Category: Featured

  • BAT Recognized for Diversity and Inclusion

    BAT Recognized for Diversity and Inclusion

    Photo: BAT

    BAT has become the first company in the tobacco industry to be awarded both the U.K. National Equality Standard (NES) and the Global Equality Standard (GES).

    The NES and GES are industry-leading benchmarks for diversity and inclusion and are awarded following a rigorous assessment process. GES certification can only be attained for global companies who are NES certified.

    Among the key strengths that secured BAT’s certification during the assessment process was its dedicated diversity and inclusion strategy, which was launched last year.

    As part of this strategy, by 2025, the company aims to increase the number of women in senior teams to 40 percent and women in management roles to 45 percent; achieve a 50 percent spread of nationalities within regional and functional leadership teams to mirror the company’s consumer base and organization; and double the number of cross-industry hires in senior teams to 24 percent.

    Also noted was a clear focus on mental health and well-being, the development of diversity and inclusion capabilities among middle management, and the fact that BAT has functional champions and leads who drive diversity and inclusion across the business.

    “Our ethos sets a clear direction for us to enable a diverse and inclusive workplace culture,” said Hae In Kim, director of talent, culture and inclusion at BAT, in a statement. “We want our employees to feel valued and proud to have a fulfilling career at BAT.”

    The NES is the U.K.’s leading diversity assessment framework, developed in partnership with the U.K. government and in collaboration with 20 public and private sector organizations. Assessments are conducted by EY.

  • Illegal Cigarette Trade Hits Record Highs

    Illegal Cigarette Trade Hits Record Highs

    Photo: Tobacco Reporter archive

    South Africa’s illegal trade in cigarettes has hit record highs, a new IPSOS report shows.

    At least two-thirds of stores in four hotspot provinces are selling cigarettes below the minimum collectible tax (MCT) of ZAR21.60 ($1.40). In Free State and Western Cape, the numbers rise to three in four stores.

    “South Africa’s illicit cigarette trade—the biggest black market for cigarettes in the world—is now officially out of control,” said British American Tobacco South Africa (BATSA) General Manager Johnny Moloto in a statement.

    “Over a year since the disastrous lockdown sales ban, the illegal networks it enabled and enriched continue to dominate the retail sector. They are destroying legal jobs and livelihoods and depriving the treasury of ZAR19 billion in cigarette excise for 2021 alone.

    “Much-publicized efforts by SARS, SAPS and SANDF to disrupt these cartels have merely scratched the surface. Government has a duty to make this menace a national priority, enforce the law without fear or favor and rid our country of this revenue-sapping scourge once and for all.”

    Following its fourth investigation of the year into the tobacco trade, IPSOS’ new report reveals: illegal cigarettes are available in almost half of stores (43 percent) nationwide; cigarettes are selling for the equivalent of ZAR8 per pack, almost less than one-third of the MCT; the number of forecourts selling illegal cigarettes has almost tripled in the past four months; and the number of stores in Northern Cape selling illegal cigarettes (63 percent) has quadrupled in the past four months.

    The latest IPSOS fieldwork was carried out from Oct. 8–15, 2021, and follows similar studies in March, February and June of this year. Using the mystery shopper model, the researchers bought the cheapest cigarettes in 4,486 stores nationwide.

  • Lawmaker Scrutinizes Synthetic Nicotine

    Lawmaker Scrutinizes Synthetic Nicotine

    Raja Krishnamoorthi

    U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, has sent letters to two companies that manufacture or sell synthetic nicotine products, requesting information about the companies and their sale of these products.

    One letter was addressed to Next Generation Labs, the self-declared market leader in the production and sale of synthetic nicotine. The company claims its unregulated synthetic nicotine is used in more than 60 products and projects its sales to increase by 1,800 percent this year.

    Synthetic nicotine has been gaining popularity among vapor companies after the FDA denied hundreds of thousands of marketing applications for products made with conventional nicotine.

    “In response, some e-cigarette and e-liquid manufacturers, banned from legally selling their products, reportedly plan to switch to synthetic nicotine in an effort to avoid FDA regulation,” Krishnamoorthi wrote in his letter to Next Generation Labs.

