Category: Regulation

FDA Sends More Warnings

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The U.S. Food and Drug Administration sent warning letters to seven online retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of popular and youth-appealing disposable e-cigarette products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava.
These warning letters were informed by the FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, according to the agency. Findings released last week from the 2023 National Youth Tobacco Survey found that more than half of current youth e-cigarette users reported using the disposable e-cigarette brand Elf Bar; earlier this year, the manufacturer of Elf Bar began marketing the product under the name EB Design. In addition, the brands Bang, Cali Bars and Lava were identified as popular or youth appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.
“FDA’s robust surveillance of the e-cigarette landscape helps us to identify youth-appealing products and to act quickly to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products. “The goal is to identify, prevent and reduce these risks to our nation’s youth before they escalate further.”
The retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack authorization from the FDA in violation of the Federal Food, Drug and Cosmetic Act. Warning letter recipients are given 15 working days to respond with the steps they’ll 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 penalties.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. For retailers looking for information on which e-cigarettes are legal to sell, the FDA created a printable, one-page flyer of these authorized products. This information is also available on the FDA’s website.
November 10, 2023
FDA Warns Nic Nac ‘Nicotine Mints’

Image: FDA
The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which resemble a pack of mints. These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children, according to the FDA.
“FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”
The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.
One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.
“Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”
The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.
November 7, 2023
Cigar Group Wants Better Justification for U.S. Flavor Rule

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The Premium Cigar Association (PCA) testified before the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) as part of the administration’s review of the U.S. Food and Drug Administration’s draft Final Rule “Tobacco Product Standard for Characterizing Flavors in Cigars.”
PCA President Scott Regina provided several examples of the impact that the rule would have on specialty tobacco retail, emphasizing that the FDA had not conducted a proper small business impact analysis. The PCA also outlined how the rule would directly affect regulatory matters outside of the FDA’s jurisdiction, including law enforcement, international trade and foreign policy.
“It’s questionable whether FDA has the authority to issue standards that result in a product ban, especially when they are acknowledging that the regulation does not address a specific risk,” said Regina in a statement.
“Ultimately, we asked OIRA to consult with a host of affected federal agencies and to remit the draft Final Rule back to FDA for better justification of authority, cost-benefit analysis and small business impact,” said Scott Pearce, executive director of the PCA.
The OIRA has scheduled meetings with additional stakeholders throughout the month as well as proponents of the characterizing flavor product standard for cigars.
The PCA published a full list of recommendations on the draft Final Rule.
November 7, 2023
King’s Speech: Activists Decry Generational Ban

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Smokers’ rights group Forest condemned the U.K. government’s official announcement of legislation that will deny future generations of adults the right to purchase tobacco.
During the opening of the new session of Britain’s parliament today, King Charles presented the government’s plans for new legislation, which includes a generational tobacco bill, as reported by the BBC and other news outlets.
The proposed legislation would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, effectively raising the legal age of purchase by one year, every year.
The government is also looking to bring in rules regulating the flavors and descriptions of vapes that critics say are targeted at children.
“This is the worst form of nanny state regulation because it treats consenting adults like children,” said Forest Director Simon Clark.
“If you’re old enough to vote, drive a car, join the army, and purchase alcohol, you’re old enough to buy cigarettes and other tobacco products.
Clark warned that the legislation would boost the black market.
“The biggest benefactor from prohibition won’t be public health but criminal gangs and other illicit traders,” he said.
“Given everything else that is going on in the world, at home and abroad, it’s staggering that a Conservative government would waste valuable parliamentary time banning the sale of tobacco to adults who are perfectly capable of making informed decisions for themselves.”
November 7, 2023
Quebec: Flavor Ban Takes Effect

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Quebec’s ban on flavored vapes took effect Oct. 31.
The measure includes vaping products with flavors other than tobacco and will prohibit e-liquid sold in bottles with a capacity greater than 30 mL and prefilled devices with a capacity greater than 2 mL.
The ban was announced in a draft published in April. More than 30,000 citizens of Quebec commented on the proposed ban, according to the Quebec Vaping Rights Coalition, but the health ministry reportedly didn’t make any changes to the rules in response.
Quebec is the largest province in Canada to enact a flavor ban. Four other provinces and territories already ban flavors, and one has passed a ban but has not set an effective date yet. Three other provinces restrict flavored products to adult-only stores.

