The abolition of Public Health England (PHE) puts at risk staff who specialize in tackling alcohol abuse, obesity and smoking, according public health experts.
Earlier this week, U.K. Health Secretary Matt Hancock announced that PHE was being scrapped and merged into a new National Institute for Health Protection alongside National Health Service Test and Trace and the Joint Biosecurity Centre.
PHE had come under fire for its performance in the coronavirus crisis, but critics suspect government officials view the agency as a convenient scapegoat for flawed decisionmaking in the early weeks of the coronavirus crisis.
The timing is also controversial. “It’s an incredibly stupid move,” a health official told The Economist. “We’re in the middle of a pandemic.”
PHE was created in 2013 with responsibilities including preparing and responding to health-related emergencies, such as pandemics. It currently employs around 5,500 full-time staff made up mostly of scientists, researchers and public health professionals.
In the nicotine business, PHE is best known for its 2015 assertion that vaping is 95 percent less harmful than smoking. The agency has been credit with Britain’s comparatively pragmatic vapor policies and progressive attitude toward tobacco harm reduction.
Turning Point Brands (TPB) has appointed Brittani Cushman as general counsel, effective Oct. 31. James Dobbins, TPB senior vice president, general counsel and secretary, will retire that day following more than 20 years leading the company’s legal and governance functions.
Cushman currently serves as senior vice president of external affairs in the company’s legal department. She joined TPB as director of external affairs in 2014. During her tenure with the company, Cushman has been a key driver of initiatives related to the company’s policy strategy and regulatory filings along with advising on significant acquisitions, TPB wrote in a statement. Prior to joining TPB, Cushman served as general counsel at a privately held tobacco product manufacturer.
“James has been an invaluable resource for our growing organization during his tenure with the company, including the successful initial public offering in 2016,” said Larry Wexler, president and CEO of TPB. “The board of directors and executive team thank James for his leadership and service to the company. I am particularly pleased that he has agreed to remain with the company in a consulting role.”
Cushman will assume the role of deputy general counsel immediately, working with Dobbins to ensure a seamless transition ahead of his departure.
“Brittani has been a critical piece of our leadership team,” Wexler commented. “Since joining the company, her unique skillset and forward-thinking contributions have strengthened the business. Brittani’s ability to diagnose and respond to evolving legal landscapes will be a significant factor to our continued success.”
South Korea’s Ministry of Health and Welfare (MOHW) said it would double the national health promotion tax on e-liquids for electronic cigarettes. The health tax for e-liquid is currently won525 ($0.46) per milliliter of nicotine solution. It will jump to won1,050, on Jan. 1, 2021.
The increase is in keeping with other tax hikes, including special tobacco consumption tax, according to an article in the Korea Biomedical Review. Cigarettes manufactured using parts other than the leaves of tobacco, which currently are not subject to taxation, will also be included in the health promotion tax.
Cigarettes made and stockpiled before the amendment come into effect will also be subject to the new health, to keep makers from making inventory profits.
The health authorities will listen to public opinions during the legislative notice period and finalize the proposal. It will submit the amendment to the National Assembly after undergoing a regulatory and legislative review, according to the article.
The U. S. Customs and Border Protection is cracking down on illegal vape products. Customs officers seized more than $200,000 worth of unapproved disposable products destined for western Pennsylvania on Aug 11.
Customs officers at the Port of Philadelphia since June, have racked up 48 combined seizures worth an estimated $444,000, according to news reports.
According to customs, eight shipments of counterfeit and unapproved e-cigarettes destined to Bucks, Chester and Delaware counties were seized at the Port of Philadelphia between June 4 and Aug. 11.
The shipments included 30,400 e-cigarette pods under brand names Eonsmoke, Pop, Puff, and St!k and Bidi.
All of the products were shipped directly from China or Hong Kong, according to reports.
The U.S. Food and Drug Administration issued warning letters notifying ten companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.
These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use
Blackbriar Regulatory Services (BRS), a firm specializing in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, is expanding.
