Category: Featured

FDA Rescinds Another Marketing Denial Order
The U.S. Food and Drug Administration has rescinded another marketing denial order (MDO), placing Fumizer’s flavored vapor products back under review, reports Filter. Fumizer received its MDO in September.
This recission comes just weeks after the agency withdrew an MDO issued to Turning Point Brands (TPB).
In a letter to Fumizer’s, the FDA stated that “upon further review of the administrative record, FDA found relevant information that was not adequately assessed previously.”
“Specifically,” the letter states, Fumizer’s “application did contain randomized controlled trials comparing tobacco flavored ENDS [electronic nicotine-delivery systems] to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review.”
The FDA has indicated that it “does not intend to initiate an enforcement action” on Fumizer’s flavored vapor products returning to the market during the new review.
Many MDO recipients have complained that the FDA has been “shifting its goal posts,” during the review process, demanding certain studies that it did not appear to require before the PMTAs were filed.
According to industry insiders, the most recent MDO recission demonstrates that TPB’s successful petition for review and motion for a stay wasn’t a one-off, resulting from the legal jurisdiction it was filed in.
“A rescission in California for Fumizer is evidence of the systemic failure of the agency to ‘adequately assess’ the science and data of a wide range of small- and mid-sized applicants while giving all of their time and attention to the large companies like Juul and Reynolds,” a source told Filter
Multiple companies have challenges their MDOs. Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.
October 26, 2021
Leadership Transition at Smoke-Free Foundation

From left to right, Derek Yach, David Janazzo and Heidi Goldstain
Foundation for a Smoke-Free World today announced that Derek Yach will no longer serve as president and board director. Heidi Goldstein, general counsel, and David Janazzo, chief financial officer and executive vice president of operations and finance, will serve as interim co-presidents, effective immediately, while the board conducts a search for a new president to lead the foundation and its vital mission forward.
“After careful consideration, the board has determined that now is the right time for a new leader to guide the essential efforts of the Foundation, its team and its work with partners around the world,” said Pamela Parizek, chair of the Foundation’s board of directors, in a statement. “As we continue to take urgent action to accelerate progress toward ending smoking in this generation, we look forward to this opportunity to take the Foundation to the next level of achievement.
“The Foundation remains squarely focused on its mission to improve global health by reducing death and disease caused by smoking, and Heidi and David, together with the rest of our talented team, will continue advancing our global research grantmaking, range of innovative programs and powerful public health collaborations without interruption.”
Parizek continued, “On behalf of the board, I want to thank Derek for helping to establish and build the Foundation. We deeply appreciate the contributions he has made to this team’s work and to communities around the world through decades of ground-breaking efforts in tobacco control and public health. We wish him all the best.”
“The Foundation’s ongoing work to end the world’s largest single preventable cause of death could not be more needed today,” said Yach. “I leave the Foundation with deep satisfaction that we now have an emerging cadre of hundreds of researchers, advocates and industry scientists dedicating themselves to this goal. My future efforts aim to complement them.”
October 25, 2021
CDC awards $35 million in contracts

Photo: Katherine Welles
The U.S. Centers for Disease Control and Prevention (CDC) has awarded global consulting and digital services provider ICF three contracts with a combined value of $35 million to provide digital transformation, health surveillance, data management, technical assistance and communications services to its programs.
The agreements include a $9 million task order with the Office on Smoking and Health to provide communications, marketing and partnership engagement services, as well as research and technical assistance support on issues related to tobacco control, including the development and implementation of campaigns and the release of Surgeon General reports.
“ICF has partnered with CDC programs for over 30 years, and we have the right people and the right skills in place to meet their complex needs—from public health research to data analytics and IT modernization to communications and citizen engagement,” said Mark Lee, ICF executive vice president and public sector lead, in a statement. “We look forward to continuing to help CDC advance the critical public health missions of its programs.”
ICF brings together public health, health technology and technical support services to help organizations solve complex challenges. ICF’s approach combines advanced analytics, industry expertise and enterprise technologies.
October 25, 2021
Mexico: Nearly One in Five Cigarettes Illicit

