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October 29, 2021
FDA Stays Bidi Vapor MDO Pending Review
The U.S. Food and Drug Administration has issued an administrative stay of its marketing denial order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).
Bidi Vapor’s flavored Bidi Sticks may remain on the market without the threat of enforcement while the FDA reviews the company’s request.
Bidi Vapor submitted PMTAs for all 11 flavor varieties of its Bidi Stick. The applications ran over 285,000 pages and contained information supporting the products as appropriate for the protection of the public health.
On Sept. 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the 11th Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act as well as the U.S. Constitution.
“We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Bidi Vapor Niraj Patel in a statement. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored Bidi Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing.”
“That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit,” Patel noted.
The company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals citing the “irreparable harm” it continues to suffer from the MDO.
Multiple companies have challenges their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.
According to Filter, 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 28, 2021
Court: Triton Can Sell Flavored E-Cigs Pending MDO Review

Photo: kwanchaift
The 5^th U.S. Circuit Court of Appeals has ruled that Triton Distribution can continue selling its flavored e-cigarettes despite a decision to the contrary by the Food and Drug Administration, reports Reuters.
In a unanimous opinion on Oct. 26, the 5th U.S. Circuit Court of Appeals said that when the FDA last month denied the Texas company’s application to sell its products, the agency did not adequately consider Triton’s marketing plan to reduce the products’ appeal to youth.
The court found the FDA pulled a “surprise switcheroo” from earlier guidance stating that manufacturers would not need long-term studies to support e-cigarette applications.
The FDA initially said in guidance accompanying the deeming rule that it did not expect companies would need long-term studies to support their application. However, in an August announcement that it would deny a first batch of applications, the agency said that manufacturers would likely need studies that followed a cohort of people over time to show that their products’ use in helping adult smokers quit cigarettes outweighed the risk to youth.
Triton challenged the agency’s decision, saying it had relied on the earlier guidance in its application.
Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.
More recently, the FDA issued an administrative stay of its MDO for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its PMTAs.
According to Filter, Bidi and Gripum too 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 28, 2021
Bangor, Maine Bans Flavored Vaping Products
The city of Bangor, Maine has banned flavored vaping products, including e-cigarettes. The Bangor City Council voted 7-1 in favor of the ban, which will not go into effect until after the Maine Legislature reconvenes next year. The ordinance bans the sale and marketing of all flavored tobacco products in the city — including menthol cigarettes and e-cigarette flavors that have a taste or smell besides tobacco — beginning on June 1, 2022.
Credit: Ianm35
While the amended ordinance falls short of the pre-session ban that advocates hoped would spur the Legislature to action on a statewide prohibition on the sale of flavored tobacco, it is a strong gesture for a council with many members who believe the flavored tobacco issue was better solved at the state level, according to Maine Public Radio.
Opponents and supporters saw the Bangor vote as an important step in the fight to ban the sale of flavored tobacco at the state level. That bill, LD 1550, was reported out of committee earlier this year but had not come to a vote before the end of this year’s legislative session.
Many opponents brought up the contents of messages the National Association of Tobacco Outlets requested under Maine’s Freedom of Access Act that they said showed an effort by Bangor councilors, especially Councilor Sarah Nichols, to not include the voices of merchants in the process of crafting and debating the ordinance. Many of the exchanges are text messages between Nichols and Matt Moonen, who had brought the proposal to ban flavored tobacco to her. Moonen is the executive director of Equality Maine.
Earlier Monday, the New England Convenience Store and Energy Marketers Association had called for the council to suspend decisions on the tobacco ban and evaluate how councilors had acted. Sprague, one of several councilors to turn back those arguments, said such allegations had ultimately hurt the opponents’ case.
“The comments about the process and how the city has not supported open dialogue are insulting, if not repulsive,” Sprague said. City Council Chair Dan Tremble was the only councilor to vote against the ordinance. Nichols did not directly respond to statements about her during the meeting, though she referenced them in her remarks on why she supported the ordinance.