    “Next Generation Labs appears to support this approach, with its co-founder, Ron Tully, offering the following thoughts on the FDA laws and regulations governing nicotine: ‘If the statute has been ill-conceived, and the regulation has been ill-drafted, it is not the responsibility of the industry to conform to some kind of idea that you can’t innovate in those spaces where the legislation doesn’t occur.’”

    Krishnamoorthi also sent a letter to Puff Bar, whose products have replaced Juul as the vape of choice for many young people after Juul Labs discontinued certain flavored products. In 2020, the Food and Drug Administration ordered Puff Bar to pull its products from the market. Earlier this year, the company introduced new versions of its products using synthetic nicotine.

    In a recent profile by The Wall Street Journal, Puff Bar co-CEO Patrick Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice. Because the Tobacco Control Act specifically gives the FDA authority to regulate nicotine “made or derived from tobacco,” most people believe the agency’s Center for Tobacco Products cannot regulate products that use synthetic nicotine—at least not without serious legal challenges, according to Vaping360.

    “You have apparently made the vile decision to continue enriching yourselves by poisoning children,” Krishnamoorthi wrote in his letter to Puff Bar. “Puff Bar’s meteoric rise in popularity among kids resulted in $156 million in sales in 2020 alone. Puff Bar should not be allowed to continue harming children due to FDA’s failure to regulate synthetic nicotine, and I intend to put an end to your predatory practices.”

    In his letter to Next Generation Labs, Krishnamoorthi requested information regarding the company’s sales and new business. In his letter to Puff Bar, Krishnamoorthi requested information regarding the company’s ownership and operations as well as support for the company’s assertion that it is using synthetic nicotine and requested the company’s co-CEOs appear for transcribed interviews.

    Greg Conley, the president of the American Vaping Association, said Krishnamoorthi lacked evidence that the targets of his  investigation have broken any laws. “As per the usual, he is playing politics, and we are hopeful the demands specified in his letter will be resisted,” Conley told Filter.

    “With youth vaping numbers and the associated moral panic continuing to decline,” he continued, “it remains to be seen whether Representative Krishnamoorthi’s primary goal—getting media attention focused on Representative Krishnamoorthi—will actually be met with this campaign.”

  • Vector Reports Third-Quarter Results

    Vector Reports Third-Quarter Results

    Image: Paulista

    The tobacco business’ performance reflects Vector’s advantages in the deep discount segment, says CEO.

    Vector Group reported consolidated revenues of $652.65 million for the third quarter of 2021, up 19 percent over those of the 2020 third quarter. Reported net income increased $10.8 million to $48.9 million. Adjusted net income was $52.6 million, $14.3 million more than in the prior year period.

    “Vector had another outstanding quarter, achieving all-time high quarterly revenues and significantly increased operating income,” said Howard M. Lorber, president and CEO of Vector Group, in a statement.

    “We are excited by the continued strong performance of our tobacco business, which validates our market strategy and reflects the competitive advantages we have in the deep discount segment. Our Douglas Elliman subsidiary also delivered record revenues up 70 percent during the quarter compared to the year ago period, and closed sales volume was up 62 percent over the same time frame. Combined with expense reductions, Douglas Elliman achieved record quarterly adjusted EBITDA during the third quarter.”

    In a press release, Vector Group announced that Douglas Elliman plans to file a Form 10 registration statement with the Securities and Exchange Commission in connection with its intended spin-off into a standalone publicly traded company.

  • New Report Questions WHO’s Vaping Stance

    New Report Questions WHO’s Vaping Stance

    A new report, published today, raises major questions about the anti-vaping arguments and approach of the World Health Organization and billionaire philanthropist Michael Bloomberg.

    The WHO and Bloomberg have both made clear their opposition to safer nicotine alternatives despite growing evidence of lower harm and efficacy for smoking cessation.

    The WHO’s tobacco control program is funded in part by Bloomberg Philanthropies. In July of this year, the two parties restated their joint position at the launch of the WHO Report on the Global Tobacco Epidemic, 2021: Addressing New and Emerging Products. In this report, the WHO emphasized that electronic nicotine-delivery systems are “a threat to tobacco control,” are harmful and should be banned or highly regulated. Bloomberg, in his capacity as the WHO Global Ambassador for Noncommunicable Diseases and Injuries and founder of Bloomberg Philanthropies, stated that tobacco companies are marketing new products such as e-cigarettes to “hook another generation on nicotine.”

