Tag: FDA

  • Status Report Confirms FDA Time Changes to PMTAs

    Status Report Confirms FDA Time Changes to PMTAs

    Credit: Fizkes

    The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.

    In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs as follows:

    • 52 percent of Covered Applications by March 31, 2023
    • 53 percent of Covered Applications by June 30, 2023
    • 55 percent of Covered Applications by Sept. 30, 2023
    • 100 percent of Covered Applications by Dec. 31, 2023

    The FDA is expected to give its next status update to the court on April 24.

    The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    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.

    The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.

    The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.

    Credit: JHVEPhoto
  • Surfing while Juggling

    Surfing while Juggling

    Five types of innovation

    By Clive Bates

    Where does innovation in the tobacco and nicotine field come from? Is it the far-sighted senior executive assessing the needs of the evolving market and committing R&D budgets to realize the corporate vision? Or is it the genius scientists and engineers toiling 24/7 in the labs to invent the wonder product that will become The Next Big Thing?

    Both are caricatures, of course, but neither explains how innovation really works.

    In his brilliant book, How Innovation Works, author Matt Ridley points out that “Innovation is not an individual phenomenon but a collective, incremental and messy network phenomenon.” For those involved, I would say it is more like surfing while juggling than a straightforward path from idea to implementation. To see why, let’s look at five types of innovation in the tobacco and nicotine market.

    First, disruptive innovation. The most prominent recent case of disruptive innovation in the tobacco and nicotine field is the rise of electrical heating as an alternative to tobacco combustion to create an inhalable nicotine-bearing aerosol. Though the Chinese inventor Hon Lik is usually credited with inventing the e-cigarette, the truly disruptive innovation came before and from outside the tobacco and nicotine industry. It is what makes the e-cigarette and modern heated-tobacco products possible. The critical disruptive innovation was the lithium-ion battery. By the 2000s, battery technology had steadily progressed to achieve a sufficiently high power and energy density, allowing rapid heating and an adequately long life between recharges within a compact form factor. Developments in battery technology were driven by the demands of the giant and ultra-competitive markets for mobile devices like smartphones and tablets.

    For decades, the intense heat, complex reactions and chemical cocktail generated by the combustion of tobacco leaf at 900 degrees Celsius in the burning coal of a cigarette were unmatched and unmatchable as a means of delivering nicotine to the lungs. The combination of electrically heated coil and e-liquid to generate an aerosol is now competitive. The disruption of the dominance of the cigarette, currently underway and likely to last two decades to three decades, is driven by a fundamental energy transition that degrades the advantage of combustion.

    I refer to the second type as system innovation. This is the consequential economic, regulatory and public health reaction to the initial disruption and may involve hundreds of innovative responses. For example, the emergence of e-cigarettes triggered a creative response in the Stop Smoking Service in the city of Leicester, U.K. Under the leadership of its manager, Louise Ross, the service changed its practice to embrace vaping as a low-risk alternative to smoking that could appeal to many smokers who had previously been beyond the service’s reach. Through the power of example, that experience led to further innovation at the National Centre for Smoking Cessation and Training and with the government’s support to guidance on e-cigarettes issued by the National Health Service.

    But this innovation did not happen linearly, driven only by personal inspiration. It is best seen as “emergent,” arising from a wide range of concurrent changes and influences triggered within the public health ecosystem. The disruptive innovation also led to system innovations in regulation, such as the 2014 European Union Tobacco Products Directive. In 2016, the U.S. Food and Drug Administration’s deeming rule brought vaping products into the definition of tobacco products and under the jurisdiction of the Tobacco Control Act. The initial disruptive innovation also led to innovation in the business models of tobacco companies, but also in the tactics of their traditional adversaries. Tobacco companies started moving their business toward a future in noncombustible nicotine products, and the anti-tobacco groups shifted their focus from preventing disease to fighting nicotine addiction.

    For tobacco and nicotine companies, the disruptive innovation and the system responses it triggers are like a “big wave,” both prized and feared by top surfers. Like a wave, the companies didn’t create it and can’t control it, but their challenge is to catch it, ride it well and not wipe out. The case of Kodak and its destruction under the breaking wave of digital photography is probably the most cited case of an innovation wipeout. But it doesn’t have to be a technology shift. In the 1970s, deregulation in the aviation sector enabled the emergence of the innovative low-cost airline business model. It wasn’t long before major airline incumbents were going under as that big wave gathered pace.

    The disruptive and systems innovations generate a changing paradigm: a big wave of opportunity or destruction that businesses must learn to surf. But why does innovation feel like juggling while surfing? The juggling reflects the frenetic activity of keeping a company moving, in financial balance and ahead of its rivals while it navigates a radically changing context. This brings us to three further types of innovation: the innovation occurring within the changing paradigm.