The company announced today that it is growing its facility and services to meet increasing client demand. Immediate expansion efforts include adding cleanroom manufacturing space, increasing its analytical capabilities and expanding regulatory service offerings.
“With the [U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline approaching within weeks for existing nicotine-based vaping products currently on the market, we are now seeing an increase in PMTA demand for new, innovative nicotine-based vaping products,” said Russ Rogers, CEO at BRS. “The FDA rightly worked with the industry to pause and take a look at the appropriateness of the products on the market, and those companies who understand how to make the highest-quality products are in a position to start working on applications for next generation technologies that should create dramatically improved user experiences and step-wise safety improvements.”
BRS was established to address challenges such as those that the PMTA process creates for manufacturers and brand holders. Its unique business model and capabilities provide numerous cost and speed advantages to clients who are looking for solutions to keep their products on the market in the United States, according to Rogers.
BRS is under contract to file more applications before the Sept. 9, 2020, deadline for several U.S. and international customers, and is now starting to prepare PMTA submissions for next generation nicotine-based vaping products for companies that are seeking to revitalize their product portfolio after the recent industry-wide focus on obtaining approval for legacy products.
Post Market Surveillance is an integral and mandatory commitment manufacturers must make to the FDA as part of their PMTA submission. BRS has also expanded its capabilities in this area to service clients both domestic and international to help them remain compliant in this regard, according to Rogers.
Juul and Juul pods will now move into the substantive review phase of the premarket tobacco product application (PMTA) process. Juul Labs has received acceptance and filing letters from the U.S. Food and Drug Administration (FDA) for its battery and nicotine cartridges, the company announced Tuesday.
Juul Labs filed the applications last month and all PMTA applications are due to the FDA by Sept. 9. The company’s submission includes “comprehensive scientific evidence for the Juul Device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5 percent, 3 percent and information on data-driven measures to address underage use of its products.
“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 Juul Labs Chief Regulatory Officer Joe Murillo in a statement.
Tasmanian smokers and the health system would save big dollars if vaping using nicotine was legalized, according to The Australian Retail Vaping Industry Association (ARVIA). The group has also suggested Tasmania could gain new businesses and jobs if it was the first jurisdiction to make the move, with much of an estimated $438 million per year spent overseas by Australian vapers being spent in Tasmania.
ARVIA said member surveys showed at least 70 per cent of Australian vape businesses would consider establishing in Tasmania and creating new jobs if the state was “first mover”.
“Legalising vaping would be a win-win-win for Tasmania’s health, jobs and economy,” ARVIA spokesman Russell Zimmerman said, according to an article in The Examiner. “With the second highest smoking rate in Australia … every measure which helps Tasmanians give up traditional cigarettes offers significant health benefits.”Zimmerman said research had shown vaping was up to 95 per cent less harmful than smoking.
He said that had led to many developed nations legalising and regulating it as a proven way to help people quit cigarettes. “Studies from New Zealand forecast the country is set to see health system savings of $720 per citizen from their liberalised approach to vaping, savings which I’m sure most would agree would be very welcome in Tasmania,” Zimmerman said.
The owner of the Prism e-liquid brand, 511 Solutions, announced today that it has filed its first premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA). The application was accepted by the FDA and has now moved to the substantive scientific review phase.
All Prism e-liquids are manufactured by Blackbriar Regulatory Services (BRS) in an ISO class 6 cleanroom, tested in an ISO 17025 laboratory, according to a press release. In compliance with FDA guidelines, Prism e-liquids will be allowed to remain on the market during the FDA review process while waiting for a marketing order.
“When 511 Solutions created this e-liquid line, their goal was to create something really special and to do it right the first time,” said Don Hashagen, sales agent for Prism e-liquids. “They invested an enormous amount of resources into creating high-quality nicotine products for adult smokers looking for alternatives. And, partnering with BRS was a natural choice. Having the ability to streamline the manufacturing, distribution and regulatory needs all under one roof has been a huge win for 511.”
