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The U.S. Food and Drug Administration (FDA) has proposed to set a new deadline for premarket tobacco product applications (PMTA), according to Morgan Stanley Research.

The agency made it suggestion in response to a Maryland court decision last month that found that the FDA exceeded its authority when it pushed back the PMTA due date to 2022 two years ago.

In its filing, the FDA proposed the court set a deadline for PMTA submissions “no sooner” than 10 months following the court’s final decision, with a one-year period for FDA review.

According to Wells Fargo Securities, this would allow e-cigarettes that have filed PMTAs to remain on the markets ostensibly until 2021–ahead of the current 2022 schedule–until the FDA completes its review. It would also allow the FDA time to “absorb a flood of applications significantly sooner than anticipated.”

Plaintiffs have five days to reply to the FDA’s proposed remedies, followed by the court issuing a final order, which will take into consideration a 98-page joint Amicus Brief also filed by several tobacco and nicotine companies yesterday.

The FDA could then appeal the judge’s decision, but the judge has denied the tobacco and e-cigarette companies efforts to intervene in this case.

In its remedy brief, the FDA also announced that it intends to finalize within 120 days its guidance on banning certain e-cigarette flavors in retail stores.

At the Global Forum on Nicotine in Warsaw, Juul Labs today presented the results of two studies—one showing a significant difference in exhaled toxicants between vapor products and combustible cigarettes, and another showing that smokers who used nontobacco-flavored Juul products were more likely to switch from cigarettes than those who used tobacco-flavored Juul products.

The first clinical study found an approximately 99 percent reduction of formaldehyde and carbon monoxide particles in secondhand (exhaled breath) vapor associated with the use of the Juul system compared to use of combustible cigarettes. The aggregate measurements of formaldehyde and carbon monoxide particles were not statistically different from the background levels measured without product use.

This study set out to evaluate the contents and quantity of the exhaled breath and emissions profiles of secondhand vapor of the Juul system and another vapor device against that from combustible cigarettes.

Thirty adult smokers, who reported smoking a minimum of 10 combustible cigarettes per day, were recruited for this study. They were divided into three groups of 10 and assigned to three different environments designed to simulate residential, office and hospitality environments. Each group used one product for a four-hour session in each of the three different simulated settings. Air quality was assessed at baseline and after each four-hour session in which subjects partook of each product as much as desired. Exhaled breath was collected into a dedicated device after each of 10 prescribed puffs. Results were evaluated against sham, or dummy, devices, and were reported for chemical levels in individual exhaled breath and general room air quality.

Data from the individual exhaled breath analysis show that levels of formaldehyde and carbon monoxide were reduced approximately 99 percent or more with the Juul system compared with combustible cigarettes. The use of vapor products resulted in elevated levels of propylene glycol across environments compared to cigarettes. Propylene glycol is a major component of the e-liquid. Emissions from the Juul device cleared more quickly than with the comparator device.

In air quality analyses, concentrations of respirable particles were elevated in every environment and product evaluated. However, the average rise in airborne particles was lower with the Juul system versus the other vapor product and combustible cigarettes. Room air nicotine levels were 89 percent–95 percent lower following ad libitum vapor product use versus cigarettes. The study authors note the presence and variability of background environmental source chemicals as a factor in the analysis.

“These findings align with the current scientific understanding of the role alternative nicotine delivery systems can play in the potential harm reduction for adult smokers and the corresponding environmental impact for nonsmokers for the good of public health,” said Josh Vose, vice president, medical and clinical affairs at Juul Labs.

The second study conducted by Juul Labs found that adult smokers who primarily used non-tobacco-flavored Juul products were more likely than those who primarily used tobacco-flavored Juul products to have successfully switched from smoking combustible cigarettes over a six-month period.

The study followed more than 37,000 U.S. adult smokers who had recently purchased Juul products at retail or on the company’s e-commerce platform. Participants completed online surveys over six months.

“There has been an active discussion about the role of flavors in supporting adult smokers who want to switch from combustible cigarettes, and at Juul Labs we are committed to driving research to inform these discussions,” said Erik M. Augustson, senior director of behavioral research and interventions at Juul Labs.

“We wanted to assess how flavor preference at various time points—30-days, 60-days and 90-days after initiating Juul use—is associated with the likelihood of smoking abstinence in the future. For example, how does a person’s flavor preference at 60 days impact their likelihood to be vaping rather than smoking at 90 days? These results show that, for the study cohort, use of Juul products in non-tobacco flavors was associated with higher switching rates compared to those who used Juul products in tobacco flavors.”

