I 114TH CONGRESS 1ST SESSION H. R. 4075 To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events, and for other purposes. IN THE HOUSE OF REPRESENTATIVES Mr. SESSIONS NOVEMBER 18, 2015 introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events, and for other purposes. 1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled, 3 SECTION 1. SHORT TITLE AND REFERENCES. tkelley on DSK3SPTVN1PROD with BILLS 4 (a) SHORT TITLE.—This Act may be cited as the 5 ‘‘Cosmetic Modernization Amendments of 2015’’. VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 2 1 2 (b) REFERENCES TO THE FEDERAL FOOD, DRUG, COSMETIC ACT.—Except as otherwise specified, AND 3 whenever in this Act an amendment is expressed in terms 4 of an amendment to a section or other provision, the ref5 erence shall be considered to be made to a section or other 6 provision of the Federal Food, Drug, and Cosmetic Act 7 (21 U.S.C. 301 et seq.). 8 SEC. 2. TABLE OF CONTENTS. 9 The table of contents for this Act is as follows: Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. 10 1. 2. 3. 4. 5. 6. 7. 8. Short title and references. Table of contents. Definitions. Registration of cosmetic manufacturing establishments. Cosmetic and ingredient statement. Serious and unexpected adverse event reporting for cosmetics. Good manufacturing practice. Safety substantiation for cosmetic ingredients and nonfunctional constituents. 9. National Cosmetic Regulatory Databank. 10. Special rules. 11. Prohibited acts. 12. National uniformity for cosmetics. 13. Importation. 14. Effective dates. SEC. 3. DEFINITIONS. 11 Chapter VI (21 U.S.C. 361 et seq.) is amended by 12 adding at the end the following: 13 ‘‘SEC. 604. DEFINITIONS. 14 ‘‘In this chapter: tkelley on DSK3SPTVN1PROD with BILLS 15 ‘‘(1) COSMETIC.—Notwithstanding 16 201(i), for purposes of this section and sections 17 601(f), 605, 606, 607, 608, and 801(a), the term •HR 4075 IH VerDate Sep 11 2014 section 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 3 1 ‘cosmetic’ includes only articles described in section 2 201(i)(1). tkelley on DSK3SPTVN1PROD with BILLS 3 ‘‘(2) ESTABLISHMENT.— 4 ‘‘(A) The term ‘establishment’ means a 5 place of business where a cosmetic is manufac- 6 tured, without further processing outside or 7 within the United States. 8 ‘‘(B) A cosmetic shall not be considered to 9 have undergone further processing for purposes 10 of subparagraph (A) solely on the basis that 11 packaging or other labeling was added or 12 changed or that any similar activity of a de 13 minimis nature was carried out with respect to 14 the cosmetic. 15 ‘‘(C) The term ‘domestic establishment’ 16 means an establishment location in any State. 17 ‘‘(D) The term ‘foreign establishment’ 18 means an establishment location outside the 19 United States. 20 ‘‘(3) SAFE; SAFETY.— 21 ‘‘(A) The terms ‘safe’ and ‘safety’, with re- 22 spect to a cosmetic, mean the cosmetic does not 23 present a significant risk of serious illness or 24 injury to humans under the conditions of use 25 recommended or suggested in the labeling of •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 4 1 the cosmetic, including the limitation of ‘for 2 professional use’ only. 3 ‘‘(B) For purposes of subparagraph (A), 4 the term ‘professional’ means an individual 5 who— 6 ‘‘(i) is licensed by an official State au- 7 thority to practice in the field of cosme- 8 tology, nail care, barbering, and or esthet- 9 ics; and 10 ‘‘(ii) is in compliance with all require- 11 12 ments of the State for such licensing.’’. SEC. 4. REGISTRATION OF COSMETIC MANUFACTURING ES- 13 TABLISHMENTS. 14 Chapter VI (21 U.S.C. 361 et seq.), as amended by 15 section 3, is further amended by adding at the end the 16 following: 17 ‘‘SEC. 605. REGISTRATION OF COSMETIC MANUFACTURING 18 tkelley on DSK3SPTVN1PROD with BILLS 19 ESTABLISHMENTS. ‘‘(a) IN GENERAL.— 20 ‘‘(1) REGISTRATION.—The Secretary shall by 21 regulation require that every domestic and foreign 22 establishment engaged in the manufacture of a cos- 23 metic intended to be sold in the United States that 24 is not exempt under subsection (e) be registered with 25 the Secretary within 60 business days after the first •HR 4075 IH VerDate Sep 11 2014 21:11 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 5 1 commercial sale of a cosmetic in the United States. 2 If a cosmetic is processed in more than one estab- 3 lishment, registration shall be required under this 4 section only for the establishment that performs the 5 final portion of the manufacturing operation. The 6 single registration shall cover all such cosmetics 7 manufactured by the establishment. The registration 8 shall state only the name of the company or other 9 organization name of the establishment, the city, 10 street address, State, and country of the establish- 11 ment, and the title, email address, and telephone 12 number for the office within the establishment that 13 is responsible for submitting and maintaining the 14 registration. For a foreign establishment, the reg- 15 istration shall include the contact information for 16 the initial United States agent of the establishment. tkelley on DSK3SPTVN1PROD with BILLS 17 ‘‘(2) UNIQUE NUMBER.