I 

116TH CONGRESS 

1ST SESSION H. R. 5017 

To amend the Federal Food, Drug, and Cosmetic Act to treat as misbranded 

cosmetics with packaging or labeling using the term ‘‘natural’’ unless 

the product meets certain standards, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 8, 2019 

Mr. SEAN PATRICK MALONEY of New York (for himself, Ms. MENG, and Ms. 

SCHAKOWSKY) 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 

treat as misbranded cosmetics with packaging or labeling 

using the term ‘‘natural’’ unless the product meets certain standards, and for other purposes. 

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. 

4 This Act may be cited as the ‘‘Natural Cosmetics 

5 Act’’. 


kjohnson on DSK79L0C42 with BILLS
2 

•HR 5017 IH

1 SEC. 2. COSMETICS WITH CERTAIN TERMS MISBRANDED. 

2 (a) IN GENERAL.—Section 602 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 362) is amended by 

4 adding at the end the following: 

5 ‘‘(g) If its packaging or labeling bears the term ‘nat6 ural’ unless— 

7 ‘‘(1) if the term ‘natural’ pertains to the cos8 metic overall, the cosmetic contains— 

9 ‘‘(A) at least 70 percent natural sub10 stances (other than water and salt); 

11 ‘‘(B) no fragrance ingredient other than a 

12 natural substance or naturally-derived ingre13 dient; and 

14 ‘‘(C) other than natural substances and 

15 water, contains only naturally-derived ingredi16 ents except to the extent a naturally-derived in17 gredient— 

18 ‘‘(i) is not available for a specific 

19 function; or 

20 ‘‘(ii) is otherwise not feasible; 

21 ‘‘(2) if the term ‘natural’ pertains to one or 

22 more ingredients in the cosmetic— 

23 ‘‘(A) the ingredient statement identifies 

24 natural ingredients individually with the terms 

25 ‘natural’ or ‘naturally-derived ingredient’; 


kjohnson on DSK79L0C42 with BILLS
3 

•HR 5017 IH

1 ‘‘(B) the listing of each such ingredient is 

2 followed by a reference mark; and 

3 ‘‘(C) the labeling contains the definition of 

4 such terms below the ingredient statement; and 

5 ‘‘(3) the cosmetic is not made using any of the 

6 following: 

7 ‘‘(A) Alkoxylation (including ethoxylation 

8 and propoxylation) using ethylene oxide, pro9 pylene oxide, or other alkylene oxides. 

10 ‘‘(B) Deterpenation (other than with 

11 steam). 

12 ‘‘(C) Halogenation as the main reaction. 

13 ‘‘(D) Ionizing radiation. 

14 ‘‘(E) Sulphonation as the main reaction. 

15 ‘‘(F) Treatment with ethylene oxide. 

16 ‘‘(G) Treatment using mercury.’’. 

17 (b) DEFINITIONS.—Chapter VI of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend19 ed by adding at the end the following: 

20 ‘‘SEC. 604. DEFINITIONS. 

21 ‘‘In this chapter: 

22 ‘‘(1)(A) The term ‘natural’ means any chemical 

23 substance that is naturally occurring and which is— 

24 ‘‘(i) unprocessed; 


kjohnson on DSK79L0C42 with BILLS
4 

•HR 5017 IH

1 ‘‘(ii) processed only by manual, mechan2 ical, naturally derived solvent or gravitational 

3 means, by dissolution in water or steam, by flo4 tation, or by heating solely to remove water; or 

5 ‘‘(iii) extracted from air by any means. 

6 ‘‘(B) Such term does not include petroleum and 

7 petroleum derived ingredients. 

