The agency stressed that the move was not an approval of Juul’s requests to market products but instead returns those applications to the status of pending review.
The company said in a statement it remains confident that a “full review of the science and evidence” will show its products are safe for the public. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process,” the company said.
The FDA ordered Juul products off shelves after saying it had worries about the e-cigarette device and pre-filled cartridges in menthol and tobacco flavors. Regulators said they had concerns about “insufficient and conflicting data” about damage to DNA and potentially harmful chemicals leaching from the company’s cartridges.
E-cigarettes emerged as a major public health concern during the past decade. Juul’s popularity skyrocketed after it introduced a sleek vaping device with fruity flavors in 2015. The company’s marketing spurred the growth of the vaping industry while prompting backlash from parents and health officials who blamed Juul for a surge in teenage vaping.
More recently, illegal disposable vapes from China have flooded the market. The FDA has denied hundreds of marketing applications from other companies as legal battles rage. So far, the agency has approved only 23 e-cigarette products.