U.S. FDA Issues First Warning Letter for Vapor Hardware

Sigelei Humvee 80 coil

The U.S. Food and Drug Administration has issued hundreds of warning letters for vaping products, typically illegal e-liquids. On Tuesday, however, the regulatory agency posted its first warning letter for vaping hardware products. The letter was issued on Feb. 14 to China-based Sigelei Vapor for two coil brands.

“Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the warning letter states.

The letter also states that Sigelei received a “refuse to accept” letter from the FDA on February 5, 2021 in response to the company’s premarket tobacco product applications (PMTAs) for six Sigelei products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a Refuse to Accept determination, are adulterated and misbranded,” the agency wrote.

The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. The agency has traditionally only issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.

“The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due. It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too,” the manufacturer said. “This is going to hurt several companies and we are going to start to see smaller businesses end their marketing in the U.S.”

The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states. “You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C [Food, Drug & Cosmetics] Act.”