Modern Oral - Tobacco Reporter

BAT to Launch Synthetic Nicotine Pouch in the U.S.

BAT will launch a new version of its Velo pouches using synthetic nicotine in the United States next year, reports Reuters.

Made in a laboratory rather than derived from tobacco leaves, synthetic nicotine has gained popularity among manufacturers recently as a means to avoid the Food and Drug Administration’s lengthy and cumbersome tobacco product authorization process.

While the FDA initially had authority only over naturally occurring nicotine, President Joe Biden in March 2022 signed into law a bill that extended the agency remit to synthetic nicotine. BAT’s launch would mark the first time a major tobacco company introduces a synthetic nicotine product in the U.S., according to Reuters. To date, synthetic nicotine has been used primarily by smaller manufacturers of vapes or pouches.

David Waterfield, president of BAT’s Reynolds American subsidiary, said that the product’s previous owner submitted a premarket tobacco product application before the May 2022 deadline, meaning it can stay on the market while its application is pending, Waterfield said.

The FDA, however, told Reuters that a pending application is insufficient for a synthetic nicotine product to be sold in the U.S. Products on the market without FDA authorization, the agency added, may be subject to enforcement.

BAT expects U.S. nicotine pouch industry revenues to grow from £1.7 billion ($2.21 billion) today to up to £7 billion by 2030.

October 18, 2024

Imperial Sued Over Zone Trademark

2ONE Labs and Performance Plus Marketing have filed both a trademark infringement lawsuit and a preliminary injunction against Imperial Brand subsidiaries Zone nicotine pouch trademark.

The suit alleges that Imperial’s Zone products willfully infringe the 2ONE nicotine pouch brand. In addition to seeking an award for damages, 2ONE is also seeking cancellation of Imperial’s Zone mark.

According to the plaintiffs, the 2ONE brand has been continuously marketed and sold to adult consumers through thousands of U.S. convenience chain and independent grocery and smoke shop stores for the last five years.

The suit alleges Imperial Brands made false statements by claiming a significantly earlier use of their mark in commerce than had occurred. The suit further alleges the false statements allowed Zone to be granted a fraudulent mark.

“We have experienced numerous instances of consumer confusion since Imperial launched its Zone brand in 2024 and we intend to vigorously fight this type of blatant infringement, no matter how big the corporate bully,” said 2ONE Labs founder and partner Vincent Schuman in a statement.

The case is before the U.S. District Court for the Central District of California.

October 8, 2024

Tucker Carlson to Launch Nicotine Pouch

Tucker Carlson plans to introduce a nicotine-pouch brand called Alp in November, reports The Wall Street Journal.

The conservative U.S. political commentator said he decided to enter the tobacco business because of the way Zyn manufacturer Philip Morris International responded to an off-color remark he made in 2023 about America’s bestselling nicotine pouch.

Until recently, Carlson styled himself as an unofficial spokesman for Zyn. He talked up the brand on frequent podcast appearances. “The truth is, Zyn is a powerful work enhancer and also a male enhancer, if you know what I mean,” Carlson told comedian Theo Von in an interview last October.

Carlson’s representatives then pitched PMI on forming a partnership with the brand. The multinational declined, citing Carlson’s commentary.

“While we understand that these may be Mr. Carlson’s views or made in jest, these statements lack a scientific foundation,” the tobacco company wrote. “Given Mr. Carlson’s popularity and reach, these statements could promote a misunderstanding and misuse of our products.”

Carlson said the message enraged him.

“Of course I wasn’t making a medical claim about their product. I was just joking,” he told The Wall Street Journal. “So I thought: ‘I’m going to launch my own product that’s not controlled by, you know, humorless, left-wing drones.’”

Last month, a Turning Point Brands subsidiary filed a trademark application for the Alp brand name and its logo, which depicts a winking man in a cowboy hat. The company currently sells a moist nicotine pouch called Fre.

Alp will come in three nicotine strengths—3 mg, 6 mg and 9 mg. Zyn in the U.S. is only available in 3 mg and 6 mg versions. Another key difference is that Alp pouches are moist while Zyn pouches are dry, like tiny tea bags, until they are tucked into the cheek, according to Carlson.

September 20, 2024

Canada to Crack Down on Pouches

Nicotine pouches may be sold in Canada only by individuals working under the supervision of a pharmacist, under a new ministerial order targeting “new and emerging” nicotine-replacement therapies (NRTs). Sellers will also be required to store nicotine pouches behind the pharmacy counter.

