Category: News This Week

Scott Gottlieb Key Voice in Pandemic
Scott Gottlieb
Scott Gottlieb, former U.S. Food and Drug Administration (FDA) commissioner, has been a consistent voice from outside the Trump administration advising on the coronavirus outbreak, according to an article on MSN.
Gottlieb has been informally advising the coronavirus task force, and he recently supplied Trump with a “roadmap,” created by him and other experts, outlining when and how the U.S. can begin returning to more normal daily activity.
He warned the administration in January that the coronavirus would spread to the U.S. and later warned that it would become a pandemic before the World Health Organization declared it so. Despite his early warnings going unheeded, Gottlieb has not criticized the administration but has “offered sharp words for officials and states when he disagreed with their policies,” according to MSN.
“He’s not going to shade his views and say something that people want to hear or that might make a headline,” said Mark McClellan, a former FDA commissioner who hired Gottlieb under the George W. Bush administration. “He’s just trying to be straight up about the critical things that need to be done to respond to the pandemic. It’s not about making a name for himself or saying something that is controversial or critical just for the sake of it. It’s really with this kind of constructive goal in mind. I’ve seen that the entire time we’ve worked together.”
Vice President Mike Pence, the coronavirus task force lead, said he had “great respect” for Gottlieb, and Trump noted that he “did a great job at [the] FDA.” Pence confirmed that Gottlieb has been advising the task force.
Others seem to take Gottlieb’s advice to heart as well—after he released the “roadmap” to the task force, the U.S. Centers for Disease Control and Prevention changed their decision on nonmedical face masks, saying the public should wear some sort of face covering when out. After Gottlieb said that the U.S. recovery would depend on states like Texas and Florida, where officials had been pushing back against lockdowns and social distancing, being more aggressive, the Florida governor issued a stay-at-home order.
April 7, 2020
ITSA Initiates Recruitment Campaign to Fight Fraudulent Trade
The International Tax Stamp Association (ITSA) is recruiting new members, including government authorities, universities, foundations, nongovernmental organizations (NGOs) and other associations, who can help fight the fraudulent trade of tobacco, alcohol and other products.
All prospective associate members must have a legitimate and established interest in tax/security stamps or secure track-and-trace systems. Associate membership is not open to individuals or to organizations that collaborate significantly with manufacturers, distributors or sellers of excisable products or with their subsidiaries and associates.
“We want to increase our influence in the fight against the illicit trade of tobacco and other products by forging closer links with NGOs, research bodies, government authorities and other key bodies,” said Juan Carlos Yanez, chairman of the ITSA. “Tobacco fraud in particular leads to a rapid increase in poor health and costs revenue authorities millions of pounds in lost excise duty.”
April 6, 2020
Philter Labs Gets $1 Million in Vapor Filter Funding

Credit: PhilterLabs
Philter Labs, a San Diego-based technology company that produces micro-sized air filters to help reduce the impacts of secondhand smoke, announced it has received $1 million in new investments.
The capital will be used for research and development, building out an extensive product roadmap, and launching what the company says will be first-of-its-kind personal filtration products, according to an article on Benzinga.com.
This new round of funding brings Philter’s total to $3 million. Bravos Capital and Explorer Equity both participated in the effort.
Philter Lab’s patented zero-5 technology utilizes a five step filtration process that manipulates smoke and vapor at the molecular level to dissipate up to 97 percent of emissions and dissolve harmful particulates and pollutants. Also unique to Philter is it’s pocket-sized design, allowing for ease of use and portability.
For over 20 years, the team behind Philter has been working to solve major medical problems, and identify consumer-centric solutions for common issues. Philter also aims to help re-frame popular associations behind controversial human behaviors, according to the article.
Philter’s technology encourages consumers to practice responsible vaping and empowers them to protect those they love, and the environment, by drastically reducing harmful emissions and airborne contaminants. The company’s overarching mission is to change the way people perceive vaping tobacco and cannabis.
CEO Christos Nicolaidis told Benzinga the goal at Philter Labs is to eliminate the impacts of secondhand smoke and harmful emissions while empowering consumers to vape responsibly, according to the article.
“This new series of funding builds on our momentum and will allow us to expand on our scientific research and launch new innovative, cutting-edge filtration products,” Nicolaidis said. “We want to lead the charge on a cultural shift for cleaner air and a better environment — and hopefully change the way people vape for the better.”
April 6, 2020
U.S. FDA to Announce Sept. 9 PMTA Deadline

