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Category: Global Regulation

  • Stricter Tobacco Rules in Thailand

    Stricter Tobacco Rules in Thailand

    Photos courtesy of Mathijs Aliet

    Tobacco manufacturers and importers in Thailand will be subject to stricter rules under a new draft regulation approved by the cabinet recently, reports The Pattaya Mail.

    Among other provisions, they will have to report the components of their products and the substances released during combustion.

    What’s more, tobacco manufacturers may not use flavor additives in their products or label them in a way that implies health benefits or suggests increased vitality.

    The regulation sets maximum limits for substances released during combustion. Tar must not exceed 10 mg per cigarette, nicotine must not exceed 1 mg per cigarette, and carbon monoxide must not exceed 10 mg per cigarette.

    The regulation also mandates the disclosure of information about the components and combustion byproducts of tobacco products.

    The certification fee is set at THB100,000 ($2,768) per certificate and THB2,000 for a replacement certificate. The regulation will take effect 180 days after its publication in the Royal Gazette and will be valid for four years.

  • CTP Updates Compliance Website

    CTP Updates Compliance Website

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.

    The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups and the tobacco industry.

    The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties and no-tobacco-sale orders.

    Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.

    This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.

  • Top Court to Hear Triton PMTA Denial Order Suit

    Top Court to Hear Triton PMTA Denial Order Suit

    supreme court of USThe U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.

  • Swedish Match Presents to FDA on General Snus

    Swedish Match Presents to FDA on General Snus

    Image: Tobacco Reporter archive

    Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.

    The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.

    Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.

    Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

    In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

    “As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.

    During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.

    General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).

    “We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”

    The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.

    Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

  • Durbin Decries Menthol Vape Order

    Durbin Decries Menthol Vape Order

    Senator Dick Durbin
    Credit: Dick Durbin

    When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Senator Dick Durbin was disappointed. He said the agency should have done better. The move marks the first nontobacco-flavored e-cigarette products to be authorized by the FDA.

    “Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”

    Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a committee hearing titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use and the role that flavors—such as menthol—play in youth use of tobacco products and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.

    Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s hearing, said he applauds the FDA’s decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.

    “The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern—the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.

    “Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”

  • Vape Registry Rule Slipped Into NC Bill

    Vape Registry Rule Slipped Into NC Bill

    North Carolina State House of Representatives Chamber (Credit: J Zehnder)

    A new bill in North Carolina, if passed, would require the state to certify vaping and other next-generation tobacco products for sale.

    The Senate Judiciary Committee approved the proposal Wednesday. It was slipped into HB 900, which deals with Wake County leadership academies and their ability to maintain state designations. The House passed it without objection.

    To become law, the bill would need to pass the Senate and then the House before the end of the session. Senate leaders have said they plan to complete their work by the end of the month, local media reports.

    The chambers, both controlled by Republicans, have been unable to come to an agreement on budget modifications for the fiscal year that begins July 1.

    A North Carolina lawmaker wrongly told other lawmakers during debate that the U.S. Food and Drug Administration regulates the products, but the regulatory agency does not have the ability to check which products are being sold.

    The bill would fine retailers who sell products that aren’t on the registry for initial violations. The legislation could also suspend or revoke the establishment’s license.

    Vaping industry representatives warned lawmakers that the bill will cost people jobs and money.

    PMTA registry laws are already being enforced in Alabama, Louisiana and Oklahoma. Wisconsin passed a registry law in December and will become effective July 1, 2025. 

    Utah also passed a registry bill that included a flavor ban that will become active on Jan. 1, 2025, and Florida has a unique registry that also begins Jan. 1, 2025.

  • Romania Bans E-cig and Pouch Advertising

    Romania Bans E-cig and Pouch Advertising

    Photo: xpable

    Romania’s Chamber of Deputies adopted a bill banning advertising of electronic cigarettes and nicotine pouches this week, reports Romania Insider.

    “It is prohibited to explicitly advertise tobacco products, electronic cigarettes, including vape types, products intended for inhalation without burning from tobacco substitutes, electronic devices for heating tobacco, and products intended for inhalation without burning from tobacco substitutes as well as nicotine pouches for oral use (pouches) broadcast within radio and television programs and on public transport tickets,” the bill states. 

    The bill also bans advertising for these products within educational institutions and healthcare facilities or within 200 meters of their entrances. Advertising is also banned in publications primarily intended for minors and in theaters before, during and after performances intended for minors. Ads are banned that target minors, depict minors consuming these products, suggest these products have therapeutic properties or have a stimulating, sedative effect or can solve personal problems, give a negative image of abstinence or do not contain warning inscriptions in Romanian.

  • South Africa Urged to Beef Up Tobacco Laws

    South Africa Urged to Beef Up Tobacco Laws

    Photo: poco_bw

    Nearly one third of South Africans smoke, according to the 2021 Global Adult Tobacco Survey (GATS) South Africa report, which was released by the Department of Health on June 13, 2024.

