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  • Court Upholds FDA Authority Over Vaping

    Court Upholds FDA Authority Over Vaping

    Photo: Michal Kalasek | Dreamstime.com

    The 5th U.S. Circuit Court of Appeals has upheld the U.S. Food and Drug Administration (FDA)’s authority to regulate e-cigarettes as tobacco products, reports Reuters.

    A unanimous panel ruled Thursday that Congress’ decision to delegate vaping regulation to the FDA was constitutional under the non-delegation doctrine because Congress had articulated an “intelligible principle” in delegating authority to determine what qualified as a tobacco product to the FDA.

    The 5th Circuit’s ruling is the latest rejection of a series of legal challenges from the vapor industry.

  • Pending Ban Triggers Run on Nicotine Vapes in Australia

    Pending Ban Triggers Run on Nicotine Vapes in Australia

    Photo: Ethan Parsa from Pixabay

    Australians have started stockpiling e-cigarettes after their government announced it would ban imports of most vapor products, reports the Daily Mail.

    From July 1, it will be illegal to import e-cigarettes and refills containing nicotine liquids or salts.

    New Zealand’s leading retailer of vaping supplies, Shosha, recorded a 130 percent spike in sales from Australia since the announcement. Shosha also experienced a 44 percent increase in foot traffic compared to the same time last year.

    Under Australia’s new regulations, individuals would need to visit a doctor and be issued a prescription to purchase their nicotine containing e-cigarettes or refills.

    Even valid prescription holders would still be prohibited from purchasing the devices from overseas themselves.

    The ban on importing nicotine e-cigarettes and refills would be in line with existing bans on their sale in each state and territory.

    The prohibition would last 12 months while the government conducts a public consultation on the regulation of nicotine products by the Therapeutic Goods Administration.

    The regulation would see nicotine products added to the Poisons Standard making them prohibited permanently with the exception of tobacco cigarettes and smoking-cessation products such as gums and patches.

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) has protested Australia’s ban, saying it will deprive millions of vapers and existing smokers of their rights to access better alternatives to combustible cigarettes.

    “Smokers in Australia have been denied access to a proven harm reduction tool and vapers in Australia have yet again been dealt a potentially fatal blow which will see many of the 300,000 strong vaping community go back to smoking cigarettes,” CAPHRA Executive Director Nancy Loucas said in a statement.

    The group pointed to studies showing that e-cigarettes are 95-percent less harmful than combustible tobacco because they do not involve combustion. “It has been known for decades that tar, and carcinogens found in tobacco smoke, cause the death and disease associated with smoking, and not nicotine,” CAPHRA stated.

  • Vuse Named ‘Pacesetter’

    Vuse Named ‘Pacesetter’

    Photo: R.J. Reynolds Vapor Co.

    R.J. Reynolds Vapor Co.’s (RJRVC) Vuse Alto and Vuse Ciro e-cigarettes were named two of the Top-10 product pacesetters by Information Resources Inc. (IRI), a data and analytics research group that closely monitors the consumer package goods (CPG) industry.

    Each year top CPG brands are recognized as IRI New Product Pacesetters, a list highlighting innovation that are resonating most with consumers.

    “Today’s adult nicotine consumers are looking for unique products that fit their modern-day lives, and Vuse has built a portfolio of options that have consumer moments in mind,” said Leila Medeiros, U.S. head of the Vuse brand.

    “Our dynamic approach to developing vapor products, paired with our team’s unrivaled industry knowledge, global market scale and commitment to responsible marketing, means we can create brands that adult nicotine consumers prefer, and products that deliver unique, enjoyable and reliable experiences.”

    R.J. Reynolds has submitted several Vuse products to the U.S. Food and Drug Administration for marketing authorization.

  • Pyxus to Delist From New York Stock Exchange

    Pyxus to Delist From New York Stock Exchange

    Photo: skeeze from Pixabay

    The New York Stock Exchange (NYSE) has commenced proceedings to delist Pyxus International. Trading in Pyxus’ common stock has been suspended.

    The NYSE determined that Pyxus is no longer suitable for listing under after the company filed for relief under Chapter 11 of the United States bankruptcy code. Pyxus does not intend to appeal the NYSE’s determination.

    Pyxus’ common stock began to be quoted on the OTC Pink marketplace on June 17, 2020, under the symbol PYXSQ. Investors can find quotes for the company’s common stock on. 

