Tag: news

FDA Fails to First Inform Hyde of MDOs Before Public

The U.S. Food and Drug Administration confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products. However, Magellan CEO Jon Glauser said the FDA acknowledged in writing that it had “erred in failing to inform the company” about the MDOs and only after the Oct. 6 announcement did Magellan receive the letters from the FDA.
“Because the affected PMTAs had been pending with the agency for over two years, we can only surmise that what the FDA deemed an “inadvertent error” in failing to inform the company was caused by an apparent rush to include the MDO action with the Agency’s press release on the National Youth Tobacco Survey data, which shows youth vaping down 50% since 2019,” Glauser states in an email. “The MDOs covered only certain Hyde products containing tobacco-derived nicotine. No Hyde products containing non-tobacco nicotine are subject to an MDO.”
In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.
“After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology, Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology, Inc. in their statement, FDA also issued a Refuse to Accept (RTA) Letter for other Hyde e-cigarette products.”
Glauser states that the FDA did issue a Refuse to Accept (RTA) letter for certain of Magellan’s Hyde
products containing non-tobacco nicotine, identifying two administrative requirements the regulatory agency claims the company’s premarket tobacco product applications (PMTAs) were lacking.
“First, with respect to two of our bundled applications, the FDA stated that a signed statement as to the accuracy of certain translated documents was missing. However, the agency misunderstood the fact that the documents themselves are dual language documents that are maintained by our Chinese manufacturer in both English and Chinese. Because the relevant FDA regulation only requires a
certification for documents that have been translated from another language into English, we believe that the cited regulation is inapplicable,” Glauser explains. “This is the only issue cited against one of our bundled applications and on October 12, 2022, we filed a petition for stay with FDA requesting that the agency immediately stay the RTA determination on this basis.”
The second Item, Glauser wrote, relates to nine other applications that the FDA claims a certification statement verifying the PMTA submissions were “true and correct” was missing from those submissions. The FDA had preciously told Magellan that the company already had submitted amendments to its applications with the certification, but the agency could not determine to which applications the amendments needed to be applied.
“To that end, the FDA noted that ‘although your submission(s) may include the required content for a PMTA,’ the absence of the form made it impossible for the FDA to review the applications. While it is unfortunate that these technical issues cropped up with respect to these applications which had to be filed under enormously short time constraints, it is not a reflection of the high quality of scientific work that Magellan has assembled and continues to generate as part of its commitment to the PMTA process, work which the FDA has not yet reviewed,” wrote Glauser. “Magellan’s counsel and consultants already are engaging with the FDA regarding these issues and are asking the Agency to reconsider its initial determination so that Magellan’s application review can progress forward. In the event that FDA refuses, Magellan intends to move promptly to seek judicial relief regarding the RTA letter.”
In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.
Magellan Technology demanded that FDA not only retract the press announcement but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.
October 14, 2022
FDA Gives Most Warning Letters to Small Companies

