Tag: news

FDA: 14 More Warning Letters for Flavored Vape Sales

The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.
The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.
The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from 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 will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.
The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.
May 1, 2024
U.S. Marshals Seize $700,000 in Unauthorized Vapes

Photo: APchanel
The U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California. The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.
“FDA has been unequivocally clear that we are committed to using the full scope of our enforcement tools—including seizures—to hold those who peddle unauthorized e-cigarettes accountable,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “The writing is on the wall for those in the tobacco product supply chain who fail to heed the law.”
This action represents the first time the U.S. Food and Drug Administration and the Department of Justice (DOJ) have seized tobacco products in coordination with the U.S. Marshals Service.
The seizure initially targeted products being held and sold by MDM Group, a distributor doing business as Eliquidstop.com. FDA issued a warning letter to MDM Group in May 2023, for offering unauthorized, flavored e-cigarette products for sale or distribution. In January 2024, FDA conducted a follow-up inspection of the firm and determined that it continued to commercially market its illegal products. While conducting the seizure at MDM’s facility, the agencies were informed that several firms may have an ownership interest in the unauthorized e-cigarettes seized.
As of April 2024, the FDA had issued approximately 670 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and issued more than 550 warning letters to retailers for the sale of unauthorized e-cigarettes. The agency has also filed civil money penalty complaints against more than 50 e-cigarette manufacturers and more than 100 retailers for manufacture and/or sale of unauthorized new tobacco products, as well as complaints for permanent injunction against seven e-cigarette manufacturers.
April 30, 2024
Charlotte’s Web CBD to Elect 2 New Board Directors
Photo: Mariakray
Charlotte’s Web Holdings will elect new directors at its annual meeting on June 13. The company has proposed reducing the number of directors from seven to six.
The following directors’ terms on the company’s board of directors will expire effective June 13, 2024, and they will not stand for reelection:
John D. Held, who joined the board in May 2018 and serves as chairperson of the board and chair of the corporate governance and nominating committee;
Thomas Lardieri, who joined the board in August 2022 and serves on the corporate governance and nominating committee and as chair of the audit committee;
Alicia Morga, who joined the board in December 2022 and serves on the audit committee and the compensation committee.
“Charlotte’s Web is grateful for the valuable contributions and guidance that each of these directors have provided during their time on the board. Their expertise and dedication have been instrumental in navigating through critical phases of our transformation in a challenging unregulated category,” said Charlotte’s Web CEO William Morachnick in a statement.
The board has proposed to nominate the following current directors for reelection:
Jonathan Atwood, group head of business communications for BAT;
Matthew E. McCarthy (independent), former CEO and board member of Ben & Jerry’s Homemade and senior executive at Unilever;
Angela McElwee (independent), former president and CEO and board member of Gaia Herbs;
William Morachnick, Charlotte’s Web CEO and former president at Santa Fe Reynolds Tobacco International in Zurich, Switzerland.
In addition, the board has proposed to nominate Jared Stanley and Maureen Usifer as new appointments to the board.
April 29, 2024
Florida has First-in-Nation Disposable Vape Registry

Credit: Ball Studios
Florida’s governor, Ron DeSantis, has signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children.
The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.
Unlike other state registry lists, Florida is the first state in the nation to include a carve-out for refillable pod systems and open-system vaping products, as well as bottled e-liquids.
Florida Smoke Free Association president and vape shop owner Nick Orlando was the driving force behind getting the open system exemption.
In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval, according to media reports.
The law now directs the state’s Department of Legal Affairs to develop and maintain a directory listing all single-use nicotine vapes it deems attractive to minors. The department must make the list publicly available on Jan. 1, 2025, and regularly update it.
Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.
Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors that ship products into Florida.
Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.
April 29, 2024
Vapor Makers Urged to Implement Graphic Warnings

Image: natatravel
The Philippines’s Department of Health (DOH) is urging businesses, distributors and importers to start printing graphic health warnings (GHW) on vaporized products, reports Tribune.
The first set of GHW templates for vape products is set to take effect on May 12.
Under Republic Act No. 11900, also known as the Vape Law,
Operators who fail to comply with the new rules risk fines of between PHP2 million and PHP5 million and imprisonment of up to six years.
Manufacturers, importers, distributors and sellers may also face revocation or cancellation of permits and licenses as well as immediate recall, ban, or confiscation of products at the direction of the Bureau of Internal Revenue.
In addition, foreign individuals found in violation risk deportation.
April 26, 2024
Altria Wants FDA to Crack Down on Illegal Vapes

Vapor Voice archives
Altria Group Inc. is calling on the U.S. Food and Drug Administration to do more to crack down on unauthorized vaping products that compete with its own authorized products produced by Njoy.
“We believe the FDA’s enforcement approach is not of the scale or scope needed to bring about fundamental change in the marketplace,” Altria CEO Billy Gifford said on the company’s first-quarter earnings call.
He described the proliferation of e-cigarettes that the agency hasn’t authorized as a “threat to public health.”
Altria’s reported revenue fell 2.5 percent year-over-year to $5.58 billion. The drop was primarily driven by lower net revenues in the smokeable products segment, partially offset by higher revenue in the oral tobacco products segment and all other categories, according to media reports.
Altria’s (MO) revenue net of excise taxes decreased 1.0 percent to $4.7 billion. Adjusted diluted EPS decreased 2.5% to $1.15 to match the consensus expectation, primarily driven by lower adjusted OCI, partially offset by fewer shares outstanding.
“In spite of the absence of an effective regulatory environment, we saw continued early momentum from NJOY and believe our businesses are on track to deliver against full-year plans,” said Gifford. “We also demonstrated our continued commitment to maximizing the return on our investments and delivering strong shareholder returns through the sale of a portion of our investment in ABI and the subsequent expansion of our share repurchase program in March.”
April 25, 2024
UKVIA Updates Suppliers on Changing U.K. Rules

