FDA Releases First Warning Letter for Vapor Device

Since the PMTA deadline on September 9, 2020, the Agency has released hundreds of warning letters to the vapor industry for illegal “adulterated or misbranded” e-liquids. However, yesterday they released the first warning letter the industry has seen for a vapor device.

The warning letter was issued to Chinese device manufacturer, Sigelei, on February 14th for their “Sigelei Humvee 80 and Sigelei 213 Fog Coil” listed on their website for sale to US consumers without a marketing authorization order from the FDA. While the letter only lists these two products specifically, it also covers any other products illegally sold by the company, stating “The violations discussed in this letter do not necessarily constitute an exhaustive list. 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 Act.”

Per the warning letter, Sigelei had previously submitted a PMTA for their products, however the company had received a refuse to accept ruling for these products, and others, on February 5th, 2021. Sale of these products in the US following the refuse to accept ruling is illegal.

This warning letter indicates a new wave of FDA regulation for the vapor industry has arrived. Devices had previously been left relatively untouched by the agency following the PMTA deadline, with warning letters and facility inspections primarily focusing on only e-liquids to date. The letter to Sigelei shows that practice has come to an end, and the US vapor industry should be prepared for a reduction in devices in the marketplace in the coming months.

Read the full letter here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-sigelei-electronic-technology-co-ltd-dba-sigelei-vape-inc-627065-0214202