II 

117TH CONGRESS 

1ST SESSION S. 438 

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

and Drug Administration’s jurisdiction over certain tobacco products, 

and to protect jobs and small businesses involved in the sale, manufacturing and distribution of traditional and premium cigars. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 24, 2021 

Mr. RUBIO (for himself, Mr. COTTON, Ms. ERNST, Mr. SCOTT of Florida, Mr. 

BARRASSO, Mr. INHOFE, Mr. GRAHAM, Mr. BOOZMAN, and Mr. KENNEDY) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

clarify the Food and Drug Administration’s jurisdiction 

over certain tobacco products, and to protect jobs and 

small businesses involved in the sale, manufacturing and 

distribution of traditional and premium cigars. 

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 ‘‘Traditional Cigar Man5 ufacturing and Small Business Jobs Preservation Act of 

6 2021’’. 


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•S 438 IS

1 SEC. 2. LIMITATION OF AUTHORITY WITH RESPECT TO 

2 PREMIUM CIGARS. 

3 (a) EXCEPTION FOR TRADITIONAL LARGE AND PRE4 MIUM CIGARS.—Section 901(c) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 387a(c)) is amend6 ed— 

7 (1) in paragraph (2), in the heading, by insert8 ing ‘‘FOR CERTAIN TOBACCO LEAF’’ after ‘‘AUTHOR9 ITY’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(3) LIMITATION OF AUTHORITY FOR CERTAIN

12 CIGARS.— 

13 ‘‘(A) IN GENERAL.—The provisions of this 

14 chapter (except for section 907(d)(3)) shall not 

15 apply to traditional large and premium cigars. 

16 ‘‘(B) RULE OF CONSTRUCTION.—Nothing 

17 in this chapter shall be construed to grant the 

18 Secretary authority to promulgate regulations 

19 on any matter that involves traditional large 

20 and premium cigars. 

21 ‘‘(C) TRADITIONAL LARGE AND PREMIUM

22 CIGAR DEFINED.—For purposes of this para23 graph, the term ‘traditional large and premium 

24 cigar’— 

25 ‘‘(i) means any roll of tobacco that is 

26 wrapped in 100-percent leaf tobacco, 


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•S 438 IS

1 bunched with 100-percent tobacco filler, 

2 contains no filter, tip or non-tobacco 

3 mouthpiece, weighs at least 6 pounds per 

4 1,000 count, and— 

5 ‘‘(I) has a 100-percent leaf to6 bacco binder and is hand rolled; 

7 ‘‘(II) has a 100-percent leaf to8 bacco binder and is made using 

9 human hands to lay the leaf tobacco 

10 wrapper or binder onto only one ma11 chine that bunches, wraps, and caps 

12 each individual cigar; or 

13 ‘‘(III) has a homogenized tobacco 

14 leaf binder and is made in the United 

15 States using human hands to lay the 

16 100-percent leaf tobacco wrapper onto 

17 only one machine that bunches, 

18 wraps, and caps each individual cigar; 

19 and 

20 ‘‘(ii) does not include a cigarette (as 

21 such term is defined by section 900(3)) or 

22 a little cigar (as such term is defined by 

23 section 900(11)).’’. 


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•S 438 IS

1 (b) CONFORMING AMENDMENTS.—Section 919(b) of 

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

3 387s(b)) is amended— 

4 (1) in paragraph (2)(B)(i)(II), by inserting ‘‘, 

5 but excluding traditional large and premium cigars 

6 (as such term is defined under section 901(c)(3))’’ 

7 before the period; and 

8 (2) in paragraph (5), by inserting ‘‘subject to 

9 section 901(c)(3),’’ before ‘‘if a user fee’’. 

Æ 


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