The Truth Initiative has revealed a new anti-vaping campaign titled “It’s Messing with Our Heads.”
The group says its campaign exposes “nicotine’s role as a contributor to the worsening youth mental health crisis and the tobacco industry’s ongoing attempts to distort public perception about the health effects of vaping products.”
As part of the campaign, the makers created a fake vape company called Depression Stick! to raise awareness of the fact that nicotine can worsen symptoms of anxiety and depression and underscore the mental health impact of real e-cigarette products.
According to the Truth Initiative, the Depression Stick! campaign follows the playbook of its e-cigarette competitors “complete with kid-friendly flavors, aiming to reach and engage young people through influencer unboxings.”
“Vaping has become so normalized in pop culture and many young people don’t even see it as an issue,” explained Mo Said, founder and chief creative officer of Mojo Supermarket, the independent agency that created the effort, in a statement.
“With everything happening in the world young people’s number one concern is their mental health. We believe that if we could show the connection between vaping nicotine and anxiety and depression, they’d never look at a vape the same way again.”
Enthalpy Analytical has hired Kim Hesse as director of business development with a focus on the testing of nicotine containing products.
Hesse’s strong business development experience will help expand Enthalpy’s market leadership in tobacco and vape testing. “I am excited to join Enthalpy Analytical,” said Hesse. “This opportunity will give me exposure to new markets, customers and geographies with expanded capabilities, including toxicology services. I look forward to continuing to contribute value to the tobacco industry and supporting clients with the best solutions.”
Hesse holds advanced degrees from Kent State University and attended Arizona State University’s School of International Business Management.
Her laboratory testing career began January 2008 in Hamburg, Germany, where she trained in laboratory instrumentation and its application in the analysis of crop protection agents. Over the years, Hesse has expanded her expertise and now works closely with both the pharmaceutical and tobacco laboratory industries.
Hesse is a recognized expert in laboratory testing and the regulatory requirements of the tobacco testing trade. Due to her extensive knowledge, Hesse is a sought-after orator and has spoken at numerous industry events around the world.
Umberto Roccatti, president of National Association of Electronic Smoke Manufacturers (ANAFE) in Italy and vice president of the Independent European Vape Alliance, is biking 700 km to protest a planned vapor tax hike in Italy.
Italian vapor taxes are set to increase from Jan. 1, 2022. “The gradual increase, every year for three years, of the taxation on electronic cigarettes is pure absurdity, that risks bringing to its knees a sector already severely affected by the pandemic and which today counts about 45,000 employees,” said Rocatti in a statement.
The new tax regime, he added, will not only cripple a supply chain comprising small and medium enterprises, but also encourage black market sales. According to Rocatti, the tax hikes would make some vapor products more expensive than some cigarette brands, encouraging vapers to return to smoking.
Rocatti’s “Ride4Vape” left Bolzano Sept. 20 and will pass through Abano Terme, Santarcangelo di Romagna and Sangemini before finishing in Rome. Along the way, Roccatti will explain on Facebook the disastrous effects of the fiscal policy call on lawmakers to reverse their plan.
“What the whole sector hopes for, is a revision of the current tax burden—which turns out to be particularly excessive,” says Roccatti. “Moreover, it should be noted that the revenue–referred to the first months when the tax came into force before it was suspended by the new government—was not what expected, but quite the opposite, thus confirming the fact that raising taxes, especially in the midst of a pandemic, does not contribute positively to state revenues. We therefore ask for stability and fiscal balance on a sector which already underwent four tax increases in the last six years.”
Imperial Brands has stepped up market testing of its heated tobacco products through a national rollout in Greece.
Insights from Greek consumers on the Pulze device and iD heat sticks will help inform the potential for further launches in a focused number of European markets. Earlier this month, Imperial Brands launched a pilot trial for its tobacco heating products in the Czech Republic.
Building a targeted and sustainable next generation product (NGP) business is a key part of Imperial’s new strategy and its commitment to make a meaningful contribution to harm reduction.
According to the company, heated tobacco is an established NGP category in a number of European territories, including where Imperial already has a strong route to market for its traditional tobacco products.
“Heated tobacco continues to gain traction among adult smokers in Greece, and we see significant growth opportunities for our promising products in this category,” said Imperial Brands’ chief consumer officer, Anindya Dasgupta, in a statement.
“The valuable consumer insights we gain from the pilot initiatives in Greece and the Czech Republic will inform the scale and pace of further market rollouts.”
Heated tobacco currently accounts for more than 10 per cent of the total tobacco sector in Greece, with further strong growth anticipated.
