Category: Regulation

  • FDA Warns 9 More for Illegal Vape Sales

    FDA Warns 9 More for Illegal Vape Sales

    The U.S. Food and Drug Administration issued warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable e-cigarettes.

    Some of the unauthorized products cited in the warning letters are marketed under brand names for disposable products, including Geek Bar and Lost Mary, according to the FDA. Other unauthorized products cited feature the names and/or images of celebrities.

    The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to be legally marketed in the U.S., which is in violation of the Federal Food, Drug, and Cosmetic Act.

    In addition to the violations mentioned in the warning letters, the firms were warned to address any violations that are the same as, or similar to, those stated in the warning letter and to promptly take necessary actions to comply with the law.

    Failure to promptly correct the violations can result in additional actions such as an injunction, seizure, and/or civil money penalty.

  • FDA Sends Nicotine Limits Proposal to White House

    FDA Sends Nicotine Limits Proposal to White House

    VV Archives

    The Biden administration has proposed a rule that would significantly lower the amount of nicotine in tobacco products. The U.S. Food and Drug Administration’s efforts to counter the dangers of the chemical in stretch back to 2018, when it first proposed the idea.

    Then, FDA Commissioner Robert Califf went even further in 2022 and announced that the agency was developing a rule requiring tobacco companies to reduce the amount of nicotine in cigarettes.

    The next step in that effort occurred Tuesday when the FDA finally submitted its refined proposal to the Office of Management and Budget. There won’t be any immediate changes to tobacco products. The approval process for the Office of Management and Budget can take months. There will also be a public comment period, and the nicotine industry often sues the government to stop new regulations.

    “A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement reported by CNN on Wednesday.

    When the FDA announced its initial plans to reduce nicotine in 2022, it estimated that reducing nicotine levels could keep more than 33 million people from becoming regular smokers, that about 5 million additional smokers would quit within a year, and that 134 million years of life would be gained.

    In the draft proposal from 2018, which the FDA has since refined, it cited a 2013 survey that found that reducing the total nicotine content of cigarettes to 0.5 milligrams per rod would minimize addictiveness. Still, it also said that questions remain with respect to the precise level of nicotine in cigarettes.

    The agency’s proposal was met with high praise Wednesday.

    “Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “Making tobacco products non-addictive would dramatically reduce the number of young people who become hooked when they are experimenting. To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to non-addictive levels in all commercial tobacco products, including e-cigarettes.”

    Not all smokers would quit if nicotine levels were limited, experts say, nor would all smoking-related diseases disappear since tobacco products contain other chemicals that can be harmful to health.

  • Dallas City Council OKs Adding Vapes to Smoke Law

    Dallas City Council OKs Adding Vapes to Smoke Law

    Credit: Lucitanija

    The Dallas City Council in Texas approved adding vaping to its smoke-free ordinance Wednesday, restricting vaping and e-cigarettes in parks. The ordinance mirrors existing restrictions on smoking in specific areas, including all indoor and enclosed spaces, within 15 feet of building entrances, and on park property.

    The change also requires businesses, such as restaurants, hotels, and fitness centers, to update their signage to clearly state that both smoking and the use of electronic smoking devices are prohibited. The new ordinance, which takes effect Dec. 11, 2025, is punishable by a fine of up to $500.

    “This ordinance fortifies the City’s commitment to restrict vaping in public spaces after collaboration with our community partners and identifying the negative health effects of vaping aerosol exposure,” said Interim City Manager Kimberly Tolbert, as reported by media. “This is an exciting day because the approval of the ordinance closes an important regulatory gap and better protects the health of our residents from the negative effects of electronic smoking devices.”

    In March, the city council’s Parks Trails and the Environment committee requested that the Office of Environmental Quality and Sustainability and the Environmental Commission recommend updating the city’s smoke-free ordinance to include vaping.

  • Mexico’s Lower House Passes Ban on Vape Products

    Mexico’s Lower House Passes Ban on Vape Products

    The lower house of Mexico’s Congress voted to alter the constitution to include a ban on e-cigarettes, reports Reuters. The measure passed with 410 votes in favor and 24 against.

    The reform also sanctions “production, distribution and sale of toxic substances, chemical precursors, the illicit use of fentanyl and other non-authorized synthetic drugs.”

    Less than 1 million people from ages 12 to 65 reported regularly using a vape in 2022, according to federal data cited by lawmakers. Meanwhile, around 500,000 teens and 300,000 adults used e-cigarettes.

    The proposal was sent to Congress by former President Andres Manuel Lopez Obrador, who argued that smoking devices were damaging public health, with children particularly susceptible to getting hooked.

    Lopez Obrador had already banned such devices through a presidential decree, though they remain widely available for purchase. Millions of Mexicans, meanwhile, smoke traditional cigarettes, which remain legal.

    Opposition legislator Ector Jaime Ramirez said banning fentanyl and vaping in the same reform was excessive and “trivializing to the effort being made to combat the most addictive and dangerous drugs.”

  • Dallas, Texas to Consider ‘Public Places’ Vape Ban

    Dallas, Texas to Consider ‘Public Places’ Vape Ban

    Credit: Lucitanija

    According to a city council committee memo, Dallas is expected to consider restricting vaping in public spaces like parks next week.

