The nation’s top court declined to hear the case in a brief written order handed down Monday.
R.J. Reynolds appealed to the high court after the 5th U.S. Circuit Court of Appeals found the warnings do not violate the First Amendment, the AP reports.
They include pictures of smoke-damaged lungs, feet blackened by diminished blood flow and a picture of a woman with an immense growth on her neck and the caption “WARNING: Smoking causes head and neck cancer.”
Nearly 120 countries worldwide have adopted more prominent, graphic warning labels. Studies from those countries suggest that image-based labels are more effective than text warnings at publicizing smoking risks and encouraging smokers to quit. The U.S. has not updated its labels since 1984.
It’s not clear when new labels might appear. Some legal claims remain, and the FDA has said it doesn’t plan to enforce any new requirements until at least December 2025.
The U.S. Supreme Court will next week 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, filed premarket tobacco product 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.”
The FDA rejected the companies’ applications, along with more than 1 million other products.
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 5th Circuit ruled that the FDA had been arbitrary and capricious by denying the applications without considering plans by the companies to prevent underage access and use.
New research by leading international health experts has found that more than 400,000 Nigerian lives could be saved if policymakers adopt a progressive approach to tobacco harm reduction (THR).
The report, released on Nov. 19, outlines how integrating alternative nicotine products such as vapes and nicotine pouches into Nigeria’s tobacco control framework could dramatically reduce the nation’s smoking-related death toll.
According to the report, Saving 600,000 Lives in Nigeria and Kenya, 3.5 million Nigerians currently smoke, and each year 26,851 Nigerians die from smoking-related illnesses. While the World Health Organization (WHO) projects that smoking-related deaths will drop to 18,000 annually by 2060, experts argue that the number remains far too high.
By adopting THR strategies, the researchers estimate that the annual smoking-related death toll could be reduced to 7,600 by 2060, saving over 416,000 lives in the process.
Derek Yach
“We have a clear opportunity to reduce the burden of smoking-related diseases in Nigeria significantly,” said Derek Yach, one of the report’s authors and former leader of the Foundation for a Smoke Free World. “By embracing safer alternatives like vapes and nicotine pouches, Nigeria can drastically lower smoking-related deaths and help people who smoke quit more effectively. Tobacco harm reduction is the key to saving lives and improving public health in Nigeria.”
The use of THR products has already been proven to reduce smoking rates in countries such as the UK, Sweden, Japan and New Zealand. In these nations, the widespread adoption of e-cigarettes and other nicotine alternatives has led to a marked decline in cigarette consumption, the leading cause of smoking-related diseases, according to an emailed press release.
Delon Human
“The success stories from other countries are undeniable,” said Dr. Delon Human, co-author of the report and founder of the African Harm Reduction Alliance. “In nations where tobacco harm reduction is embraced, smoking rates are dropping, and lives are being saved. Nigeria can achieve similar results by adopting a more inclusive tobacco control policy incorporating standard measures and access to these life-saving alternatives.”
The report calls on Nigerian policymakers to take bold steps in reducing smoking-related harm by considering the introduction of safer nicotine products into the national health strategy. Nigeria could make significant progress toward its public health goals by offering people who smoke alternatives that are far less harmful than combustible cigarettes.
“As Nigeria’s leaders continue to refine tobacco control measures, they have a unique opportunity to reduce smoking-related harm while empowering people who smoke with the tools to quit,” Yach added. “With the right policy choices, Nigeria can not only improve the health of its citizens but also set an example for the rest of Africa.
Xu Ying, the deputy head of China’s State Tobacco Monopoly Administration, commonly referred to as China Tobacco, has been expelled from the Communist Party of China and removed from his position due to serious violations of discipline and laws, according to the country’s top anti-corruption authorities on Wednesday.
The probe has been carried out by the Communist Party of China Central Commission for Discipline Inspection and the National Commission of Supervision.
Xu, 59, was found to have reportedly accepted gifts and money and attended banquets in violation of regulations. He also failed to report personal matters truthfully and sought benefits for multiple relatives regarding employment and job transfers, the top anti-corruption authorities said in a statement.
It added that Xu abused his power and misused public resources to seek benefits for others and for personal gain. He allegedly engaged in significant power-for-money transactions, using his position to seek benefits for others in administrative approvals, business operations, and employee recruitment, and illegally accepting large amounts of money and goods.
