A warning letter was received by the FDA last week to a producer of premium vape coils meant to be used with rebuildable atomizers (RBAs). The FDA could not regulate the sales of what are essentially microscopic pieces of wire, and beautiful pre-built coils are made for a very specific user base, so the agency's actions are puzzling.
Ohm Centric Coils LLC, located in New York, was identified in the warning letter for selling a "staggered fuse coil set" without obtaining premarket permission. The FDA has only taken enforcement action against standalone vape hardware—that is, hardware that isn't loaded with e-liquid—in this instance. A warning notice was sent to Chinese producer Sigelei in February 2022 for selling prebuilt replacement coils and vape mods without premarket permission.
It is unknown if this fresh warning letter portends an impending enforcement wave against open-system components. As it usually does when attempting to highlight particular product categories, the FDA refrained from issuing a press release that would have otherwise promised a crackdown on comparable goods (including bottled e-liquid, disposable vapes, and novelty products).
"The FDA is attempting to outlaw open-system vaping products' coils. Gregory Conley of the American Vapor Manufacturers Association tweeted, "This is like the DEA going after a pipe screen company." They lack direction and priorities. Since they function in such a disorganized manner, they aren't even capable of being anti-vaping.
Rebuildable tank atomizers (RTAs) and rebuildable dripping atomizers (RDAs) are devices used by a tiny minority of devoted hobbyist vapers that use coils similar to those mentioned by the FDA. These coils are primarily offered online and aren't mass-produced in Chinese factories like more well-known vaping items. Convenience stores don't carry them at all, and many vape shops don't carry them either.
Pre-built coils for RBAs became less popular when premium vape tanks with sealed, non-replaceable cotton wicks began to use packaged drop-in replacement coils. Furthermore, many of the few vapers who still use rebuildable atomizers construct their coils from spools of wire rather than spending money on goods that are manufactured by professionals.
When it comes to underage vaping, rebuildable atomizers, and premium coils are not even mentioned in polls, in contrast to the widespread use of pod and disposable vapes found in convenience stores and petrol stations. Just 5.9% of middle and high school vapers reported using any type of open-system (refillable) device, and that percentage covers refillable vapes of all kinds, including much more widely used models than rebuildables, according to the 2023 National Youth Tobacco Survey.
Under the Tobacco Control Act, the FDA permitted itself to regulate items such as standalone coils in the 2016 Deeming Rule.
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," the agency classifies them as "tobacco product components or parts."
The FDA has also classified e-liquid, atomizers, batteries, digital displays, tanks, flavors, bottles, and programmable software as parts or components. The legality of the FDA's regulatory power over these products has not yet been challenged. However, as many of the parts used by hobby vapers are used for other (unregulated) uses, it would be nearly impossible to enforce against the producers of the numerous parts utilized by them—legal considerations apart.
Recipients of warning letters have 15 working days to respond to the agency outlining any corrective measures they have implemented or refuting any accusations made by the agency. Additional FDA sanctions may be imposed on those who fail to withdraw the items from the market or respond to the FDA.
