Juul Labs Inc. confirmed Tuesday analyst and media reports that the device-locking Bluetooth technology it has been testing in Canada and the United Kingdom will be included in its premarket tobacco application to the Food and Drug Administration.
The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as they compare with traditional cigarettes.
Juul began the test market in August with the C1 version of its top-selling e-cigarette. The technology allows for monitoring usage “to help adult smokers in their switching journey and combat unauthorized use,” particularly by youths.
Juul said data it is collecting through the C1 device includes: errors and diagnostics to help resolve technical problems; user’s phone numbers to authenticate the account; personal information, including a user’s name, birth date and official identity document number, “only to verify that the customer is of the legally-accepted age to purchase and use our products.”
The device can be manually locked or set to automatically lock when not in use or not in proximity of the connected smartphone. The GPS technology helps smokers find their Juul device when misplaced.
The company said C1 allows smokers to monitor in real time the number of puffs they take daily, weekly and monthly. It would be available in Virginia tobacco and menthol flavors, and at 3% and 5% nicotine strength.
May 12 is the deadline for manufacturers to submit PMTA e-cigarette applications to the FDA. Those products are allowed to remain available at retail during an up to 12-month review process.
Juul said Tuesday that “we are committing all necessary resources to submit a scientifically rigorous PMTA designed to provide FDA with the science and evidence needed to assess the role our products can play moving smokers away from cigarettes, while combating underage use.”
Sandhill Tobacco analyst Stefanie Miller said she views the Bluetooth technology as “meaningfully helpful in our view to the company securing FDA approval.”
“The FDA is politically incentivized to reject most, if not all, of those applications. We also, however, continue to believe that an updated suite of Juul products are well positioned to receive PMTA approval.
“The science is just too compelling that the political stars align fully in Juul’s favor for all four products submitted to FDA,” Miller said.
According to the latest Nielsen report on e-cigarette convenience-store sales, Juul had a 57.6% market share as of Jan. 25, down from 63.9% on the Nov. 30 report and down from 74.5% in August.
Juul’s e-cigarette product has drawn criticism for its popularity among teenagers, which the FDA has said is contributing to a national epidemic. The product is sold in the form of a pen or a USB flash drive that’s easy to use — and hide — because the vapor typically does not have a smell and quickly dissipates.
A 2019 report in the Journal of American Medical Association disclosed that 27.5% of U.S. high school students had tried an e-cigarette product at least once over a 30-day period. That’s up from 20.8% in 2018 and just 4.5% in 2013.
Also contributing to the months-long decline in e-cigarette consumption has been an outbreak of severe vaping-related illnesses, focused primarily on open-pod e-cigarettes in which liquids containing the marijuana compound THC are being vaped.
On Jan. 28, the federal Centers for Disease Control and Prevention said “evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC or non-THC products, in some of the reported cases.”
However, there have been few incidents reported involving the closed-pod e-cigarette cartridges of Juul, Vuse, Njoy and blu eCigs.
R.J. Reynolds Vapor Co. entered the FDA’s regulatory gauntlet Oct. 11 with its submission for PMTA approval of multiple Vuse e-cigarette products. The FDA said Nov. 30 it would review whether Vuse products can remain on the market in current form.
The FDA is required to measure in the premarket review four areas:
* Risks and benefits to the population as a whole, including both users and nonusers of tobacco products;
* Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
* Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
* The methods, facilities, and controls used to manufacture, process and pack the new tobacco product.
Reynolds spokeswoman Kaelan Hollon said in October the company “is well positioned to submit applications for the remaining Vuse portfolio ahead of the deadline of May 12.”
Gregory Conley, president of American Vaping Association, said the May 12 deadline signifies that “the exact class of vaping products President Trump exempted from his ban — open tank systems — being banned because of the sky-high costs associated with Obama-era rules the FDA is retroactively enforcing on vaping companies.”