FDA cracks down on e-cigarette makers that didn’t submit marketing applications

The Food and Drug Administration (FDA) is putting pressure on e-cigarette makers to apply for premarket authorization.

The FDA posted several warning letters to vape companies on Tuesday cracking down on their unapproved products and marketing tactics.

The warning letters note that as of August, all e-cigarette and vape products are required to be in compliance with the Food, Drug & Cosmetic Act (FD&C Act). The agency said the vape products are “adulterated” and “misbranded” because they were not authorized by the FDA.

All makers of vape products were required to submit an application for premarket authorization by September 9, or request an year-long extension by that date. The authorization requires manufacturers of tobacco products to list their products with FDA, to not market their products with claims of reduced risk and not to sell these tobacco products to youth. 

The warning letters ding these vape companies not only for selling the products without approval, but also for marketing in a way that appeals to young people.

One company was warned for selling colorful smartwatch lookalike products that concealed a vape product. The FDA said in its letter, “The product design contains features that resemble smartwatches that are commonly worn by children and, therefore, your product can be carried and worn without revealing to parents, teachers or other adults that the product is a tobacco product.”

Another company was warned for selling “Johnny Creampuff,” a lemon flavored vape product. The FDA wrote, “It features graphic images that imitate food products that are typically marketed toward and/or appealing to children. Specifically, the ENDS product packaging features graphics/images of creampuffs, which are commonly marketed toward, and/or appealing to children.”

The FDA is requesting that these companies comply with the FD&C Act, which requires them to gain premarket approval before selling a tobacco product. If they don’t, the agency said it will take regulatory action, likely trying to pull the product off the market.