Premium Cigars Could Be Exempted From FDA’s Final Deeming Rule

On July 28, Commissioner of the U.S. Food & Drug Administration, Dr. Scott Gottlieb, announced a new comprehensive plan for the approach the agency will take to the regulation of tobacco products, placing an emphasis on a science-based method, that notes a “continuum of risk” that recognizes the differences in tobacco products.

Importantly, Dr. Gottlieb stated that FDA will reexamine the treatment of premium cigars under the agency’s current regulatory structure. Ultimately, the agency will open a new rule making process to engage with the industry to better understand premium cigars, specifically. As representatives of the premium cigar industry, the International Premium Cigar & Pipe Retailers Association and Cigar Rights of America are encouraged by the FDA’s renewed and objective approach to the industry, and welcome the opportunity to again demonstrate the skilled artisan nature of premium cigars, and how they are truly distinctive, at all levels.

For premium cigar manufacturers and retailers, this announcement provides some clarity on the path forward. Of note, IPCPR and CRA applaud the decision to provide targeted relief to some pending deadlines dictated in the 2016 final rule. This includes revising the pre-market application deadline to August 8, 2021. Moreover, under today’s guidelines tobacco products with pre-market applications submitted to the FDA can stay on the market for the duration of the application review process. In addition to changes announced in this statement, IPCPR and CRA are awaiting further information from the FDA regarding other key future compliance deadlines. Importantly, compliance requirements that have already gone into force will remain in effect for manufacturers and retailers alike.

IPCPR, CRA and other industry partners look forward to working with the FDA as it implements the approach announced today. IPCPR CEO Mark Pursell and CRA Executive Director Glynn Loope also jointly stated, “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.”