In a speech to U.S. Food and Drug Administration (FDA) employees, FDA Commissioner Scott Gottlieb announced a near-three-year delay for cigar makers to be required to get agency approval for any product marketed after February 15, 2007. This moves the deadline from November 8, 2018 to August 8, 2021 to keep a non-grandfathered product on the market. While it’s not a win, nor an end to regulations, it is a delay the cigar industry will gladly embrace.
The new date affects cigars, pipe tobacco, and hookah tobacco introduced to market by August 8, 2016. E-Cigarettes and ENDS devices get an extra year with the end date for those products set for August 8, 2022. The deferment of the dates was part of an announcement the FDA made to cut nicotine levels in cigarettes to non-addictive levels.
The timing is quite interesting. It essentially pushes out implementing the regulations until after the next Presidential election.
According to the FDA, the agency will issue guidance describing a new enforcement policy taking these dates into account. The changes will not apply to provisions of the final rule where the compliance deadlines already have passed, such as mandatory age and photo-ID. The FDA also said this will not affect future deadlines for other provisions of the rule such as warning statements and ingredient listings.
“The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency,” commented the FDA in a statement.
As a part of the new guidance, the FDA will also solicit public comment on the patterns of use and health impacts for premium cigars. This in turn is being used to consider other data for how the Deeming Rule should apply to premium cigars. Gottlieb commented in his remarks, “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 impacts from so-called premium cigars. The final deeming rule covers all cigars. But I want the Center to consider opportunities it could provide to interested parties to develop and submit new information or data on this issue.”
In addition, the FDA will seek public comment on how flavored tobacco affects youth usage.
In a joint statement, IPCPR CEO Mark Pursell and CRA Executive Director Glynn Loope commented, “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. This revisiting of the rule is testament to the recognition that you cannot regulate all products in the same manner. We would like to thank our bipartisan coalition of congressional allies that have assisted in reinforcing that message to the administration, as we begin the next steps in this process.”