Tag: FDA

Senators Ask Retailers to End Flavored Vape Sales

Credit: Roland Magnusson
The chairmen of five key Senate committees on Thursday warned the chief executives of major convenience stores and wholesalers to stop selling illicit flavored vaping products, which they called “widespread violations of federal law.”
The senators voiced their concerns in letters to the companies, amplifying the frustration among some lawmakers in Congress over the continued availability of disposable e-cigarettes. They say the vivid colors and candy flavors only attract kids. The unchecked sales, they wrote, “pose a tremendous public health threat.”
“F.D.A. and the industry must do more to address the youth vaping epidemic and remove unauthorized vaping products from their shelves immediately,” Senator Dick Durbin said, according to media reports.
The letters were addressed to retailers including 7-Eleven, Circle K, bp America, Pilot, Kwik Trip and others. The U.S. Food and Drug Administration had earlier issued warnings about sales of unauthorized brands like Elf Bar, E.B. Design and Funky Republic.
“Today, millions of children use unauthorized e-cigarettes, risking nicotine addiction, respiratory illness, exacerbation of depression and anxiety, and many other harms,” read the letter to Joseph DePinto, the chief executive of 7-Eleven.
The other senators who signed the letter were Ron Wyden, Bernie Sanders, Sherrod Brown, and Richard Blumenthal.
March 7, 2024
FDA Warns 5 More Online Retailers for Illegal Vapes
The U.S. Food and Drug Administration has warned five more online retailers for selling flavored disposable vaping products.
On Feb. 28, the regulatory agency announced the warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze, and Cali Bars, according to a press release.
“Protecting our nation’s youth from the harms of tobacco products is crucial to our center’s public health mission,” said Brian King, director of FDA’s Center for Tobacco Products. “We’re committed to continuing to use a data-driven approach to identify and prevent the sale of unauthorized tobacco products and to take compliance and enforcement action when appropriate.”
February 28, 2024
More Penalties for Unauthorized Elf Bar Sales

Photo: mehaniq41
On Feb. 26, the U.S. Food and Drug Administration announced the filing of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers for the sale of unauthorized Elf Bar e-cigarettes. The FDA previously issued each retailer a warning letter relating to their sale of unauthorized e-cigarettes. However, follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20,678 for a single violation from each retailer.
Including these complaints, the FDA has filed more than 100 CMP complaints against retailers for the illegal sale of Elf Bar e-cigarettes. Data indicate these products are appealing to youth. According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among U.S. youth e-cigarette users; among middle and high school students who reported using e-cigarettes in the past 30 days, more than half said they used Elf Bar products during that period.
“These retailers have not adequately addressed the violations noted in previous warnings from FDA regarding the sale of unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products. “Their continued failure to comply with the law is inexcusable, and as is evidenced by today’s actions, we’re committed to holding them accountable for it.”
As of Feb. 15, the FDA has issued more than 440 warning letters to and filed 100 CMP actions against retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, the FDA has issued more than 660 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed CMP complaints against 50 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.
February 27, 2024
Altria set to Submit PMTA for Flavored Njoy Products

