Category: Regulation

  • China: E-Cig Licensing Rules Explained

    China: E-Cig Licensing Rules Explained

    Photo: Taco Tuinstra

    The law firm Kelller & Heckman has published an article summarizing the requirements for obtaining an e-cigarette manufacturing license in China.

    The State Tobacco Monopoly Administration (STMA) has now published a rule outlining the process for Chinese e-cigarette manufacturers to obtain the required manufacturer license. This rule applies not only to manufacturers producing e-cigarettes for the domestic Chinese market, but also to the manufacturing of e-cigarettes solely for export.

    According to Keller & Heckman, manufacturers will have to prepare many materials for their license application. Among other information, they will have to provide proof of suitable funds, production and sales information, including the balance sheet, income statement, cash flow statement and production and sales statistics.

    E-liquid manufacturers will have to supply a license for operating dangerous chemicals and identify the sources of nicotine used in the past three years. Applicants for export must submit materials explaining the export business and the scale of export, including the customs declaration forms for the past three years

    Remarkably, the rules require companies manufacturing exclusively for export to obtain trademark registration in China. Although Keller and Heckman considers it unlikely that the STMA intended to impose the Chinese trademark registration requirement on exporters, the law firm advises clients to seek clarification from the authorities.

  • Los Angeles Bans Sale of Flavored Tobacco

    Los Angeles Bans Sale of Flavored Tobacco

    Photo: imagecatalog | Adobe Stock

    The Los Angeles City Council voted unanimously to end the sale of nontobacco-flavored tobacco products—including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    The council’s action will make Los Angeles the largest city in the country to end the sale of flavored tobacco products, according to the Campaign for Tobacco-Free Kids (CTFK). Los Angeles joins over 120 California communities that have taken similar action.

    The legislation will now move to Mayor Eric Garcetti, who is expected to sign it, according to Filter. If passed, the ban would go into effect in January 2023.

    Mitch O’Farrell, the councilmember who introduced the legislation, tweeted after the vote went through, “We just took a huge step forward against Big Tobacco’s deadly agenda in Los Angeles. This morning, I led the City Council’s unanimous approval of a prohibition on the sale of flavored tobacco to everyone 21 and younger in LA, making us the largest city in California and the nation to take this kind of action against these products.”

    The ban applies to people of any age, however, not just those 21 and younger.  

    The ordinance also applies to zero-nicotine vapor products, but it does not, however, apply to hookah. “Normally, proponents and supporters of flavor bans will object heavily to … exemptions for hookah tobacco and lounges,” said Stefan Didak, a California-based vape advocate. “More often than not, an attempt at passing a ban fails because they withdraw their support.”

    “However, several of the major groups—including Annie Tegen, the vice president of state advocacy for CTFK—praised the council ahead of their vote on the amendments and congratulated them on doing the right thing,” Didak said. “Not a single word of dismay about the exemption for hookah lounges. I thought that was very much out of character.”

    Hookah lounge owners and retailers protested the ban, stating that it would eliminate a cultural tradition. It’s also speculated that the CTFK may have overlooked the exception of hookah in order to gain what they see as a big win with the LA ban, especially after years of back and forth trying to pass said ban.

  • Mexico Outlaws E-Cigarettes

    Mexico Outlaws E-Cigarettes

    Photo: niroworld

    Mexican President Andrés Manuel López Obrador signed a decree on May 31 outlawing the sale of e-cigarettes, reports AP.

    Assistant Health Secretary Hugo López Gatell lashed out at industry claims that vaping is safer than smoking, calling it “a big lie.”

    Mexico has aggressively legislated against vapor products. Imports of vaping devices have been prohibited since at least October. Before that, legislators used consumer protection and other laws to discourage sales.

    Despite the most recent decree, many Mexicans import or buy vaping cartridges or fluid illicitly.

    At least 5 million Mexicans have tried vaping at least once, according to government figures.

  • A New Sheriff in Town

    A New Sheriff in Town

    Photo: Taco Tuinstra

    China’s tobacco monopoly asserts its authority over vapor products.

