Author: Staff Writer

Firm With 15 Million Products Registered With FDA Warned
The U.S. Food and Drug Administration has issued a warning letter to Visible Vapors. The regulatory agency advised the company that marketing its electronic nicotine-delivery system (ENDS) products, which lack a premarket tobacco product authorization (PMTA), is illegal, and therefore they cannot be sold or distributed in the U.S. The FDA states that the company did not submit PMTAs by the Sept. 9, 2020 deadline.
While the warning letter issued cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanut Butter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement, according to the letter. Visible Vapors has the largest number of products registered with the FDA to have received a warning letter to date.
From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.”
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
July 29, 2021
FBI, DEA Raid Las Vegas CHAMPS Show for Delta-8
In Nevada, Delta-8 THC is illegal. During the cannabis culture and accessories trade show, CHAMPS, the Federal Bureau of Investigation and the the Drug Enforcement Administration (DEA) allegedly raided the show because a vendor participating in the event unwittingly gave the Las Vegas district attorney an unauthorized Delta-8 THC product sample. Several social media posts by vendors at the show said they were detained and products were confiscated.
Credit: CHAMPS
Providing samples to the show’s attendees is against the rules. As a result, some vendors were asked to vacate the premises. CHAMPS vendors received notice last week that samples of Delta-8, Delta-10 THC and similar products were illegal in Nevada and vendors should refrain from offering samples.
Several social media posts began to report of the feds raiding the venue started cropping up late Wednesday evening. By Thursday, various vendors began posting that the officers ordered the attendees to wait outside while they inspected the scene, according to CannaTech Today. As a result of yesterday’s occurrence, plainclothes police officers are walking the show floor today while its vendor booths are currently being searched for any Delta-8 THC and similarly prohibited products.
Through the last year, several states, including states where Delta-9 THC is legal, such as Oregon, California and Arizona, passed laws specifically banning Delta-8 THC. Nevada went a step further in early July to specifically include Delta-8 in its definition of cannabis. The Nevada Cannabis Compliance Board recently stated, “products exceeding 0.3 percent THC, including Delta-8 and Delta-9 THC, would be considered cannabis. As such, a license from the Cannabis Compliance Board would be required to make it or sell it.”
The Champs trade show is one of the largest cannabis industry trade shows in the U.S. The 2021 sow is being held from Jul 27 to Sat, July 31 at the Las Vegas Convection Center. Smoke shops, vape shops, dispensaries, 420 counter-culture, adult novelty shops, C-Stores, online marketers and branders, entrepreneurs, glassblowers, and counter-culture industry professionals who are seeking to grow in their market sectors and gain current knowledge and product opportunities to better leverage their business in a thriving marketplace attend CHAMPS, according to the show’s website.
July 29, 2021
VPZ Launches AEQ Pod Device Kit in U.K. Stores
A new pod device has been launched by the largest vapor retailer in the U.K. VPZ’s AEQ Pod Device Kit has been designed and developed in VPZ’s purpose-built facility in Edinburgh to support smokers looking to make the switch to vaping, according to a press release.
Credit: VPZ
“The device is an easy-to-use new to vaping product which offers smokers the freedom to choose a range of flavors and e-liquid strength,” the release states. “The AEQ is already outselling other packages in the new to vaping category and has been introduced as VPZ launches its first ever Vape Clinic.”
Doug Mutter, director of VPZ, said VPZ is spearheading the fight against the U.K.’s No. 1 killer: smoking. “The Pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups,” he said. “The launch of our new AEQ device has been developed by us in response to helping smokers take the first steps in their stop-smoking journey. The development of this dedicated new to vaping product, as well as the launch of our pilot Vape Clinic truly underlines our commitment to helping the UK achieve its ambitions to be a tobacco-free nation by 2030.”
VPZ is the UK’s largest vaping retailer with over 150 stores. A new report from Royal College of Physicians Tobacco Advisory Group backs vaping as an effective treatment for tobacco dependency and recommends that it should be included and encouraged in all treatment pathways. The report also found that the long-term impact of vaping is 95 per cent less harmful than smoking cigarettes.
