How the FDA Is Handling Synthetic Nicotine, PMTAs and More

MINNEAPOLIS — Convenience-store retailers have questions about the U.S. Food and Drug Administration’s (FDA) tobacco priorities—and Center for Tobacco Products (CTP) Director Mitch Zeller has answers.

Zeller spoke on a Dec. 2 webinar hosted by Minneapolis-based trade organization the National Association of Tobacco Outlets (NATO) covering a range of topics from the results of the 2021 National Youth Tobacco Survey (NYTS) to premarket tobacco product application (PMTA) progress to how it’s handling synthetic nicotine.

Click through to find out what Zeller had to say…

More than 2 million youth in middle and high school currently use e-cigarettes, Zeller said, citing data from the 2021 NYTS.

Nearly 85% of those users smoke flavored e-cigarettes, and disposables are the most used e-cigarette device type, according to the survey. About two in five students reported using e-cigarettes frequently, which is defined as vaping on 20 or more of the past 30 days, Zeller said.

“The reason why the frequency of use numbers are important is it sends a signal that for kids who are vaping on 20 or more of the past 30 days—including 25% of all current e-cigarette users vaping every day—that those kids have progressed beyond experimentation and are on a pathway toward initiation, regular use and possible addiction,” Zeller said.

The survey was administered from Jan. 18 through May 21, 2021, and it was the first to be fully conducted during the COVID-19 pandemic. Data were collected during an online survey, and therefore should not be compared to findings from previous surveys, which were conducted in schools, Zeller said.

One of the ways to help combat teen use is through the FDA’s “The Real Cost” public education campaign, which Zeller said reaches youth aged 12 to 17 who have used e-cigarettes or are open to trying them. Since the prevention effort launched in 2017, it has shown effective reach and engagement results, reaching up to 85% of all teens nationwide through paid media messages, he said.

The FDA received PMTAs for close to 6.7 million deemed tobacco products, Zeller said. Most were submitted close to the Sept. 9, 2020, deadline.

As of early December, the FDA took action on about 99% of those products, which included issuing nearly 300 marketing denial orders (MDOs). The FDA issued its first marketing granted order for e-cigarettes under the PMTA pathway to R.J. Reynolds Vapor Co.’s Vuse Solo electronic nicotine delivery system (ENDS) device and accompanying tobacco flavored e-liquid pods.

The agency has about 55,000 products pending that are the subject of timely submitted PMTAs, Zeller said. Many of the product applications are in the final stages of review.

For the more than 1 million non-tobacco flavored ENDS products that have been issued MDOs, there are more than 45 cases filed for judicial review of specific MDO actions, Zeller said. As of Dec. 2, the FDA has rescinded or partially rescinded MDOs to four companies, issued stays on MDOs to three companies and the courts have issued stays on MDOs to three companies, he said.

All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at the FDA’s discretion, Zeller said. However, the agency is focusing its enforcement actions on flavored products that appeal to youth and products for which no application is pending.

Some retailers, though, are questioning what products they need to pull from their shelves to avoid enforcement actions. While the FDA’s public list of MDOs includes the companies that received denials it does not list the specific products that were denied.  

Zeller said he understands the need for the specific product brand names—but there are some challenges that come with it.

“We absolutely understand the high level of interest, not just from retailers, but from many interested parties, about the specific names of deemed products that were on the receiving edge of a negative decision,” Zeller said. “And we have pledged to remain just about as transparent as we can be about this information, but here’s the challenge: We need to avoid the inadvertent disclosure of commercial confidential information (CCI).”

The FDA is working to update this information where they can, but it takes a lot of time and resources to make sure the agency isn’t violating any CCI rules, he said.

“For now, the best source for retailers for questions like this is your suppliers,” Zeller said.

Synthetic nicotine is posing a new challenge to the FDA, Zeller said. There are an increasing number of ENDS products that use, or claim to use, synthetic nicotine instead of nicotine derived from tobacco, he said.

One of these companies is Puff Bar, which was reported in the 2021 NYTS as the most popular brand among youth e-cigarette users, Zeller said.

To try to avoid FDA regulation and evade enforcement, several companies that received MDOs are publicly saying they are switching to synthetic nicotine to keep their products on the market.

“The intent of these companies is clear…they’re doing this because they believe that by switching to synthetic nicotine, they can evade regulation by FDA,” he said.

The definition of a “tobacco product” includes any product made or derived from tobacco including a component part or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts of tobacco products and, therefore, subject to FDA’s tobacco control authorities, Zeller said.

It can be difficult for the FDA to test and differentiate between tobacco-derived nicotine and synthetic nicotine because of their close compositions, he said.

“What may be the most challenging is a completely disposable product where it has been verified that the only nicotine that’s present is not derived from tobacco, and there’s nothing else in that product that is made or derived from tobacco. But these really are case-by-case determinations that need to be made,” Zeller said.

When asked if he was concerned about the proliferation of synthetic nicotine products, Zeller said, “Yes, from a public health perspective, from a good government perspective, from a fairness to industry perspective, yes, we are concerned.”

For now, the FDA intends to make determinations on whether a synthetic nicotine product falls into its jurisdiction on a case-by-case basis.