The PRISM brand represents three unique, high-quality e-liquid lines with a total of 19 flavors going through the PMTA process, according to the release. The flavor profiles range from tobacco, menthol, fruits and bakery in a variety of nicotine strengths.
Contrary to what its authors suggest, a recent study led by Stanford University fails to demonstrate a causative relationship between vaping and Covid-19 infection, according to the U.K. Vaping Industry Association (UKVIA).
Researchers at the Stanford University School of Medicine recently found that among young people who were tested for the coronavirus, those who vaped were five times to seven times more likely to be infected than those who did not use e-cigarettes.
“Whilst we welcome any research which can assist people in staying safe during the Covid-19 pandemic, the UKVIA is disappointed by the Stanford-led study which appears to dismiss the vital harm-reduction role of vaping for smokers. The study draws disproportionate conclusions, is fundamentally flawed and inconclusive,” said John Dunne, director of the UKVIA.
“While the leader of the study, Dr. Shivani Gaiha, has attempted to account for study participants ‘sheltering in place,’ this metric is self-reported and as such may be unreliable.
“Dr. Gaiha’s study also considers ‘ever-use’ to indicate that a person is a vaper. When this is corrected for those who were vaping within 30-days of a Covid-19 diagnosis, the connection between vaping and the virus is no longer significant. To suggest that any use of a vaping product dramatically increases the chances of contracting Covid-19 is therefore a gross exaggeration.”
“Furthermore, the UKVIA is concerned to see the researchers taking a partial approach to this research and calling upon regulation as a result of dubious findings. Putting such a call out on the back of the research seriously calls into question its purpose.”
Dunne also noted that the issue of youth vaping observed in some other countries is not representative of the situation in the U.K.
Several vapor companies have stepped up during the Covid-19 crisis to help the communities they serve.
By Timothy S. Donahue
The vapor industry has produced millions of bottles of hand sanitizer during the Covid-19 pandemic. Several e-liquid manufacturing companies redesigned their production lines to help replenish one of the most-needed products since safety protocols to help slow the virus began in March. Manufacturers and retailers then donated much of the product to frontline organizations in need such as hospitals, police departments and nursing homes across the U.S.
Turning Point Brands (TPB) was one of the first companies to start producing hand sanitizer. The company said it expected to produce 6,600 liters of hand sanitizer for hospitals and retirement communities. TPB repurposed select manufacturing infrastructure to produce the free hand sanitizer for communities in California, Kentucky and Tennessee, according to the company.
“Our company takes very seriously our role in providing support to the communities where we operate. We hope that through this action we can both help those impacted by the Covid-19 situation and inspire others to act,” said Larry Wexler, president and CEO of TPB.
E-Liquitech was another company that repurposed infrastructure to produce hand sanitizer. George Cassels-Smith, president of E-Liquitech, said that his company teamed up with bottling partner C&C Bottling, which also manufactures several over-the-counter drugs. “We are producing about 11,000 gallons of hand sanitizer a day, six days a week,” said Cassels-Smith. “We had some extra equipment as well that we are using strictly for sanitizer production.”
Maryland-based E-Liquitech donates several hundred gallons of hand sanitizer to local hospitals in Maryland every week. The company plans on continuing to produce hand sanitizer and has now teamed up with several major distribution companies in order to resupply depleted store shelves. Cassells-Smith says it was just the right thing to do.
“There was a need and we had the ability to help out, so we put a plan in place and acted on it,” he says. “You are going to see people cleaning their hands with hand sanitizer for a long time. It’s going to be the new normal.”
In Virginia, Avail Vapor donated more than 5,000 masks to the Virginia Department of Emergency Management to help medical professionals on the frontlines of the coronavirus battle protect themselves.
James Xu, CEO and chairman of Avail, said that the idea came to light early in the pandemic when Avail employees heard about the shortage of masks in China when Covid-19 initially struck. Avail works closely with many Chinese suppliers, and Avail employees wanted to support these suppliers in their time of need. When the virus began impacting the United States, those same Chinese colleagues returned the generosity and shipped thousands of masks to Avail head-quarters for employees and healthcare workers.
