Amend FDA Deeming Rule:
Exclude Premium Cigars

Proposal: This FDA rule should exempt premium cigars from premarket application (PMTA) requirements.

Position Summary: The FDA originally considered excluding premium cigars ("Option 2"), but ultimately decided to include premium cigars. The premium cigar industry employs between 15,000 and 20,000 American workers and is responsible for as much as $1.8 billion in annual revenue. Premium cigars are a unique product, with a unique consumer base that can research products for themselves and make sophisticated buying decisions. FDA regulation would result in more costs to premium cigar makers than would result in health benefits for premium cigar consumers. Regulating premium cigars under this rule will have the unintended result of the loss of American jobs, and would limit consumer freedom while unnecessarily detracting from the FDA's ability to accomplish the goals Congress intended.

  1. Minnie Norton on behalf of J.C. Newman Cigar Co. "This is about saving Tampa's last cigar factory. There used to be more than 150 cigar factories in Tampa. J.C. Newman's Tampa factory has been here for 119 years. I am not a smoker, but the cigar industry is an integral part of the Tampa's history and culture. My grandfather used to roll cigars here. If J.C. Newman is not given an exemption from FDA regulation, they will be forced to close their doors and a part of Tampa's history and culture will be lost forever. I hope you will grant them their requested exemption." Link
  2. Hon. Bill Posey (FL-8). "A premium cigar should be defined as any roll of tobacco that is wrapped in 100 percent leaf tobacco, bunched with 100 percent tobacco filler, contains no filter, tip, or nontobacco mouthpiece, and weighs at least 6 pounds per 1,000 count. It also must either have a 100 percent leaf tobacco binder and be hand rolled, or have a homogenized tobacco leaf binder and be made in the United States using human hands to lay the 100 percent leaf tobacco wrapper onto only one machine that bunches, wraps, and caps each individual cigar. Additionally, this should explicitly exclude cigarettes or little cigars, as defined by the FDA." - See letter from Congress members to the FDA.
  3. Madvapes LLC. "Even if we assume, arguendo, that “electronic cigarettes” should be regulated under the same regulatory regime as combustible tobacco cigarettes, such regime should only apply to cigalike devices, and not to ARPVs and the refillable e-liquids used in them. ARPVs should instead be exempted from the meaning of “covered tobacco products,” along with premium cigars, under the NPRM’s “Option 2”. This is because ARPVs differ from cigalike devices in many of the same ways that premium cigars differ from cigarettes and little cigars. For example, both products are used by adult connoisseurs and can generally only be found in specialty stores (cigar shops and tobacconists for premium cigars and “vape shops” for ARPV mods and e- liquids). These products are also much more expensive than their cheaper counterparts. ARPVs can cost a few hundred dollars to assemble, significantly more than the typical ready-made cigalike device which, like cigarettes and little cigars, are widely distributed in convenience stores and gas stations, for example, where they are more likely to be viewed by non-smokers, including children." Details
  4. Hon. Harold Rogers (KY-5) - See letter from Congress members to the FDA.
  5. Hon. Sam Graves (M0-6) - See letter from Congress members to the FDA.
  6. Hon. Edward Royce (CA-39) - See letter from Congress members to the FDA.
  7. Hon. Don Young (AK-At-large) - See letter from Congress members to the FDA.
  8. Hon. Doug Lamborn (C0-5) - See letter from Congress members to the FDA.
  9. Hon. Ileana Ros-Lehtinen (FL-27) - See letter from Congress members to the FDA.
  10. Hon. Ken Calvert (CA-42) - See letter from Congress members to the FDA.
  11. Hon. Richard Nugent (FL-11) - See letter from Congress members to the FDA.
  12. Hon. Andy Harris (MD-1) - See letter from Congress members to the FDA.
  13. Hon. Mike Kelly (PA-3) - See letter from Congress members to the FDA.
  14. Hon. Billy Long (M0-7) - See letter from Congress members to the FDA.
  15. Hon. Tom Marino (PA-10) - See letter from Congress members to the FDA.
  16. Hon. David Schweikert (AZ-6) - See letter from Congress members to the FDA.
  17. Hon. David W. Jolly (FL-13) - See letter from Congress members to the FDA.
  18. Hon. Reid Ribble (Wl-8) - See letter from Congress members to the FDA.
  19. Hon. Frederica Wilson (FL-24) - See letter from Congress members to the FDA.
  20. Hon. Duncan Hunter (CA-50) - See letter from Congress members to the FDA.
  21. Hon. Brett Guthrie (KY-2) - See letter from Congress members to the FDA.
  22. Hon. John Kline (MN-2) - See letter from Congress members to the FDA.
  23. Hon. Tom Cole (OK-4) - See letter from Congress members to the FDA.
  24. Hon. Pete Sessions (TX-32) - See letter from Congress members to the FDA.
  25. Hon. John Carter (TX-31) - See letter from Congress members to the FDA.
  26. Hon. Andy Barr (KY-6) - See letter from Congress members to the FDA.
  27. Hon. Bill Huizenga (MI-2) - See letter from Congress members to the FDA.
  28. Hon. Steve Womack (AR-3) - See letter from Congress members to the FDA.
  29. Hon. Jeff Miller (FL-1) - See letter from Congress members to the FDA.