July 28, 2021
Significant Growth in New Category Sales for BAT

Photo: BAT
BAT reported revenue of £12.18 billion ($16.89 billion) for the six months that ended June 30, down 0.8 percent (up 8.1 percent on an adjusted basis) from the comparable 2020 period. Revenue from new categories increased by more than 50 percent to £883 million. Profit from operations totaled £4.91 billion, down 3.7 percent (up 5.4 percent on an adjusted basis) from the comparable six months a year earlier.
“This has been an exciting period of growth in New Categories, with New Category constant currency revenue up by 50 percent in the first half,” said BAT CEO Jack Bowles in a statement. “We added 2.6 million consumers—our highest ever increase—to our noncombustible product consumer base, to reach 16.1 million. This demonstrates our accelerating transformation driven by our multi-category portfolio, with continued key market share gains in all three New Categories.
“We are building strong, global brands of the future with Vuse, Velo and Glo. These are underpinned by industry leading multi-category consumer insights and science, with increasing digitalization. We have invested a further incremental £346 million in the first half, funded by continued value growth from combustibles and expect to reach our £1 billion Quantum savings target 12 months early. We have now increased our savings target to £1.5 billion by 2022.
“Our rapid growth in New Categories is driving significant scale benefits and 2021 is shaping up to be a pivotal year in our journey towards ‘A Better Tomorrow.’”
July 28, 2021
WHO Reiterates Unscientific Stance Against Vaping
While progress has been made in the fight against tobacco use, the marketing of e-cigarettes toward young people could have harmful health outcomes going forward, according to World Health Organization Director-General Tedros Adhanom Ghebreyesus.
Ghebreyesus gave the warning in a statement along with the release of the “WHO report on the global tobacco epidemic 2021,” the eighth study from the United Nations public health agency measuring progress on efforts to curb the sale of tobacco and nicotine products worldwide.

While the report found that more than four times as many people are covered under WHO-recommended tobacco control measures than in 2007, it expressed concern that children who use “electronic nicotine delivery systems, such as e-cigarettes, are “up to three times more likely to use tobacco products in the future.”
“Nicotine is highly addictive. Electronic nicotine delivery systems are harmful, and must be better regulated,” Tedros said.
He went on to argue that in places where e-cigarettes are not banned, “governments should adopt appropriate policies to protect their populations from the harms of electronic nicotine delivery systems, and to prevent their uptake by children, adolescents and other vulnerable groups.”

Over 100 million ex-smokers use reduced-risk products and the WHO should be taking advantage of massive investment in the sector by encouraging governments to provide an incentivized regulatory framework to enable greater expansion.
Derek Yach, president, Foundation for a Smoke-Free World
Tobacco harm reduction advocates and vaping industry representatives denounced the WHO report as “nonsensical and dangerous.”
“The WHO has a long-standing anti-vaping stance and this latest attack on a sector that is literally saving millions of lives worldwide flies in the face of scientific evidence, common sense and harm reduction,” said John Dunne, director general of the U.K. Vaping Industry Association (UKVIA) in a statement.
“This report demonstrates that, sadly, the WHO still doesn’t understand the fundamental difference between addiction to tobacco smoking, which kills millions of people every year, and addiction to nicotine, which doesn’t,” said John Britton, professor of epidemiology at University of Nottingham.
“The WHO is also evidently still content with the hypocrisy of adopting a position which recommends the use of medicinal nicotine products to treat addiction to smoking, but advocates prohibition of consumer nicotine products which do the same thing, but better.”
Derek Yach, president of the Foundation for a Smoke-Free World, said the WHO’s comments were “fundamentally flawed.” “The exceptional growth of next generation devices offers the WHO a real opportunity to tackle combustible consumption once and for all,” he said.
“Over 100 million ex-smokers use reduced-risk products and the WHO should be taking advantage of massive investment in the sector by encouraging governments to provide an incentivized regulatory framework to enable greater expansion.”
David Jones MP, who sits on the U.K. All Party Parliamentary Group for Smoking and Health, described the WHO’s opposition to all smoking alternatives, not just vaping, as “bizarre.”
“Our advice remains that people who smoke are better to switch completely to vaping,” he said. “That opinion, however, is not shared by the WHO, which has long pursued an almost pathological campaign against e-cigarettes.”