John Dunne (Photo: UKVIA)
John Dunne, director general of the U.K. Vaping Industry Association (UKVIA), traveled to China to educate vape companies on Britain’s changing regulatory landscape.
The U.K. will ban disposable e-cigarettes from April next year, and the Tobacco and Vapes Bill, which is currently working its way through Parliament, seeks to give ministers unprecedented powers to ban flavors and decide how vapes are packaged and sold.
Speaking at the headquarters of the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), Dunne shared his expert knowledge to conduct on-site compliance training to some of the world’s leading vape companies, including Elf Bar, SKE, ELUX, HQD, Hangsen, Greensound, Aspire, ICCPP, RELX, ALD, Uwell and Zinwi.
Describing the U.K. regulatory landscape as “complex and changeable,” Dunne said issues such as the protection of minors, battery recycling and environmental protection were high on the agenda of politicians, regulators and the general public.
“It is absolutely vital that all companies operating in the U.K. are fully compliant with all local laws and work at all times to show the industry in the best possible light,” he said in a statement.
Dunne said the UKVIA would continue to work with the ECCC to help members comply with current requirements, prepare for future regulatory change and to foster global cooperation to promote the development and prosperity of the global vaping industry.
April 25, 2024
U.K. Misleading Public on Relative Risk: Gilchrist

Mora Gilchrist (Photo: PMI)
Philip Morris International has accused the U.K. Department of Health of spreading misinformation about heated-tobacco products after a social media post warning that “all forms of tobacco are harmful,” reports The Grocer.
A tweet posted by the department in a thread of “myths” about vaping and tobacco contained false and misleading statements and risks driving consumers back to cigarettes or dissuading current smokers from making the switch to alternatives, according to the multinational.
“What hope do adult smokers have when seeking out accurate information on smoke-free products if it’s the government that’s spreading misinformation?” said PMI Chief Communications Officer Moira Gilchrist.
“All forms of tobacco are harmful, and there is no evidence that heated-tobacco products are effective for helping people to quit smoking,” the tweet stated.
“Laboratory studies show clear evidence of toxicity from heated-tobacco products. Unlike vapes, there is no evidence they are effective for helping people to quit smoking,” the post continues, citing a 2017 report by the Committee on Toxicity.
According to Gilchrist, such statements “distort the scientific evidence base” and “seriously misleads the public.”
While acknowledging that heated tobaccos are not risk-free, Gilchrist said it is misleading to imply that all forms of tobacco are equally harmful.
A Public Health England report in 2018 said that available evidence suggested that heated-tobacco products “may be considerably less harmful than tobacco cigarettes” but “more harmful than e-cigarettes.”
The Grocer
April 25, 2024
Former Researcher Sues KT&G Over E-Cig Patents

Photo: Ian O’Hanlon
A former KT&G Corp researcher has filed a lawsuit against his former employer claiming that he was insufficiently compensated for inventing “the world’s first e-cigarette” while working at the firm, reports the Yonhap News Agency.
Kwak Dae-geun demands KRW2.8 trillion ($2 billion), reportedly the highest amount ever claimed by an individual in a South Korean legal action
According to the suit, Kwak joined the Korea Ginseng and Tobacco Research Institute in 1991 and began developing a tobacco-heating product in 2005.
In July that year, he registered his first patent for a prototype. In December 2006, he registered another patent for an upgraded version with a controllable heater.
Subsequently, he developed a full e-cigarette set, and registered a patent for part of the device in 2007 before leaving the company in 2010 as part of corporate restructuring.
After Kwak’s departure, KT&G allegedly registered patents for some of his technologies without recognizing his contributions.
In addition to his claim about compensation, Kwak contends that a prominent rival global tobacco firm was able to commercialize its internal heating-based e-cigarette model in South Korea in 2017 due to the absence of overseas patents.
Kwak’s requested damages reflects his portion of the revenue KT&G is expected to generate through Kwak’s patented technology during the 20-year patent term, as well as what KT&G would have earned if it had registered patents overseas.
KT&G counters that it has properly rewarded Kwan in the form of offering a technology advisory deal, and that Kwak had agreed not to raise any legal issues.
The firm also said the technologies invented by Kwak are not currently used in the products it is selling.
The e-cigarettes being sold by the global firm in question, meanwhile, did not involve technologies patented by Kwak, according to KT&G, which also noted that the rival firm had already commercialized early-model heated tobacco-type products in 1998.
April 24, 2024
Civil Money Penalties for 22 Retailers for Elfbar Sales
Credit: Jeff McCollough
The U.S. Food and Drug Administration today announced the issuance of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers and two online retailers for selling unauthorized e-cigarettes, including Elf Bar, a popular youth-appealing brand.
The regulatory agency previously issued warning letters to these retailers for selling unauthorized tobacco products. However, according to an FDA release, follow-up inspections revealed that the retailers had failed to correct the violations.
Accordingly, the agency is now seeking a CMP of approximately $20,000 from each retailer.
The approximately $20,000 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including in Sept., Nov., Dec. and Feb.
The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or 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.
April 23, 2024