—The Secretary shall 18 establish and provide to each registrant under this 19 section a unique cosmetic establishment registration 20 number within 15 business days after receiving the 21 registration. If the Secretary does not provide a 22 unique cosmetic establishment registration number 23 within such 15 business days, any requirement 24 under this Act for such number shall be deemed to 25 be inapplicable until 30 business days after such •HR 4075 IH VerDate Sep 11 2014 21:11 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 6 1 number is received by the person who submitted the 2 registration. Where more than one person registers 3 the same establishment, the Secretary shall provide 4 only one unique establishment registration number 5 for the establishment. The unique cosmetic estab- 6 lishment number shall not be required to be included 7 in cosmetic labeling. 8 ‘‘(b) MAINTENANCE.—The information required in a 9 registration under subsection (a) or in an existing reg10 istration under subsection (e)(1)(A) shall be maintained 11 as current and accurate by the registrant by withdrawing 12 or amending the registration within 60 business days after 13 the information becomes no longer current and accurate. 14 ‘‘(c) ENFORCEMENT.—The Secretary shall enforce 15 this section under section 301(ddd) and shall not suspend 16 or revoke a registration under this section. 17 ‘‘(d) LIST.—The Secretary shall compile and main- 18 tain an up-to-date and publicly available electronic list of 19 establishments that are registered under this section. 20 ‘‘(e) EXEMPTIONS.— tkelley on DSK3SPTVN1PROD with BILLS 21 ‘‘(1) IN GENERAL.—Registration under sub- 22 section (a) shall not be required for any entity based 23 on such entity operating as— 24 ‘‘(A) an establishment that as of the date 25 of enactment of this section is registered as a •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 7 1 cosmetic establishment under part 710 of title 2 21, Code of Federal Regulations (as in effect on 3 such date); 4 ‘‘(B) a beauty shop or salon or spa; 5 ‘‘(C) a cosmetic retailer, including any 6 such retailer that is— 7 ‘‘(i) an individual sales representative; 8 ‘‘(ii) a wholesale or retail distribution 9 or sales facility; or 10 ‘‘(iii) a pharmacy or other person or 11 organization that— 12 ‘‘(I) compounds cosmetics at a 13 single location and administers, dis- 14 penses, or distributes such cosmetics 15 at retail from that location; and 16 ‘‘(II) does not otherwise manu- 17 facture or package cosmetics from 18 that location; 19 ‘‘(D) a health care provider, including a 20 hospital or clinic; 21 ‘‘(E) a public health agency or other non- 22 profit entity; tkelley on DSK3SPTVN1PROD with BILLS 23 ‘‘(F) a hotel or other entity that provides 24 complimentary cosmetics; •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 8 1 ‘‘(G) a trade show or other venue where 2 cosmetic samples are provided; 3 ‘‘(H) an establishment that manufactures, 4 prepares, compounds, or processes cosmetics for 5 use in research, teaching, or chemical analysis 6 or pilot plant production; 7 ‘‘(I) a handcrafted soap or cosmetic made 8 in a home, a community facility, or a similar es- 9 tablishment; or 10 ‘‘(J) a business with less than $1,000,000 11 annual net sales of cosmetics. 12 ‘‘(2) ADDITIONAL EXEMPTIONS.—The Sec- 13 retary may supplement the list of exemptions under 14 paragraph (1) with additional exemptions for per- 15 sons and activities where the cost of compliance ex- 16 ceeds the safety benefit to the public.’’. 17 SEC. 5. COSMETIC AND INGREDIENT STATEMENT. 18 Chapter VI (21 U.S.C. 361 et seq.), as amended by 19 sections 3 and 4, is further amended by adding at the end 20 the following: 21 ‘‘SEC. 606. COSMETIC AND INGREDIENT STATEMENT. 22 ‘‘(a) IN GENERAL.—The Secretary shall by regula- tkelley on DSK3SPTVN1PROD with BILLS 23 tion require that every domestic establishment and foreign 24 establishment engaged in the manufacture of a cosmetic 25 intended to be sold in the United States submit to the •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 9 1 Secretary, for each cosmetic so manufactured in the estab2 lishment, except such cosmetics manufactured by entities 3 exempted by section 605(e) from registration under sec4 tion 605, within 60 business days after the first commer5 cial sale of the cosmetic, a cosmetic and ingredient state6 ment. The Secretary shall require the statement to contain 7 only— 8 ‘‘(1) the unique establishment registration num- 9 ber of the manufacturing establishment where the 10 cosmetic is manufactured or, if the same cosmetic is 11 manufactured in more than one establishment, the 12 unique establishment registration number