    By George Gay

    It is wise to take seriously the warning that you should be careful what you wish for.

    At the Global Tobacco and Nicotine Forum (GTNF) in London in September, which was held about six months after new vaping industry regulations had been publicly mooted in China, one speaker told those listening how vaping industry regulations were overdue, necessary and to be welcomed. At the time, I assumed this welcome was predicated on the belief that the regulations would be beneficial—that they would allow the industry to grow in a stable way and, in doing so, serve the interests of the businesses involved, smokers wanting to quit their habit, and society at large while, at the same time, helping to remove from the industry cowboy operators and substandard products.

    Things have moved on since then. The regulations, formulated by the State Tobacco Monopoly Administration, were foreshadowed at the end of 2021, published in March 2022, became effective from May and are due to come fully into force in October.

    The question is: Are the regulations beneficial? I would say they are far from ideal, but then ideal would probably have been an ambition too far. Looking on the bright side, they are better than a ban, as has been introduced in Hong Kong and elsewhere, and, furthermore, given the considerable investment in these regulations and the systems necessary to operate them, unless some unforeseen catastrophe occurs, they seem to rule out a ban being introduced, at least in the short term to medium term. But they will undoubtedly rein in the country’s vaping industry—severely in some areas.

    The rise of China’s vaping industry has been hugely impressive, and the future had held out the offer of phenomenal growth, but now, predictions must surely be revised downward, particularly in respect of the domestic market, probably much less so in respect of exports. But in taking stock of this situation, it is necessary to bear in mind the relative importance of the huge and so far largely untapped domestic market.

    Domestic Sales Versus Exports

    One of the provisions of the regulations that will likely have upset those businesses and consumers looking for beneficial outcomes, assuming consumers in China tend to prefer the sorts of vaping products most popular in other countries, is the ban on flavored products other than those with tobacco flavors. They are unlikely, too, to have been overjoyed by a ban on nicotine-free products.

    On the other hand, the industry can take heart from the fact that products with flavors other than tobacco and those that are nicotine-free may be manufactured for export where such products do not conflict with the laws of the country of destination. Basically, export products must comply with the laws, regulations and standards of the destination country, though, where the country of destination does not have vaping regulations in place, export products will have to comply with China’s regulations.

    This difference between the requirements for local and export products raises an interesting question. The ban on the sale of nontobacco flavored and nicotine-free vaping products in China seems to be based, at least in part, on the idea that products with these properties are the ones favored by young people, who should be discouraged or, where minors are concerned, banned from vaping. This seems to be an ethical stance, but it is difficult to see how, given such an ethical stance, exports of such products could be allowed, even to countries that do not ban them.

    The regulation’s authors say, in translation, the “Measures for the Administration of Electronic Cigarettes” are being put in place in order “to further strengthen the supervision of new tobacco products such as e-cigarettes, regulate the market order, ensure the health and safety of the people, and promote the legalization and standardization of industrial governance in accordance with the Tobacco Monopoly Law of the People’s Republic of China, the Law of the People’s Republic of China on the Protection of Minors [and] the Regulations on the Implementation of the Tobacco Monopoly Law of the People’s Republic of China.” The regulations are said to cover the production, sale, transport, import and export, supervision and management of vaping products.

    Market Order

    There seem to be some curiosities in the regulations. From my reading, the regulators have gone down the U.S. route in deeming electronic cigarettes to be tobacco products, at least for the purposes of incorporating them under expanded tobacco laws. And while they refer to “vaping products,” they tend to refer to the use of these products as involving “smoking” rather than “vaping.” Having said that, I should point out that these are issues picked up by Western eyes from a translation of the regulations, which, unsurprisingly, have gone through a number of revisions.

    One of the things that jumps out at a Westerner from the stated aims of the regulations is the idea of regulating “the order of the market.” China’s economic system is such that, in part, the regulations are concerned with supply-side matters whereas in much of the rest of the world, such considerations would not come into the picture. Elsewhere, the market is controlled, if that is the right word, by demand, so if it becomes oversupplied, prices fall and, eventually, companies go bust. Or that’s the basic theory. In reality, some companies are considered to be too “important” to fail and have to be bailed out by taxpayers.

