Category: News This Week

  • Focus on young people

    Focus on young people

    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.”

  • FDA acting chief named

    FDA acting chief named

    Ned Sharpless, the director of the US’ National Cancer Institute, is expected to be named as the temporary chief of the Food and Drug Administration, according to a story by Anna Edney for Bloomberg News.

    Sharpless is due to serve as acting head of the agency when commissioner Scott Gottlieb leaves later this year, the Health and Human Services Secretary Alex Azar was quoted as saying at an appearance on Capitol Hill on Tuesday.

    Edney said that the appointment of Sharpless could allay the concerns of health advocates that Gottlieb’s departure would signal a let-up in the FDA’s crackdown on flavored electronic cigarettes and teen smoking. Sharpless has apparently supported Gottlieb’s efforts to stem what the commissioner has called an “epidemic” of smoking among young people.

    In addition, Edney said, the National Cancer Institute had worked closely with the FDA to fund research related to e-cigarette use, including the device’s impact on smoking cessation.

  • Sales set to start

    Sales set to start

    Zimbabwe’s 2019 flue-cured tobacco marketing season is scheduled to start on March 20, according to a story by Kudakwashe Mhundwa for The Herald, quoting the Tobacco Industry and Marketing Board (TIMB).

    The start of the marketing season was delayed this year because planting was held up by the late onset of rain.

    The TIMB said that the auction season would start on March 20, while contract tobacco sales would start on March 21.

    Sales bookings started yesterday and deliveries will be accepted from March 18.

    Meanwhile, another story in the Herald, this one by Nesia Mhaka and Ellen Chasokela, quoted the TIMB’s corporate communications manager Isheunesu Moyo as saying that three auction floors had been licensed for the 2019 sales season: the Tobacco Sales Floor, Boka Tobacco Auction Floors and Premier Tobacco Auction Floors.

    He said all the licensed floors were ready.

  • Haste urged

    Haste urged

    The U.S. Food and Drug Administration wants to bring forward the deadline by which manufacturers of flavored electronic nicotine delivery systems (ENDS) are required to submit their pre-market applications to Aug. 8, 2021—one year earlier than expected.

    The agency’s new draft guidance “Modifications to compliance policy for certain deemed tobacco products” proposes to end the August 2017 compliance policy regarding pre-market review requirements for flavored ENDS products other than tobacco-, mint-, and/or menthol-flavored and flavored cigars other than tobacco-flavored.

    Beginning 30 days after issuance of the final guidance, all flavored ENDS products and cigars covered by the new policy would no longer be subject to FDA’s enforcement discretion which gave manufacturers until Aug. 8, 2022 to submit a premarket application. Beginning March 14, comments on this draft guidance may be submitted to the public docket at Regulations.gov.

    Comments must be received by April 15, 2019, to be considered by the FDA as it develops its policy.

    In a statement, FDA Commissioner Scott Gottlieb described the agency’s vision as “a world where combustible cigarettes no longer create or sustain addiction—making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or transition to potentially less harmful products.”

    Some elements of the plan echo the FDA’s earlier announced strategies, such as putting nicotine at the center of the regulatory efforts and seeking to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive.

    The FDA said the proposed policy shift could cause some flavored e-cigarettes to disappear from the market, while others could continue to be sold only in a manner that prevents youth access pending pre-market authorization.

     

     

  • Criticality opens hemp plant

    Criticality opens hemp plant

    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.

  • Seeking a grand settlement

    Seeking a grand settlement

    British American Tobacco’s Canadian subsidiary, Imperial Tobacco Canada (ITCAN) has obtained an Initial Order from the Ontario Superior Court of Justice granting it protection under the Companies’ Creditors Arrangement Act (CCAA). This has the effect of staying all current tobacco litigation in Canada against ITCAN and other Group companies.