July 28, 2021
Bidi Vapor Parent, Kaival Brands to Trade on NASDAQ

Image: immimagery
Kaival Brands Innovations Group, the exclusive global distributor of products manufactured by Bidi Vapor, has been approved to list the company’s common stock on the Nasdaq Capital Market. The ticker symbol will remain unchanged, as “KAVL,” and the stock will begin trading on Nasdaq at the opening of the market on July 29, 2021.
“I am pleased to announce that the company has been approved to begin trading on Nasdaq,” said Niraj Patel, Kaival’s founder and CEO, in a statement. “This event represents another monumental milestone in our company’s short history.”
“We have worked diligently to achieve this goal and are humbled and grateful on the inclusion to the Nasdaq,” said Patel. “We are more enthusiastic than ever about being able to harness Kaival’s exciting potential.”
“Step by step, we continue our work to build a world-class, global organization—our elevation to Nasdaq represents a very large strategic evolution for the company,” noted Eric Mosser, chief operating officer of Kaival Brands.
July 28, 2021
Study: TikTok Must Age Restrict Access to Vape Videos
A study of vaping videos on TikTok by Australian researchers found that there is an “urgent need” for age restrictions to reduce teens’ exposure to videos that positively portray vaping. University of Queensland researchers analysed e-cigarette content posted by TikTok users globally and are now calling for tighter regulations to prevent nicotine products being promoted to underage users of the video-sharing platform.
Credit: Tashatuvango
The study, published in the journal Tobacco Control, evaluated the content of 808 popular vaping videos that had been collectively viewed more than 1.5 billion times as of November 2020. The videos had a median count of 1 million views each, according to a story posted by The Guardian.
The videos that portrayed e-cigarette use positively comprised 63 percent of the total and were viewed more than 1.1 billion times, while neutral depictions accounted for 24 percent. The researchers estimated that a quarter of the people in the videos appeared to be younger than 18, while 71 percent were male.
“The use of comedy, lifestyle references, nicotine addiction references, vaping tricks and ‘how to’ tutorials may create social norms around vaping and increase its social acceptance,” the researchers concluded. “Considering vaping-related videos are widely accessible on TikTok, there is an urgent need to consider age restrictions to reduce youth uptake.”
Tianze Sun, a PhD student at UQ and the study’s first author, said the researchers were interested in looking at how e-cigarette use was portrayed on TikTok, given the app’s popularity among young people. “Because it’s a relatively new platform, they also can potentially lack in regulations when it comes to effective age restrictions,” she said.
July 27, 2021
Arcus Compliance Appoints CBD Guru Robert Sidebottom

Photo: tadamichi
Arcus Compliance appointed a new nonexecutive director, Robert Sidebottom.
Sidebottom has broad commercial, management and board-level experience across the vape and CBD sectors. He is the group managing director for the Eco Vape Group of companies and was formerly the managing director for the vape compliance company Adact Medical.
Sidebottom is a leading advocate of vaping, which he views as one of the essential tools in assisting smokers to quit traditional cigarettes. His commercial and compliance experience is underpinned by his qualifications and experience in project management, personnel management and finance.
“I am thrilled to be joining the Arcus Compliance leadership team, and I look forward to contributing to their strategic direction and continuing the exponential growth as the prime compliance agency in the sector,” said Sidebottom in a UKVIA press note. “The Arcus board have set the correct tone of professionalism and customer service, and I am very happy to have the opportunity to work with them.”
“We are thrilled to have Robert on board,” said Lee Bryan, managing director of Arcus Compliance. “He will be working closely with our other directors and in particular our other [nonexecutive director,] John Dunne. Prior to his appointment and for the last 12 months, Robert and I have discussed how we can improve vaping compliance, with the aim of making products as safe as possible for the vaping community and switching smokers to the 95 percent safer alternative of vaping.”
Arcus Compliance has enjoyed rapid growth over the last 18 months and has significantly increased its market share within the SaaS space in the electronic nicotine-delivery systems (ENDS) and vape product sector. Arcus Compliance is currently regarded as the leading regulatory consultancy in Europe for ENDS products and boasts a client base of many of the world’s leading brands.
