Author: Staff Writer

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
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
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
Snowplus its Expands Operations in the Philippines

Photo: Snowplus
Snowplus of China is expanding its vaping business in the Philippines, reports The Philippine Star.
Co-founder and head of overseas markets Derek Li is confident the company can build a good distribution network in the country.
Snowplus has invested $2 million in quality and safety research since 2019 and has received over $150 million in financing, which is among the largest funding for any startup in the e-cigarette industry.
Snowplus has also committed to raising industry quality and standards to deliver safe and reliable e-cigarettes to consumers in the Philippines.
In line with new vapor industry regulations in China, Snowplus recently obtained permission to operate from the State Tobacco Monopoly Administration. The license authorizes the company to produce 80 million pods per year.
The company established three advanced scientific laboratories with equipment to test its products’ power supply and durability, among other characteristics.
“Consumers can trust Snowplus. We work only with the most reputable partners and deliver products of the highest quality that are 100 percent safe,” Li said.
October 7, 2022
Malaysia Removes NRT, not Vape from Poisons List

Photo: dalaprod
Malaysia’s Health Ministry has categorized nicotine-replacement products as nonpoisons to make them more accessible to consumers, reports The New Straits Times.
Minister Khairy Jamaluddin said the move was done by granting an exemption to nicotine under the Poisons Act 1952 for products in the form of patches or gum registered under the Control of Drugs and Cosmetics Regulations 1984.
“This exception is expected to help smokers, who are motivated to quit smoking, in dealing with the withdrawal symptoms,” said Khairy.
At present, smokers who want to quit smoking have limited access to nicotine-replacement products as they are regulated under the Poisons Act 1952.
Under the law, nicotine is classified as a “Group C poison” and can be dispensed only by licensed pharmacists or registered medical practitioners.
The New Straits Times article made no mention of nicotine vapor products, which tobacco harm reduction advocates consider to be the most effect nicotine-replacement products on the market.
Malaysian lawmakers are currently considering the Control of Tobacco Product and Smoking Bill 2022, which, among other measures, would ban the sale of tobacco products, including e-cigarettes, to anyone born after 2007.
October 7, 2022
Juul Labs Bankruptcy Conjecture Continues to Grow

Credit: Vitalii Vodolazskyi
Juul Labs may be preparing to file for Chapter 11 bankruptcy, according to reports by Bloomberg and The Wall Street Journal and a tweet by Reorg reporter Harvard Zhang.
The vaping company has reportedly received inquiries from lenders and will soon formally request debtor-in-possession financing options.
“We will continue the preparation process for both a restructuring and other strategic options as we determine what path is best for our company,” a Juul spokesman said on Oct. 4.
Chapter 11 allows a company to continue operating while it works with a court and its creditors to reorganize its finances. It doesn’t necessarily herald the end of the company.
A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.
Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.
Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.
In June, the U.S. Food and Drug Administration ordered Juul’s products off the market, then stayed the decision pending Juul’s appeal.
Last month, Juul agreed to pay at least $438.5 million in a settlement with more than 30 states.
The uncertainty over Juul’s ability to remain on the market could make it difficult for the vaping company to raise money or secure traditional loans to pay for legal settlements or court judgments.
In September, Juul’s largest shareholder, Altria Group, terminated its noncompete agreement with Juul. Altria’s decision gives Juul more options to secure its business, including the freedom to sell itself—or a significant stake—to one of Altria’s competitors.
The rumors about a possible Juul bankruptcy are not new. Clive Bates, director of The Counterfactual, described them as a “nothing burger with a side of thin air.”
“It has been obvious since @FDA maliciously denied Juul’s marketing application that Chapter 11 is a possibility,” Bates wrote in a tweet. “The ‘scoop’ is that this has not changed.”
October 6, 2022
Nov. 18 is New Date for UKVIA Forum and Dinner
The UKVIA Vaping Industry Forum and Celebration Dinner will now take place on Friday, Nov. 18 at the QEII Centre in Westminster, London. The event had been canceled on Sept. 9, the day after the queen’s passing.
The agenda remains the same, and the UKVIA expects some additional speakers to be part of the lineup.
“We have had a fantastic response since the event was canceled, and we are looking to accommodate some additional speakers in our program,” said UKVIA Director General John Dunne in a statement. “We would like to thank delegates, sponsors, exhibitors and dinner guests for their patience, and we look forward to seeing everyone in November at what will be the biggest B2B event in the U.K. vaping calendar.
“The occasion will be particularly poignant as the original planned forum and dinner came the day after the announcement of the queen’s death. The event will allow us to pay tribute to Britain’s longest reigning monarch.”
While the original event had been at near full capacity, more tickets for the conference and dinner have now been released.
October 5, 2022