    The International Network of Nicotine Consumer Organizations (INNCO) has now compiled a new dossier, titled Bloomberg, WHO and the Vaping Misinfodemic, containing statements and evidence from healthcare experts, leading academics, politicians, respected journalists and research organizations that question the stance of the WHO and Bloomberg on safer nicotine alternatives to smoking and the relationship between the two parties.

    This dossier comes just a week after the U.K. Department of Health and Social Care announced that e-cigarettes could be prescribed on the National Health Service, a world first. That move by the U.K. government provoked significant public debate around the polar opposite views toward safer nicotine alternatives, such as vaping, held by the British government and the WHO.

    The dossier also comes as the Parties to the WHO Framework Convention on Tobacco Control convene to discuss tobacco and nicotine policy.

    The outcomes from COP9 discussions will determine how international tobacco control policies are implemented at a country level across the globe to address the fact that 1.1 billion people still smoke worldwide and 8 million die every year from tobacco-related diseases.

    The dossier highlights nine reasons why serious questions need to be raised about the WHO’s and Bloomberg’s outright opposition to safer nicotine alternatives to deadly smoking. High on the list is their failure to distinguish between smoking addiction and nicotine dependence.

    They are shifting the harm focus from smoking to tobacco to nicotine—where it obviously doesn’t belong.

    Charles A. Gardner, executive director, INNCO

    “Effectively, through this failure, they are shifting the harm focus from smoking to tobacco to nicotine—where it obviously doesn’t belong—nicotine does not cause cancer, heart or lung disease. Smoking does,” says Charles A. Gardner, executive director at INNCO.

    This is backed up in the dossier by expert views on the profound difference between cigarette smoke and the drug, nicotine, including those expressed by Jamie Hartmann-Boyce, senior research fellow in health behaviors at the University of Oxford; John Britton, emeritus professor of epidemiology at the University of Nottingham and special advisor to the Royal College of Physicians on Tobacco; Adam Afriye MP; and a joint statement by 15 past presidents of the world’s top professional society in the field of tobacco control, the Society for Research on Nicotine and Tobacco.

    The report also scrutinizes the WHO’s role in COP events, with evidence suggesting that it is very controlling in terms of the agenda and attendance. Unlike COP26, these tobacco control COP meetings are described as “all but excluding the media,” “well-known for the routine ejection of the public from proceedings” and “notoriously secretive.”

    The dossier also reports on claims that the only tobacco control nongovernmental organizations (NGOs) allowed to attend are those who subscribe to the WHO’s tobacco harm reduction denialist stance. The U.K. Parliament’s All-Party Parliamentary Group for Vaping recently issued a warning about the participation at COP9 of The Union, a major global NGO funded by Bloomberg Philanthropies.

    “The Union [International Union Against Tuberculosis and Lung Disease] recently issued a major report titled Where Bans are Best: Why Low- and Middle-Income Countries Must Prohibit E-cigarette and HTP Sales to Truly Tackle Tobacco. The Union is one of Bloomberg Philanthropies’ two top tobacco control grantees—the other is the U.S.-based Campaign for Tobacco-Free Kids,” says Gardner.

    “We are a good case in point. INNCO, which represents and supports the rights of 98 million adults worldwide who use safer nicotine to avoid toxic forms of tobacco, has once again been denied observer status at COP9 (as it was denied at COP8 and at COP7).”