of each es- 13 tablishment where it is manufactured; 14 ‘‘(2) the brand name or names for the cosmetic; 15 ‘‘(3) the applicable cosmetic category or cat- tkelley on DSK3SPTVN1PROD with BILLS 16 egories for the cosmetic; 17 ‘‘(4) the ingredients in the cosmetic (in accord- 18 ance with section 701.3 of title 21, Code of Federal 19 Regulations (as in effect on the date of enactment 20 of the Cosmetic Modernization Amendments of 2015 21 and including any successor regulations), and using 22 the name of each ingredient established under sub- 23 section (d), if any), in descending order of predomi- 24 nance by weight, except that— •HR 4075 IH VerDate Sep 11 2014 00:04 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 10 1 ‘‘(A) flavors and fragrances may be des- 2 ignated as such; and 3 ‘‘(B) all variations in color, flavor, or fra- 4 grance may be included in one statement; and 5 ‘‘(5) the title, email address, and telephone 6 number for the office within the establishment that 7 is responsible for submitting and maintaining the 8 statement. 9 ‘‘(b) UNIQUE NUMBER.—The Secretary shall estab- 10 lish and provide to the office submitting a statement re11 quired by subsection (a) a unique cosmetic and ingredient 12 statement number within 15 business days after receiving 13 the statement. If the Secretary does not provide a unique 14 cosmetic and ingredient statement number within such 1515 business-day period, any requirement under this Act for 16 such number shall be deemed to be inapplicable until the 17 date that is 30 business days after such number is received 18 by the office that submitted the statement. The unique 19 cosmetic and ingredient statement number shall not be re20 quired to be included in cosmetic labeling. 21 ‘‘(c) CHANGE IN LABELING.—An establishment shall 22 not be required to submit a new or revised statement tkelley on DSK3SPTVN1PROD with BILLS 23 under subsection (a) because of a change in labeling ex24 cept to the extent necessary to maintain the accuracy of •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 11 1 the information included in a statement under subsection 2 (a). 3 ‘‘(d) NAME OF INGREDIENT.—For purposes of this 4 section and cosmetic ingredient labeling under section 5 701.3 of title 21, Code of Federal Regulations (as in effect 6 on the date of enactment of the Cosmetic Modernization 7 Amendments of 2015 and including any successor regula8 tions), the name of a cosmetic ingredient shall be the 9 name, if any, in the most recent edition of the Inter10 national Cosmetic Ingredient Dictionary, unless the Sec11 retary by regulation establishes a different name for the 12 ingredient. 13 ‘‘(e) MAINTENANCE.—The information required in a 14 statement submitted to the Secretary under subsection (a) 15 or in an existing statement under subsection (g)(1) shall 16 be maintained as current and accurate by the office that 17 filed the statement by withdrawing or amending the state18 ment within 60 business days after the information be19 comes no longer current and accurate, except that no 20 amendment shall be required for a change in the order 21 of predominance of the ingredients or for any other type 22 or category of change for which the costs of amending the tkelley on DSK3SPTVN1PROD with BILLS 23 statement exceed the safety benefit to the public. 24 ‘‘(f) ENFORCEMENT.—The Secretary shall enforce 25 subsections (a) and (e) under section 301(eee) and shall •HR 4075 IH VerDate Sep 11 2014 00:04 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 12 1 not suspend or revoke a cosmetic and ingredient state2 ment. 3 ‘‘(g) LIST.—The Secretary shall compile and main- 4 tain an up-to-date and publicly available electronic list of 5 cosmetics and ingredients for which statements are sub6 mitted under this section. A statement submitted pursuant 7 to this section shall not be subject to disclosure under sec8 tion 552 of title 5, United States Code. The Secretary may 9 make publicly available information derived from such 10 statements that discloses the names of ingredients used 11 in cosmetics and the number of cosmetics in which a spe12 cific ingredient is used, but may not make publicly avail13 able any information that relates to any ingredient that 14 is exempt from public disclosure under section 720.8 of 15 title 21, Code of Federal Regulations (as in effect on the 16 date of enactment of the Cosmetic Modernization Amend17 ments of 2015 and including any successor regulations), 18 or that discloses at what establishment a cosmetic is man19 ufactured. At the written request of the director of a State 20 agency responsible for regulating the safety of cosmetics 21 stating good cause therefor, the Secretary may disclose to 22 such official confidential business and trade secret infor- tkelley on DSK3SPTVN1PROD with BILLS 23 mation contained in a statement and such official and 24 other State employees who have access to such informa25 tion shall then be subject to the provisions of section •HR 4075 IH VerDate Sep 11 2014 00:04 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 13 1 301(j) of this Act, section 552(b) of title 5, United States 2 Code, and section 1905 of title 18, United States Code, 3 with respect to such information. 