FDA Announces New Comprehensive Plan for Premium Cigar RegulationJuly 31st, 2017
Pre-Market Application Deadline Extended for Cigars, Pipe Tobacco, and E-Cigarettes
FDA Commissioner Scott Gottlieb announced that the FDA is extending the pre-market application deadline for newly-regulated cigars and pipe tobacco products until August 8, 2021, while the deadline for e-cigarettes will be extended until 2022.
In order to further explore the regulatory framework, the FDA will also issue new guidelines on substantial equivalence applications, including the solicitation of additional public comment on premium cigars. Under Commissioner Gottlieb, this “trajectory shift” will focus on nicotine and addiction prevention, especially with regard to young people. According to a statement from the Cigar Association of America, “This is a positive sign from the new administration that we can work together for the interest of our industry.”
Dr. Gottlieb also stated that the FDA will take another look at the status of premium cigars under the agency’s current regulatory structure. Eventually, the agency will undertake a new rule making and guidance process that will engage the industry in order to better understand the manufacturing and marketing of premium cigars. Moreover, Dr. Gottlieb also expects that cigar manufacturers will to continue to market their products while the agency reviews the product applications.
It should be noted that the new guidelines will apply only to newly-regulated tobacco products, nor will it affect any future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, such as “light,” “low,” “mild” and similar descriptive verbiage.
The announcement helped provide some clarity going forward for premium cigar manufacturers and retailers. Following the FDA’s announcement, Glynn Loope, CRA Executive Director, and Mark Pursell, IPCPR CEO, issued the following joint statement:
“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.”
In addition to the changes announced last week, CAA, CRA and IPCPR are awaiting further information from the FDA, regarding other key future compliance deadlines; most importantly, compliance requirements that have already gone into effect will remain in-effect for both manufacturers and retailers.