Photo: Postmodern Studio
Current U.S. Food and Drug Administration oversight of the vaping industry in the U.S. is likely to have minimal impact, suggests an analysis of the regulator’s warning letters for marketing violations, published online in the journal Tobacco Control.
The regulator is failing to target the key players or the products most popular with young people, the analysis suggests, with over 90 percent of warnings sent to small online retailers rather than leading tobacco companies, and a focus on refillable devices.
While the prevalence of vaping among U.S. adults remains low, at just under 4 percent in 2020, it is four times higher among young people.
In 2016, the FDA announced plans to regulate the vaping industry, including a requirement for the manufacturers of e-cigarettes to obtain premarket approval (PMTA) to ensure that their products protect public health.
In 2017, the regulator began sending warning letters to manufacturers, retailers and distributors for potential violations, such as advertising to young people, selling to minors, packaging or labeling that contravened regulations, and failure to apply for a PMTA.
But little is known about who received these letters, the types of product they concerned, or details of the violations and their consequences.
To try and find out, researchers from Truth Initiative assessed the content and recipients of publicly available FDA warning letters issued in 2020 and 2021. In total, the FDA issued 303 warnings: 126 in 2020 and 177 up to Sept. 9, 2021.
The analysis revealed that in 2021, over 98 percent of all the targeted companies fulfilled all three roles (manufacturer, distributor and retailer).
But nearly all the letters (97 percent) were sent to small online retailers, none of which were large companies with measurable market share, as evidenced by sales data.
Companies were cited for between one and three infractions. Most involved failure to obtain a PMTA. In 2020 and 2021, respectively, 56 percent and 99 percent-plus of the infractions concerned a PMTA violation.
And more than 90 percent of the products cited—880 different ones in total—were flavored refillable e-cigarette liquids rather than the disposable vaping devices that the evidence indicates are most popular with young people.
Penalties ranged in severity from product detention to product seizure and fines. But loss of tobacco distributor license and criminal charges appeared less frequently in both years than these other consequences.
At the time of the review, most (72 percent) of the websites cited for 2020 infractions were still operating as were 29 percent of websites cited for 2021 infractions.
And as the authors note, it was impossible to find out how the targeted companies responded and whether the FDA followed through with the consequences cited in the warning letters because that information isn’t publicly available.
“While current research estimates that online sales comprise around one-third of the marketplace, data tell us that most young people get their products from friends (32.3 percent), buy them from another person (21.5 percent) or purchase from a vape shop (22.2 percent),” the authors noted in a statement.
“Prioritizing the products most accessed by youth, which are made available from a variety of sources, will be important to curb youth use,” they add.
“Strong, impactful and transparent consequences need to be in place to prevent the sale of products that violate regulations necessary in protecting the health of adult users of e-cigarettes and preventing youth use alike,” the authors added.
“The FDA should use its enforcement powers to target the manufacturing, distribution and sellers of the tobacco products that have the greatest impact on youth and products that provide no public health benefit.”
October 14, 2022
‘U.K. Unlikely to Enact Khan Recommendations’

Photo: William Richardson
The U.K. government is unlikely to enact the actions recommended by Javed Khan in his recent report on smoking, according to an article in The Guardian citing insiders.
The British government has committed to make the country “smoke-free” by 2030. This defined as getting the proportion of adults who smoke down from 14.1 percent to just 5 percent.
Published in June, Khan’s report says that ministers need to accelerate the reduction in smoking by 40 percent if want were to hit the 2030 target. Among other actions, he recommended raising the legal age of buying tobacco by a year every year and putting, imposing a new “polluter pays” levy on tobacco firms, and requiring sellers of tobacco products to have a license.
According to The Guardian, U.K. Health Secretary Thérèse Coffey also intends to break her predecessor’s promise to publish an action plan to tackle smoking.
The paper writes that Coffey has previously accepted hospitality from the tobacco industry. Since becoming an MP in 2010 she has voted in the House of Commons against an array of measures to restrict smoking, including the ban on smoking in enclosed public spaces, the outlawing of smoking in cars containing children and forcing cigarettes to be sold in plain packs.
The Department of Health and Social Care said it was “inaccurate” to suggest that the tobacco control plan was being dropped—but did not say if or when it would publish it.
Labour and anti-smoking campaigners voiced alarm at the potential U-turn over the tobacco control plan. It follows a Treasury-ordered review of measures to tackle obesity, and Coffey scrapping a promised white paper on health inequalities.
October 13, 2022
Foster City Again Plans to Ban Flavored Vapes