    ‘ITCAN’s decision to file for protection under the CCAA follows the Quebec Court of Appeal judgment holding the industry jointly and severally liable for a maximum of C$13.6 billion, and the recent decision by one of the other Canadian tobacco companies, JTI-Macdonald, to seek, and subsequently obtain, CCAA protection,’ BAT said in a note posted on its website yesterday. ‘If ITCAN had not also obtained court protection, it could have been required to pay for all or part of JTI-Macdonald’s share of the Quebec judgment, in addition to its own.’

    ITCAN’s share of the judgment was said by BAT to be a ‘maximum of approximately C$9.2 billion.

    Meanwhile, BAT said that, across Canada, other tobacco plaintiffs and provincial governments were collectively seeking significant damages that substantially exceeded ITCAN’s assets. ‘In seeking protection under the CCAA, ITCAN will look to resolve not only the Quebec case but also all other tobacco litigation in Canada under an efficient and court supervised process, while continuing to trade in the normal course,’ BAT said.

    ‘It will remain business as usual for ITCAN, its employees, customers and suppliers, and during the CCAA process, ITCAN’s management will continue to focus on growing its current cigarette and potentially reduced risk products business.

    ‘The Group will continue to consolidate the results of ITCAN, in line with IFRS 10 “Consolidated Financial Statements”, and ITCAN’s CCAA filing will not negatively affect the Group’s adjusted net debt to adjusted EBITDA ratio.

    ‘The £2.3 billion of goodwill relating to ITCAN on the Group’s balance sheet at 31 December 2018 will continue to be reviewed on a regular basis. Any future impairment charge would result in a non-cash charge to the income statement that will be treated as an adjusting item.

    ‘Since 2014 the Group has received no dividends from ITCAN and expects that this situation will continue whilst ITCAN remains under CCAA protection.  Notwithstanding this, there will be no impact on the BAT Group’s dividend payments or policy.’

    A BAT spokesperson was quoted as saying that ITCAN disagreed with the Court’s judgment. “However, we understand that CCAA protection will provide Imperial Tobacco Canada an opportunity to settle all of its outstanding tobacco litigation under an efficient and court supervised process whilst continuing to run its business in the normal course,” the spokesperson said.

  • Juul heads to South Korea

    Juul heads to South Korea

    Juul Labs Inc. is expected to enter the South Korean market this year, according to a story by Cho Chung-un for The Korea Herald, quoting a company representative.

    The San Francisco-based company was said to have launched in the US in 2017 its electronic-cigarette brand Juul, which, by September 2018, had captured a 72 percent share of that country’s market.

    “We are aiming to put the Juul on the South Korean market during the first half of this year or at the start of the latter half at the latest,” a company representative was quoted as saying.

    Juul is already available outside the US in Germany, France, Britain, Switzerland, Canada, Russia and Israel.

    The e-cigarette maker established its local subsidiary, Juul Labs Korea, late last year.

    It has filed a trademark application with the Korean Intellectual Property Office and has been working to establish a sales network.

    The story said that Juul Labs planned to offer its brand with a nicotine content of less than one percent.

    Korea permitted the sale of e-cigarettes with nicotine levels of up to two percent, while Juul pods sold in the US contained 3-5 percent nicotine.

  • The ban didn’t work. Why?

    The ban didn’t work. Why?

    After numerous failed attempts to enforce a ban on tobacco smoking and chewing in public places, the city of Kathmandu, Nepal, is to have another try, according to a story in The Kathmandu Post.

    Deputy mayor Hari Prabha Khadgi, who also leads a five-member inspection committee, said she was holding consultations with representatives of the 32 wards of Kathmandu to make the drive a success.

    “I’m in consultation with the ward representatives and stakeholders,” Khadgi was quoted as saying. “We have decided to run awareness programs at schools and reach every nook and corner of the city with anti-tobacco visuals and street performances.”

    On February 25, 2018, Mayor Bidya Sundar Shakya announced an 18-month action plan to make Kathmandu a healthy city. However, the action plan was not followed.

    Although the ban on tobacco smoking and chewing was enforced initially, the effort did not last.