In addition, the new rules prohibit youth-appealing advertising or promotion and sales of nicotine pouches with flavors other than mint or menthol.

Manufacturers will be required to print a front-of-package nicotine addiction warning as well as a clear indication of the intended use as a smoking cessation aid for adults trying to quit smoking. They must also submit mock-ups of labels and packages for all new or amended NRT licenses to ensure no youth appeal.

The new restrictions will take force Aug. 28, 2024, though there will be a six-month transition period for the provisions on advertising and labeling. Established smoking cessation aids, such as nicotine gums, lozenges, sprays and inhalers, will continue to be available in a wide range of retail locations, with a variety of flavors.

“Stronger measures are needed to protect youth from the harmful effects of nicotine and stop dependency before it starts,” said Minister of Health Mark Holland in a statement. “The action our government is taking will keep these products available for adults who need them to quit smoking while making sure they don’t get into the hands of youth for recreational use.”

Public health advocates welcomed Health Canada’s announcement. “These new measures put an end to the easy access young people have had to a very addictive substance,” said Rob Cunningham, senior policy analyst with the Canadian Cancer Society, in a statement. “These restrictions will help protect youth from tobacco industry marketing and from nicotine addiction. We must avoid a repeat of the experience that has seen a dramatic increase in youth vaping.”

Imperial Tobacco Canada (ITCAN), which makes the popular Zonnic nicotine pouches, warned that the ministerial order would derail efforts to reduce smoking rates.

“The Minister of Health is making smoking cessation products more difficult to buy for adults who smoke and who want to quit,” said ITCAN Vice President of Corporate and Regulatory Affairs Eric Gagnon in a statement. “It goes against all logic for a country that wants to reduce smoking rates to target products that actually help people quit.”

According to ITCAN, Zonnic is quickly becoming the leading smoking cessation aid product in locations where it’s sold. The company claims to have received testimonials suggesting that consumers have stopped or reduced smoking by using Zonnic.

Canada regulates NRTs as drugs under the Food and Drugs Act. All NRTs must be approved by Health Canada and carry an approved health claim to be legally sold in Canada. Health Canada authorized sales of Zonnic in October 2023.

August 26, 2024

Altria Worried About Illicit Pouches

Altria Group is worried about growing illicit sales of modern oral products in the United States, reports Reuters. The company has shared data on illegal nicotine pouches with the U.S. Food and Drug Administration.

“This illicit market echoes the beginning of the illicit e-vapor market several years ago,” Altria CEO William Gifford told analysts during a financial update. “We believe it is critical that the FDA acts decisively to regain control of the oral nicotine pouch category to prevent another widespread illicit market from taking hold,” he added.

Altria said it had identified more than 350 unique illegal nicotine pouches on sale, with new brands launching every month.

Gifford said Altria had also observed an increase in illicit cigarettes, one survey of discarded packs in California finding that some 25 percent were non-U.S. brands, mostly originating from duty-free channels or China.

Last month, Philip Morris International said it had observed sales of its nicotine pouches intended for the Scandinavian market on sale in the United States.

Recently, British American Tobacco’s CEO expressed concern about the continued lack of enforcement against unauthorized single-use vapes in the U.S., which makes it difficult for authorized brands to compete in that market.

August 1, 2024

Asia Pacific Urged to Permit Oral Nicotine

The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is urging governments across the Asia Pacific region to follow New Zealand’s lead and allow the sale of oral nicotine products as part of a comprehensive tobacco harm reduction strategy.

New Zealand’s government recently agreed in principle to permit the sale of reduced-harm smokeless tobacco and oral nicotine products, such as Swedish snus and nicotine pouches. This progressive policy aligns with mounting evidence that these products can play a crucial role in reducing smoking rates and improving public health outcomes.

“New Zealand’s approach demonstrates how embracing tobacco harm reduction can accelerate progress towards smoke-free goals,” said Nancy Loucas, executive coordinator of CAPHRA. “Their smoking rates have plummeted to historic lows, proving that pragmatic policies focused on harm reduction work.

“Recent data from New Zealand shows daily smoking rates have dropped to just 6.8 percent, down from 16.4 percent in 2011/2012. This remarkable decline coincides with the country’s adoption of progressive vaping regulations and openness to other reduced-risk nicotine products.”

