A Long & Winding Road

It has taken 10 years, but the Food and Drug Administration finally gave the regulatory thumbs-up to some vapor products

By Melissa Kress

ONE. That is the number of vapor products that had received the greenlight to remain on the market in the United States as of mid-October. The Food and Drug Administration (FDA) on Oct. 12 authorized the Vuse Solo electronic nicotine delivery system (ENDS) and its accompanying

In 2011, the FDA announced it would regulate the relatively new electronic cigarette and vapor segment as tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act. Five years later, in May 2016, the

agency released its final deeming rule extending its regulatory authority to e-cigarettes, cigars, hookah tobacco, and pipe tobacco.

On Aug. 8, 2016,

the deeming rule went into effect. Under the rule, tobacco companies were given two years to submit marketing applications to the FDA for products that were not on the market as of Feb. 15, 2007. In the summer of 2017, the agency revealed a new tobacco roadmap and revised some of the timelines spelled out in the deeming rule. Among the changes, applications for newly regulated combustible products would have to be submitted by Aug. 8, 2021, and applications for non-combustible products, such as ENDS and e-cigarettes, would have to be submitted by Aug. 8, 2022.

Following legal challenges, U.S. Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ruled on May 15, 2019 that the FDA sidestepped its authority when it pushed back the deadlines set by the deeming rule. Two months later, Grimm set a May 12, 2020 deadline for tobacco companies to submit PMTAs to the agency. However, that deadline was pushed back another 90 days to Sept. 9, 2020 after the agency — citing the COVID-19 pandemic — asked for a delay. Grimm also gave the FDA 12 months to act on the PMTA submissions.

tobacco-flavored e-liquid pods for the U.S. market.

The agency’s action on the submission by R.J. Reynolds Vapor Co., an operating company of Reynolds American Inc., marked the first time the FDA authorized an electronic cigarette or vapor product under the premarket tobacco product application (PMTA) pathway.

Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the tobacco product would be appropriate for the protection of public health. The FDA must approve PMTA bids for e-cigarette and vapor products to stay on the market. The inaugural approval is a big step forward for the backbar at convenience stores, and the future of tobacco, but a drop in the bucket considering that the FDA received PMTAs for more than 6.5 million tobacco products by its Sept. 9, 2020 deadline. As of Oct. 13, 2021, the FDA had taken action on 98 percent of those applications.

Where things stand now and what the future holds for the vapor segment — and c-store backbars across the country — is known only to the FDA. What we do know is that it has been a long, winding and somewhat bumpy road to get to this point. CSN

As the clock expired on the FDA’s original 12-month deadline to complete its review of all PMTAs, the agency announced that it needed more time, but had taken action on 93 percent of the applications. Of those submissions, the FDA issued MDOs for nearly 1 million flavored ENDS. On Oct. 12, 2021, the tobacco industry got some good news when the FDA authorized R.J. Reynolds Vapor Co.’s PMTAs for Vuse Solo. The agency, though, also announced it issued 10 MDOs for flavored ENDS products submitted under the Vuse Solo brand.

Reversing an earlier decision, the FDA rescinded its MDOs for some Turning Point Brands Inc. products. As of late October 2021, the agency was still taking a second look at those applications.

In August 2021,

the agency issued its first Marketing Denial Orders (MDOs) under the PMTA pathway, impacting approximately 55,000 flavored electronic cigarette products.

Retail trade groups NACS, Energy Marketers of America, FMI, NATSO and SIGMA sent a letter to the FDA on Oct. 14, 2021 reiterating an earlier call for the agency to release the names of the products that have received MDOs. The list, they argue, will help c-store retailers know which products cannot remain on the backbar.