FDA Issues Warning 112, 113 in 2021 for Illegal E-Liquid

On the same day it released its much anticipated list of legal electronic nicotine-delivery system (ENDS) products, the U.S. Food and Drug Administration (FDA) issued its 112 warning letter to a company for selling products without a marketing order. Companies must have submitted a Premarket tobacco product application to the FDA by Sept. 9, 2020 in order to legally sell vaping products. The following day the agency issued No. 113.

Louisiana-based Big Chief Vapor received the letter for selling its Zulu Pride 6mg nicotine e-liquid product without a marketing authorization order, according to the FDA. The letter was posted to the regulatory agency’s website on May 20. Big Chief Vapor has over 4,400 products registered with the FDA.

On May 21, the FDA posted on its website that it had issued also a letter to Mississippi-based Vape Lizard Co. for selling Vape Lizard Strawmelon 3mg without a marketing order. The company has over 400 products registered with the FDA.

The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.