Category: News This Week

  • Pyxus Enters into Agreement with Shenzhen Smoore for PMTA Project

    Pyxus Enters into Agreement with Shenzhen Smoore for PMTA Project

    Pyxus International, a global value-added agricultural company, and Shenzhen Smoore Technology Co, a leading manufacturer of electronic nicotine delivery systems (ENDS), have entered into an agreement to share key costs, as well as research and testing data, significantly improving efficiencies related to their respective premarket tobacco product applications (PMTA).

    Pursuant to FDA guidance, all PMTAs are due by May 12, 2020.

    “We are committed to developing and manufacturing high-quality e-liquid products that meet the regulatory requirements set forth by the FDA,” said Pieter Sikkel, president, CEO and chairman of Pyxus. “After thorough consideration, Pyxus identified Smoore as the clear ENDS supplier for PMTA submissions of Pyxus’ affiliate brands, Bantam and Humble Juice Co., given their leadership in this space, execution of forward-thinking technology and adherence to the highest technical standards. The PMTA submissions are the next step in continuing to make our adult-use e-liquid products available for purchase and enjoyed by our consumers for years to come.”

    Under the new agreement, Bantam and Humble Juice Co. have paired certain Smoore ENDS devices—both an open tank device and a refillable cartridge-based device—with the brands’ 84 e-liquid nicotine SKUs. The selected SKUs include many of Bantam and Humble’s top-selling flavor profiles in various nicotine strengths and bottle sizes. These flavor profiles are manufactured by Purilum, LLC, a manufacturer of top-quality e-liquids, flavor concentrates and finished bottle products and a Pyxus joint venture.

    “Smoore is pleased to partner with a company as well respected as Pyxus. Both of our companies have developed complementary expertise related to the PMTA process as we look to FDA for validation of our compliance, ensuring our products’ availability to our customers,” said Weidong Pan, general manager of Technology Center of Shenzhen Smoore Technology. “This agreement is the foundation for a long-term, mutually beneficial relationship that we anticipate expanding across various markets and lines of business.”

    “We are on track with the necessary research and testing that will form the basis for our respective PMTAs,” added Anthony Dillon, senior vice president of Global Specialty Products and managing director of E-liquids at Pyxus International. “We have a clear plan that we are executing against, and preliminary testing results are in line with and supportive of our strategy.”

    Both companies’ respective e-liquids businesses plan to submit their PMTAs to the FDA on or before the May 12 filing deadline.

  • Pyxus and Turning Point Brands Join Forces in PMTA Project Alliance

    Pyxus and Turning Point Brands Join Forces in PMTA Project Alliance

    Pyxus International, a global value-added agricultural company, announced today its collaboration with Turning Point Brands, a leading U.S. provider of Other Tobacco Products (OTP) and adult consumer alternatives, according to a press release.

    The companies have chosen to share certain science-based research and testing data in order to form the foundation for potions of their respective premarket tobacco product applications (PMTAs) prior to submission to the U.S. Food and Drug Administration (FDA).

    Additionally, the companies announced that Turning Point Brands has signed a supply agreement for its house brands of e-liquids, thereby expanding its existing relationship with Pyxus’ joint venture, Purilum, LLC, a manufacturer of top-quality e-liquids, flavor concentrates and finished bottle products.

    “We understand that in order to meet the rigorous requirements of the FDA, we need reputable, like-minded partners,” said Pieter Sikkel, President, CEO and Chairman of Pyxus. “Turning Point Brands, which already has a strong relationship with our joint venture Purilum, LLC, has continually demonstrated their commitment to compliance and quality. We’re pleased to be partnering with them to benefit our respective PMTAs.”

    The companies will share various costs and key data associated with extensive studies performed to support their respective PMTA submissions. In addition, Purilum currently provides the flavor formulations for some of TPB’s next generation products.

    “Purilum has earned a well-deserved reputation for excellence in flavor formulation and e-liquid production,” said Graham Purdy, COO of Turning Point Brands. “The quality and consistency of their products are exemplary, and we are excited to continue working with them, as well as Pyxus, over the decades to come.”

    “We are proud to be partnering with Turning Point Brands, a leader in the OTP space and an emerging leader in next generation products. This enhanced relationship will be positive for all parties,” said Anthony Dillon, Senior Vice President of Global Specialty Products and Managing Director of E-liquids at Pyxus. “We are on track with the necessary research and testing needed for PMTA filings.”

    Both Pyxus and Turning Point Brands anticipate submission of their respective PMTAs on or before the May filing deadline. 

  • U.S. Flavor Ban, Slowing Sales Sink Imperial Brands Outlook for 2020

    U.S. Flavor Ban, Slowing Sales Sink Imperial Brands Outlook for 2020

    Due to U.S. flavor bans and weaker than expected demand for vapor products, Imperial Brands expects its adjusted earnings per share to be slightly lower than last year. Constant currency full-year group net revenue will likely be at a similar level to last year’s, according to the company.

