Category: News This Week

Juul ban sought
Schlesinger Law Firm has filed a motion for preliminary injunction asking a U.S. federal court in Florida to ban the sale of Juul electronic cigarettes across the United States. The firm says it wants halt “an epidemic of youth nicotine addiction that has surged due to the skyrocketing growth of Juul.”
Juul and other e-cigarette makers have not applied for or received FDA premarket authorization to sell their electronic nicotine devices, as required under the Tobacco Control Act.
“Under the law, companies must have regulatory permission before they can sell new tobacco products in the public space,” said Scott P. Schlesinger, an attorney at Schlesinger Law Offices in Fort Lauderdale.
“In 2017, the FDA granted makers of e-cigarettes a five-year extension to file for approval. Since then, sales of the product have exploded and created an epidemic.”
A federal judge in Maryland recently ordered the FDA to shorten that time “but that relief is insufficient to end the dramatic increase of nicotine addiction among youth,” says Schlesinger.
Citing independent research, the FDA says that 3.62 million middle and high school students used e-cigarettes in 2018. E-cigarette use jumped 78 percent among high school students from 2017 to 2018 and 48 percent among middle school students during the same time period.
“The motion to enjoin Juul from selling its products seeks only to treat the company as it should have been all along,” said Jonathan R. Gdanski, an attorney at Schlesinger. “You don’t get to sell a tobacco product, take over the marketplace and then ask for permission for that product after it is engrained in society.”
The FDA says that five brands, including Juul, control 97 percent of the U.S. market for e-cigarettes. Juul had 72 percent of the market in August, according to Nielsen. The company has forecast $3.4 billion in revenue this year, triple that in 2018.
In April, Schlesinger Law Firm filed a class-action lawsuit on behalf of a Sarasota County teenager, age 15, and her parents against Juul Labs and Altria Group, which owns Philip Morris USA, which claims in part that the plaintiff is addicted to the nicotine in Juul e-cigarettes. Altria holds a 35 percent interest in Juul.
The lawsuit, filed in U.S. District Court for the Middle District of Florida, seek damages under the RICO Act and for fraud, product liability and deceptive trade practices. It says that Juul and Altria/Philip Morris are violating federal racketeering laws by intentionally exploiting adolescents while falsely denying they are doing so.
According to Jeffrey Haberman, an attorney at Schlesinger Law Offices, “Juul knew that its e-cigarettes were unsafe for non-smokers and that the product posed a risk of aggravating addiction in those addicted to cigarettes.”
July 26, 2019
Investing in Cannabis
Imperial Brands will invest approximately CAD123 million ($94 million) in Auxly Cannabis Group, an international cannabis company, reports New Cannabis Ventures.
As part of the deal, Imperial will grant Auxly global licenses to its vaping technology as well as access to its vapor innovation business, Nerudia.
“This investment from Imperial Brands will enhance Auxly’s ability to continue to deliver on our business plans and accelerate our growth initiatives to expand our portfolio of branded derivative products,” said Hugo Alves, president of Auxly.
“The timing is ideal as we prepare to bring our portfolio of innovative cannabis products to the Canadian market following the legalization of edibles, extracts and topicals later this year.”

July 25, 2019
Advocating scientific transparency
Philip Morris International (PMI) has created an open online platform for sharing data, software and scientific protocols.
Called Intervals, the platform has been built to address what PMI describes as a scientific reproducibility crisis, and gather in a single place scientific data relating to modified risk tobacco products, also known as reduced-risk products.
Open to scientists from both academia and industry, and designed to enable third-party collaboration and analysis, Intervals follows the “FAIR” guiding principles for data sharing, i.e., data should be findable, accessible, interoperable and reusable.
Scientists are encouraged to add their own independent research to Intervals, thereby contributing to transparency in the field and increasing the visibility of their work.
“Across the life-sciences we see consistently low rates of the reproducibility of scientific research,” said Stéphanie Boué, scientific data transparency, PMI.
“Sharing data in a way that enables reanalysis and reuse is not yet done in a systematic manner, despite the fact that doing so would clearly benefit the scientific community and society in general.
“This is particularly true where the quality of science may be questioned due to the affiliations of researchers, funding sources or research topics. Tobacco harm reduction is one such area, and Intervals is a crucial resource to ensure full transparency and reproducibility of the scientific research being conducted in the field.”
