Tag: e-cigarettes

U.S. Senators Demand FDA Reform its PMTA Process

Credit: Blue
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.”
December 15, 2023
U.S. FDA, Customs Seize $18 Million in Illegal Vapes

Credit: Eduardo Barraza
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.
December 14, 2023
Vuse Market-Share Lead Over Juul Continues to Grow
Credit: Konstiantyn Zapylaie
R.J. Reynolds’ top-selling Vuse electronic cigarette saw an increase in market share after a recent small decline, according to the latest Nielsen convenience store report for the four-week period ending Dec. 2.
Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent.
In May 2019, Juul held a dominant 74.6 percent share of the U.S. e-cigarette market, but regulatory actions led to a decrease in product availability.
Despite Altria Group’s ownership of No. 3 NJoy, their market share remained stagnant at 2.6 percent.
Fontem Ventures’ blu eCigs, affiliated with Imperial Brands Plc, also had no change in market share at 1.2 percent. Overall, the e-cigarette category saw an 8 percent decline during this period.
December 14, 2023
More Warning Letters for Unauthorized Products

Photo: Adobe
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.
December 14, 2023
One-Use Vape Batteries Can ‘Recharge’ Many Times
Credit: Chepko Danil
While the lithium-ion batteries in disposable vapes are thrown away after a single use, researchers found that they can continue to perform at high capacity for hundreds of cycles.
The study, published in the journal Joule, was conducted by scientists from University College London (UCL) and the University of Oxford and supported by The Faraday Institution.
“The surprise for us were the results that pointed toward just how long these batteries could potentially cycle, Professor Paul Shearing, of the University of Oxford and UCL, said, according to media reports. “If you use a low charge and discharge rate, you can see that for over 700 cycles, you still have more than 90 percent capacity retention.
“That’s a pretty good battery. And these are just being discarded. They’re being chucked on the side of the road.”
December 14, 2023
Mexico President to Push Forward Anti-Vape Bill
Mexican President Andres Manuel Lopez Obrador stated his intentions to introduce a law forbidding the use of e-cigarettes and vapes before he finishes his term in 2024.
This comes after the Supreme Court overturned his previous attempt to ban their sale.
Mexico already has one of the most stringent anti-tobacco laws globally, as evidenced by their implementation of a bill in January that prohibits smoking in all public spaces – including outside on the street, according to media reports.
Mexico has already banned the import of e-cigarettes.
December 14, 2023
WHO Seeks to Equate Risks of Vaping and Smoking

Image: Andrey Popov
The World Health Organization has urged governments to ban all flavors in e-cigarettes, treating them like combustible products.
While some consider e-cigarettes a key to reducing death and disease caused by smoking, the WHO said “urgent measures” are needed to control them, according to Reuters.
“Kids are being recruited and trapped at an early age to use e-cigarettes and may get hooked to nicotine,” said Tedros Adhanom Ghebreyesus, WHO director-general.

Regulating vapes like cigarettes would only serve to reinforce misunderstandings about the relative risks of vaping and send the wrong message to smokers.
Marina Murphy, senior director of scientific and medical affairs, ANDS
He urged countries to implement strict measures, such as bans on all flavors and introducing tobacco control measures to vapor products. These would include high taxes and vape bans in public places.
While the WHO does not have authority over national regulations, its recommendations are often voluntarily adopted.
“Regulating vapes like cigarettes would only serve to reinforce misunderstandings about the relative risks of vaping and send the wrong message to smokers,” said Marina Murphy, senior director of scientific and medical affairs at ANDS, adding that the WHO’s position was “detached from reality.”
December 14, 2023
Bulgaria Readies to Ban Flavored Nicotine Products

Image: Delyan
Bulgaria will ban products with flavors other than tobacco effective Jan. 1, 2024, reports Novinite.com
The ban is in response to the European Commission’s directive.
The amendment will also require that all packaging for heated-tobacco products display a warning highlighting associated risks of use. The Ministry of Economy and Industry will now be tasked with prohibiting tobacco products containing additives that significantly increase toxicity, with addictive properties or that pose risks of cancer, mutations or reproductive toxicity.
Enactment of the changes is pending official publication in the State Gazette.
December 14, 2023
Another City in Maine Bans Flavored Nicotine Sales

Credit: Gary L Hider
The state of Maine is a hotbed of nicotine regulation. The town of Falmouth became the sixth municipality in the state to outlaw flavored tobacco products.
The town council voted 5-2 in support of an ordinance that will make it illegal to sell any vaping or other tobacco product that imparts or is advertised to impart a taste or smell “other than that of tobacco” when the ban goes into effect on March 12, 2024.
Falmouth has a population of just over 12,000 residents. The town joins Portland, South Portland, Brunswick, Bangor and Bar Harbor in passing similar bans on selling flavored tobacco products.
Retailers found violating the law will be subject to a written warning for a first offense, followed by a fine of $500 for a second offense and $1,000 fine for each subsequent violation.
The ordinance does not prohibit the use of flavored tobacco products; however, it does aim to make it harder for individuals, youth and adults, to acquire the products.
One supporter of the ban, councilmember Janice de Lima, said she considered the ordinance a win even if only five kids were prevented from using flavored nicotine products, regardless of the impact on other residents or businesses.
Council vice-chair Jay Trickett spent several minutes critiquing the ban, citing studies that show bans on flavored tobacco products result in increased levels of cigarette use, adding that the council had public health policy backward with the ordinance, according to Halfwheel.
Trickett said the ordinance’s passage will result in increased health risks for certain residents of the town, possibly forcing some current vapers to return to smoking more deadly combustible cigarettes. It could also potentially drive some youth who use vaping products to switch to combustible tobacco products. The ban would also negatively impact local businesses.
“We are blundering about with a sweeping regulation that only indirectly addresses the problem and absolutely harms other residents because we feel the need to do something,” he said during Monday’s meeting.
Additionally, the council passed a resolution to codify its support of the ban:
“The Falmouth Town Council believes that reduced access to flavored tobacco products could potentially reduce youth resident initiation to tobacco products and thereby decrease youth tobacco and nicotine addiction and associated health risks. The Council believes that this outweighs the potential impacts on adult tobacco product users and retailers. The Council supports the enactment of an ordinance to prohibit the sale of flavored tobacco products by tobacco retailers in Falmouth.”
The Hallowell City Council has also held a first reading of a similar ordinance.
December 13, 2023
EU Parliament Endorses Vaping to Help Quit Smoking

Credit: Ronstik
The European Parliament, in full assembly, adopted a report recognizing the role of vaping in aiding smoking cessation. This comprehensive adoption by the Parliament marks a pivotal moment in the fight against smoking-related illnesses, according to an emailed World Vaper’s Alliance release.
The report, a part of the Parliament’s broader initiative on non-communicable diseases, acknowledges vaping as an effective method for smoking cessation and may also set a new direction for health policies within the EU.
The move follows the EU’s Subcommittee on Public Health (SANT) endorsement on Nov. 7. However, the initial recommendation by the SANT to limit vaping in certain public areas remains a point of contention.
Michael Landl, director of the WVA, said the full adoption of the report by the Parliament is a step forward and underscores a significant shift in recognizing vaping’s positive impact on public health.
“We now call on the European Commission to align with this perspective, as it represents the collective voice and decision of the Parliament, the direct representatives of EU citizens,” he said. “Listening to this voice is not just a matter of policy but of democratic responsibility.
“While we welcome the Parliament’s endorsement, the proposed restrictions on vaping in public spaces are concerning. Such measures could inadvertently hinder smokers’ transition to a less harmful alternative.”
December 13, 2023