    The Bloomberg, WHO and the Vaping Misinfodemic report calls for:

    • Governments around the world to collectively challenge the WHO’s and Bloomberg’s current prohibitionist position on safer nicotine alternatives and to demand to know why, in the face of 8 million tobacco-related deaths every year, the tobacco control field is the only field of public health that rejects harm reduction
    • The formation of a global independent Tobacco Harm Reduction Working Group comprised of independent scientists, global health experts, specialist academics and people who use safer nicotine (ex-smokers)
    • Withdrawal of funding from and/or boycott of future Conference Of Parties (COP) tobacco control meetings until the WHO considers the overwhelming evidence that safer nicotine alternatives such as vapes, snus, nicotine pouches and heat-not-burn help smokers quit and save lives
    • Complete transparency in all tobacco control funding, grants and collaborations involving the WHO and Bloomberg
    • A full independent and international review into current and past tobacco control dialogue between Bloomberg Philanthropies, Bloomberg-funded NGOs and national governments in low-income and middle-income countries (LMICs) following allegations in the Philippines that the country’s Food and Drug Administration received funds from Bloomberg groups to support the implementation of the national tobacco control program
    • A complete review of the WHO’s public web-based Q&A on e-cigarettes, which has been described as “astonishingly bad.”

    The dossier also spotlights the EVALI (e-cigarette, or vaping, product-associated lung injuries) crisis of 2019. The U.S.-only outbreak of lung injuries caused by bootleg THC (cannabinoid) vape oils “cut” with one or more adulterants was wrongly reported to be caused by legal nicotine vaping.

    According to the report, the EVALI outbreak triggered Bloomberg Philanthropies to invest $160 million over a three-year period to prohibit all e-cigarette flavors other than tobacco flavor. EVALI is also still incorrectly referenced by the WHO in its Q&A on vaping products in response to the question as to whether e-cigarettes cause lung injuries.

    However, by early 2020, U.S. authorities identified vitamin E acetate, a cutting agent used in some bootleg THC vaping oils—mainly in U.S. states where cannabis remains illegal—as the primary cause of the outbreak.

    As reported in the dossier and which escaped the attention of the world’s media, last month, 75 global experts with no tobacco industry ties, including seven individuals who have served as president of the Society for Research on Nicotine and Tobacco, wrote to the CDC’s director asking her to change the name “EVALI” because it fails to alert THC vapers to their potential risks and it misleads smokers and nicotine vapers to believe e-cigarettes were the cause.

    “I’ve spent 30 years in global health, including three years as a senior advisor on research to the WHO. For most of my career, I worked on HIV, TB, malaria, dengue, rabies, nutrition and child health issues. So, I’ve never seen anything as crazy as what’s happening now in tobacco control. What troubles me is how few people outside of my ‘little’ echo chamber, the community of millions of ex-smokers who use safer nicotine, knows what’s going on,” says Gardner.

    “There are 1.1 billion smokers now in the world, a situation that has barely changed in the last 20 years. The anti-harm reduction conservatism of the WHO and Bloomberg is not working.

    “That’s why we are calling for a global response in the form of a tobacco harm reduction working group and international governments collectively questioning and challenging the WHO[‘s] and Bloomberg’s prohibitionist and evidence-denialist approach to safer nicotine. Because we are ex-smokers who use safer nicotine. We see what’s happening, and we have great empathy for smokers and ex-smokers who vape.

    “The goal is simple. Save lives. Only the starting assumptions and strategies to get there differ. These can be debated. But this debate is unethical if it does not include people who have, themselves, made the transition from smoking to not smoking, using tobacco harm reduction products (nicotine patches, nicotine gum and lozenges, nicotine vapes, nicotine pouches, snus and HTPs).”

    “Our future policy recommendations will focus on the need to change research priorities, just as HIV/AIDS activists sought to do in the 1990s. Global tobacco control research priorities today are skewed toward finding harms of alternative nicotine products while ignoring—or not even exploring—benefits, in particular the potential therapeutic benefits of nicotine. The health benefits of medical marijuana are now recognized because of research. The potential therapeutic benefits of psilocybin are now being explored (e.g., for PTST and even for smoking cessation). However, research to explore those potential benefits was locked in amber for 30 years because of prohibitionist drug laws.”

  • PMI Picks Stamford for New Headquarters

    PMI Picks Stamford for New Headquarters

    Photo: Edwin

    Philip Morris International’s new corporate headquarters will be located in the heart of Stamford, Connecticut, USA, and is expected to open in summer 2022. The move will initially bring approximately 200 jobs with an estimated economic impact of approximately $50 million in 2022.

    In June, PMI first announced it would relocate its headquarters to Connecticut from New York.

