On the first full day of business for the new decade, the U.S. Food and Drug Administration issued final guidance on how it plans to enforce regulations around deemed tobacco products that do not have the proper pre-market authorization. At the top of the list are flavored ENDS (Electronic Nicotine Delivery System) products. At the bottom of the list appears to be flavored premium cigars, and traditional premium cigars.

Starting May 12, 2020, new tobacco products as well as tobacco products released after February 15, 2007, will require the FDA’s pre-market approval, including demonstrating substantial equivalence to remain on the market. As a result, the FDA is now preparing an enforcement plan for compliance which has been issued through the guidance.

According to the guidance, the FDA recognizes when deemed products are subject to regulation. Beginning on May 12th, it is going to be challenging to enforce regulations across the board for all products. Specifically, the FDA has said it will be “prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.”

This is not a statement indicating the FDA will exempt premium cigars, or premium flavored cigars. It’s simply that these types of products are going down on the food-chain of enforcement actions. Much of this is due to the fact FDA has limited resources, and it is will be focusing its attention on combatting the problem of youth usage of deemed tobacco products. By the FDA’s own admission, cigars and flavored cigars are being used at a much lower rate than ENDS products – which are the target of the enforcement actions.

While premium cigars are still very much a regulated item, this most recent announcement by the FDA is significant because it acknowledges premium cigars are different with different usage patterns.

When the Deeming Regulations were announced in May 2016, the plan was that pre-market approval, which includes Substantial Equivalence for deemed tobacco products, would be implemented beginning August 8, 2018. Shortly after U.S. President Donald Trump named Dr. Scott Gottlieb FDA Commissioner, Gottlieb announced a delay that pushed FDA approval out nearly three years to August 8, 2021. This triggered a lawsuit filed by the American Academy of Pediatrics in the U.S. District Court of Maryland against the FDA claiming the FDA did not have the authority to delay the implementation. It created an interesting scenario where the cigar industry and FDA were on the same page as far as the 2021 deadline. In May 2019, Judge Paul Grimm of the Maryland Court ruled against the FDA, restoring the original August 8, 2018 deadline. Since that time had passed, Grimm implemented a new date of May 12, 2020. The change in date has created a burden as now the FDA has to start enforcing 15 months earlier than originally planned.

The following language appeared in the final guidance:

FDA received numerous comments relating to the proposed policy for flavored cigars in the March 2019 Draft Guidance. Some of the comments were supportive of that proposed policy, although some wanted the Agency to take even more aggressive action. Other comments opposed inclusion of flavored cigars as an enforcement priority and disagreed with the bases for the proposed policy. For example, some commenters argued that flavored cigars are used most commonly by adult users and that the inclusion of flavored cigars as an enforcement priority limits adults’ freedom to choose their preferred product. Other commenters argued that FDA did not have the data necessary to support the need for “a drastic and unprecedented change in enforcement priorities.” Some commenters also stated that the evidence cited by FDA discussing initiation of youth usage of flavored cigars was inconsistent and inconclusive. 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.

Comments regarding deemed tobacco products other than ENDS products and cigars, such as waterpipe tobacco (hookah) products, also provided data showing the use of such tobacco products among high school students and stating that evidence reflects that flavors for these tobacco products entice youth. However, such data do not appear to raise comparably urgent public health concerns, as the lower prevalence of youth use of these products suggests that they do not appear to be as appealing to youth at this time.

Accordingly, at this time, FDA has decided to prioritize use of its limited enforcement resources to address the sudden and dramatic increase in youth use of ENDS products, as well as to focus on health and safety concerns connected to ENDS products such as vaping-associated lung injuries. While acknowledging that all new tobacco products on the market without the required authorization are marketed unlawfully and are potentially subject to enforcement action, at any time, in FDA’s discretion, FDA’s primary focus will be to address the sudden and dramatic increase in youth use of ENDS products, and the products covered by this section of the guidance will therefore be a lower priority.

We have decided not to prioritize enforcement of the tobacco products covered by this section before May 12, 2020. Manufacturers of flavored cigars, however, just like manufacturers of all other deemed new tobacco products, will be required to submit marketing applications for those products by May 12, 2020, consistent with the U.S. District Court for the District of Maryland’s order directing FDA to require that applications be submitted to the Agency by May 12, 2020, for deemed new tobacco products on the market as of August 8, 2016, or be subject to FDA enforcement actions, in FDA’s discretion. As part of the premarket review process, FDA may evaluate, among other things, the product’s constituents, ingredients, additives, and properties; manufacturing practices; and any studies or investigations into the health risks of the tobacco product. 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.

After May 12, 2020, FDA will make enforcement decisions on a case-by-case basis, recognizing that it is unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that it needs 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

Following the issuing of the final guidance, the Cigar Association of America (CAA) issued the following statement: “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.”

Notes: Corrected “Draft Guidance” to “Final Guidance”