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FDA proceeds with Juul review as pivotal regulatory deadline looms

FDA proceeds with Juul review as pivotal regulatory deadline looms

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The U.S. electronic cigarette industry is 17 days away from the most pivotal deadline in its 13-year history.

Manufacturers, whether large corporations, vape shops or mom-and-pop nicotine liquid makers, have until Sept. 9 to submit a premarket tobacco-product application to the Food and Drug Administration. The deadline was set by a federal judge April 23.

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 those factors compare with traditional cigarettes.

According to analysts, the FDA apparently has accelerated steps in its preliminary review process, with Juul Labs Inc. an unexpected beneficiary.

Juul, maker of the controversial top-selling e-cigarette, said last week that the FDA has given notice that its premarket application has entered the substantive review phase.

The company has declined to comment on whether the review will include the device-locking Bluetooth technology contained in the C1 version of its product.

The FDA acceptance came about three weeks after Juul's application submission in July, which FiscalNote managing director Stefanie Miller considers as an important shift in FDA review timing. Miller has speculated that the review could involve the C1 version of the product.

"This turnaround time of less-than three weeks was much faster than the approximately four-month time frame we had anticipated," Miller said.

"We expect that many of the smaller vape shops and vape manufacturers will struggle to pull together adequate applications in time, despite some recent efforts to encourage (that) they bundle like-applications together."

Miller said that while the FDA likely won't begin halting sales of tobacco products not in the premarket application gauntlet, "we think the agency will soon after (Sept. 9) start sending warning letters ... to immediately cease U.S. sales of their products or else risk greater penalties."

If e-liquid manufacturers don’t file a premarket submission, their products would be deemed as illegal to sell.

However, being in the process allows the product to stay in the marketplace through what could be up to a 12-month review.

"As the calendar approaches Sept. 9, we are beginning to see some e-liquid manufacturers shut their doors," said Gregory Conley, president of American Vaping Association.

"Other manufacturers are refusing to go down without a fight and are working together to put together potentially thousands of PMTAs using publicly available scientific information.

"It remains to be seen whether the FDA will accept these applications," Conley said.

Juul controversy

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.

Juul has been attempting to reset the FDA's view of its products and its reputation over the past year.

"As part of that process, the company reduced its product portfolio, halted television, print and digital product advertising, built up its science and evidence-based capabilities, and supported the Trump administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence," the company said.

Premarket submissions are required to include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data and nonclinical health-risk information.

Juul began a test market in August 2019 with the C1 version in the United Kingdom and Canada.

The Bluetooth technology allows for monitoring usage “to help adult smokers in their switching journey and combat unauthorized use,” particularly by youths.

When it launched the test market, 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; and 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.

“We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application," said Joe Murillo, Juul's chief regulatory officer.

Miller said the Bluetooth technology in the C1 product "will represent a new product not yet sold in the U.S., we think it gives FDA the political breathing room to approve Juul’s application in spite of the overwhelming negative press and public opinion that hit a fever pitch in late 2019."

Can Vuse benefit?

Because the FDA needed less time on the substantive review process, Miller is projecting an FDA decision on the premarket application in the second quarter of 2021, rather than a quarter later.

"FDA’s ability to much more quickly advance Juul's application to the substantive review phase has, we think, read-throughs for Juul’s, but also other companies', pending applications," Miller said.

Miller said the FDA's timing with Juul has led her to move up her projections on when the FDA will decide on the Vuse Solo premarket submission of R.J. Reynolds Vapor Company.

Reynolds entered the FDA’s regulatory gauntlet Oct. 11 with its submission for premarket approval of multiple Vuse e-cigarette products. 

Reynolds is requesting permission to market Vuse, the No. 2-selling U.S. e-cigarette, as an electronic nicotine delivery system aimed at adult consumers.

Reynolds said its submission contained more than 150,000 pages of documentation. The FDA also will conduct inspections of manufacturing sites, as well as sites and entities involved in clinical and nonclinical studies.

Prior to the Juul decision from the FDA, Miller had expected a decision on Vuse Solo in the first quarter of 2021.

Now, she is expecting the decision by the end of 2020.

She's also moved up her decision timetable for Reynolds' Vuse Vibe and Vuse Ciro styles — both submitted in April — from the fourth quarter of 2021 to third quarter of 2021.

"The clear evidence of FDA’s ability to quickly move through this initial review phase, we think, is as much a result of the quality of applications FDA is receiving now relative to prior years, as well as the agency overcoming its own steep learning curve," Miller said.

Since the FDA was given authority by Congress to regulate the tobacco industry in 2009, it has approved just three premarket applications. They include three styles of Marlboro HeatSticks and eight styles of General Snus by Swedish Match.

Eyes on the FDA

A coalition of seven public-health and anti-tobacco groups sued the FDA in March 2018 to accelerate the premarket application timetable from August 2022.

"The FDA’s enforcement of this deadline and rigorous scientific review of e-cigarettes are critical to reversing skyrocketing youth use of e-cigarette," the coalition said in a joint statement.

The coalition said it remains concerned about "the FDA’s repeated failure to effectively regulate e-cigarettes."

"The FDA must apply (standards) to ensure that any authorized products actually protect public health — to ensure these products do not attract kids and benefit current smokers."

Conley said that "it is not a leap to say that Juul's long-term survival as a global consumer products company hinges on the FDA authorizing the sale of these products."

"While the U.S. regulatory system is imperfect, the thoroughness of our FDA is known worldwide. If the FDA concludes that Juul products are appropriate for the protection of public health, it would give the company a chance to change its presently toxic image."

Meanwhile, Conley said that "of course, all across America there are vape shops and manufacturers that are continuing on with business as usual and will run their businesses until the FDA forces them to shut their doors."

Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health, said the FDA's developments related to Juul "are for the most part a very positive development in terms of public health."

"First, Juul seems to have 'cleaned' house and replaced key people with those who are working to dot their 'I's and cross their 'T's.

"Many suggested that Juul's past behaviors were tantamount to a death sentence," Ballin said. "That may not be the case."

Ballin said the FDA is fulfilling former Commissioner Dr. Scott Gottlieb's pledge from July 2017 of "doing a better job of processing applications in a more timely manner while ensuring that the applications are complete."

Still, Ballin said he “remains concerned that the processes that the FDA/Center for Tobacco Products has used in consideration of potentially lower-risk products is costly, burdensome and does not encourage innovation, but rather stifles it.”

“I believe that the agency should be establishing product standards that would allow for great competition in the market place, rather than dealing with products on a one-by-one basis.”

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@rcraverWSJ

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