Retailers who continued to sell or market flavored tobacco products after the ordinance took effect would first face a warning, and then a $50 to $100 fine for their next offense within a two-year period after the warning. A fine of $300 to $1,000 would then be levied for each additional offense within that two-year period.
October 27, 2021
WHO Urged to Embrace Tobacco Harm Reduction
The ninth Conference of the Parties (COP9) to the World Health Organization Framework Convention on Tobacco Control (FCTC) will operate under conditions of secrecy comparable to those of the U.N. Security Council, according to a new report by the Global State of Tobacco Harm Reduction (GSTHR) titled, Fighting the Last War: The WHO and International Tobacco Control.
The public and media are banned from attending all but one largely ceremonial opening plenary, yet millions will be affected by the decisions taken at COP9, which is scheduled to take place virtually Nov. 8–13.
The report contends that current implementation of the FCTC is a global public health failure. In force since 2005, when there were 1.1 billion smokers around the world, the FCTC set out the principles of global tobacco control—to reduce the death and disease caused by smoking. In 2021, however, there are still 1.1 billion smokers worldwide and 8 million smoking-related deaths each year. What’s more, the number of smokers is predicted to rise, and the number of smoking-related deaths is set to top 1 billion this century.
Change is urgently needed, and harm reduction for tobacco offers the opportunity for that change, according to the GSTHR.

Fighting the Last War notes that while tobacco control policy has remained frozen in time, innovative noncombustible nicotine technology and supporting evidence have moved forward. Vaping devices, snus, nicotine pouches and heated-tobacco products are significantly safer than cigarettes as they deliver nicotine without combustion, according to the report’s authors. This, they argue, enables people who cannot or do not want to stop using nicotine to quit deadly smoking and switch to less risky products.
“Just as delegates at COP26 will be discussing the world’s urgent need to stop fossil fuel combustion, the technology is now in place to ensure the end of the age of combustion for tobacco as well,” the GSTHR wrote in a press note. “A number of Parties to the FCTC, such as the United Kingdom and New Zealand, have successfully introduced tobacco harm reduction policies alongside their tobacco control regimes and have seen marked decreases in smoking rates.”
When given accurate information about comparative risk, many smokers switch, the organization notes. Worldwide, the GSTHR estimated in 2020 that 98 million people worldwide were using safer nicotine products.
The authors also point out that the concept of harm reduction is embedded in the WHO response to drug use and HIV/AIDS. It is explicitly named as the third pillar of tobacco control alongside demand and supply reduction in the FCTC. Yet the WHO has remained implacably opposed to harm reduction for tobacco and is increasingly viewed as having overseen a “mission creep,” which now sees international tobacco control setting its sights on prohibition for nicotine in all its forms.
“There are concerning signs in published agenda and briefing papers that the FCTC secretariat and leadership continue to urge Parties against increasing access to, or even to prohibit, safer nicotine products,” the GSTHR wrote.
Fighting the Last War considers the motivations—ideological, financial and historical—that have led to many global tobacco control practitioners becoming so hostile to what others see as the greatest potential public health advance in decades.
The report argues that Parties to the FCTC need to seize back control of the COP meetings from the FCTC secretariat, which it says has become overly influential with little oversight. FCTC Parties should press for more evidence-based discussions, calling upon the widest breadth of scientific, clinical and epidemiological expertise on safer nicotine products and tobacco harm reduction, according to the authors. “This should include evidence from Parties that have implemented harm reduction policies, those involved in manufacturing safer nicotine products and the lived experience of consumers,” they wrote. “The establishment of a working group on tobacco harm reduction would offer a pragmatic route to move the FCTC toward a tobacco control regime fit for purpose in the 21st century.”

“As global leaders prepare to make important pledges on climate change under the glare of the media spotlight at COP26, we urge them to demand more from their delegations inside the closed and unscrutinized rooms of COP9,” says Gerry Stimson, director of Knowledge-Action-Change and emeritus professor at Imperial College London. “Every day, more than one billion smokers are being failed by the international tobacco control regime. The age of combustion—for tobacco as for fossil fuels—must end.
