Tag: Fontem

FDA Denies Blu Marketing of 5 Flavored Products
Credit: Fontem US
The U.S. Food and Drug Administration continued its de-facto flavor ban and issued marketing denial orders (MDOs) to Fontem US LLC for four Blu disposables and one Myblu brand e-cigarette product.
The currently marketed products that received an MDO are:

Blu Disposable Menthol 2.4%
Blu Disposable Vanilla 2.4%
Blu Disposable Polar Mint 2.4%
Blu Disposable Cherry 2.4%
Myblu Menthol 1.2%
After reviewing the company’s premarket tobacco product applications (PMTAs), the regulatory agency 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, according to a press note.
“The application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products,” the release states. “Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.”
While the FDA has approved 23 vaping products, none have been a flavored product. Last month, the agency also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products. Fontem is expected to appeal the FDA decision.
February 5, 2024
FDA Denies Marketing of Suorin, Blu Plus+ Products
The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products. It also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products.
“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”
The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs, according to an agency press release.
The FDA denied Suorin Air refillable vaporizers in various colors and an empty refillable cartridge. The FDA stated that Suorin Air’s empty cartridges would allow consumers to fill the cartridge with an e-liquid purchased separately.
“The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence,” the release states.
SMOK recently had 22 products denied, including devices, pods, atomizers, and cartridges. It was the first time the agency has denied strictly hardware products from one company en mass. The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA.
The denied Blu PLUS+ products include a battery and several prefilled e-liquid pods:

blu PLUS+ Battery
blu PLUS+ Carolina Bold 2.0%
blu PLUS+ Classic Tobacco 1.2%
blu PLUS+ Classic Tobacco 2.4%
blu PLUS+ Gold Leaf 1.2%
blu PLUS+ Gold Leaf 2.4%
blu PLUS+ Menthol 1.2%
blu PLUS+ Menthol 2.4%
“Among other deficiencies in their applications, Fontem US, LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information.,” the FDA stated. “In addition, the applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.
The FDA also issued MDOs for additional blu PLUS+ products not listed above. The regulatory only publicly names products that the FDA or the manufacturer has confirmed to be currently marketed to avoid the release of confidential commercial information.
January 19, 2024
Another Appeals Court Accuses FDA of ‘Switcheroo’

The U.S. Court of Appeals for the D.C. Circuit yesterday found that the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications.
The court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent, but rejected the FDA’s denial of Fontem’s applications for unflavored products.
This is the second circuit court of appeals to accuse the FDA of a “surprise switcheroo” when reviewing vaping product applications.
Fontem, the company behind the Blu and myBlu vaping brands, argued that the FDA had not conducted the proper analysis prior to rejecting their applications. The D.C. Circuit Court agreed with Fontem in regards to their unflavored products, ruling that the FDA had “neglected to conduct the overall public health review specified by law.”
Judge Rao’s opinion for the court (joined by Judge Walker and Senior Judge Ginsburg), stated that with respect to Fontem’s unflavored products, the FDA also denied Fontem’s applications on the public health ground.
“While the FDA identified multiple ‘deficiencies,’ it failed to analyze the tradeoffs necessary to make a public health finding. Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health,” the opinion states. “The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”
In denying Fontem’s unflavored products, the FDA relies solely on the public health ground. The FDA could have promulgated regulations imposing consistent requirements on the composition and manufacturing of tobacco products, according to the order.
“Had the agency done so, Fontem’s failure to meet those standards would be an independent and sufficient ground for denying the applications, regardless of the overall public health consequences of Fontem’s products,” the order states. “But the agency has not exercised its regulatory authority. Because the FDA has chosen to proceed application by application under the public health ground, it must undertake the holistic inquiry required by the statute.”
Instead of making an overall assessment that Fontem had not shown its products were beneficial to the public, the agency identified five highly technical deficiencies, according to the order. But nothing in the denial order explains how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.
The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the order. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.
“Cf. 21 U.S.C. § 387j(c)(3) (providing an application denial “be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form”),” the order states. “But in several instances, the FDA changed its tune in the denial order, reproaching Fontem for failing to provide information the agency had never explicitly sought.
“Shifting the regulatory goalposts without explanation is arbitrary and capricious. By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”
August 30, 2023
U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.
The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.
“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).
“After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”
The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.
In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.
July 10, 2023
Juul’s Market Share Still Falling, Vuse Continues Growth

