Author: Timothy Donahue

FDA OKs Vuse Alto Tobacco-Flavor Pods, Device
The U.S. Food and Drug Administration authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway.
Following an extensive scientific review, FDA issued marketing granted orders to R.J. Reynolds Vapor Co. for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable:
Vuse Alto Pod Golden Tobacco 5%
Vuse Alto Pod Rich Tobacco 5%
Vuse Alto Pod Golden Tobacco 2.4%
Vuse Alto Pod Rich Tobacco 2.4%
Vuse Alto Pod Golden Tobacco 1.8%
Vuse Alto Pod Rich Tobacco 1.8%
While the FDA says it remains concerned about the risk of youth use of all e-cigarettes, youth are less likely to use tobacco‐flavored e-cigarette products compared to other flavors.
According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarettes.
However, only 6.4 percent of students who currently used e-cigarettes reported using tobacco‐flavored products. To further mitigate youth use of these products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.
The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of those applications. To date, the agency has authorized 34 e-cigarette products and devices, including the seven authorized today.
A list of all authorized e-cigarette products is available here.
July 18, 2024
NYC Shutters More Than 600 ‘Illegal’ Vape Shops

Credit: Zoran Milic
Over 600 illegal vape shops in New York City have been shut down during Operation Padlock to Protect, Mayor Eric Adams told media.
“Many of them have remained closed,” he said. “We’re gonna stay committed to closing down these shops.”
A Throggs Neck deli was shut down on Wednesday after illegal flavored THC and nicotine vapes were discovered, officials said. The Sheriff’s Office “likely seized $1 million” in illegal products and nine people were arrested, according to authorities, according to media reports.
Some of the products were marketed toward children, Adams said.
“I believe this is a well-organized, almost chain store-type distributer,” Adams said about where the illegal products are believed to be coming from. “They are really supplying not only here in the city, but probably throughout the entire state.”
July 18, 2024
Uwell Launches Caliburn G3 Vaping System in UK

Uwell has announced the release of the Uwell Caliburn G3 Pro Kit, which combines advanced features with user-friendly design.
One of the standout features of the Uwell Caliburn G3 Pro Kit is its full-screen dynamic user interface (UI). The innovative display provides easy visibility of vaping details at a glance, ensuring that users can easily monitor their devices, according to a press release.
The Uwell Caliburn G3 Pro Kit boasts a 3mL pod capacity and a maximum output of 35W. The 0.42ohm coil is designed to maximize flavor and deliver a powerful restricted direct-lung (RDL) vape.
For the first time in the Caliburn series, the G3 Pro Kit includes fine-tuning airflow control. This feature allows vapers to tailor their vaping experience more precisely and conveniently.
The Caliburn G3 Pro Kit accommodates users’ preferences for a tighter draw or a more open airflow.
July 17, 2024
Off-Stamp Launches Latest Upgrade to Vape System

The vaping brand Off-Stamp unveiled the new SW16000, the latest of a series of single-use pods in the U.S. and a part of the dual-form interchangeable pod-battery pair.
An upgrade from the previous SW9000, SW16000 delivers up to 7,000 more puffs and eight new flavors.
With 17 ml of e-liquid, an SW16000 pod provides a longer-lasting vaping session of up to 16,000 puffs in pair with an attachable battery.
The new replaceable pod’s magnetic structure boosts cost efficiency and reduces parts disposal in the long run.
Adult users are strongly advised to keep the attachable battery and couple it with SW16000 reshuffled pods for a longer product lifespan.
Equipped with a built-in battery, the standalone SW16000 pod offers a more enduring vaping session, without the attachable battery part, according to a press release.
With eight brand-new flavors offered by the SW16000 pod, users can now choose from a selection of 16 flavors in the series on top of the eight existing ones from the SW9000.
July 17, 2024
Critics Blast UK’s Focus on Generational Tobacco Ban