“Tobacco harm reduction offers new routes out for adult smokers. GSTHR estimates suggest that 98 million of them have already switched. At COP9, government delegations must seize back control and prevent the slide into outright nicotine prohibition that would see many return to smoking and many millions more never succeed in quitting.”
“The fight to reduce eight million smoking-related deaths a year is now being actively undermined by the WHO and the international tobacco control establishment,” said report author Harry Shapiro. “Together, they are fighting the last war against the tobacco industry—to direct attention away from the evidence that safer nicotine products can make a significant contribution to reducing that death toll.”
“If those who dominate the global tobacco control discourse were truly committed to public health imperatives, harm reduction principles and policies would be front and center,” said Ethan Nadelmann, founder of the Drug Policy Alliance. “This valuable report exposes the ways in which international institutions have turned their backs on scientific evidence and the human and political rights of hundreds of millions of people whose lives might be saved by safer nicotine products.”
“Fighting the Last War provides an insight into the dark arts of the WHO that many would find breathtaking and incomprehensible,” said Jeannie Cameron from JCIC Consulting. “It shows a concerning difference between the world’s preparations for COP26 on climate change and COP9 on tobacco. Governments need to stand up at COP9 to support tobacco harm reduction against the outdated views of the WHO.”

The fight to reduce eight million smoking-related deaths a year is now being actively undermined by the WHO and the international tobacco control establishment. Together, they are fighting the last war against the tobacco industry—to direct attention away from the evidence that safer nicotine products can make a significant contribution to reducing that death toll.”
Harry Shapiro, author, ‘Fighting the Last War’
“The challenge for lower and middle-income countries while fighting the last war and promoting real tobacco control is about two major issues,” said Nataliia Toropova from Healthy Initiatives. “Firstly, the current provisions of the WHO FCTC have not been properly implemented due to stretched government resources. Thus, smoking cessation programs are nonexistent, and adult smokers feel hopelessly stuck while making their numerous unsuccessful attempts to quit with no medical help or guidance provided. Secondly, the lack of a comprehensive harm reduction strategy is aggravated by a massive misinformation campaign about harm reduction products and a declared war on nicotine. Unless these two issues get tackled, unless the powerful voice of doctors becomes loud and gets heard, unless education and awareness building campaigns take place, no changes will occur, and this last war will be lost.”
October 27, 2021
Turning Point Brands Posts Third-Quarter Results
Turning Point Brands reported net sales of $109.9 million in the third quarter of fiscal 2021, up 5.5 percent over that of the previous year’s third quarter. Gross profit increased 12.3 percent to $54.3 million and net income increased 49.3 percent to $13.4 million.
“Our third quarter performance fell within our expectations with sales growth of 11 percent in our core business despite facing the headwind of Covid-related consumption and other benefits we experienced in the prior year period,” said TPB President and CEO Larry Wexler in a statement.
“Zig-Zag had another robust quarter driven by our strategic initiatives and growth within our Canadian business. Stoker’s saw double-digit growth in our Moist Snuff Tobacco (MST) business which drove growth in the overall segment. Regarding capital deployment, we continued to repurchase our shares during the quarter and today announced an increased share repurchase authorization. We also maintain a strong balance sheet to pursue a healthy pipeline of investment opportunities. Overall, we remain optimistic about the growth prospects in our core business.”
NewGen Products gross profit increased 22.4 percent to $13.5 million for the quarter. The segment gross margin expanded 760 basis points to 36.2 percent with the improvement partially driven by industry pricing pressure ahead of the PMTA submission deadline in the previous year comparable period.
Wexler said he was encouraged by the U.S. Food and Drug Administrations recent decision to reconsider and place back into review the premarket tobacco product application for TPB’s proprietary vapor products, which the agency had earlier rejected.
“I am confident that we submitted a robust application and look forward to engaging with the FDA in its review,” he said. “We continue to believe that robust regulatory oversight is a positive for the industry and we believe we are favorably positioned to leverage our strong regulatory and logistics capabilities to capitalize on an attractive long-term opportunity.”
