The U.S. Supreme Court declined on Oct. 10 to hear Avail Vapor’s objections to the Food and Drug Administration’s regulatory authorization process.
In 2021, the regulatory agency denied Avail Vapor’s request to approve fruit-flavored and dessert-flavored e-cigarettes. The company protested that the agency had made the application process intentionally difficult.
In a Supreme Court brief filed Aug. 3, Avail claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco-flavored products as an aid in adult smoking cessation.
Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.
In its petition, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues that the FDA’s decision-making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
In a tweet from Member of Parliament Charlie Weimers, news of a potential ban on snus in the EU has come to light.
“A secret report I shouldn’t have landed on my desk,” the tweet said. “In the report that will be presented to the EU member states this week, there are two notable writings: (1) praise for how successful the snus ban has been and (2) a recommendation that the EU should extend the snus ban to the tobacco-free white snus (nicotine portions).”
“That the EU snus ban is a success is completely wrong,” he wrote. “It is actually snus that makes Sweden the only country in the EU that is on the way to reaching the U.N.’s goal of a smoke-free society (defined as less than 5 percent smokers), which has saved many lives. A ban on nicotine pouches would have been a hard blow to the attempt to eradicate smoking in the EU.
“Unfortunately, the Swedish exception for tobacco snus does not apply to nicotine pouches. If the EU Commission and the member states accept the report’s recommendation, nicotine pouches will also be banned in Sweden. Men have largely opted out of smoking in favor of snus while women looking for less dangerous alternatives choose nicotine pouches more often. Therefore, such a ban would hit women extra hard.
“The report has been written by consultants who work for DG SANTE (the EU’s health bureaucrats), and the writings probably would not have crept into the report if they did not have the support of the bureaucrats. Most likely, this is a test balloon from the bureaucracy. If the proposal falls to the ground at the meeting with the member states, the bureaucrats can blame the consultants, and if the proposal does not meet resistance, the bureaucrats can interpret it as a clear support and work on with a sharp proposal. This is how you often work in the EU’s bureaucracy.
“The government must therefore already make it clear at the meeting this week that our country opposes a ban on white snus and work to ensure that citizens continue to have the opportunity to choose the least harmful way to use nicotine. Our negotiators are also welcome to raise the issue of the risks to public health of having too many do-gooding bureaucrats in DG SANTE.”
The news has left many angry, with calls for “SWEXIT” if the proposal passes—meaning, those against the measure are calling for Sweden to leave the EU if the ban passes.
The premium cigar industry recently declared victory in the fight against oversight by the U.S. Food and Drug Administration. Celebrations may have been premature.
The lawsuit was filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association. The case focused in part on the rulemaking process, which requires the FDA to inform the public about upcoming regulations and solicit feedback on those proposed rules.
In last month’s decision in Cigar Association of America et al. v. United States Food and Drug Administration, Judge Amit P. Mehta made a sweeping, albeit expected, ruling that granted relief to the three cigar industry trade groups that sued the regulatory agency in 2016 on behalf of the premium cigar industry.
The news confirms industry fears that warning labels, premarket tobacco product application (PMTA) review of cigars and other limitations that have impeded the ability of cigarmakers are still a possibility.
Recently, the FDA acknowledged the decision and one of its impacts, telling cigar companies that it did not plan to assess user fees for “premium cigars” sold during Q4 FY23.
The Department of Justice, which represents FDA on legal matters, had 60 days to appeal the ruling. It’s unclear whether the agency will ask a court for a stay, which could reenact the deeming regulations for “premium cigars” as the appeal process works itself out.
The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.
The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.
The retailers can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Courtesy: US FDA
In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.
Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
Turkiye has expanded the scope of its ban on serving and selling tobacco and alcohol products, according to Xinhua News Agency.
Sales of tobacco products and alcoholic beverages are banned on all premises of health, education and cultural and sports facilities. The ban does not apply to points of sale in accommodation, recreational and camping areas, however.
The Cyprus government is moving to ban the sale of flavored heated-tobacco products (HTPs) following the Ministerial Council’s decision to adopt the relevant European legislation, according to In-Cyprus.
HTPs still allowed on the market will have to apply special warning labels and images to packaging, which will align the packaging with that of conventional cigarettes.
The aim of these changes is to “harmonize national legislation with European directives, as today’s Ministerial Council approved an amendment to regulations regarding the withdrawal of certain exemptions for heated-tobacco products.”