Darryl Tempest
“It’s high time for provinces like Quebec, New Brunswick, Nova Scotia and PEI to reevaluate their stance and stop yielding to the influence of big tobacco companies. These regions must come to the realization that they are inadvertently supporting the very issues they claim to be combating.”
Darryl Tempest, government relations counsel to the CVA
The Canadian Vaping Association (CVA) has expressed concerns to the Quebec government, arguing that this regulation will not achieve its intended goal of curbing youth experimentation.
According to the CVA, the consequences will include the closure of specialty vape shops within the province, the loss of over 1,000 jobs and a shift in consumer demand toward foreign suppliers and the illicit market.
“It’s high time for provinces like Quebec, New Brunswick, Nova Scotia and PEI to reevaluate their stance and stop yielding to the influence of big tobacco companies. These regions must come to the realization that they are inadvertently supporting the very issues they claim to be combating,” said Darryl Tempest, government relations counsel to the CVA.
The available data consistently finds that flavor bans fail to effectively protect youth and lead to increased tobacco sales among both young people and adults.
November 1, 2023
RJR Complaint Could Wreck Vaping Industry

The implications could be far-reaching. Reynolds American Inc. (RAI) has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.
Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Tobacco Reporter that if the ITC agrees with Reynolds, all flavored disposable vaping devices without marketing authorization could be stopped at the border and prevented from entering the U.S. market.
Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.
Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the “manufacturers, importers, distributors and retailers” of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.
Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.
The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.
“As a result of the relentless influx of illegal vapor products flowing through U.S. borders, Reynolds American Inc. subsidiaries R.J. Reynolds Tobacco Co. and R.J. Reynolds Vapor Co. have filed a complaint with the U.S. International Trade Commission against more than 30 companies involved in illegally importing unregulated, youth appealing flavored disposable vapor products,” RAI wrote in a statement. “Many of the manufacturers of these disposable vapor devices intentionally and systematically market to youth, selling products with dessert and candy flavors and featuring cartoon characters.
“These illegal disposable vapor devices, which have unknown ingredients and bypass regulations, are jeopardizing public health by refusing to adhere to the laws that regulate the sale of tobacco products. The complaint requests that the ITC institute an investigation into unfair acts in the importation and sale of these Chinese-manufactured, youth appealing flavored disposable vapor devices into the United States.”
Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order, ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA. The marketing denial order was subsequently stayed by the Fifth Circuit Court of Appeals.
In its ITC complaint, Reynolds states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”
The ITC has not yet made a decision on the complaint that was filed on Oct. 13.
October 18, 2023
Menthol Rule Advances to U.S. Budget Office

Photo: Alicia
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) sent its rules to prohibit the sale of menthol cigarettes and flavored cigars to the White House Office of Management and Budget (OMB) for final review, reports CNN.
The final rules will be issued following this last regulatory step.
The American Lung Association (ALA) said this regulation may be the most significant action the FDA has taken in the 14 years since it was given the authority to regulate tobacco.
“It’s a big, vital and critical step on the way to banning these products,” said ALA Assistant Vice President of National Advocacy Erika Sward. “ Truly, it’s momentous.”
According to a 2022 study published in Tobacco Control, prohibiting menthol cigarettes would save up to 654,000 lives in the U.S. within 40 years, including the lives of 255,000 members of the Black community.
The Campaign for Tobacco-Free Kids called for the White House and the OMB to expedite their review and issue the final rule by the end of 2023.
October 17, 2023
PMI: COP10 Missed Opportunity

Image: PMI
Philip Morris International is concerned that participants in the upcoming Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control (FCTC) will promote prohibitionist policies for noncombustible tobacco products, according to an article in The Guardian.
“The agenda and meeting documents have been made public for the main part,” PMI Senior Vice President of External Affairs Gregoire Verdeaux wrote in an email. “Unfortunately, they reconfirmed every concern we had that this conference may remain as the biggest missed opportunity ever in tobacco control’s history … WHO’s agenda is nothing short of a systematic, methodical, prohibitionist attack on smoke-free products.”
Without “reasonable, constructive outcomes,” Verdeaux wrote, the “WHO will have irreversibly compromised the historic opportunity for public health presented by the recognition that smoke-free products, appropriately regulated, can accelerate the decline of smoking rates faster than tobacco control combined.”
While tobacco companies are not invited to the Conference of the Parties to the FCTC, Verdeaux said he will be in Panama “to publicly denounce the absurdity of being excluded from it while PMI today [is] undoubtedly the most helpful private partner WHO could have in the fight against smoking.”
Last year, PMI made $10.19 billion in revenue from products like heated-tobacco and electronic cigarettes.
October 13, 2023
Supreme Court Declines to Hear Avail Vapor Case

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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.
October 11, 2023
EU Considering Ban on Tobacco-Free Snus

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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.
October 4, 2023