The U.S. Food and Drug Administration has announced a series of reforms designed to take steps to curb underage smoking. As a part of the program, the agency is calling for a sweeping ban on flavored tobacco, flavored e-cigarettes, and the use of menthol in tobacco products. This ban includes flavored cigars. The announcement was made via a press release today.
The move on flavored cigars is not a surprise. Last month when the FDA published its Unified Agenda, it listed that it was considering a ban on flavored cigars. The FDA now plans on prioritizing this proposed rule.
While liquids used in ENDS (Electronic Nicotine Delivery System) were a target, this time banning flavors in premium cigars was explicitly called out. In a statement released by FDA Commissioner Dr. Scott Gottlieb: “Finally, to ensure that we’re taking a comprehensive approach, we must evaluate our regulatory approach to flavored cigars. Flavors are added to cigars and other tobacco products for various reasons, such as reducing the harshness, bitterness and astringency of tobacco products during inhalation and to soothe irritation during use. Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars.” The FDA contends eliminating flavors from cigars would prevent initiation by younger people.
Gottlieb made several points in regards to flavored cigars:
- He believes flavored cigars should no longer be subject to the extended compliance date for premarket authorization — regardless of the location in which the products are sold.
- In addition, Gottlieb is calling for those flavored cigars that are grandfathered to be removed. Accordingly, the FDA intends to propose a product standard that would ban flavors in all cigars.
- In July, the comment period for ANPRM on flavors in tobacco products closed. The FDA has expedited review and analysis of these comments, and intends to proceed with developing a proposed regulation. As included in the most recent Unified Agenda, the FDA intends to prioritize the issuance of this proposed rule.
Gottlieb also stated that he has the full support of his boss, Secretary of Health and Human Services Alex Azar.
Flavored tobacco was the focus of one of three ANPRMs that included reducing nicotine levels, and how or if premium cigars should be regulated. In particular premium cigars were mentioned as a part of the ANPRM on flavored tobacco.
The FDA also said it would crack down on marketing ENDS (Electronic Nicotine Delivery System) products and liquids marketed to minors. They specifically mention using children’s cartoon or animated characters or names of products favored by kids like brands of candy and soda. There is reason to believe this will extend to all tobacco products. Ironically one cigar company rebranded one of its products today using marketing similar to a popular soda.
The FDA has not mentioned a timetable for enforcement of the planned regulation, but it is expected to set off a long industry battle challenging this decision.
Gottlieb’s full statement can be read here.