Category: Regulation

Attorneys General Urge Menthol Ban

Credit: Jet City Image
A coalition of 21 state attorneys general submitted a letter to the White House Office of Management and Budget urging the Biden administration to complete its review and swiftly implement proposed bans on menthol cigarettes and flavored cigars.
“The proposed FDA rules, which are supported by ample evidence, have been long overdue,” said California Attorney General Rob Bonta in a press release. “In today’s letter, the coalition specifically highlights calls for action by civil rights and public health groups to remove menthol tobacco products from the marketplace to protect public health and address the systemic and disproportionate impact of these products on minority communities and other vulnerable populations, including young people.”
Bonta said tobacco companies have intentionally targeted specific communities across the nation, particularly communities of color, which has contributed to significant health disparities and inequities.
“The time to act is now,” said Bonta. “I urge the Biden Administration to finally halt the sale of these flavored tobacco products, which will lay the groundwork to reverse decades of disparities in tobacco use and save lives.”
In the letter, the multistate coalition urges the Biden Administration to finalize its review of the U.S. Food and Drug Administration’s proposed rules without delay.
“As state and territorial chief legal officers, the attorneys general address unfounded claims that the proposed menthol ban will increase illicit trade or criminalize the individual purchase, possession, or use of menthol cigarettes and flavored cigars,” the letter states. “The coalition argues that the FDA’s proposed rules are critical steps for advancing health equity and protecting public health. Moreover, banning menthol cigarettes and flavored cigars will bring the country closer to achieving the Cancer Moonshot, President Biden’s historic push “to end cancer as we know it.”
Bonta co-leads the attorneys general of Arizona, Connecticut, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Mexico, New York, North Carolina, North Mariana Islands, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, and District of Columbia.
A copy of the letter can be found here.
January 16, 2024
Taxes had ‘No Impact’ on Singapore’s Vape Ban

The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.
In his reply to a question by a Workers’ Party and Sengkang member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”
… our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

Lawrence Wong
Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today,” according to a Yahoo news report.
“In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans,” he said.
January 12, 2024
Durbin Blasts FDA Failures in Vape Rules

U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.
In a press release, Durbin stated that he has repeatedly criticized the FDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.
FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.
During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.
“I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”
The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
January 12, 2024
Supermarkets Dodging Ban With Tobacco Shops

Dutch supermarkets are opening specialist tobacco shops next to their food retail stores in anticipation of a tobacco sales ban set to come into force on July 1, reports Dutch News.
Beginning in July, the Netherlands will prohibit supermarkets from selling cigarettes and rolling tobacco, but tobacconist shops can be opened without a license.
TabakNee, an anti-tobacco group, is pushing for the introduction of licenses to sell tobacco.
“There was a lot of demand,” said Rolf Hoogkamer, a Jumbo franchise owner who opened a specialist store next to his shop. “It is often older people who live in the flats near here and can’t walk far. They can now easily still pick up [their cigarettes] and that is a good thing.”
“There is a 7.5 percent profit margin on each packet,” said Hoogkamer. The total tobacco product market reached €4.4 billion ($4.8 billion) in 2020, €2.4 billion of which came from supermarkets.
“Some 7 percent of our turnover comes from tobacco, so you are talking about €700 million a year,” Jumbo chief executive Ton van Veen said.
The outgoing government has raised taxes, bringing the price of a 20-pack of cigarettes to €10, banned advertising and introduced plain packaging. Tobacco sales will be restricted to specialist stores only by 2032.
The government agreed to leave the issue of tobacco shop licensing to the next administration.
January 10, 2024
Oman Bans Shisha and Vaping Products