The Pulze device heats but doesn’t burn ‘iD heat sticks’ to provide nicotine and tobacco aromas containing fewer and substantially lower levels of the harmful chemicals found in combustible cigarette smoke.
Unlike other heated tobacco products, the Pulze device does not require a charging case, offering up to 20 consecutive uses. It is available in copper and silver colors.
ID tobacco consumables are being made available in Greece in four flavors: Rich Bronze, Balanced Blue, Capsule Polar, and Ice.
As of Sept. 17, the U.S. Food and Drug Administration has issued 295 marketing denial orders (MDOs) for more than 1,089,000 flavored e-liquid products. The move has sent shockwaves through the industry and crippled many vapor industry businesses ranging from prominent players to small business owners. All of the MDOs were for flavored e-liquids that were not either tobacco or menthol.
Credit: Elnur
Many of the most surprising denials were from company’s that many believed had the funds and experience to submit extensive and detailed premarket tobacco product applications (PMTAs). Turning Point Brands (TPB) International, Humble Juice Co., Beard Vape Co. and Avail Vapor were a few of the long-standing vapor industry companies whose flavored other-than-tobacco products were denied marketing approval.
The letters are straightforward, according to James Xu, founder of Avail Vapor. “It just says you failed to demonstrate in your application for a flavored [electronic nicotine delivery system] ENDS product [that the benefits] outweigh the known risks of youth appeal,” Xu said, speaking only with Vapor Voice. “Then it goes on to say that it can be corrected with some form of a randomized controlled trial or longitudinal cohort studies that the FDA had previously stated weren’t required.”
Many industry experts believe the FDA will only approve some tobacco and menthol flavors, most expected to be in closed-system formats. The FDA has yet to make a decision on any major tobacco company’s PMTA submissions for brands such as Juul, Logic, Vuse and Blu. The agency has not denied any synthetic product, although it’s difficult to know for sure since only brand names have been released and not actual flavor profiles.
Many companies are moving towards using synthetic nicotine in their products in hopes to avoid current FDA regulations. The agency has stated that a synthetic product “may” be outside the agency’s jurisdiction.
Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as tobacco product or push for synthetic nicotine to be regulated like any other drug.
The lawsuits are coming. At least two companies have already filed lawsuits against the FDA, although Vapor Voice could not confirm what companies had filed suit. The FDAs public list of companies released on Sept. 17 only includes 241 brands, the remaining 54 MDOs are believed to for brands that had not yet been on the market.
“If smoking rates go up in 2022 and beyond, do not blame the tobacco industry. This predictable result will entirely be the fault of elected officials and regulators who have utterly failed to protect public health,” said Gregory Conley, president of the American Vaping Association. “The FDA’s opaque review process was intentionally designed to eliminate all but the largest players from the market. We look forward to lending our support to future court challenges.”
Pfizer has recalled all lots of anti-smoking treatment Chantix due to high levels of cancer-causing nitrosamines, reports Reuters.
Pfizer paused distribution in June and asked wholesalers and distributors last week to stop use and distribution immediately.
Patients taking Chantix are in no immediate risk, according to the company, but they should consult healthcare providers about alternative treatment options.
The FDA approved Chantix in 2006 as a quit-smoking aid.
No company is safe. The U.S. Food and Drug Administration has now issued marketing denial orders (MDO) to some of the largest manufacturers in the vaping industry. Turning Point Brands announced today that on Sept. 14 it had received an MDO in response to TPB’s premarket tobacco product applications (PMTAs) covering many of the company’s vapor products. All MDOs were for flavored products other than tobacco.
Credit: Cursed Senses
“While we believe the FDA’s current conclusion is misguided, we will continue our dialogue with the agency in search of a path forward,” said Larry Wexler, president and CEO, Turning Point Brands. “As we explore options for appealing this decision, we are hopeful that the agency reaffirms its commitment to science-based decision making and to its announced Comprehensive Plan, which includes fully transitioning adult consumers down the continuum of risk in order to reduce the morbidity and mortality associated with combustible cigarette use by preserving the diverse vapor market.”
Numerous other major e-liquid manufacturers, including Avail Vapor, have confirmed to Vapor Voice that they have also received MDOs from the regulatory agency for e-liquid flavors other than tobacco. Other major manufacturers say they are expecting an MDO any day now.
TPB stated that its PMTA included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use. The data demonstrated that TPB products “do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes. The scientific literature on lower-risk nicotine delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes.”
TPB’s press release stated that the company believed it had established that the products’ it had continued marketing would be “appropriate for the protection of public health,” the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. “These products are crucial to improving public health by helping adult smokers migrate to less harmful products,” the statement reads. “TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief.”