The study, “Flavored Juul Use and Smoking Abstention Among Adult Smokers,” analyzed data from a subset of 21,332 smokers aged 21+ years who had purchased a Juul starter kit and completed at least two follow-up assessments. Study participants completed baseline and 30-day, 60-day, 90-day and 180-day follow-up assessments via online surveys. The assessments asked study participants about Juul flavor use and switching—defined as no smoking, not a single puff, for the previous 30 days prior to the assessment.

The study was designed to assess what flavors were being used and how the use of flavors was associated with smoking behavior over time: that is, the likelihood of abstaining from smoking and switching to vaping at the next follow-up survey. Juul Labs commissioned and funded the study, the Centre for Substance Use Research (CSUR) independently designed and administered the survey underlying this data analysis.

Across 30-, 60- and 90-day assessments, use of mint/menthol and non-tobacco/menthol-based (NTM) flavors, compared with the use of tobacco flavors, were positively associated with past 30- day smoking abstinence at the 60-, 90- and 180-day assessments. Adult smokers who primarily used mint/menthol and NTM flavors were 14 percent and 7 percent more likely, respectively, to have switched than those primarily using tobacco flavors across the 6-month study period.

“These results add to a growing body of evidence that suggest that use of vapor products in non- tobacco flavors may potentially help adult smokers switch from cigarettes,” Augustson said.

Today, the U.S. Food and Drug Administration (FDA) finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems (ENDS), such as e-cigarettes or “vapes,” and the liquid nicotine and nicotine-containing e-liquids used with such products, as part of the agency’s continued commitment to its oversight of tobacco products, according to a statement from the FDA.

“The FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health,” said Acting FDA Commissioner Ned Sharpless. “The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product. There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications. At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.”

Following an extensive review of input from the public on the previous draft guidance, the guidance issued today further clarifies the PMTA process for ENDS products and the FDA’s current thinking about information the agency recommends applicants include in a PMTA submission for ENDS products, according to the release. Importantly, it also includes recommendations for how applicants should address public health issues in the design and manufacture of their products, such as accidental nicotine exposure and battery safety.

For example, the agency is recommending that manufacturers provide information describing the kind of packaging their product will be sold in to mitigate the risk of accidental exposure to e-liquids, such as child-resistant, exposure-limiting packaging or nicotine exposure warnings on labels, the release states.

Additionally, to enable the FDA to assess the risks of a battery to be used in a particular product, the agency is also recommending that applications include, among other things, information on: amperage, voltage, wattage, battery type (chemistry), whether the battery is consumer-replaceable, testing certificates for any voluntary electrical standards for the battery or device—including UL 8139, the recently published, first-ever standard specifically for ENDS products—and under- or over-voltage protections, as well as plans for addressing the likelihood of use and foreseeable misuse leading to overheating, fire and explosion during operation, charging, storage and transportation for distribution, according to the release.

The guidance also includes recommendations for constituent or chemical testing, applying existing scientific literature or analyses about similar products to the proposed new tobacco product, including multiple distinct products in a single submission and referencing tobacco product master files, according to the release.

JUUL Labs recently launched New Technology JUULpods, available in multiple nicotine strength options, to reach a broader range of smokers in the U.K. who want to switch from combustible cigarettes, according to a story in Grocery Trader.

The new JUULpods will be available in the 18mg/ml strength and a new 9mg/ml strength across an adult oriented-flavour range to help smokers in their switching journey.

The new JUULpods use a cotton wick, rather than a silica wick, providing a more satisfying vapour experience. The new 18mg/ml JUULpod contains the same amount of nicotine as the previous JUULpod but offers more consistency puff-to puff and has the potential to deliver more nicotine per puff and more vapour depending on usage patterns, according to the story.

The new 9 mg/ml JUULpod offers adult smokers a lower nicotine alternative. Both JUULpods are compatible with the existing JUUL device.

A new website that provides information and advice on vaping in New Zealand has been launched, according to an article in the RNZ.co.zn.

The site – www.vapingfacts.health.nz – was developed by the Ministry of Health and the Health Promotion Agency with input from an expert advisory group.

Associate Health Minister Jenny Salesa said the website gives clear and credible information about vaping as a way to stop smoking, according to the story.

“Many people miss the nicotine when they quit smoking. Vaping can replace this nicotine but without the toxins found in cigarette smoke. The combustion of the chemicals found in cigarette smoke is what causes almost all of the harm from tobacco.”

Shares of Cronos Group soared more than 15 percent on May 5 after the Canadian cannabis company announced it plans to launch cannabidiol (CBD) in the United States within the next six to 12 months.

