Is Sigelei’s FDA Warning Letter a Sign of Things to Come

The FDA Center for Tobacco Products issued a warning letter Feb. 14 to Sigelei Vape for products sold without authorization. The letter appears to be the first warning issued to a Chinese manufacturer since Sept. 9, 2021, when the CTP ended a one-year period of non-enforcement against manufacturers selling vape products without FDA authorization.

The products specifically cited in the warning letter are the Sigelei Humvee 80 (an 80-watt mod) and the Sigelei 213 Fog Coil. The FDA also notes that the rules violated by the sales of those two products may also apply to other products sold by the company.

The Sigelei letter is being discussed by some in the vaping industry as a signal that the CTP is set to crack down on Chinese companies. But that isn’t necessarily the case. Sigelei has engaged in some activities that may set them apart from most Chinese hardware manufacturers.

The letter sanctions Sigelei for offering products for sale in the United States that were part of a Sigelei Premarket Tobacco Application (PMTA) that was rejected by the FDA without review. Sigelei was issued a Refuse to Accept determination, which means the application lacked the most basic requirements to move into the next stage of review.

“FDA received your Premarket Tobacco Product Application (PMTA) assigned STN PM0001221 on September 7, 2020,” says the warning letter. “However, FDA issued a negative action for PMTA STN PM0001221 in the form of a Refuse to Accept determination on February 5, 2021 which covers six products. As discussed above, 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 one-year enforcement discretion given most manufacturers that submitted PMTAs required their applications be accepted for further review. Any negative decision made by the FDA after the Sept. 9, 2020 PMTA submission deadline (including Refuse to Accept) requires the manufacturer to immediately stop selling the product in question or face enforcement. Sigelei’s products should have been removed from the market as soon as the company’s PMTA was rejected on Feb. 5, 2021.

“All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion,” writes the FDA to Sigelei. “Products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities.”

Sigelei has continued to sell those products without a pending PMTA for more than a year, which makes the company an FDA target. But, even worse—and probably even more triggering for FDA enforcement officials—is a bold graphic on Sigelei’s website (see above) calling the Humvee 80 and the 213 Fog device “PMTA SAFE,” with the FDA logo in the background and a fat green checkmark. The graphic is like waving a red flag in the regulatory agency’s face.

The fact that the FDA finally got around to following up on one hardware manufacturer—after issuing warning letters to many non-compliant domestic e-liquid companies—doesn’t automatically bode ill for other manufacturers. Very few Chinese hardware manufacturers sell their products directly to consumers, as Sigelei does. And hopefully none of the other device manufacturers advertise their products as being “PMTA safe,” when in fact their PMTA was rejected over a year ago.

Many companies, including some Chinese hardware manufacturers, have PMTAs still awaiting review. The FDA has shown no inclination to pursue enforcement against those firms. Indeed, if the FDA wanted to send a bold message to the Chinese vape industry, it seems likely the agency would have chosen a more popular and visible brand to use as an example.