    The regulations aim to balance supply with demand through such mechanisms as setting production and sales targets, overseeing imports, controlling the expansion of companies, concentrating production sites, restricting product transport and overseeing wholesale and retail trading.

    Some of these controls are to be exercised through the licensing and registration of existing and new manufacturers, wholesalers and retailers, and even the expansion of their operations, or other changes, including moves into the trading of imported products. One of the requirements for obtaining a license will be that the applicant has access to sufficient funds to carry out whatever enterprise it wants to engage in, which, along with certain other restraints, some observers believe will tend to favor the bigger companies and weed out smaller ones. Again, this weeding out of the smaller players seems to be following the U.S. route, though by using a registration requirement applied to the company rather than the product.

    Big Versus Small

    Whether you view such provisions as good or bad will probably depend on whether you are a small vaping industry operator in China likely to be driven out of business or a big one that will benefit from fewer competitors. Of course, if China is successful in using such a system to stabilize the market and ensure underfunded companies don’t go bust with all the social fallout such failures can cause, it will probably be seen to have done a good job. But there are clearly dangers in disadvantaging smaller businesses working within an industry that, because of its youth, is dependent on innovation for its success, commercially and socially.

    In addition, the market will be closely controlled by “a unified national e-cigarette transaction management platform” through which manufacturers, wholesalers and retailers will have to process and record all their trading and transactions. Wholesalers wishing to trade in imported vaping products will have to obtain permission to do so, and the imported goods will have to comply with all local technical requirements and regulations and be sold, appropriately labeled, through the transaction management platform.

    There are provisions in the regulations for dealing with counterfeit and inferior products and the infringement of intellectual property rights, including through the encouragement by rewards of people reporting cases of the illegal production and sale of vaping products.

    The regulations will govern registered trademarks along with warnings and other messages applied to tobacco packaging, and they hold that e-cigarette advertising will be in line with tobacco advertising, which is consistent with their being regarded as tobacco products. E-cigarette exhibitions aimed at promoting such products are banned.

    Sales of vaping products through “information networks” other than the transaction management platform are banned, as are sales through vending machines and sales to minors, with the onus being on retailers to check identity documents where the age of the would-be purchaser is in doubt.

    The regulations will see the introduction of a product traceability system, and they will control the sites of retail outlets, including in respect of banning such outlets “around” schools. And they will provide for quality control through the inspection, testing, monitoring and evaluation of products under institutions set up to conduct technical reviews based on the submission of application materials, such as inspection and testing reports. Those engaged in production will be required to establish product quality assurance systems and be responsible for the quality of their products.

    Meanwhile, in April, the State Administration for Market Regulation, the standards committee, published the national standards for electronic cigarettes (GB 41700-2022), which provides, among other things, details about the technical requirements for vaping products and relevant test methods, safety standards, permitted ingredients and nicotine levels and concentrations.

    Encouragingly, some reports indicate that the newly regulated industry players will be encouraged to carry out vaping industry R&D in respect of raw materials, finished products and risk assessments, and that they will be encouraged to promote the application of green technology and other environmentally friendly practices.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • The Takeaways

    The Takeaways

    Photo: Jhvephotos | Dreamstime.com

    What lessons should regulators learn from the United States?

    By Clive Bates

    The U.S. Food and Drug Administration has had jurisdiction over tobacco products since Congress passed the Tobacco Control Act and it entered into force in 2009. Through its Center for Tobacco Products (CTP), the FDA regulates tobacco products, which include nicotine products such as e-cigarettes and e-liquids in the United States. With the recent retirement of Mitchell Zeller, the CTP’s director since 2013, it is an excellent time to take stock. Here we look at six lessons from the experience that might help guide regulation in other jurisdictions.

