Tag: e-cigarettes

FDA Reports Progress With NTN Applications

Photo: Postmodern Studio
The U.S. Food and Drug Administration has sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine (NTN) products since President Joe Biden signed legislation authorizing the agency to regulate tobacco products containing nicotine from any source. Additionally, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage purchasers.
In an update, the agency detailed what it described as “significant progress” in processing and reviewing premarket tobacco product applications for synthetic nicotine products.
On March 15, 2022, a new federal law gave the FDA the authority to regulate tobacco products containing nicotine from any source. This law took effect April 14, 2022, and after July 13, 2022, any new NTN product that has not received premarket authorization from the FDA cannot be legally marketed.
The FDA says it received nearly 1 million NTN applications from more than 200 companies. To date, all applications submitted by May 14 have been processed, and more than 85 percent have been reviewed to determine if they meet the minimum requirements to be accepted for further review, according to the agency. In total, the FDA has issued refuse to accept (RTA) letters for more than 800,000 NTN products in applications that do not meet the criteria for acceptance.
In total, the FDA has accepted over 350 applications for NTN products, with the vast majority being for e-cigarette or e-liquid products. The agency stresses that acceptance is not a determination about the products’ authorization status. “Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review,” the FDA wrote in its update.
More information about the FDA’s premarket review progress and compliance and enforcement actions is available at the agency’s NTN product webpage.
September 8, 2022
Court Confirms FDA’s Authority Over Vaping Products

Photo: Mikhail Reshetnikov
A U.S. appeals court endorsed the Food and Drug Administration’s authority over vaping products in a case challenging a marketing denial order (MDO), reports ECigIntelligence.
New York-based Prohibition Juice had disputed an MDO, asserting that the agency lacked the statutory authority to consider a product’s “relative effectiveness at promoting cessation of combustible cigarette use versus another product with an otherwise similar health risk profile and labeling.”
However, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the FDA is entitled under the Tobacco Control Act to determine whether a product is appropriate for the protection of public health, and that meant an applicant must supply all information concerning investigations that have been made on the health risks of a product as well as whether a product presents less risk than others.
September 8, 2022
Paper Calls for More Balanced Rules for Vaping

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Four tobacco control specialists have called for a more balanced approach toward vaping regulation.
In a paper titled “A Proposed Policy Agenda for Electronic Cigarettes in the U.S.: Product, Price, Place and Promotion,” the authors observe that many Americans are confused about the relative harms of nicotine use and that public messaging around the substance tends to be more focused on stopping youth use than educating adults, according to Filter.
“Policy regarding e-cigarettes in the U.S. has focused on measures intended to reduce youth vaping, including imposing taxes on e-cigarettes and restricting flavors,” said Kenneth Warner, who wrote the paper with his University of Michigan colleagues Cliff Douglas and Karalyn Kiessling, along with Alex Liber of Georgetown University.
“Unfortunately, some of the measures may be backfiring. For example, if not matched by at least comparable increases in cigarette taxes, e-cigarette taxes that reduce youth vaping may also increase kids’ smoking. As well, some of these youth-oriented taxes appear to be reducing adult smokers’ use of e-cigarettes, increasing their smoking and reducing smoking cessation. We need to find policies that simultaneously address the widely shared dual goals of preventing youth vaping and increasing adult smoking cessation.”
The authors advocate for the U.S. Food and Drug Administration to reduce nicotine levels in combustibles, adding that it would have the best outcome if “accompanied by regulations ensuring the availability of alternative products, such as e-cigarettes.”
They also advocate for “states and the federal government [levying] large excise taxes on cigarettes and other combustible tobacco products and a more modest excise tax on e-cigarettes.”
The authors insist that only vape and tobacco shops should be allowed to sell nicotine products, that flavors should be banned in combustible tobacco products and that “all e-cigarette flavors other than tobacco and menthol and possibly a relatively small selection of other flavors with clearly adult-oriented marketing” should be banned.
September 8, 2022
Juul Settles Teen Vaping Investigation With 33 States

