R.J. Reynolds Vapor Co. has filed the final pre-market tobacco product application submissions with the U.S. Food and Drug Administration for its Vuse Pro age-gated device. The electronic nicotine delivery system device platform connects to a mobile application that verifies the consumer’s age through a third-party provider.
Once verified, the device will unlock. It uses a unique design to only allow compatible Vuse Pro pods to be used. The technology and mobile application also enable features such as auto-lock and proximity lock to further secure device access.
“Our PMTA submissions to the FDA underscore our commitment to both offering adult tobacco and vapor consumers choices as well as underage access prevention,” said Reynolds Executive Vice President of Scientific Research and Development Tim Nestor in a statement. “We don’t want our products in the hands of youth, period. The Vuse Pro ENDS platform provides a solution that limits access to adult consumers while also offering flavors that appeal to current adult smokers and a unique vapor experience.”
The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.
After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.
“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”
Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.
These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.
Vuse e-cigarettes continue to grab market share from Juul. The gap is growing in both monthly and yearly comparisons, according to the latest Nielsen convenience store report.
The R.J. Reynolds Vapor Co. brand’s market share rose from 41.5 percent in the previous report to 42.7 percent, compared with Juul declining from 26.4 percent to 25.6 percent.
Over the past 12 months, Vuse’s market share was 36.6 percent, compared with 29.5 percent for Juul. The latest Nielsen analysis of convenience-store data covers the four-week period ending Feb. 25.
On Friday, Altria Group Inc. announced that it had exchanged its 35 percent ownership stake in Juul Labs for a non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual properties.
No. 3 NJoy was unchanged at 2.7 percent, while Fontem Ventures’ blu eCigs was unchanged at 1.4 percent. Njoy’s future looks brighter after an announcement Monday that Altria plans to pay $2.75 billion in cash for NJoy.
Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 25.7 percent decline in the latest report.
By comparison, Reynolds’ Vuse was up 34 percent in the latest report, while NJoy was down 8.7 percent, blu eCigs down 39.5 percent and Japan Tobacco’s Logic brand vaping product was down 4.9 percent.
As recently as May 2019, Juul held a 74.6 percent U.S. e-cig market share. Neilson data does not consider vape shop sales, which may include more than 40 percent of all vaping product sales.
The two weeks ended April 9, 2022, was the first time Vuse surpassed Juul to become the No.1 e-cigarette brand in the U.S., according to Nielsen. The company had a market share of 35 percent, driven by the Vuse Alto, which represents more than 90 percent of Vuse’s 2021 revenues in the U.S. Vuse has been narrowing the gap with Juul since Dec. 2021.
Several analysts reported on May 3 that Vuse had barely edged past Juul in the Nielsen analysis of convenience store data that covers the four-week period ending April 23. Vuse was at a 34.8 percent market share, while Juul was at 34.4 percent.
It was the first time Vuse held the top market share in the Nielsen report since November 2017. However, for the past 52 weeks, Juul remains ahead 36.6 percent to 30.5 percent.
By comparison, Juul held a 74.6 percent U.S. e-cig market share as recently as May 2019, which is when a series of regulatory actions led to product-reduction concessions by Juul Labs. In the Neilsen report released May 3, NJoy dropped from 3.2 percent to 3.1 percent, while Fontem Ventures’ blu eCigs was at 2.1 percent, down from 2.3 percent.
Juul overtook Vuse as market leader in 2017. Juul, founded in 2015, captured a 68 percent share of the U.S. vaping market within 3 years while Vuse’s market share had reduced to 10 percent from all-time high of 44.2 percent in 2016, according to a press release from Bluehole New Consumption.
While the Juul and Vuse products differ in many ways, one major difference is that the Juul and Vuse Alto products use diferent coils. Juul products use a traditional cotton coil, while Vuse Alto has adopted a FEELM ceramic coil. In 2018, Vuse entered into partnership with FEELM, the flagship atomization brand for SMOORE and launched Vuse Alto later that year. SMOORE has been instrumental in every approved vaping product (Vuse, Logic and Njoy) brand.
In 2021, Vuse announced its status as the No.1 global vaping brand with a full year value share of 33.5 percent in the top five vapor markets (the U.S, Canada, France, Germany and the UK), according to Bluehole. The five markets represent approximately 75 percent of total industry vapor revenue for closed-system products.
R.J. Reynolds Vapor Co. (RJRV) has petitioned the U.S. Patent and Trademark Office for a review of six claims relating to the basic functionality of e-cigarettes in a patent assigned to Philip Morris Products, reports Law Street Media.
RJRV argues that the patent describes an approach that dates from 1990 and has “become accepted in view of its comparatively easy technical realizability in combination with its convincing functionality.’”
According to the filing, there are disadvantages in the prior technology that the asserted patent claims to fix, such as the increasing contamination of the vaporizing unit throughout its life, a fluid leak, and that due to its design, the e-cigarette’s length cannot be shortened.
RJRV takes issue with the patent’s six claims on the basis that to a person having ordinary skill in the field, it would have been obvious to combine previous inventions to overcome the claimed deficiencies.
RJRV requests the cancellation of the claims as unpatentable.
It’s not the first time that Reynolds and Philip Morris have quarreled about intellectual property. In June 2020, Philip Morris International filed counterclaims against Reynolds for patent infringement in the federal court action that RJR commenced against PMI and Altria, PMI’s IQOS distributor in the U.S., on April 9, 2020 in the Eastern District of Virginia.
British American Tobacco South Africa (BATSA) has opened the first VUSE Inspiration store in South Africa in the Canal Walk shopping center in Cape Town.
VUSE Inspiration stores will be opened at 67 existing sites throughout South Africa.
“To date, we have made an extensive investment in bringing Twisp into BATSA’s portfolio, and we plan to invest further in our tobacco harm reduction strategy in South Africa,” said BATSA General Manager Johnny Moloto in a statement. “We will be expanding our number of kiosks, investing in bringing our new products to market and enhancing the skills of our BAT team.”
Another 15 new sites in key locations will be added to the VUSE network by December as part of a significant expenditure project.
“The opening of our first flagship VUSE Inspiration store in South Africa is an important milestone in delivering on our harm reduction strategy and our investment in science and innovation to demonstrate the potential of our extended portfolio of products,” said Moloto.
The Vuse vapor brand announced today a national expansion in the United States of Vuse Alto Golden Tobacco 5.0 percent and Alto Menthol 5.0 percent four-pod packs and the national release of Vuse Alto Golden Tobacco 2.4 percent and Alto Menthol 2.4 percent four-pod packs.
The four-pod packs provide adult vapor consumers with three Vuse Alto configuration options as they can now choose from single-pod, two-pod or four-pod packs. The national availability of four-pod packs gives Vuse the most expansive portfolio of choice for adult vapor consumers with three flavors, in three nicotine strengths across three configuration formats, as well as the many options for device customization with a range of device colors, wraps and engraving options.
“Done responsibly, our ambition is to make Vuse the No. 1 vapor brand in the U.S. market,” said Christy Canary-Garner, vice president—Vuse commercial development at R.J. Reynolds Vapor Co, in a statement. “This portfolio expansion provides us with the opportunity to better compete and enhances our price competitiveness to drive conversion among existing adult vapor consumers and boost loyalty.
“The four-pod pack configuration is the most popular among competitive pod-mod vapor products and 4-pod packs enable Vuse Alto to compete against competitors on a per-pod price point. The new four-pod packs are available to all retail outlets.
“Coupled with our release of single-pods in November of 2020, this national rollout of four-pod packs now gives adult Vuse consumers more options than any other brand.”
The national expansion of the four-pod packs will begin this week.