While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.
Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.
The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.
For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.
April 4, 2020
U.S. House Subcommittee Asks FDA to Ban Vapor

Photo: Srdjan Randjelovic | Dreamstime.com
In what turned out not to be an April Fool’s Day joke, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter urging the U.S. Food and Drug Administration (FDA) to use its authority to clear the market of e-cigarettes for the duration of the coronavirus pandemic and use all available tools to encourage Americans to stop smoking and vaping.
Earlier this week, FDA asked a federal court to delay by four months its order requiring e-cigarette manufacturers to submit applications to remain on the market by May 12, 2020, according to a statement from, according to a statement for the House Committee on Oversight and Reform.
The Subcommittee did not oppose this request, but instead asked FDA to take the following steps for the duration of the coronavirus crisis:
(1) use all available tools to encourage Americans to stop smoking combustible cigarettes and using e-cigarettes;|
(2) suspend all approvals of Premarket Tobacco Product Applications; and
(3) commit to immediately clearing the market of all e-cigarettes by prioritizing enforcement against them.
April 2, 2020
U.K. Vape Shops Closed; Factories, Online Sales Remain Open

Credit: VPZ
The U.K. Vaping Industry Association (UKVIA), the country’s largest trade body representing the vapor sector, has moved to reassure vapers and smokers that the industry is still very much “open for business” despite the closure of shops following the government’s lockdown.
In addition to online retailers and manufacturing facilities operating as usual, physical store owners are focusing on ramping up their e-commerce operations via their websites, with others setting up home delivery services.
“Vaping businesses are by nature extremely entrepreneurial and agile and a number are repurposing their business models to continue to serve their customers,” said John Dunne, a director at the UKVIA. “Specialist online retailers are also reporting significant increases in demand during the lockdown.”
“It is critical during these highly stressful times that vapers have access to vape products to prevent them from taking the backward step and reverting to smoking. Likewise, it enables smokers looking to quit to switch to vaping.
“The UKVIA has published a list of its retail members who provide online and home delivery services so that vapers and smokers can simply access vape devices and e-liquids during the lockdown period.”
The UKVIA has issued a guide to coronavirus for all its members that not only provides government guidance but also highlights a range of best practice health and safety measures to implement in the workplace to ensure the wellbeing of workers and customers.
April 1, 2020
BAT Working on Potential Covid-19 Vaccine
British American Tobacco’s (BAT) U.S. bio-tech subsidiary, Kentucky BioProcessing (KBP), is developing a potential vaccine for Covid-19 and is now in pre-clinical testing.
BAT hopes that if testing goes well, between 1 million and 3 million doses of the vaccine could be manufactured per week beginning in June. The work is intended to be carried out on a not-for-profit basis.
The potential vaccine uses BAT’s proprietary, fast-growing tobacco plant technology, which is potentially safer than conventional vaccine production technology because tobacco plants can’t host pathogens that cause human disease. This technology is also faster because the elements of the vaccine accumulate in tobacco plants more quickly (six weeks in tobacco plants versus several months using conventional methods). The vaccine formulation also remains stable at room temperature unlike many conventional vaccines that require refrigeration. A single dose has the potential to deliver an effective immune response.
In 2014, KBP was one of the few companies that created an effective treatment for Ebola, ZMapp, in conjunction with Mapp BioPharmaceuticals and the U.S. Biomedical Advanced Research and Development Authority.
KBP was recently in headlines for cloning a portion of Covid-19’s genetic sequence, leading to the development of a potential antigen. The antigen was then inserted into tobacco plants for reproduction, purified once plants were harvested, and is now undergoing pre-clinical testing.
BAT is exploring partnerships with government agencies to bring the vaccine to clinical studies as soon as possible. “We are engaged with the U.S. Food and Drug Administration and are seeking guidance on next steps,” said David O’Reilly, director of scientific research at BAT. “We have also engaged with the U.K.’s Department for Health and Social Care and BARDA in the U.S. to offer our support and access to our research with the aim of trying to expedite the development of a vaccine for Covid-19.
“Vaccine development is challenging and complex work, but we believe we have made a significant breakthrough with our tobacco plant technology platform and stand ready to work with governments and all stakeholders to help win the war against Covid-19. We fully align with the United Nations’ plea for a whole-of-society approach to combat global problems,” he said.
April 1, 2020
Vype Debuts Week-Long Virtual Music Series