8 ‘‘(2) The term ‘naturally-derived ingredient’ 

9 means— 

10 ‘‘(A) any substance where the starting ma11 terial is of mineral, plant, microbe, or animal 

12 origin but has been chemically processed; 

13 ‘‘(B) any substance where the starting ma14 terial is of mineral, plant, microbe, or animal 

15 origin but has been chemically processed and 

16 combined with other ingredients, excluding pe17 troleum and fossil fuel-derived ingredients; or 

18 ‘‘(C) an ingredient that is derived from a 

19 plant feedstock and bio-manufactured using 

20 processes like fermentation, saponification, con21 densation, or esterification in order to improve 

22 performance or make the ingredient biodegrad23 able or sustainable.’’. 

24 (c) APPLICABILITY.—Section 602(g) of the Federal 

25 Food, Drug, and Cosmetic Act, as added by subsection 


kjohnson on DSK79L0C42 with BILLS
5 

•HR 5017 IH

1 (a), applies beginning on the date that is 2 years after 

2 the date of enactment of this Act. 

3 SEC. 3. RECALL AUTHORITY FOR MISBRANDED COSMETICS 

4 PURPORTING TO BE ‘‘NATURAL’’. 

5 Chapter VI of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 361 et seq.), as amended by section 2, 

7 is further amended by adding at the end the following: 

8 ‘‘SEC. 605. RECORDKEEPING, NOTIFICATION, NONDIS9 TRIBUTION, AND RECALL OF MISBRANDED 

10 COSMETICS PURPORTING TO BE ‘NATURAL’. 

11 ‘‘(a) RECORDKEEPING.—A manufacturer or 

12 distributer of a cosmetic purporting to be natural within 

13 the meaning of section 602(g) shall— 

14 ‘‘(1) maintain records— 

15 ‘‘(A) verifying such claim; and 

16 ‘‘(B)(i) demonstrating that each ingredient 

17 in the cosmetic has been dated by the supplier 

18 of such ingredient using carbon-14 testing; and 

19 ‘‘(ii) including the results of such testing; 

20 and 

21 ‘‘(2) make such records available to the Sec22 retary for inspection, request, or audit. 

23 ‘‘(b) NOTIFICATION OF MISBRANDED COSMETICS.— 

24 ‘‘(1) IN GENERAL.—A responsible party that 

25 has reason to believe that a cosmetic, when introVerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5017.IH H5017

kjohnson on DSK79L0C42 with BILLS
6 

•HR 5017 IH

1 duced into or while in interstate commerce, or while 

2 held for sale (regardless of whether such sale is the 

3 first sale of such cosmetic) after shipment in inter4 state commerce, is misbranded under section 602(g) 

5 shall notify the Secretary of the identity and location 

6 of the cosmetic. 

7 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

8 under paragraph (1) shall be made in such manner 

9 and by such means as the Secretary may require by 

10 regulation or guidance. 

11 ‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur12 poses of this subsection, the term ‘responsible party’ 

13 means a brand owner, manufacturer, packager, re14 tailer, or distributor of the cosmetic. 

15 ‘‘(c) VOLUNTARY RECALL.—The Secretary may re16 quest that any person who distributes a cosmetic that the 

17 Secretary has reason to believe is misbranded under sec18 tion 602(g) voluntarily— 

19 ‘‘(1) recall such cosmetic; and 

20 ‘‘(2) provide for notice, including to individuals 

21 as appropriate, to persons who may be affected by 

22 the recall. 

23 ‘‘(d) ORDER TO CEASE DISTRIBUTION.— 

24 ‘‘(1) IN GENERAL.—If the Secretary has reason 

25 to believe that the cosmetic is misbranded under secVerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5017.IH H5017

kjohnson on DSK79L0C42 with BILLS
7 

•HR 5017 IH

1 tion 602(g), the Secretary shall have the authority 

2 to issue an order requiring any person who distrib3 utes such cosmetic to immediately cease distribution 

4 of such cosmetic. 

5 ‘‘(2) CEASE DISTRIBUTION AND NOTICE.—Any 

6 person who is subject to an order under paragraph 

7 (1) shall immediately cease distribution of such cos8 metic and provide notification as required by such 

9 order. 

