On Friday, June 24, 2022, the U.S. Food and Drug Administration (FDA) denied an application to continue selling menthol and tobacco-flavored e-cigarette cartridges manufactured by Juul Labs Inc. FDA ordered the removal of these products from the market, citing these products play a significant role in the increase in youth vaping.
In recent years, FDA has been focusing on the e-cigarette market, ensuring they are aiding adults to quit smoking and not marketing to entice young adults to start vaping, potentially leading to nicotine addiction. FDA announced that Juul must stop selling and distributing these products and ordered the removal of these products from store shelves.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system (ENDS) products currently being marketed to consumers meet our public health standards,” Robert M. Califf, FDA Commissioner, said in a statement. The agency alleges Juul’s premarket applications did not contain sufficient evidence to demonstrate that marketing of the products would be appropriate for the “protection of the public health.”
While the agency said it has not received information to suggest an immediate hazard associated with the use of Juul products, “there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
Juul’s marketing campaigns involved showcasing young people having fun while vaping; this prompted objections from parents and regulators who blamed the advertising for igniting a surge in teenage vaping and called for the removal of flavored pods from the market earlier in the year. FDA eventually prohibited sales of any sweet and fruity e-cigarette pods. FDA’s denial of the application for nicotine and tobacco-flavored e-cigarettes is yet another hit for Juul.
Juul has continuously battled FDA during its tenure of manufacturing ENDS:
2018, data showed a huge increase in teenage vaping, causing FDA to conduct an “undercover nationwide blitz to crack down on the sale of e-cigarettes – specifically JUUL products – to minors at both brick-and-mortar and online retailers.” FDA released in a statement, “The illegal sale of these JUUL products to minors is concerning. In fact, since the beginning of March, FDA compliance checks have uncovered 40 violations for illegal sales of JUUL products to youth.”
2019, Juul announced its intent to regain the trust of the public and regulators by taking steps to prevent teenagers from buying its products, terminating its advertising campaigns.
The battle may not be over for Juul yet; Juul still has an opportunity to appeal, allowing them to continue to sell these products while the matter is pending. FDA can also be named in a suit to seek a stay pending the outcome of the case.
If you manufacture, distribute, or sell ENDS products and have questions about how this affects you, we can answer any questions and help provide a clear path! Please feel free to reach out to us directly at 410.220.2800 or contact us online.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
