Cigar Aficionado

FDA Extends Deadline—Will Reconsider Premium Cigars

FDA Extends Deadline—Will Reconsider Premium Cigars

Today the U.S. Food and Drug Administration announced a new, comprehensive plan on its approach to regulating tobacco products that includes extending the pre-market application deadline for cigars.

In a short speech, Dr. Scott Gottlieb, who was appointed commissioner of the FDA in May, spoke mainly about reducing the levels of nicotine in cigarettes to protect children. The commissioner, though, did mention that the agency will take a fresh look at the treatment of premium cigars under the agency's current regulatory structure. He also hinted that premium cigars could be exempted from the FDA's Final Deeming Rule in the future.

Gottlieb said that the agency will open a new rulemaking process to engage with the premium cigar industry to better understand its products.

"... I'm also asking the tobacco center leadership to explore a process by which it could ask for new information related to the patterns of use and resulting public health impact of so-called premium cigars," said Gottlieb. "The Final Deeming Rule covers all cigars, but I want the center to consider opportunities that could provide to interested parties to develop and submit new information or data on this issue. This will take the form of an advanced notice of proposed rulemaking to develop a new administrative record to explore these questions. We'll explore any new and different questions raised, and seriously consider any additional data submitted relevant to the appropriate regulatory status of premium cigars."

To punctuate the agency's new approach to premium cigars, the FDA is extending its deadline by several years for manufacturers to submit their pre-market applications, to August 8, 2021. This new deadline applies only to cigars that were on the market as of August 8, 2016. However, under the guidelines that the FDA outlined today, products with pre-market applications already submitted to the agency can continue to be sold for the duration of the application review process.

According to the FDA, the new 2021 date does not apply to deadlines that have already passed, or to the "other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports..." (The deadline for many of these rules was extended back in May.)

Additionally, Gottlieb said that the agency will be releasing a new draft guidance in hopes of clarifying exactly what cigar manufacturers need to include in their applications.

"Among other things we will advance rules that will lay out what needs to be in applications for substantial equivalence, modified risk tobacco products, and premarket tobacco product applications, and whether and how we would exempt premium cigars from regulation," Gottlieb said.

Many in the cigar industry, from cigar manufacturers to the heads of cigar industry took today's FDA announcement as positive news.

"This has been a long and complicated process, which is not over. However, we commend the objective approach announced today by the commissioner of the FDA," said Mark Pursell, chief executive officer of the International Premium Cigar & Pipe Retailers association, and Glynn Loope, executive director of the Cigar Rights of America, in a joint statement.

In an interview with Cigar Aficionado, Loope also said that "such distinctive treatment of premium cigars in Gottlieb's remarks is clear evidence that he has received this industry's message from those that have reached out to him."

"Since the Final Deeming Rule was published last year, there has been tremendous anxiety within the premium cigar industry about FDA regulation and how to comply with its many expensive and arduous requirements," said Drew Newman, general counsel for the J.C. Newman Cigar Co. "Today's announcement gives us all some breathing room, allowing us to continuing rolling cigars just as we have been doing for 122 years, while giving the FDA time to reconsider the regulation of premium cigars and provide more guidance to the premium cigar industry."

"This is a good first step," said Marvin R. Shanken, editor and publisher of Cigar Aficionado, "but there's a lot more that needs to be resolved."

This is a breaking story, with more developments expected next week. Revisit CigarAficionado.com for further updates as they become available.

To learn how to write the FDA and show your support for premium cigars, check out Cigar Aficionado's form letter by clicking here.




"Ben Balliro: Dr. Gottlieb (as appointed by Trump) appears to be a more reasonable man and is likely to be one more friendly to business - which is exactly why we need Executives in the Oval office to come from business, not from law schools and political organizations. At least once in awhile." —August 1, 2017 19:40 PM
"Any delay from the FDA is a welcome relief to the cigar industry. Consumers and manufacturers have enough to worry about without the FDA threatening their very existence based on misguided research and a false sense of "safety" for the community. It appears as though Gottlieb is purposely delaying the ruling on the FDA to give the cigar manufacturing industry enough time to develop a viable checkmate against the FDA ruling." —August 1, 2017 16:48 PM
"Well said, David. While I am very aware of all the time and effort Rocky (and others on the manufacturing side) have put into the efforts, to think IPCPR or CRA were any less important to the process is pretty much just being uninformed. Hats off to all of them and let's hope this continues to move in a positive direction." —July 31, 2017 12:30 PM
"Today was a very busy day for many in the cigar industry, including Rocky Patel. We did reach out to him for comment on this story but he was unable to comment in time for our deadline. And calling the CRA and IPCPR useless in this regard shows a lack of understanding for what is going on behind the scenes. There are many people working very hard to protect our right to smoke fine cigars. " —July 28, 2017 22:16 PM
"Today was a very busy day for many in the cigar industry, including Rocky Patel. We did reach out to him for comment on this story but he was unable to comment in time for our deadline. And calling the CRA and IPCPR useless in this regard shows a lack of understanding for what is going on behind the scenes. There are many people working very hard to protect our right to smoke fine cigars. " —July 28, 2017 22:16 PM
"Perhaps the election of a new President (Trump) has begun to pay off for premium cigar smokers? Though not a smoker himself, his choice for a more reasonable head of the FDA may prove to be a good thing for the industry." —July 28, 2017 21:17 PM
"Why wouldn't Rocky be interviewed for this? He the reason this happened, not useless CRA or IPCPR. They just have mastered how to take credit for shit they didn't do. " —July 28, 2017 18:38 PM