Tag: United States

U.S. E-Cigarette Sales Up Nearly 50 Percent: Report

A new report from the CDC Foundation and Truth Initiative showed that from 2019 to 2023, there was a 47 percent increase in e-cigarette unit sales at U.S. retail outlets. Flavors like fruit, candy, mint, menthol and desserts accounted for more than 80 percent of sales.
The report, Monitoring E-Cigarette Trends in the United States: Urgent Action Needed to Protect Kids from Flavored E-Cigarettes, urges states to adopt comprehensive statewide policies restricting flavored e-cigarette sales. The report found that the most effective policies to restrict these sales clearly define products and include comprehensive flavored tobacco restrictions without flavor or product exceptions, incorporate community and retailer education and are supported by enforcement.
“The rise in e-cigarette sales, particularly those with youth-appealing flavors and graphics, is deeply concerning, especially as manufacturers evolve e-cigarette products to feature gamified devices and increased nicotine strength,” said Judy Monroe, president and CEO of the CDC Foundation, in a statement. “However, the data from states like Massachusetts, California and New York demonstrate how comprehensive policies can effectively curb youth access. This report underscores the urgent need for widespread adoption of similar measures to protect our young people from the risks associated with e-cigarette use.”
“E-cigarette sales have skyrocketed in recent years, with an explosion of new products—many designed to attract and addict our youth with increasingly high levels of nicotine,” said Kathy Crosby, CEO and president of Truth Initiative. “Today’s e-cigarettes are available in a vast array of enticing flavors and feature sleek, colorful designs. They’re also bigger, stronger and cheaper than previous devices, which only heightens their appeal. Even more concerning, over 80 percent of e-cigarettes are on the market illegally. While enforcement is vital to ending the youth e-cigarette crisis, retailers also must do the right thing, take responsibility to protect their young customers and remove all illegal products from store shelves.”
“While the latest data from the CDC Foundation and Truth Initiative show a dangerous rise in sales of e-cigarettes, they also reveal a notable decline in sales where strong policies restricting flavored e-cigarettes are implemented,” said Kelly Henning, public health program lead for Bloomberg Philanthropies. “The progress in states with strong policies underscores the urgent need for more action to swiftly and successfully combat the flavored e-cigarette epidemic among youth across the United States.”
November 22, 2024
FDA Renews MRTPs for 8 General Snus Products

After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.
With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.
The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.
“The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.
“In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”
The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.
November 7, 2024
VTA Celebrates Impact of U.S. Vaper Voters
The Vapor Technology Association (VTA) celebrated the political currency and success of vaper voters in critical 2024 battleground election states and districts during the recent U.S. elections. According to the trade group, vaper voters helped secure electoral victories for Conservative candidates up and down the ballot.
VTA says its “I Vape I Vote” campaign activated over 360,000 low-propensity voters to support Conservative principles and candidates, including President-elect Donald Trump, in key battleground states and districts in Arizona, Michigan, Nevada, Ohio, Pennsylvania, Virginia and Wisconsin.
“Vaper voters showed up in droves to support Conservative candidates who will protect and preserve the rights of Americans to use flavored vaping products,” said VTA Executive Director Tony Abboud.
“VTA’s I Vape I Vote campaign made clear that vaper voters had their voices heard at the ballot box and ensured that Conservative candidates would deliver full-throated endorsements of Americans’ right to use flavored vapes and, critically, use that support to establish a voter currency which propelled several Conservative candidates into office.
“While we are proud to have engaged in the process with several of these Conservative candidates, we are now ready to see their campaign promises committed to action as they work with President-elect Trump and the relevant federal agencies to fix the broken regulatory process by implementing a streamlined regulatory process that ensures access to flavored vapes is protected and companies and distributors have transparent, rational and affordable rules of the road when it comes to this regulatory framework.”
November 7, 2024
Trump Says He Will Save Flavored Vapes if Elected

Photo: Alexander
Former U.S. President Donald Trump said he will save flavored e-cigarettes if re-elected, according to Newsmax.
“I saved flavored vaping in 2019, and it greatly helped people get off smoking,” Trump wrote in a Sept. 20 post on his Truth Social account. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save vaping again.”
In his first term, Trump promised to crack down on sales of flavored products but then backtracked, saying vaping could help people stop smoking. Trump’s watered-down proposal banned the sale of all sweet and fruity flavored vape pods and cartridges but allowed gas stations and convenience stores to continue selling menthol cartridges and vapes. It also allowed vape shops to sell a broad range of e-cigarette liquids in open-tank vaping systems.
Free market advocates and small business vape shop owners and vape-makers supported the new proposals while anti-tobacco advocates accused Trump of caving to pressure from the nicotine business.

