Author: Staff Writer

Tobacco Bill Would Tax Vapor Same as Combustibles
The proposed U.S. Tobacco Tax Equity (TTE) Act would tax vaping products the same as combustible cigarettes. According to research from the Tax Foundation, an independent tax policy nonprofit, the proposal would double the rates on combustible cigarettes and increase the rates on all other tobacco and nicotine products – including electronic nicotine-delivery systems (ENDS) – to achieve parity with the traditional tobacco tax rate.
Credit: TS Donahue
The proposed rule aims for the tax per 1,000 cigarettes to be increased to $100.66. Vaping products would be taxed at this same rate, with 1,000 cigarettes being equal to 1,810 milligrams of nicotine.
“In addition to the one-time increase, the rates would be indexed to inflation, which means they would automatically increase every year,” the report states. “According to Tax Foundation estimates, the tax increases would raise $112 billion over 10 years. The bulk of the revenue, $74.8 billion, is from the doubling of cigarette taxes. The tax on vapor products would raise roughly $15 billion over 10 years.”
According to Alex Norcia of Filter, the proposal would benefit large corporations and traditional tobacco products, while unfairly hurting people in lower socioeconomic classes as most smokers do not typically belong to the upper classes. Current cigarette smoking in the United States “is higher among people with low annual household income than those with higher annual household incomes,” according to the Centers for Disease Control and Prevention.
“This means that a 30-milliliter bottle of e-liquid containing 3 milligrams of nicotine per milliliter would be subject a tax rate of $5 for the bottle. A 120-milliliter bottle of e-liquid that contains 6 milligrams of nicotine per milliliter would attract a tax rate of $40 for the bottle,” writes Norcia. “In comparison, critics and tax reformists have estimated that a four-pack of Juul pods would be taxed around $9—giving a clear advantage to a giant over the smaller player. More alarmingly, a pack of cigarettes would only be taxed around $2, creating an incentive for nicotine users to pick cigarettes over less-risky vapor products.”
Credit: Tax Foundation
The TTE Act as part a massive $3.5 trillion spending bill appear to be heading for a collision with President Joe Biden’s pledge not to raise taxes on America’s middle class. In an interview with C-Span on Sept. 15, White House Press Secretary Jen Psaki was asked if the White House believes that the proposed bill on taxing tobacco/vaping products would violate Biden’s promise to not raise taxes on those making under $400,000 per year. She replied, “No, we don’t,” adding that it was “just one of the ideas out there.”
Vape Shop owners are saying that the proposed tax increase would “completely destroy” their businesses, saying it would be even worse than the U.S. Food and Drug Administration’s failure to approve any ENDS products by the Sept. 9 deadline and the issuing of nearly 200 marketing denial orders (MDOs).
“This is going to more than double, and in some cases triple or quadruple, the price of liquids that I sell,” says Keith Gossett, the owner of Bucky’s Vape Shop in Columbus, Georgia, told Reason. “I’m going to sit there and try to tell a man with a $6 pack of cigarettes that my [$75] product is better. This tax will close my shop.”
The last time the federal excise tax on tobacco was increased was in 2009. While the federal tax has not changed for 12 years, the average tax paid by consumers has increased drastically. Including the last federal increase, the average combined state and federal excise tax rate on tobacco products has jumped more than 80 percent (the average state excise tax rate increased 65 percent between 2009 and 2021), according to Tax Foundation.
September 15, 2021
Bidi Vapor to Market Menthol Sticks Despite MDO
Bidi Vapor will continue to manufacture and market its Artic (menthol) Bidi Stick in the United States despite receiving a marketing denial order (MDO) for the product, according to a trading update issued by Kaival Brands Innovations Group, the exclusive distributor of Bidi Vapor products.
As of Sept. 10, the U.S. Food and Drug Administration has issued MDOs for some 992,000 electronic nicotine delivery system products from 168 companies. Bidi Vapor received an MDO for its non-tobacco flavored Bidi Sticks, including its Artic (menthol) Bidi Stick.
The company, however, insists the FDA mischaracterized the Artic (menthol) Bidi Stick as flavored. Because its Arctic Bidi Stick is menthol, Bidi Vapor believes that this product is not subject to the MDO.
“This position is aligned with the FDA’s public statements and press releases stating that tobacco and menthol ENDS are not deemed flavored products subject to the MDOs,” the company wrote in a press note. “Accordingly, along with the Classic (tobacco) Bid Stick, Bidi intends to continue to manufacture and market its Arctic (menthol) Bidi Stick for distribution by us.”
The company, which has historically derived nearly all its revenues from sales of flavored Bidi Sticks, appears willing to accept the risk of enforcement.
“If the FDA disagrees with Bidi Vapor’s position, issues a warning letter, or takes other action against Bidi Vapor resulting in us not being able to distribute the menthol (Arctic) Bidi Stick in the United States, or consumers do not purchase the tobacco (Classic) or menthol (Arctic) Bidi Sticks, our revenues and, thereby our financial results and condition, would be materially adversely affected, Kaival Innovations Group wrote in its news release.
For the three and nine months ended July 31, 2021, Arctic (menthol) Bidi Stick constituted approximately 15.2 percent and 18.5 percent, respectively, of the company’s total Bidi Sticks sales.
September 15, 2021
Bidi Vapor Wants FDA to Ban Synthetic Nicotine Products

