I 119THCONGRESS 1 STSESSION 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 MARCH14, 2025 Mr. D ONALDS(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-1 tives of the United States of America in Congress assembled, 2 SECTION 1. FINDINGS. 3 The Congress finds the following: 4 (1) Premium cigars comprise only 1 percent of 5 all cigars sold in the United States. 6 (2) Most manufacturers of premium cigars are 7 family-owned small businesses. 8 VerDate Sep 11 2014 03:23 Mar 27, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2111.IH H2111 ssavage on LAPJG3WLY3PROD with BILLS 2 •HR 2111 IH (3) Premium cigars are typically sold in age- 1 controlled retail establishments, such as tobacco spe-2 cialty shops or cigar bars. 3 (4) At the request of the Food and Drug Ad-4 ministration and the National Institutes of Health, 5 the National Academies of Sciences, Engineering, 6 and Medicine (in this section referred to as the 7 ‘‘NASEM’’) convened an expert committee to exam-8 ine 4 premium cigar topics: product characteristics, 9 patterns of use, marketing and perceptions, and 10 health effects. 11 (5) The NASEM expert committee produced a 12 resulting report, published in 2022 and titled ‘‘Pre-13 mium Cigars: Patterns of Use, Marketing, and 14 Health Effects’’, which among other things, identi-15 fied numerous facts regarding premium cigar use. 16 (6) The NASEM expert committee found that 17 premium cigars are only used by about 1 percent of 18 the United States adult population. 19 (7) The NASEM expert committee found that 20 premium cigar use is less common among youth 21 than among other users and only 0.6 percent of 22 those who reported smoking a premium cigar were 23 under 18 years of age. 24 VerDate Sep 11 2014 03:23 Mar 27, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2111.IH H2111 ssavage on LAPJG3WLY3PROD with BILLS 3 •HR 2111 IH (8) The NASEM expert committee found that 1 premium cigar use is less common among women, 2 non-Hispanic Black persons, and persons with less 3 than a high school education than other users. 4 (9) The NASEM expert committee found that 5 premium cigar users are less likely to smoke ciga-6 rettes or other cigar types concurrently than other 7 cigar type users. 8 (10) The NASEM expert committee found that 9 the frequency and intensity of smoking is lower for 10 premium cigars compared to other types of cigars 11 and cigarettes. 12 (11) The NASEM expert committee found that 13 as compared to users of other types of cigars, pre-14 mium cigar users are more likely to be never or 15 former cigarette smokers. 16 (12) The NASEM expert committee found that 17 there is strongly suggestive evidence that the health 18 consequences of premium cigar smoking overall are 19 likely to be less than those of smoking other types 20 of cigars because the majority of premium cigar 21 smokers are nondaily or occasional users and be-22 cause they are unlikely to inhale the smoke. 23 (13) The NASEM expert committee found that 24 premium cigars are used virtually exclusively by 25 VerDate Sep 11 2014 03:23 Mar 27, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2111.IH H2111 ssavage on LAPJG3WLY3PROD with BILLS 4 •HR 2111 IH adults, premium cigar use is extremely limited, and 1 premium cigar use poses less physical risk than the 2 use of other tobacco products. 3 (14) The definition of premium cigar used by 4 the NASEM expert committee is broader and would 5 encompass a larger class of cigars than the defini-6 tion adopted by Judge Amit P. Mehta, of the United 7 States District Court for the District of Columbia, 8 in a recent decision striking the latest attempt by 9 the Food and Drug Administration to regulate pre-10 mium cigars. 11 (15) The narrower definition adopted by Judge 12 Mehta is the definition that would apply if this bill 13 were enacted. 14 (16) The District Court concluded that the few 15 health risks posed by premium cigars can be regu-16 lated at the State level. 17 SEC. 2. EXEMPTION OF PREMIUM CIGARS FROM CERTAIN 18 TOBACCO REGULATION IN FEDERAL FOOD, 19 DRUG, AND COSMETIC ACT. 20 Section 201(rr) of the Federal Food, Drug, and Cos-21 metic Act (21 U.S.C. 321(rr)) is amended by adding at 22 the end the following: 23 ‘‘(6)(A) The term ‘tobacco product’ does not mean 24 a premium cigar. 25 VerDate Sep 11 2014 03:23 Mar 27, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2111.IH H2111 ssavage on LAPJG3WLY3PROD with BILLS 5 •HR 2111 IH ‘‘(B) In clause (A), the term ‘premium cigar’ means 1 a cigar that— 2 ‘‘(i) is wrapped in whole tobacco leaf; 3 ‘‘(ii) contains a 100 percent leaf tobacco binder; 4 ‘‘(iii) contains at least 50 percent (of the filler 5 by weight) long filler tobacco (whole tobacco leaves 6 that run the length of the cigar); 7 ‘‘(iv) is handmade or hand rolled, meaning no 8 machinery was used apart from simple tools, such as 9 scissors to cut the tobacco prior to rolling; 10 ‘‘(v) has no filter, nontobacco tip, or nontobacco 11 mouthpiece; 12 ‘‘(vi) does not have a characterizing flavor other 13 than tobacco; 14 ‘‘(vii) contains only tobacco, water, and vege-15 table gum with no other ingredients or additives; 16 and 17 ‘‘(viii) weighs more than 6 pounds per 1,000 18 units.’’. 19 Æ VerDate Sep 11 2014 03:23 Mar 27, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H2111.IH H2111 ssavage on LAPJG3WLY3PROD with BILLS