According to Loucas, scientific evidence increasingly supports the harm reduction potential of oral nicotine products. She cited a study published in the Harm Reduction Journal, which found that snus use in Sweden has led to “substantially lower rates of smoking-related disease” compared to other European countries. Loucas also referenced research from the U.K.’s Royal College of Physicians, which concluded that nicotine products are “unlikely to exceed 5% of the harm from smoking tobacco.”

“Asia Pacific nations have an opportunity to dramatically improve public health by allowing and properly regulating these products,” Loucas said. “Continuing to ban safer alternatives while deadly cigarettes remain widely available is counterproductive and harmful to public health.

“CAPHRA emphasizes that regulations should ensure product quality and safety while making these alternatives accessible to adult smokers looking to quit. The organization calls for a balanced approach that protects youth while helping millions of current smokers transition away from combustible tobacco.

“We urge policymakers across the region to objectively review the evidence and engage with consumers and experts in tobacco harm reduction,” said Loucas. “It’s time to move beyond outdated ‘quit or die’ approaches and embrace the full range of tools available to end the smoking epidemic.”

July 19, 2024

Surprisingly Low Adult Pouch Use: Study

Despite a 641 percent increase in sales of nicotine pouches between 2019 and 2022, few U.S. adults use modern oral products, according to a nationally representative study conducted by the Keck School of Medicine of the University of Southern California (USC) and the University of Nebraska Medical Center.

“The low prevalence of nicotine pouch use in adults surprised us, given the rapid increase in sales,” said study co-author Adam Matthew Leventhal, a professor in the Department of Population and Public Health Sciences at the Keck School of Medicine and executive director of the USC Institute for addiction science, in a statement. “But it’s also possible that the sales are being diverted to adolescents, who were not represented in this survey.”

The researchers surveyed nicotine pouch use in a nationally representative sample of 39,557 U.S. adults. They found that 2.9 percent of adults had ever used nicotine pouches, with 0.4 percent reporting current use. The majority of adults currently using pouches also currently smoke cigarettes. Additionally, 5.2 percent of those who attempted to quit smoking in the past year and had relapsed back to smoking reported using pouches to help with their cessation efforts.

One question raised by the findings is whether adults who use nicotine pouches may be using them to “top off” nicotine in situations where they cannot smoke or use other tobacco products, Leventhal said, rather than as a way to quit smoking.

Based on the study results, Leventhal estimates that of all U.S. adults who currently used nicotine pouches in 2022, about 35 percent had previously smoked cigarettes and 25 percent were currently smoking cigarettes. The remaining 40 percent of adult pouch consumers had never regularly smoked cigarettes and could be at risk for developing nicotine dependence.

“In summary, we didn’t see a large population of adults using nicotine pouches, and fewer appear to be using them in a fashion that would potentially reduce their harm from smoking cigarettes,” Leventhal said.

July 11, 2024

Altria Submits PMTA for ‘On! Plus’ Pouches

Altria Group has submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration for its “On! Plus” oral nicotine pouch products. The PMTAs were submitted by Altria’s wholly owned subsidiary Helix Innovations.

On! Plus is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary “soft-feel” material to provide a more comfortable product experience. The On! Plus pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip).

According to Altria, On! Plus pouches are seamless and larger than the leading U.S. TDN brands. Similar to the currently marketed On! products, On! Plus packaging features a compartment to responsibly dispose of used product. Helix submitted PMTAs for three distinct On! Plus varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.

“Helix’s submission of the On! Plus applications underscores Altria’s commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that On! Plus is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, managing director and general manager of Helix in a statement.

“We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed On! Plus pouches can provide a compelling alternative in the marketplace,” said Paige Magness, senior vice president of regulatory affairs, Altria Client Services.

Upon authorization, Altria expects the products to be distributed by Altria Group Distribution Co.

Helix currently sells On! nicotine pouches in the U.S. In the first quarter of 2024, On! shipment volume grew 32 percent versus the prior year and the brand achieved a 7.1 percent retail share of the total U.S. oral tobacco category.

Altria entered the U.S. oral nicotine products market in 2019 after signing a deal with Burger Söhne to acquire an 80 percent ownership stake in some companies that commercialized On! Products, according to The Wall Street Journal. In December 2020 and April 2021, Altria subsidiaries concluded transactions to buy the remaining 20 percent stake of the global on! business for about $250 million.