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Juul Labs will pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping, reports AP.
The probe found that Juul marketed its e-cigarettes to underage teens with launch parties, product giveaways and ads and social media posts using youthful models.
“Through this settlement, we have secured hundreds of millions of dollars to help reduce nicotine use and forced Juul to accept a series of strict injunctive terms to end youth marketing and crack down on underage sales,” Connecticut Attorney General William Tong said on Sept. 6 in a statement.
In reality, most of the limits imposed by the settlement won’t affect Juul’s practices, which halted use of parties, giveaways and other promotions after coming under scrutiny several years ago.
While Juul’s early marketing focused on young, urban consumers, the company has since shifted to pitching its product as an alternative nicotine source for older smokers.
“We remain focused on our future as we fulfill our mission to transition adult smokers away from cigarettes—the number one cause of preventable death—while combating underage use,” the company said in a statement.
While resolving one of the biggest legal threats, Juul Labs still faces nine separate lawsuits from other states. Additionally, Juul faces hundreds of personal suits brought on behalf of teenagers and others who say they became addicted to the company’s vaping products.
The company is also in the process of appealing a marketing denial order (MDO) by the U.S. Food and Drug Administration, which, if upheld, would force its products off the market.
In June, the FDA rejected Juul Labs’ premarket tobacco product applications, saying that the company has submitted insufficient evidence that its products were appropriate for the protection of public health.
While the agency subsequently suspended its MDO, citing scientific issues in the application that warrant additional review, the agency stressed that the stay does not rescind the order.
September 6, 2022
Bangladesh Urged to Keep E-Cigarettes Legal

Delon Human (Photo: Taco Tuinstra)
Bangladesh must keep e-cigarettes legal if it wants to achieve its goal of becoming a tobacco-free country by 2040, according to tobacco harm reduction activists.
Speaking during a webinar organized by the Bangladesh-based Voices of Vapers and reported by The Daily Star, several experts addressed the government’s recent proposal to ban vapor products, heat-not-burn devices and other cigarette alternatives in a new amendment to the country’s tobacco control legislation.
Delon Human, president of Health Diplomats, said there is no evidence for the National Tobacco Control Cell’s statement that nicotine in vapes is more harmful than cigarettes.
“There needs to be a credible harm reduction strategy as practiced by many developed countries,” he added. “The authorities must consider regulating a safer alternative, such as vape, and make it accessible to smokers wanting to quit.”
Schumann Zaman, president of the Bangladesh Electronic Nicotine Delivery System Traders Association, said not recognizing vape traders and vape users as stakeholders will have major consequences as many of these vapers are using e-cigarettes as a smoking cessation tool.
John Dunne, director general of the U.K. Vaping Industry Association, said vapes should be regulated separately because vapes and cigarettes are different products.
“Vapes are far safer and a proven method of nicotine-replacement therapy [NRT]. Regulating vapes will help smokers who are trying to quit have access to vapes,” he added.
“Countries such as the U.K., France, New Zealand and Canada have successfully lowered smoking rates by using vaping as NRT. Banning vapes will lower the number of smokers trying to quit.”
September 6, 2022
Teens Influenced by Parent’s Vaping, Smoking Habits