Foster City, California, plans to ban the sale of flavored tobacco products and e-cigarettes, with the city council to consider an ordinance at its next meeting. The city tabled the bill in August for lack of support.
“I firmly believe this is our opportunity to do right by our children,” Councilmember Sanjay Gehani said.
The council originally only planned to apply an ordinance to flavored tobacco, but a push from Gehani and Vice Mayor Jon Froomin at the Oct. 3 meeting to have a more stringent ban that includes e-cigarettes swayed Mayor Richa Awasthi and Councilmember Patrick Sullivan, according to the Daily Journal.
Staff will also bring back a tobacco resale license ordinance to address violations of the smoking ordinance ban brought. The ordinance, suggested by Froomin, will detail enforcement the city can take for those who defy the ban. Froomin said stringent enforcement was needed to be effective in the community.
The proposed ordinance would apply to convenience stores, grocery stores, gas stations and other businesses.
Cities like Half Moon Bay, South San Francisco, Burlingame, San Carlos, San Mateo and Redwood City have prohibited selling flavored tobacco. The state has passed Senate Bill 793, signed into law in 2020, which calls for tobacco retailers not to sell flavored tobacco products.
However, the state has halted implementation due to a referendum calling for its repeal, stalling a decision. California voters in the November election will vote on the status of SB 793, called Proposition 31.
October 12, 2022
VPASA: Bill Will End South African Vapor Industry

Asanda Gcoyi
South Africa’s new tobacco bill will destroy the vapor industry if it becomes law, the Vapour Products Association of South Africa (VPASA) warned.
Among other provisions, the Tobacco Products and Electronic Delivery Systems Control Bill opens an avenue for the government to ban the sale of flavored e-liquids, which tobacco harm advocates insist are key to entice smokers away from cigarettes.
VPASA contends that the government neglected to consult the industry about its proposed legislation, which mistakenly conflates vaping with smoking, according to the industry group.
“While the Cabinet statement announcing the adoption of the bill noted that the Department of Health had conducted extensive consultations, it conveniently failed to state that other than anti-tobacco campaigners, no other stakeholders had seen a copy of the revised bill before it was gazetted on Sept. 29,” VPASA CEO Asanda Gcoyi was quoted as saying by The Saturday Star. “This is despite numerous requests for a copy made by industry stakeholders.”
VPASA also believes the proposals on table are not based on science or empirical evidence, treating vaping and smoking as if they are one and the same thing. “Vaping requires a separate set of guidelines recognizing that it is not the same as smoking and therefore cannot be regulated in the same manner,” said Gcoyi.
October 12, 2022
BAT’s Glo Brand Doubles its Market Share in Korea

Credit: Radub85
Non-combustible products are rising in popularity in South Korea, especially the heated tobacco market. According to the latest government data, 210 million packs of heat-not-burn devices were sold in the first half of 2021, up 16.2 percent from the same period a year earlier.
The category’s share in Korea’s entire tobacco market has also increased to 12.4 percent in 2021 from 2.2 percent in 2017, according to Korea Biz Wire.
The country is a key market for the BAT’s glo device, with its market share growing twofold in the past two years. “Our local share has grown greatly since the launch of our heat-not-burn glo pro in 2019. Glo’s share in the non-combustible tobacco market has doubled from two years ago,” BAT’s Country Manager Kim Eun-ji said at the news conference.
BAT’s share in Korea’s non-combustible tobacco market has grown from 6.04 percent in 2017 to around 12 percent in June 2022, said Kim.
In line with such a trend, BAT, the maker of Dunhill and Lucky Strike cigarettes, has invested over $488 million in Korea, which includes a factory in Sacheon, 440 kilometers south of Seoul, which has served as a core export base of BAT since 2002.
“We are aware that the industry’s position is different from that of the health ministry. If we continue to push with more ‘data-driven’ (ways of) communication, we think it will create momentum (that can push) the government to take a step forward, but it will take time,” Kim said.
BAT is the third-largest player in the Korean market for non-combustible tobacco products. The front-runner is KT&G, which accounts for 47 percent of the local market as of June.
BAT Rothmans, the Korean arm of BAT, also reported Tuesday its tobacco heating device glo can reduce health risks of traditional cigarettes, according to a recent study published in the medical journal “Internal and Emergency Medicine.”
The study compared the health effects of glo against traditional cigarettes among 500 British adults aged between 23 and 55 over a one-year period. Researchers found that aerosol produced from glo had 90 to 95 percent less toxicant compared with smoke from traditional cigarettes.
Toxic compounds produced by burning tobacco were either not detected or significantly reduced through the glo device, the company added. “This real-world study allows us to assess the changes that adult smokers switching exclusively to glo experience. It reinforces glo’s potential as a reduced-risk product,” Sharon Goodall, BAT’s head of regulatory science, said at the news conference.
The study results come amid growing calls from the Korean government to increase regulations on e-cigarettes. In September, the health ministry pointed out that e-cigarette devices should go under tighter regulations, citing a growing number of teenage users of such products in the country.
E-cigarette heating devices, like glo, are categorized as ‘industrial products’ in Korea and are subject to looser regulations compared with cigarettes. “It’s hard to entirely trust a clinical study result unilaterally conducted by the tobacco industry. The World Health Organization has concluded that there’s insufficient evidence to support that e-cigarettes are less harmful than traditional cigarettes,” a health ministry official said. He asked not to be identified, citing the issue’s sensitivity.
October 11, 2022
Clinical Trial Using Nicotine to Combat Memory Loss

