Juul seeks FDA approval to continue marketing

Juul Labs Inc, owned at 35% by cigarette maker Altria, has filed an application for authorization with the Food and Drug Administration (FDA) to continue selling its electronic cigarettes, including its menthol-flavored pods, in the United States.

Companies must convince the FDA that their products are appropriate

Juul said it is seeking approval[1] to continue selling its device as well as its Virginia tobacco and menthol flavored pods, with nicotine concentrations of 3% and 5%. Juul stopped selling other flavors (mango, etc.) last year after coming under regulatory scrutiny for targeting minors. Those flavors are not included in this application.

Vaping companies are required by the FDA to provide a premarket application (Premarket Tobacco Product Application) which must include scientific data demonstrating that the product is suitable for public consumption.

Manufacturers have until September 9 to submit their applications or their products will be removed from the market. Once the application is submitted, companies can continue to sell their products for one year from the deadline, absent a negative decision from the FDA. The United States is Juul’s largest market, and obtaining FDA approval is crucial to its business.

Juul heavily criticized in the United States

This request is perceived negatively by public health advocates.[2] who are calling on the FDA to reject Juul's application, particularly regarding menthol, a flavor that encourages minors to use these products and tobacco products. Moreover, following the ban on the sale of mint products in the United States in November 2019, sales of menthol e-cigarettes have exploded. In addition, a nicotine concentration in pods of up to 5% (maximum concentration of 1.9% in the EU) exposes people to massive nicotine shots leading to rapid addiction, which is resulting in an epidemic of Juul consumption among adolescents in the United States.

A national survey conducted in 2019 by the FDA and the Center for Disease Control and Prevention observed a significant increase in vaping among adolescents, with more than 5 million middle and high school students[3] reporting having used an e-cigarette in the past 30 days. The issue of underage vaping will be central to the regulatory review for Juul and all companies marketing e-cigarettes.