The top anti-corruption authorities identified Xu’s behavior as severe violations of the Party disciplines. Therefore it decided to expel him from the Party and confiscate all his illicit gains, reports China Daily.
The statement added that his suspected violations of national laws will be transferred to prosecutors for further criminal review and investigation.
Public information shows that Xu started his career in the administration in 1988. Since then, he has worked for the nation’s tobacco industry for decades.
In March 2014, he became the deputy head of the tobacco administration.
Swedish Match North America is being sued for allegedly overcharging U.S. customers for its popular tobacco-free Zyn nicotine pouches.
The class action lawsuit, filed on Monday in federal court in Richmond, Virginia, alleges that the Philip Morris International subsidiary is violating federal and state antitrust laws concerning the market for modern oral nicotine pouches.
The plaintiff, a resident of Florida, claimed that Swedish Match illegally gained monopoly power through various business practices aimed at eliminating rival Dryft from the market, Reuters reports.
Swedish Match now has an estimated 80 percent of the market for nicotine pouches, which the company sells in different flavors and strengths for about $6 a tin, according to the lawsuit.
In a statement, Philip Morris, which was not named as a defendant, said, “We believe the plaintiff’s claims are without merit, and we intend to vigorously defend against them.
Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).
According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.
IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.
This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.
“The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.
Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.
FDA alignment on key points:
Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.
IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.
“Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer
American adults are now more likely to smoke marijuana than tobacco cigarettes.
That’s according to new survey data from Gallup finding that 15 percent of U.S. adults reported that they smoke cannabis, which is more than the 11 percent of those who told the polling firm that they had smoked any cigarettes in the past week.
“While not statistically different from the average of 14 percent in 2021-2022,” Gallup said of the latest two-year average of U.S. marijuana use polling data, the rise to 15 percent is “consistent with the upward trend in recent years.”
Among other findings, the latest data—from 2023 to 2024—indicate that men are more likely than women to report smoking marijuana, at 17 percent compared to 11 percent, media reports. Younger adults, ages 18 to 34, were also more likely (19 percent) to smoke cannabis than adults aged 35 to 54 (18 percent) and those 55 and older (10 percent).
Gallup says the results are reported in two-year averages to improve statistical reliability.
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!”
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.
An Ontario judge says any outstanding issues regarding a proposed $32.5 billion settlement between three major tobacco companies and their creditors should be solvable in the coming months. Ontario Superior Court Chief Justice Geoffrey Morawetz released his reasons for approving a motion last week to have creditors’ representatives review and vote on the proposal in December.
One of the companies, JTI-Macdonald Corp., said last week it objects to the plan in its current form and asked the court to postpone scheduling the vote until several issues were resolved. The other two companies, Rothmans, Benson & Hedges and Imperial Tobacco Canada Ltd., didn’t oppose the motion but said they retained the right to contest the proposed plan.
The proposal announced last month includes $24 billion for provinces and territories seeking to recover smoking-related healthcare costs and about $6 billion for smokers across Canada and their loved ones.
If a majority of creditors accept the proposed deal, it will move on to the next step: a hearing to obtain the court’s approval, tentatively scheduled for early next year. In a written decision released Monday, Morawetz said it was clear that not all issues had been resolved at this stage of the proceedings.
He pointed to “outstanding issues” between the companies regarding their respective shares of the total payout and debate over the creditor status of one of JTI-Macdonald’s affiliate companies. In order to have creditors vote on a proposal, the court must be satisfied the plan isn’t “doomed to fail” either at the creditors or court approval stages, court heard last week, media reports.
Lawyers representing plaintiffs in two Quebec class actions, those representing smokers in the rest of Canada, and 10 out of 13 provinces and territories have expressed their support for the proposal, the judge wrote in his ruling. While JTI-Macdonald said its concerns have not been addressed, the company’s lawyer “acknowledged that the issues were solvable,” Morawetz wrote.
“At this stage, I am unable to conclude that the plans are doomed to fail,” he said. “There are a number of outstanding issues as between the parties, but there are no issues that, in my view, cannot be solved.”
The proposed settlement is the culmination of more than five years of negotiations in what Morawetz has called one of “the most complex insolvency proceedings in Canadian history.”
