Category: Regulation

  • FDA Issues Final Rule to Raise Minimum Sales Age

    FDA Issues Final Rule to Raise Minimum Sales Age

    Credit: Onticello

    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.

  • Retailers Move to Reinstate Challenge of Registry Law

    Retailers Move to Reinstate Challenge of Registry Law

    Credit: Lulla

    Kentucky vape retailers plan to appeal the dismissal of their challenge to a 2024 state ban on selling some vaping products. A Franklin Circuit judge in late July dismissed their lawsuit challenging the 2024 law.

    Greg Troutman, with the Kentucky Smoke-Free Association representing vape retailers, filed a notice of appeal with the Kentucky Court of Appeals last week.

    Troutman, on behalf of the retailers, had sued Allyson Taylor, commissioner of the Kentucky Department of Alcoholic Beverage Control and Secretary of State Michael Adams, arguing the new law did not pass constitutional muster, according to media reports. 

    Franklin Circuit Judge Thomas Wingate disagreed in a July 29 opinion. He dismissed the challenge, saying the law did not violate the state Constitution. 

    House Bill 11, which passed during the 2024 legislative session, goes into effect Jan. 1. Backers of the legislation said it aims to curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their status with the U.S. Food and Drug Administration (FDA). 

    Opponents have said it will hurt small businesses, lead to a monopoly for big retailers and could drive youth to traditional cigarettes. 

    According to Legislative Ethics Commission records, Altria, the parent company of tobacco giant Phillip Morris, lobbied for the Kentucky bill. Based in Richmond, Virginia, the company is pushing similar bills in other states. Altria, which has moved aggressively into e-cigarette sales, markets multiple vaping products that have FDA approval.

  • UK Medical Group Wants Tougher Rules for Vapes

    UK Medical Group Wants Tougher Rules for Vapes

    Credit: Studio Romantic

    E-cigarettes and other vaping products should only be sold from behind the counter, like cigarettes, and not be on display in shops, according to the British Medical Association (BMA). In a report published on Wednesday, the doctors’ union called on ministers to introduce legislation to tackle the “growing epidemic” of vaping in the UK.

    The report is the first comprehensive paper laying out BMA’s policy on vaping since 2017. It is also the first time the organization has explicitly called for restrictions on all forms of advertising and marketing of e-cigarettes.

    It follows a 2023 conference resolution for the BMA to review the dangers of vaping. Wednesday’s report, “Taking our breath away: why we need stronger regulation of vapes,” calls on the government to legislate to ensure that vapes are kept behind the counter and not on display in shops and retail outlets, according to media reports.

    “More must be done to restrict advertising of [vapes] and reduce their visibility, so children and young people are not encouraged to use them,” the report states. “Removing the visibility of vapes in shops will help to reduce exposure and awareness of the product, and in turn, their use.”

    It also recommends banning the sale of disposable vapes and the use of any non-tobacco vape flavors. Vapes should only be sold in plain packaging, with any imagery, coloring, and branding for both the packaging and vape device prohibited, as is the case for cigarettes.

    Responding to the report, Deborah Arnott, chief executive of Ash, said: “In order for tougher regulations to curb youth vaping to be put in place, the tobacco and vapes bill must be fast tracked on to the statute book.

    “We support strict regulation of the display and promotion of vapes and prohibiting use of sweet names, bright colours and cartoon imagery. However, vapes are a highly effective quitting aid for smokers, and it is important that they continue to be so.”

    John Dunne, director general of the UK Vaping Industry Association (UKVIA) agrees that stronger measures are needed to cut off the supply of youth vaping and illicit products, however, actions laid out in the BMA report would “sooner supercharge the black market and push the nation’s smokefree ambitions further out of reach” by deterring adult smokers from making the switch and driving current vapers towards the black market or back to combustible cigarettes.

    “The BMA undersells the quitting power of vapes when it says the reduced risk alternative ‘can be useful in helping some people to stop smoking,” Dunne said. “The latest data from leading public health charity Action on Smoking and Health UK found more than half of ex-smokers in Great Britain who quit in the past five years used a vape in their last attempt – ASH also reports that current and ever use of vapes amongst 11-17-year-olds has decreased since last year.