    First half adjusted earnings per share are expected to be down about 10 percent at constant currency due to the phasing of inventory write-downs, primarily relating to the U.S. flavor ban.

    Regulatory uncertainty and adverse headlines continue to affect next-generation product (NGP) demand in the U.S. and Europe, according to Imperial Brands. This will result in significantly lower year-on-year NGP net revenue as well as increased provisions for slow-moving stock.”

    “We are implementing a further cost savings program to mitigate some of these short-term headwinds, which will result in a full-year net impact on adjusted operating profit of c. £40 million ($51.98 million),” Imperial Brands wrote in a statement.

    The upcoming FDA flavor ban “has resulted in a write-down of flavored inventory with a first half adjusted operating profit impact of c. £45 million, in line with previous estimates,” according to the company.

  • Vapor CEOs Face Lawmakers’ Questions on Role in Youth Vaping

    It was like a flashback to 1994. In early February, The House Energy and Commerce oversight and investigations subcommittee grilled the CEOs of Juul Labs, Reynolds American and NJOY, as well as the presidents of Logic Technology Development and Fontem US. It was reminiscent of when, in 1994, the CEOs from seven major tobacco companies testified before Congress about the marketing tactics for tobacco products. The tension in the rooms was also similar.

    For more than two hours, lawmakers on the House Energy and Commerce Subcommittee on Oversight and Investigations asked questions ranging from marketing strategies to how to curb youth usage of these products. K.C. Crostwaite, CEO for Juul Labs, expressed his understanding of the serious need for companies to combat the uptick in youth use.

    “I fully recognize that the opportunity for the millions of adult smokers who still use combustible cigarettes to have an alternative is at risk if we don’t address this issue,” K.C. Crosthwaite, Juul’s CEO, said. “We are focused on combating underage access because I know it puts it all at risk if we don’t make progress here.”

    Legislators also wanted to understand the possible health effects vaping products pose to consumers and the role each company sees itself as playing in the ongoing effort to curb the nation’s uptick of youth use. Antoine Blonde, president of Fontem, said the company had a detailed youth access prevention program and maintained efforts to safeguard its products from youth.

    “Fontem uses industry-standard online age-gating and age-verification mechanisms to prevent youth access to its products online,” Blonde said. “For example, for all purchases through our website, Fontem relies on industry-standard age-verification technology that compares a potential purchaser’s information against records of trusted data sources to verify the age of the purchaser.”

    Blonde said Fontem recognizes that there “may be” bad actors in the marketplace who attempt to purchase bulk quantity of its products through e-commerce web sites in order to re-sell them (a practice often called strawman sales. “Fontem has always had policies in place to monitor for strawman sales and further is implementing a strict 4-Stage standard to monitor site access for any potential strawman purchases on its online platform,” Blonde explained. “This standard will track registered adult consumers’ monthly order frequency of pods from its online platform and will flag potential strawman sales.”

    The companies are said to represent nearly 97 percent of the $19.3 billion U.S. e-cigarette market, according to Rep. Diana DeGette, chairwoman of the subcommittee. That data only includes convenience store sales, and many industry insiders say the figure is grossly inaccurate. Vape shop sales are not included in Nielsen data DeGette is citing.

    “While consumers remain in the dark of the possible health consequences, these companies are making billions of dollars as they lure a new generation of young people into a lifetime of nicotine addiction,” DeGette, the chair of the oversight panel conducting the hearing, wrote in a press release.

  • FDA’s Flavor Ban on Closed-Pod Systems Starts at 12:01 am Thursday

    FDA’s Flavor Ban on Closed-Pod Systems Starts at 12:01 am Thursday

    The Trump administration’s partial ban on flavored e-cigarettes will go into effect at a minute after midnight Thursday.

    The partial vape ban will impact most vapor products that use pre-filled pods, often called closed systems. Sales of fruit-, dessert- and mint- flavored pods will be banned; menthol and tobacco flavors will escape prohibition, according to an article in the Washington Post. The closed-pod products products, which were popularized by Juul Labs, have been widely available in convenience stores and in some vape shops.

    The goal of the restrictions is to reduce youth vaping, which health officials say has reached epidemic levels, according to the story. The White House initially indicated it would ban even more products, but backed off amid objections from the vaping industry.

  • Altria Again Devalues Juul Investment as Lawsuits Continue, U.S. Sales Slump

    Altria Again Devalues Juul Investment as Lawsuits Continue, U.S. Sales Slump

    Altria Group announced on Jan. 30 that it reduced its investment value in Juul Labs to around $12 billion, almost 70 percent less than the $38 billion valuation that Altria bought into in December 2018.

    Last October, Altria wrote down its Juul Labs stake by $4.5 billion followed by the $4.1 billion write down just announced.

    “I’m highly disappointed in the performance of our Juul investment,” said Altria CEO Howard Willard.