4 ‘‘(h) EXEMPTIONS.—Submission of a statement 5 under subsection (a) shall not be required— 6 ‘‘(1) for a cosmetic for which as of the date of 7 enactment of this section a cosmetic ingredient 8 statement has been submitted to the Secretary 9 under part 710 of title 21, Code of Federal Regula- 10 tions (as in effect on the date of enactment of the 11 Cosmetic Modernization Amendments of 2015); 12 ‘‘(2) for a cosmetic ingredient exempt from 13 public disclosure under section 720.8 of title 21, 14 Code of Federal Regulations (as in effect on the 15 date of enactment of the Cosmetic Modernization 16 Amendments of 2015 and including any successor 17 regulations); or 18 ‘‘(3) by an entity to the extent such entity is 19 exempted by section 605(e) from registration under 20 section 605.’’. 21 SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT RE- 22 tkelley on DSK3SPTVN1PROD with BILLS 23 PORTING FOR COSMETICS. (a) IN GENERAL.—Chapter VI (21 U.S.C. 361 et 24 seq.), as amended by sections 3, 4, and 5, is further 25 amended by adding at the end the following: •HR 4075 IH VerDate Sep 11 2014 21:11 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 14 1 ‘‘SEC. 607. SERIOUS AND UNEXPECTED ADVERSE EVENT RE- 2 3 PORTING FOR COSMETICS. ‘‘(a) IN GENERAL.—The Secretary shall by regula- 4 tion require that a domestic or foreign manufacturer, 5 packer, or distributor whose name appears on the label 6 pursuant to section 602(b)(1) of a cosmetic marketed in 7 the United States submit to the Secretary under sub8 section (b) a report containing— 9 ‘‘(1) information received concerning any seri- 10 ous and unexpected adverse event in the United 11 States allegedly associated with the use of the cos- 12 metic for which it is reasonably likely that the ad- 13 verse event was caused by the cosmetic when used 14 as recommended or suggested in the labeling; and 15 ‘‘(2) a copy of the label for the cosmetic. 16 ‘‘(b) SUBMISSION OF REPORTS.—A report on an ad- 17 verse event under subsection (a) shall be submitted to the 18 Secretary not later than 15 business days after informa19 tion concerning the adverse event is received at the place 20 of business labeled on the cosmetic pursuant to section 21 602(b)(1). 22 ‘‘(c) REQUIRED CONTENTS.—A report under sub- tkelley on DSK3SPTVN1PROD with BILLS 23 section (a) shall include all of the following information: 24 ‘‘(1) An identifiable patient. 25 ‘‘(2) An identifiable reporter. 26 ‘‘(3) A suspect cosmetic or component thereof. •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 15 1 ‘‘(4) A serious adverse event. 2 3 ‘‘(d) ADDITIONAL CONTENTS; SUPPLEMENTAL REPORTING.—The person submitting a report under sub- 4 section (a) may— 5 6 ‘‘(1) include pertinent information in addition to the information listed in subsection (c); and tkelley on DSK3SPTVN1PROD with BILLS 7 ‘‘(2) after submitting the initial report, supple- 8 ment the report with additional information. 9 ‘‘(e) SPECIAL RULES.— 10 ‘‘(1) PROTECTED INFORMATION.—A 11 and unexpected adverse event report (including all 12 information submitted in the initial report or added 13 later) submitted under subsection (a)— 14 ‘‘(A) shall be considered to be a safety re- 15 port under section 756 that is subject to the 16 provisions of that section; and 17 ‘‘(B) shall be considered to be a record 18 about an individual under section 552a of title 19 5, United States Code, and a medical or similar 20 file the disclosure of which would constitute a 21 violation of section 552 of such title 5, and 22 shall not be publicly disclosed unless all person- 23 ally identifiable information is redacted. •HR 4075 IH VerDate Sep 11 2014 serious 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 16 1 ‘‘(2) NO TREATMENT AS ADMISSION.—The sub- 2 mission of a serious and unexpected adverse event 3 report in compliance with subsection (a)— 4 ‘‘(A) shall not be construed as an admis- 5 sion that the cosmetic involved caused or con- 6 tributed to the adverse event; and 7 ‘‘(B) may be accompanied by a statement 8 that denies that the report constitutes an ad- 9 mission that the cosmetic involved caused or 10 contributed to the adverse event. 11 ‘‘(3) INCLUSION OF STATEMENT IN PUBLIC DIS- 12 CLOSURE.—In 13 (a) or portion thereof for public disclosure, the Sec- 14 retary shall include any statement under paragraph 15 (2)(B). 16 ‘‘(f) LABELING.—The label of a cosmetic shall bear releasing any report under subsection 17 the domestic telephone number, email address, or mailing 18 address through which the person whose name and place 19 of business appear on the label may receive a report of 20 a serious adverse event. 