Tag: Myblu

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
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
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
Imperial Opinion: New Zealand Vapor Sales

Credit: Dan Freeman
Dr Grant O’Connell, Strategic Science and Policy Engagement Director, Imperial Brands, explains why Imperial Brands decided to sell vaping products in New Zealand ahead of new legislation designed to legalize the next generation of nicotine products in an opinion piece with Scoop, a New Zealand independent news outlet.
For the past five years, New Zealand smokers have been embracing the new generation of less harmful alternatives such as e-cigarettes. The number of adult smokers vaping in New Zealand is growing along with new devices, flavours and nicotine levels that suit the very individual habits of smokers.
These dramatic shifts in smoker behaviour, and the maturing of the vape category itself, occurred at a time of great uncertainty. No one knew the legal status of these products. The Government now accepts the scientific consensus that vaping is significantly less harmful than smoking, so getting more smokers to transition is a desirable public health goal. This mature policy objective has been praised by public health experts here and overseas.
That should not be surprising, as public health experts have accepted the “harm reduction” approach to diseases and addictions for some decades now. Harm reduction involves a range of pragmatic policies, regulations and actions that either reduce health risks by providing safer forms of products or substances or encourage less risky behaviours.
It was initially developed for adults with substance abuse problems where abstinence was not practically achievable. It has successfully reduced teen pregnancies, sexually transmitted diseases, and risky alcohol use. Harm reduction strategies have reduced morbidity and mortality.
Harm reduction is at the heart of the Government’s planned legislation on vaping. The aim is to utilise the appeal and accessibility of vape products to transition adult smokers. The only practical challenge is that vaping products need to be sold publicly, like many other “R18” things. That creates a small challenge to prevent vaping being used regularly by youth and those who never have smoked or are unlikely to smoke.
This is the challenge being wrestled with by the Health Select Committee looking at the Bill. They are weighing the evidence and personal testimony of hundreds of vapers, retailers, manufacturers and public health experts. It is exactly the same challenge we faced when we decided to launch our global vaping brand myblu in New Zealand.
Without legislation and regulations to guide us, we had to consider advantages to public health, practicalities of availability and restrictions on sale, and consumer safety parameters. We deliberated what the product should look like, where it should be available, and how it should be advertised or promoted in store. And importantly, who it shouldn’t be available to.
Underpinning all of these discussions and the decisions we made, was that we would apply our global best practice in lieu of any regulatory framework. The approach we’ve taken achieves the regulatory balance the Select Committee is looking for.
Our vaping products are as available for smokers to purchase as our combustible ones. Myblu is available for sale at our network of dairies and convenience stores throughout New Zealand and we do this because familiarity of the retail store and convenience for access are necessary for adult smokers to transition.
Store managers are equipped with information so they can talk to smokers, to help them understand the reduced risk potential with vaping and how to begin their transition. We offer a small but varied range of flavours and strengths and our products are clearly labelled in English and Maori with warning messages describing the addictiveness of nicotine.
Like many in the industry, we self-imposed an R18 age restriction on all sales of myblu. Marketing and advertising do not target youth or seek to glamorise vaping. Every message communicated describes the relative health, price and physical appearance advantages of vaping compared with smoking.
Our team of over 300 scientists, engineers and innovators work to ensure myblu’s vaping products are made to the highest safety and quality standards and are supported by the best-in-class science. Myblu is a closed pod, ‘tamper proof’ system. We purposely chose a closed pod system to restrict opportunities for people to misuse or mix illicit ingredients into the liquids.
We use pharmaceutical grade nicotine, propylene glycol and glycerol and high-quality flavour ingredients in our e-liquids. All of our blu vaping products, their ingredients and the vapour produced undergo thorough scientific assessment prior to manufacture and sale.
The work that has gone into consumer safety and product design is necessary to guarantee the quality of myblu and for smokers to have confidence in our product. We have learnt much in the past 10 months in New Zealand. We know that convenient access, reliable information and confidence in the quality and satisfaction of vape products are the critical success factors for smokers to quit smoking.
Our approach to selling and marketing myblu is based on the principles of having restrictions in proportion to the risk posed by the product relative to cigarettes. It is our hope that this experience, and indeed that of many vape manufacturers and retailers, guides the Committee’s thinking for a harm reduction framework in regulation that makes vaping a more appealing option for smokers.
Dr Grant O’Connell, Strategic Science & Policy Engagement Director, Imperial Brands.
May 14, 2020
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