    “Connecticut’s position as a leader in innovation and forward thinking, paired with a commitment to open-minded civil discourse, allows us to foster an even stronger company culture. PMI will continue to attract an educated workforce, becoming an integral part of the local community and a source of pride for the state,” said Deepak Mishra, president of the Americas region at PMI, in a statement.

    “We are making rapid progress toward our smoke-free future,” continued Mishra, “and our new base in Connecticut is more than just an office building—it will be a full campus with a state-of-the-art innovation facility that will help accelerate our transformation.” State officials recognize that PMI is a company with a new purpose and bright future. We are proud that we will be able to call Connecticut home.”

    Connecticut’s position as a leader in innovation and forward thinking, paired with a commitment to open-minded civil discourse, allows us to foster an even stronger company culture.

    Deepak Mishra, president of the Americas region, PMI

    The new 71,484 square foot headquarters will be located at 677 Washington Boulevard in the heart of Stamford’s central business district, steps away from the Stamford Transportation Center and the entrance to I-95, making it easily accessible. The office will open as home to the PMI Americas region and other corporate functions. PMI’s Operations Center will remain in Lausanne, Switzerland, to continue to support the business across the globe. The company employs a worldwide workforce of more than 71,000.

    “The decision by PMI to locate its corporate headquarters in downtown Stamford is validation that our economic recovery in Connecticut is in full swing, and we are continuing to see meaningful growth in one of our fastest growing cities,” said Governor Ned Lamont. “We are looking forward to a long and fruitful relationship with PMI and it is clear they are focused on maintaining a strong partnership with the State of Connecticut for the foreseeable future.”

    According to PMI, the Connecticut location will offer employees a better range of commuting and living options following the paradigm shift caused by Covid-19. The headquarters will be aligned with PMI’s science- and technology-focused transformation, using state-of-the-art innovation to accommodate remote work and ensure that employees have an inspiring and comfortable workplace.

    The decision by PMI to locate its corporate headquarters in downtown Stamford is validation that our economic recovery in Connecticut is in full swing, and we are continuing to see meaningful growth in one of our fastest growing cities.

    Ned Lamont, governor, Connecticut

    “We are excited that our new location will offer employees and their families a wide range of living options, from the suburbs of Fairfield County to the rural areas of Litchfield County, while also having the advantages of easy access to the New York metropolitan area. More encouraging are the pioneering and community-minded populace, an excellent school system and healthcare facilities, and ample recreational and green space,” said Charles Bendotti, senior vice president of people and culture at PMI.

    PMI will take possession of the headquarters on March 1, 2022, with the goal of having the office operational by mid-to-late summer 2022.

  • WHO Tobacco Control Conference Kicks Off

    WHO Tobacco Control Conference Kicks Off

    Image: Tobacco Reporter archive

    The Conference of the Parties to the WHO Framework Convention for Tobacco Control (FCTC) today opens its ninth session (COP9). One significant point to be discussed by the Parties is a potential new funding strategy, seen as a means of strengthening and expanding the support that can be offered to Parties of the global health treaty.

    Parties at COP9 are expected to consider how to address a common problem described by many countries—the lack of sufficient financial resources to strengthen tobacco control measures. This will mean a plan to establish a capital investment fund is high on the COP9 agenda. The Parties will decide on the adoption of a mechanism for new income streams to help fight the tobacco epidemic.

    The proposal offers the opportunity to raise a targeted $50 million for the FCTC. A similar fund will be proposed for adoption at the second session of the Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products to take place later this month—but in the case of the Protocol, the fund proposed will be for $25 million to strengthen implementation of that treaty.

    In a press release, the WHO said it would continue pushing forward with comprehensive implementation of the FCTC as the real solution to the tobacco epidemic, despite what it described as tobacco industry efforts to “stir up confusion and falsely parade itself as a solution to harmful tobacco consumption.”

    The COP9 discussions Nov. 8-13 bring together Parties, representing countries, United Nations agencies, other intergovernmental organizations and civil society. The participants will be exchanging their experiences in implementing tobacco control measures and reducing the prevalence of tobacco use. They will also be looking at strategies that improve tobacco control efforts, amid what the WHO describes as “attempts by the tobacco industry to interfere in ending the tobacco epidemic that is killing over 8 million people annually.”