21 ‘‘(g) EXEMPTION.—The Secretary may, by regula- 22 tion, establish an exemption to the requirements under tkelley on DSK3SPTVN1PROD with BILLS 23 subsections (b) and (d) if the Secretary determines that 24 such exemption would have no adverse effect on public 25 health. •HR 4075 IH VerDate Sep 11 2014 21:11 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 17 1 ‘‘(h) DEFINITIONS.—In this section: 2 3 ‘‘(1) The term ‘serious’, with respect to an adverse event, means— 4 ‘‘(A) resulting in— 5 ‘‘(i) death; 6 ‘‘(ii) a life-threatening experience; 7 ‘‘(iii) inpatient hospitalization; 8 ‘‘(iv) a persistent and significant dis- 9 ability or incapacity; 10 ‘‘(v) a congenital anomaly or birth de- 11 fect; or 12 ‘‘(vi) permanent disfiguration; or 13 ‘‘(B) requiring, based on reasonable med- 14 ical judgment, a medical or surgical interven- 15 tion to prevent an outcome described under 16 subparagraph (A). 17 ‘‘(2) The term ‘unexpected’, with respect to an 18 adverse event, means not identified on the cosmetic 19 label.’’. 20 (b) MISBRANDING.—Section 602 of the Federal 21 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend22 ed by adding at the end the following: tkelley on DSK3SPTVN1PROD with BILLS 23 ‘‘(g) If it is a cosmetic that is marketed in the United 24 States, unless the label of such cosmetic includes a domes25 tic address or domestic phone number through which a •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 18 1 report of a serious and unexpected adverse event (as such 2 term is used in section 607) associated with the use of 3 such cosmetic may be submitted to the person described 4 in section 607(f).’’. 5 SEC. 7. GOOD MANUFACTURING PRACTICE. 6 (a) PROHIBITION.—Section 601 (21 U.S.C. 361) is 7 amended by adding at the end the following: 8 ‘‘(f) If it has been manufactured under conditions 9 that do not satisfy the principles and standards for good 10 manufacturing practice established under section 608 and 11 as a result presents a significant risk of serious adverse 12 health consequences or death to humans.’’. 13 (b) PRINCIPLES AND STANDARDS.—Chapter VI (21 14 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, and 15 6, is further amended by adding at the end the following: 16 ‘‘SEC. 608. GOOD MANUFACTURING PRACTICE. 17 ‘‘(a) IN GENERAL.—The Secretary may by regulation 18 establish principles and standards for good manufacturing 19 practice for the manufacture of cosmetics in accordance 20 with paragraphs (a) and (d) of section 601. 21 ‘‘(b) NOTICE AND COMMENT.—A regulation under 22 subsection (a) shall be promulgated only after providing tkelley on DSK3SPTVN1PROD with BILLS 23 notice and an opportunity for comment in accordance with 24 chapter 5 of title 5, United States Code. •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 19 1 ‘‘(c) GOOD MANUFACTURING PRACTICES OF OTHER 2 PARTIES.—A manufacturer shall not be responsible under 3 section 601(f) or this section for the good manufacturing 4 practice of its suppliers. A distributor shall not be respon5 sible under section 601(f) or this section for the good man6 ufacturing practice of its manufacturers.’’. 7 SEC. 8. SAFETY SUBSTANTIATION FOR COSMETIC INGREDI- 8 ENTS AND NONFUNCTIONAL CONSTITUENTS. 9 Chapter VI (21 U.S.C. 361 et seq.), as amended by 10 sections 3, 4, 5, 6, and 7, is further amended by adding 11 at the end the following: 12 ‘‘SEC. 609. COSMETIC INGREDIENTS AND NONFUNCTIONAL 13 CONSTITUENTS THAT ARE SAFE FOR USE IN 14 COSMETICS. 15 ‘‘(a) IN GENERAL.—A manufacturer or distributor of 16 a cosmetic may rely on this section to substantiate the 17 safety of such cosmetic. 18 ‘‘(b) SAFE INGREDIENTS.—Unless and until prohib- 19 ited or limited by the Secretary by regulation, the fol20 lowing ingredients are deemed to be adequately substan21 tiated for safe use in cosmetics subject to the requirements tkelley on DSK3SPTVN1PROD with BILLS 22 of good manufacturing practice: 23 ‘‘(1) Color additives approved by the Secretary 24 for use in cosmetics, within any limits established in 25 such approval. •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 tkelley on DSK3SPTVN1PROD with BILLS 20 1 ‘‘(2) Food additives approved by the Secretary 2 for direct addition to food for human consumption, 3 within any limits established in such approval. 4 ‘‘(3) Food ingredients that have been deter- 5 mined by the Secretary to be generally recognized as 6 safe for direct addition to food for human consump- 7 tion, within any limits established in such deter- 8 mination. 9 ‘‘(4) Food ingredients for which monographs 10 have been included in the Food Chemicals Codex for 11 direct addition to food for human consumption, 12 within any limits established in such monographs. 13 ‘‘(5) Pharmaceutical excipients and inactive in- 14 gredients approved or permitted by the Secretary, 15 listed on a Food and Drug Administration website 16 for use in drugs for human consumption or for 17 which monographs have been included in the Hand- 18 book of Pharmaceutical Excipients, within any limits 19 established in such lists or monographs. 