Image: Benjaminet
The new U.K. government’s intention to progressively increase the age at which people can buy cigarettes will not achieve its objectives, according to the smoker’s group Forest.
Responding to an announcement in today’s King’s Speech, the annual ceremony in which the British monarch sets out the policies of and proposed legislation that the government plans to introduce, Forest Director Simon Clark said the measure would fail to stop people smoking. Instead, he warned, it would drive more people to the black market and make smoking cool again.
SImon Clark
Originally proposed by former Prime Minister Rishi Sunak, the generational tobacco ban would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, effectively raising the legal age of purchase by one year, every year.
The measure passed its first parliamentary hurdle in April but was put on hold after Sunak, a conservative, called a national election, which was won by the Labour party.
While vowing to ditch many Tory policies, Labour reiterated its commitment to the generational tobacco ban, prompting criticism from smoker rights activists.
“Labour, like the previous Conservative government, is addicted to the nanny state,” said Clark.
“It’s ironic that Labour wants to reduce the voting age to 16 whilst denying adults the freedom to legally purchase cigarettes.
“If you are old enough to drive a car, join the army and buy alcohol, you are old enough to buy cigarettes and other tobacco products.”
July 17, 2024
King Confirms UK Generational Ban Moving Ahead

Credit: Michael
The new Labour government will propose a bill to gradually raise the legal age for purchasing cigarettes and impose restrictions on the sales and promotion of vaping products, as confirmed by the UK’s King Charles III in a speech.
Under the proposed Tobacco and Vapes bill, children born on or after Jan. 1, 2009 will never be able to legally be sold cigarettes.
The bill will also stop vapes and other consumer nicotine products from being deliberately branded and advertised to appeal to children.
The Tobacco and Vapes bill was proposed under the previous Conservative government and was voted through the House of Commons in April, according to media reports.
It has also passed the Committee stage but must still pass a third reading in the House of Commons, three readings in the House of Lords, amendments, and Royal Assent before becoming legislation.
July 17, 2024
Court Bans Soul Vapor From Selling Illegal Vapes

Credit: Yelp
The United States District Court for the Southern District of West Virginia enjoined Soul Vapor LLC, a West Virginia-based company, and the company’s owner, Aurelius Jeffrey, from “directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product” that has not received marketing authorization from FDA.
The court also ordered Soul Vapor and Jeffrey to destroy e-cigarette products that were manufactured by Soul Vapor and are in their custody, control, or possession.
“FDA vigorously enforces the law and will continue to work with the U.S. Department of Justice to take enforcement actions, such as pursuing permanent injunctions, against those who defy the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “This injunction is another reminder that FDA will use the full scope of its enforcement tools to protect public health.”
According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, the defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The complaint also alleged that the defendants submitted materially false information to FDA.
“The court’s order is yet another example of how FDA – in coordination with federal partners – is successfully ramping up enforcement to combat unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “We will continue to work with our federal partners to identify and bring enforcement actions against bad actors, while continuing to educate stakeholders about the need for additional resources to best support these efforts.”
CTP’s ability to pursue enforcement actions, including injunctions, is solely dependent on user fees. CTP is 100 percent funded by user fees, which the FD&C Act authorizes FDA to collect from manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. However, this authority has not been updated to reflect the realities of the tobacco product marketplace, including the emergence of e-cigarettes over a decade ago, according to a release.
As a result of this inequity, e-cigarette manufacturers are currently paying no fees while continuing to profit off unauthorized products. In order to enhance the CTP’s enforcement actions, including pursuit of injunctions, the agency has requested updated authority from Congress to modernize the tobacco user fee framework to apply to all tobacco products regulated by the agency.
The injunction against Soul Vapor highlights the successful cooperation between FDA and the DOJ to enjoin bad actors from manufacturing, selling, and distributing unauthorized e-cigarette products. FDA has taken numerous judicial enforcement actions as a part of its comprehensive approach to enforcing the law, including eight injunctions in coordination with DOJ since 2022, according to the FDA.
Additionally, on June 10, 2024, FDA and DOJ announced the creation of an interagency task force focused on using an all-government approach to combat the illegal distribution and sale of unauthorized e-cigarettes in the U.S.
July 16, 2024
FDA Issues Warning Letters for Delta-8 THC Foods