    First lesson: Understand how well-intentioned but poorly designed regulation can harm public health. The regulation of newer, safer products should reflect the political reality that the most hazardous products, cigarettes, will remain pervasively available. In the United States, variants of just under 3,000 cigarette products have been on the market since 2009, largely untouched by onerous regulation. The Royal College of Physicians signaled the risks that flow from excessive regulation of safer alternatives in its 2016 report Nicotine without smoke: “… if [a risk-averse and precautionary] approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking.”

    Regulatory regimes that are tougher on the alternatives to cigarettes function as anti-competitive barriers to entry. Sound regulatory practice requires efficiency, transparency and predictability with burdens proportionate to risk. Unfortunately, the premarket tobacco product application process by which safer products must enter the market to compete with cigarettes is astonishingly expensive and opaque and fails any test of proportionate regulation. It functions to protect the cigarette trade and concentrate the vape market into a monoculture of uninspiring products. This is partly the law itself, but much is down to how the FDA has interpreted its responsibilities under the law.

    Second lesson: Use standards and a notification regime rather than a product-by-product regime. The problem with an authorization regime is that it requires a public health agency to say “yes” to allowing a nicotine product onto the market. For institutional cultural reasons, many will find this challenging to do. Asymmetries in risk aversion mean regulators tend to be far more reluctant to accept the risk of saying “yes” and something bad happening than saying “no” and something good not happening. Both outcomes are harmful, but the former is what energizes regulators while the latter is hidden. A further issue with authorization systems is that they are easily politicized, providing a focus for campaign organizations to press for the decisions they want from regulatory agencies. For example, the FDA has been pushed hard by well-funded campaigns to ban flavored e-cigarette products. In contrast, the European Union has used a notification system with standards codified into the EU’s Tobacco Products Directive and, as a result, has a diverse and competitive market without a huge problem of youth uptake and far less political tension.

    Third lesson: The regulator should accept the same disciplines it imposes on the regulated entities. The Tobacco Control Act, which is the FDA’s regulatory foundation, repeatedly refers to “appropriate for the protection of public health” as a guiding principle. For example, this test is applied to new nicotine products as part of the premarket review process. But does the FDA ensure that its own approach is appropriate for the protection of public health? By setting the burden of proof so high, the FDA has implemented a de facto ban on flavors other than tobacco and (possibly) menthol in vaping products. This is probably a response to intense and well-funded activism. But it will have the effect (if not the intent) of closing all the vape shops and radically collapsing the diversity of products on the U.S. market. Imagine if the FDA had to prove that its approach to flavors is “appropriate for the protection of public health.” That is precisely what it would have to do if it introduced a product standard to ban flavored products. The agency would not be able to do it, and it should not be doing it by default.

    Fourth lesson: Risk perceptions matter, and regulators can help. One of the important purposes of public health regulation is to promote consumer behaviors that improve health. That should include, for example, making it easier and more desirable to vape than to smoke. But that cannot work if consumers do not understand which options are safer. In the United States, despite federal communications budgets of hundreds of millions of dollars, the public risk perceptions about nicotine are in a terrible state and, in many cases, deteriorating. In 2020, less than 3 percent of adults held the correct belief that e-cigarettes are much less harmful than cigarettes, but 62 percent wrongly believed that e-cigarettes are as harmful or more harmful than cigarettes—a view for which there is no evidence. Seventy-two percent wrongly believe that smokeless tobacco is no less harmful than cigarettes. A majority (56 percent) wrongly believe that nicotine is the primary cause of smoking-related cancer. The statements and communications campaigns of regulators and public health agencies like the Centers for Disease Control and Prevention  in the United States can improve these perceptions or make them worse. Either through risk aversion or by design, the leading federal agencies have contributed to the landscape of poor risk perceptions and have hence undermined their own effectiveness. This has especially been the case through agency efforts to deter youth use. These have strayed into the exaggeration of the harms of nicotine vaping and inappropriately capitalized on the scare over the outbreak of lung injuries in 2019 that was widely but falsely attributed to nicotine vaping.