Credit: Duster 112
A groundbreaking new clinical trial taking place at Georgetown University that is studying the use of nicotine to treat memory loss.
Georgetown University’s Clinical Trials Manager, Angelica Forero, said the study is personal for her. “I think it’s wonderful,” said Forero. “In my family, I have my grandmother who has been diagnosed with Alzheimer’s.”
Her grandmother’s struggle with Alzheimer’s Disease is inspiring her to find a cure. It’s called the “(MIND) study.”
“Don’t be afraid, nicotine has been around for a very long time. Nicotine is not bad, what is bad is the tar and chemicals used in cigarettes. Nicotine does not cause cancer or heart disease or respiratory illnesses,” Forero told abcNews7.
Forero maintains nicotine has been used for more than 30 years for conditions like Parkinson’s, depression, mental illness and now memory loss.
“So, we know that nicotine stimulates areas of the brain associated with memory and attention,” said Forero, adding thar they need more participants from minority communities.
“Hispanic and Black communities are disproportionately affected by Alzheimer’s Disease and memory impairment, higher than white adults. You make a difference. Whether you are Hispanic or Latino or Black or white, you make a difference in participating in clinical trials. The more people that we get, the better because we learn more about it and we just hope that it will become an approved treatment for mild memory loss just as a way to prevent Alzheimer’s Disease,” said Forero.
The MIND study is a guided trial, not something individuals should try in any form on their own. Click here to learn more.
There is no cost to take part in the MIND study, and Georgetown University will cover transportation costs for you to come to the 12 visits that are required. It’s a two-year commitment for participants in the trial.
October 11, 2022
VTA Skeptical of FDA’s Latest Youth Vaping Analysis

After the U.S. Food and Drug Administration released its latest National Youth Tobacco Survey, Vapor Technology Association (VTA) Executive Director Tony Abboud said the FDA’s reporting of the data is misleading.
“Yesterday, the FDA, in coordination with the [U.S. Centers for Disease Control and Prevention ], released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth,” Abboud stated. “The FDA represents the NYTS data to show that youth vaping ‘remains high,’ yet a deeper dive into the data show only a small uptick in experimental or infrequent use while regular use remains flat or is slightly down.
Abboud notes that since 2019, according to the CDC, the number of high school students who have tried vaping (1 time in the last 30 days) has dropped by 50 percent, and the number of middle school students has plummeted by 70 percent. During that same time period, the number of high-school students who ‘frequently’ vape dropped by 37 percent and the number of middle school students dropped by 65 percent.
” FDA’s near single-minded focus on youth who experiment with vaping versus those who are frequent users ignores what clearly is a consistent trend of youth away from vaping products. Rather than focusing on removing products from the market in an attempt to impact youth vaping, the FDA should instead support common-sense regulatory reforms that would better restrict access to products instead,” Abboud stated. “Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit.”
Abboud explained that it is well documented that flavored vapor products help adult smokers to switch to less harmful vaping and “study after study after study” has confirmed the data. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half, he stated.
“Tobacco use is down. Youth vaping is down. These are both good things and are not in dispute. Unfortunately, there are still 40 million Americans addicted to cigarettes,” Abboud stated. “Every year, 500,000 die from smoking-related diseases and yet less than three percent of our kids are using vapes on a regular basis. The FDA’s failure to acknowledge this reality ignores the role vaping plays in harm reduction and smoking cessation, and puts more lives at risk.”
October 9, 2022
‘We Vape, We Vote’ Bus Tour Kicks Off in Arizona