“To be successful, our business has always been highly collaborative with global partners,” said Xu. “To see our employees proactively answer a need for their Chinese counterparts was special. Now we are so grateful to our Chinese friends for helping us defend our citizens in this pandemic.”
LCF Labs, a Southern California-based e-liquid manufacturer, also began producing sanitizer. The company donated 100,000 bottles and is co-packing up to 20 million bottles with a distributor for Costco, Walgreens and other large retailers. River Supply Company has produced 10,000 bottles of hand sanitizer to date for local hospitals and nursing homes in California. Mr. Salt-E donated 10,000 bottles to e-liquid manufacturers that are producing hand sanitizer.
In Ohio, James Jarvis, who owns three vape shops, donated several hundred bottles of hand sanitizer to local police departments. Jarvis said that recipients of the sanitizer were genuinely pleased and excited. Tony Abboud, executive director for the Vapor Technology Association (VTA), a vapor industry advocacy group, says that his organization was informed of numerous examples of the vapor industry joining together to combat the coronavirus.
“[The] VTA has been working to support our member companies, which have stepped up to manufacture, bottle and distribute much needed hand sanitizer throughout our communities. [The] VTA is working with its members to source additional materials to further expand the great work already being done,” said Abboud in an email. “We are all in this together, and we are so proud of the way our community has rallied together to help get our nation through this public health crisis.”
Several China-based manufacturers also donated supplies to those in need. Relx Technology announced the extension of the Relx “For You With Care” project to support its inter-national partners during the Covid-19 crisis. Relx initially sent 78,200 masks and over 515 gallons of hand sanitizer to its global distributors, partners and store owners.
Credit: Praveen Kumar
“Relx is wholly committed to supporting the well-being of our employees, partners and store owners during the Covid-19 pandemic. As a global startup, we are doing what we can to help our global community. We hope our modest donation will help them during these trying times,” said Relx founder and CEO Kate Wang.
Abboud says he isn’t surprised by the generosity of the vapor industry. After all, the industry is founded on the principle of harm reduction and ending the 400,000 deaths caused every year by combustible cigarettes.
“We are incredibly proud of the vapor industry for stepping up, even as their own businesses continue to confront the economic fallout of this crisis,” said Abboud. “Vapor companies haven’t hesitated to take a leading role in their communities, making a difference in innovative and impactful ways. Their commitment to service is no surprise given that these business owners have made it their mission to support smokers and former smokers as they transition away from deadly cigarettes.” V
The companies mentioned in the article aren’t the only ones practicing good corporate social responsibility. The list of vapor companies helping their communities is long. While we can’t possibly name them all, here are just a few more examples, courtesy of the Vapor Technology Association:
• Lakes Vape and Rec Supply donated 363 bottles of hand sanitizer to fire departments, nursing homes and businesses in their Minnesota community, including UPS and FedEx. • Madwell Collective has produced 6,340 gallons of hand sanitizer to date.• Ripe Vapes has produced 500,000 bottles of hand sanitizer to date, donating one of every two bottles sold VapeRite has produced 12,000 bottles of hand sanitizer to date for first responders and food delivery workers in Atlanta, Georgia.
• Mech Sauce produced 1,500 bottles of hand sanitizer for the local U.S. Postal Service and seniors in Virginia.
• Chubby Gorilla donates empty bottles to be filled with hand sanitizer for distribution. • Midnight Manufacturing produces 300,000 bottles weekly to support hand sanitizer distribution efforts. • Mob Liquid is committed to producing 10,000 bottles of hand sanitizer weekly. • EjuiceBLVD is producing 6,000 to 7,000 bottles of hand sanitizer weekly. • Euless Vapor donated 150 bottles to their local fire and police departments in Texas. • USA Vape Labs has produced 5,000 gallons of hand sanitizer for local nursing homes, local medical facilities and government employees. • Boosted Juice donated 600 bottles to local police departments in Colorado.
