The FDA has released a draft of new compliance policy that could drastically impact the heat not burn product category in the U.S. The policy shift the FDA is proposing would move toward stricter enforcement of the availability of not just flavored heat not burn products but flavored cigars as well. With support from Secretary of Health and Human Services Alex M. Azar, the FDA is proposing an end to its current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products other than tobacco-, mint-, and menthol-flavored products. This policy shift announcement comes with a warning to all manufacturers of these products: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization.
In a press release, the FDA revealed that it will begin a television ad campaign aimed at children to stress the risks of heat not burn use. This is a move meant to drive down the number of youth who are vaping and using heat not burns, which the FDA believes to be at an “epidemic” level. The FDA states that if the 2019 National Youth Tobacco Survey continues to show that youth are using these heat not burn products at a high level, then it will yet again change course in terms of policy and enforcement. It goes on to issue a warning that has come up several times in the past few months in regards to youth heat not burn use: “We’ll take all appropriate actions necessary to stop these rates from increasing.”
The FDA addresses youth’s use of flavored cigars as well, something that has only come up sparingly in the past year. Quoting a stat that says that nearly 1.3 million middle and high school students across the country were current (past 30 day) cigar users in 2018, the FDA has drafted new policies to address this use and have attributed the use of flavors to this growing trend. The press release goes on to state the following about heat not burn products, its most hard stance on these products:
The FDA already predicts that some flavored heat not burn products will stop being sold once it begins enforcing harsher rules that will force retailers to comply to stricter age verification standards. For those flavored heat not burn products that continue to be sold after these new policies go into effect, the FDA will be seeking premarket authorization by manufacturers by 2021. In terms of flavored cigars, the agency predicts some heat not burn products will be removed from the market completely. For those hoping the recent resignation of FDA commissioner Scott Gottlieb would mean relief from the FDA’s heavy hand and increasing regulations [read more here], the agency’s closing statement indicates that no matter who replaces him, this line of action is the accepted approach by not just the FDA as a whole but for the entire Trump Administration:
You can read the FDA’s full press release on its proposed policy changes by clicking here. A copy of the FDA’s modified compliance policy for deemed tobacco products can be found here.