    According to Altria, the devaluation was driven by issues such as lawsuits, investigations into Juul’s marketing practices, flavored vapor product bans and a vaping health crisis.

    While Altria will no longer provide marketing and retail distribution for Juul Labs as originally agreed, it will now focus on helping Juul Labs with regulatory affairs, including the submission of its products for approval by the U.S. Food and Drug Administration.

  • U.S. FDA Chief Vows Action if Necessary to Combat Youth Uptake

    U.S. FDA Chief Vows Action if Necessary to Combat Youth Uptake

    Stephen Hahn, the new U.S. Food and Drug Administration (FDA) commissioner, defended the Trump administration’s partial e-cigarette ban but said he would take more actions to stop teen vaping if necessary.

    The vaping ban will take effect on Feb. 6 and will ban the sale of most flavored cartridge-based vapor products, with the exception of menthol and tobacco flavors and single-use disposable products. Critics of the ban say it is too weak and fear youth will simply switch to the nonbanned products.

    In his first interview with a national media outlet since his confirmation in December, Hahn told the Washington Post that the sales restrictions will target the products most popular with youth but that the FDA will closely monitor the situation, and if minors do switch to menthol-flavored products, the agency will take further action to curb vaping.

    “The good thing about this policy is we have the ability without jumping through a lot of hoops to change our enforcement prioritization based on the data we are getting in,” Hahn said.

    Advocates on both sides expressed skepticism at the FDA’s ability to quickly assess and respond to changing patterns in youth vaping. “There is zero percent chance the FDA can quickly respond to what they view as the risks associated with vaping because in three years, they have failed to implement sensible regulations,” said Paul Blair, director of strategic initiatives for Americans for Tax Reform.

    “The agency’s record of monitoring the marketplace in real time is troubling,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. “There have been enormous changes with no evidence of their knowing it.”

  • NJoy Removes Non-Tobacco Flavors From the U.S. Market

    NJoy Removes Non-Tobacco Flavors From the U.S. Market

    NJOY Holdings voluntarily ended sales of its fruit-flavored products in the U.S. market. The announcement came as lawmakers and anti-vaping advocates voice concerns that young users might migrate to the disposable devices.

    The Food and Drug Administration’s (FDA) new electronic delivery system (ENDS) rules will remove all sweet and fruit-flavored products from the U.S. market. The agency also announced it wouldn’t restrict sales of “completely self-contained, disposable products.”

    The flavor takes effect on Feb. 6.

  • U.S. CDC No Longer Making Broad Warning to Stop Vaping Nicotine

    U.S. CDC No Longer Making Broad Warning to Stop Vaping Nicotine

    The U.S. Centers for Disease Control and Prevention (CDC) has removed from its website a broad guidance stating people should stop vaping in response to the outbreak of vaping-related illnesses.

    The CDC first said people should stop using all vapor products in September but later narrowed that recommendation to vapor products containing THC—the psychoactive ingredient in cannabis. The new recommendation no longer includes the broad reference to stopping vaping, though the agency still says youth, pregnant women and nontobacco users shouldn’t vape.

    “Recommendations were refined to reflect the best available scientific evidence and to best protect public health,” said Brian King, the chief science officer for the CDC’s vaping-related outbreak response.

    Evidence has linked the vaping-related illnesses and deaths to vitamin E acetate, a cutting agent used in vape oils that contain THC. There have been 2,668 hospitalizations from the vaping-related illness as of Jan. 14 and at least 60 deaths, the CDC said. Hospitalizations have slowed since peaking in September, but new cases and deaths are still being reported.

    The CDC also made a distinction between the vaping-related illnesses and the uptake in youth vaping, two different epidemics, according to a report in the New England Journal of Medicine.

  • WHO Warns There is ‘Little Evidence’ That E-cigarettes Help Smokers Quit

    WHO Warns There is ‘Little Evidence’ That E-cigarettes Help Smokers Quit

    The World Health Organization (WHO) issued its strongest warning yet against vaping, stating the habit harms developing teenage brains and can damage a growing fetus as well as increase the risk of heart disease and lung disorders.

    The WHO warned there is “little evidence” that e-cigarettes help smokers quit smoking and that they may instead addict nonsmokers to nicotine.

    The warnings come from a Q&A session on Twitter.

    When asked if vapor devices were less dangerous than regular cigarettes, the WHO refused to give a definitive answer. “This depends on a range of factors, including the amount of nicotine and other toxicants in the heated liquids, but we know that e-cigarettes pose clear health risks and are by no means safe,” a WHO representative wrote.

    The WHO’s stance contrasts that of Public Health England (PHE), which finds vaping to be 95 percent less risky than smoking. Commenting on the WHO’s tweets, John Newton, director for health improvement at PHE, said the agency was “continuing to review evidence of e-cigarettes.”

    The WHO called for governments to consider taxing vapor products the same way they tax traditional tobacco products.