    So, the third type of innovation is evolutionary. It resembles the Darwinist process of evolution in nature. Here, the consumer provides what evolutionary biologists call selection pressure, and innovation emerges from incremental improvement through trial and error, mirroring what biologists recognize as mutation and natural selection. It will usually be incremental, but its impact will not always be gradual. Evolutionary innovation can make radical inroads into a market by solving a particular problem or exploiting an opportunity.

    A good example is pod-based vaping products using nicotine salts. Salts change how nicotine is absorbed in the airways and allow users to consume smaller volumes of higher strength liquids. The effect of the salts is to allow high-strength nicotine liquids to be used without undue harshness with a smaller battery and tank, enabling a compact and convenient device. This addressed the challenge of providing a convenient and discreet product with effective nicotine delivery. It was wildly successful—at least where regulators allowed it.

    I have seen much handwringing about the recent rise of disposable vaping products. But this is another case of evolutionary innovation. The disposables solve the problem of finding a quick and convenient way into vaping for smokers in the early or tentative stages of switching away from smoking. They are simple to use, low cost and convenient. They don’t require an upfront investment in a device, so they lower the cost of consumer trial and experimentation. Like many innovations, these products have downsides, such as the waste generated. But this is manageable and must be set against the potential benefits and in context with other waste material flows.

    The fourth type of innovation is adaptive. This is a variation of evolutionary innovation, but it arises in response to regulation. Ultimately, it is driven by meeting consumer preferences, but it is triggered by regulatory interventions that would otherwise compromise the consumer experience—ether by design or as an unintended consequence. One example is the mentholation cards that emerged after the European Union ban on menthol-flavored cigarettes. These are inserted into cigarette packs to infuse nonmenthol cigarettes with menthol flavor. Another case is the “shortfill” e-liquid containers that became popular as a workaround to overcome the European Union ban on e-liquid containers of more than 10 mL volume. Much larger containers of nicotine-free vaping liquid are sold only partially filled, allowing the nicotine to be added later—often from nicotine liquids stronger than permitted in the EU.

    As the FDA imposed ever more burdensome regulation on nicotine vapes, small companies introduced synthetic nicotine products because the law confined FDA jurisdiction to nicotine derived from tobacco. This example also illustrates the arms race fought between adaptive innovators and responsive regulators. By March 2022, the FDA had prompted Congress to amend the Tobacco Control Act to apply to nicotine derived from any source, not just tobacco. Adaptive innovations can come with novel risks. For example, regulated bans on flavored e-liquids may lead to consumers adding food or aromatherapy flavoring agents not necessarily intended for vaping.

    The fifth type of innovation is user-driven. The early vaping enthusiasts were hybrid producer-consumers, interacting on user forums with a strong problem-solving ethos and a hands-on approach to product design and construction. Users created innovations like “squonkers” or “squonk mods” to facilitate dripping, a niche style of vaping, by incorporating a flexible liquid bottle into the design of the vaping device. But the most impressive innovations from the user side have been social and community in nature. The vaping forums and vape meets created an elaborate technical and moral support infrastructure. This online community blossomed into vape shops as centers of expertise, personalization and encouragement. The vape shops are now de facto cutting-edge stop-smoking services but with a very different offer to the more clinical settings of traditional services. Even the biggest corporate beasts benefit and learn from user innovation. They should take care not to crush it.

    Innovation is a fluid and dynamic business phenomenon with many simultaneously moving parts embedded in an unpredictably evolving, threatening or promising context. Surfing while juggling is hard and risky, but it is no longer a choice in the tobacco and nicotine business.

  • Kaival’s Fiscal 2022 Hit by Marketing Denial Order

    Kaival’s Fiscal 2022 Hit by Marketing Denial Order

    Photo: Kaival Brands

    Kaival Brands Innovations Group reported revenues of $3 million for the fourth quarter that ended Oct. 31, 2022, compared with revenues of $100,000 million for the prior fourth fiscal quarter. Revenues for the full fiscal year were approximately $12.8 million, down from $58.8 million for fiscal year 2021.

    Kaival attributed the full-year decrease to the U.S. Food and Drug Administration’s marketing denial orders (later overturned), which temporarily prevented the company from selling its products, and to increased competition in general, which Kaival suspects resulted from lax enforcement by federal and state authorities against subpart and low-priced vaping products that continued to enter the market illegally without FDA authorization.

    “Fiscal 2022 was an exceptionally challenging year for us, primarily due to regulatory action by the FDA that was ultimately overturned in August,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

    “For a portion of fiscal 2022, we were prohibited from selling our flavored Bidi Sticks, and our 2022 revenues reflect the significant extended impact of this. The good news is that this impediment is behind us. Moreover, despite the challenges, we accomplished several important milestones during the year which we believe has laid the foundation for renewed growth and progress in 2023, including expanding existing sales channel relationships and initiating significant new ones. We expect and hope that the FDA will continue to pull bad actors from the marketplace, paving the way for companies like ours to provide our products to adult smokers deserving of premium e-cigarette product and experience.”