20 ‘‘(6) Cosmetic ingredients that have been re- 21 viewed for safety by a qualified nongovernmental or 22 governmental expert scientific body, including the 23 Cosmetic Ingredient Review Expert Panel, and that 24 are the subject of a monograph published in a peer- •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 21 1 reviewed scientific journal, within any limits estab- 2 lished in such monographs. 3 ‘‘(7) Fragrance ingredients that have been re- 4 viewed for safety by a qualified nongovernmental or 5 governmental expert scientific body, including the 6 Research Institute of Fragrance Materials Expert 7 Panel, and that are the subject of a monograph pub- 8 lished in a peer-reviewed scientific journal, within 9 any limits established in such monographs. 10 ‘‘(8) Cosmetic ingredients approved or per- 11 mitted for use in cosmetics by any of the countries 12 listed in section 802(b)(1)(A) as having an adequate 13 regulatory authority, within any limits established by 14 such regulatory authority. 15 ‘‘(c) SAFE NONFUNCTIONAL CONSTITUENTS.— 16 17 ‘‘(1) DEFINITION.—A nonfunctional constituent in a cosmetic is any substance that— 18 ‘‘(A) has not been intentionally added as a 19 separate substance; and tkelley on DSK3SPTVN1PROD with BILLS 20 ‘‘(B) serves no technical or cosmetic func- 21 tion in the cosmetic. 22 ‘‘(2) ADEQUATE SUBSTANTIATION.—The 23 lowing nonfunctional constituents are deemed to be 24 adequately substantiated for safe use in cosmetics, 25 subject to the requirements of good manufacturing •HR 4075 IH VerDate Sep 11 2014 fol- 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 tkelley on DSK3SPTVN1PROD with BILLS 22 1 practice and any limits or bans established by the 2 Secretary by regulation: 3 ‘‘(A) The levels approved or permitted for 4 nonfunctional constituents by the Secretary for 5 color additives for cosmetic use and for food ad- 6 ditives and generally recognized as safe food in- 7 gredients for direct human consumption. 8 ‘‘(B) The levels approved or permitted for 9 nonfunctional constituents by the Secretary for 10 cosmetics and for food and food ingredients for 11 direct human consumption in compliance policy 12 guides, guidance, and website statements. 13 ‘‘(C) The levels approved or permitted for 14 nonfunctional constituents by the Secretary or 15 the United States Pharmacopeia for oral non- 16 prescription drugs. 17 ‘‘(D) The levels approved or permitted for 18 nonfunctional constituents by the Environ- 19 mental Protection Agency for direct human 20 consumption in drinking water. 21 ‘‘(E) The levels for nonfunctional constitu- 22 ents approved or permitted in cosmetics and 23 human food and food ingredients by any of the 24 countries listed in section 802(b)(1)(A) as hav- 25 ing an adequate regulatory authority. •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 23 1 ‘‘(d) CENTER.—The Secretary shall establish a pro- 2 gram within the center of the Food and Drug Administra3 tion with primary responsibility for regulating cosmetics 4 to evaluate and make determinations, by regulation, on 5 the safe use of cosmetics and ingredients and nonfunc6 tional constituents thereof. 7 ‘‘(e) APPLICATION; PREEMPTION.—A safety deter- 8 mination accepted or made by the Secretary or established 9 under this section shall apply in every State. No State may 10 establish or enforce a safety determination for a cosmetic 11 or an ingredient or nonfunctional constituent of a cosmetic 12 ‘‘(f) EFFECTIVE DATE OF REGULATIONS.—Any reg- 13 ulation or guidance by the Secretary pursuant to this sec14 tion concerning the safety of a cosmetic or an ingredient 15 or nonfunctional constituent of a cosmetic shall apply be16 ginning no earlier than the date that is 2 years after the 17 date on which such regulation or guidance is issued as 18 final, unless the Secretary determines, after public notice 19 and an opportunity for public comment, that an earlier 20 date of applicability is required to prevent serious adverse 21 health consequences or death to humans.’’. 22 SEC. 9. NATIONAL COSMETIC REGULATORY DATABANK. tkelley on DSK3SPTVN1PROD with BILLS 23 Chapter VI (21 U.S.C. 361 et seq.), as amended by 24 sections 3, 4, 5, 6, 7, and 8, is further amended by adding 25 at the end the following: •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 24 1 ‘‘SEC. 610. NATIONAL COSMETIC REGULATORY DATABANK. 2 ‘‘(a) IN GENERAL.—For the purpose of consolidating 3 information pertaining to the regulation of cosmetic safe4 ty, the Secretary shall establish and maintain in the center 5 of the Food and Drug Administration with primary re6 sponsibility for regulating cosmetics a database, to be 7 known as the National Cosmetic Regulatory Databank, 8 containing— 9 10 ‘‘(1) the information submitted to the Secretary under sections 605, 606, 607, and 609; and 11 ‘‘(2) such other information pertaining to the 12 regulation of cosmetics as the Secretary deems ap- 13 propriate. 