    The Environmental Commission, a group appointed to advise the city council on environmental issues, recommended in May 2023 that the city restrict vaping in public spaces “after identifying the negative health effects of vaping aerosol exposure,” according to a city memo.

    The city council’s Parks Trails and the Environment committee requested in March that the Office of Environmental Quality and Sustainability and the Environmental Commission recommend updating the city’s smoke-free ordinance to include vaping.

    The full city council is expected to consider the issue on Dec. 11.

    “An outdoor park, as long as you’re being respectful of people and you’re keeping your distance and you’re not getting it in anyone’s face,” said Chris Self, owner of Trilogy Smoke, CBD & Vape Shop in Coppell. Self is a vape advocate who isn’t surprised by the possible rule change. He also says this won’t bother his clients who are used to being discrete anyway.

    WFAA reports that banning vaping in city parks would include all of Fair Park and likely during the State Fair of Texas. The media outlet said it had contacted the city’s Parks department for clarification on this to see if any ordinance change would also extend to the fair.

    “I know they can do a designation area, I know they have a designation area for smoking,” said Self.

  • Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy Jr. (Credit: Cage Skidmore)

    President-elect Donald Trump has nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services (HHS). The effects Kennedy will have on the nicotine market remain unclear. Kennedy must still be confirmed by Congress.

    “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump posted. “The Safety and Health of all Americans is the most important role of any Administration, and HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country.”

    As the leader of HHS, Kennedy will oversee the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products.

    Kennedy’s position on vaping, nicotine, and tobacco harm reduction (THR) remains an unknown. During the presidential campaign, Trump promised that, if elected, he would “save vaping” after meeting with Tony Abboud of the Vapor Technology Association.

    “I saved Flavored Vaping in 2019, and it greatly helped people get off smoking,” Trump said on his Truth Social platform in September. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save Vaping again!”

  • FDA Renews MRTPs for 8 General Snus Products

    FDA Renews MRTPs for 8 General Snus Products

    After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.

    With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

    The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.

    The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.

    “The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

    “In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”

    The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of FDA’s Center for Tobacco Products. “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers, or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug, and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • Taiwan Regulators Concerned About ‘Zombie Vapes’

    Taiwan Regulators Concerned About ‘Zombie Vapes’

    Image: Pavelkant

    Taiwan authorities are concerned about the growing popularity of “zombie vapes,” e-cigarettes containing etomidate, reports The Taipei Times.

    According to health experts, etomidate is a type of central nervous system depressant that can induce anesthesia. Abusing etomidate could lead to irritability, disorganized behavior, tremors, twitching or even death, explained Lin Yi-ching, a pediatrician at Kaohsiung Medical University Chung-Ho Memorial Hospital.

    From July to October, authorities seized 14,128 zombie vape cartridges, along with e-liquid and powders that could be made into more than 1.83 million cartridges worth about NTD4.6 billion ($143.33 million).

    While etomidate is listed as a Category 3 narcotic, a review committee will consider whether to upgrade the drug to Category 2, Ministry of Justice Department of Prosecutorial Affairs Director-General Kuo Yung-fa said.

    Overall e-cigarette use among junior high school students in Taiwan increased from 1.9 percent in 2017 to 3.9 percent in 2021, a HPA survey reported by Taiwan News showed. Among senior high school students, the rate rose from 3.4 percent to 8.8 percent during the same period.

    Taiwan outlawed vapes in 2023, with violators risking fines of up to NTD10,000.

  • Bangladesh Bill Would Ban Vaping Products, Bidis

    Bangladesh Bill Would Ban Vaping Products, Bidis

    Credit: Sergey Fedoskin

    Shopkeepers who sell nicotine products, including vaping products and traditional cigarettes, will have to get a license, without which they will face penalties of TK50,000 ($418). The products will also be prohibited from being sold within 100 meters of schools, hospitals, clinics, sports venues and playgrounds.

    The country considered the same ban last year.

    A fine of Tk5,000 will be imposed on anyone selling vapes or loose combustible cigarettes. Currently, the fine for smoking or using tobacco products in public places is Tk300, but the draft ordinance proposes to increase this to Tk1,000.

    With these provisions in it, the draft “Smoking and Tobacco Products Usage (Control) Ordinance, 2024” is expected to be presented for approval during the Advisory Council meeting on Thursday (Oct. 24), sources familiar with the matter told TBS.

    According to the draft ordinance, seen by TBS, tobacco products, including cigarettes, cannot be sold at mobile shops or by hawkers. Additionally, no sweeteners, spices, flavors, or colors will be permitted to be used in nicotine products.

    Violations of this law may result in monetary fines as well as imprisonment for varying durations, with penalties doubling for repeat offences.

    The government first enacted the Smoking and Tobacco Products Usage (Control) Act in Bangladesh in 2005, with one amendment made in 2013. In 2020, the previous government initiated a revision of the Act to strengthen regulations on the use of tobacco and tobacco products.

    In June 2022, the Ministry of Health published a revised draft of the law on its website for stakeholder feedback, which is now being presented to the Advisory Council as a draft ordinance.