Credit: Acantha Lang Music
As a growing list of music gigs are being cancelled or postponed, musicians are still eager to connect with their fans. British American Tobacco’s (BAT) Vype brand has launched a week-long, live music series from musician’s homes.
Each performance will feature intimate conversations with up-and-coming musicians about how they find inspiration at home along with a one of a kind live music shows, according to a Vype press note. Playing songs of resilience and hope, this free musical series is designed to inspire creative ways to connect while at home. The series will take place on Tuesday, Thursday and Friday and will be streamed on Vype_worldwide Instagram page.
“We are committed to bringing inspiration to as many of our adult consumers as we can across the globe,” says Elly Criticou, Vapour Category Director, British American Tobacco. “We are excited to continue to offer unique experiences that encourage people to find different ways to stay in touch with each other.”
The music series will kick-off this week with New Orleans-born Acantha Lang on Tuesday 31^st March at 5pm GMT; followed by composer and pianist Okiem on Thursday April 2^nd at 5pm GMT and finishing the week with singer Lil Rice on Friday April 3^rd at 5pm GMT. Performances will feature a range of musical genres including blues and soul, cinematic classical and country rock.
March 31, 2020
Relx Receives Red Dot Award
Relx Technology has been awarded the Red Dot Award: Product Design 2020 for its latest e-cigarette, Relx Infinity. The Red Dot Award is awarded to products that feature exceptional design.
The Red Dot Award: Product Design is one of the world’s largest design competitions. The international jury comprises experienced experts from different disciplines and has been convening for more than 60 years. True to the motto “In search of good design and innovation,” their assessment focuses on criteria such as innovation, functionality, formal quality, longevity and ergonomics.
Unveiled in Shenzhen, China, in January, Relx Infinity is the company’s latest product.
March 31, 2020
U.S. FDA Asks District Court for PMTA Extension

The US Food and Drug Administration (FDA) has submitted a letter to the U.S. District Court for the District of Maryland asking Judge Grimm to extend the May 12, 2020 court-ordered PMTA deadline by 120-days to September 9, 2020 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”
The FDA explained in its submission that “the global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework.” In addition, FDA explained that telework also will complicate and delay FDA’s review of applications, according to a release by the Vapor Technology Association (VTA).
In deciding to request a 120-day extension, the FDA noted that it had received requests from numerous trade associations and companies, including consultants involved in the PMTA process, for extensions “between 8 weeks and 180 days, with the majority of requests for 180 days.” The VTA was one of those entities that submitted a request to FDA and did so on March 20, 2020 outlining the basis and necessity for deadline extensions for large manufacturers and small manufacturers.
At this point in time, no one can predict the length and severity of the COVID-19 commercial shutdown. The FDA explicitly recognized this point in the Second Declaration of Director the FDA’s Center for Tobacco Products (CTP) Mitch Zeller which accompanied the letter to the Court.
In his Declaration, Zeller stated that “it is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.”
That is precisely why VTA requested a new deadline of November 2020 (or at least 180 days from business resumption) for large manufacturers, and a new deadline of February 2021 (or at least 270 days from business resumption) for small manufacturers, according to the VTA statement. “To that end, VTA explained that ‘the question of whether these deadline changes are sufficient or ultimately realistic can and must be re-evaluated in the coming months as more information comes to light about the length and severity of the commercial shutdown due to COVID-19.’”
In its letter to the District Court, FDA notes that the plaintiffs (American Academy of Pediatrics, et al.) will not oppose the FDA’s request, though the plaintiffs have requested the opportunity to “express their misgivings about the extension on the record.” In order to rule, Judge Grimm still will have to have the case remanded to him by the Fourth Circuit and then he would need to make his decision on whether or not to grant the FDA’s request.
However, given the strong case made by the FDA, the obvious insurmountable obstacles created by the coronavirus, and the apparent lack of opposition by the plaintiffs, a ruling extending the deadline is reasonably likely though still not certain.
March 31, 2020