14 ‘‘(b) AVAILABILITY.—In the case of information in 15 the National Cosmetic Regulatory Databank that is not 16 subject to public disclosure under section 552 of title 5, 17 United States Code, the Secretary may nonetheless dis18 close such information to the director of a State agency 19 on written request by such director demonstrating good 20 cause for the disclosure. A director receiving information 21 pursuant to the preceding sentence shall agree to limit to 22 the disclosure of such information by State officials and tkelley on DSK3SPTVN1PROD with BILLS 23 employees to the same extent such disclosure is limited 24 with respect to Federal officials and employees under sec25 tion 301(j) of this Act, section 552(b) of title 5, United •HR 4075 IH VerDate Sep 11 2014 21:11 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 25 1 States Code, and section 1905 of title 18, United States 2 Code, with respect to such information. 3 ‘‘(c) PREEMPTION.—No State or political subdivision 4 thereof may require submission of information that is 5 available in the National Cosmetic Regulatory Databank, 6 whether in the same or a different format.’’. 7 SEC. 10. SPECIAL RULES. 8 (a) CERTAIN RULES.—Chapter VI (21 U.S.C. 361 et 9 seq.), as amended by sections 3, 4, 5, 6, 7, 8, and 9, is 10 further amended by adding at the end the following: 11 ‘‘SEC. 611. SPECIAL RULES. 12 ‘‘(a) CONTRACTORS.—The person described in sec- 13 tion 607(f) with respect to a cosmetic (referred to in this 14 section as the ‘responsible party’) may, by agreement, au15 thorize a manufacturer, distributor, or packer of the cos16 metic or a third-party contractor to submit any required 17 report of a serious and unexpected adverse event (as such 18 term is used in section 607) so long as the responsible 19 party directs to the manufacturer, distributor, packer, or 20 third-party contractor all such adverse events associated 21 with such cosmetic that are reported to the responsible 22 party through the address or telephone number described tkelley on DSK3SPTVN1PROD with BILLS 23 in section 607(f). 24 ‘‘(b) EXEMPTIONS.—The Secretary, on the Sec- 25 retary’s own initiative or in response to a petition, may •HR 4075 IH VerDate Sep 11 2014 00:04 Nov 24, 2015 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 26 1 establish exemptions from the requirements of sections 2 601(f), 605, 606, 607, and 608— 3 4 ‘‘(1) for the efficient and cost-effective implementation of such requirements; or 5 ‘‘(2) where the cost of compliance exceeds the 6 safety benefit to the public.’’. 7 (b) COSMETIC DEFINITION.—Section 201(i) (21 8 U.S.C. 321(i)) is amended by adding at the end the fol9 lowing: ‘‘An article described in subparagraph (1) that is 10 intended only for topical external use to alter the appear11 ance by temporarily affecting the structure or any function 12 of the human skin, and that is not the subject of an ap13 proved new drug application under section 505, shall, for 14 purposes of this Act, be treated only as a cosmetic and 15 not a drug.’’. 16 (c) COLOR ADDITIVES.—Section 721(f) (21 U.S.C. 17 379e(f)) is amended— 18 (1) by striking ‘‘(f) The Secretary shall’’ and 19 inserting ‘‘(f)(1) The Secretary shall’’; and 20 (2) by adding at the end the following: 21 ‘‘(2) A color additive, including mixtures thereof, in- 22 tended for use in externally applied cosmetics and not in tkelley on DSK3SPTVN1PROD with BILLS 23 the area of the eye is exempt from the requirements of 24 this section if it is generally recognized, among experts 25 qualified by scientific training and experience to evaluate •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 27 1 its safety, as having been shown through scientific proce2 dures to be safe under the conditions of its intended use. 3 Notwithstanding the preceding sentence, the Secretary 4 may by regulation require certification of batches under 5 subsection (c) for any such color additive.’’. 6 SEC. 11. PROHIBITED ACTS. 7 (a) IN GENERAL.—Section 301 (21 U.S.C. 331) is 8 amended by adding at the end the following: 9 ‘‘(ddd) The failure to register a cosmetic establish- 10 ment as required under section 605 or to maintain the 11 registration current and accurate. 12 ‘‘(eee) The failure to submit a cosmetic and ingre- 13 dient statement as required under section 606 or to main14 tain the statement current and accurate. 15 ‘‘(fff) The failure to submit a serious and unexpected 16 adverse event report, or to include on the label of a cos17 metic the domestic telephone number, email address, or 18 mailing address through which a report of a serious ad19 verse event may be received, as required under section 20 607.’’. 21 (b) INFORMATION SECURITY.—Section 301(j) (21 22 U.S.C. 331(j)) is amended by inserting ‘‘605, 606, 609,’’ tkelley on DSK3SPTVN1PROD with BILLS 23 after ‘‘573,’’. 