Category: News This Week

Bidi Vapor Pushes for Synthetic Nicotine Ban

Photo: Andrii
Bidi Vapor is pushing for a ban on the marketing and distribution of synthetic nicotine in the United States, the company’s exclusive distributor, Kaival Brands Innovations Group, reported in a press release. The company, which manufactures a synthetic nicotine-based smokeless pouch, insists synthetic nicotine should be classified as an unapproved drug and thus be subject to applicable Food and Drug Administration drug regulations.
Bidi Vapor appears to be betting that a ban on synthetic nicotine pouches will benefit sales of its tobacco-derived nicotine pouch, which will be subject to the FDA premarket tobacco product application (PMTA) process before it can be distributed in the U.S. The reviewing process will further delay the launch of the tobacco-derived nicotine pouch, which had already been postponed due to Covid-19, according to Bidi Vapor.
Following the FDA’s rejection of numerous PMTAs earlier this month, many companies have set their sights on synthetic nicotine, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product”—a position suggesting that synthetic nicotine remains outside its remit.
Bidi Vapor is now taking the opposite approach.
“We believe that the delay in the distribution of the Bidi Pouch in the U.S. will lower revenues in the short term. However, we believe that in the longer term, the removal of all synthetic nicotine products in the U.S. market could prove to be a positive event for us,” the company wrote.
“Based on the FDA’s PMTA decisions related to disposable ENDS [electronic nicotine-delivery system] products, we anticipate that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s PMTA process. Conversely, we believe that many other ENDS manufacturers are utilizing synthetic nicotine as a loophole to avoid the rigorous PMTA process and that if synthetic nicotine is deemed to be an unapproved drug, the FDA will need to regulate synthetic nicotine products as unapproved drugs or remove them from the market in order to enforce and bolster compliance requirements.”
September 15, 2021
CVA Protests ‘Double Standard’ in Regulation

Photo: Валентин Копалов
The Canadian Vaping Association (CVA) says it is astounded by “the hypocrisy and inequity” in the regulation of adult products.
Alcohol, a substance known to cause significant harm to health, faces no restrictions on the use of flavorings or warning label requirements in Canada, according to the association. On the other hand, nicotine vape products, harm reduction products used primarily by smokers seeking to quit, have undergone rigorous regulation culminating in a proposal to restrict all pleasant “sensory attributes.”
Darryl Tempest
“Flavors are a common denominator across adult products,” the CVA wrote in a statement. “As the cannabis and vaping industries battle to keep flavors for adults, the alcohol sector operates freely and advertises broadly. The staggering double standard that exists for alcoholic beverages is absurd when compared side by side.”
“Vaping, unlike recreational cannabis or alcohol, provides a public health benefit,” said Darryl Tempest, executive director of the CVA. “The goal of health policy should be to capitalize on public health gains. Canada has now seen through Nova Scotia’s flavor ban that reducing the appeal of vaping products to smokers results in increased smoking and the destruction of small businesses. The proposed regulations are not fit for purpose. Canadians don’t want regulation that causes increased smoking rates and fewer jobs.”
September 14, 2021
Progress Toward Smoke-Free Goal