10 ‘‘(3) APPEAL.— 

11 ‘‘(A) 48 HOURS.—A person subject to an 

12 order under paragraph (1) may appeal such 

13 order to the Secretary within 48 hours of the 

14 issuance of such order. 

15 ‘‘(B) CONTENTS OF APPEAL.—Such appeal 

16 may include a request for an informal hearing 

17 and a description of any efforts to recall such 

18 cosmetic undertaken voluntarily by the person, 

19 including after a request under subsection (b). 

20 ‘‘(C) INFORMAL HEARING.—An informal 

21 hearing shall be held as soon as practicable, but 

22 not later than 5 calendar days (or less as deter23 mined by the Secretary) after such an appeal is 

24 filed, unless the parties jointly agree to an ex25 tension. 


kjohnson on DSK79L0C42 with BILLS
8 

•HR 5017 IH

1 ‘‘(D) IMPACT ON RECALL.—If an appeal is 

2 filed under subparagraph (A), the Secretary 

3 may not amend the order to require a recall 

4 under subsection (d) until after the conclusion 

5 of the hearing under subparagraph (C). 

6 ‘‘(4) VACATION OF ORDER.—If the Secretary 

7 determines that inadequate grounds exist to support 

8 the actions required by the order under paragraph 

9 (1), the Secretary shall vacate the order. 

10 ‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI11 CIALS.—The Secretary shall, as the Secretary determines 

12 to be necessary, provide public notice of an order to cease 

13 distribution or recalling a misbranded cosmetic under this 

14 section to all consumers in a prominent manner on the 

15 website of the Food and Drug Administration and to ap16 propriate State and local health officials. 

17 ‘‘(f) SUPPLY CHAIN INFORMATION.— 

18 ‘‘(1) IN GENERAL.—In the case of a cosmetic 

19 that the Secretary has reason to believe is mis20 branded under section 602(g), the Secretary shall 

21 request that the brand owner named on the label of 

22 such cosmetic (as required under section 602(b)(1)) 

23 submit all of the following information: 

24 ‘‘(A) The name and place of business of 

25 the manufacturer, packager, supplier, or disVerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5017.IH H5017

kjohnson on DSK79L0C42 with BILLS
9 

•HR 5017 IH

1 tributor from which such entity received the 

2 cosmetic or ingredients for manufacturing such 

3 cosmetic. 

4 ‘‘(B) The name and place of business of 

5 any entity (including any retailer) that was pro6 vided with such cosmetic by the entity named 

7 on the label. 

8 ‘‘(2) COLLECTION OF ADDITIONAL SUPPLY

9 CHAIN INFORMATION.—In the case of a cosmetic 

10 that the Secretary has reason to believe is mis11 branded under section 602(g), to the extent nec12 essary to protect the safety of the public, the Sec13 retary may request that any entity (including a sup14 plier of an ingredient, manufacturer, packer, dis15 tributor, or retailer) in the supply chain of such cos16 metic submit to the Secretary information that is 

17 similar to the information described under subpara18 graphs (A) and (B) of paragraph (1). 

19 ‘‘(3) MAINTENANCE OF RECORDS.—Any entity 

20 in the supply chain of a cosmetic (including the 

21 brand owner named on the label of a cosmetic) 

22 shall— 

23 ‘‘(A) maintain records sufficient to provide 

24 the information described in subparagraphs (A) 

25 and (B) of paragraph (1); and 


kjohnson on DSK79L0C42 with BILLS
10 

•HR 5017 IH

1 ‘‘(B) provide such information to the Sec2 retary upon the request of the Secretary. 

3 ‘‘(g) SAVINGS CLAUSE.—Nothing contained in this 

4 section shall be construed as limiting the authority of the 

5 Secretary to issue an order to cease distribution of, or to 

6 recall, a cosmetic under any other provision of this Act.’’. 

Æ 


kjohnson on DSK79L0C42 with BILLS