October 27, 2021
Youth THC Vaping More Than Doubles Since 2013
While nicotine vaping by youth takes the headlines, teen vaping of marijuana more than doubled between 2013 and 2020, according to a new study. Youth use of nicotine vaping products, however, dropped the past two years. The results may indicate that young people may be swapping out joints, pipes or bongs for vape pens, according to a new study.
Credit: H Ko
Researchers also found that adolescents who say they vaped cannabis within the last 30 days increased 7-fold — from 1.6% to 8.4% — during the same period. The report was published in JAMA Pediatrics on Monday by researchers who analyzed 17 studies involving nearly 200,000 adolescents in the U.S. and Canada.
Overall, they say, the cumulative data points to what may be a shift in preference from dried herb to cannabis oil products, which is how marijuana is ingested via vaping, according to NPR. This may be due to the more intense high that can be achieved by cannabis oils, which contain higher levels of THC, the psychoactive ingredient in marijuana, and the “misconception” that vaping devices are safer than smoking.
“Regular use of high THC products could increase the risk of dependence, other substance use and many other health, social and behavioral problems later in life,” study author Carmen Lim, a doctoral candidate in health and behavioral sciences at the University of Queensland in Australia, told NPR.
The Monitoring the Future survey — a large U.S. survey on drug and alcohol use related attitudes in adolescents — is one of the 17 studies included in the new meta-analysis. Although it showed that marijuana use has remained relatively stable among 12th graders in the last few years, hovering around the 35 percent mark, the growing popularity of electronic pot vaping devices is alarming, Lim said.
October 26, 2021
Texas Vape Shops Sue Over State’s Delta-8 THC Ban
Texas recently released an updated guideline making Delta-8 THC products illegal in the state. Delta-8 THC products now are listed as a Schedule I controlled substances, and state health officials noted that the products have been banned for months now.
Credit: Promesaartstudio
The move prompted several Texas CBD and vape shops owners to file for temporary restraining orders regarding the announcement. Those who filed the temporary restraining orders prayed it to be granted against the state. According to The Dallas Morning News, Ashley Flood, the owner of a CBD American Shaman franchise, said that she and other owners and consumers were not informed of the move to update the state’s website regarding the use and selling of marijuana-related products.
The Dallas Morning News quoted Flood saying, “We didn’t find out from the state, we didn’t find out from law enforcement, we didn’t find out via letter, email — nothing. We found out from one of our suppliers.” Flood added that she purchased $20,000 word of Delta-8 products for her store, accounting for 50 to 60 percent of her profit. If they are illegal, her business will be badly hit.
What is interesting about the DSHS’ statement regarding Delta-8 is that it follows a popular trend among states regarding Delta-8: state agency prohibition against certain cannabinoids that appear damning, despite the fact they might not carry the force of law, according to renowned cannabis attorney Rod Kight.
“Other states across the country, including Iowa, Kentucky, Massachusetts, North Carolina, South Carolina, and Vermont, to name a few, have, through various agencies, enacted similar prohibitions. However, while other states across the country are attempting to chill the fervor of Delta-8 via agency or administrative actions, what makes Texas’ prohibition unique is that it appears to be the result of deliberate action taken over a period of time to amend Texas’ list of controlled substances to be different than the federal list of controlled substances,” Kight said. “Importantly, this agency amendment followed the Texas legislature’s inability to pass a bill that would have banned Delta-8 THC during its most recent legislative session.”
The Dallas Morning News said that the 2018 Farm Bill might be the one confusing sellers and consumers regarding Delta-8 products. The bill legalized Delta-8 products at the federal level, but it allows individual states to develop more stringent laws regarding the selling and consumption of such.
Further, many believe the Delta-8 products remain legal because, under the law that Gov. Greg Abbott signed in 2019, hemp products with less than 0.3 percent tetrahydrocannabinol are legal.
October 26, 2021
FDA Rescinds Another Marketing Denial Order
Credit: AliFuat
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 rescission 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
Foundation for a Smoke-Free World Changes Leadership

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