Credit: FDA
The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat food products containing delta-8 THC and introducing them into the marketplace in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The warning letters were issued to: Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC and Life Leaf Medical CBD Center. The FDA also issued a warning letter independently to the company GrowGod LLC for the same FD&C Act violations.
These warnings are part of the FDA and FTC’s ongoing joint effort to take action against companies selling illegal copycat food products containing delta-8 THC. In June 2023, the two agencies worked together to warn six other companies about selling edible food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.
All six of those companies no longer have such products in stock.
“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus. “As accidental ingestion and/or overconsumption of delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.
“The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”
In June 2022, the FDA warned consumers about children accidentally ingesting food products containing delta-8 THC. From Jan. 1, 2021, to Dec. 31, 2023, the FDA received over 300 adverse event reports involving children and adults who consumed delta-8 THC products.
Nearly half of these reports involved hospitalization or emergency department visits, and approximately two-thirds of these adverse events followed ingestion of delta-8 THC-containing food products such as candy or brownies. Adverse events included, but were not limited to, hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness.
July 16, 2024
Health Groups Contest IQOS Quit-Rate Data

Photo: Arkadiusz Fajer
Anti-tobacco activists are questioning Philip Morris International’s figures on the number of people who have quit smoking using the company’s bestselling heat-not-burn device, IQOS, reports Reuters.
The move comes as the U.S. Food and Drug Administration is considering PMI’s application for renewal of its IQOS3 exposure modification order, along with the company’s premarket tobacco product applications for IQOS Iluma and request for permission to make reduced exposure claims for that product.
In a joint letter to the U.S. Food and Drug Administration, dated June 27, six health groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics and the American Lung Association, cited yet-to-be published independent studies contradicting PMI’s findings about how many IQOS users completely switch to the device from cigarettes.
According to letter writers, the International Tobacco Control Project (ITC) at Canada’s University of Waterloo found a far lower rate of IQOS users had quit smoking in Japan and Korea than estimates from PMI.
PMI estimates more than seven out of 10 of its registered IQOS customers globally have quit cigarettes. A 2023 PMI application to the FDA emphasized that the majority of IQOS users were using IQOS exclusively.
However, the ITC’s researchers put the percentage of all IQOS users that had quit smoking at just 15 percent in Japan and 30 percent in Korea in 2021.
Users most commonly used IQOS and cigarettes simultaneously, often leading to an overall increase in tobacco consumption, the ITC researchers found.
PMI pointed to a 2019 Japanese government health survey, where 75 percent of respondents who reported using heated tobacco said they did not smoke.
However, a paper published this year, led by researchers from Georgetown University, highlighted flaws in the government’s survey, including changes to the question format that can lead to under-reporting of smoking.
Other surveys have also found higher rates of dual use than the government, it said.
In addition to questioning the smoking cessation rates quoted by PMI, the health groups accused the multinational of making deceptive statements wrongly suggesting that the FDA has found IQOS reduced the risk of disease, citing examples of such statements in the U.S., Kazakhstan, the Philippines and Mexico.
A PMI spokesperson told Reuters the language flagged by campaigners was, in the company’s view, compatible with the FDA’s orders.
“Wherever we discuss our science and our products, we do so in accordance with all applicable laws,” the spokesperson was quoted as saying.
July 16, 2024
PMI to Invest Millions in Colorado Zyn Production

Photo: PMI
Philip Morris International will invest $600 million in a factory in Aurora, Colorado, to help meet U.S. consumers’ growing appetite for the company’s Zyn nicotine pouches. The factory is poised to begin operations by the end of 2025 with regular production starting in 2026.
“PMI and its U.S. affiliates are accelerating their mission to move adults who smoke away from cigarettes in the U.S. by investing in new U.S. manufacturing capacity to meet the increasing demand for nicotine options that are scientifically substantiated as better alternatives,” said PMI Americas President and U.S. CEO Stacey Kennedy in a statement.
“We believe Colorado is likeminded in its commitment to innovation, economic opportunity and public health, and we’re eager to work with the state and its talented workforce as we expand our U.S. manufacturing presence.”
Sales of Zyn jumped 80 percent in the first quarter, leaving PMI struggling to keep up with demand. Retail stores have been experiencing Zyn shortages, with some even limiting the number of cans customers can buy each month.
Supply was further constrained after the company decided to halt online sales nationwide in June following a subpoena in the District of Columbia asking for information on the sale of flavored pouch products that are banned there.
PMI is also increasing production of Zyn at its factory in Owensboro, Kentucky. In addition to meeting U.S. demand, the investments will also help create capacity for exports, according to PMI.
Zyn accounted for more than 70 percent of the $8.6 billion nicotine pouch market in 2023, according to sources. Given the relatively young age of the category, there is little brand loyalty, and analysts believe continued supply constraints may prompt some consumers to defect to other brands.
July 16, 2024