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Ireland has made progress toward its goal of being smoke-free by 2025, according to the republic’s department of health, reports Joe.
The announcement follows the publication of the Tobacco-Free Ireland 2020 Annual Report, which outlines “several key achievements” in 2020, despite Covid-19 disruptions. These achievements consist of the inclusion of information on the dangers of tobacco use in Healthy Choices 1, the first substance misuse module of Junior Cycle Social, Personal and Health Education; the launch of a new quit marketing campaign called The Last Stop; the completion of three comprehensive evidence reviews on electronic cigarettes and heated-tobacco products by the Health Research Board; and an increase of $0.50 per pack of cigarettes with pro-rata increases on other tobacco products included in Budget 2021.
“By working to remove smoking from daily life in Ireland and educating young people on the dangers of tobacco while making cessation assistance as widely available as possible, we can continue to build on the promising results we have seen in recent years,” said Health Minister Stephen Donnelly. “I urge anyone that is thinking of quitting to act now. Stopping smoking remains one of the best decisions a person can make for their health. The last 18 months has further highlighted the importance of being proactive about our own health and the health of those around us. The HSE quit service remains available to anyone that needs it.”
September 13, 2021
Iowa AG Worried About FDA Marketing Denials
Tom Miller
Iowa Attorney General Tom Miller has expressed unease about the U.S. Food and Drug Administration’s Sept. 9 decision to deny large numbers of e-cigarettes access to the marketplace.
“We are concerned about the impact of the FDA’s actions, particularly the unintended consequences of pulling from the market less harmful alternatives to cigarettes,” Miller wrote in a statement. “We believe the best information available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.
“Let’s not forget the overwhelming risk to public health: The CDC estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes.
“We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policymakers must strike the right balance between making accessible potentially lifesaving lower risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”
On Sept. 9, the FDA issued marketing denial orders to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The next day, the agency denied another set of applications, bringing the total to 946,000 products and 168 companies.
The regulatory agency released a revised list of MDOs that includes 125 company names but not any specific products that were denied.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
September 13, 2021
Fortune: Reynolds Among Best Workplaces
Photo: RAI
Reynolds American Inc. (RAI) has been named one of Fortune magazine’s Best Workplaces for Manufacturing and Production.
The Best Workplaces in Manufacturing and Production is highly competitive. Great Place to Work, the global authority on workplace culture, selected the list using rigorous analytics and confidential employee feedback.
“This recognition is a testament to our employees, who are at the forefront of rapid transformation in our industry,” said Guy Meldrum, Reynolds president and CEO, in a statement. “We are committed to being an organization where everyone feels accepted, empowered and valued. We are proud our people continue to have a positive experience here at Reynolds.”
By 2025, Reynolds aims to reach gender parity in management roles and to significantly increase minority representation in management and senior management roles. The company continues to implement progressive policies and programs with a sharpened focus on diversity and inclusion. The company offers first-in-class benefits, including:
A comprehensive parental leave policy with 16 weeks of paid leave for new parents
Dynamic employee resource groups comprising individuals with common interests or backgrounds and their allies
Tuition reimbursement and best-in-class recognition programs
Company-wide diversity and inclusion trainings and programs
Enhanced employee wellness resources and learning and development support during the Covid-19 pandemic
“As leaders, we need to listen to our people—hear their different perspectives and reactions to what is going on within our companies and build upon their ideas,” said Anna Dolgikh, Reynolds’ senior vice president of human resources. “We invite all current and prospective employees to bring their difference and be the change.”
Reynolds has a record of receiving accolades for its employment practices and taking actions that make it a good place to work. The organization scored 100 percent on the Human Rights Campaign’s 2021 Corporate Equality Index for the second year in a row, designating the company as a Best Place to Work for LGBTQ Equality. Reynolds was also recently named a DiversityInc top regional company, and for two years in a row has participated in CEO Action for Diversity and Inclusion.
September 13, 2021
FDA Issues Another Round of Denial Orders

Photo: Surendra
The U.S. Food and Drug Administration has now issued 168 companies marketing denial orders (MDOs) for an estimated 992,000 products. According to a press release, the regulatory agency on Sept. 10 released a revised list of MDOs that includes 125 company names but not any specific products that were denied.
“Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), we cannot release additional information about those actions,” the agency stated.
On Sept 9, the FDA announced it had issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
September 13, 2021
BAT Accused of Bribery in Zimbabwe

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A joint investigation by the Bureau of Investigative Journalism, the University of Bath and BBC Panorama suggests BAT may have paid a bribe to Zimbabwe’s former president, Robert Mugabe, reports the BBC.
The investigators obtained leaked documents suggesting BAT funded a network of secret informants to undermine its competitors in southern Africa.
One of its contractors was Forensic Security Services (FSS) of South Africa. Officially tasked with fighting the black market cigarette trade, former employees told the BBC that they broke the law to sabotage BAT’s rivals.
FSS paid a local firm to conduct surveillance on a Savanna Tobacco factory in 2012, but the company got caught. Three of its directors were charged in connection with illegal surveillance.
The joint investigation suggests bribes were paid to secure the release of the directors.
BAT denied the accusations. “We emphatically reject the mischaracterization of our conduct,” the company said in a statement. “Our efforts in combating illicit trade have been aimed at helping law enforcement agencies in the fight against the criminal trade in tobacco products.
“Acting responsibly and with integrity underpins the foundations of our culture.”
BAT’s lawyers said it was not unlawful to pay sources to gather information about criminal behavior.
They said the company rejects the allegation that any steps were taken with the aim of impacting the lawful activities of legitimate competitors or for commercial advantage.
September 13, 2021
States Urged to Act Absent Action on Majors