Credit: Golib Tolibov
The top-selling Vuse electronic cigarette of R.J. Reynolds Vapor Co. continued to expand the market-share gap with Juul in both monthly and yearly comparisons.
Vuse’s market share rose from 40.7 percent in the previous report to 41.1 percent, compared with Juul declining from 27 percent to 26.7 percent. For 2022 overall, Vuse’s market share was 35.7 percent, compared with 30.1 percent for Juul.
No. 3 NJoy slipped from 2.8 percent to 2.7 percent, while Fontem Ventures’ blu eCigs was unchanged at 1.4 percent.
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 23.7 percent decline in the latest report, according to media reports.
By comparison, Reynolds’ Vuse was up 32.7 percent in the latest report, while NJoy was up 0.1 percent, blu eCigs down 33.4 percent and Japan Tobacco’s Logic down 15.1 percent.
As recently as May 2019, Juul held a 74.6 percent U.S. e-cig market share.
On Sept. 30, Altria Group Inc. cleared the way to re-enter the e-cigarette marketplace after choosing to permanently end its non-compete agreement with Juul Labs.
January 12, 2023
Court Denies Stay of Fontem’s Marketing Denial Order
Fontem US had its request for an emergency motion for a stay of its marketing denial order (MDO) denied by the United States Court of Appeals for the District of Columbia. The court denied the stay mainly because Fontem waited too long to file the motion. The denial was filed July12.
Fontem Ventures, a subsidiary of Imperial Brands PLC and parent to Fontem US, owns the global e-cigarette brand blu. The ruling means that legally, Fontem should have to pull its Myblu products from store shelves that received MDOs from the FDA while the appeal of its MDO goes through the legal process.
“Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote. “That delay also suggests it may have been practicable to seek a stay from the agency.”
The court stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO issued by the U.S. Food and Drug Administration on merits, noting that as to the multiple bases for the MDO identified by the FDA, the agency likely afforded Fontem fair notice.
“Fontem US, LLC has not satisfied the stringent requirements for a stay pending court review,” the court wrote.
The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US.
“On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.
Fontem’s appeal is expected to move forward and the court is requiring the case to be expedited
and the following briefing schedule is to apply:

Petitioner’s Brief August 10, 2022

Respondent’s Brief September 9, 2022

Petitioner’s Reply Brief September 30, 2022

Deferred Appendix October 7, 2022

Final Briefs October 14, 2022
“The Clerk is directed to calendar this case for oral argument on the first appropriate date following completion of briefing. The parties will be informed later of the date of oral argument and the composition of the merits panel,” the court wrote.
July 25, 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
Fontem US Receives Marketing Denial Orders for Myblu
The FDA has issued marketing denial orders (MDOs) to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US.
“On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.
Credit: blu
The currently marketed products receiving MDOs include:

myblu Device Kit

myblu Intense Tobacco Chill 2.5%

myblu Intense Tobacco Chill 4.0%

myblu Intense Tobacco 2.4%

myblu Intense Tobacco 3.6%

myblu Gold Leaf 1.2%

myblu Gold Leaf 2.4%
Based on the information provided in the applications submitted by Fontem US, for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the agency. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.
Generally, the submission of a premarket application and intent to commercially market a new tobacco product that has never been marketed would be considered confidential commercial information (CCI) that the FDA would not disclose, according to the FDA. However, the agency determined that the named products are currently marketed based on communication with the applicant during the development of the publicly available Deemed New Tobacco Product Application List, and therefore the applicant has acknowledged the submission of these premarket applications.
“FDA is issuing MDOs for additional myblu products that do not appear on the publicly available list,” the agency stated. “FDA has publicly named only products that the FDA or the manufacturer have confirmed to be currently marketed to avoid potential CCI issues.”
April 8, 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
Fontem U.S. Submits PMTAs for Myblu

Imperial Brands subsidiary Fontem US has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its Myblu electronic vapor products.
Fontem US’s Blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products. The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.
Fontem US believes the evidence provided shows that Blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA.
“We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem US.
“Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”
April 29, 2020