Tag: RJ Reynolds Vapor Co.

Jury Awards PMI $10 Million in Vuse Patent Violation Suit

Credit: Aleksandar Radovanov
Philip Morris International was awarded $10.7 million by a jury in Alexandria, Virginia on Wednesday after finding rival R.J. Reynolds Vapor Co’s Vuse e-cigarettes violate its patent rights.
The federal court jury said RJR’s Vuse Solo and Alto devices infringe two Philip Morris patents covering parts of a vaping device for heating substances and preventing leaks. The case is part of multi-front patent dispute between Philip Morris and RJR parent company BAT.
A spokesperson for Winston-Salem, N.C.-based RJR said the company was disappointed by the infringement findings and said it may appeal, but was pleased that the jury cleared its Vuse Alto of infringing one of the patents, according to Reuters.
A Philip Morris spokesperson said the company was “grateful” for the verdict, which “rejects an attempt by BAT to free-ride on our hard work and investment.”
RJR’s Vuse line is one of the two top-selling e-cigarette brands in the United States, along with Juul. The Tuesday verdict concerned counterclaims in RJR’s ongoing patent lawsuit over Philip Morris’ IQOS heated-tobacco device, which is on hold.
June 16, 2022
New U.K. Study on Public Health Effects of Vuse

The “real world” public-health effects of BAT’s Vuse e-cigarette is the subject of a new study.
The study is “designed to assess and provide insights” into the growing role of the e-cigarette brand. Vuse has been market momentum in since some of its branded products received marketing approval from the U.S Food and Drug Administration.
The study involves a cross-sectional confinement study of exclusive Vuse users in the United Kingdom over at least a six-month period, according to a press release.
“This innovative study demonstrates our commitment to researching the reduced-risk potential of our New Category products. What makes it particularly relevant and exciting is that the results generated will be from people who have been using Vuse as they normally would for more than six months prior to testing,” Sharon Goodall, BAT’s Group Head of Regulatory Sciences, said. “The results will provide important new insights and show us the differences between Vuse users, smokers and former smokers across a range of important biomarkers thought to be predictive of disease development. We look forward to sharing the data once available.”
Also participating were current or former smokers of traditional cigarettes and people who have never smoked. Former smokers would have had to quit for at least six months to qualify. Study participants were between 19 and 55 years old, and in good general health.
“It is hoped that the results, which are currently being analyzed and will be published later this year, will provide further supportive evidence that using Vuse can reduce relative risk for certain diseases among adult consumers compared to smoking,” BAT said in a news release.
Unlike longitudinal studies where participants attend multiple clinic visits over an extended period of time, participants in this study made a single clinic visit where samples of blood, urine and other measurements were collected. These samples were then tested for “biomarkers of exposure” (to selected cigarette smoke toxicants) and “biomarkers of potential harm”. Differences between the groups were assessed, rather than changes from baseline.
In addition, to ensure compliance, the Vuse and former smoker groups were tested for the biomarker, CEVal, which indicates if they have recently smoked cigarettes.
Results from the completed study will be published in due course.
June 7, 2022
FDA Hands Court PMTA Status Report for Market Leaders
The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year. However, the agency does not expect to complete its review of timely submitted applications until June, 2023.
“The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse).”
During a House subcommittee meeting after the release of the report, the head of the FDA said the agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry.
“This is an industry that has amazing capabilities on the legal front,” FDA Commissioner Robert Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.
The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that its best forecast, based on current information, the FDA will take action on:

51% of covered applications by June 30, 2022;

52% of covered applications by September 30, 2022;

56% of covered applications by December 31, 2022;