July 27, 2021
U.S. Lawmakers Introduce Bill to Require Vapor User Fees
Six U.S. senators have introduced legislation that would require e-cigarette manufacturers pay user fees to the Food and Drug Administration (FDA) to provide the regulatory agency. The fees would finance additional resources for the FDA to conduct stronger oversight of the e-cigarette industry and increase awareness of the danger of e-cigarettes.
U.S. Senate Majority Whip Dick Durbin joined U.S. Senators Jeanne Shaheen, Lisa Murkowski, Susan Collins, Tammy Baldwin, and Mitt Romney introduced the Resources to Prevent Youth Vaping Act to protect children from the dangers of e-cigarettes, according to press release from Durbin’s office. Companion legislation will be introduced in the House by U.S. Representatives Cheri Bustos and Brian Fitzpatrick.
Credit: Larry
“Big Vape has hooked nearly four million kids on e-cigarettes, creating a vaping epidemic that is threatening our next generation with a lifetime of nicotine addiction and disease,” said Durbin. “The FDA needs to clear the shelves of these dangerous and addictive products, and Congress needs to pass the Resources to Prevent Youth Vaping Act, which will help provide FDA with the resources to better regulate this market. Enough is enough. The health of our children cannot wait any longer.”
The Resources to Prevent Youth Vaping Act increases the total amount that will be collected in tobacco user fees by $100 million in Fiscal Year (FY) 2022 and indexes that amount to inflation for future years. The bill also authorizes FDA to collect user fees from all manufacturers of products that have been deemed as tobacco products by FDA, including e-cigarettes, according to Durbin.
Currently, manufacturers of traditional combustible tobacco products pay into FDA user fees, but e-cigarette companies are exempt due to a loophole in the law. The amount collected from individual e-cigarette manufacturers will be proportional to their share of the overall tobacco market, as determined by FDA. FDA would be able to use this additional revenue from e-cigarette user fees to conduct safety review of vaping products, prevent sales of e-cigarettes to minors, help support efforts to educate youth on the dangers of e-cigarettes and increase the agency’s oversight and enforcement capabilities.
Earlier this year, Durbin introduced the bicameral Tobacco Tax Equity Act to reduce youth tobacco use by closing loopholes in the tax code that have long been exploited by the tobacco industry to avoid regulation and taxes for their products. The bill would also apply tax parity across all tobacco products, including establishing the first federal e-cigarette tax and increased the tobacco tax rate for the first time in a decade.
July 26, 2021
Group: UK COP9 Delegation Must Support Science
A parliamentary group in the U.K. has released a report that criticizes anti-vaping groups funded by Bloomberg Philanthropies for being hostile to tobacco harm reduction (THR). The report also states that Bloomberg diminishes the rights of consumers and vapers in low and middle-income countries (LMICs) such as the Philippines.
Credit: Olrat
The UK’s All-Party Parliamentary Group for Vaping (APPG) said these anti-vaping “civil society observers” will be allowed to participate in the World Health Organization Framework Convention on Tobacco Control Conference of the Parties 9 (FCTC COP 9) in November this year, concluding that the WHO continues to attempt to discredit UK’s science and policy approach to address the smoking problem, reports the Manila Bulletin. It said THR is a public health approach which is supposedly one of the original commitments of FCTC.
The APPG warned about the participation of The Union, a group funded by Bloomberg Philanthropies, as well as other anti-vaping non-government organizations in the FCTC COP 9 meeting in November. The APPG is asking the UK delegation to the FCTC COP9 meeting to ensure that its national experience and real-life evidence/data are reflected in the discussions within the WHO.
The APPG also wanted to ensure that the WHO would not move away from the fundamental objectives set forth by the FCTC given its original commitment to harm reduction—a public health approach being opposed by some influential non-government organizations. “The majority of NGOs listed as ‘Observers’ are hostile to the concept of tobacco harm reduction and thus the UK’s policy approach. For instance, ‘The Union’ has advocated a complete ban on e-cigarettes and heated tobacco products in low and middle-income countries, which are home to 80 percent of the world’s smokers,” the APPG said in the report.
July 26, 2021