WASHINGTON- The United States Court of Appeals for the District of Columbia Circuit has granted Juul Labs Inc. an emergency administrative stay of enforcement that temporarily blocks a Food and Drug Refusal to Market Order (MDO) U.S. administration bans sale of company’s e-cigarettes while Juul seeks formal stay of FDA 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 in nicotine strengths of 5 % and 3% and menthol-flavored pods at 5% and 3% nicotine strengths.
“Following the Court’s action, we will continue to market our products responsibly as we have done thus far pending the Court’s decision on our next stay motion,” the company said. in a letter to its partners. “While a reprieve is in effect, all of our products remain available for sale and there is no legal prohibition on continuing to market Juul products.”
The letter, signed by Gregg Augustine, senior vice president for U.S. commerce, added: “In granting the emergency stay, the court took into account the irreparable harm caused by the FDA’s action in the absence of suspension, the absence of prejudice to the government and this public interest. favors the granting of a 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 that we have provided sufficient information and high-quality research-based data to resolve all issues raised by the agency. We continue to believe that our app has provided strong data showing that Juul products meet the legal standard of being “appropriate for the protection of public health”. This order allows us to continue to engage with our regulators in pursuit of a scientific and evidence-based determination for our products.
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