Altria’s PMTA announcement comes after Philip Morris International’s Swedish Match North America unit suspended nationwide sales on its U.S. website as local officials in Washington, D.C., investigate whether the company is in compliance with the district’s ban on the sale of flavored products.

June 27, 2024

Pouches Scrutinized

Scientists at Georgetown University’s Lombardi Comprehensive Cancer Center have synthesized evidence from 62 studies related to the use of oral nicotine pouches to better understand their potential impact on public health. The findings have been published in Nicotine and Tobacco Research.

Oral nicotine pouches are rapidly increasing in popularity. While they may present a less harmful nicotine alternative for cigarette users, there is considerable concern about them becoming a new form of nicotine dependence, especially in youth who don’t use tobacco or nicotine,” said the study’s corresponding author, Nargiz Travis, in a statement.

The investigator’s analysis was based on 45 academic and 17 industry-funded studies, mostly from the U.S. Sales of the products have been concentrated in Scandinavia and the U.S., mainly because of the established smokeless tobacco market in these regions.

In the U.S., the researchers found, based on nationally representative surveys, that through 2023, oral nicotine pouches were currently used by 1.5 percent of all youth while lifetime use by young people was under 2.5 percent.

In terms of awareness of the products, between 35 percent and 42 percent of U.S. adolescents and young adults have heard of oral nicotine pouches, and 9 percent to 21 percent of tobacco-naive (nontobacco users) youth surveyed were not opposed to trying them. U.S. adult usage estimates varied widely across surveys; in 2023, 0.8 percent to 3 percent of Americans currently used the products while 3 percent to 16 percent used them at some point in time. In view of rising nicotine pouch sales trends in 2024, their use in the U.S. population has likely increased.

Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products.

Nargiz Travis, project director for the Center for the Assessment of Tobacco Regulations at Georgetown Lombardi

The investigators’ findings suggest fewer harmful chemical compounds are present in the pouches and occur at lower levels than in cigarettes and smokeless tobacco, with the exception of formaldehyde. However, an analysis of 37 oral nicotine pouches of different brands, nicotine strengths and flavors yielded a wide range of total nicotine content from 0.89 mg to 6.73 mg per pouch.

“Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products,” says Travis.

“In the U.S., oral nicotine pouches are currently neither authorized by the FDA for marketing as a modified-risk product nor approved as a cessation product. It is important to know that nicotine is an addictive chemical with harmful health effects, regardless of whether it is synthetic, meaning tobacco-free, or derived from tobacco.

One of the studies included in the authors’ analysis was a U.S. survey of young adults 18 years to 34 years of age, many of whom used cigarettes and e-cigarettes. The survey found that among those who had tried nicotine pouches, curiosity about the product (28 percent), flavors (26 percent) and the ability to use in places where other tobacco products are prohibited (26 percent) were among the main reasons for trying the pouches. The availability of flavors (31 percent) was the main motive for use in another U.S. sample of adult current nicotine pouch users.

Leading brands of the products are currently owned by major tobacco companies. The authors note that a substantial investment in marketing by the companies suggests that oral nicotine pouches are becoming increasingly important to the tobacco industry.

“As more evidence on oral nicotine patches becomes available, and more importantly, more independent studies become published, it will be essential to conduct further analyses comparing the findings of industry versus non-industry sponsored research and critically assess the quality and risk of bias of such studies,” said Travis.

June 17, 2024

Health Canada Recalls Zyn Pouches

Health Canada recalled eight types of Zyn nicotine pouches on June 12, saying they were sold without market authorization, reports Global News.

They affected variants are flavored apple mint, bellini, black cherry, citrus, cool mint, espresso, original and spearmint. The pouches had 1.5 or three milligrams of nicotine in them.

Philip Morris International, which manufactures Zyn products, said it does not sell in Canada and applauds Health Canada for taking action.

“The products at issue are being sold by unauthorized parties,” a spokesperson for PMI’s Rothmans Benson & Hedges affiliate was quoted as saying by the Global News.

“RBH works with law enforcement to stop illicit trade and we are supportive of government efforts on this front.”

Health Canada has approved only one nicotine pouch for sale—Imperial Tobacco Canada’s Zonnic brand.

The introduction of nicotine pouches in Canada has run into opposition from health activists.

Experts say these products are appealing to children, who face the risk of becoming addicted to nicotine.

In March, Health Minister Mark Holland said that he was “seeking authority” to restrict such products “so they are solely for the purposes of cessation.”

June 14, 2024

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