VTA’s meeting with President Trump represents a great day for small businesses across America who fear the Biden-Harris administration’s efforts to shut down small businesses and deprive adults who smoke of their flavored vaping products.
Tony Abboud, executive director, VTA
The Vapor Technology Association (VTA) welcomed Trump’s latest comments.
“Today, VTA had the opportunity to meet with President Donald J. Trump,” wrote VTA Executive Director Tony Abboud on Sept. 20. “We had a wide-ranging conversation, and we thanked President Trump for taking two bold and decisive actions in 2019: Saving flavored vapes for adults and protecting youth by raising the age to 21.”
“Since then, youth vaping has dropped to an all-time low, and many adults have used flavored vaping to quit smoking. VTA’s meeting with President Trump represents a great day for small businesses across America who fear the Biden-Harris administration’s efforts to shut down small businesses and deprive adults who smoke of their flavored vaping products. We are pleased that former President Trump is continuing to fight for vapers.”
September 23, 2024
ITC Recommends Ban on U.S. Imports of Njoy Ace

Photo: JHVEPhoto
An administrative law judge (AJL) of the International Trade Commission (ITC) has recommended a ban on importing Njoy Ace products into the United States following a patent-infringement claim filed by Juul Labs.
Ace is the first pod-based vapor product and the only pod-based menthol vapor product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. According to Njoy parent company Altria Group, an exclusion order banning the importation of Ace would severely limit FDA-authorized choices for adults and undermine public health.
“Altria and NJOY respectfully disagree with the ALJ’s initial determination, and Njoy looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” Altria Group wrote in a statement.
In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul with the ITC seeking a ban on the importation and sale of Juul products in the U.S. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against Njoy Ace from taking effect.
“We continue to work to bring this issue to resolution,” Altria wrote in its statement. “The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes. In addition, Njoy recently filed substantial equivalence (SE) exemption requests with the FDA to allow Njoy to market an already-developed Ace product with minor modifications that we believe avoid three of the four Juul patent claims at issue in the case.”
August 27, 2024
FDA Almost Finished Reviewing PMTA Products

Photo: thodonal
The U.S. Food and Drug Administration is almost done reviewing premarket tobacco product applications (PMTAs) for mass-market vaping products.
In a July 22 progress report the agency said it had taken action on 185 of 186 marketing applications for e-cigarette products covered by a 2022 court order, which applied to products with significant market share that filed applications by Sep. 9, 2020.
The manufacturers of those orders have received either a marketing denial order (MDO) or FDA authorization.
Observers say the one application still under review is Juul. The FDA issued an MDO to Juul in 2022, but quickly stayed its order and agreed to further review the application. In June, the FDA rescinded the denial order, returning Juul’s products to full scientific review.
In its report, the FDA says it has also issued more than 18 million refuse-to-accept decisions, over 67,000 refuse-to-file decisions, and approximately 46,000 MDOs—most of them for bottled e-liquid made by small- to medium-sized manufacturers.
The new progress report is the most recent in a series of reports mandated by the U.S. District Court for Maryland as part of its decision that forced the FDA to move the PMTA submission deadline forward.
July 26, 2024
PMI Mysteriously Postpones U.S. Launch of IQOS

Credit: F Armstrong Photo
Philip Morris International has postponed the test launch of its IQOS heated tobacco device in the U.S. to the fourth quarter, reports Reuters. The company declined to say why.
The pilot was earlier scheduled to run in Austin, Texas, in the second quarter, for which the company reported results on the day.
Anti-tobacco activists have been seeking to derail the U.S. introduction of IQOS, arguing among other things that PMI exaggerates the number of people who have quit smoking regulator cigarettes using IQOS.
In a joint letter to the U.S. Food and Drug Administration dated June 27, six health groups cited yet-to-be published independent studies contradicting PMI’s findings about how many IQOS users completely switch to the device from cigarettes.
Meanwhile, PMI said the impact of the EU ban on flavored heated tobacco in the European Union has had a “slightly greater” impact on IQOS sales than previously assumed.
This led the company to temper its expectations for volume growth in the heated tobacco category to around 13 percent for the full year, down from between 14 percent and 16 percent expected earlier.
July 24, 2024
Altria Submits PMTA for ‘On! Plus’ Pouches

