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CRA & IPCPR Issue Statement on FDA’s Substantial Equivalence Delay

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Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR) have issued a joint statement regarding the announcement that the U.S. Food & Drug Administration (FDA) would delay the deadline for cigar makers to submit their products for approval until August 2021.

The two organizations are two of the three major cigar trade groups and two of the three plaintiffs in a joint lawsuit against FDA and its deeming regulations. The third member of the lawsuit, the Cigar Association of America, a group which consists of generally larger cigar manufacturers, was not part of this statement.

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Today, 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, today’s 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 today, 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.”

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Charlie Minato
About the author

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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