56% of covered applications by March 31, 2023; and

100% of covered applications by June 30, 2023.
The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.
The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of August 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of August 8, 2016. The FDA has not included information about these five applications in the current status report.
“Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product, with one application. Other e- cigarette devices, by contrast, consist of many components, with separate tanks, coils, tubes, and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”
The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.
This story will be updated throughout the day.
May 16, 2022
Vuse Vibe, Ciro Issued U.S. Marketing Orders by FDA
The U.S. Food and Drug Administration today issued decisions on several R.J. Reynolds Vapor Company for several Vuse branded e-cigarette products, including the authorization of six new tobacco products through the premarket tobacco product application (PMTA) pathway. It’s the second and third Vuse branded device to garner an marketing approval. The company’s top selling Alto device is still under PMTA review.
The FDA issued marketing granted orders (MGO) to for the Vuse Vibe and Vuse Ciro e-cigarette devices and accompanying tobacco-flavored closed e-liquid pods. For each device, two versions of the power units were authorized to reflect different battery manufacturers described in the company’s applications. In total, the products receiving MGOs include:

2 Vuse Vibe Power Units

Vuse Vibe Tank Original 3.0%

2 Vuse Ciro Power Units

Vuse Ciro Cartridge Original 1.5%
The authorization allows the products to be legally marketed in the U.S. The FDA also issued marketing denial orders to R.J. Reynolds Vapor Company for multiple other Vuse Vibe and Vuse Ciro e-cigarette products, presumably for flavors other than tobacco. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
Neither the Vibe or Ciro device is popular with vapor consumers. Many consider the products old and outdated technically, unlike Njoy’s Ace device that was granted marketing orders in April. This marks the fourth and fifth vaping product brands (Vuse has 3 seperate products under the Vuse name) to receive an MGO from the FDA. In October 2021, the FDA issued its first marketing granted orders to Vuse Solo. In late March, the agency approved several Logic products for sale in the U.S.
Vuse Vibe / Photo: RJR Vapor

“Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
“The authorized Vuse products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke,” the FDA explained. “Further, data provided by the applicant demonstrated that participants who had used only the authorized Vuse Vibe and Vuse Ciro products had lower levels of exposure to non-nicotine HPHCs compared to the dual users of the new products and combusted cigarettes.
“Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”
The FDA said it considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, especially youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth – provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
The authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products, according to the agency. “The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products,” it wrote.
Credit: RJRVC
The FDA may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
Before making marketing decision documents available to the public, the FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the MGO webpage until after the order issuance date, according to the agency.
In the interim, to provide as much information as possible at the time of order issuance, the FDA is making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.
The agency is also expected to give status reports on the remaining PMTAs that have a more than 2 percent market share according to Nielsen.
May 12, 2022
Vapor Product C-Store Sales Up More Than 12 Percent
E-cigarette sales continue to recover from a Covid-19 slump. Sales in C-stores are up 12.7 percent after rising 2.9 percent in the previous data release, according to the latest Nielsen convenience store report released last week. Nielsen does not track vape shop data.
Credit: William Thompson
Sales overall had slumped since February 2020, when the U.S. Food and Drug Administration implemented its latest round of heightened regulations on the products, according to the Winston-Salem Journal. Overall e-cigarette sales-volume growth has declined steadily since Nielsen’s Aug. 10, 2019, report, when it was up 60.2 percent year over year.
On Feb. 6, 2020, the FDA, among other things, required manufacturers of cartridge-based e-cigarettes, such as Juul Labs, R.J. Reynolds Vapor Co., NJoy and Fontem Ventures, to stop making, distributing and selling “unauthorized flavorings” by Feb. 6, or risk enforcement actions.
Top-selling Juul’s four-week dollar sales have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 5% uptick in the latest report. By comparison, Reynolds’ Vuse was up 82.2 percent in the latest report and NJoy down 22.3 percent.
Juul’s market share dropped from 52.1percent in the previous report to 51.3 percent. It was at 53.3 percent a year ago. Vuse’s market share climbed from 29.2 percent to 30.6 percent, while No. 3 NJoy slipped from 5 percent to 4.9 percent, and Fontem Ventures’ blu eCigs slipped from 3.5 percent to 3.4 percent.
February 8, 2021