Intervals includes full, standardized and extensively annotated datasets from a number of clinical and pre-clinical studies that PMI has conducted as part of the assessment of its MRTPs. These range from large in vivo inhalation studies, to novel in vitro studies using three-dimensional human tissue cultures, to clinical studies investigating the pharmacokinetics of different nicotine delivery systems.
The platform provides detailed information on study protocols and interoperable data files that allow independent reanalysis of key findings, meta-analyses and efficient data reuse. Alongside raw data, rich metadata are also provided to describe experiments, data production, data processing and additional relevant information. Each study, protocol, and dataset are assigned a unique DOI, making them easily findable and citable.
Many of the PMI-conducted studies that are included on Intervals have been reviewed through a novel and comprehensive panel review process organized independently by SciPinion of Bozeman, Montana, USA.
This has been done in addition to the traditional peer-review of study publications. Seven panels of five to 12 anonymous experts scrutinized publications and raw data, resulting in consistent support of the robustness of methods and results, and the validity of conclusions. Intervals facilitates such detailed reviews, allowing any interested party to independently evaluate data, methodologies and conclusions. In doing so, the platform is able to contribute to the review processes of regulatory bodies such as the U.S. Food and Drug Administration, while also allowing the reuse of data in the generation and testing of new hypotheses.
Scientists who wish to add their own research and data to Intervals can do so with no word or figure limit. Storage space is virtually unlimited, and they will be assigned DOIs as appropriate for the individual aspects of their contributions.
By sharing their research in the standardized Intervals format, scientist have the opportunity to make their data part of future meta-analyses and contribute to a new vision and strategy for transparency and reproducibility. Intervals also includes direct links to a number of powerful computational tools and resources, which are free for contributors to use for their own research purposes.
“Intervals is set to become an international hub for scientists with a common interest in tobacco harm reduction,” said Manuel C. Peitsch, chief science officer, PMI. “This includes scientists from industry, academia, not-for-profit research organizations and regulatory bodies. In working collectively, and with a commitment to transparency and reusability, the community can establish standards in data sharing and management which will lead to the optimization of research funds and the leveraging of research findings to enable effective evidence-based decision making.”
According to PMI, the need for innovative and concerted efforts to improve reproducibility is being increasingly acknowledged across the scientific community. The U.S. National Academies of Science, Engineering, and Medicine has recently published a report—Reproducibility and Replicability in Science—calling on researchers to “convey clear, specific, and complete information about any computational methods and data products that support their published results.” The Intervals concept can be applied in many other areas of societal concern. According to PMI, any field that deals with large and complex data could benefit from this approach as the issues concerning transparency, data reusability and reproducibility are general across the sciences.

July 24, 2019
Vaping aids cessation
A new study from the Massachusetts General Hospital’s Tobacco Research and Treatment Center found evidence demonstrating that using e-cigarettes daily helps U.S. smokers quit smoking combustible cigarettes.
Using data from more than 8,000 adult smokers, the investigators measured how likely a smoker was to quit smoking and remain off combustible cigarettes, comparing daily and non-daily e-cigarette users with those who only smoked combustible cigarettes.
They found that smokers who used e-cigarettes every day, compared with e-cigarette nonusers, were more likely to quit combustible cigarettes within one year and to stay off them for at least another year. They also found that smokers who used e-cigarettes were no more likely to relapse back to smoking combustible cigarettes than smokers not using e-cigarettes.
“This finding suggests that smokers who use e-cigarettes to quit smoking need to use them regularly—every day—for these products to be most helpful,” said the study’s lead author, Sara Kalkhoran.
July 24, 2019
Anti-vaping ads released
The U.S. Food and Drug Administration (FDA) is releasing its first anti-vaping television ads Monday targeting teens as part of its “The Real Cost” youth e-cigarette prevention campaign. A statement said ads will run on ESPN, TeenNick, CW and MTV, along with music sites and social media.
The ads, titled “Magic,” feature street magician Julius Dein turning teens’ vapes into cigarettes.