It seems U.S. regulators are prepared to accept premarket tobacco product applications (PMTAs) for some flavored vaping products other than tobacco from a brand that already has a marketing authorization for its tobacco-flavored products.
A marketing authorization for a fruit flavor would be unexpected from U.S. regulators. And giving a flavored-product authorization to a major tobacco company would likely cause an uproar from a majority of the vaping industry.
According to media reports, Altria Group is finalizing its submissions to the U.S. Food and Drug Administration to sell Njoy vape products in blueberry and watermelon flavors, CEO Billy Gifford said Wednesday at the Consumer Analyst Group of New York (CAGNY) conference in Florida.
Altria is already waiting for action from the FDA on a menthol version, he said. The company said it hopes its plans to employ Bluetooth technology to prevent underage use in a way it hasn’t yet detailed will be enough to sway the regulatory agency that has yet to approve a flavored e-liquid vaping product in a flavor other than tobacco.
“We’ve demonstrated the age-gating restrictions are effective at preventing underage access in virtually all cases,” Gifford said, according to a transcript of the company’s webcast.
Altria plans to get its regular tobacco-flavored Njoy vape products into 100,000 stores in 2024, up from around 75,000 last year, with new packaging, Gifford said. He estimated that the international opportunity to sell heated tobacco and vape products is worth $35 billion to $50 billion.
After encouraging results from the launch of its larger-sized oral nicotine pouches, On! Plus, in Sweden, Altria plans to expand distribution there, and launch the On! Plus products in the U.K. this year, according to CFO Salvatore Mancuso.
February 22, 2024
Ispire Technology Adds Partners for Joint Venture
Credit: Kamiphotos
Ispire Technology has partnered with Touchpoint World Wide, parent to Berify, a platform that links physical products to the digital world, digital engagement, and brand protection, and Chemular International, a multi-disciplinary regulatory consulting firm to form a joint venture.
The group hopes to expedite innovation in the e-cigarette technology space, including developing secure, user-friendly solutions for age verification and age-gating nicotine vapor devices.
“The U.S. market is ripe for technological disruption that addresses age-verification, safety, and counterfeit issues,” said Berify Founder and CEO Dan Kang. “Our mission is also to create smart products that generate a new level of consumer satisfaction. We plan to achieve this by leveraging our blockchain authentication, tokenized rewards, and creating true decentralization while keeping companies in control of their products and data.”
Leveraging Berify’s multi-patented technology, Chemular’s regulatory consulting and PMTA expertise, and Ispire’s hardware capabilities, the joint venture’s goals are to introduce an industry-standard age-verification solution for vapor devices as well as the submission of PMTA applications that incorporate new technologies across the U.S. e-cigarette market.
“Our commitment is not only to create next-gen vapor devices but also to elevate market education. This venture includes additional partnerships that will bring together biometric identity and access control, ensure the solution is embedded into vapor devices during manufacturing, and provide safety, security, and privacy for consumers,” Kevin Burd, CEO of Chemular, added. “It is also a testament to our dedication to positively shaping the future of vape hardware innovation.”
Some of the possible solutions include:

Next-generation e-cigarette hardware with a user-friendly point-of-use age-verification and geo-fencing capability that eliminates the use of hardware in certain designated areas such as schools and sensitive areas;
E-cigarettes with end-to-end a range of dynamic features such as authentication, direct-to-consumer engagements, and exclusive offerings all built on the foundations of blockchain technology;
A real-time biometric identity platform for user access controls, creating added security and reliability that deters counterfeiting.
“By combining our collective expertise in hardware, blockchain and regulatory consulting, we aim to set a new standard for age verification, security and overall quality in the e-cigarette space,” said Ispire Technology Co-CEO Michael Wang. “Our hope is that this JV will be a large step forward in innovative device control, safety, counterfeit prevention and enhanced user experiences that increase overall market and consumer satisfaction.”
February 22, 2024
Georgia Lawmaker Introduces Vaping Registry Bill

Credit: VFHNB12
A Georgia lawmaker is seeking for the state to create a registry of vape products approved by the U.S. Food and Drug Administration.
The goal is to let retailers and consumers know what’s legal and what’s not. The bill was introduced in committee.
Lawmaker Houston Gaines showed several examples of vape products that are illegal. Media reports also state that if you check on the back, they say, “Made in China.” Nearly all vaping hardware products, legal or otherwise, are produced in China.
The FDA does not approve them, so Gaines said Georgia shouldn’t either. The FDA does not approve vaping products for sale; it only authorizes them.
The state agriculture department would maintain and publish the list. Any product not on that list could not be sold legally in the state of Georgia.
At a Monday afternoon committee hearing, there were so many people that the committee chairman agreed to hold a second one so everyone could have their say, and some pushed back hard.
One of those who got their say Monday was vape store owner Dillon Gilbert, who insists this bill will destroy their industry.
“I own vape stores in Savannah and Columbus,” Gilbert said. “We want common sense regulation, but unfortunately, this bill is a death blow to our industry.”
But Gaines insists the bill will help keep vape products laced with fentanyl or THC off the shelves. No nicotine vaping product has ever been found to be laced with fentanyl. The GFDA does not regulate THC products.
Under the bill, any store caught selling these unapproved vape products could face serious fines and possible suspension of their licenses.
Louisiana’s passed a law that bans retailers from selling vape products not listed on a state-approved registry, known as the V.A.P.E. Directory. Alabama and Florida use the same list. Nebraska is also seeking to pass a bill to create a vape registry in the state.
February 20, 2024
SWT Global Asks 8th Circuit to Stay PMTA Denials

