United States: FDA reverses ban on marketing of JUUL products

Nearly two years after rejecting marketing applications for all Juul e-cigarettes and then suspending that decision following a lawsuit filed by Juul, the U.S. Food and Drug Administration announced it was reversing its decision to deny marketing. The FDA said the change did not mean the products were cleared for sale and that a full review of Juul products was underway.[1].

In 2022, when the FDA banned Juul’s products, it said the company’s applications did not include “sufficient evidence” to demonstrate that marketing the products met the public health standards required by law. It specifically cited potentially dangerous chemicals leaching from the manufacturer’s e-liquid pods.

A marketing ban quickly contested by the manufacturer JUUL

June 23, 2022[2], the FDA issued marketing cease orders (MDOs) against manufacturer JUUL Labs Inc. for all of its products then marketed in the United States. Two days later, following a petition by JUUL, the federal court in Washington granted the manufacturer a temporary stay, ruling that the ban should be “administratively suspended” while JUUL’s lawyers prepare a full appeal of the FDA’s decision. In its initial appeal, JUUL said the FDA acted under political pressure from Congress, which holds the company responsible for the youth vaping epidemic.

On July 5, 2022, the FDA placed an administrative hold on the MDOs after determining that certain scientific issues warranted additional review. Since then, the FDA has conducted this additional review and has also conducted additional in-depth reviews of the applications in a variety of areas, including product toxicology. In its June 6, 2024, statement, the FDA said it rescinded its MDO against JUUL’s products, citing FDA’s review of the information provided by the applicant, but clarified that the rescission does not constitute a marketing authorization or denial and does not indicate whether the marketing application is likely to be accepted or denied. The agency also added that FDA regulations severely limit what it can disclose about the content of applications under review.

Inaction detrimental to adolescents' health

FDA decision 'unacceptable' and 'insane', says Campaign for Tobacco-Free Kids (CTFK)[3]The organization believes that the FDA’s continued delays in reviewing Juul’s marketing applications are harmful to teens, as Juul remains one of the most widely used e-cigarette brands among youth according to the 2023 National Youth Tobacco Survey. CTFK calls on the FDA to expeditiously complete its review of all e-cigarette marketing applications and, working with the U.S. Department of Justice and Customs and Border Protection, to significantly increase enforcement efforts to remove illegal and unauthorized products from the market, including products with applications under review, such as JUUL.

The FDA has officially authorized the sale of only 23 tobacco-flavored vaping products and has stated that “These are the only vaping products that can currently be legally sold in the United States.”. Despite this statement, a large number of vaping products, including JUUL, that have not received official marketing authorization remain widely available in the country. Health officials say much greater efforts are needed to remove these products from the market.

©Generation Without Tobacco

AE

[1] Press release, Update on FDA's Scientific Review of JUUL Product Applications, FDA, published June 6, 2024, accessed June 11, 2024

[2] Press release, FDA Denies Authorization to Market JUUL Products, FDA website, published June 23, 2022,

[3] Press release, FDA's Continued Delays in Reviewing Juul's Marketing Applications Are Unacceptable and Harmful to Kids, CTFK, published June 6, 2024, accessed June 11, 2024