Juul Labs to Submit PMTA, Includes Tech to Curb Youth Use

Juul Labs will propose to federal regulators an e-cigarette that will unlock only for users 21 and older.

The company will submit the proposal as part of its premarket tobacco product application (PMTA) that is due to the U.S. Food and Drug Administration (FDA) by May 12. All vapor product manufacturers must submit their PMTAs for review by May 12 to keep their products on the market.

Juul Labs intends to submit more than 250,000 pages, including scientific research, marketing materials and an update on its efforts to curb illegal sales to minors, according to a Juul Labs official. The company plans to submit additional applications over the next three to five years, including an application to market its products as less harmful than combustible cigarettes.

The company plans to outline a new marketing campaign and a proposal for a U.S. device capable of verifying the user’s age. The company has launched vaporizers in Canada and the U.K. that include an option to lock or unlock the device using a Bluetooth connection to a mobile app; to sign into the app, users must submit a photo of themselves as well as government identification. The app also allows users to monitor their nicotine consumption. The U.S. version of the device would not monitor nicotine consumption.

The company also plans to submit two flavors, menthol and Virginia tobacco, in two strengths, 3 percent and 5 percent, to the FDA for approval as well as evidence that shows lower levels of toxicants in its products’ aerosol than in cigarette smoke.

Altria, which owns a 35 percent stake in Juul Labs, has been assisting the company with the application. “Altria is working day by day with us, side by side, helping us extensively,” according to Juul Labs. “They took the lead on certain [areas] of the studies.”