PMTA Decision Day: FDA Leaves Vape Industry Twisting in the Wind

After a year of hype and endless stories about FDA's Sept. 9, 2021 decisions that would “determine the future of vaping,” the agency punted on its obligations and left the vaping industry twisting in the wind. The FDA issued no product authorizations, announced no exemptions for manufacturers allowing continued sales, and offered no enforcement discretion assurances for businesses whose products haven’t been denied.

The agency reaffirmed in April that it would not (and could not, based on the court order) issue a blanket exemption to the industry. Companies that have not received a specific Marketing Denial Order (MDO) or authorization for a product will technically be selling it illegally tomorrow, but the agency said it recognizes “that we are unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that we need to make the best use of Agency resources.”

That probably means that, unless local authorities take action, there will be no real enforcement against products still on the market. The FDA notes that “we have identified flavored products that appeal to youth as enforcement priorities.”

In a statement attributed to Acting Commissioner Janet Woodcock and Center for Tobacco Products Director Mitch Zeller, the FDA leaders congratulated themselves on making “significant progress in the months since” last September’s PMTA submission deadline, and said they are “working diligently to better understand these products.”

The FDA says it has taken “action on about 93% of the total timely-submitted applications”—meaning it has denied the applications of 132 small companies’ flavored products. (The list of Marketing Denial Orders was updated today with the names of companies receiving denials as of today for some or all of their submitted products.) An FDA spokesperson confirmed to Vaping360 that the process is not complete, and the agency will continue to issue MDOs to additional companies.

The Wall Street Journal reported this morning that the FDA would delay a decision on approving Juul Labs’ products. The agency previously said it would prioritize decisions based on market share, implying that the JUUL device and pods would be among its first announced decisions. Juul is the biggest seller in the convenience store/gas station vape market.

The agency announced no exemption that would specifically protect JUUL if it remains on the market; the company will face the same risk of enforcement as other non-flavored products. Vaping360 has also learned that Reynolds American neither sought nor received an exemption from enforcement for its Vuse and Velo products, but intends to leave them on the market based on the FDA's enforcement discretion statement. Essentially, these large companies believe the risk of enforcement actions is low, since they are not currently selling vapor products in flavors other than tobacco and menthol.

Mainstream media outlets have portrayed the entire PMTA debacle as a decision on Juul Labs’ products, with barely any attention paid to the thousands of independent small- and medium-sized companies whose fortunes will be largely determined by the FDA’s choices.

After lawsuits and delays, Sept. 9, 2020 was set as the deadline for manufacturers to submit Premarket Tobacco Applications (PMTAs) for existing products. The judge who approved the deadline agreed that manufacturers could have up to one year—until today, Sept. 9, 2021—to remain on the market while the FDA considered their applications, and he agreed that the FDA could issue case-by-case exemptions beyond that.

But small manufacturers have been receiving Market Denial Orders (MDOs) for their flavored e-liquids for two weeks, notified without warning on Aug. 26 that the agency required “product-specific” proof that producers of non-tobacco flavored products must “demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.” The FDA added more MDOs to its list a week later—and many more since then, although they weren’t publicly announced until today.

The focus on flavored products has been driven by the Campaign for Tobacco-Free Kids, which received $160 million from Bloomberg Philanthropies in 2019 to promote passage of flavor bans and discourage the FDA from authorizing flavored products. The anti-flavor campaigners claim that flavored vapes are a trick of the tobacco industry, intended to ensnare kids in a lifetime of addiction. The reality is that vape flavors are a user innovation, developed by early vapers dissatisfied with the flavors available in Chinese products. But while flavors make up a huge part of the argument against vaping, the evidence that they’re a primary driver of youth vaping is less than convincing.

Many small manufacturers that haven’t received denials have requested exemptions to continue selling while the FDA considers their applications. The FDA didn’t announce any formal exemptions. (Meanwhile, the FDA continues to issue warning letters to companies that didn’t submit PMTAs for some or all of their products.)