Tag: regulation

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.
December 19, 2024
Denver, Colorado Again Passes Tobacco Flavor Ban

Credit: Marek Photo Design
On Monday evening, the Denver City Council passed the final reading of an ordinance that will ban the sale of flavored tobacco products in the city. The ban passed by a vote of 11-1.
The law, which still needs the signature of Mayor Mike Johnson, will go into effect in 90 days and will ban the sale of all forms of flavored tobacco, including cigars and pipe tobacco, as well as flavored vaping products. It does not apply to flavored tobacco intended to be smoked in a hookah that is sold at a hookah tobacco retailer.
Retailers who violate the ban will face suspensions of their privilege to sell tobacco products should they receive two or more violations within the one-year window. Suspensions start at least 30 days and increase to a year for four or more violations. Additionally, that window will go wider in the coming years; as of Jan. 1, 2027, two violations in two years earn a 30-day suspension.
A total of 34 individuals signed up to present comments to the council, which limited the public comment portion to 30 minutes before the vote. People came to speak in support of and in opposition to the ordinance; retailers told the council that a ban would hurt numerous businesses and cost the city tax revenue, as customers would take their businesses elsewhere. A council member indicated that 15 of the 18 municipalities that border Denver do not have similar bans in place.
Retailers also said they would shift sales to the unregulated black market while taking ancillary purchases, usually made at convenience stores, into other cities and towns. One retailer noted that 536 tobacco retail stores in the city will be adversely affected by the ban. Other retailers also said that the council failed to adequately work with retailers in developing the ban and enforcing its existing laws on sales to minors.
Speakers connected to law enforcement also suggested that it would fuel the growth of the black market, which comes with increased criminal activity and products of inferior quality that could pose an even greater health risk, Halfwheel reports.
The Cigar Association of America wrote to the council to oppose the ban, saying in a Dec. 3 letter that “this blanket approach is a disproportionate and ineffective attempt to address any issues of youth usage, especially considering that the only facts and allegations presented as justification for the Proposed Ordinance relate to other product categories – such as vapor and cigarette products.”
A representative from Mayor Mike Johnston told Denver7.com that “we’re committed to protecting youth health through common sense measures, and Mayor Johnston would be in support of this initiative should Council pass it.”
The ordinance does not make it illegal to use a tobacco product, with city representatives telling the council that a person would not be stopped and cited for using a flavored tobacco product.
In 2021, the Denver City Council passed a similar ban, only to have it vetoed by then-Mayor Michael Hancock. The council came up one vote short of overriding the ban.
December 17, 2024
PMI to Pay $1.2 Million for Violating D.C. Flavor Ban

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Philip Morris International’s subsidiary Swedish Match North America (SMNA) will pay $1.2 million to settle an investigation into violations of Washington D.C.’s flavored tobacco ban.
The District of Columbia attorney general’s office said it had found evidence that SMNA facilitated online sales of “tens of thousands” of flavored Zyn nicotine pouches to D.C. consumers between October 1, 2022, when the ban was enacted, and June 30, 2024.
PMI, which acquired a 90% stake in Swedish Match for $16 billion in November 2022, must now monitor its distributor’s compliance with D.C.’s ban quarterly and stop sales of flavored Zyn pouches through Zyn.com and related e-commerce platforms, the AG’s office said on Friday.
Nicotine pouches became the second most commonly used tobacco product in the U.S., according to a report by the Centers for Disease Control and Prevention.
The tobacco giant suspended sales on Zyn.com after it had been issued a subpoena by the D.C. attorney general earlier this year, according to Reuters reports.
Swedish Match would continue to focus on its brick-and-mortar stores, PMI said in an emailed statement. Sales of Zyn, which PMI says does not contain tobacco, have surged, growing 41.1% in PMI’s most recent quarterly results.
The company, which has been looking to move beyond traditional cigarettes, has also expanded production to counter Zyn supply shortages in the U.S. amid a budding black market for nicotine pouches.
December 15, 2024
FDA Sends Nicotine Limits Proposal to White House

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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.
December 12, 2024
New Kentucky Vape Rules Start on New Year’s Day

Credit: Andreykr
A law taking effect on Jan. 1 will limit what smoke shops in Kentucky can sell.
Kentucky House Bill 11 will make disposable vape products illegal and place restrictions on other vape products based on their status with the Food and Drug Administration.
FOX 19 spoke with Jay Armstrong from Dripwell Vapors in Fort Wright, who said he opposed the law.
“I think it’s a huge waste of time, and all it’s going to do is hurt the legitimate businesses that are doing things right,” Armstrong said.
Armstrong explained that enforcement of policies like this seems to be lacking. He said that he rarely sees anyone come into the store to make sure they’re selling products that they’re allowed to sell.
“People are going to go where they can get what they want,” Armstrong explained. He believes stores will be selling banned products, while stores that follow the rules will lose profits.
Ben Chandler with the Foundation for a Healthy Kentucky told FOX 19 that the new law would be a step in the right direction.
“It’s a start,” Chandler said. “It’s got lots of holes in it that need to be closed.”
December 10, 2024
Rhode Island Shop Owners Sue Over Flavor Ban