Following the announcement, Bank of America Merrill Lynch gave the stock a double upgrade—from “under-perform” to “buy”, with analyst Christopher Carey raising his price target to US$20 a share—nearly 40 percent above where shares settled on May 4.

Wall Street has postulated that the CBD market, currently worth $1 billion, could increase to as much as $16 billion by 2025.

In March, Cronos closed a deal with Altria Group, allowing Cronos access to Altria’s domestic farmer network, positioning the company to source hemp locally. Cronos will also be able to leverage Altria’s distribution arm, which includes 230,000 retail locations.

ALD Group has agreed to transfer 10 percent of its stake to Veken Technology for RMB100 million ($14 million).

Headquartered in Shenzhen, China, ALD is a high-tech firm specializing in the research and application of electronic atomization technology, with business covering electronic nicotine delivery systems, inhaled medical vaporizers and heat-not-burn devices.

The company says it has strategic partnerships with leading global tobacco companies, including British American Tobacco, ITC and Canopy Growth.

Veken Technology is focused on lithium-ion batteries for the renewable and sustainable energy sectors with a focus on 3C digital battery and power battery segments.

ALD and Veken Technology expect their alliance to deliver a synergy across the industry chain.

“With the support of the reputable top-tier company, ALD will further optimize its supply chain and improve its overall competitiveness, while continuing to expand its presence in the global electronic atomizer market,” ALD wrote in a statement.

“In addition, the partnership will drive Veken Technology’s profit growth in the lithium-ion battery segment and help the company improve the operational efficiency of its assets.”

Federal regulators sent warning letters to four e-cigarette companies for failing to follow advertising rules in social media posts.

The influencer endorsements on Instagram, Facebook and Twitter neglected to include the required nicotine warning, the Food and Drug Administration and the Federal Trade Commission announced Friday in a joint statement, according to a story in the Washington Post.

The posts invited followers to try the liquid capsules, which come in an array of flavors, used in vape pens. The FTC, which polices unfair and deceptive corporate practices, said promotions lacking health-risk disclosures could be in violation of federal law, according to the story.

The agencies sent warning letters to Solace Technologies, Hype City Vapors, Humble Juice Co. and Artist Liquid Labs. 

A Greek cardiologist and top harm reduction expert asked the Philippine government to regulate, and not ban, the use of electronic cigarettes to help smokers quit the habit and save them from premature death, according to an article on the website manilastandard.com.

Dr. Konstantinos Farsalinos, a researcher at Onassis Cardiac Surgery Centre in Athens, says other countries are in fact lifting the ban on vaping—the act of inhaling and exhaling the vapor produced by an electronic cigarette which is a  battery-operated device that vaporizes a flavored liquid made of nicotine, propylene glycol, glycerine and flavorings, according to the article.

“The trend today is to lift the ban, not to implement the ban,” says Farsalinos who managed to quit a 36-year habit of smoking by switching to e-cigarettes seven years ago.“Switzerland and Belgium used to ban nicotine-containing products but now they have lifted the ban.  New Zealand is now actively encouraging the use of e-cigarettes and they are changing the legislation, the article states.  

The same is happening in Canada, which is the only country in the world where the e-cigarette packaging is going to have an encouragement label that this product is less harmful than smoking,” he says in an interview in Makati City where he spoke during the 50th Annual Convention and Scientific Meeting of Asia Pacific Society of Cardiology 2019 Congress, the article states.

Farsalinos advised countries to look at the European example.  “Europe is the only region in the world with a comprehensive and fully implemented regulation on e-cigarettes for the past three years since 2016.

This could be a good starting point for every country in the world to use this as a basis and adjust the regulation based on their local, unique characteristics,” he says.He says among countries, the UK has the strongest support for electronic cigarettes, the article states.

“The problem comes from the lack of regulation.  In countries where you don’t have any regulation, you don’t have any control. We fully support the need for regulation because all consumer products are regulated.  We want smokers to use them [e-cigarettes] in an effort to quit smoking,” he says, according to the article.

The Jordan Food and Drug Administration (JFDA) has suspended the operations of 19 tobacco shops and shut down 41 unlicensed tobacco-selling establishments, in addition to confiscating dozens of pieces of e-cigarette equipment, reports The Jordan Times.

On May 19, Jordan’s Cabinet tasked the JFDA with monitoring and controlling the trade and sale of electronic and non-electronic tobacco-related commodities.

To date, the agency has seized 104 pieces of e-cigarette and e-arghileh equipment, Jordan’s News Agency, Petra, reported.

The JFDA additionally disposed of 470 packs of e-liquid that failed to meet the general quality, safety and production requirements and standards.