A Missouri-based maker of menthol-flavored e-liquids urged a federal appeals court to revive its application with the U.S. Food and Drug Administration to continue selling its products, saying the agency had not given it fair notice of what approval would require.
The appeal by SWT Global Supply Inc. is one of a slew of similar cases by e-cigarette companies in the wake of the FDA’s rule deeming e-cigarette products to be subject to the same law as combustible cigarettes and the agency’s subsequent denial of millions of premarket tobacco product applications (PMTAs) by manufacturers to sell their products, according to media reports. The question of whether the FDA acted fairly has already created a split among federal appeals courts.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
The question of whether the FDA acted fairly has already created a split among federal appeals courts. Most other appeals courts that have considered similar appeals by manufacturers over denied applications – including the D.C., 2nd, 3rd, 4th, 7th and 9th Circuits – have sided with the FDA. However, the 5th Circuit last month ordered the agency to reconsider the denial of two companies’ applications in a case also involving menthol-flavored products.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
Navjar said the lack of fair notice was particularly hard on small companies like SWT with limited resources. “A client like mine doesn’t have a lot of arrows in its quiver when it’s trying to fight a decision by a federal agency,” he said.
Catherine Padhi, a lawyer for the FDA, said that comparing products’ effectiveness to tobacco-flavored products was “a natural part of the risk-benefit analysis,” given that tobacco-flavored products have a “much-reduced risk of enticing children.” She also said that SWT could submit additional information to support its application.
February 16, 2024
VTA Buys Ads Targeting Senator Over Zyn Comments

The Vapor Technology Association (VTA) announced the launch of a cable news ad buy targeting Sen. Chuck Schumer and his proposed ban on Zyn nicotine pouches. The ad runs this week on FOX News and FOX Business during key programming slots, including “FOX and Friends,” “Kudlow,” and “The Five.”
Sen. Charles Schumer
The ad connects a proposed ban on e-cigarettes with a ban on all less harmful, tobacco-free nicotine products, such as Zyn nicotine pouches. The ad also calls out entrenched bureaucrats at the Food and Drug Administration’s Center for Tobacco Products (CTP), led by Brian King, for repeatedly blocking access for millions to e-cigarettes as harm reduction tools that the science has proven are the most effective product on the market to help people quit smoking cigarettes, according to an emailed press release.
“Sen. Schumer and the FDA are simply wrong: wrong on e-cigarettes, wrong on Zyn, and wrong on the science,” said Tony Abboud, executive director of VTA. “Rather than give adult smokers broader access to a greater number of lower-risk alternatives, the FDA and CTP have instead imposed a de facto ban on e-cigarettes – and Zyn is next.”
The ad states that Schumer’s proposed Zyn ban precisely mimics his attempts to eliminate e-cigarette use nationwide, amounting to an assault on Americans’ personal freedom to choose lower-risk, tobacco-free nicotine products that overwhelming scientific and medical data demonstrates are effective at helping adults quit smoking.

February 6, 2024
FDA Denies Blu Marketing of 5 Flavored Products
Credit: Fontem US
The U.S. Food and Drug Administration continued its de-facto flavor ban and issued marketing denial orders (MDOs) to Fontem US LLC for four Blu disposables and one Myblu brand e-cigarette product.
The currently marketed products that received an MDO are:

Blu Disposable Menthol 2.4%
Blu Disposable Vanilla 2.4%
Blu Disposable Polar Mint 2.4%
Blu Disposable Cherry 2.4%
Myblu Menthol 1.2%
After reviewing the company’s premarket tobacco product applications (PMTAs), the regulatory agency determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, according to a press note.
“The application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products,” the release states. “Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.”
While the FDA has approved 23 vaping products, none have been a flavored product. Last month, the agency also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products. Fontem is expected to appeal the FDA decision.
February 5, 2024
FDA Issues Civil Penalties to 21 Small Business Owners

Credit: Valiantsina
The U.S. Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.
In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.
The agency now seeks the maximum penalty of $20,678 from each retailer.
The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”
Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.
The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, according to the release.
“Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.
“In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.
“The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”
January 30, 2024