Tag: news

U.S. FDA Issues 6,500 MDOs to Small Businesses
Credit: Waldemarus
On Friday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies that collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products.
The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action.
“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”
The companies that received MDOs include:

Imperial Vapors LLC
Savage Enterprises
Big Time Vapes
SWT Global Supply Inc.
Great Lakes Vapor
DNA Enterprise LLC dba Mech Sauce
Absolute Vapor Inc.
ECBlend LLC
FDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).
The FDA added the premarket tobacco product applications (PMTAs) submitted for a variety of flavored e-cigarette products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for public health.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol.
“It doesn’t really matter to the FDA what your scientific evidence is or anything else, they’re pretty much handing anyone out there an MDO,” said Char Owen, president of the American Vapor Manufacturers Association.
She said some of the companies targeted Friday had just one or two storefronts and were genuinely trying to help adults stop smoking through the use of flavored products, according to the Washington Post.
“It’s tough out here because you’re dealing with lives and businesses,” Owen said.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
May 14, 2023
British Poll Reveals ‘Trust Gap’ In Vaping Harm

Photo: Taco Tuinstra
There is a major trust gap in vaping among smokers, with over half now believing they’re just as harmful as cigarettes or more harmful than cigarettes.
The poll of 2,000 smokers revealed a growing distrust in switching to vapes. Nearly 38 percent who lack trust, say it could stop them from attempting to quit their smoking habits through vaping in the future.
The government’s independent Kahn Review said vaping had a central role to play in a smokefree future across the country, with more than 6.5 million people still smoking in the U.K. And evidence last year by the Office for Health Improvement and Disparities (OHID) re-confirmed that vaping was at least 95 percent less harmful than smoking.
But according to the Adult Smokers Trust in Vaping study conducted by One Poll and commissioned by SMOORE, pioneers in inhalation technology, 29 percent only trust vaping a little as a method to quit smoking, whilst 13 percent do not trust it at all.
And of those whose trust is diminishing, 35 percent cite the lack of independent long term clinical research showing vaping to be less harmful than smoking. While 31 percent are concerned about the lack of any information available about the harm profile of different vape products. Other factors that had caused a lack of trust included: negative reports and studies that smokers had come across, inconsistency of government attitudes across the world towards vaping, the growing black market for vapes, and the view of the World Health Organization on vaping.
“There’s a major push to get smokers to move to vape products, but as of now, they just do not have all the information they need to make an informed decision to switch,” said Chenxing Pei, a senior aerosol engineer at the Smoore Centre for Analysis, Testing, and Safety Assessment, in a press release publish by the U.K. Vaping Industry Association.
“It’s vital smokers are confident enough to switch, especially since health minister Neil O’Brien said the government must ‘exploit the huge potential of vaping to help adult smokers to quit.’
“But reducing or quitting is incredibly difficult, it’s imperative to give them the belief that what they are attempting isn’t going to be a waste of time.
“And if vaping is to be viewed as a credible way to quit, urgent efforts need to be made to ensure smokers trust these products to have the desired impact.”
The research also revealed how trust among these smokers could be regained, with 30 percent claiming public health campaigns promoting the evidence-based facts could turn the tide. Better education of doctors to give more advice on how vaping can be an effective way to reduce harm caused by smoking, was cited as another key way to build trust.
Meanwhile, 21 percent would welcome advertising regulations for vaping companies to be lifted—as long as they are promoting evidence from credible sources.
But confusion persists among 68 percent of smokers when it comes to understanding which products would be suitable to help quit. And 70 percent now “don’t know who to believe” when it comes to vape products.
Three quarters of smokers want information to be made available on the harm profile of the vape product at the point of purchase. With 87 percent of these saying it is important to know exactly what it is you are inhaling. Many are looking for clarification about the chemical constituents (60 percent), carbon residues (46 percent) and heavy metal content (44 percent) in their vapes.
However, of those who smoke and vape, 74 percent initially started to reduce their reliance on cigarettes, with 58 percent of these claiming they were successful.
The study coincides with Smoore establishing an independent think tank of scientific, smoking cessation and compliance experts from the U.K. and U.S. to lay the foundations for an industry-wide harm reduction rating system that can be communicated to consumers on product packaging or accessed via a QR code.
“The concept of tobacco harm reduction is not widely understood by smokers, and there are widespread misperceptions regarding the relative safety of vaping products compared with cigarette smoking among the general public,” said Ian Fearon, one of the experts on the panel, who has previously worked for Juul Labs and BAT in senior scientific and clinical roles.
“The development of a harm reduction label may help smokers to understand the reduced risk potential of vaping and encourage switching, in addition to reassuring vapers regarding the quality of the products they use and allowing them to differentiate between different products.
“Government statistics last year showed that the proportion of smokers in the U.K. was at its lowest level since records begun, a decline which was attributed largely to the major role played by vapes.
“However, the findings of this study, highlight a significant trust gap amongst adult smokers and it’s crucial for the vaping industry, government, regulators and healthcare professionals to come together to bridge it and support smokers on their quitting journey.
“It’s clear that open and transparent communication is essential in this process and to supporting the government’s ambitions for the country to go smokefree.”
Click here to view the report
May 12, 2023
U.S. Supreme Court Asked to Review Avail Case

Avail Vapor has asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the Food and Drug Administration to Avail products.
In its petition, known as a Writ of Certiorari, Avail asks the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decisionmaking was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
The Supreme Court has not yet decided whether it will hear Avail’s case.
May 12, 2023
Altria Agrees to Pay $235 Million to End San Fran Suit

