FDA Extends Deadline—Will Reconsider Premium Cigars
WASHINGTON, D.C. - 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 back 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Additionally, Gottlieb said that the agency will be releasing a new draft guidance in hopes of clarifying exactly what cigar manufacturers need to include in their applications.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 (IPCPR), and Glynn Loope, executive director of the Cigar Rights of America (CRA), in a joint statement.
In a recent interview, 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."
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