  30. Hon. Patrick Murphy (FL-18) - See letter from Congress members to the FDA.
  31. Hon. JeffDenham (CA-10) - See letter from Congress members to the FDA.
  32. Hon. Collin Peterson (MN-7) - See letter from Congress members to the FDA.
  33. Hon. Sanford Bishop, Jr. (GA-2) - See letter from Congress members to the FDA.
  34. Hon. Alan Grayson (FL-9) - See letter from Congress members to the FDA.
  35. Hon. Gus Bilirakis (FL-12) - See letter from Congress members to the FDA.
  36. Hon. Tom McClintock (CA-4) - See letter from Congress members to the FDA.
  37. Hon. Blaine Luetkemeyer (M0-3) - See letter from Congress members to the FDA.
  38. Hon. Thomas Rooney (FL-17) - See letter from Congress members to the FDA.
  39. Hon. Mario Diaz-Balart (FL-25) - See letter from Congress members to the FDA.
  40. Hon. Bob Gibbs (OH-7) - See letter from Congress members to the FDA.
  41. Hon. Mark Amodei (NV -2) - See letter from Congress members to the FDA.
  42. Hon. Robert Pittinger (NC-9) - See letter from Congress members to the FDA.
  43. Hon. Lou Barletta (PA-ll) - See letter from Congress members to the FDA.
  44. Hon. JeffDuncan (SC-3) - See letter from Congress members to the FDA.
  45. Hon. Glenn Thompson (PA-5) - See letter from Congress members to the FDA.
  46. Hon. Lee Terry (NE-2) - See letter from Congress members to the FDA.
  47. Hon. Roger Williams (TX-25) - See letter from Congress members to the FDA.
  48. Hon. Kevin Yoder (KS-3) - See letter from Congress members to the FDA.
  49. Hon. Stevan Pearce (NM-2) - See letter from Congress members to the FDA.
  50. Hon. Tim Walberg (MI-7) - See letter from Congress members to the FDA.
  51. Hon. Mike Coffman (C0-6) - See letter from Congress members to the FDA.
  52. Hon. Tim Murphy (PA-18) - See letter from Congress members to the FDA.
  53. Hon. Michael Turner (OH-10) - See letter from Congress members to the FDA.
  54. Hon. Doug Collins (GA-9) - See letter from Congress members to the FDA.
  55. Hon. Keith Rothfus (PA-12) - See letter from Congress members to the FDA.
  56. Hon. H. Morgan Griffith (V A-9) - See letter from Congress members to the FDA.
  57. Hon. Ted Yoho (FL-3) - See letter from Congress members to the FDA.
  58. Hon. Dennis Ross (FL-15) - See letter from Congress members to the FDA.
  59. Hon. Dan Benishek (MI -1) - See letter from Congress members to the FDA.
  60. Hon. F. James Sensenbrenner, Jr. (WI-5) - See letter from Congress members to the FDA.
  61. Hon. Virginia Foxx (NC-5) - See letter from Congress members to the FDA.
  62. Hon. John Mica (FL-7) - See letter from Congress members to the FDA.
  63. Hon. Christopher Gibson (NY -19) - See letter from Congress members to the FDA.
  64. Anonymous, Individual Consumer "As an adult who enjoys premium cigars I support FDAs proposal that premium cigars be exempted from FDA regulation. Details
  65. Anonymous, Individual Consumer "As an adult consumer of premium cigars, I am opposed to FDA's attempt to regulate these products. In particular, I don't believe premium cigar manufacturers should be required to go through a very long and very expensive approval process before any new premium cigar can be sold. I understand manufacturers will have to spend thousands of hours and millions of dollars to complete such an application – so most won't do it. I also understand that, for those who do, it could be a year or more before the application gets decided. This will mean I won't have the selection of cigars I enjoy, and won't have any limited edition or seasonal blend cigars. Finally, I don't see how FDA can say a "new" cigar is one that was first sold after February 2007. "New" should mean a cigar I haven't tried yet, not one I've been enjoying for seven years. We all know there are much greater concerns for the government to be focusing on at this time than for them to get in the cigar business. FDA should recognize that premium cigars are unique in the way they're made and smoked, and leave them alone. Thank you for your time and consideration." Details
  66. Anonymous, Individual Consumer. "The new proposed regulations will infringe on my rights as a cigar consumer: the freedom to enjoy a variety of premium cigars; The freedom to patronize small businesses across America who will now find their livelihood at risk; The freedom to assemble with fellow cigar enthusiasts because of intrusive government intervention into an adult pursuit.   These devastating new restrictions on premium cigars and the businesses that manufacture and sell premium cigars, must recognize that premium cigars, are not what Congress intended with the Family Smoking Prevention and Tobacco Control Act." Details 

Agency Response

The FDA: "FDA understands these concerns, but believes that this rule will not increase current illicit practices or create new illicit markets, because FDA is not banning any tobacco product with this deeming rule. Even if some illicit trade were to develop in an attempt to evade the requirements of this rule, FDA does not believe it would result in a volume sufficient to outweigh the public health benefits of the rule. FDA authority over the newly deemed tobacco products will give it means to determine which products are legally on the market and which are counterfeit or otherwise illegally marketed. The Tobacco Control Act gives the Agency these and other authorities, such as section 920 of the FD&C Act (21 U.S.C. 387t), to help address illicit tobacco products." Read More