Photo: steheap
The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu and Logic by yesterday’s deadline.
On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine-delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.
“The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”
The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the best-selling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.
The CTFK indicated if the FDA does not decide on major applications soon, it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.
September 10, 2021
Compliance Guidance Issued for Disposables

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The U.K. Vaping Industry Association (UKVIA) has issued compliance guidance for U.K. retailers who sell disposable vape products. Earlier, the association had called on regulators to crack down on resellers and retailers who were found to be flouting U.K. regulations for such products.
An investigation by the UKVIA has revealed mounting evidence of illicit and inappropriately branded disposable vape products hitting the U.K. market and noncompliant sales of such products, particularly in convenience shops and on major online marketplaces. U.K. regulations mean they should contain no more than 20 mg/mL of nicotine, yet evidence collected by the UKVIA reveals that some listed as this amount contain higher concentrations of nicotine and some products are being openly sold with 50 mg/mL strength. Furthermore, product packaging is not including warnings about the nicotine content, which is a legal requirement.
The association has been in discussions with the Medicines and Healthcare Products Regulatory Agency and Trading Standards to address the problem.
“We are doing all we can as a trade association to ensure the industry’s reputation is not tarnished by a minority of resellers and retailers intent on making a quick buck out of a trending product,” said John Dunne, director general of the UKVIA, in a statement. “Whilst disposables have a major role to play in the vape market, like all products, they need to adhere to the legislation.
“Our guidance is designed to ensure retailers keep on the right side of the law. We’re also working closely and are in discussions with leading disposable vape product manufacturers and the major online marketplaces to ensure they play a key role in taking a hard line against those behind the sale of noncompliant products in the country.”
The free guide, available for download here, which has been produced in conjunction with leading vaping compliance specialists Arcus Compliance, provides information on current U.K. regulations in relation to tank/reservoir capacity of devices, nicotine levels and the elements that must be contained on packaging. It also provides details in respect to registrations with and notifications from the MHRA.
September 10, 2021
No Clarity for Top Brands at FDA Deadline

Photo: Araki Illustrations
The much-anticipated deadline for the U.S. Food and Drug Administration to decide on millions of premarket tobacco product applications (PMTAs) passed without bringing the clarity about the future of tobacco harm reduction that many health advocates and industry representatives had hoped for.
On Sept. 9, the agency issued marketing denial orders (MDOs) to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. However, despite a court order to complete the PMTA review process by that date, the FDA failed to make decisions on some of the best-selling vapor products on the U.S. market.
There were no updates on high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” acting FDA Commissioner Janet Woodcock and FDA Center for Tobacco Products Director Mitch Zeller wrote in a joint statement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
Interestingly, the agency saw fit to issue marketing orders for more than 350 combustible tobacco products under the standard equivalency pathway, many of which, hookah tobacco for example, are flavored tobacco products. All of the issued MDOs were for flavored electronic nicotine-delivery system products.
The FDA’s announcement baffled health advocates and vapor industry representatives alike.
“This looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at the Penn State University College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”
“I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized,” echoed Greg Conley, president of the American Vaping Association. “But to see them likely get more time from @FDATobacco after good small businesses spent the last month getting wrecked … Just wrong.”
Vuse owner BAT, for its part, was sanguine. “We remain confident in the quality of our applications, which are supported by scientific evidence that our Vuse and Velo products are appropriate for the protection of public health,” the company wrote in a statement. “In addition, we believe that these categories of important, innovative products may be potentially less harmful than traditional tobacco products.”
Vapor industry representatives have long complained that the PMTA system favors big players. In 2019 court filings, the Vapor Technology Association noted the expenses greatly exceeded the $300,000 to $500,000 per product the FDA estimated in its regulatory impact analysis. Such a burden, say critics, can be borne only by the best-resourced players—i.e., the established tobacco companies. As a result, the products denied market access on Sept. 9 are unlikely to have been rejected because they present a greater health risk than any approved products. Rather, they failed because their manufacturers were unable to navigate the FDA’s complex and costly system.
Meanwhile, the Campaign for Tobacco-Free Kids (CTFK), which helped set the Sept. 20, 2021, deadline through litigation, hinted it might resume legal action to have the court enforce its order requiring the FDA to begin to remove unauthorized products.
“While FDA has said it has ruled on 93 percent of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic,” said CTFK President Matthew Myers. “Every day those products remain on the market, our kids remain in jeopardy.”
September 9, 2021