(This article first appeared in the August 2023 issue of NACS Magazine.)

Q: For retailers, it can be quite confusing to know what tobacco and vape products are legally allowed to be sold. Can you explain the latest FDA actions on flavored tobacco products?

The FDA has continued to ramp up enforcement against unauthorized flavored nicotine vape products, particularly non-tobacco flavored disposables that contain synthetic nicotine and are likely not subject to pending PMTAs. We have seen this in the form of warning letters issued against companies selling Breeze Smoke, Esco Bars and Puff Bar disposables. We’ve also seen FDA work with U.S. Customs and Border Protection to create “import alerts” to detain without inspection specific unauthorized products coming in from overseas, namely Elf Bars, Esco Bars and ST!K disposables by Eonsmoke (Import Alert 98-06).

Now these companies have to show they are compliant to return to market. Then finally, the FDA recently issued warning letters to 189 retailers, over half of them were convenience stores. In the past, they’ve targeted tobacco and smoke shops. Now it’s the convenience channel.

Q: How do we know what vape products can be sold?

Generally, there are three main areas of compliance.

The first is FDA authorization. The FDA has complex processes for manufacturers to obtain marketing authorization to sell nicotine vape products. The FDA has refused or denied over 99% of the premarket tobacco product applications (PMTAs) it has received over the last few years for 26 million products. This has led to dozens of lawsuits in federal court. Most lost, some won. But that’s the first zone of compliance.

The second is with synthetic nicotine. Last year, Congress redefined the term “tobacco products” to include synthetic nicotine and required those companies to submit PMTAs by May 14, 2022. After July 13, 2022, if a PMTA for a synthetic nicotine product is not approved, it is automatically illegal. Since no synthetic nicotine products have been authorized yet, this means that synthetic nicotine products are, effectively, banned. All of it. Anything synthetic. So, only products with nicotine made or derived from tobacco leaves and that are following the FDA’s compliance policy for timely submitted PMTAs are legal to sell subject to FDA enforcement discretion.

Then third has to do with the Prevent All Cigarette Trafficking (PACT) Act. That’s about proper registration and licensing in every state. It’s something the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) oversees in coordination with state authorities.

Q: Can you tell me why the FDA has allowed retailers to carry and sell Bidi Vapor?

In August of last year, Bidi Vapor succeeded in its marketing denial order challenge in the 11th Circuit Court of Appeals. That court vacated the MDO we received for our non-tobacco flavored BIDI® Sticks and remanded our comprehensive PMTA back to FDA for further review. A few weeks later, the FDA decided not to appeal against the decision. So, according to the ruling, the FDA had to place the PMTAs for our flavors back into its review process. Its original guidance said any product under review could stay on the market during the evaluation subject to FDA enforcement discretion. Although we are subject to FDA enforcement discretion pending the outcome of our PMTA review, we are confident that Bidi Vapor is not the FDA’s priority.

This is because the FDA has indicated that it is prioritizing enforcement of unauthorized ENDS against companies (1) that never submitted PMTAs, (2) whose PMTAs have been refused acceptance or filing by the FDA, (3) whose PMTAs remain subject to MDOs and (4) that are continuing to market unauthorized synthetic nicotine products after the July 13, 2022, cutoff. That’s where things stand today.

To continue reading, check out the August 2023 issue of NACS Magazine.