Credit: AVM
A new bus tour to promote vaping in the U.S. began on Oct. 8. The event kicked off at American Vapor Manufacturers (AVM) president Amanda Wheeler’s vape shop, Jvapes Vape & Smoke Shop in Prescott, Arizona.
“Every American should have the right to use vaping to quit cigarettes. Critical health decisions should be up to the individual. Not the [U.S. Food and Drug Administration]. Not the [U.S. Centers for Disease Control and Prevention]. And certainly not nanny-state politicians in Congress,” the We Vape, We vote website states. “This fundamental belief underlies our entire effort. That’s why we need leaders who recognize vaping as a powerful harm reduction tool and the single most effective smoking cessation device ever created.”
The tour is designed to coincide with the midterm elections, and is intended to “amplify the voices of vapers in the 2022 elections,” according to Americans for Tax Reform (ATR), the Washington, D.C.-based organization sponsoring the tour. Events will include “rallies at vape shops, voter registration drives, discussions with lawmakers” and more, says ATR.
Alongside ATR and the AVM, the U.S. vape trade groups joining the tour are the Consumer Advocates for Smoke-free Alternatives Association (CASAA) and the Iowa Vape Association.
“Events will be covered by local media and promoted on our social media accounts, sending a clear message to lawmakers in state and federal legislatures that vaping saves lives and America’s vapers vote accordingly,” says ATR.
The tour will make 13 stops in 13 states, including Colorado, Iowa, Wisconsin, Illinois, Ohio, Pennsylvania, Washington, D.C. and, North Carolina, South Carolina, Georgia and Florida.
The entire schedule can be found at WeVapeWeVote.org website.
October 9, 2022
WVA Campaigns for Harm Reduction in Strasbourg

Photo: WVA
As a kickoff for the #BackVapingBeatSmoking campaign, representatives of the World Vapers Alliance (WVA) presented Members of the European Parliament in Strasbourg with a “Vaping Products Directive” to show how e-cigarettes need to be treated to fulfill their potential as tobacco harm reduction tools.
The campaign launches as European legislators review the Tobacco Products Directive. Responding to the EU Commission’s public call for evidence, the WVA has spoken out against flavor bans and excessive regulation.
“By backing vaping, we can beat smoking and save 19 million lives with sensible regulation,” said Michael Landl, director of the WVA. “The EU call for evidence has seen a record number of 24,000 responses, showing that consumers want to embrace tobacco harm reduction, and it happens that vaping has been proven one of the most successful so far.
“The EU needs to put an end to current discussions about flavor bans, and vaping must be kept affordable and accessible. It is time for the EU to fully endorse tobacco harm reduction and to make vaping a centerpiece of it.”
The #BackVapingBeatSmoking campaign launched in Strasbourg, France, with a “Don’t Let 19 Million Lives Fall” protest art installation and will spread to 10 cities in six countries during October 2022 through November 2022.
“We will host community events and protests in France, Poland, Czech Republic, Italy, Portugal and Belgium to draw attention to one of the most crucial pieces of legislation for the future of vaping. It is time for politicians to listen to consumers and science,” said Landl in a statement.
The WVA has also launched a petition against harmful vaping regulation, such as flavor bans or high taxation on vaping products. The signatures will be delivered to Members of the European Parliament at the end of the tour in November.

October 8, 2022