Juul Labs announced on Tuesday that it is seeking FDA approval for its new menthol-flavored pods. The JUUL2 pods require age verification and are designed to be used with Juul’s e-cigarette device, which is currently under regulatory review.
The new menthol-flavored pods have a nicotine concentration of 18 mg/mL and are Juul’s latest premarket tobacco product application (PMTA) submission to the FDA, according to media reports.
This follows a submission Juul Labs made in July for a vaporizer with a unique Pod ID chip to prevent the use of counterfeit cartridges and restrict underage access. The July application included a proposal for tobacco-flavored pods.
The vaporizer is already on sale in the UK after its launch in 2021 as the JUUL2 System.
The menthol pod contains a secure microchip that communicates a requirement for age verification to the device before use. The device can be locked by users at any time to prevent unauthorized usage.
To mitigate the risk of social sourcing, Juul said it would limit not only the number of devices that can be purchased but also the number of new devices each unique age-verified user can activate and use with menthol-flavored pods.
So far, the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including British American Tobacco, which is appealing those decisions.
Juul Labs said in a statement it has submitted evidence showing its new menthol pods can help more cigarette smokers transition from smoking than tobacco-flavored e-cigarettes.
Starting next month, the use of vapes and other e-cigarette products will be prohibited in public places in Illinois.
In 2007, the Smoke-Free Illinois Act was implemented to ban smoking of cigars and cigarettes indoors and within 15 feet of entrances. The law is now being strengthened and will take effect on Jan. 1st.
“E-cigarettes, in all of their many forms, continue to be one of the most addictive products readily available for purchase in gas stations, vape shops and online,” State Senator Julie Morrison, who sponsored the bill in the Senate, said in a release. “We have made solid progress toward de-normalizing the perception of tobacco, and I am proud that on Jan. 1, e-cigarette usage will be banned indoors.”
On the first offense, individuals caught smoking e-cigarettes in public places in the state will be fined $100.
The governor signed the bill into law in July 2019, which also raised the legal age for purchasing tobacco products from 18 to 21 in Illinois.
Localities in Ohio will not be allowed to enact flavor bans for nicotine products.
The Ohio House voted to override Gov. Mike DeWine’s veto of legislation prohibiting cities from imposing flavored tobacco bans.
The move marked the latest effort by lawmakers to block local regulation of flavored tobacco products, including menthol.
Columbus is preparing to ban the sale of flavored tobacco starting next month, and Cincinnati, Dayton and Cleveland are considering similar proposals, according to Cincinnati.com.
The vote also highlighted divisions between DeWine and legislative leaders on the issue that have persisted for months. Veto overrides are rare because they require more votes in the House and Senate.
Anti-tobacco groups say these bans are necessary to reduce teen vaping. Officials in the House and Senate contend the state should have uniform guidelines and say the legislation will protect small businesses.
Last week, U.S. authorities publicly announced the first seizure of some Elf Bar products and other disposable vape brands as part of an operation confiscating 1.4 million illegal, flavored vapes from China.
Officials pegged the value of the items at $18 million.
The Associated Press, however, is also reporting the vapor maker of Elf Bar and other disposable brands, Shenzhen iMiracle and others, has imported products worth hundreds of millions of dollars while repeatedly dodging customs and avoiding taxes and import fees, according to public records and court documents.
Records show the makers of disposable vapes routinely mislabel their shipments as “battery chargers,” “flashlights” and other items, hampering efforts to block products that critics say are driving teen vaping in the U.S.
“The steps toward regulating disposables have been very weak and that has enabled this problem to get bigger and bigger,” said Eric Lindblom, a former Food and Drug Administration official.
Elf Bar is the lead product of Shenzhen iMiracle, a privately held company based in Shenzhen, the sprawling Chinese manufacturing hub that produces more than 95% of the world’s e-cigarettes.
Elf bar lost mary
Elf Bar, Lost Mary and several other iMiracle brands are expected to generate $3.5 billion to $4 billion globally this year, according to industry analyst ECigIntelligence.
In the U.S., iMiracle recently abandoned the Elf Bar name due to a trademark dispute and efforts by regulators to seize its imports. Instead, its products are sold as EB Create.
At a 2022 court hearing in the case, U.S. distributors described skyrocketing sales.
