Small U.S. e-cigarette makers are challenging the FDA's regulatory process for synthetic nicotine products, and they are counting on e-cigarette users to help delay enforcement that could disrupt many businesses.

A new FDA citizen petition filed by an e-cigarette industry trade group could prompt the agency to give some manufacturers and sellers a chance at survival — at least in the short term.

Manufacturers have 60 days to submit a Premarket Tobacco Application (PMTA) for synthetic nicotine products after passage of a comprehensive spending bill in March that included requirements for the FDA to regulate synthetic nicotine. After that, they were granted an additional 60 days to continue selling products with pending PMTAs, regardless of whether the FDA took action on the application.

For now, all synthetic nicotine products that have not been authorized or extended by the FDA — and are not or may be available — must be withdrawn from the market by July 13 or enforced immediately.

The PMTA process for tobacco-derived nicotine products, although also abbreviated, gives manufacturers at least 10 months to submit an application, and a one-year grace period after the PMTA submission deadline to allow the product to continue serving without enforcement market.

But the FDA's timeline for evaluating synthetic nicotine products -- four months from announcement to withdrawal -- doesn't give manufacturers time to measure the chemical composition of e-liquids, let alone complete any of the complex studies that now require successful PMTA submissions .

Congress gave the FDA's Center for Tobacco Products authorization of synthetic nicotine with a clear intention to shut down disposable e-cigarette makers like Puff Bar, which switched to synthetic nicotine in early 2021, rather than seeking FDA authorization for its tobacco-derived nicotine products.

Recent youth surveys show that Puff Bar is the most popular vaping brand among high school vapers.

Small e-liquid makers make products that are of little interest to school-age e-cigarette users and are sold almost exclusively in stores that do not include underage customers.

Some companies that use synthetic nicotine to make vaping juice have been doing so for years. Others have introduced synthetic e-liquids after the FDA issued millions of boilerplate documents for vaping products in virtually every flavor except tobacco or menthol.

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

Small e-cigarette companies ask FDA to delay enforcement

E-cigarette users have the opportunity to help small manufacturers and themselves by submitting comments in support of a citizen petition filed by the AVM. The petition asks the FDA to use its enforcement discretion to allow synthetic products (bottled e-liquids) made by open-system manufacturers to continue to be placed on the market after the July 13 deadline, and to allow manufacturers to continue adding and modifying their PMTAs as More data on their products is available.

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

FDA citizen petitions are not as meaningless as the petitions on Change.org. This is a legal avenue described in federal regulations that allows an individual or company to request FDA to issue, modify, or rescind a regulation or order, or to take or refrain from taking any other form of administrative action.

In May 2017, e-cigarette maker NJOY filed a citizen petition asking the FDA to delay deadlines set by the presumptive rule, including the original 2018 PMTA submission deadline. Two months later, then-FDA Commissioner Scott Gottlieb announced that the agency had pushed back the PMTA deadline by four years. While the citizen petition may not have been the only reason for Gottlieb's decision, it could be helpful.

FDA Citizen Petition in Support of AVM

Those who support AVM efforts can submit comments to the FDA docket electronically or via U.S. mail, or through the CASAA's call for action to take a simpler route to comment, which will then automatically be posted to the FDA docket. Calls to action include pre-written comments from CASAA, which can be modified or added, or deleted and replaced.

It is important to register your support of an AVM request with the FDA.

As of June 26, the FDA has recorded nearly 3,000 electronic petition comments. That's not a huge number, but in the 10 days since the citizen petition was published, it has faced stiff publicity competition in the vaping world.