SAN FRANCISCO — Juul Labs Inc. has been exploring a variety of options—including bankruptcy—after the U.S. Food and Drug Administration issued its marketing denial order (MDO).
While the company confirmed to CSP on Oct. 4 that it has been considering filing for Chapter 11 reorganization since June, a spokesperson said no decisions have been made.
“As we continue to operate in the market and go through the FDA’s review process, we are exploring a variety of options including various potential financing alternatives to protect our business and to address the impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes,” the Juul spokesperson told CSP. “We remain confident in our science and evidence and believe that we will be able to demonstrate that our products do in fact meet the statutory standard of being ‘appropriate for the protection of the public health’.”
The FDA banned Juul’s products from the market on June 23 after issuing MDOs for the San Francisco-based company’s 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%. A Washington, D.C., appeals court and the FDA later stayed the decision, allowing the products to remain on the market while the review process for Juul’s premarket tobacco product application (PMTA) is ongoing.
It's not the only challenge Juul has faced in recent months.
The company in September agreed to pay $438.5 million to 34 states and territories to settle a two-year investigation into its marketing and sales practices. Then, Altria, Richmond, Va., which has a 35% stake in Juul, ended its noncompete agreement with the vaping company, freeing itself up to take on new vapor products.
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