  • FDA Says PMTA Reviews to Take Until End of Year

    FDA Says PMTA Reviews to Take Until End of Year

    Credit: F Armstrong Photo

    In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.

    Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.

    “On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”

    Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.

    “While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.

  • U.S. FDA to Seek Congress’ Help in CBD Regulations

    U.S. FDA to Seek Congress’ Help in CBD Regulations

    • “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”

    The U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks, according to a press release.

    The FDA is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

    “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the release states. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”

    FDA Principal Deputy Commissioner Janet Woodcock stated that a working group she chaired on the subject of CBD regulations closely examined studies related to the CBD-based drug Epidiolex, published scientific literatureinformation submitted to a public docket, as well as studies both conducted and commissioned by the agency.

    “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she stated. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.

    “CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”

    Woodcock said the FDA will continue to take action against CBD and other cannabis-derived products to “protect the public, in coordination with state regulatory partners,” when appropriate.

    The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.

    The FDA has said it is planning to release CBD guidance this year.

  • FDA Denies Marketing of 2 Vuse Menthol Products

    FDA Denies Marketing of 2 Vuse Menthol Products

    Unsurprisingly, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.

    In a release today, the regulatory agency said that the products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now banned from marketing or distributing these products in the U.S. or they risk FDA enforcement action.

    The company may resubmit applications or submit new applications to address the deficiencies of the products that are subject to these MDOs. The company may also file a lawsuit against the agency’s denial.

    “Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products, wrote. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”

    The FDA isn’t expected to approve any flavored vaping products in the near future.

    Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and CTP King, reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.

    The Vuse products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory. 

    “Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

  • FDA Issues Final Guidance on Clinical Cannabis Research

    FDA Issues Final Guidance on Clinical Cannabis Research

    Credit: Nocturnal

    The U.S. Food and Drug Administration today issued the final guidance on clinical cannabis research. The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” guidance provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds, according to a press release. 

    FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.

    The final guidance also:  

    • Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems. 
    • Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug. 
    • Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds. 

    “It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”

    Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.

  • U.S. House Oversight Committee to Grill FDA on CBD

    U.S. House Oversight Committee to Grill FDA on CBD

    Credit: Dogora Sun

    The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.

    The FDA has said it is planning to release CBD guidance this year.

    Rep. James Comer, chair of the Oversight Committee, said during an interview with the U.S. Hemp Roundtable advocacy group that his panel wants to ask Califf about the FDA’s “lack of action” on issues including hemp-derived CBD that fall under the agency’s regulatory jurisdiction, according to MJBiz Daily.

    “I want to bring the FDA commissioner in front of the committee, and this is one of the things that we want to talk about,” Comer, a Republican from Kentucky, told the U.S. Hemp Roundtable.

    “It’s not just their lack of action with respect to CBD and other types of hemp – it’s their inaction regarding a lot of areas of their jurisdiction.”

    Comer said he believes the FDA’s focus on Covid-19 and vaccines might have prevented the agency from addressing other issues.

    According to Hemp Today, the FDA has focused on enforcement rather than clarifying what the rules are.

    In March, for example, the FDA and Federal Trade Commission sent letters to several CBD companies warning them about making health claims related to Covid-19.

  • AVM to Hold Public Forum With CTP Director King

    AVM to Hold Public Forum With CTP Director King

    Brian King / Credit: FDA

    The U.S. Food and Drug Administration’s Center for Tobacco Products Director Brian King will participate in an open discussion with the vaping industry in late February.

    The virtual event will be moderated by American Vapor Manufacturers Association (AVM) legislative director Gregory Conley and newly-named AVM vice president Allison Boughner.

    “The Future of Vaping in the US: A Conversation with FDA’s Dr. Brian King” will be held on Feb. 24 at 1:00 p.m. EST, and is open to the public. Participants must register in advance, and AVM has provided an opportunity to submit questions for King.

    King has been quiet since memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that he reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. 

  • Fifth Circuit Grants Triton Rehearing Before Full Court

    Fifth Circuit Grants Triton Rehearing Before Full Court

    Fifth Circuit Court of Appeals

    The U.S. Court of Appeals for the Fifth Circuit granted Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s, request for the full court to re-hear Triton’s appeal of its marketing denial order (MDO), according to a court order handed down today.

    Triton lost before a three-judge panel in July, but attorneys for Triton then filed a petition for a rehearing en banc by the entirety of the Fifth Circuit.

    Most circuit court appeals are decided by a three-judge panel, however, the special circumstances surrounding the U.S. Food and Drug Administration’s denial of Triton’s premarket tobacco product applications (PMTAs) motivated the court to allow a majority of the active judges (an estimated 17 judges) to vote to rehear the case “en banc.”

    The FDA rejected applications to market 55,000 flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

    A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.

    The court then denied Triton’s request for review of the agency’s MDOs in a 2-1 decision.

    The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. U.S. Food & Drug Administration in May.