    “A ban on all non-tobacco flavors, as advocated by the BMA, would be counter-productive, with the Royal College of Physicians recently warning flavors are an ‘integral part’ of the effectiveness of vaping as a quit aid – this is also reinforced by the findings of a Freedom of Information investigation conducted by the UKVIA. The soon-to-be-released data reveals that, of 31 surveyed stop-smoking services across England, more than nine in ten provide flavored vaping products as a quitting tool and that fruit options were most often recorded as, or amongst, the most popular choices for adult smokers.

    “The industry does recognize that action should be taken to prevent youth-appealing products from ever making it to the shelves and has long campaigned for the government to adopt a balanced set of flavor names, descriptors, and packaging guidelines.

    “If the BMA wants to see underage and illicit vape sales stopped, it should join the industry in calling for the introduction of a first-of-its-kind licensing scheme which would prevent inappropriate businesses – including sweet shops – from selling these products, bring into play stronger penalties for those caught flouting the law and generate upwards of £50 million in annual, self-sustaining funding which could be used to empower under-resourced Trading Standards.

    “With regards to future public education campaigns, the BMA should be supporting initiatives that raise awareness of how adult smokers can benefit from considerably less harmful alternatives to conventional cigarettes, such as compliant vapes, which will save the NHS millions of pounds in not having to care for those suffering from smoking-related conditions, a cost which is estimated to be some £2.6 billion a year.”

  • Kurdistan Bans Imports, Sales of Vaping Devices

    Kurdistan Bans Imports, Sales of Vaping Devices

    Credit: Dalpings

    Local authorities have vowed to take legal action against those who defy the ban.

    The Kurdistan Regional Government (KRG) has intensified efforts to crack down on the use of e-cigarettes, with both the Ministry of Health and the Ministry of Interior enforcing a decision to ban their import and sale.

    E-cigarettes are prohibited under the new regulations, and local authorities are committed to taking legal action against anyone who violates the ban.

    According to media reports, Akar Mohammed, a local cigarette and hookah seller, supported the measure. “Dozens of men and children ask me about vapes and e-cigarettes every day,” he said. “This decision is appropriate.”

    In Erbil, the governor’s office has been leading the crackdown on e-cigarettes, announcing that more than 26,000 devices were seized and destroyed this month. Many were found hidden in shops and warehouses.

    Authorities are stepping up their efforts by increasing inspections at checkpoints and markets and monitoring online sales.

    Erbil Mayor Nabaz Abdulhamid stated on Aug. 19 that investigations have uncovered the illegal smuggling of e-cigarettes into Erbil from Sulaimani. “We want to control this phenomenon together,” Abdulhamid said, emphasizing the need for collective action to tackle the issue.

  • Brazil Considers Legalizing Vaping Products, Again

    Brazil Considers Legalizing Vaping Products, Again

    VV Archives

    The Brazilian Senate’s Economic Committee was set to vote on Tuesday on a bill that would legalize e-cigarettes in the country. Currently, e-cigarettes are prohibited in the country for manufacture, import, marketing, distribution, storage, transportation, and advertising.

    The vote on the text has been repeatedly postponed due to a lack of consensus among legislators, according to media reports.

    Although the National Health Surveillance Agency (ANVISA) banned them in Brazil in 2009, the products are still on the market and are sold illegally.

    In a joint statement led by the Brazilian Medical Association (AMB) and the Brazilian Society of Pulmonology and Tisiology (SBPT), the medical entities unequivocally reiterate their stance against any changes to the regulation of electronic cigarettes, also known as vapes, “without any reservations.”

    Ricardo Meirelles, coordinator of the AMB Anti-Smoking Commission, argues, “This project is a disservice to the Brazilian population because it intends to release a product that causes a lot of harm to health.”

    In April, the board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of e-cigarettes and other vaping products.

  • Illinois Bans ‘Highlighter’ Looking Vaping Devices

    Illinois Bans ‘Highlighter’ Looking Vaping Devices

    Credit: High Light Vape

    Illinois lawmakers have decisively passed a law that forbids vaping companies from targeting teens with their advertising, particularly by promoting electronic cigarettes that resemble school supplies such as highlighters, markers, or erasers.