Credit: YTA
The chairman of the Consumer Protection Authority states that a fine of up to OMR2,000 ($5,196) for multiple violations will be imposed on anyone who trades in e-cigarettes, shisha, and their accessories in the Sultanate of Oman.
His Excellency Sulayem bin Ali Al-Hakmani issued Ministerial decision No. 756/2023 on Sunday, January 7, 2024, creating the ban, according to media reports.
Article One stipulates that the circulation of e-cigarettes, shisha, and their accessories is prohibited.
Article Two states that, “without prejudice to the penal penalties stipulated in the aforementioned Consumer Protection Law, an administrative fine not exceeding OMR1,000 shall be imposed on anyone who violates the provisions of this decision, and the fine shall be doubled in the event of a repeat violation.
Credit: Helga Bragina
“If this violation continues, an administrative fine of OMR 50 will be imposed for each day that the violation continues, provided that its total does not exceed OMR 2,000. The seized quantities of electronic cigarettes, shishas, and their accessories will be destroyed in accordance with the controls in force at the Consumer Protection Authority.”
The new bill also repealed an earlier Resolution (No. 698/2015), as well as any laws or rules that contravene the current resolution or conflict with its provisions.
It also stipulates that the decision “shall be published in the Official Gazette, and shall be effective from the day following the date of its publication.”
January 8, 2024
Thailand Urged to Strengthen Enforcement

Photo: kikujungboy
Thailand should strengthen its monitoring and enforcement of e-cigarettes, according to World Health Organization representative Jos Vandelaer, reports The Nation.
Speaking at the Thai Health Promotion Foundation on Dec. 18, Vanderlaer praised the kingdom’s decision to prohibit vaping in the country.
However, because vaping is still widespread in Thailand, he believes the government must do a better job of enforcing the law.
Vandelaer rejected the notion that e-cigarettes are an effective smoking cessation tool, as claimed by tobacco harm reduction activists. “Don’t get fooled,” he was quoted as saying. “There is as of now no evidence that the commercialization of e-cigarettes as consumer products has had a net benefit for public health.”
According to a recent study by the Faculty of Medicine Ramathibodi Hospital, 8.8 percent of Thais aged 13 to 15 used e-cigarettes in 2021, up from 3.3 percent in 2015.
Vanderlaer’s comments come in the wake of a WHO statement urging action to prevent the uptake of e-cigarettes to counter nicotine addiction. On the same day, the global health body released a technical note with detailed information on the evidence and factors underpinning its guidance.
December 20, 2023
CTP Releases Strategic Plan

Image: Tada Images
On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.
The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.
King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.
In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.
December 18, 2023
FDA Asked to Clarify PMTA Process

Photo: Me studio
U.S. senators Ted Budd, Rand Paul and Joe Manchin, sent a letter to Food and Drug Administration Commissioner Robert Califf requesting he explain and clarify the FDA’s approach to nicotine product regulation and urging him to reform the tobacco product application process, according to Vaping360.
“Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S.,” the senators wrote.
“Of those 26 million applications, the CTP [Center for Tobacco Products] has authorized fewer than 50. Remarkably, it has also authorized a total of only 16 modified-risk tobacco products (MRTPs) for only four unique products and their accessories.
“This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk. The availability of scientifically substantiated, authorized PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”
The Tobacco Control Act requires that the CTP review and decide on PMTAs and MRTPs within 180 days, however, the FDA has not delivered on this timeline.
The senators cited the Reagan-Udall Foundation’s report on the CTP and posed a series of questions to Califf.
The senators are asking Califf to respond to their questions within 30 days.
December 15, 2023
Malaysia Tobacco Law Passes Upper House