    During the conference, delegates will also be evaluating the most recent Global Progress Report, which was launched last week. A total of 148 Parties reported on the comprehensive tobacco control measures contained in the treaty. For example, in relation to progress on Article 11, two-thirds of Parties confirmed that the required health warnings are being displayed on tobacco product packaging and, 17 countries confirmed that they have adopted the requirements for plain packaging of tobacco products.

    Parties have reported that they have struggled to introduce comprehensive advertising, promotion and sponsorship bans. Many complained of persisting interference in policymaking by the tobacco industry.

    In her keynote speech at the opening of COP9, Adriana Blanco Marquizo, head of the Convention Secretariat referred to the ongoing COP 26, on Climate Change. There are important parallels between the Framework Convention on Climate Change and the WHO FCTC, she noted.

    “Both treaties aim to protect present and future generations,” said Blanco Marquizo. “It’s clear that tobacco damages the environment throughout its life cycle, from crop to post-consumer waste, contributing to deforestation, desertification, greenhouse emissions and plastic contamination. But probably the most important point shared at both COPs, is that the tobacco epidemic and climate change are both manmade and preventable.”

    Critics, by contrast, focused on the differences between the two COPs, with the Climate Change gathering welcoming public scrutiny and industry input, and COP9 convening behind close doors and banning dialogue with the industry.

    Immediately after COP9, the second Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products will be convened, Nov. 15-18. The Protocol is a separate treaty expanding Article 15 of FCTC.

  • Vapor Tax Resurfaces in Build Back Better Act

    Vapor Tax Resurfaces in Build Back Better Act

    Photo: DedMityay

    U.S. Lawmakers have reintroduced a tax on vapor products into the Biden administration’s Build Back Better Act, reports the Winston-Salem Journal. Earlier a series of controversial tobacco hikes had been removed from the legislation.

    The latest version of the bill calls of $50.33 per 1,810 milligrams of nicotine for “any nicotine product that has been extracted, concentrated or synthesized.” The previously proposed vapor tax was $100.66 per 1,810 mg.

    Vapor industry representatives were unimpressed. “American voters are already livid with paying high prices at the pump and the grocery store,” Amanda Wheeler, president of the American Vapor Manufacturers Association, was quoted as saying by the Winston-Salem Journal.

    “It’s a certainty they will be outraged with a gigantic tax on a product that millions use to quit cigarettes.”

  • ITC Veteran Rajiv Mohan Continues as Consultant

    ITC Veteran Rajiv Mohan Continues as Consultant

    D.V.R. Rajiv Mohan

    D.V.R. Rajiv Mohan of Indian Leaf Tobacco Exports ended his nearly 34 years of association with ITC, on mutual consent basis, on Nov. 1, 2021.

    In addition to working as an independent business consultant, Mohan intends to mentor agricultural startup firms, teach at business schools and farm, among other activities.

    During his career, Rajiv managed multiple assignments across the agricultural value chain, including operational, marketing and strategic functions. He was instrumental in taking ITC’s and India’s leaf tobacco exports to new heights during 2002-2012, establishing a footprint across all continents and customer segments.

    Subsequently, Mohan moved to agricultural commodities, overseeing the value chain for grains, cereals, plantation, horticulture and aquaculture. In his final assignment as vice president, Mohan oversaw value addition of a range of agricultural products.

    A vivid reader and active speaker, Mohan intends to travel, become an active blogger and continue his philanthropic activities.

    He can be reached at rajivmohan.dvr@gmail.com.

  • FDA Rescinds Marketing Denial for Humble Juice

    FDA Rescinds Marketing Denial for Humble Juice

    Photo: AliFuat

    The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) issued Sept. 15, 2021, for Humble Juice Co.’s flavored e-liquid products, the company announced on Nov. 5.

     Humble had filed a petition in October with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA’s decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition as FDA’s rescission of Humble’s MDO places the brand’s flavored e-liquids back into the PMTA review process and provides Humble with a pathway to market its products while its PMTAs are pending.

    FDA’s rescission letter states that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”

    The agency also stated that due to the unusual circumstances, it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.

    “FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”