    Pyxus does not expect a transition to the OTC Pink marketplace to affect the company’s operations. 

    “The company can provide no assurance that its common stock will continue to trade on this market, whether broker-dealers will continue to provide public quotes of the company’s common stock on this market, whether the trading volume of the company’s common stock will be sufficient to provide for an efficient trading market or whether quotes for the company’s common stock may be blocked by OTC Markets Group in the future,” Pyxus wrote in a statement.

  • Australia Extends Nicotine Vape Ban

    Australia Extends Nicotine Vape Ban

    Photo: Haiberliu from Pixabay

    E-cigarettes containing nicotine will remain illegal in Australia for at least another year, reports The Daily Mail.

    The federal government is extending a ban on the importation of such products unless prescribed by a doctor.

    The ban will remain in place for 12 months to allow for public consultation on the regulation of nicotine products by the Therapeutic Goods Administration.

    Under the ban, Australians would still be able to vape nicotine if their doctor provides a prescription.

    They would get their e-cigarettes or refills via a permission granted by the health department to a doctor or medical supplier who would be able to import the goods using a courier service or by cargo service.

    The goods cannot be imported through international mail.

    The Australian Medical Association (AMA) welcomed the decision, saying that vaping is not a healthy alternative to smoking.

    “Nicotine is a highly addictive substance and there is no level of tobacco use which is safe,” AMA Vice President Chris Zappala said.

  • Study: Assessment of Relative Risk Determined by Questioning

    Study: Assessment of Relative Risk Determined by Questioning

    Photo: 104691896 | © Milkos | Dreamstime.com

    The share of people who believe e-cigarettes are equally harmful or more harmful than traditional cigarettes depends on how the question is asked, according to new research published in Tobacco Control.

    Tobacco companies often claim that a large proportion of the population perceives potential modified risk tobacco products as equally or more harmful than cigarettes, and argue misperceptions need to be corrected using modified risk claims.

    However, the studies they cite predominantly use one specific measurement of comparative risk, according to the researchers.

    Image: Tobacco Control

    The authors studied the way questions were posed in the 2017 Tobacco Products and Risk Perceptions Survey. When asked directly to compare harms of e-cigarettes and cigarettes, 33.9 percent of participants identified e-cigarettes as less harmful than cigarettes, 36.4 percent reported equal harm, 4.3 percent said e-cigarettes were more harmful and 25.3 percent said, “I don’t know.”

    When asked indirectly, however, 42.1 percent identified e-cigarettes as less harmful than cigarettes, 23.8 percent said they were of equal harm, 7.1 percent perceived e-cigarettes to be more harmful and 27.1 percent did not know.

    The authors say researchers should use both direct and indirect risk questions when assessing the public’s perceptions of harms associated with novel tobacco products.

  • Respira to Submit Nebulizer For FDA Approval

    Respira to Submit Nebulizer For FDA Approval

    Photo: Respira Technologies

    Respira Technologies plans to submit an inhaler device to the U.S. Food and Drug Administration by late 2021 for authorization as nicotine-replacement therapy.

    The company aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.

    Based in West Hollywood, California, USA, Respira Technologies says that the Covid-19 pandemic has sparked new interest in quitting, and today’s users of vapor devices and e-cigarettes need updated cessation products.

    “The reality is we have folks who are addicted to nicotine who never tried combustible products before,” Respira CEO Mario Danek told Bloomberg Technology, referring to tobacco products that are burned like cigarettes and cigars.

    “They’re used to sleeker products, and we have that design.”

  • Pyxus Files For Chapter 11

    Pyxus Files For Chapter 11

    Photo: Darren4155 | Dreamstime.com

    Pyxus International announced today that it and its subsidiaries, Alliance One International, Alliance One North America, Alliance One Specialty Products and GSP Properties, have filed voluntary petitions for relief under Chapter 11 of the U.S. bankruptcy code in the U.S. Bankruptcy Court for the District of Delaware as part of a “prepackaged” Chapter 11 Case.

    In connection with the filing, the company entered into a restructuring support agreement (RSA) with noteholders holding more than 92 percent in principal amount of the company’s first lien notes and more than 67 percent in principal amount of its second lien notes. In addition, the company’s receivables financing lenders and certain key foreign lenders have granted waivers and amendments under their respective facilities, demonstrating significant global financial support for the company.