Photo: Hassan
Illicit products account for 18.8 percent of Mexico’s cigarette market, reports Mexico Daily, citing a report released by the Confederation of Industrial Chambers of Mexico (Concamin). The figure is up from just 2 percent in 2011.
The illicit trade has cost the government an estimated MXN13.5 billion ($667 million) in uncollected excise and VAT taxes. The report added that the illicit sales create unfair competition for legitimate sellers and noted that the black market was helping to fund criminal activities, which negatively affect public security.
Concamin said that two-thirds of illegal cigarettes do not carry the security code that proves compliance with tax regulations “Illegal cigarettes are a multidimensional problem that has become sophisticated in recent years,” it noted.” Although before there was no local production of illegal cigarettes, today we can see in the market many brands do not have the security code that the government requires through the [tax regulator] SAT. This dynamic represents two-thirds of the problem.”
The Federal Commission for Protection Against Health Risks reported that there are more than 245 brands of illegal cigarettes in Mexico, mainly of Chinese origin, with the brands Win and Brass standing out as leaders in the cigarette contraband market, with 6.7 percent of total cigarette sales.
October 22, 2021
‘MDO Rescission Not Necessarily a Precedent’

Photo: tashatuvango
Even as consumer activists, vapor manufacturers and tobacco harm reduction advocates have taken heart from the U.S. Food and Drug Administration’s decision to rescind the marketing denial order (MDO) it had issued to Turning Point Brands (TPB), it is unclear whether that move sets a precedent, writes Alex Norcia in Filter.
The problem, according to Norcia, is that TPB’s premarket tobacco product application is not publicly available, so that other manufacturers are left to guess how the company managed to get the agency to backtrack.
At least 27 manufacturers and distributors, including Avail Vapor, Triton Distribution and My Vape Order (MVO), have filed petitions asking federal circuit courts to review their MDOs, according to Vaping360.
In his article, Norcia details the travails of MVO, which on Oct. 20 petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.
Lawyers for MVO revealed that their client had shared studies and data with TPB and other companies, essentially arguing that the company did not receive the same treatment as TPB, even though the applications contain some of the same information.
October 22, 2021
THR Activists to Broadcast During COP9

Image: sCOPe
Nancy Loucas
A group of tobacco harm reduction experts will hold a round-the-clock broadcasting event Nov. 8-12, coinciding with the Ninth Session of the Conference of the Parties (COP9) to the World health Organization Framework Convention on Tobacco Control (FCTC).
Dubbed “sCOPe,” or “streaming Consumers On Point everywhere,” the five-day livestream will be simulcast via YouTube and Facebook. Presenters and panelists will challenge and scrutinize COP9, questioning, for example, who is influencing and funding its efforts to demonize vaping.
“Before the Covid-19 pandemic, consumers were planning to front up to COP in person and show media our increasing anger for being shut out, once again, from the proceedings,” said sCOPe organizer Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Harm Reduction Advocates. “The FCTC’s decision to delay COP9 and host it exclusively online, with no discussions to be publicly released, meant consumers had to take alternative action. Hence, the development of sCOPe,”
“sCOPe is our response to being excluded from the table, as the main stakeholders, of the discussion and decision-making process that directly impacts our health and our right to make informed decisions,” she said.
October 22, 2021
Hong Kong Bans ENDS Sales

