Category: Regulation

  • Brazil Mulls Legalizing the Vaping Business

    Brazil Mulls Legalizing the Vaping Business

    Image: Patricia Fragoso

    Brazilian lawmakers are considering a proposal to legalize the vaping business, reports JP.

    E-cigarettes are currently prohibited in Brazil, but they are widely available throughout the nation. To restore order to the market, Senator Soraya Thronicke has proposed legislation that would regulate the production, commercialization, importation and use of vaping devices, as well as establish rules for control, inspection and advertising.

    Among other measures, the proposed legislation would require vaping companies to register their products with the health regulatory agency, the federal revenue service and other agencies. It also prescribes fines ranging from BRL20,000 ($3,678) to BRL10 million for those who sell vapes to buyers under 18 years of age.

    Proponents see regulation as a way to combat the illegal market and protect the population, especially youth. According to the Brazilian Institute of Geography and Statistics, 22.7 percent of Brazilian teenagers have experimented with electronic cigarettes.

    Lauro Anhezini Jr, a board member of the Brazilian tobacco industry association Abifumo, believes the ban is ineffective because it enables suppliers to skirt quality standards. “What we have in Brazil today are illegal products, without any type of oversight, and they pose a risk to consumers’ health, especially teenagers,” he was quoted as saying.

    Anhezini cited the example of the United States, where strict regulations have reduced youth consumption. “In the United States, after the creation of clear rules, the use of electronic cigarettes by teenagers dropped from 27.5 percent in 2018 to 5.9 percent in 2024. This demonstrates how regulation can bring a safer and more controlled scenario for consumers,” he said.

    According to Anhezini, regulation would allow for greater control over product quality, reducing health risks and especially protecting young Brazilians who have easy access to illegal products.

    The discussion also involves economic considerations. The federal revenue service estimates that controlled legalization of e-cigarettes could generate up to BRL700 million in annual revenue.

    However, the federal highway police warns that legalization will not necessarily reduce smuggling, citing the rampant illicit trade in the regulated combustible cigarette market.

    The bill is currently in the Senate’s Economic Affairs Committee and expected to return to the agenda in November.

  • New Zealand Urged to Rethink Disposables Ban

    New Zealand Urged to Rethink Disposables Ban

    Photo: Evgeniy Vershinin

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is urging New Zealand to reconsider its proposed vaping regulations, which include a ban on closed systems, tighter limits on displays in retail shops and new flavor restrictions.

    “This amendment will make it more difficult for adults who smoke to access vaping products, potentially pushing them back to smoking,” said CAPHRA Executive Coordinator Nancy Loucas. “It’s a step backward in our journey toward a smoke-free New Zealand.”

    The CAPHRA submission highlights several concerns. According to the advocacy group, the ban disproportionately affects older adults and those with dexterity issues who rely on simpler closed systems. The proposed display restrictions, says CAPHRA, may deter smokers from switching to less harmful alternatives. Meanwhile, the focus on further display restrictions in retail shops ignores the real issue of social supply to youth, according to the organization, while flavor restrictions could hinder successful smoking cessation efforts.

    “Consumers have the right to make informed choices about their health. This amendment proposes to restrict consumer autonomy and may hinder harm reduction efforts,” said Loucas. 

    “Even the Ministry of Health suggested that the regulations, as they are, are fit for purpose, and the ASH Year 10 survey has shown that youth vaping has declined from the peak a couple of years ago.

    “CAPHRA calls for a more balanced approach, focusing on education and transparent risk communication. By highlighting the facts about vaping, who it is for and what it is, we can combat misinformation and support public health,” said Loucas.

  • Korea Urged to Regulate Vapes as Tobacco

    Korea Urged to Regulate Vapes as Tobacco

    Photo: Teo

    Health advocates are calling on South Korea to regulate e-cigarettes as tobacco products, reports the Maeil Business Newspaper.