Many companies say they are readying lawsuits. TPB’s states that it continues to monitor regulatory developments and intends to take appropriate measures to manage and mitigate any risk exposure that may result from these and any future MDOs. “The FDA’s scorched earth policy towards the vaping industry will move on to the courts,” a source told Vapor Voice this morning. “This has become a political process instead of a scientific one and the FDA is only trying to save face.”
Some companies, such as Bidi Vapor, stated they will continue to sell products even after receiving an MDO. Many other companies state that they will be switching to synthetic nicotine, an area where the FDA’s authority may be limited or even not exist.
Bidi believes its particular decision to be a mistake on the FDA’s part, and is currently exploring next steps to address the situation, according to Filter.
“It looks like FDA is making a mistake in many, many cases,” said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises Bidi and other clients on nicotine regulations. “I have a number of companies that have received MDOs, but those MDOs are also identifying their menthol products. It seems like FDA, in their rush to get all these out, they’re not doing a very thorough job.”
Kaival Brands Innovations stock was up slightly today as the company’s stock value has decreased sharply after the U.S. Food and Drug Administration issued the company marketing denial orders for some of its Bidi Stick flavored products. It’s third-quarter report results sent them even lower. Shares (NASDAQ: KAVL) were down 43 percent to $2.58 after the company reported Q3 earnings results.
Credit: Argus
Tuesday, the company announced its third-quarter report, which stated that the company earned drastically lower revenues of $3.4 million for the three months ended July 31, 2021, compared to $32.4 million for the three months ended July 31, 2020.
The company now expects revenues for the year to be approximately $68 million, as compared to previous guidance of $400 million. The company stated that now that 93 percent of the vaping market has been eliminated by the FDA, the company expects Bidi Vapor’s market share to, at a minimum, reach pre-premarket tobacco product applications (PMTA) levels, according to Market Watch.
“We believe that the [PMTA] process undertaken by the [FDA] has had a significant impact on the e-cigarette industry. Prior to the September 9, 2021 court-ordered deadline for the FDA to make PMTA determinations for pending applications, we believe that many retailers and distributors were reluctant to take on new inventory, the statement reads. “We believe these retailers were concerned with the potential for being left with inventory that after September 9, 2021 could be ruled adulterated or misbranded by the FDA and, thus, illegal to sell.”
The FDA, which had faced a Sept. 9 deadline to declare which e-cigarettes can remain on the market, said last week that it needed more time before making a decision on products from Juul Labs Inc. and other companies.
In August, Kaival said that it expressed strong support of “enforcement of rules and regulations governing the electronic nicotine delivery systems industry” and that it exceeded stringent FDA compliance mandates.
Bidi Vapor also announced it 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 company said Tuesday that it believes 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 it. Based on previous FDA decisions, it said it expects that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s premarket tobacco application process.
Poda Lifestyle and Wellness’ board of directors approved a proposal to change the company’s name from Poda Lifestyle and Wellness Ltd. to Poda Holdings Inc. The change remains subject to the approval of the Canadian Securities Exchange.
There is no consolidation of the company’s share capital in connection with the planned name change. The proposed name change will not affect the company’s share structure or the rights of the company’s shareholders.
In addition to the intended name change, the company also announced plans for a new corporate structure, whereby the company will create six strategic subsidiaries, each focused on specific growth areas of the company. The proposed names for the six subsidiaries are Poda (Tobacco), Poda (Alternatives), Poda (Therapeutics), Poda (THC), Poda (CBD) and Poda (Research and Development).
“This proposed name change is consistent with our business objectives and our long-term strategy,” said Poda CEO Ryan Selby in a statement. “Our valuable intellectual property has applicability across a wide-ranging scope of applications, and I believe the name Poda Holdings Inc. more accurately serves the overarching vision the board has for the company.
“In addition to the name shift, creating the six new subsidiaries will provide strategic focus and strong growth opportunities in each of the target opportunities. I look forward to sharing more information about our customized strategies for each subsidiary over the coming weeks.”
The Food and Drug Administration Center for Tobacco Products (CTP) is requesting nominations for individuals to serve as members on the Tobacco Products Scientific Advisory Committee (TPSAC). Nominees may be self-nominated or nominated by an organization.
Nominations received on or before Nov. 8, 2021, will be given first consideration. Nominations received after Nov. 8, 2021, will be considered as later vacancies occur.
TPSAC advises CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the FDA commissioner.
The committee shall consist of 12 members including the chair. Members and the chair are selected by the commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products.
Members will be invited to serve for overlapping terms of up to four years.
More information on the nomination process TPSAC members is available at the Federal Register notice