    The study found that 21.2 percent of adults in South Africa smoke daily, while 4.6 percent smoke occasionally. Daily smokers light up an average of 8.5 cigarettes per day.

    The data also revealed that a higher percentage of men (41.7 percent) are currently using tobacco compared to women (17.9 percent).

    Meanwhile, 2.2 percent of survey respondents said they were currently using e-cigarettes, of which 3.8 percent are men and 0.7 percent are women.

     Of those using e-cigarettes, 70.3 percent cited enjoyment, 67.5 percent cited flavor, 45.1 percent perceived it as less harmful than tobacco, while 43.5 percent said their use was influenced by friends or family members who use e-cigarettes.

    The study also found that 3.1 percent of adults reported smoking hookah pipe.

    Data also shows that 74.4 percent of adults who visited public places were exposed to second-hand smoke.

    The Department of Health’s Deputy Director of General Primary Healthcare, Jeanette Hunter urged the government to adopt new measures to discourage tobacco use, including stronger tobacco taxes, smoke-free laws, graphic health warnings and bans on advertising.

    “Effective strategies to reduce tobacco use, including putting in place more comprehensive laws that are compliant with the WHO Framework Convention on Tobacco Control, should be implemented to protect more people from exposure to SHS, and provide cessation services to help more people who smoke to quit,” Egbe was quoted as saying by the South African Government News Agency.

  • U.S. Top Court May Tame ‘Chevron Doctrine’

    U.S. Top Court May Tame ‘Chevron Doctrine’

    Photo: maurice norbert

    The U.S. Supreme Court may overturn a legal doctrine that according to some vapor industry advocates has allowed the Food and Drug Administration to reach beyond its legal authority, reports Reuters, citing legal scholars.

    Known as Chevron deference, the doctrine calls for judges to defer to federal agency interpretations of U.S. laws that are deemed to be ambiguous. This doctrine, among the most important principles in administrative law, arose from a 1984 Supreme Court ruling involving oil company Chevron.

    It is opposed by conservatives and business interests but supported by liberals who favor robust corporate regulation. Vaping activists contend that the Chevron doctrine has, among other things, enabled the FDA to essentially ban all nontobacco-flavored e-cigarettes.

    The U.S. Chamber of Commerce, which represents more than 300,000 businesses, has argued that Chevron deference has let Congress “outsource core policy decisions (particularly controversial ones) to agencies through broadly worded statutes.” That has given the agencies, it added, “free rein to enact their own new regulatory requirements through sweeping rulemakings or after-the-fact enforcement actions.”

    Many legal scholars expect the Supreme Court, which has a 6-3 conservative majority, to scale back or overturn the Chevron doctrine in a case in which fishing companies are seeking to avoid bearing costs associated with a government-run program to monitor for overfishing of herring off New England’s coast. The suit is part of a broader conservative project to strip away regulatory power from federal agencies.

    The justices heard arguments in the case on Jan. 17 and are expected to rule on the case by the end of June.

  • New U.S. Task Force to Combat Illegal Vapes

    New U.S. Task Force to Combat Illegal Vapes

    Photo: Orhan Çam

    The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration have established a federal task force to combat the distribution and sale of illegal vaping products.

    “Enforcement against illegal e-cigarettes is a multipronged issue that necessitates a multipronged response,” said Brian King, director of the FDA’s Center for Tobacco Products.

    In addition to the FDA and the DOJ, partners in the task force will include the Bureau of Alcohol, Tobacco, Firearms and Explosives; the U.S. Marshals Service; the U.S. Postal Inspection Service; and the Federal Trade Commission (FTC).

    “Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans—particularly children and adolescents—across the country,” said acting Associate Attorney General Benjamin Mizer. “This interagency task force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this task force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority.”

    The federal task force will focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the Prevent All Cigarette Trafficking Act; the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; and other authorities.

    “The U.S. Marshals Service asset forfeiture division stands ready to work with our task force partners in the seizure of unauthorized e-cigarettes from domestic distributors seeking to sell them unlawfully,” said Ronald Davis, director of the U.S. Marshals Service.

    “The Justice Department is committed to enforcing the laws that prevent the sale and distribution of unlawful e-cigarettes,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the DOJ’s civil division. “We will work closely with our task force partners to address this crisis with all of the enforcement tools available to us.”

    The FTC, which releases reports about cigarette, smokeless tobacco and e-cigarette marketing and enforces various statutory and regulatory prohibitions on false and misleading advertising, will support the task force’s activities, including by sharing its knowledge about the marketplace for vaping products.

    “We look forward to sharing our experience with this rapidly changing, multibillion-dollar market through this important task force,” said Samuel A.A. Levine, director of the FTC’s Bureau of Consumer Protection.