    The current law does not classify vapes as cigarettes, which means they are exempt from many of the regulations that apply to tobacco products. For example, vaping companies do not have to print graphic health warnings on their products or charge their customers tobacco consumption tax.

    Article 2 of the Tobacco Business Act defines “cigarettes” as products suitable for smoking, sucking, inhaling, chewing or smelling.

    The calls for expanding the legal definition follow concern about the growth of unmanned e-cigarette stores in Seoul, which are said to have inadequate age-verification procedures.

    A survey by the Seoul metropolitan government revealed that the number of unmanned e-cigarette stores has quadrupled since April.

    According to data from the Korea Centers for Disease Control and Prevention, three out of 10 youth smokers started smoking e-cigarettes from 2019 to 2023. Six out of 10 teenagers who started with e-cigarettes are currently smoking regular cigarettes, the center said.

    Bills to regulate e-cigarettes were tabled in the 20th and 21st National Assembly but failed to cross the plenary session threshold in each instance.

  • Frustration Voiced at FDA Hearing

    Frustration Voiced at FDA Hearing

    Photo courtesy of Plus PR

    U.S. lawmakers and advocacy groups expressed concern about the Food and Drug Administration’s regulation of smoke-free products during a Sept. 10 House of Representatives’ Energy and Commerce Subcommittee hearing.

    Health Subcommittee Chair Brett Guthrie criticized FDA delays and what he viewed as a lack of transparency. “Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an ‘appropriate [for the] protection of public health’ still have no clear guidance and are waiting for hundreds of days for outreach on their applications,” he said.

    “More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences.”

    Full Committee Chair Cathy McMorris Rodgers highlighted the massive backlog of product applications at the FDA’s Center for Tobacco Products (CTP). “Out of the over 26 million applications for electronic nicotine-delivery systems, or ENDS products, the center has authorized fewer than 50 products,” he said.

    “However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is in keeping up with demand.”

    Representative Richard Hudson blamed the CTP for the increase in illegal products on the U.S. market from abroad. “Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or [to] even hear a word from FDA about their application,” he said.

    “The illicit market has been enabled by the Center for Tobacco Products’ lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.”

    In a separate statement, Philip Morris said the hearing put a bright bipartisan spotlight on the fact that the agency is neglecting millions of adult smokers by failing to authorize scientifically substantiated, smoke-free nicotine products that are better alternatives to combustible cigarettes.

    “More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress,” said PMI Director for Regulatory Communications Matthew Sheaff.

    “FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and more importantly provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes.”

    The Taxpayers Protection Alliance (TPA) criticized the FDA’s authorization process and noted the low rate of youth e-cigarette use. “The PMTA costs to manufacturers are astronomical while the regulatory requirements are obscure at best,” Lindsey Stroud wrote on the TPA’s website.

    “To date, the FDA has only authorized 56 products under the PMTA pathway. Given the current low rate of youth e-cigarette use and the high number of adults using novel tobacco products, there is a pressing need for the FDA to adapt its authorization strategies to better serve adults seeking to quit smoking through these alternatives. Lawmakers are urged to advocate for this necessary shift in FDA policy.”

    Americans For Tax Reform (ATR) called on the FDA to educate the public about the continuum of risk for nicotine products. “The agency’s failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75 percent of Americans inaccurately believe vaping is equal to or worse than smoking,” Tim Andrews wrote on ATR’s website.

    “The fact that the agency’s leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA’s tobacco control plan, is a downright scandal.”

  • Mixed Feelings at PMTA Anniversary

    Mixed Feelings at PMTA Anniversary

    Photo: stokkete

    Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).

    Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.

    However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.

    At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.

    According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices for as alternatives to cigarettes, compared with 1,270 combustible products.

    Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.

    “Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.

