Yesterday the FDA released its Final Guidance on “Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed Products on the Market Without Premarket Authorization.” This is the updated, and final, version of the Draft Guidance originally released in March 2019. The Final Guidance differs significantly from the Draft Guidance; most importantly, the Draft Guidance would have subjected flavored cigars to enhanced enforcement but the Final Guidance does not. The Final Guidance enhanced enforcement, which becomes effective in 30 days, applies only to cartridge-pod based ENDS products in flavors other than tobacco and menthol.
FDA stated the following regarding its decision not to subject flavored cigars to enhanced enforcement:
“After consideration of the data regarding youth use of cigars generally and comments received on this issue, we have decided to not prioritize enforcement of flavored cigars before May 12, 2020. While there is no public health benefit associated with flavored cigars and FDA remains concerned with youth use of flavored cigars, current data indicate that youth are using flavored cigars at a lower rate than they are using flavored ENDS products.”
Further, FDA stated the following regarding its future enforcement priorities and a proposed rule on flavors in cigars:
“….to make the best use of Agency resources, FDA intends to prioritize enforcement based on the likelihood of youth use or initiation to make the most efficient use of its resources. In assessing this, factors the Agency intends to consider include, but are not limited to:
- What FDA understands about the number of youth currently using the product or category of product;
- The trends in those numbers, particularly since 2016;
- Whether the product contains added flavors;
- What FDA understands about how the product or category of product is typically sold and how that is likely to impact access and use by minors; and
- What FDA understands about the frequency and other demographics of use by minors.
To illustrate, based on these factors, FDA’s lowest priority among these products will include relatively expensive, large hand-rolled cigars that do not have flavors (e.g., fruit, candy, or mint), given what FDA understands to be their comparatively lower youth usage rates.
FDA also has stated its intention to issue a regulation that would ban the use of characterizing flavors in cigars, and FDA is actively working towards that proposed rule.”
CAA filed detailed comments outlining both the legal, factual, and scientific reasons why FDA’s proposed policy regarding flavored cigars in the Draft Guidance was flawed, and detailed comments on why premium cigars should be treated differently from other tobacco products. The comments in this Final Guidance continue to show the valuable impact of CAA’s work on behalf of the entire industry.
The Guidance can be found here below.
