The U.S. Food & Drug Administration (FDA) has announced its much new anticipated rules for e-cigarettes and in it is a change that could affect some flavored cigars. FDA’s proposed rule, which was announced this morning, is just that—a proposal. While it seems likely that the agency will expedite its implementation and also expects to implement much of the language described in today’s 19-page document, it must go through additional steps, notably a comment period, then review, then become a finalized rule and implementation will follow 30 days later.
This change was brought about by what the agency believes is an epidemic of minors using vaping and e-cigarette products. As such, most of the rule focuses on e-cigarettes and vaping products but specifically flavored e-cigarettes and vaping products.
The agency says it expects that some flavored e-cigarettes will be removed from the market, while others will be sold “only in a manner that prevents youth access.” As part of that, FDA’s plan is pushing that will change how these products are sold at the brick-and-mortar level, most notably likely creating a physical space separate from the general area for the store where you must be 18 to enter.
However, a part of the rule change will also affect some flavored cigars.
FDA would begin premarket enforcement of any non-grandfathered flavor cigar—i.e. one that was not on the market prior to Feb. 15, 2007—30 days after the rules are changed. This would mean any flavored cigar sold after Feb. 15, 2007 would need to apply for premarket review much earlier than the August 2021 date currently on the books for all non-grandfathered cigars, flavored or otherwise.
So long as those cigar companies applied for premarket review within the 30-day period, companies could continue selling the cigars until FDA rejected the premarket review.
The agency describes this as a change in enforcement. It says that it previously decided to delay enforcement of the premarket review for existing products, currently set to August 2021 for cigars, but is simply changing the timeline for some cigars.
All non-flavored cigars and grandfathered flavored cigars would not be affected by today’s plans.
FDA said it expects some flavored cigars to be removed from the market because of this change.
Today’s announcement is just a proposal and so there’s no definitive timeline on when this will become law, other than it will be at least 30 days. FDA’s press release seems optimistic regarding the changes going into effect, it specifically mentioned having the support of President Donald Trump.
“Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored).”
The guidance also stated that FDA acknowledges that flavored cigars are more appealing to minors than non-flavored cigars.
“FDA understands that tobacco-flavored cigars are not as appealing to minors as other flavored cigars.”
An article from The New York Times indicated that the convenience store lobby is in Washington D.C. lobbying heavily against today’s proposal.
Dr. Scott Gottlieb, FDA’s current commissioner who championed more enforcement against e-cigarettes, will no longer head the agency when these rules go into effect as he is resigning and leaving the post next month.