Category: Regulation

FDA Launches Online Vaping Resource Center

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The U.S. Food and Drug Administration has launched the Vaping Prevention and Education Resource Center, which provides free science-based, standards-mapped materials that teachers can use to help their students understand the risks associated with vaping and nicotine addiction. The Center for Tobacco Products also developed free materials for parents and teens.
Teachers will find lesson plans, interactive tools, infographics and videos with tobacco facts and tips about how to teach teens about the dangers of vaping.
Parents will find fact sheets, videos and resources to help them understand and recognize vapes, talk with their children and keep the conversation going over time.
According to the FDA, students will find real-life stories and relatable content to help them understand vaping, nicotine addiction, common myths about vapes and how to say no to vaping.
The resource center will be continuously updated, according to the FDA.
January 19, 2023
Mexico Tightens Tobacco Laws

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Mexico has banned smoking in public places, reports Mexico News Daily.
The country has also prohibited the advertising, promotion and sponsorship of tobacco products, which means that cigarettes cannot be displayed inside shops. E-cigarettes and heated-tobacco products are also facing tighter new restrictions, particularly indoors, as per BBC. Last year, Mexico banned the import, sale and distribution of vaping and heated-tobacco products.
Several other Latin American countries have also passed legislation to create smoke-free public spaces. Last year, for example, Panamanian President Laurentino Cortizo also signed legislation banning the sale of vapor products in his country.
However, Mexico’s legislation is considered to be the most wide-ranging in the Americas.
Critics have cautioned against unintended consequences. Given the prevalence of corruption in Mexico, they fear that some police officers will use the smoking ban as a pretext for demanding bribes.
January 17, 2023
Taiwan Lawmakers Approve Vape Ban

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Lawmakers in Taiwan approved amendments to the Tobacco Hazards Prevention Act that would ban e-cigarettes, raise the legal buying age for combustibles and require heated-tobacco products to comply with strict regulations, reports Taiwan News.
People caught using unauthorized vapor products or tobacco-heating devices risk fines of between TWD2,000 ($66) and TWD10,000.
Manufacturers and sellers of such products would be required to submit health risk assessment reports backed by product samples. Unauthorized tobacco manufacturers, importers and advertisers are subject to fines ranging from TWD10 million to TWD50 million, according to the amendments.
Other changes involve raising the legal smoking age from 18 to 20, increasing the proportion of tobacco package warning messages from 35 percent to 50 percent and designating childcare centers and schools as no-smoking areas.
The amendments to the Tobacco Hazards Prevention Act were proposed in part due to concern about the growing popularity of vaping among youth.
The share of e-cigarette users in junior high schools grew from 1.9 percent in 2018 to 3.9 percent in 2021, according to a survey by the Health Promotion Administration, while the share in senior high and vocational schools rose from 3.4 percent to 8.8 percent during the same period. Some critics blame flavors for the increase.
The clauses on e-cigarettes and heated-tobacco products are to take effect one month after the amendments’ contents are announced to the public. The clauses on vapes with additional flavors as well as regulations on packaging are to take effect one year after the amendments are announced.
The last time the Tobacco Hazards Prevention Act was amended was in 2009.
January 13, 2023
New Zealand Solicits Feedback on New Rules

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New Zealand’s government is seeking feedback on measures to help reduce the number of young people vaping, reports The Times Online.
According to Associate Health Minister Ayesha Verrall, vaping is becoming increasingly popular among New Zealand youth, including among youngsters who have never smoked.
“Vaping has a role to play in ensuring smokers who wish to quit smoking can do so using vaping products; however, youth vaping rates are too high, and we need to strike a better balance,” she was quoted as saying.
The proposed measures include proximity restrictions for all new specialist vape retailers, so they are not near schools and sports grounds; restrictions on flavor names to avoid attracting youth; and restrictions on single-use vaping products, which are cheaper and more easily accessible than other e-cigarettes.
In addition, the government wants to reduce the maximum concentration of nicotine salts in single-use products from 50 mg/mL to 35 mg/mL and require vaping companies to print serial or batch numbers on their products to make them traceable.
The consultation document is available on the Ministry of Health website with submissions closing at 5 p.m. on March 15.
January 11, 2023
Vietnam Wants to Ban New Tobacco Products

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Vietnam’s Ministry of Health has called for a ban on all new tobacco products following the publication of a study suggesting that youth vaping has led to more hospitalizations for psychosis, hallucinations or respiratory failure, reports VietnamPlus.
A recent study found that the e-cigarette smoking rate among students increased to 3.5 percent in 2021 from 2.6 percent in 2019, according to Nguyen Thi Thu Huong, an official from the Vietnam Tobacco Control Fund at the Ministry of Health.
“E-cigarette devices that look like USB drives, pen or pen boxes are making it tough for parents to detect and keep their kids from vaping,” said Nguyen Huu Hoang, a lecturer from the Medical Education Center at Ho Chi Minh City’s University of Medicine and Pharmacy. “They also make young people curious and excited by their eye-catching, fashionable and modern designs.”
January 10, 2023
Menthol and Nicotine Timelines Accelerated