Rhode Island State House in Providence, Rhode Island. (Credit Design Pics)
Two Rhode Island businesses are challenging the impending statewide ban preventing them from selling flavored vaping products.
Vaporetti LLC, an East Providence vape shop, and Sunshine Vape LLC, which runs three stores in Providence, Warwick and South Kingstown, filed a lawsuit against the Rhode Island Department of Revenue, Division of Taxation and Department of Health last month in an attempt to block the statewide ban.
The business owners are asking the court to stop the “unconstitutional” and “unlawful” ban from taking effect on Jan. 1, 2025, media reports. Gov. Dan McKee signed the statewide ban, which was included in his $14 million budget proposal for the next fiscal year, into law over the summer.
In the lawsuit, the business owners warned that the ban would severely impact their bottom lines and force their inevitable closures. “Each [business] derives more than 70% of its annual sales revenue from flavored ENDS products,” the lawsuit explained. “The sale of flavored ENDS products is an integral part of [their businesses], and the viability of their businesses is directly related to their ability to sell these products.”
If enforced, the ban “will prove fatal to these businesses because they cannot survive the loss of nearly three quarters of their revenue.” In the lawsuit, the business owners also stressed that the ban may do more harm than good.
December 6, 2024
FDA Issues Warnings to 115 Retailers for Illegal Sales

Credit: Marcus Krauss
The U.S. Food and Drug Administration issued warning letters to 115 brick-and-mortar retailers for selling unauthorized vaping products. The warning letters cite the sale of disposable e-cigarette products owned by Chinese manufacturers and marketed under popular brand names, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar.
The warning letters result from the FDA’s ongoing enforcement efforts, in coordination with state partners, to identify and crack down on the sale of unauthorized e-cigarettes, according to the agency. FDA has contracts with states, territories, or third-party entities to assist with compliance check inspections of retail establishments.
Findings from the 2024 National Youth Tobacco Survey indicated that 5.8 percent of current youth e-cigarette users reported using products under the Geek Bar brand. FDA’s review of additional rapid surveillance data and preliminary data from the Population Assessment of Tobacco and Health Study has also identified the brand as popular or youth-appealing.
Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.
A new tobacco product must have FDA authorization before it can be legally marketed, and generally, products without authorization are at risk of enforcement action. To date, the FDA has authorized 34 e-cigarette products and devices.
December 5, 2024
SCOTUS to Hear Triton Vaping Case Next Week

Credit: Renas Child
In one week, the U.S. Supreme Court will 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 live audio of the hearing can be found here.
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.
The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.
Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications.
In January, the full slate of 5th Circuit judges ruled 10-6 that the FDA had been arbitrary and capricious, in violation of a federal law called the Administrative Procedure Act, by denying the applications without considering plans by the companies to prevent underage access and use.
November 25, 2024
Surgeon General Releases Report on Tobacco Use
Vivek Murthy
The Surgeon General of the United States released a new report on health disparities related to tobacco use. The report finds that despite the nation’s substantial progress in reducing cigarette smoking and secondhand smoke exposure in the overall U.S. population, that progress has not been equal for all population groups.
Disparities in tobacco use persist by race and ethnicity, income, education, sexual orientation and gender identity, occupation, geography, behavioral health status, and other factors. Additionally, cigarette smoking and secondhand smoke exposure continue to cause nearly half a million deaths a year in the United States—nearly one in five of all deaths.
“Tobacco use continues to decline. Americans increasingly understand tobacco products are dangerous and addictive and many are taking advantage of available tools to help them quit. That’s great news,” said Xavier Becerra, HHS Secretary for Health. “Smoking is still the leading cause of preventable death in the United States. That’s unacceptable. We will keep working until tobacco is no longer a menace to individuals and families across the nation. We will continue our efforts to improve health equity and support communities that remain the most vulnerable.”
This report expands upon the 1998 Surgeon General’s report on tobacco use among U.S. racial and ethnic groups to include data and trends by additional demographic factors and their intersection. This report also summarizes research on factors that influence tobacco-related disparities, and outlines actions everyone can take to eliminate these disparities and advance health equity in the United States.
“Tobacco use imposes a heavy toll on families across generations. Now is the time to accelerate our efforts to create a world in which zero lives are harmed by or lost to tobacco,” said Surgeon General Dr. Vivek Murthy. “This report offers a vision for a tobacco-free future, focused on those who bear the greatest burden, and serves as a call to action for all people to play a role in realizing that vision.”
Tobacco-Related Disparities Today
Smoking has declined more than 70% in the United States since 1965. However, progress achieved through improvements in tobacco-related policies, regulations, programs, research, clinical care, and other areas, has not resulted in the same outcomes across all U.S. population groups.
Cigarette smoking is higher among American Indian and Alaska Native people than other racial and ethnic groups, and smoking among men and women living in poverty is more than twice as common compared to those not living in poverty. Smoking is also higher among adults with lower levels of education; people who identify as gay, lesbian, or bisexual; adults who work in manual labor and service jobs; people who reside in rural areas; adults who reside in the Midwest or South; and people living with a mental health condition or substance use disorder.
Despite the good news that deaths due to secondhand tobacco smoke exposure have declined by more than 50% since 2006, among people who don’t smoke, secondhand smoke exposure remains disproportionately high among children, Black people, people with lower incomes, and adults with lower levels of education. The magnitude of these disparities has increased since 2000.
“While there is much to celebrate, the progress has not been equal across all populations or communities. Progress, in the form of improvements in tobacco-related policies, regulations, programs, research, clinical care, and other areas, has not resulted in the same outcomes for everyone,” said Adm. Rachel L. Levine, HHS Assistant Secretary for Health. “We have not made progress unless we have all made progress.”
While cigarette smoking remains the leading preventable cause of disease and death in the United States, disparities exist in smoking-related health outcomes. For example, American Indian and Alaska Native adults have the highest prevalence of COPD, and Black men have the highest incidence and death rate due to lung cancer of any racial and ethnic group of men or women.
Factors that Influence Tobacco-Related Disparities
Multiple factors influence tobacco-related health disparities, including:

