Category: News This Week

British American Tobacco has said that it will continue to work with the US Food and Drug Administration as the agency advances new policies aimed at preventing youth access to flavored tobacco products.

The FDA Commissioner Scott Gottlieb, MD, yesterday made a statement on preventing young people from obtaining such products; as described on this website yesterday under the heading Haste urged.

“We welcome the FDA … shining a spotlight on the important issue of youth access to vapor products,” a BAT spokesperson was quoted as saying in a note posted on the company’s website. “We have always been clear that youth should not use vapor products and have had stringent measures in place to address this for some time.

“In relation to today’s announcement, we share the FDA’s concerns that some flavors, such as those resembling ‘kid-friendly’ food products, may play a role in increasing youth appeal and that marketing activities should not be directed to youth. We have never marketed such vapor flavors; we have supported measures to remove vapor products intended to mimic children’s food products or otherwise designed to target youth and have procedures in place to ensure our products are only marketed to adult tobacco consumers.

“We believe flavors are important in helping adult smokers migrate away from cigarettes, and the flavors we market are directed at helping adult smokers who are looking for a potentially less harmful alternatives to cigarettes.

“We already have third-party age verification processes for online sales. We will work with our many convenience retailers to ensure that tobacco, mint and menthol, which are our top selling flavours, remain available for consumers who are looking for potentially less harmful alternatives to cigarettes. We also have plans to make our flavored products available in other age restricted locations, including in specialist vape stores. As with all our retail partners, we will work with any new partners who stock our products to ensure they have appropriate age verification mechanisms.

“In respect of the proposals on bringing forward the PMTA [FDA pre-market tobacco applications] date for flavored products, given our years of product development and scientific assessment of our vapor products, we are well-positioned to file PMTAs for our VUSE products and plan to do so ahead of the 2021 deadline.

“We will continue working with the FDA as the agency moves this proposed compliance change forward over the coming weeks. We will be submitting comments for the FDA to review and consider as the agency works to finalise the guidance document.”

Philip Morris International has said that the results of a new study add to the existing evidence that switching smokers to smoke-free products can be part of a successful tobacco-harm-reduction strategy for adult smokers worldwide.

The study was conducted on mice, which were exposed to air, cigarette smoke, or three formulations of e-cigarette vapors for three hours/day, five days/week for six months via a ‘whole-body inhalation system’ [a whole-body inhalation system, though not necessarily the one used in the study, is described here].

In a note posted on its website yesterday, PMI said that it had presented ‘today’ the results from a new study on electronic cigarettes at the 58th Annual Society of Toxicology Meeting in Baltimore.

‘The study demonstrates that after six months, e-cigarette vapors with and without nicotine induced a significantly lower biological responses associated with cardiovascular and pulmonary diseases than cigarette smoke,’ the note said.

‘The study, conducted in collaboration with Altria Group, Inc., assessed the biological response of mice exposed to e-cigarette vapors compared with that of exposure to cigarette smoke.

‘According to the World Health Organization, there are more than one billion people worldwide who smoke cigarettes and will continue to smoke in the foreseeable future. ‘Tobacco harm reduction can play an important role by supplementing existing tobacco control strategies to help reduce the risk of smoking-related diseases.

‘For harm reduction to be successful, current adult smokers need access to smoke-free products that deliver nicotine but with significantly lower levels of toxicants than cigarettes.’

Dr. Julia Hoeng, PMI’s director of systems toxicology was quoted as saying that the results of the study comprised “a powerful addition to the evidence showing that switching to e-cigarettes is a much better choice than continuing to smoke”.

“This study truly is a landmark study, not just demonstrating the reduced toxicity and disease risk between e-cigarettes and cigarettes but also evaluating the role of nicotine and flavors.”

The U.S. market for cannabidiol (CBD) oil is about to explode, and Criticality, an integrated industrial hemp company, is in a prime position to serve it. On March 12, the company inaugurated a 55,000-square-foot, state-of-the-art extraction and purification facility in Wilson, North Carolina, USA. In a ceremony attended by employees, business partners and press representatives, senior management and local dignitaries cut a ribbon and wrote a new chapter in Criticality’s remarkable history.

Derived from hemp plant, CBD can be used to treat a variety of health issues, including anxiety, insomnia and chronic pain. According to Harvard Medical School, it has also been proven to be effective in treating childhood epilepsy syndromes that typically don’t respond to antiseizure medications.

Like marijuana, hemp is a species of cannabis. Both species contain tetrahydrocannabinol, a potentially psychoactive constituent. However, the levels in hemp are so low—less than 0.3 percent—that products derived from hemp do not intoxicate the user.

In recent years, CBD sales have skyrocketed. In the U.S. alone, CBD consumption increased from $108.1 million to $512.7 million between 2014 and 2018, according to the Hemp Business Journal. This year, the publication forecasts sales of $813.2 million. But the real growth has yet to come. Analysts of the Brightfield Group expect the U.S. CBD market to hit a whopping $22 billion by 2022.