    The World Health Organization’s Tobacco Free Initiative had provided Rs10 million to assist Kathmandu conduct the ‘Healthy City’ campaign, and the city authorities plan to follow through on the campaign this time around.

    The Tobacco Product (Control and Regulatory) Act-2011 bans smoking in public places. Anyone breaching the law is liable to a fine of Rs100 to Rs100,000, depending on the nature of the offense.

  • Oral cancer on the rise

    Oral cancer on the rise

    A Greek member of the EU Parliament has asked the Commission what it is doing to address an ‘alarming’ increase in cases of oral cancer, some of which are down to tobacco smoking and alcohol consumption.

    In a preamble to two question, which are due to be answered by the Commission in writing, Lampros Fountoulis said the Piraeus Dentists’ Association had raised the alarm about the worrying increase in the incidence of oral cancer because ‘the number of cases has risen by 25 percent over the past 10 years and every year more than 300,000 new cases are reported worldwide’.

    ‘According to Mr Goutzanis [Lampros Goutzanis of the National and Kapodistrian University of Athens], oral cancer is difficult to treat and, when diagnosed at an advanced stage, the outcome is usually fatal,’ Fountoulis said.

    ‘He goes on to point out that a large number of patients only consult doctors when the disease has reached an advanced stage, adding that, unfortunately, only 31 percent of oral tumors are diagnosed at an early stage.

    ‘At least three-quarters of cases of oral cancer could have been avoided if patients had stopped smoking and drinking alcohol; but other factors are also responsible for the increase in the incidence of oral cancers, namely solar radiation and HPV (human papillomavirus), which is sexually transmitted*.’

    Fountoulis asked the Commission:

    1)         ‘Is it aware of the increase in cases of oral cancer in the EU?

    2)         ‘What steps will it take to address this phenomenon?’

    *https://www.in.gr/2019/02/04/health/anisyxitiki-ayksisi-sta-krousmata-karkinou-tou-stomatos/?fbclid=IwAR3EE-_HL4mLT3DqfbL6wKcssZqz9hg5bw6sto78hovxhaRwbqeO14udWxY; and http://www.amna.gr/health/article/331248/Anisuchitiki-auxisi-parousiazoun-ta-krousmatakarkinou-tou-stomatos

  • Question of balance

    Question of balance

    A Greek member of the EU Parliament has said that the use of heat-not-burn (HNB) products should not be seen as safer than smoking or vaping.

    ‘The IQOS device, which came out in 2014 and which heats solid tobacco, is no less harmful to cells than smoking and vaping, according to scientists, who said that a new study is a further indication that the new devices – which are now being used in 41 countries – are no safer,’ Lampros Fountoulis said as a preamble to two questions put to the Commission.

    ‘The scientists, who will continue their research into smoke heating appliances, emphasised that “it is already known that the failure of two types of lung cells can destroy the lung tissue and lead to fatal diseases, such as chronic obstructive pulmonary disease, lung cancer and pneumonia, and increase the risk of asthma, so these devices should not be considered a safer option*”.’

    Fountoulis asked the Commission if it could say:

    (1)       ‘What steps will it take to establish homogeneous arrangements in member states?

    (2)       ‘How will it control tobacco products and other related products in order to protect public health, given that more and more young people are addicted to nicotine as a result of this trend?’

    The Commission is due to answer in writing.

    *https://www.in.gr/2019/02/11/health/body/oi-syskeyes-thermansis-kapnou-eksisou-epivlaveis-gia-ton-anthropo-kapnisma-kai-atmisma/?fbclid=IwAR1-VUiRQ2-ZIIDUQjYkzMc8c_S1nkuqC4CnU3reNKqpi8w31owvR5TIdv; and http://scinews.eu/ta-nea-tis-epistimis/1735-oi-syskeves-thermansis-kapnoy-eksisou-epivlaveis-gia-ton-anthropo-me-to-kapnisma-kai-to-atmisma.