    “In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”

  • Accorto Joins Institute for Novel Nicotine

    Accorto Joins Institute for Novel Nicotine

    Accorto Regulatory Solutions has joined the Global Institute for Novel Nicotine (GINN), an organization dedicated to advancing tobacco harm reduction through supporting the research and development of non-vaporized tobacco alternatives for adult smokers. The GINN also promotes compliance standards, focusing on youth access prevention, responsible marketing and product quality.

    Accorto Chief Scientific Officer Vince Angelico will join the GINN’s science and standards committee, which helps shape regulatory recommendations for the industry.

    “Becoming a member of GINN is a pivotal move in our ongoing commitment to advancing public health through robust, evidence-based regulation,” said Accorto Regulatory Solutions CEO Tom Beaudet in a statement. “GINN’s dedication to upholding industry integrity and prioritizing consumer safety mirrors our own values. We are eager to collaborate with fellow members to drive impactful progress in the tobacco harm reduction space.”

    Through this collaboration, Accorto Regulatory Solutions aims to contribute to the development of comprehensive, science-driven regulations that will enhance public health outcomes and promote responsible industry practices. Additionally, Accorto says it is dedicated to helping GINN members with novel, science-backed reduced-risk products fortify their regulatory applications, enabling these products to reach the market.

    “Accorto Regulatory Solutions joining GINN marks a significant step forward in our shared mission to advance tobacco harm reduction through evidence-based regulation,” said GINN Director Shem Baldeosingh. “Accorto’s deep expertise in regulatory compliance and their commitment to public health align perfectly with GINN’s core values. We are particularly excited about Dr. Vince Angelico’s involvement in our science and standards committee, as it will further enhance our ability to develop comprehensive, science-driven regulatory frameworks that support the safe and responsible marketing of reduced-risk nicotine products.”

  • Switzerland to Tighten Tobacco Rules

    Switzerland to Tighten Tobacco Rules

    Photo: Heorshe

    Switzerland will strengthen its restriction on tobacco advertising and nicotine product notification requirements effective Oct. 1, reports Swissinfo.

    The new rules include a nationwide ban on sales to people under the age of 18 and stricter advertising restrictions, for example on posters, on public transport, in cinemas, in publicly accessible buildings such as train stations and airports and on sports grounds.

    Existing smoking bans will now also apply to heated products and electronic cigarettes.

    Sponsorship of events with an international character or for an underage audience is no longer permitted.

    Cigarette manufacturers will also be required to print pictorial warnings on tobacco packaging

  • FDA Issues Final Rule for Tobacco 21

    FDA Issues Final Rule for Tobacco 21

    The U.S. Food and Drug Administration announced a final rule raising the minimum age for certain restrictions on tobacco product sales. The requirements are in line with legislation signed in December 2019, which immediately raised the federal minimum age for the sale of tobacco products in the United States from 18 to 21.

    Once implemented, the requirements are expected to help decrease underage tobacco sales.  

    Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone. 

    Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machines in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time.

    These changes, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation, according to an agency press release.

    “Today’s rule is another key step toward protecting our nation’s youth from the health risks of tobacco products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Decades of science have shown that keeping tobacco products away from youth is critical to reducing the number of people who ultimately become addicted to these products and suffer from tobacco-related disease and death.”

    The Further Consolidated Appropriations Act, signed into law on Dec. 20, 2019, increased the federal minimum age for selling tobacco products from 18 to 21 across the United States. Since then, it has been illegal to sell tobacco products, including e-cigarettes, to anyone under 21. The law also directed the FDA to take action today, increasing the age of certain requirements for tobacco product sales, as explained above.

    The agency also continues to provide retailers with resources to improve compliance with tobacco laws and regulations, including age of sale restrictions. For example, the FDA has developed a voluntary education program, “This is Our Watch,” which offers free resources to assist retailers in calculating the age of customers, including a digital age verification calendar and an age calculator app. Retailers can also find information on tobacco products that may be legally marketed in the United States through the Searchable Tobacco Products Database. Updated resources, including further information on these latest requirements, will be made available on the FDA’s website in the near future.

