The Food and Drug Administration announced on Tuesday it administratively stayed the marketing denial order, citing “scientific issues unique to the JUUL application that warrant additional review”.
The new decision to administratively stay temporarily suspends the marketing denial order, which was issued on June 23 and consequently halted the sale of JUUL products from the U.S. market. Just one day after the order was issued, the U.S Court of Appeals for the D.C. Circut entered a temporary administrative stay, temporarily blocking the government ban.
With the agency’s latest decision citing scientific issues, the company is effectively allowed to continue selling the product.
The agency tweeted that the administrative stay temporarily suspends the marketing denial order during the additional review, but it does not rescind it.
“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 agency wrote in a statement.
In the agency’s initial decision to administer the order, it said the company’s premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
Concerns regarding the company’s study findings were highlighted due to “insufficient and conflicting data– including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods”. In announcing their initial decision, FDA Commissioner Robert M. Califf, M.D. cited a “disproportionate role in the rise in youth vaping.”
In response to the agency’s initial decision, Chief Regulatory Officer at Juul Labs Joe Murillo said “We 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.”
Under the PMTA pathway, applicants must demonstrate to the agency, among other things, that permitting the marketing of the new tobacco product would be appropriate for the protection of public health. The FDA has authorized 23 ENDS products to date.