“Did you know that if you vape, you are more likely to start smoking cigarettes?” Dein asks a group of young people after the e-cigarette in one teen’s hand disappears and is replaced by a cigarette. “It’s not magic, It’s statistics.”
The FDA will also distribute posters for high school bathrooms in the upcoming school year with anti-vaping messages.
“You might as well flush your lungs while you’re at it,” one poster reads. “Vaping can deliver toxic metal particles like nickel, lead and chromium directly into your lungs.”
July 23, 2019
New CEO
British American Tobacco (BAT) Korea has named Kim Eui-soung as its new CEO, according to The Korea Times.
He replaced Matthieu Juery who has been leading the brand here for the last two years.
As the first Korean to become the CEO of BAT Korea, Kim will be responsible for managing operations as well as leading both domestic and international businesses.
Under Kim’s leadership, BAT Korea aims to implement a strong corporate culture by catering to the sophisticated needs of Korean customers and diversifying the company’s product portfolio.
“I’m honored to serve as CEO of BAT Korea with a great team full of passion and commitment for growth,” Kim said in a statement.
July 23, 2019
Smokers threatened
Philippines President Rodrigo Duterte slammed cigarette smokers during his fourth State of the Nation Address saying, “They should be exterminated from the face of the earth.” He also called on Congress to further raise the tax on tobacco and alcohol because of its negative effects on health.
“I am also asking Congress to pass the remaining packages of my administration’s tax reform program,” Duterte said, referring to excise tax on tobacco and alcohol.
However, Senator Imee Marcos opposed Duterte’s call to increase taxes on tobacco, one of the primary products of her home province of Ilocos Norte. Marcos said current taxes imposed on tobacco products should be enough.
July 23, 2019
Nicotine expert joins Juul
Juul Labs has hired Mark Rubinstein, a prominent University of California researcher known for his work on the risks nicotine poses for the adolescent brain, as its medical director, reports The Los Angeles Times.
Juul Labs said the hiring will support its efforts to stem a teen vaping craze that the FDA has labeled an epidemic.
In a statement, Juul Labs said Rubinstein would oversee research on underage use of vapor products, guide the company’s youth prevention programs and policy positions and help form links with the public health community.
Colleagues of Rubinstein, however, said they were disturbed by the move and skeptical of Juul Labs’ motivation. At the heart of their concern is whether Juul Labs is willing to lose the giant base of teen users who have helped fuel the company’s meteoric rise and hefty market share.
“Even if you believe in harm reduction,” said Stanford University professor Bonnie Halpern-Felsher, “to go work for a tobacco company, to me, goes against everything that anybody doing control should believe in.”
July 22, 2019
Retailers unprepared
Thousands of tobacco retailers in the United Kingdom have yet to apply for their mandatory track-and-trace codes, without which they will soon be unable to buy tobacco legally, reports Convenience Store.
Track-and-trace compliant tobacco packs feature unique identifiers and security measures.
Unitas Wholesale senior trading controller Jim Brown said there were reports that “as little as 30 percent of retailers have registered” for their codes so far.
The Federation of Wholesale Distributors (FWD) echoed the call for retailers to act now and register.
“As track-and-trace marked stock arrives on the market, retailers need to be aware that they cannot make purchases from a wholesaler unless they have the necessary economic operator identifier code and facility codes for each of their premises,” FWD chief executive James Bielby said.
“Without these, they will only be able to purchase older non-marked packs, which will sell through quickly on the most popular brands,” Bielby said. “The authorization can’t be issued immediately, and we don’t want retailers to turn up at their wholesaler and be unable to buy the stock they need.”
July 22, 2019
Application accepted
The U.S. Food and Drug Administration (FDA) has accepted and filed for substantive scientific review the 22^nd Century Group’s modified-risk tobacco product (MRTP) application for its Very Low Nicotine Content (VLNC) cigarettes under the proposed brand name of VLNTM.
22nd Century Group’s proposed VLNTM cigarettes are made with the company’s proprietary VLNC tobacco and, as a result, contain very low levels of nicotine.
“The FDA acceptance and filing of our MRTP application marks an important milestone in our mission to reduce the harm caused by smoking,” said Michael Zercher, chief operating officer of 22nd Century Group.
“We look forward to working with the FDA as the agency enters the next phase of its review process for our historic application.”

July 22, 2019