  • Thailand: Home Vaping is Domestic Violence

    Thailand: Home Vaping is Domestic Violence

    Image: Zerophoto

    Exposure to secondhand vapor from vaping at home could be considered a violation of Thailand’s child protection laws, according to child health and rights experts who are calling for more awareness of the dangers of vaping around children, reports The Pattaya Mail.

    Under national laws, vaping around children could be considered “domestic violence,” according to Thai authorities. They are calling for stricter enforcement.

    The Royal College of Pediatricians of Thailand wants stronger government measures to restrict the import and sale of e-cigarettes and increase educational campaigns about the risks of nicotine.

  • The Takeaways

    The Takeaways

    Image: Parin April

    What can we learn from the first FDA marketing order for menthol ENDS?

    By Chris Allen

    In good news for the next-generation nicotine industry, the U.S. Food and Drug Administration recently granted marketing orders (MOs) for four menthol-flavored e-cigarette products. This marks the first time that the FDA has granted MOs for nontobacco-flavored products via the premarket tobacco product application (PMTA) pathway. In this article, Chris Allen, CEO of PMTA specialist Broughton, summarizes the documentation and shares some pertinent learning points from the decision summaries of the applications from the technical project lead (TPL) review.

    The new products that were granted MOs are Altria’s Njoy Ace Pod Menthol 2.4 percent, Njoy Ace Pod Menthol 5 percent, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 6 percent. The Ace products are sealed pod-based systems whereas the Daily products are disposable e-cigarettes with a prefilled, nonrefillable e-liquid reservoir. At the time of writing, Njoy Ace is the only pod-based e-cigarette product with an MO.

    A Big Step for Tobacco Harm Reduction

    Granting an MO for a menthol e-cigarette is a huge step in the right direction for the FDA, opening up a new avenue for tobacco harm reduction to millions of adult smokers across the U.S.

    It is crucial that we have a diverse portfolio of convenient, satisfying and appealing smoke-free products to meet adult smokers’ preferences and needs as they transition away from combustible cigarettes (CC). We hope the fact that the FDA has granted MOs for menthol products will encourage adult smokers to opt for regulated alternatives to smoking rather than illicit products. However, we must bear in mind that these products are now eight years old, so it’s imperative that the FDA streamlines the PMTA process to reduce the time to market for products that are aligned with changing consumer behaviors.

    The PMTA Process

    Compiling a PMTA is a rigorous and lengthy task, with manufacturers required to provide data and evidence to demonstrate that the product is “appropriate for the protection of public health” (APPH) as required under the Tobacco Control Act. Manufacturers must consider the risks and benefits of the product, both to users and nonusers. To date, 27 products and devices have been granted marketing orders, and a full list is kept here.

    The FDA’s approval of menthol products demonstrates that it is possible to achieve the requirements of PMTA approval with a high-quality menthol product and compelling data. Shannon Leistra, president and CEO of Njoy, said, “We believe these marketing orders are a testament to the quality of the Njoy products and the strength of evidence supporting the authorizations of the Njoy menthol e-vapor products.”

    It will be interesting to see the FDA’s next move regarding flavored electronic nicotine-delivery systems (ENDS) and whether granting MOs for menthol opens up the door to other flavors. Njoy has resubmitted PMTAs for blueberry-flavored and watermelon-flavored pod products that work exclusively with the new Njoy Ace 2.0 age-gated device and is awaiting the outcomes.

    What Can We Learn from These Products?

    PMTAs are reviewed on a case-by-case basis, and the MO is specific to these products only. Understandably, many in the industry are looking to learn from this industry first to apply it to their own products and PMTAs.

    The most interesting outcome, naturally, is that the FDA determined there was robust and reliable evidence of an added benefit from the menthol flavor relative to that of tobacco-flavored products in facilitating adult smokers switching from CCs. This was deemed to outweigh the increased risk of youth use.