Photo: fazon
Hong Kong has banned import, sale and manufacture of electronic nicotine-delivery systems, but personal use is still allowed. The ban will come into effect in mid-2022, Secretary for Food and Health Sophia Chan Siu-chee said. The maximum penalty for offenders will be a HK$50,000 ($6,431) fine and six-month imprisonment.
The long-delayed Smoking (Public Health) (Amendment) Bill 2019 passed Oct. 21, “delivering a major victory for health activists and educators who have blamed the devices for encouraging smoking among young people,” according to the South China Morning Post.
While the new law targets only vape shops and the local business of vaping, consumers will still be free to use the devices, prompting some politicians to call for more aggressive measures to curb tobacco use, including banning smoking in all public places except for designated areas. Others, however, argued Hong Kong should allow reshipment of vaping products and warned the ban would hurt logistics companies.
The bill was approved by a vote of 32 to three in the Legislative Council. Two lawmakers abstained.
October 21, 2021
U.K. Lawmakers Want Warnings on Sticks
Photo: vchalup
U.K. lawmakers want to require tobacco manufacturers to print the message “smoking kills” on each individual cigarette, reports The Guardian.
Members of Parliament have submitted an amendment to the health and care bill going through parliament which would allow the health secretary to make such warnings mandatory.
“We know that cigarettes are cancer sticks and kill half the people who use them. So I hope that health warnings on cigarettes would deter people from being tempted to smoke in the first place, especially young people,” said Mary Kelly Foy, the Labour MP behind the move.
Foy’s amendments would also let the health secretary:
Raise the legal age for buying cigarettes from 18 to 21.
Stop e-cigarette makers using tactics that might entice children to try them, such as sweet flavorings and cartoon characters.
Make it illegal to give e-cigarettes away free as sampler products.
Empower the government to impose a new levy on tobacco company profits, with the proceeds being used to fund stop smoking activities.
The plan is backed by Cancer Research UK and the Royal College of Physicians.
These stale and tired ideas have been around for years. The reason they haven’t been adopted in the U.K. is because there is no evidence that they will significantly reduce smoking rates.
Simon Clark, director, Forest
Simon Clark, the director of the pro-smoking group Forest, criticized Foy’s proposal.
“These stale and tired ideas have been around for years,” he said in a statement. “The reason they haven’t been adopted in the UK is because there is no evidence that they will significantly reduce smoking rates or discourage young people from smoking.
“Everyone is aware of the health risks of smoking. There are huge, impossible-to-miss health warnings on every pack of cigarettes including grotesque images of smoking-related diseases.”
He added: “Introducing a levy on tobacco companies would disproportionately hurt less well-off smokers because it will inevitably be passed on to consumers who already pay punitive rates of taxation on tobacco.”
October 21, 2021
Altria and Juul Support Age-Verification System
Altria Group Distribution Co. and Juul Labs have announced their support of TruAge, a new digital solution that enhances current age-verification systems and protects user privacy.
Developed by the National Association of Convenience Stores and Conexxus, TruAge makes it easier and more accurate to verify a customer’s age when purchasing age-restricted products. At the same time, the system makes identity theft difficult. One-time-use tokens are used to share only the most important elements to confirm the purchaser is of legal age, which also protects the user’s privacy.
TruAge is free to retailers, consumers and POS providers, and its relevant intellectual property will be placed in the public domain—removing barriers to adoption.
“We are excited to join this important initiative because TruAge deepens our trade partners’ support of underage prevention and helps establish retail as the most trusted place to responsibly sell tobacco products,” said Scott Myers, president and CEO of Altria Group Distribution Co., in a statement.
“Over the past few years, we have worked closely with our retailer partners across the United States to implement enhanced access controls for the sale of Juul products, automatically requiring electronic ID scanning to verify the purchaser is at least 21 years of age and limiting the amount of product sold to reduce social sourcing,” said Parker Kasmer, vice president of regulatory engagement for Juul Labs.
“We are eager to support TruAge and the extension of technologically based age-verification solutions across all vapor and other age-restricted products to combat underage use and support a more responsible marketplace.”
TruAge is also supported by more than 130 retail companies that represent 22,000-plus convenience store locations in the United States, plus four industry point-of-sale providers.
October 21, 2021
Health Policies Linked to Corporate Influence

Photo: svetazi
Governments around the world have been slow to implement the World Health Organization’s recommended public health policies on alcohol, unhealthy foods and tobacco, according to a study led by researchers at Karolinska Institutet and the London School of Hygiene & Tropical Medicine, published in the journal The Lancet Global Health.
Implementation has been particularly low in poor less-democratic countries where corporations had more influence for example through corruption and political favoritism, the study found.
In 2013, the WHO’s 194 member states endorsed a list of policies to combat non-communicable diseases (NCDs), such as heart disease, cancer, diabetes and chronic lung disease.
The researchers found that on average, only a third of the public health policies had been fully implemented in 2020.
Progress was especially slow in low-income countries and countries with less democracy. At the bottom of the list are three countries in West Africa—Equatorial Guinea, Guinea-Bissau and Sierra Leone—with one to two partially implemented policies.
The researchers found that the positive relationship between democracy on implementation was cancelled out in countries with above-average levels of corporate influence. Corporate influence was measured using an existing index with 25 metrics of corporate power, including corruption, bribery, government official favoritism, foreign investments and foreign contributions to political campaigns. Lobbying was not part of the assessment due to a lack of reliable data for many countries.
“Our analysis shows that corporate political influence is associated with the degree of implementation—the more influence corporations had, the lower the degree of implementation of preventive public health measures,” says Luke Allen, the first author of the study, told KI News. “While we cannot establish causality, our findings indicate that more work is needed to support particularly low-income countries in introducing effective NCD policies, especially around commercial determinants.”
October 21, 2021