Poverty, racism, discrimination, and other social determinants of health—such as where people live, how much money they make, access to health care – and exposure to tobacco product advertising and marketing.
The tobacco industry, whose tactics include concentrated marketing of tobacco products in neighborhoods with greater percentages of Black and Hispanic people, and residents with lower incomes; and marketing flavored products, including menthol, to specific groups. Menthol can make it easier to start smoking and harder to quit.
Financial and other obstacles to accessing treatments proven to help people quit using tobacco.
Social and environmental influences, such as whether family and friends smoke, smokefree air policies at home and work, and stress and exposure to dangers in the workplace.
Gaps in tobacco prevention and control protections, such as smokefree air policies.
Preemptive laws that block communities from protecting their members’ health.
What Can be Done to Eliminate Tobacco-Related Disparities
Everyone has a role to play in eliminating tobacco-related disparities, according to a press release.
“To do this, we must:

Address the factors that influence tobacco-related disparities, such as inequitable access to health care; high-quality education; and safe, smokefree housing and workplaces.
Drive down the appeal, addictiveness, and availability of commercial tobacco products, such as by placing restrictions on the sale of flavored tobacco products, establishing a maximum nicotine yield to reduce the addictiveness of cigarettes and other combusted tobacco products, and regulating the number of stores that sell tobacco.
Equitably implement strategies proven to reduce commercial tobacco use and exposure to secondhand smoke. These strategies include tobacco product price increases, comprehensive smokefree air policies, effective counter-marketing and media campaigns, and evidence-based quitting resources.
Encourage friends, family members, and coworkers—including youth—to quit the use of tobacco products and support them in getting help to quit through resources, such as 1-800-QUIT-NOW and smokefree.gov.”
For Surgeon General’s report information and resources, including the full report, a report executive summary, a consumer guide, and fact sheets, visit www.SurgeonGeneral.gov or www.CDC.gov/EndTobaccoDisparities
November 19, 2024
THR Group Asks Kazakhstan to Reassess Policies
Credit: Zero Photo
The Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA) today called on the government of Kazakhstan to reassess its stance on tobacco harm reduction (THR) products, citing compelling evidence from Japan demonstrating the significant health and economic benefits of embracing safer alternatives to smoking.
A recent study published in the journal Healthcare reveals that if 50 percent of smokers in Japan switched from combustible cigarettes to heated tobacco products (HTPs), it could prevent 12 million patient cases and save JPY 454 billion in healthcare costs. This data underscores the immense potential of THR strategies in countries with high smoking rates.
Nancy Loucas, the executive coordinator of CAPHRA, stated that the Japanese example clearly illustrates that HTPs can be an effective harm reduction tool in nations where smoking prevalence remains high, and other safer nicotine products are unavailable.
“Kazakhstan, with its significant gender disparity in smoking rates and tobacco-related health issues, could greatly benefit from adopting a more progressive approach to THR. Kazakhstan’s current policies treat all nicotine products, including less harmful alternatives, the same as traditional cigarettes,” Loucas explains in an e-mailed release. “This approach, coupled with the recent ban on vapes and high taxes on smokeless alternatives, demonstrates a concerning lack of acceptance for harm reduction strategies.
“By ignoring the potential of THR products, Kazakhstan is missing a crucial opportunity to save lives,” Loucas added. “Our analysis suggests that embracing harm reduction policies could prevent 165,000 premature deaths in Kazakhstan over the next four decades.
The government must reconsider its stance for public health, stated Loucas. CAPHRA urges Kazakh policymakers to:

Review and revise current regulations to differentiate between combustible cigarettes and less harmful alternatives.
Following Japan’s successful model, the introduction of HTPs should be considered as a harm reduction tool.
Engage with public health experts and THR advocates to develop evidence-based policies.
Implement a tiered taxation system encouraging smokers to switch to less harmful products.
“The time for Kazakhstan to act is now,” Loucas stated. “By embracing tobacco harm reduction, the country can significantly improve public health outcomes, reduce healthcare costs, and potentially narrow the life expectancy gap between men and women. We stand ready to support Kazakhstan in developing and implementing effective THR policies.”
November 18, 2024