JUUL to appeal FDA decision that orders its vapes off shelves
Vaping company JUUL said Thursday it plans to appeal the Food and Drug Administration’s decision to order its products off U.S. shelves.
The company said adult smokers will need its products to wean off combustible cigarettes and disagreed with the FDA’s conclusion that JUUL hasn’t addressed toxicological hazards in its products.
“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,” said Joe Murillo, the chief regulatory officer at Juul Labs. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
The FDA’s decision follows a multi-year review and was widely expected.
Lawmakers who’ve accused JUUL of sparking the youth vaping crisis hailed the decision. They highlighted a portion of the FDA findings that said JUUL did not address whether harmful chemicals are leaching from its proprietary e-liquid pods.
“While I have long held concerns that JUUL used enticing flavors and slick marketing to get young people hooked on their products, these new revelations that JUUL’s pods are leaching dangerous chemicals is deeply alarming,” House Energy and Commerce Committee Chairman Frank Pallone, New Jersey Democrat, said.
JUUL said the FDA got its review wrong and plans to fight the decision.
“We respectfully disagree with the FDA’s findings and 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,” Mr. Murillo said. “In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health.’”