FDA Reverses Course on Marketing Orders for JUUL System
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has given its nod for the JUUL System to remain on the market in the United States.
The FDA's marketing granted orders (MGOs) come a little more than a year after the agency rescinded the marketing denial orders (MDOs) it issued in June 2022 against the premarket tobacco product applications (PMTAs) submitted by Juul Labs Inc.
According to Juul Labs, the company submitted more than 110 scientific studies to the FDA covering nonclinical, clinical and behavioral science as part of its 2020 PMTAs.
"Following rigorous evaluation of the data, FDA decided that an MGO for the JUUL System was 'appropriate for the protection of public health' — the standard required by statute for authorization. This is good news for the millions of Americans who still smoke cigarettes," the company said on July 17.
"While more than 2 million Americans have switched completely away from combustible tobacco using JUUL, we're focused on making the cigarette obsolete. And for us, that mission is non-negotiable: we're the only company in the U.S. market with a vapor MGO that doesn't also sell cigarettes," Juul Labs added.
The FDA's MGOs cover the on-market JUUL System, which is a closed, cartridge-based nicotine vapor product that utilizes proprietary heating technology to aerosolize and deliver nicotine without combustion. The JUUL System is comprised of the JUUL Device and JUULpods. JUULpods are pre-filled with a nicotine-containing e-liquid formulation, which varies by tobacco or menthol flavor and nicotine concentrations of 5% (59 milligrams/milliliter) and 3% (35 milligrams/milliliter).
"While today marks an important milestone for our company and our consumers, we're looking to what's next. Over the past decade, our product design team in Silicon Valley has been working on the next generation of JUUL products to provide adults who smoke with preferred alternatives to cigarettes," Juul Labs said. "Today's authorization of the JUUL System, including the market-leading tobacco-flavored vapor product in the U.S., enables us to submit applications with updates to the device and pod hardware with the goal of improving the user experience."
On June 23, 2022, the FDA initially issued its MDOs for all of Juul's products marketed in the U.S. at the time. The agency had determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law.
However, the following month, the agency administratively stayed the MDOs after determining that certain scientific issues warranted additional review, as Convenience Store News previously reported.