    About the approval, Brian King, director of the FDA’s Center for Tobacco Products, said, “It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome. This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”

    Reducing the Risk of Youth Use

    A shared concern of the general public, manufacturers and regulators is the youth appeal of nontobacco-flavored products. The FDA has placed stringent marketing restrictions to prevent youth access and exposure, and for flavored products, there is a higher burden of proof on the manufacturer that the benefit to adults who use CCs outweighs the increased risk of youth use.

    While the application did include studies of youth use with low prevalence estimates for the new products, the FDA deemed the sample size insufficient. It noted the recent National Youth Tobacco Survey on popular flavors and devices, referencing the increased risk of youth appeal of menthol-flavored ENDS compared with tobacco-flavored ones, but adding the risk is lower than some other flavors (e.g., fruit).

    The TPL noted, “FDA’s experience shows that advertising and promotion restrictions and sales access restrictions cannot mitigate the substantial risk to youth from flavored ENDS sufficiently to reduce the magnitude of adult benefit required to demonstrate APPH. Rather, for flavored ENDS, only the most stringent mitigation measures have such potential; to date, the only such measures identified with the potential for that kind of impact have been device access restrictions.”

    The FDA’s ruling highlights that “stringent mitigation measures” such as device access restrictions have the mitigation potential to demonstrate APPH. However, the Njoy menthol-flavored PMTAs did not propose such mitigation restrictions and therefore required reliable and robust evidence of a potential benefit to adults who smoke, i.e., cessation of combustibles with continued ENDS use or cessation of combustibles leading to cessation of ENDS use.

    The application also proposed limiting youth exposure by not engaging in social media promotions, limiting human portrayals to those over 45 and prohibiting these products from being sold on third-party websites.

    Comparisons from Adult Smokers

    In this case, the FDA found “acceptably strong evidence” from submitted data from an online, observational longitudinal cohort study comparing its menthol Njoy Daily product with its tobacco-flavored Njoy Daily device. The study suggested a 21 percent to 31 percent rate of switching over a period of six months (three months primary outcome cohort), higher than the rate of ENDS in the literature.

    The comparison analyses showed the menthol Daily products were associated with statistically significant and higher rates (32 percent to 43 percent) of complete switching than the rate of tobacco-flavored Njoy Daily ENDS (21 percent to 37 percent) at three months or six months.

    Additionally, the comparison analyses demonstrated a 24 percent to 45 percent substantial added benefit from the menthol-flavored Njoy Daily ENDS in switching away from CCs among smoking adults compared with their tobacco-flavored equivalent. The submitted clinical studies demonstrated a similar abuse liability to CCs, suggesting they are a suitable substitute.

    For Njoy Ace menthol products, the longitudinal cohort study found behavioral benefits compared with tobacco-flavored Njoy Ace products in robust and reliable rates of switching from CCs, though the exact figures were redacted.

    Overall, the studies showed that the products have the potential to promote CC cessation, or significantly reduced use, compared with tobacco-flavored comparator products. The review concluded that there was a benefit to public health in the significantly higher smoking cessation rates achieved as compared with equivalent tobacco-flavored products.

    Biomarker data showed fewer and lower levels of harmful and potentially harmful constituent exposure compared with CCs, and toxicological evaluation of the aerosol suggested a lower excess lifetime cancer risk using Njoy Daily than using CCs. Ultimately, the FDA ruled that this data “demonstrated the potential for these new products to benefit adults who smoke combustible cigarettes as compared to adults who continue to use combustible cigarettes exclusively.”

    All of these points contributed to the FDA’s decision to designate the products as APPH. This monumental ruling has excited many in the next-generation nicotine industry, as it helps us achieve our shared goal of tobacco harm reduction for millions of adult smokers across the U.S. We are likely to see manufacturers working closely with regulatory consultants like Broughton to ensure their PMTAs contain robust and rigorous data and that their regulatory dossier is presented to support the best chance of success.

    Chris Allen is the CEO of Broughton.