WASHINGTON — The U.S. Court of Appeals for the District of Columbia Circuit has granted Juul Labs Inc. an emergency administrative stay of enforcement that temporarily blocks a U.S. Food and Drug Administration’s marketing denial order (MDO) banning the sale of the company’s electronic cigarettes while Juul seeks a formal stay of the FDA’s action.
On June 23, the FDA issued MDOs to the San Francisco-based company for its products marketed in the United States including the Juul device and four types of Juulpods—Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol-flavored pods at nicotine concentrations of 5% and 3%.
“As a result of the Court’s action, we will continue to responsibly market our products as we have up to this point pending the Court’s ruling on our forthcoming motion to stay,” the company said in a letter to its partners. “While a stay is in effect, all of our products remain available for sale and there is no legal prohibition against continuing to market Juul products.”
The letter, signed by Gregg Augustine, senior vice president for U.S. commercial, added, “In granting the emergency stay, the court considered the irreparable harm caused by FDA’s action absent a stay, the lack of harm to the government, and that public interest favors granting the stay. We now continue to pursue all of our legal and regulatory options while continuing to operate in the market.”
Juul said, “We strongly disagree with the FDA’s decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency. We continue to believe our application provided robust data showing Juul products meet the statutory standard of being ‘appropriate for the protection of the public health.’ This order allows us to continue engaging with our regulators in pursuit of a science and evidence-based determination for our products.”
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