Photo: natatravel
Malaysia’s upper house of Parliament has passed the Control of Smoking Products for Public Health Bill 2023, reports The Star. Earlier, the legislation had been approved by the country’s lower house.
The legislation prohibits the sale and purchase of tobacco products, smoking materials of smoking substitute products and providing any smoking-services to minors.
A provision banning the sale of tobacco products to individuals born from Jan. 1, 2007, onwards in an earlier version of the legislation was dropped.
The so-called generational tobacco ban (GEG) was abandoned after the Attorney General’s Chambers suggested it might violate the constitution by creating different rules for different age groups. Critics however blamed tobacco industry pressure for Malasia’s U-turn.
A day earlier, Malaysia’s newly appointed health minister, Dzulkefly Ahmad, expressed his regrets for the GEG exclusion.
He noted that 18 engagement sessions with stakeholders and three roundtable discussions had taken place before the bill was finalized.
“However, human plans, and Allah decides, and fate has placed us here today, where you cannot see or read the GEG provisions in this bill,” said Ahmad. “I apologize sincerely.”
In related news, new figures suggested that vaping has overtaken smoking as the main method of nicotine consumption among young Malaysians. According to the Southeast Asian Tobacco Control (SEATCO) Alliance, e-cigarette use among this age group is about 30 percent, compared with 12.5 percent for smoking.
“Claims of harm reduction are unproven and deceptive,” said SEATCO. “It is more accurate to say this is harm initiation for youths that have never smoked and harm substitution for smokers trying to quit,” it added.
The organization called on Malaysia to follow the example of neighboring countries that have banned e-cigarettes. Vapor products are prohibited in Brunei, Cambodia, Laos, Singapore and Thailand.
December 15, 2023
Argentina Asked to Repeal E-cigarette Ban

Image: simonmayer
The Argentinean vapers’ association, Asovape Argentina, and the World Vapers’ Alliance have sent an open letter Argentina’s recently elected president, Javier Milei, calling for the repeal of the National Administration of Medicines, Food and Medical Technology Provision 3226/2011 banning the commercialization of e-cigarettes.
The provision banned the import, distribution, marketing, advertising and promotion of e-cigarettes. It went into effect May 6, 2011.
The letter explains that numerous studies conducted since the ban took effect have demonstrated the significantly lower risk profile and the usefulness of e-cigarettes for smoking cessation as well as the low health risk of nicotine. The signatories also argue that the ban is incompatible with respect for the individual freedom of Argentinian adults and the rights to free development of personality, information and health of users and smokers.
“The ban violates the rights and freedoms of Argentine adults and should be repealed,” said Juan Facundo Teme, president of Asovape Argentina, in a statement. “The state is not the one to tell Argentines how to consume nicotine and should respect the decisions of individuals who choose to vape in order to consume it in a less harmful way. Moreover, all the arguments on which the ban was based have been disproved.”
Argentina has a smoking rate of 24.5 percent, the second highest in Latin America and one of the highest in the world.
“Smoking is a huge problem for Argentina, and the ban has only exacerbated it,” said Teme. “It spreads the misconception that vaping is the same or worse than smoking, makes it difficult for millions of smokers to switch to a safer alternative and has pushed thousands of vapers back to tobacco. With clear information and proper regulation of vaping, we could reduce smoking rates quickly and significantly.”

Argentina should respect smokers who choose to consume nicotine in a less harmful way.
Alberto Gomez Hernandez, policy manager, WVA
“Argentina is one of the most restrictive countries on vaping in the whole region and consequently has one of the highest smoking rates,” said Alberto Gomez Hernandez, policy manager of the World Vapers’ Alliance. “It is second only to Chile, which has just passed a law regulating vaping to allow adults to use it to quit smoking, as Brazil is also working to do. Argentina should not lag behind and should respect smokers who choose to consume nicotine in a less harmful way.”
Michael Landl, director of the World Vapers’ Alliance, added, “Argentina’s approach to vaping is outdated and irreconcilable with upholding the individual freedom of consumers. Argentina now has a great opportunity to take the lead and adopt the approach of countries like Sweden or the U.K., which respect users’ right to choose while improving public health. Sweden is on the verge of becoming the first smoke-free country thanks to this approach, and the U.K. is reducing its smoking rate rapidly. We encourage President Milei and his government to follow these examples. Vaping is not a crime and should be legalized immediately.”
December 13, 2023