    Fifth lesson: Apply some skepticism and science to the claims of activists. A regulator should be objective and cautious about activists’ claims and draw on the best possible science to guide its actions. Between 2017 and 2019, the rate of vaping among U.S. high school students shot up from 11.7 percent to 27.5 percent, an alarming rise by any standard. This generated a climate of moral panic in the public, media and politics—with flavored vapes and the marketing practices of e-cigarette companies blamed for the rise. Cooler heads advised caution and to look more carefully at the underlying patterns. That was good advice. It turned out that most teen vaping was infrequent, most frequent use was concentrated in young people who might otherwise be smoking, and very few tobacco-naive users showed any sign of dependence. We know that the causes of youth vaping are similar to the causes of youth smoking: characteristics of the individual and their circumstances rather than the products being the primary driver. For many young people, their frequent vaping may have been a beneficial displacement from smoking or diversion from cigarette uptake. From 2019 to 2021, teenage vaping fell sharply, especially among the infrequent users, suggesting that the dramatic rise had been a frothy and transient fad. Yet, by basing a response on the headline numbers rather than the underlying usage patterns, the FDA may have done more harm than good to both adolescents and adult smokers by overreacting to a moral panic based on a false premise. The science and data were there to navigate this crisis with a steady hand, but the FDA chose the path of least resistance and accepted activists’ claims at face value and acted accordingly.

    Sixth lesson: Adopt a realistic economic and behavioral model. How can a regulator use its powers wisely and make proper determinations if it has a poor grasp of the products and behaviors it is regulating? One way of looking at vaping products is that they are a form of smoking cessation device, a kind of pimped-up nicotine-replacement therapy. In that case, a regulator might demand clinical trials to show efficacy in smoking cessation and intervene to reduce “abuse liability”—the risk that the product will attract users for reasons other than its therapeutic indication. The other way of looking at vaping products is that they are competitive alternatives to cigarettes for people who wish to use nicotine for whatever reason. They work by presenting a rival value proposition to smokers. To do this successfully, they must be appealing and pleasurable and meet the needs of people who do not even want to quit smoking (those most at risk from smoking-related harm). Few medical or public health regulators have the conceptual tools to deal with ideas like pleasure or appeal without seeing them as an abuse liability. In reality, vaping and heated-tobacco products are best understood as part of a major technology transition from combustible to noncombustible technologies in the consumer nicotine market. The regulatory regime for such products needs to encourage and not suppress innovation, allowing innovators to do the heavy lifting in securing the eventual obsolescence of cigarettes. That is a far more ambitious aim than placing smoking cessation products on the market. Alas, few regulators, including the FDA, appear equipped for the challenge.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Latest PATH Data Files Released

    Latest PATH Data Files Released

    Photo: Tobacco Reporter Archive

    The U.S. Food and Drug Administration’s Center for Tobacco Products and the National Institute of Health’s National Institute on Drug Abuse announced the availability and location of newly released and updated data files from the Population Assessment of Tobacco and Health (PATH) Study, including the following:

    New data sets:

    Updated datasets:

    The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Additionally, Restricted-Use Files have been updated to include Wave 5 Ever/Never Reference Data, and the Restricted-Use and Public-Use Master Linkage Files have been updated.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com.

  • FDA Names New CTP Director

    FDA Names New CTP Director

    Photo courtesy of Robert Califf’s Twitter

    The U.S. Food and Drug Administration has named Brian A. King as the new Center for Tobacco Products (CTP) director.

    “After a robust executive search, I have selected Dr. Brian A. King as FDA’s new Center for Tobacco Products Director,” Robert Califf wrote on Twitter. “Dr. King brings extensive and impressive expertise in tobacco prevention and control and has broad familiarity with FDA from his more than 10-year tenure at CDC.”

    King is the deputy director for research translation in the Office on Smoking and Health (OSH) within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention. In this capacity, he is responsible for providing scientific leadership and technical expertise to CDC/OSH, the lead federal agency for comprehensive tobacco prevention and control.