Credit: Aleksandr Yu
Parents who vape of smoke are 55 percent more likely to have teenagers who will pick up the habit, according to research presented at the European Respiratory Society International Congress in Barcelona, Spain.
The researchers have also found that the proportion who have tried e-cigarettes has been increasing dramatically and that although boys are more likely to use e-cigarettes, the rate of use among girls is increasing more rapidly, according to the study of Irish teens, according to media reports.
The research was carried out by a team at the Tobacco-Free Research Institute Ireland (TFRI), in Dublin. The group examined data on 6,216 17-18-year-olds, including data on whether their parents smoked while they were growing up. The teenagers were asked whether they smoked or used e-cigarettes.
The study showed that teenagers whose parents smoked were around 55 percent more likely to have tried e-cigarettes and around 51 percent more likely to have tried smoking.
The team also combined several Irish data sets to provide the most comprehensive analyses of teenage e-cigarette use in Ireland, with information on more than 10,000 Irish teenagers (aged 16 to 17), to look at the overall numbers of teenagers trying or regularly using e-cigarettes and how this is changing over time.
This showed that the proportion who had tried e-cigarettes had increased from 23 percent in 2014 to 39 percent in 2019.
The main reasons teenagers gave for trying e-cigarettes were curiosity (66 percent) and because their friends were vaping (29 percent). Only 3 percent said it was to quit smoking.
The proportion who said they had never used tobacco when they first tried e-cigarettes increased from 32 percent in 2015 to 68 percent in 2019.
September 6, 2022
Brazil Cracks Down on E-Cigarette Retail Sales
Credit: Sharaf Maksumov
Brazil’s Justice Department Thursday ordered 32 businesses to stop selling e-cigarettes. They have 48 hours to comply or face a $960 fine.
Vaping products have been banned in Brazil since 2009. However vaping products are still easily available, according to reports.
One of the businesses on the list is Carrefour, the country’s largest supermarket with over 1,000 stores, according to a media report.
In July, the Brazilian National Health Surveillance Agency (ANVISA), voted to uphold the country’s e-cigarette brand.
A survey carried out in the first quarter of 2022 by the Vital Strategies organization and the Federal University of Pelotas, revealed that 19.7 percent of Brazilians aged between 18 and 24 have tried electronic cigarettes.
September 2, 2022
Vapor Recycling Programs Highlighted in New Report
Research and Markets has published a global overview of recycling programs for e-cigarettes, heated tobacco products and vaporizers.
Every year, manufacturers and consumers generate 44.7 million tons of e-waste containing up to $65 billion worth of raw materials like gold, silver and platinum. The amount of global e-waste is expected to increase by almost 17 percent to 52.2 million tons in 2021, or around 8 percent every year.
Vape products are e-waste because they contain lithium-ion batteries, a heating element and a circuit board, which can contain plastics and heavy metals.
While the world’s leading jurisdictions have legislation governing the management of e-waste in general, they generally have no rules designed specifically for e-cigarettes, heated tobacco products or vaporizers.
To fill the void, manufacturers of electronic nicotine delivery devices have developed their own initiatives to tackle e-waste. The Research and Markets report list the following examples:
Philip Morris International has established hubs in Europe and Asia that inspect, process and separate materials from electronic devices for recycling.
BAT has replaced plastic elements of vapor products with pulp-based alternatives.
JTI launched a return scheme of used devices through the recycling boxes at shops.
Imperial Brands has launched take-back recycling schemes for used vaping devices and pods.
Other vape companies, such as DotMod, Shanlaan and Dovpo, have launched their own recycling programs by return schemes. Innokin is working on battery utilization programs. Recycling companies, such as Gaiaca and TerraCycle cooperate with vape manufacturers to provide services for collecting and recycling e-waste.
The Bowman company offers pod refill stations to reduce plastic usage for vapor bottles production in future.
In the current issue of Vapor Voice, recycling and vapor waste is a main focus.

Photo: alexlmx
September 2, 2022
SEC Investigating Ignite International for Fraud

