US bans the sale of their electronic cigarettes, company requests stay on enforcement

• The U.S. Food and Drug Administration  prohibited the sale of Juul e-cigarettes
• Following a nearly two-year-long analysis of the company’s data, the agency concluded that the applications “lacked adequate evidence” to demonstrate that the sale of the products would be appropriate for public health.
• Due to incomplete and inconsistent data, certain findings prompted questions, according to the FDA, including whether potentially dangerous substances could leak out of Juul pods.

The U.S. Food and Drug Administration on Thursday prohibited the sale of Juul e-cigarettes, dealing a severe blow to the once-promising company whose products have been linked to a rise in teen vaping.

Following a nearly two-year-long analysis of the company’s data, the agency concluded that the applications “lacked adequate evidence” to demonstrate that the sale of the products would be appropriate for public health.

Due to incomplete and inconsistent data, certain findings prompted questions, according to the FDA, including whether potentially dangerous substances could leak out of Juul pods.

“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul.

The business claimed that the toxicological profile of its products had been accurately described and that the data complied with the legal requirement that it be “suitable for the protection of the public health.”

There was a deadline of September 2020 for Juul and other e-cigarette brands to submit applications to the FDA demonstrating the products had a net positive impact on public health, including British American Tobacco’s (BATS.L) Vuse and Imperial Brands’ (IMB.L) Blu.

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