    King joined the CDC in 2010 as an epidemic intelligence service officer before which he worked as a research affiliate in the Division of Cancer Prevention and Population Sciences at Roswell Park Comprehensive Cancer Center in Buffalo, New York. During his time at Roswell Park, his primary research focus related to tobacco prevention and control.

    King has worked for over 15 years to provide sound scientific evidence to inform tobacco control policy and to effectively communicate this information to key stakeholders, including decision makers, the media and the general public. He has authored or co-authored over 200 peer-reviewed scientific articles pertaining to tobacco prevention and control, was a contributing author to the “50th Anniversary Surgeon General’s Report on Smoking and Health,” was the lead author of CDC’s 2014 update to the evidence-based state guide, “Best Practices for Comprehensive Tobacco Control Programs,” and was the senior associate editor of the 2016 Surgeon General’s report, “E-cigarette Use Among Youth and Young Adults” and the 2020 Surgeon General’s report, “Smoking Cessation.” He was also the renior official for the CDC’s emergency response to the 2019 outbreak of e-cigarette, or vaping, product use-associated lung injury.

    King holds a doctorate degree and a Master of Public Health degree in epidemiology from the State University of New York at Buffalo.

  • Senator Calls on U.S. FDA to End Enforcement Discretion

    Senator Calls on U.S. FDA to End Enforcement Discretion

    Photo: Tobacco Reporter Archive

    In a speech on the Senate floor, U.S. Senator Dick Durbin blasted the U.S. Food and Drug Administration for its delays in completing its public health review of e-cigarette premarket tobacco product applications (PMTAs). The deadline for the FDA to finish reviewing e-cigarette applications was Sept. 9, 2021, more than eight months ago.

    On June 13, the regulatory agency submitted an update on the agency’s review of e-cigarette applications and stated it will not finish reviewing e-cigarettes until July 2023 and that products under review may continue being sold.

    “These companies have flooded the market with addictive devices. Companies like Juul, partially owned by the tobacco companies, understand that they’ve promoted their products to children,” Durbin said, according to a release from his office. “For years, none of these products were legally authorized. Who was supposed to be the cop on the beat? The Food and Drug Administration, but they were nowhere to be found.”

    In March, Durbin led a bipartisan letter with 14 of his colleagues calling on the FDA to finish its review of e-cigarettes immediately; reject applications for e-cigarettes, especially kid-friendly flavors, that do not prove they will benefit the public health; and clear the market of all unapproved e-cigarettes.

    “I am calling on the FDA to immediately halt its enforcement discretion and remove all unauthorized e-cigarettes from the market,” Durbin stated. “Don’t allow Juul and other tobacco companies one more day of endangering our children. Stop cowering before Big Tobacco’s highly paid lawyers.”

  • Cigarette Health Warnings Effective Date Postponed Again

    Cigarette Health Warnings Effective Date Postponed Again

    Photo: Tobacco Reporter Archive

    On May 10, the U.S. District Court for the Eastern District of Texas issued an order in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176 to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule.

    The new effective date of the final rule is July 8, 2023. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, the FDA strongly encourages entities to submit cigarette plans as soon as possible but no later than Sept. 8, 2022.

    This is not the first time the new health warnings have been delayed. The rule was most recently delayed to April 9, 2023, after being postponed multiple times before this over the past few years. The rule was originally supposed to go into effect in 2021.

    Additional details on the rule, as well as the new effective date and recommended date for submission of cigarette plans, can be found on the FDA’s website.

  • FDA Hands Court PMTA Status Report

    FDA Hands Court PMTA Status Report

    Photo: Tobacco Reporter Archive

    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.

    “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).”

    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, based on current information, the FDA will take action on:

    • 51 percent of covered applications by June 30, 2022;
    • 52 percent of covered applications by Sept. 30, 2022;
    • 56 percent of covered applications by Dec. 31, 2022;
    • 56 percent of covered applications by March 31, 2023; and
    • 100 percent 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 Aug. 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 Aug. 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.