AVM Asks FDA to Delay Business-Killing Enforcement

The clock is ticking for synthetic nicotine products

Following passage in March of the omnibus spending bill that included language requiring that the FDA regulate synthetic nicotine, manufacturers were given 60 days to submit Premarket Tobacco Applications (PMTAs) for synthetic nicotine products. They were granted an additional 60 days after that to continue selling products with pending PMTAs, whether the FDA takes action on the applications or not.

As it stands now, all synthetic nicotine products that haven’t been granted FDA authorization or an extension—and none have or are likely to be—must be removed from the market by July 13 or be subject to immediate enforcement.

The PMTA process for tobacco-derived nicotine products, while also abbreviated, at least gave manufacturers 10 months to submit applications and a one-year grace period after the PMTA submission deadline for products to remain on the market without enforcement.

But the FDA timeline for assessing synthetic nicotine products—four months from announcement to removal from market—didn't give manufacturers time to measure chemical constituents in e-liquid, let alone complete any of the complex studies now mandated for successful PMTA submissions.

Congress gave the FDA Center for Tobacco Products authority over synthetic nicotine with the express intention of shutting down manufacturers of disposable vapes like Puff Bar, which switched to using synthetic nicotine in early 2021 rather than seeking FDA authorization for its tobacco-derived nicotine products. Recent youth surveys have shown Puff Bar to be the most popular vape brand among high school vapers.

Small e-liquid manufacturers make products very few school-age vapers are interested in, and sell them almost exclusively in stores that exclude underage customers. Some of the companies making vape juice with synthetic nicotine have been doing so for years. Others launched synthetic e-liquids after the FDA issued millions of boilerplate denials for virtually all vape products in flavors other than tobacco or menthol.

More than 100 such businesses—including many members of the American Vapor Manufacturers Association (AVM)—have rushed to submit PMTAs for synthetic products, and many will face ruin if the FDA begins enforcement against synthetic products as scheduled in July.

Small vape companies ask FDA to delay enforcement

Vapers have an opportunity to help small manufacturers (and themselves!) by submitting comments in support of a citizen petition filed by AVM. The petition asks the FDA to use its enforcement discretion to allow synthetic products made by open-system manufacturers (bottled e-liquid) to remain on the market after the July 13 deadline, and to allow manufacturers to continue to add to and amend their PMTAs as more data on their products become available.

AVM’s request to the FDA only applies to bottled e-liquid manufacturers that have submitted PMTAs on time, whose applications meet the agency’s filing and acceptance requirements, that have taken steps to eliminate access to products by underage users. The group is not seeking enforcement discretion for disposable products like Puff Bar.

An FDA citizen petition isn’t a meaningless exercise like the petitions on Change.org. It’s a legitimate pathway, described in the Code of Federal Regulations, that allows individuals or companies to ask the FDA to “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”

In May 2017, vape manufacturer NJOY filed a citizen petition asking the FDA to delay the deadlines imposed by the Deeming Rule, including the original 2018 PMTA submission deadline. Two months later, then-FDA Commissioner Scott Gottlieb announced the agency would delay the PMTA deadline by four years. While the citizen petition probably wasn’t the only reason for Gottlieb’s decision, it may very well have helped.

Support AVM’s FDA citizen petition