JUUL/FDA

The news was stunning: vaping brand JUUL Labs Inc. may continue marketing its e-cigarettes and refill cartridges. You can, it turns out, fight City Hall.

In mid-July, the Food and Drug Administration (FDA issued the PMTA (Premarket Tobacco Product Application) Marketing Granted Orders (MGO) for JUUL Labs’ pods and device, which included JUULpods Virginia Tobacco 3.0% and 5.0%, JUULpods Menthol 3.0% & 5.0% and JUUL device.

In authorizing MGO, the FDA said it had determined that the products “are appropriate for the protection of public health." The authorization, according to the New York Times, ended “a lengthy standoff with regulators and lawmakers who accused the company of spurring an epidemic of e-cigarette use among youths. The company was required to prove that the products were ‘appropriate for the protection of public health’ under agency rules. JUUL said in a statement that it met the bar, in part, by showing that its products had helped about two-million adults quit smoking cigarettes.

“JUUL was once a vaping juggernaut and one of the most valuable startups in America,” The Wall Street Journal said. “But in 2022, the FDA ordered JUUL to halt its sales because of unresolved questions related to the toxicology data that JUUL had submitted in its application to remain on the U.S. market.”

The FDA ordered the company to remove its products from the market in June 2022, the-independent.com reported, “but quickly changed course after JUUL pushed back in court. JUUL had argued that regulators overlooked thousands of pages of scientific data, and the agency then allowed to reopen its scientific review of JUUL’s application.”

In explaining the decision, FDA officials said that Washington, DC-based JUUL had “submitted robust data — including a two year longitudinal cohort study — demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored JUUL products.”

“The decision comes as the once-pioneering company struggled for years against heightened regulatory scrutiny and backlash as its flavored pods became popular amongst young people, contributing to the rise in teen vaping,” reported the Independent.

“The end of smoking in America is within our grasp,” the company proclaimed following the decision. “Our team remains com mitted to our mission to make the cigarette obsolete.”

‘Vaping Juggernaut’

The decision has breathed “new life into the vaping company after a 2022 federal ban pushed it to the brink of bankruptcy,” accord ing to the Journal. It “removes JUUL from the limbo it has been mired in since then, not knowing whether its products would be allowed to remain on store shelves. With clearance from the Food and Drug Administration, JUUL could now raise money from outside investors or sell part or all of the company.”

The JUUL System is a closed, cartridge-based nicotine vapor product that utilizes proprietary heating technology to aerosolize and deliver nicotine without combustion. It is comprised of the JUUL Device and JUULpods. JUULpods are pre-filled with a nicotine-containing e-liquid formulation, which varies by to bacco or menthol flavor and nicotine concentrations of 5.0% (59 mg/mL) and 3.0% (35 mg/mL).

“As part of our 2020 applications, we submitted over 110 scientific studies to FDA covering nonclinical, clinical, and behavioral science,” the company noted in its statement. “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.

While more than two million Americans have switched completely away from combustible tobacco using JUUL, the statement continued, “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.”

Cigarette smoking “still accounts for one in five preventable premature deaths in the U.S.,” company officials said. “This means nearly 500,000 Americans die prematurely each year, and mil lions more suffer unnecessarily from smoking-related chronic diseases caused by how they get their nicotine. The U.S. spends over $240 billion annually on smoking-related healthcare costs – with an estimated 60% of these expenses covered by taxpayers through Medicare, Medicaid, and other federally-sponsored programs.”

‘Another Way’

But, JUUL continued, “there’s another way.” Americans who use nicotine “deserve a reliable marketplace where they can confidently choose from an array of FDA-authorized smoke-free nicotine products. These products must be backed by rigorous re search, manufactured in regularly-inspected facilities, authorized by FDA before introduction to the market, and then marketed and sold responsibly to adults. We fully support FDA in its mis sion to create such a market.”

JUUL executives concluded by looking to the future. America, they said, “must continue to build on the substantial progress made to reduce underage use of nicotine products, and JUUL Labs remains committed to doing our part. JUUL Labs markets responsibly and uses age-verification measures to ensure that our products are marketed to and used by adults. Currently, underage use of all vapor products is at the lowest point in more than a de cade, and reported underage use of JUUL products has decreased by more than 98% since 2019. We support category-wide stan dards to limit access by those underage to all tobacco products.”