    Under the terms of the RSA, Pyxus’ second lien noteholders will convert approximately $635 million of the company’s debt into equity or cash, and its first lien noteholders will, among other things, extend the maturity date of their existing notes by four years. To implement the financial restructuring contemplated under the RSA, the company commenced solicitation of a prepackaged Chapter 11 plan of reorganization and thereafter filed for Chapter 11 to restructure its debt and delever its balance sheet.

    The prepack plan contemplates that all outstanding shares of Pyxus common stock and rights to acquire Pyxus common stock will be cancelled and each holder of outstanding Pyxus common stock will be entitled to receive its ratable share of $1 million in cash provided that such holder does not opt out of the third-party releases contained in the prepack plan or object to the prepack plan.

    The Chapter 11 process does not include the company’s international subsidiaries or affiliates and Pyxus anticipates continuing to operate its worldwide operations in the ordinary course during the proceeding as it restructures its balance sheet. The terms of the restructuring contemplate paying, among others, all vendors and foreign lenders, in full.

    In addition, Pyxus has secured commitments for a $206.7 million debtor-in-possession financing facility (DIP facility) from certain existing noteholders. Proceeds from the DIP facility will be used to refinance the company’s existing asset-based revolver, for working capital and general corporate purposes, and to pay expenses incurred in connection with the Chapter 11 cases. Subject to court approval, the DIP facility, combined with the company’s projected cash flows, are expected to provide liquidity to support its operations during the restructuring process, allowing the company to emerge with a strengthened balance sheet to complement its operations and future growth plans.

    “This agreement with our noteholders represents a significant milestone in the ongoing process to transform our business as we continue to focus on driving long-term, sustainable growth and greater efficiency,” said Pieter Sikkel, Pyxus’ president and CEO. “We will continue to provide our customers with the quality products and services they are accustomed to without interruption and work with our business partners throughout the Court-supervised process. We also expect there will be no impact to vendors. As we look to quickly re-emerge from this process, we expect to be a stronger company, better able to execute on our long-term strategy and positioned for long-term growth and success.”

    Simpson Thacher & Bartlett is serving as legal counsel, and Lazard and RPA Advisors are serving as financial advisors to Pyxus.

  • Australian Regulator Rejects Heat-not-Burn Products

    Australian Regulator Rejects Heat-not-Burn Products

    Photo: PMI

    Australia’s Therapeutic Goods Administration (TGA) on June 10 in an interim decision rejected a request by Philip Morris Australia to adjust nicotine regulations in a manner that would allow the company’s heat-not-burn product (HTP) reach store shelves.

    Currently, only combustible tobacco products such as cigarettes and cigars are permitted to be sold in Australia.

    Philip Morris (PM) spokesperson Simon Breheny called the decision disappointing. “It puts Australia at odds with many other countries who have decided to regulate heated-tobacco and smoke-free alternatives,” he said.

    “The right decision was made,” said Becky Freeman, a researcher from Sydney University’s School of Public Health. “They [HNB products] are not some miracle product that reduces smoking.”

    While Breheny noted that PM will not challenge the interim decision, he maintained that a regulatory mechanism is the appropriate way forward. “People who are looking for these alternatives will continue to make the case for why they are important,” he said.

    The TGA is scheduled to release its full final decision in August.

  • Lil Hybrid 2.0 Goes Nationwide in Korea

    Lil Hybrid 2.0 Goes Nationwide in Korea

    Photo: KT&G

    KT&G will expand the sales of its Lil Hybrid 2.0 heated tobacco cigarette to all cities in South Korea.

    The product debuted in February in major cities, such as Seoul, and expanded to 37 metropolitan areas in April.

    The expansion follows a series of inquiries from consumers in areas where the product had not yet been released, according to Lim Wang-seop, business director for next-generation products at KT&G.

    “Since the launch of the product, we have continued to expand our sales outlets,” Lim said. “We will continue to lead the e-cigarette market by strengthening product competitiveness and enhancing customer satisfaction through technological innovation.”

    Lil Hybrid 2.0 is equipped with a function that automatically warms up when a stick is inserted for the first time. An OLED display provides information on the battery charge, the cartridge level and the remaining number of puffs.  

    The recommended consumer price is KRW110,000 ($90.27).