Category: News This Week

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.

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.

Today, the U.S. Food and Drug Administration 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.

“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.”

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. 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. 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.

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.

Greece loses €690 million ($781 million) annually in revenues due to illicit tobacco trade, according to The Stella Report.

Illegal cigarette sales in Greece soared to 23.6 percent last year, up 5.6 percentage points from 2017. In the EU the average rate of illegal tobacco represents 8.6 percent of all tobacco consumed.

Taxation makes up 85 percent of the retail price of cigarettes in Greece.

That means that of a €4.50 cigarette pack, €3.85 goes to the state and €0.85 is split between the retailer, the distributor and the tobacco industry.

The Stella Report was carried out by KPMG and commissioned by Philip Morris International.

Juul Labs has pledged $7.5 million to Meharry Medical College in Nashville, Tennessee, USA, to research the impact of electronic cigarettes and vaping, reports CBS News.

The medical college said that Juul Labs has structured the $7.5 million grant in ways meant to ensure the “full autonomy” of the new Meharry Center for the Study of Social Determinants of Health, including “sole ownership of the sponsored research and complete control over publication of the findings.”

“The grant from Juul Labs gives Meharry the unique opportunity to take the lead on a new line of fully independent research in this critical area of public health,” said James Hildreth, Meharry’s president and CEO.

“Smoking has had disproportionately negative effects on minority, and particularly African-American, populations for decades. At Meharry, we have been on the front lines of treating those impacted by this scourge and see firsthand how smoking can destroy lives. Our goal is to help set a new course for education, prevention and policy surrounding the use of tobacco and e-cigarettes.”

The Juul grant comes on the heels of a New York Times report that Juul aggressively recruits scientists to prove to the Food and Drug Administration, and to the public, that “juuling” offers more public health benefit than risk.

ITG Brands has appointed Oliver Kutz as its president and CEO. He will replace Dan Carr, who has left the company to pursue other interests.

Kutz brings to the position 20 years of experience with Imperial Brands and reports directly to Dominic Brisby, Imperial Brands division director, Americas, Africa, Asia & Australia (AAAA). Previously, he was general manager of the company’s Russia-AAAA Division.

“Oliver Kutz brings a wealth of international experience in tobacco and next-generation products to ITG Brands,” said Brisby. “This will further drive our performance and build on our strong capabilities and world class brands.”

Kim Reed has joined the company as executive vice president—sales. Reed has almost 30 years of experience in the consumer-packaged goods industry, and reports directly to Kutz. Reed was previously with the Kellogg Co., where she was general manager of U.S. sales, and the Pepsi Bottling Group.

Oman will introduce a 100 percent tax on tobacco, alcohol and pork beginning June 15, with the electronic system for registering excise taxpayers going live the same day, reports The National.

This new tax is in line with the agreement struck between all six nations of the Gulf Cooperation Council and follows a royal decree by Sultan Qaboos bin Said.

In a statement reported by Oman’s national news agency ONA on Saturday, Sulaiman bin Salim Al Aadi, director-general of survey and tax agreements, said there will be a 90-day grace period to allow people and companies to register for the tax, which will come into effect once the grace period ends.

The new taxes could generate about OMR100 million ($260 million) annually.

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.”

Brad Winstead has been appointed the new head of Casa de Montecristo, a unit of Tabacalera USA.

Previously, Winstead served as head of marketing, Altadis USA (AUSA), and head of sales. He began his career at AUSA in July 2007 as a territory sales manager.

“We are very proud of Brad’s continued growth within the company,” said Javier Estadesa, head of Tabacalera USA. “We expect Brad will bring the same energy and passion to Casa de Montecristo that we’ve seen with his leadership of the AUSA marketing and sales teams.”

Luis Torres, former head of Casa de Montecristo, has left the company to pursue other opportunities.

The illicit trade in cigarettes caused EU governments to miss out on €10 billion ($11.28 billion) in tax revenues in 2018, according to the Project Stella Report.

Prepared by KPMG and commissioned by Philip Morris Products, the Stella Report notes that the EU black market for cigarettes was equivalent in size to the total legal cigarette sales in the U.K., Austria and Denmark combined.

Overall illicit cigarette consumption levels remained stable compared with the previous year; however, the report found a more than 30 percent increase in counterfeit consumption—the largest amount recorded to date.

“Beyond damaging government revenues, harming legitimate businesses and fueling crime in local communities, the availability of cheap, unregulated cigarettes on the black market undermines efforts to reduce smoking prevalence and prevent youth from smoking,” said Alvise Giustiniani, vice president of illicit trade prevention at Philip Morris International.

“For PMI to have impact in our drive to ‘unsmoke’ the world, we must sustain our combined efforts to eliminate illicit cigarette trade, while ensuring responsible access to better alternatives for the men and women who would otherwise continue to smoke.”

According to the report, illicit cigarette consumption in the E.U. in 2018 was 8.6 percent of total consumption, representing 43.6 billion cigarettes.