I 
119TH CONGRESS 
1ST SESSION H. R. 2111 
To amend the Federal Food, Drug, and Cosmetic Act to exempt the premium 
cigar industry from certain regulations. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 14, 2025 
Mr. DONALDS (for himself, Mr. LANGWORTHY, Ms. TITUS, and Mr. PANETTA) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
exempt the premium cigar industry from certain regulations. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. FINDINGS. 
The Congress finds the following: 
(1) Premium cigars comprise only 1 percent of 
all cigars sold in the United States. 
(2) Most manufacturers of premium cigars are 
family-owned small businesses. 
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(3) Premium cigars are typically sold in age- 
controlled retail establishments, such as tobacco spe-
cialty shops or cigar bars. 
(4) At the request of the Food and Drug Ad-
ministration and the National Institutes of Health, 
the National Academies of Sciences, Engineering, 
and Medicine (in this section referred to as the 
‘‘NASEM’’) convened an expert committee to exam-
ine 4 premium cigar topics: product characteristics, 
patterns of use, marketing and perceptions, and 
health effects. 
(5) The NASEM expert committee produced a 
resulting report, published in 2022 and titled ‘‘Pre-
mium Cigars: Patterns of Use, Marketing, and 
Health Effects’’, which among other things, identi-
fied numerous facts regarding premium cigar use. 
(6) The NASEM expert committee found that 
premium cigars are only used by about 1 percent of 
the United States adult population. 
(7) The NASEM expert committee found that 
premium cigar use is less common among youth 
than among other users and only 0.6 percent of 
those who reported smoking a premium cigar were 
under 18 years of age. 
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(8) The NASEM expert committee found that 
premium cigar use is less common among women, 
non-Hispanic Black persons, and persons with less 
than a high school education than other users. 
(9) The NASEM expert committee found that 
premium cigar users are less likely to smoke ciga-
rettes or other cigar types concurrently than other 
cigar type users. 
(10) The NASEM expert committee found that 
the frequency and intensity of smoking is lower for 
premium cigars compared to other types of cigars 
and cigarettes. 
(11) The NASEM expert committee found that 
as compared to users of other types of cigars, pre-
mium cigar users are more likely to be never or 
former cigarette smokers. 
(12) The NASEM expert committee found that 
there is strongly suggestive evidence that the health 
consequences of premium cigar smoking overall are 
likely to be less than those of smoking other types 
of cigars because the majority of premium cigar 
smokers are nondaily or occasional users and be-
cause they are unlikely to inhale the smoke. 
(13) The NASEM expert committee found that 
premium cigars are used virtually exclusively by 
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adults, premium cigar use is extremely limited, and 
premium cigar use poses less physical risk than the 
use of other tobacco products. 
(14) The definition of premium cigar used by 
the NASEM expert committee is broader and would 
encompass a larger class of cigars than the defini-
tion adopted by Judge Amit P. Mehta, of the United 
States District Court for the District of Columbia, 
in a recent decision striking the latest attempt by 
the Food and Drug Administration to regulate pre-
mium cigars. 
(15) The narrower definition adopted by Judge 
Mehta is the definition that would apply if this bill 
were enacted. 
(16) The District Court concluded that the few 
health risks posed by premium cigars can be regu-
lated at the State level. 
SEC. 2. EXEMPTION OF PREMIUM CIGARS FROM CERTAIN 
TOBACCO REGULATION IN FEDERAL FOOD, 
DRUG, AND COSMETIC ACT. 
Section 201(rr) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(rr)) is amended by adding at 
the end the following: 
‘‘(6)(A) The term ‘tobacco product’ does not mean 
a premium cigar. 
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‘‘(B) In clause (A), the term ‘premium cigar’ means 
a cigar that— 
‘‘(i) is wrapped in whole tobacco leaf; 
‘‘(ii) contains a 100 percent leaf tobacco binder; 
‘‘(iii) contains at least 50 percent (of the filler 
by weight) long filler tobacco (whole tobacco leaves 
that run the length of the cigar); 
‘‘(iv) is handmade or hand rolled, meaning no 
machinery was used apart from simple tools, such as 
scissors to cut the tobacco prior to rolling; 
‘‘(v) has no filter, nontobacco tip, or nontobacco 
mouthpiece; 
‘‘(vi) does not have a characterizing flavor other 
than tobacco; 
‘‘(vii) contains only tobacco, water, and vege-
table gum with no other ingredients or additives; 
and 
‘‘(viii) weighs more than 6 pounds per 1,000 
units.’’. 
Æ 
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