Jon Glauser, of Demand Vape in Buffalo, N.Y., told a federal judge his company had sold more than $132 million worth of Elf Bar products, accounting for a third of its yearly profits.
“We were selling it faster than we could get it in,” Glauser said, according to the court transcript.
Glauser attributed Elf Bar’s quick rise to its profit margin. Sellers make about a 30% profit, double that of other disposable e-cigarettes, he said.
IMiracle’s parent company, Heaven Gifts, previously described how it could help customers evade import fees and taxes. Heaven Gifts’ website advertised “discreet” shipping methods to buyers, including not mentioning e-cigarettes or its company name “anywhere on the package.” Instead, the company said contents would be labeled as “atomizer, coil, tube, etc.”
“We also mark a lower value to avoid tax,” the website stated, adding that customers could suggest their own value for the shipment.
In June, Heaven Gifts announced it would “go offline,” shortly after the FDA directed customs officials to begin seizing shipments from the company.
Despite the update, the company’s spokesman indicated Heaven Gifts remains in business and staffers continue using email accounts bearing its name. The spokesman did not answer numerous follow-up questions about the company’s business.
Neither Heaven Gifts nor iMiracle appear in customs data reviewed by the AP and compiled by ImportGenius, a global trade analytics company.
The seizure announced last week suggests part of the answer: The shipments arrived at Los Angeles International Airport, and air carriers are not required to disclose the same details about their cargo as ocean vessels. The e-cigarettes were mislabeled as toys, shoes and other items.
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.
Vaping products were the fastest growing category in U.K. grocery sales for the second year running in 2023, while sales of cigarettes, cigars and loose tobacco fell sharply, industry data showed.
Britain’s government in October proposed banning younger generations from ever buying cigarettes and Prime Minister Rishi Sunak said it also needed to act on youth vaping, according to Reuters.
Vaping products saw growth in value sales in Britain of 897.4 million pounds ($1.15 billion) in 2023, according to the data published on Saturday by market researcher NIQ and The Grocer.
The Lost Mary brand, owned by Chinese vaping firm Heaven Gifts, was the UK’s fastest growing product with sales up by 310.6 million pounds on the previous year, the data showed.
NIQ said vaping products also saw growth on a volume basis, or the amount people bought, while sales of cigarettes, cigars and loose tobacco were down 849.1 million pounds and 393.1 million pounds, respectively, on a sales value basis.
The World Medical Association (WMA) has joined the World Health Organization (WHO) in warning about the dangers of electronic cigarettes and other electronic nicotine delivery systems (ENDS).
“This warning comes amidst rising global popularity of e-cigarettes, particularly among young people, and a lack of adequate regulation in many countries,” a press release states.
The Italian publication Formiche recently published a report raising concerns about the WHO’s tobacco control policies and strategies in combating smoking-related diseases.
Titled, “Framework Convention on Tobacco Control: Challenges and Prospects for WHO,” the report provides a comprehensive overview of the smoking crisis, the limitations of current tobacco control policies, and the role of harm reduction and non-combustion products. Additionally, it emphasizes the need for innovative strategies and a re-evaluation of the WHO’s approach to effectively combat the global smoking epidemic.
The report highlights how the FCTC has not considered harm reduction efforts which led to a deviation from the original stance of the WHO. Despite the FCTC’s efforts, the number of smokers have remained stable over the last 20 years, with the decrease in smoking rates being countered by the effects of population growth.
Lujain Alqodmani, president of the WMA, said there is an urgent need for government action to safeguard children and adolescents, and the WMA supports the WHO’s efforts to eliminate nicotine products. She highlighted the “alarming situation” reported by the WHO, where 88 countries have no minimum age restriction for purchasing e-cigarettes, and 74 countries lack regulations for these harmful products.
The Formiche report’s author also worries about the tobacco control policies pursued by many low- and middle-income countries, which are home to 18 percent of the world’s smokers and where policies either ban alternative nicotine solutions entirely or treat them like cigarettes.
The effect of these approaches, according to the report, is that smokers who do not quit are not supported in changing to options that could present less risk to them. “The hope is that the forthcoming Conference of the Parties can represent an opportunity for public health but also, in the spirit of the United Nations, a moment of confrontation to guide policy choices based on established scientific evidence,” the report states.
U.S. Senators Joe Manchin, Rand Paul and Ted Budd (R-NC) penned a letter urging the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) to reform its premarket tobacco product application (PMTA) process.