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 PMTA’s earlier this month, many companies have set their sights on synthetic nicotine, a legal grey 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 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
Charlie’s Holdings Confirms its PMTAs Still Under Review
Charlie’s Holding’s, parent to e-liquid manufacturer Charlie’s Chalk Dust, confirmed that it premarket tobacco product applications (PMTA) remain under scientific review by the U.S. Food and Drug Administration. The company has not received a marketing denial orders (MDOs) or refuse-to-file letters for any of its submitted products.
“Including product-specific scientific data, thorough perception studies, and detailed environmental assessments, Charlie’s PMTA’s cost more than $5 million and are among the most comprehensive PMTA’s in the entire industry,” a press release states. “The Company has publicly expressed its commitment to full regulatory compliance and youth access prevention and believes its submissions to the FDA will be recognized as both distinguished and suitable for approval.”
Ryan Stump, Charlie’s COO, explained that in addition to human clinical trials that measured the nicotine delivery efficiency of the company’s products via pharmacokinetic studies, Charlie’s PMTA’s also included “product-specific, scientific evidence” that demonstrates the marketing of Charlie’s products meets the statutory standard of appropriate for the protection of the public health that is required for an FDA marketing order.
“This is an important reason why we are highly confident that the FDA will recognize Charlie’s PMTA submissions as both distinguished and suitable for approval,” said Stump. “As a result of the painstaking efforts we invested in our PMTA’s, when others are forced to withdraw their products from the market, Charlie’s will be one of a very select group still legally allowed to operate in the flavored nicotine product space. We look forward to the competitive advantage – and to the corresponding increases in sales, profits, and market share – that will result from our steadfast commitment to providing Charlie’s customers with a trusted product portfolio in full regulatory compliance.”
To date, the FDA has now issued 168 companies MDOs for an estimated 992,000 products. According to a press release, the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied. 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.
September 14, 2021
Vape Group Protest ‘Hypocrisy’ of Rules for Adult Products

Credit: Annaadel
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, a harm reduction product 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
Iowa Attorney General ‘Concerned’ About FDA Actions
When the U.S. Food and Drug Administration announced it was delaying premarket tobacco product application (PMTA) decisions, Iowa Attorney General Tom Miller says he become concerned about the impact the regulatory agency’s actions. What worried him was the unintended consequences of pulling from the market less harmful alternatives to combustible cigarettes.
Iowa AG Tom Miller
“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,” Miller wrote in a statement. “We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policy makers 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 finally made its announcement on the fate of millions of PMTAs. However, only small businesses that submitted PMTAs for flavored products got any answers. The FDA issued marketing denial orders (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.
The following day, the agency increased that number to 168 companies that were issued MDOs for an estimated 992,000 products. According to a press release, the regulatory agency released a revised listing 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
Ireland Making Progress Towards 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
FDA Issues Another Round of PMTA Denial Orders
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, today the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied.
Credit: FDA
The remaining 43 are expected to be for companies that did not currently have any electronic nicotine-delivery products on the market. “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.
Yesterday, 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 10, 2021
States Urged to Act in Absence of FDA 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 bestselling 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 application soon it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.
September 10, 2021
UKVIA Issues Compliance Guidance 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 20mg/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 50mg/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 & 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 non-compliant 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 UK 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