By Alice Seeley
On July 5, the U.S. Food and Drug Administration (FDA) announced it is temporarily suspending its ban on Juul Labs Inc’s marketing and sales of Juul’s e-cigarettes. The FDA stated this suspension is because the agency “has determined that there are scientific issues unique to the JUUL application that warrant additional review.”
This additional review does not cancel the June 23 ban, which ordered Juul to remove its products from stores.
“All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed. The stay and the agency’s review does not constitute authorization to market, sell or ship Juul products,” the FDA said.
The FDA issued its ban on sales of Juul e-cigarettes because Juul did not prove that keeping its products on the market “would be appropriate for the protection of the public health.” One day later, on June 24, Juul received temporary relief from the ban after the U.S. Court of Appeals for the District of Columbia Circuit granted a stay to the FDA decision to allow the court more time to consider the ban.
For the company to keep its products on the market, Juul must demonstrate that its e-cigarettes help consumers reduce nicotine consumption and that teenagers are unlikely to become addicted to its products.
The original FDA ban was part of an effort to stop teenage use of e-cigarettes after years of regulatory delays.
“It is deeply disappointing and harmful to our nation’s kids that the FDA has issued an administrative stay of its marketing denial order for Juul’s e-cigarette products,” said the President of the Campaign for Tobacco-Free Kids, Matthew Myers. “We are nearly 10 months past a court-ordered deadline for the FDA to complete its review of e-cigarette marketing applications and can’t afford more delays by the FDA in removing kid-friendly products from the market. The FDA’s continued delays are inexcusable and leave our kids at risk.”