Image: maurice norbert
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
PMI Suspends Online Zyn Sales Due to DC Probe

Photo: Swedish MAtch
Philip Morris International halted sales of Zyn nicotine pouches on its U.S. website as Washington, D.C., officials investigate the company’s compliance with the district’s ban on the sale of flavored tobacco products, reports The Wall Street Journal.
On June 17, the company’s Swedish Match North America division announced it had received a subpoena from the District of Columbia’s attorney general, requesting among other things information about the unit’s compliance with local restrictions on flavored tobacco.
A preliminary investigation by the company indicated that there had indeed been sales of flavored nicotine pouch products in the district. According to PMI, these related predominantly to certain online sales platforms and some independent retailers.
Swedish Match is currently conducting a full review of its sales and supply chain arrangement in D.C. and other U.S. localities where flavor bans apply.
Pending the investigation, PMI has suspended all online sales on Zyn.com. Sales on this platform have represented “a very small” percentage of the company’s U.S. Zyn volumes, according to PMI.
In the March quarter, Philip Morris’ shipment volumes of oral smoke-free product volumes surged by 40 percent, mainly driven by Zyn nicotine pouches in the U.S., where shipment volume reached 131.6 million cans.
Zyn has been available in the U.S. since 2014, but its sales have skyrocketed over the past year and a half, and its parent company is investing in Zyn capacity in the U.S.
Philip Morris bought Swedish Match in a $16 billion deal in 2022 as the company looked to reduce its reliance on cigarettes amid stricter regulations and a consumer shift toward alternatives to tobacco and traditional cigarettes.
June 18, 2024
FDA, DOJ Grilled for ‘Unserious’ Action on Illegal Vapes

Photo: Katherine Welles
U.S. Senators criticized top health and law enforcement officials for their failure to tame the rapidly growing illicit e-cigarette market, reports the Associated Press.
During a hearing on June 12, lawmakers on the Senate Judiciary Committee questioned officials from the Food and Drug Administration and Department of Justice (DOJ) about attempts to manage the vaping market, which has grown to include thousands of flavored, unauthorized e-cigarettes imported from in China.
To date, the agency has approved only a handful of e-cigarettes as alternatives for adult smokers. All other products on the market, including popular products like Juul, are pending review or considered illegal by regulators.
“I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application,” said the committee’s chairman, Dick Durbin.
Brian King, director of the FDA Center for Tobacco Products, said the agency has been slowed by a backlog of applications submitted by vape companies seeking approval to sell their products in the U.S. The FDA received millions of premarket tobacco product applications, each of which must be scientifically reviewed.
An industry lobbyist told the committee that the FDA has created an untenable marketplace by rejecting more than 99 percent of applications submitted by companies.

I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application.
Dick Durbin, chairman, Senate Judiciary Committee
Ahead of the congressional hearing, several government agencies, including the FDA and the DOJ established a task force to better coordinate the fight against illegal e-cigarettes. Republican Senator Thom Tillis called the timing of the announcement “a political stunt,” and criticized the absence of other federal agencies from the initiative, including Customs and Border Protection (CBP).
“If the timing of the task force formation wasn’t evidence of how unserious the FDA is about tackling the flood of illicit e-cigarettes, FDA’s exclusion of CBP from the task force makes it crystal clear,” said Tillis, who represents North Carolina, a major tobacco-producing state. He urged officials to concentrate enforcement on Chinese brands, rather than large domestic manufacturers like Reynolds American, which is based in North Carolina.
The FDA can conduct investigations and recommend cases, but only the Justice Department can bring lawsuits. The FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.
Disposable vapes account for an estimated 30 percent to 40 percent of the roughly $7 billion-dollar U.S. vaping market. The two best-selling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs.
Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos and flavors.
King noted that products like Elf Bar cannot legally be sold in China because the government there has banned non-tobacco flavored e-cigarettes. Outraged that brands banned in China are sold in the U.S., Texas Senator John Cornyn vowed to introduce legislation to rectify that situation.
Jefferies analyst Owen Bennett said the Congressional testimony could spur the FDA to approve more products from British American Tobacco and Juul. “This hearing is another example of increasing political pressure for the FDA to act” against unauthorized products, he said in a research note quoted by Bloomberg.
June 13, 2024