The Senators also requested information regarding CTP’s policies and actions that would ensure they are acting in an efficient way that is based on science and evidence.
“Cigarette smoking is the leading cause of preventable disease and death in the United States, where nearly 31 million Americans smoke cigarettes,” the group wrote in part. “For the FDA to meet its harm reduction goals, it must have a functioning authorization process.
“Since 2009, more than 26 million [PMTAs] have been submitted for new tobacco products in the U.S. Of those 26 million applications, the CTP has authorized fewer than 50… The availability of scientifically substantiated, authorized-PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”
For the FDA to meet its harm reduction goals, it must have a functioning authorization process, the Senators state, adding that the agency’s authorization rate is not in keeping with CTP policy acknowledging that tobacco products fall on a continuum of risk.
“The CTP has previously attributed its backlog to staffing shortages, but CTP’s staff has more than doubled over the past decade, from 426 employees in 2013 to more than 1,100 today,” the Senators state. “Since 2009, the FDA has also had the authority to assess and collect user fees from tobacco manufacturers and importers, with those fees being $712 million annually since 2019.
“Given these significant resources, there is no reason why the CTP should be so drastically out of step with the [Food, Drug and Cosmetic] Act’s requirements.”
The U.S. Food and Drug Administration and U.S. Customs and Border Protection (CBP) have announced that they have confiscated about 1.4 million unauthorized e-cigarette products, including controversial brands like Elf Bar.
The estimated value of these seized products is over $18 million. The impressive seizure occurred during a three-day joint operation, where 41 shipments containing banned e-cigarettes were found and taken into custody.
“The FDA is committed to continuing to stem the flow of illegal e-cigarettes into the United States,” said FDA Commissioner Robert Califf. “Unscrupulous companies try everything they can to bring unauthorized, youth-appealing tobacco products into the country. The FDA will remain vigilant, and together with our federal partners, stop these imports before they make it into the hands of our nation’s youth.”
The FDA and CBP conducted the joint operation at a cargo examination site at Los Angeles International Airport, where the team examined incoming shipments for potentially violative items.
In preparation for the three-day operation, the team worked for months to review shipping invoices, identify potentially illegal incoming shipments, and complete other investigative work that led to the operation’s success, according to an FDA release.
Once the merchandise is forfeited to the government, it will be disposed of in accordance with the law; in the case of unauthorized new tobacco products, that generally means they will be destroyed.
“This enforcement action is a prime example of CBP’s commitment to keeping our communities safe by disrupting the importation of illegal goods into our country,” said Troy A. Miller, senior official performing the duties of the commissioner for CBP. “The rise in illicit e-commerce demands that our agencies remain vigilant in intercepting shipments that could pose serious health risks to the public, including youth, while disrupting the supply chains that bring them to our borders.”
Upon examining shipments, all of which originated in China, the team found various brands of illegal flavored disposable e-cigarette products.
In addition to Elf Bar, among the seized e-cigarettes were EB Create products; earlier this year, the manufacturer of Elf Bar began marketing the product under the names “EB Design” and “EB Create.”
Other seized brands included Lost Mary, Funky Republic, RELX Pod and IPLAY Max, among others. In an attempt to evade duties and detection, many of these unauthorized e-cigarettes were intentionally mis-declared as various items such as toys or shoes and listed with incorrect values.
“Those shamelessly attempting to smuggle illegal e-cigarettes, particularly those that appeal to youth, into this country should take heed of today’s announcement,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Federal agencies are on to their antics and will not hesitate to take action. The significant value of these seized products is also a sobering reminder to these bad actors that their time and money would be better spent complying with the law.”
The FDA uses a comprehensive approach to tobacco product compliance and enforcement, taking action against those in the supply chain that violate the law, including manufacturers, importers, distributors and retailers, such as the targeted operations described in today’s announcement.
The FDA also regularly addresses the importation of illegal e-cigarettes by placing certain firms on an FDA import alert red list, which allows the FDA to detain products without conducting a full inspection at the time of entry, according to the release.
For example, in May, the FDA placed certain firms associated with unauthorized youth-appealing e-cigarettes on a red list, including firms associated with the Elf Bar brands.
On Dec. 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure and/or civil money penalties.
“It is illegal to sell, import, distribute or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said CTP Director Brian King in a statement. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”
As of December 2023, the FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.
To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.
