‘‘(D) provide notice to consumers to whom 

24 such cosmetic was, or may have been, distrib25 uted. 


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1 ‘‘(2) VACATING OF ORDER.—If, after such hear2 ing, the Secretary determines that adequate grounds 

3 do not exist to continue the actions required by the 

4 order, or that such actions should be modified, the 

5 Secretary shall vacate the order or modify the order. 

6 ‘‘(e) COOPERATION AND CONSULTATION.—The Sec7 retary shall work with State and local public health offi8 cials in carrying out this section, as appropriate. 

9 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 

10 under this section, the Secretary shall— 

11 ‘‘(1) ensure that a press release is published re12 garding the recall, as well as alerts and public no13 tices, as appropriate, in order to provide notifica14 tion— 

15 ‘‘(A) of the recall to consumers and retail16 ers to whom such cosmetic was, or may have 

17 been, distributed; and 

18 ‘‘(B) that includes, at a minimum— 

19 ‘‘(i) the name of the cosmetic subject 

20 to the recall; 

21 ‘‘(ii) a description of the risk associ22 ated with such cosmetic; and 

23 ‘‘(iii) to the extent practicable, infor24 mation for consumers about similar cos25 metics that are not affected by the recall; 


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1 ‘‘(2) shall consider providing a list to the public 

2 of retail consignees receiving products involved in a 

3 Class I recall, as determined appropriate by the Sec4 retary; and 

5 ‘‘(3) if available, publish on the Internet Web 

6 site of the Food and Drug Administration an image 

7 of the cosmetic that is the subject of the press re8 lease described in (1). 

9 ‘‘(g) NO DELEGATION.—The authority conferred by 

10 this section to order a recall or vacate a recall order shall 

11 not be delegated to any officer or employee other than the 

12 Commissioner. 

13 ‘‘(h) EFFECT.—Nothing in this section shall affect 

14 the authority of the Secretary to request or participate 

15 in a voluntary recall, or to issue an order to cease distribu16 tion or to recall under any other provision of this Act or 

17 under the Public Health Service Act. 

18 ‘‘(i) RESPONSIBLE PERSON DEFINED.—In this sec19 tion, the term ‘responsible person’ has the meaning given 

20 to such term in section 604(c).’’. 

21 SEC. 8. EFFECTIVE DATES. 

22 (a) The amendments made by sections 2(a), 3, 4, 5, 

23 and 7 shall take effect 18 months after the date of enact24 ment of this Act. 


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1 (b) The amendments made by sections 2(b) and 6 

2 shall take effect 3 years after the date of enactment of 

3 this Act. 

Æ 


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