FDA Announces New Proposed Policies on Flavored E-Cigarettes, Menthol Cigarettes and Cigars

FDA Announces New Proposed Policies on Flavored E-Cigarettes, Menthol Cigarettes and Cigars

The tobacco industry had been anticipating a announcement by the U.S. Food and Drug Administration (FDA) on the next steps it was taking on the subject of e-cigarette use among teens and flavored products and with a new press release from the agency’s commissioner, Dr. Scott Gottlieb, it now has an idea of what’s coming.

Gottlieb has directed the FDA’s Center for Tobacco Products (CTP) to revisit its compliance policy as it applies to deemed ENDS (electronic nicotine delivery systems) that are flavored. According to Gottlieb, his move will help protect kids from having access to e-cigarette products. One method of accomplishing this would be to have flavored e-cigarette products sold in age-restricted, in-person locations and if they are sold online to increase the age verification process. This would not impact mint- or menthol-flavored e-cigarette products, which Gottlieb says data has shown are more popular with adults than they are with kids. Imposing restrictions on menthol-flavored and mint-flavored e-cigarette products may drive consumers toward combustible tobacco products with the same flavors, which isn’t desirable.

At the same time, Gottlieb is concerned about the availability of menthol-flavored cigarettes.

“I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” he says in a press release on the matter. “The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities.”

The FDA will also be advancing a Notice of Proposed Rulemaking that will seek to ban menthol in combustible tobacco products, including cigarettes and cigars. Gottlieb has instructed the CTP to revisit its compliance policy for all flavored ENDS products. He also has asked the CTP to publish new information on the best practices for selling products online to help prevent youth access to these ENDS products.

While e-cigarettes and combustible cigarettes have been a focus of the FDA for most of 2018, Gottlieb indicates his crusade against flavors will now extend to cigars. He’s proposing a policy that would lead to the ban of flavors in cigars. According to Gottlieb, eliminating flavors from cigars would help prevent young people from smoking cigars to begin with. He states that flavors are added to cigars for various reasons that include reducing harshness, bitterness and astringency of tobacco products and that research shows that a high number of youth that smoke cigars use flavored cigar products.

Gottlieb ends his statement by saying if these proposed policy changes don’t reverse the “epidemic” of youth having access to and using flavored tobacco products, he and the FDA will “explore additional actions.”

This new policy is already getting responses from different areas of the tobacco industry. The International Premium Cigar & Pipe Retailers Association (IPCPR) points out that though Gottlieb outlined new policies that will restrict the sales of vapor products, require retailers to meet higher age verification needs, and ban flavored cigars and cigarettes, the FDA has yet to set a timetable for the enforcement of many of these new policies.

In a press release, the IPCPR states: “Today’s FDA announcement was driven by FDA’s growing focus on preventing youth access and use of tobacco and nicotine products. As the premier organization representing Premium Tobacconists and the customers who patron their stores, IPCPR remains proud that our retail members are ardent enforcers of federal, state and local age and ID requirements. This is reflected in government data that IPCPR recently shared with the FDA showing only .02% of all youth (17 & younger) surveyed had recently smoked a premium cigar. IPCPR will continue pressing the agency to ease the ineffective restrictions on premium cigars and the people who sell them, and focus FDA resources on objectives that actually benefit the public health.”

British American Tobacco (BAT), whose VUSE brands sells 12 flavor varieties that include tobacco, mint and menthol, also responded to the FDA’s news by stating: ” We also share the FDA’s concern regarding balancing the importance of encouraging adult smokers to consider potentially reduced-risk alternatives to cigarettes – like vapor products – whilst ensuring that youth do not use them. Whilst research shows that flavors play an important role in an adult smoker’s transition out of smoking, we understand the FDA’s concern that some flavors can play a role in increasing youth appeal. That is why we are happy to work with our nearly 200,000 contracted retail stores to address youth access to vapor products. In relation to these vapor proposals we encourage the FDA to introduce enforceable regulations as soon as possible. Further, we encourage the FDA to bring forward the PMTA deadline earlier than 2022.”

On the subject of the proposed menthol cigarette ban, BAT pointed out that any regulation of menthol cigarettes has to be done through a comprehensive rule-making process and must be based on a thorough review of the science while also taking into account possible unintended consequences of such a rule. They also suggest that regulating menthol cigarettes differently from non-menthol cigarettes will increase the chances of an illegal market forming and would bring with it an increase of criminal activity. You can read more of BAT’s comments by clicking here.

To read Dr. Scott Gottlieb’s press release on the new proposed rules in their entirety, click here. For all the latest legislation and FDA news impacting the tobacco industry, click here.