FDA Warns Maker of Niche Pre-Built Coils

Last week the FDA sent a warning letter to a manufacturer of high-end vape coils intended for use in rebuildable atomizers (RBAs). The agency’s action is confusing because fancy pre-built coils are designed for a tiny niche of users, and because it would be impossible for the FDA to police the sales of what are essentially small pieces of wire.

The warning letter cited New York-based Ohm Centric Coils LLC for selling a “staggered fuse coil set” without applying for or receiving premarket authorization. It is only the second example of an FDA enforcement action against standalone vape hardware (not filled with e-liquid). In February 2022, Chinese manufacturer Sigelei received a warning letter for selling a vape mod and prebuilt replacement coils without premarket authorization.

Whether the new warning letter indicates a coming wave of enforcement against open-system components is not known. The FDA did not issue a press release promising a crackdown on similar products, as it typically has before when trying to make examples of specific groups of products (like bottled e-liquid, disposable vapes, and novelty products).

“FDA is trying to ban coils for open system vaping products. This is like the DEA going after a company that makes pipe screens,” tweeted Gregory Conley of the American Vapor Manufacturers Association. “They have no priorities or direction. They aren't even competent at being anti-vaping, as their actions are so scattered that nothing ever gets done.”

FDA F’n Ban this!! I used to make coils out of this and still can if you ban everything!! pic.twitter.com/2xdwDr3fgQ

— David Emanuel (@davemanuel0) November 18, 2023

Coils like the ones cited by the FDA are used by a small percentage of dedicated hobbyist vapers in rebuildable tank atomizers (RTAs) and rebuildable dripping atomizers (RDAs). Unlike more popular vaping products, such coils aren’t mass-produced in Chinese factories, and are mostly sold online. They aren’t available at all in convenience stores, and even many vape shops don’t sell them.

Since the advent of high-quality vape tanks that use packaged drop-in replacement coils (which are sealed and contain a non-replaceable cotton wick), demand for pre-built coils for RBAs has waned. And even among the few vapers who still use rebuildable atomizers, many buy spools of wire and build their own coils, rather than paying for professionally made products.

Unlike use of mass-market pod and disposable vapes, which are sold in convenience stores and gas stations, underage vaping of rebuildable atomizers and high-end coils doesn’t even register on surveys. According to the 2023 National Youth Tobacco Survey, just 5.9 percent of middle and high school vapers used any kind of open-system (refillable) device, and that number includes all refillable vapes, including vastly more popular devices than rebuildables.

The FDA granted itself authority in the 2016 Deeming Rule to regulate products like standalone coils under the Tobacco Control Act. The agency defines them as “tobacco product components or parts” because they are “intended or reasonably expected” to “alter or affect the tobacco product’s performance, composition, constituents, or characteristics” or “to be used with or for the human consumption of a tobacco product.”

Other items the agency has defined as components or parts include e-liquid, atomizers, batteries, digital displays, tanks, flavors, bottles, and programmable software. The FDA’s authority to regulate such products has not yet been tested in court. But—legal issues aside—enforcing against manufacturers of the various parts hobbyist vapers use would be virtually impossible, since many are used for other (unregulated) purposes.

Warning letter recipients are given 15 working days to reply to the agency, describing what corrective actions they’ve taken or disputing the agency’s allegations. Those who don’t remove the products from the market or reply to the FDA may face additional FDA sanctions.