Much of that growth is related to the legalization of industrial hemp and related products. The 2014 U.S. Agricultural Act permitted select research and state departments to grow industrial hemp as part of agricultural pilot programs. Criticality joined North Carolina’s program, following the state’s legalization of medical marijuana in 2014.

In 2017, Pyxus International, the parent company of leaf tobacco merchant Alliance One International, purchased a 40 percent share in Criticality. Faced with declining demand for tobacco, Pyxus has been exploring new business opportunities where it can leverage its expertise in agronomy and agricultural supply chains, along with its extensive farmer base.

According to specialists, there are many similarities between the cultivation of tobacco and that of hemp. Tobacco transplanting equipment and curing barns, for example, can easily be adapted for hemp production. And now, the potential offered by CBD has been turbocharged by the 2018 U.S. Farm Bill, which became law in December and legalized the cultivation of industrial hemp nationwide, removing it from the Controlled Substances Act.

“Through our investment in Criticality […] our goal is to become a leader in the production of CBD and related consumer products,” said Pyxus President, CEO and Chairman Pieter Sikkel. “The opening of the facility is a critical step in achieving that goal and is a glimpse of what’s to come in the future.”

Unsurprisingly, many companies have entered the hemp business, hoping to cash in on the growing popularity of CBD. Criticality intends to set itself apart through meticulous attention to quality and compliance—both with current and future regulations. During the Wilson ceremony, Criticality CEO Brian Moyer said the company is committed to producing a fully traceable product, using good manufacturing practices and meeting all applicable dietary supplement guidelines.

Criticality’s Chief Technical Officer Jose Martinez compares the company’s CBD extraction process from hemp to the process used by coffee manufacturers to remove caffeine from beans. But rather than using environmentally harmful solvents, he says, Criticality relies on carbon dioxide, one of the most common elements in nature. While carbon dioxide is also a greenhouse gas, Martinez is quick to point out that the extraction process does not generate carbon dioxide; the gas used already exists.

Wilson Mayor C. Bruce Rose and Wilson Chamber of Commerce President Ryan Simons praised not only Criticality’s innovative spirit but also the company’s contribution to the local economy.

The factory is expected to generate 88 relatively high-paying jobs by 2024—a figure that might increase even further if the hemp market continues its current growth trajectory.

Anticipating strong demand, Moyer noted that the facility has been designed with expansion in mind. “This factory is only the beginning,” he said.

It’s getting complicated. The US Food and Drug Administration (FDA) is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.

In addition, FDA expects manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under these new conditions to submit premarket applications to the agency by Aug. 8, 2021. This application date is one year earlier than the agency previously proposed.

See more here.

The UK pro-smoking group Forest (Freedom Organisation for the Right to Enjoy Smoking) has called for the lifting of restrictions on vaping within hospital grounds.

Fifty-five percent of National Health Service (NHS) trusts did not allow electronic cigarettes to be used outdoors last year, according to a report by Forest, Prejudice and Prohibition: Results of a study of smoking and vaping policies in NHS hospital trusts in England.

This was despite Public Health England (PHE) advice that it should be made easier for people to vape on site.

Forest is calling also for greater freedom for patients, visitors and staff who want to smoke cigarettes at hospitals.

Freedom of Information requests were made to 200 NHS trusts in England by Forest, 170 of which provided a response.

‘Around 45 percent said they allowed e-cigarettes to be used outside in 2018 and 11 percent of trusts, mainly specialising in mental health, permitted vaping indoors,’ the research was said to have found.

‘However 14 percent said they were planning to amend their policies in 2019 to allow vaping outside buildings, in shelters or in wards.’

Forest said vaping should be permitted in all outdoor areas at hospitals and inside buildings and on wards if management considered it appropriate.

Seventy-six percent of NHS trusts did not allow cigarettes to be smoked anywhere on hospital grounds while 22 percent provided smoking shelters, the research also found.

Meanwhile, thirty two percent of trusts said they had installed a button which triggers a recorded message when pressed by a member of the public or staff, to help deter smokers.

Forest described the devices as ‘shame-a-smoker buttons’.

“We welcome the fact that some trusts are reviewing their policies on the use of e-cigarettes, but adopting a more sensible approach to vaping shouldn’t come at the price of a complete ban on smoking,” Simon Clark, director of Forest, was quoted as saying.

“Banning smoking on hospital grounds demonstrates a staggering lack of compassion for smokers who may be stressed, upset and in need of a comforting cigarette.

“A reasonable policy would lift restrictions on vaping, but give those who prefer to smoke the option of sheltered smoking areas.”

The NHS trust responses were collected between July and December 2018.

JUUL Labs UK has joined the UK Vaping Industry Association (UKVIA), according to a joint press note issued yesterday.

