US' FDA Issues First-Ever Round of E-Cigarette Marketing Authorizations

Back in 2018, the US Food and Drug Administration (FDA) labeled a rise in the US of underage vaping an "epidemic" worthy of addressing through a series of departmental measures, including the prohibition of flavored e-cigarette cartridges - excluding menthol and tobacco.

In a first-of-its-kind decision on Tuesday, the FDA moved to authorize three tobacco products as appropriate for the protection of public health.

The authorizations, which permit the legal US sale of the products, come in the first round of decisions for the FDA's electronic nicotine delivery system (ENDS), and were submitted via the Premarket Tobacco Product Application (PMTA) pathway by R.J. Reynolds (RJR) Vapor Company.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the moves play a key role in the department's "robust, scientific premarket evaluation" and efforts to reduce Americans' exposure to known harmful chemicals.

The FDA official highlighted that authorizations could be revoked, if the department deems it necessary.

"We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth," Zeller said in quoted statement. "We will take action as appropriate, including withdrawing the authorization.”

The Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2 have all received authorization. Vuse is ranked #2 - behind Juul - for e-cigarette sales in the US.

It is suggested by those in the industry that an FDA authorization is equivalent to an endorsement or backing.

Per PMTA criteria, authorization is reached after the FDA weighs the product's risks and benefits to the US population, including those who do not directly use the product.

Today, FDA announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever authorized by FDA through the Premarket Tobacco Product Application (PMTA) pathway. https://t.co/sKJ12sMgjv pic.twitter.com/KUd8zHb1l6

— FDA Tobacco (@FDATobacco) October 12, 2021

At the same time, the FDA handed down 10 marketing denial orders related to flavored Vuse Solo products. The specific flavors denied were not disclosed due to "potential confidential commercial information issues."

The rejection of the company's flavored products likely hinges on 2021 National Youth Tobacco Survey data showing most American youth and young adults who use ENDS begin with sweet or fruity flavors.

Food and Drug Administration Commissioner Scott Gottlieb listens during an interview with The Associated Press in New York on Monday, March 5, 2018.

© AP Photo / Kathy Young

Then-FDA Commissioner Scott Gottlieb sounded an alarm over what he described as an "epidemic of youth e-cigarette use" in 2018, arguing that the nation must drastically change course to reverse a sharp increase in the use and availability of e-cigarettes and related vaping products.

A Vuse spokesperson told the Associated Press that the FDA authorization strengthens the company's assertion "that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research."