24 SEC. 12. NATIONAL UNIFORMITY FOR COSMETICS. 25 Section 752 (21 U.S.C. 379s) is amended— •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 28 1 (1) by amending the section heading to read as 2 follows: ‘‘NATIONAL 3 METICS’’; 4 UNIFORMITY FOR COS- (2) by amending subsection (a) to read as fol- 5 lows: 6 ‘‘(a) IN GENERAL.—Except as provided in subsection 7 (b) or (d) of this section, no State or political subdivision 8 of a State may establish or continue in effect any require9 ment for labeling or packaging of a cosmetic.’’; 10 (3) by amending subsection (c) to read as fol- 11 lows: 12 ‘‘(c) COSMETIC SAFETY.—No State or political sub- 13 division of a State may establish or continue in effect any tkelley on DSK3SPTVN1PROD with BILLS 14 law, regulation, order, or other requirement— 15 ‘‘(1) relating directly or indirectly to, or relying 16 upon, a human health or safety evaluation of a non- 17 functional cosmetic constituent, cosmetic ingredient, 18 or cosmetic (as defined in section 201(i)(1)), or re- 19 lating in any way to the safety standard and the 20 human health-based requirements, evaluations, and 21 determinations under chapter VI, the Poison Preven- 22 tion Packaging Act of 1970, or the Fair Packaging 23 and Labeling Act; or 24 ‘‘(2) relating directly or indirectly to registra- 25 tion or listing of cosmetic facilities, establishments, •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 29 1 cosmetics, or cosmetic ingredients, reporting of any 2 information relating to cosmetics including adverse 3 event reporting, cosmetic manufacturing processes 4 or standards including good manufacturing practice, 5 cosmetic labels or labeling including any general or 6 health related warnings or public statement, or the 7 requirement of any fees on cosmetic establishments, 8 cosmetics, ingredients, or nonfunctional constitu- 9 ents.’’; and 10 11 (4) by repealing subsection (e). SEC. 13. IMPORTATION. 12 Section 801(a) (21 U.S.C. 381(a)) is amended by 13 adding at the end the following: ‘‘If a cosmetic is being 14 imported or offered for import into the United States and 15 the importer does not present both the unique cosmetic 16 establishment registration number required under section 17 605 for the establishment that performs the final portion 18 of the manufacturing operation and the unique cosmetic 19 and ingredient statement number required under section 20 606 for the cosmetic, or the registration or statement 21 number is not correct and accurate, the cosmetic shall be 22 denied entry.’’. tkelley on DSK3SPTVN1PROD with BILLS 23 SEC. 14. EFFECTIVE DATES. 24 (a)(1) The amendments made by sections 4, 5, 6, and 25 13 of this Act apply beginning on the later date of— •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 30 1 (A) the date that is one year after the Sec- 2 retary of Health and Human Services promulgates 3 final regulations implementing such amendments; or 4 (B) the date that is one year after the Sec- 5 retary of Health and Human Services publishes a 6 notice in the Federal Register determining that an 7 effective electronic system has been established and 8 is fully operational for— 9 (i) the submission of cosmetic manufac- 10 turing establishment registrations, cosmetic and 11 ingredient statements, and reports of serious 12 cosmetic adverse events; and 13 (ii) the National Cosmetic Regulatory 14 15 Databank. (2) Until the date applicable under paragraph (1), 16 the voluntary establishment registration and voluntary in17 gredient listing programs established in parts 710 and 720 18 of title 21, Code of Federal Regulations (as in effect on 19 the date of enactment of this Act), shall remain effective 20 and shall be fully implemented by the Secretary of Health 21 and Human Services. 22 (b) The amendments made by sections 7 and 8 apply tkelley on DSK3SPTVN1PROD with BILLS 23 beginning on the date that is two years after the date of 24 enactment of this Act. •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H4075.IH H4075 31 1 (c) Notwithstanding subsections (a) and (b), the 2 amendments made by sections 5 and 7 shall not apply with 3 respect to a cosmetic manufacturer with less than 4 $5,000,000 of annual net sales of cosmetics until the later 5 of— 6 (1)(A) with respect to the amendment made by 7 section 5, the date that is 36 months after the date 8 otherwise applicable under subsection (a); and 9 (B) with respect to the amendments made by 10 section 7, the date that is 36 months after the date 11 otherwise applicable under subsection (b); and 12 (2) such later date as may be determined by the 13 Secretary of Health and Human Services. 14 (d) Except as provided in subsections (a) through (c), 15 this Act takes effect on the date of enactment of this Act. tkelley on DSK3SPTVN1PROD with BILLS Æ •HR 4075 IH VerDate Sep 11 2014 22:12 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6301 E:\BILLS\H4075.IH H4075