The council decided on the “extension of the ban on the sale of tobacco products with characteristic aroma/flavor or containing aromatic substances in any of their ingredients and on heated-tobacco products.”
“It was also decided to include verbal warnings/notifications about the harmful effects of smoking on the packaging of heated-tobacco products. These warnings will be accompanied by deterrent images.”
“In the legislation for smoking control, established in 2017, these products were exempted, and the sale of conventional cigarettes and rolling tobacco that contained aromatic substances in their ingredients was prohibited,” said Health Minister Popi Kanari. “With these regulatory amendments, the sale of heated-tobacco products containing aromatic substances in any of their ingredients is prohibited beyond conventional cigarettes and rolling tobacco.”
“The amendment does not apply to vaping products that contain liquid but only to the category involving heated-tobacco products in which cigarettes with aromatic substances are placed,” said Kanari.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.
In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.
Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.
TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.
The U.S. Food and Drug Administration will not assess user fees for premium cigars in the fourth quarter of fiscal year 2024, the agency told manufacturers and distributors, according to Halfwheel.
User fees help fund the Center for Tobacco Products. The amount of user fees is set by Congress; companies that import or manufacture cigarettes, roll-your-own products, snuff, chewing tobacco, cigars or pipe tobacco are assessed fees, and individual shares are calculated based on excise taxes paid on each product compared to the total amount of excise taxes paid by all products.
The FDA, however, does not know whether a cigar company is selling premium cigars, nonpremium cigars or a mixture of both. Due to this, the FDA is asking companies to submit dispute letters within 45 days of the assessment of user fees. The agency is allowing companies the option of either paying the full amount of user fees with the intent of getting refunded for user fees assessed to premium cigars or paying what the company believes it will owe for nonpremium cigars.
The FDA has stated that it will introduce a better process going forward, but it has not released information regarding what that will look like.
There was no mention as to whether the FDA plans to refund user fees paid for premium cigars from August 2016 to the second quarter of fiscal year 2023.
On Sept. 14, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech.
According to the FDA, the youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the agency to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.
“Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”
Leading international public health experts have expressed serious concern about Kazakhstan’s imminent ban on vapes as a “backward step” that contradicts the unprecedented success of more progressive countries that are dramatically reducing tobacco’s toll through the use of alternative nicotine products.
The Kazakh government’s intention to enact the prohibition by Jan. 1, 2024, endangers the lives of the country’s 3.2 million smokers who will be deprived of their best chance to quit their deadly habit, according to the Smoke Free Sweden, a movement highlighting Sweden’s progress in becoming smoke-free.
“We note with great concern this retrogressive move by the Kazakhstan Ministry of Health, which defies the extraordinary achievements of some countries that have adopted a progressive approach to modern products such as vapes and oral pouches,” said Delon Human, a global health advocate and founder of Smoke Free Sweden, in a statement.
“Around the world, alternative nicotine products are helping to save millions of lives by giving smokers an escape from combustible cigarettes. They are proven to be at least 95 percent less harmful than cigarettes and the most effective way for smokers to quit.
“To ban these reduced-risk products will simply condemn many smokers to stick with cigarettes and sentence them to an unnecessarily premature death.”
Sweden is the first EU country to achieve this milestone—17 years ahead of schedule—through its policy of making vapes and pouches available, acceptable and affordable to adult smokers.
“Quitting smoking like Sweden saves lives,” says Human. “Compared to the rest of Europe, Sweden has 44 percent fewer tobacco-related deaths, a cancer rate that is 41 percent lower, and 38 percent fewer deaths attributable to any cancer.
“Sweden is leading the way for other nations, such as the United Kingdom where the health service is giving free vape kits to smokers to help them quit. The government is funding the ‘swap to stop’ scheme with the aim of turning the country smoke-free by 2030.
“Meanwhile, only last month, the largest study of its kind in the United States confirmed the immense value of vapes as cessation aids. Researchers at Hollings Cancer Center in South Carolina found that vapes nudged people towards quitting smoking – even those who had entered their trial saying they had no intention of quitting.
“Such evidence is compelling and should be ignored no longer. If Kazakh authorities are serious about saving lives, they should be following the science and offering affordable access to vapes, instead of blocking this proven ‘fire escape’ for smokers,” concluded Human.