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The Biden administration released its Unified Agenda and Regulatory Plan for fall 2022, which includes moving forward the timeline for a federal ban on menthol-flavored cigarettes, reports The Winston-Salem Journal.
There are eight rules that address the tobacco industry, and three have “notable changes” from the spring 2022 plan, according to Jain Gaurav, a Barclays analyst. These include: Rules on a menthol ban in cigarettes and flavored cigars have moved to the “final rule stage” versus the “proposed rule stage”; rules to ban characterizing flavors in cigars have also progressed to the final rule stage; and the nicotine cap proposed standard development has been moved from May to October.
“We continue to believe the Food and Drug Administration’s focus is going to revolve around the evaluation of premarket tobacco [product] applications of deemed products, notably e-cigarettes, in the next few months,” Gaurav said.
“The FDA intends to publish a final (menthol) rule by August 2023. We expect a two-[year] to three-year cycle from the day FDA passes any rule to the time such rule survives the inevitable court challenges.
“We don’t expect a menthol cigarette ban from the FDA implemented (if it were to pass) at least until 2026.”
A cigarette menthol ban could have negative impacts on tobacco stocks with a significant U.S. presence, according to Gaurav and other tobacco industry analysts. Menthol cigarettes account for 35 percent of cigarettes sold in the U.S.
“While there is some risk, a federal ban on menthol cigarettes could reduce smoker initiation and potentially be a catalyst that prompts a number of smokers to quit, thereby having some negative impact on cig volumes,” said Bonnie Herzog, Goldman Sachs analyst, “we continue to believe a more likely scenario is for menthol cig users to convert to nonmenthol cig products or to reduced-risk products that have a menthol variant, such as e-vapor.”
It is expected that the FDA will face lawsuits from tobacco manufacturers and anti-smoking groups if the ban goes through because Congress exempted menthol from banned flavorings in traditional cigarettes in the federal Tobacco Control Act in 2009.
In June, the FDA issued its proposal to reduce nicotine content in traditional cigarettes to minimal and potentially nonaddictive levels as early as May 2023.
“We think it will take a decade or longer for the FDA to introduce nicotine caps due to the long nine-step process at the FDA, the inevitable litigation and then the one year given to retailers to get rid of the excess inventory,” Gaurav said.
January 9, 2023
Holland and Belgium Tighten Vaping Rules

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The Netherlands banned flavored e-cigarettes effective Jan. 1, reports The Brussels Times. Companies have until Oct. 1 to remove the flavored products from shelves; retailers can sell their current stock until that date, but new flavors may not be marketed.
Belgium plans to tighten vaping regulation as well, according to Federal Health Minister Frank Vandenbroucke.
“E-cigarettes contain some 1,800 different products of which we are far from knowing all the health consequences,” he said. “Maybe some people will switch from regular cigarettes to e-cigarettes, but maybe by using e-cigarettes, people will just end up smoking regular cigarettes.”
A ban on flavors is not currently planned in Belgium, but a royal decree will soon be published imposing more restrictions on the sale of flavored e-cigarettes. “No more trendy names will be allowed to be given to those flavors, and lights will no longer be allowed on e-cigarettes either,” said Vandenbroucke.
There will be a six-month transition period for the industry to adapt to the new rules and another six-month period to sell current stock.
January 5, 2023
New Smoking Rules in Portugal

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New smoking rules come into effect Jan. 1 in Portugal, dictating that “In catering or drinking establishments, including those with rooms or spaces intended for dancing, places where smoking is allowed in areas intended for customers may be set up, provided that these establishments have an area for customers equal to or greater than 100 square meters and a minimum ceiling height of 3 meters,” reports The Portugal News.
Spaces intended for smokers “can be constituted up to a maximum of 20 percent of the area intended for customers,” according to the law. There must be posted signs relaying maximum capacity for the spaces and “no entry for persons under 18 years of age.”
January 3, 2023
Bantam Receives PMTA Acceptance Letter

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Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its nontobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.
Bantam submitted its application for its nontobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.
“The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”
Prior to its nontobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.
December 22, 2022
California’s Flavored Tobacco Ban Begins

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California’s controversial ban on flavored tobacco begins today, reports ABC10. A week ago, the U.S. Supreme Court blocked R.J. Reynolds Tobacco Company’s contention that the new state law conflicted with federal law.
Flavored tobacco products, such as e-cigarettes, menthol cigarettes, flavored cigars and more, can no longer be sold in stores.
“If they wanted to ban flavored tobacco or regulate it, I feel they should have selected certain stores to be authorized to retail it. It’s saved so many lives, helped so many people get off cigarettes,” said Carlo Sharmoug, owner of Ziggy’s Smoke Shop in Stockton.
Sharmoug says in his 14 years in business, his store has never once sold tobacco to a minor.
Lindsey Freitas, an advocacy director representing California and Hawaii for the Campaign for Tobacco-Free Kids, says California’s tobacco rates among teens at one point began to decline until e-cigarettes appeared.
“They started being sold in flavors like grape and cherry and gummy bear. And all of a sudden, we saw our youth tobacco rates increasing again,” said Freitas.
Smoke shops like Ziggy’s say California will lose out on millions in tax revenue and believes product will be sold on the black market. However, Freitas disagrees, saying the savings in medical treatment in California alone will be huge.
December 21, 2022