Litigation Update: FDA Takes Action on JUUL Labs

by | Sep 12, 2019

Every day seems to bring new developments in the Juul story, with none of them good for Juul. On September 9, the U.S. Food and Drug administration issued a warning letter to Kevin Burns, the CEO of e-cigarette manufacturer JUUL Labs, Inc., for allegedly marketing the Juul device as a “modified risk tobacco product” without FDA approval. The letter states that JUUL has engaged in labeling and advertising directed to consumers claiming that its e-cigarette products “present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products” and has requested more information from the company regarding its outreach and marketing practices, including those directed to students, tribes, health insurers and employers.

The FDA asserts that JUUL has ignored the law requiring that prior to marketing its products as having a lower risk, it demonstrate scientific evidence that its products are in fact less harmful. In a news release from the FDA, the agency expressed particular concern that some of JUUL’s promotional activities have been made to students in schools, stating “We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren’t being marketed or sold to kids. We’ve also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we’ll take even more aggressive action.”  JUUL has been given 15 working days within which to submit a written response describing the corrective actions it will take and its plan to comply with the Federal Food, Drug and Cosmetic ACT (FD&C Act) or it runs the risk of the agency fining the company or seizing its assets.

Earlier today President Trump called on the FDA to ban all non-tobacco flavored e-cigarettes.

These developments come in the wake of an increasing number of vaping-related hospitalizations and deaths that have occurred across the country, which have prompted the CDC to urge people to stop the use of e-cigarettes.

Juul Labs’ request to form a MDL is scheduled for consideration at the next JPML hearing on September 26 in Los Angeles.

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