Since the UKVIA was formed by top vaping brands in 2016, it has been at the forefront of spreading the positive public health message about vaping to the UK’s smokers.

“The UKVIA is a partnership of the leading most respected vaping brands in the UK,” John Dunne (pictured), director of the UKVIA was quoted as saying.

“We only allow companies to become members if they share our ambition to set high standards for the industry and our aim to help the UK’s seven million adult smokers make a life changing switch to a safer alternative.

“Our new code of conduct confirms the standards that all of our members follow every day as they work to grow and expand the dynamic vaping industry.

“That’s why we are delighted that JUUL have decided to join the Association in recognition of our shared aims and values. We are excited to work with them to achieve the ambitious aims of the UKVIA.”

Meanwhile, Dan Thomson, JUUL Labs UK’s MD said the UKVIA’s new code of conduct had been a crucial part of JUUL’s decision to join the Association.

He made special note of the UKVIA’s Challenge 25, which was aimed at restricting youth access – a key policy that JUUL had enforced since it launched in the UK last year.

“This is alongside a wider program of responsible measures that we have implemented exceeding regulatory or legal requirements, including sanctions for any non-compliant retailers on Challenge 25; two-factor authentication for purchase online; a limited range of adult-focused flavours; marketing which is entirely focused on adult smokers over 30 years; and zero presence on social media,” he said.

“JUUL’s mission is to improve the lives of the world’s one billion adult smokers and to achieve this we are committed to having an open dialogue with government and stakeholders to promote vaping and its benefits over combustible cigarettes. Greater collaboration across the sector will provide both the wider industry and the UKVIA with a more credible voice to achieve our mission.”

The authors of a new report have recommended that vaping products should be primarily regulated in Australia as consumer goods rather than as therapeutic, medicinal or tobacco products.

The report, Legalising Vaping in Australia, was published on Saturday by the McKell Institute, and was the subject of a story posted on the website of the Australian Harm Reduction Association.

In the report’s executive summary, the authors said that ‘legalising vaping has enormous potential to improve public health, particularly for disadvantaged smokers who are disproportionately affected by smoking-related diseases’.

‘We recommend that vaping products should be primarily regulated as consumer goods rather than as a therapeutic, medicinal or tobacco product,’ they said.

‘Regulation should aim to maximise the benefit for adult smokers while reducing any potential risks to users and harm to the wider population, especially young people who have never smoked.

‘Regulation should be proportionate to the risk of vaping.

‘The authors strongly recommend that Australia’s successful tobacco control policy continues and is supplemented by two changes: first, ending the de facto ban on vaping; and second, re-introducing appropriately funded mass media campaigns and supporting counselling to increase quitting rates.’

The McKell Institute is described as an independent, not-for-profit, public policy institute dedicated to developing practical policy ideas and contributing to public debate.

The report’s co-authors are: Dr. Alex Wodak AM, Conjoint Associate Professor Colin Mendelsohn.

At least one manufacturer of cigarette alternatives has criticized the Greek Government for lumping heat-not-burn products and electronic cigarettes with combustible cigarettes when considering legislation, according to a story at ekathimerini.com.

An urgent bill debated in Parliament yesterday provides for the alternative products to be treated in the same way as conventional tobacco products are treated.

The story said that, under the provisions of the bill, the alternatives would have to carry warnings saying that they damage health, but it wasn’t clear from the report whether those warnings would mirror those carried by combustible products.

In a statement, the Philip Morris International subsidiary Papastratos accused the Health Ministry of avoiding launching a dialogue and examining the scientific data relating to alternative products.

It said that because the bill assumed cigarette alternatives to be equal to cigarettes [in respect of risk], eventually, smokers would choose the most damaging option – continuing to smoke.

A congresswoman in Colorado, US, Diana DeGette, is introducing legislation that, if passed, would ban electronic-cigarette flavors on a national level, according to a story by Michael Nedelman for CNN quoting a Monday announcement by DeGette’s office.

The bill was expected to be introduced to the House of Representatives yesterday.

Nedelman described flavors as being at the center of the regulatory debate, with some people saying they were an important tool in getting adults to switch from combustible cigarettes, while others wanted to ban them entirely because in their view they appealed to young people and minimized how harmful and addictive vapes were perceived to be.

“To me, there is no legitimate reason to sell any product with names such as cotton candy or tutti fruitti, unless you are trying to market it to children,” DeGette, a Democrat, said in a statement on Monday.

“Most experts agree that the kid-friendly flavors that e-cigarette manufactures are selling with these products are one of the leading causes of this spike in use among our high school and middle school students.”

If DeGette’s bill becomes law, it will ban these flavors within a year unless companies can prove to the US Food and Drug Administration that flavors are not implicated in the rise in vaping among young people.

It would require companies also to show that flavors are instrumental in getting smokers to quit combustible cigarettes and that they don’t make vapes ‘more harmful to the user’.

The bill could ban flavors in cigars on the same timeline.