Dan Bilzerian (right), owner of the cannabis company Ignite
A cannabis company led by social-media influencer Dan Bilzerian is under investigation by the U.S. Securities and Exchange Commission (SEC).
The agency issued a litigation release earlier this week, noting that it “has filed an action against Ignite International Brands, Ltd., a publicly traded company based in Ontario, Canada, seeking an order directing it to comply with an investigative subpoena for documents.”
Among other things, the SEC is investigating whether the Markham, Ont.-headquartered company violated the federal securities laws by making false or misleading statements in reporting its 2020 financial results.
The company has failed to produce requested documents, despite multiple accommodations from SEC staff, according to the release.
“The SEC is continuing its fact-finding investigation and, to date, has not concluded that any individual or entity has violated the federal securities laws,” the release adds.
The company, which sells a line of cannabis and CBD products, such as CBD-infused toothpicks, reportedly lost $67 million in 2019 and stayed afloat by raising money via debt and selling shares of the company’s stock, according to The Growth Op.
The company recently went private but was previously traded on the Canadian Securities Exchange under the ticker “BILZ.” In 2020, the company was trading for around 94 cents a share, down from a high of more than $5.
Last year, the company announced it was pulling out of the Canadian marijuana market, citing “too many barriers” to build a successful cannabis business.
“The government’s excessive restrictions of the marketing, sales and distribution of products has diminished the business opportunity while simultaneously making the consumer experience less than optimal,” Bilzerian said at the time.
During a shareholders meeting held on Aug. 24, 2022, Ignite shareholders approved a resolution to go private that was announced on July 19, 2022, and that the going private transaction has been completed, according to a press release.
September 1, 2022
FTC Report Shows Surge in Sales of Disposable Vapes
Credit: Andriy Blokhin
The Federal Trade Commission’s second report on e-cigarette sales and advertising across the U.S. shows sales of flavored disposable e-cigarettes and menthol e-cigarette cartridges surging dramatically in 2020.
The coincides with a federal ban on the flavored cartridges for closed systems. Regulators state that closed systems were popular with youth, so the FTC report suggests that youth e-cigarette use has shifted to disposable flavored products rather than declined.
The report also found that the distribution of free and discounted e-cigarettes reached record highs.
“This report shows that youth are still at risk from flavored or deeply discounted e-cigarettes,” said Samuel Levine, director of the FTC’s Bureau of Consumer Protection. “Marketers of e-cigarettes have proven skillful at evading FDA regulation and hooking youth on addictive products.”
The FTC has been reporting on tobacco sales annually since 1967 and smokeless tobacco sales since 1987. Last year, the agency expanded its studies of industry and published its first-ever report on e-cigarettes.
This year’s e-cigarette report covers sales and advertising data from 2019 and 2020, a period in which the U.S. Food and Drug Administration published an enforcement policy banning the sale of flavored e-cigarette cartridges other than menthol.
Overall, the report found that total e-cigarette sales, which had increased from $304.2 million in 2015 to $2.046 billion in 2018, grew to $2.703 billion in 2019, but then declined to $2.24 billion in 2020. The FTC report notes that the 2020 decline may not represent the market given major industry shifts. Key findings in the report include:
Significant shift to flavored disposable e-cigarettes: Publicly available sources indicate that the sale of disposable e-cigarettes – which are exempt from the FDA’s 2020 policy – increased substantially, with “other” flavored disposable products making up 77.6 percent of all disposables sold in December 2020. The FTC’s data did not show an increase in disposable sales. However, FTC’s data likely does not represent an accurate picture of the market for disposable e-cigarettes. Only two of the five companies submitting data for 2019-20 continued to market disposable e-cigarettes in 2020, and those that did provided more limited offerings. In order to improve the representativeness of its industry sales data for future FTC reports, the FTC recently sent orders to four additional e-cigarette companies.
Major increase in menthol cartridge sales: Similarly, the report found that the sale of the remaining non-FDA-banned flavored cartridge, menthol, increased significantly, to 63.5 percent of all cartridges sold in 2020.
Record high e-cigarette discounting: The data also reveal that price discounting for e-cigarettes reached a record high of $182.3 million in 2019, and, although it decreased slightly in 2020, such discounting still represented the largest category of ad expenditures by e-cigarette manufacturers.
Doubling of nearly free e-cigarette samples: The data collected for 2019-20 suggest that spending on the sampling and distribution of free and deeply price-discounted e-cigarettes more than doubled in just two years, making it the second-largest spending category in 2020. This occurred because, after the FDA banned tobacco product sampling in 2016 to limit youth access, some companies began offering e-cigarettes for $1 (or even less) in an apparent attempt to get around the ban.
“This report shows that partial bans on certain types of flavors for certain types of e-cigarettes are unlikely to be successful in achieving a reduction in youth addiction to nicotine via e-cigarette usage,” the FTC wrote in statement.
The Commission vote approving the FTC’s E-Cigarette Report and related data tables for 2019-20 was 5-0.
August 31, 2022