    The changes come at a time when lawmakers from both sides of the aisle in Springfield have been bombarded with complaints about students bringing vapes into schools that could easily be mistaken for such common items, according to media.

    Seilback argues that none of the deception should come as a surprise.

    “The industry is always needing to replace those that quit using their products,” he adds. “They’re always looking for the next generation. They’re going to keep saying what they say and we need to make sure that our elected officials stand with the public health community.”

    The new law will be enforced by the Illinois Department of Revenue, the Attorney General’s office, and local law enforcement. At the same time, Senate Bill 3098, which will ban electronic cigarette companies from allowing anyone under 21 to order vaping products online or by mail, is also slated to soon take effect.

    Illinois Senate Bill 3098, signed into law Aug. 9, prohibits e-cigarettes purchased by mail, online or through other remote sale methods from being shipped to anyone in the state other than a distributor or retailer. Senate Bill 3098 goes into effect Jan. 1, 2025.

  • Thailand: Home Vaping Violates Child Protection Laws

    Thailand: Home Vaping Violates Child Protection Laws

    VV Archives

    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.

  • Costa Rica Bans Vaping in Public Places

    Costa Rica Bans Vaping in Public Places

    Credit: Adobe Stock

    Costa Rica has banned vaping in public places such restaurants, offices and educational institutions, reports The Tico Times.

    The move follows a dramatic increase in vaping-related disorders. In 2023 alone, the Costa Rican Social Security Fund recorded 14 cases of vaping-related intoxication, including nine minors, with seven requiring hospitalization.

    Vaping has become increasingly popular among young people in recent years. Gabriela Rojas of the Institute on Alcoholism and Drug Dependence (IAFA) warned that electronic cigarettes contain harmful chemicals.

    “The tobacco industry has cleverly marketed these products, using technology, attractive colors, and various flavors to target underage individuals,” said Zeanne Gonzalez, another IAFA official.

  • FDA Posts 2 Regulatory Science Memos for Vapes

    FDA Posts 2 Regulatory Science Memos for Vapes

    Credit: Araki Illustrations

    FDA posted the following two regulatory science policy memos related to the agency’s review of premarket tobacco product applications (PMTAs) for new e-cigarette products: 

    • June 03, 2024: Genotoxicity Hazard Identification and Carcinogenicity Tiering of Constituents in ENDS Premarket Tobacco Product Applications
    • June 03, 2024: Calculating Excess Lifetime Cancer Risk in ENDS Premarket Tobacco Product Applications

    In general, the science policy memos provide a snapshot of FDA’s internal thinking on a specific topic at a certain point in time. Therefore, the information contained in the memos is subject to change, for example, based on changes in policy, the regulatory framework, or regulatory science, according to a press release.  

    FDA’s review of tobacco product applications is based on the specific facts presented in each application and is documented in reviews particular to each application. The memos posted today should not be used as a tool, guide, or manual for the preparation of applications or submissions to FDA.

    For applicants seeking to market new tobacco products, FDA has issued final regulations, such as the PMTA final rule that describes the required content, format, and review procedures for PMTAs, as well as guidance documents. FDA also regularly posts additional resources, such as webinars and application tips, on CTP’s website and social mediaExternal Link Disclaimer.  

    In April, FDA resumed the posting of regulatory science policy memos, with a subsequent release in May. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation.

  • Fifth Circuit Cites Triton to Vacate 5 Denial Orders

    Fifth Circuit Cites Triton to Vacate 5 Denial Orders

    Fifth Circuit Court of Appeals

    The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.

    The court sent the company’s marketing denial orders (MDOs) back to the U.S. Food and Drug Administration for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco applications (PMTAs), or until the Supreme Court takes action.

    “Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.

    Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.

    In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month the Supreme Court agreed to hear the agency’s appeal.

    The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now another panel of the Fifth Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.

    The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote.

    “Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials, as well as those of thousands of other e-cigarette manufacturers. Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying Petitioners’ PMTAs based on the absence of long-term clinical studies.”