Credit: Bill Oxford
Altria has reportedly struck a $235 million deal to end a lawsuit brought by the San Francisco public school system one day after the plaintiff’s lawyers ended closing arguments.
This settlement represents a positive step forward in addressing the harmful impacts of vaping on the public,” said Girard Sharp partner Dena Sharp, Co-Lead Counsel for Plaintiffs in the litigation. “The settlement funds will compensate JUUL purchasers, young people, parents, and governmental organizations across America, and avoids the delay and uncertainty of continued court proceedings. We are proud of our clients and the federal court system that made this result possible. The legal system worked in this case, and we thank the jurors who devoted their time to this trial over the past few weeks.”
The Altria settlement brings a final resolution to the personal injury, consumer class action, and government entity cases brought in the MDL and the JCCP brought on behalf of children, families, and JUUL purchasers everywhere in the U.S.
Much of the school district’s argument in its case against Altria involved the distraction which occurred when vaping became “endemic,” interfering not only with teachers’ abilities to control their classrooms but nearly all levels of student life.
The bellwether trial forced Altria to publicly defend itself solo for the first time as it faces thousands more cases that were brought against the company and Juul. In December, Juul Labs agreed to pay more than $1.2 billion to settle more than 5,000 suits blaming the company for a youth vaping epidemic across the U.S.
Juul and Altria defended the first trial that started in March over a case brought by Minnesota over deceptive marketing of e-cigarettes. The companies settled the state’s case earlier this year.
In April, Juul agreed to pay $462 million to six states and the District of Columbia to resolve lawsuits and investigations into the marketing of addictive vaping products to children.
May 11, 2023
Illinois Indoor Vape Ban Heads to Governor’s Desk

Credit: Karen Roach
In the U.S. state of Illinois, a statewide ban on vaping inside public buildings is just a signature away from becoming law.
Both the Illinois House and Senate passed a bill that would make Illinois the 18th state in the country to outlaw indoor vaping, according to CBS News.
The bill was sponsored by state Sen. Julie Morrison. It expands the Smoke-Free Illinois Act, which forbade smoking in public buildings and within 15 feet of entrances.
The bill now heads to Governor JB Pritzker’s office to be signed into law.
Illinois also passed a law to raise the age to buy tobacco products from 18 to 21 in 2019, and limited the advertising of e-cigarette products in 2022.
May 11, 2023
Logic Challenges Marketing Denial Of Its Menthol Product

E-cigarette maker Logic filed papers in court on May 9 that challenge the U.S. Food and Drug Administration’s marketing denial orders (MDO) that it issued against two brands: Logic Pro Menthol E-Liquid Package and Logic Power Menthol E-Liquid Package, reports Bloomberg Law.
Logic called the FDA’s MDOs “arbitrary and capricious.”
The 3rd Circuit Court entered a stay on the FDA’s MDOs in December 2022. The MDOs were the FDA’s first-ever MDOs directed at menthol e-cigarette products.
May 10, 2023
Washington Passes Marijuana Law to Protect Workers

Credit: Jdoms
The governor of the U.S. state of Washington has signed a bill into law that will protect workers from facing employment discrimination during the hiring process over their lawful use of marijuana.
At a signing ceremony on Tuesday, Gov. Jay Inslee gave final approval to the legislation, enacting the bill into law about three weeks after it cleared the legislature, according to Marijuana Moments.
The reform is limited to job applicants. As Inslee noted before signing the measure, employers would still be able to maintain drug-free workplaces, or prohibit the use of cannabis by workers after they are hired.
SB 5123 “seeks to protect applicants from hiring discrimination if they use legal cannabis outside of work,” the governor explained, adding that “there are exceptions” for certain industries.
May 10, 2023
Zinwi to Hold Flavoring Event at UK Vapor Expo

Zinwi Biotech, a major Chinese e-liquid manufacturer, has announced it will bring its Good Flavor products to the UK Vaper Expo from May 12 – 14 in Birmingham. Attendees of the occasion will have the opportunity to witness firsthand Zinwi’s Good Flavor and will be able to customize their own flavors during the event.
“Zinwi’s products are known to be equivalent to three keywords in the industry: high return to flavor, high smoothness and high stability,” stated to a Zinwi spokesperson. “The primary reason behind the ‘high return to flavor’ characteristic is the stringent fragrance selection process.”
The “high return to flavor” concept is the requirement that each component of Zinwi’s e-liquids to have the highest levels of quality and purity. One of the most important components of an e-liquid is fragrance and the fragrance selection process begins in Quality Control where Zinwi analyzes a fragrance’s physical and chemical indicators and the legality of the components used, according to the spokesperson.
“It is then followed by our sensory evaluation team to evaluate the richness and purity level of the fragrances,” the spokesperson said. “The samples and the finished products will then be evaluated by Quality Control to ensure the highest level of quality of the e-liquid after the fragrances have been added to the products in the testing and manufacturing stage.”
Another reason Zinwi’s e-liquid has an enhanced flavor profile is the company’s Atomization Technology Research Center, which has self-developed nicotine salts and the sweeteners used in the e-liquids to ensure the highest quality of those components of the e-liquid formula, according to the spokesperson.
“Nicotine salt has been delicately developed taking into close consideration the stirring time, the temperature, and the amount of nicotine added in combination with other components such as benzoic acid. The diverse range of sweeteners are also developed to match different vaping devices, for example, different puff-range disposable devices and ceramic core vaping devices,” the spokesperson explained.
“Sweeteners can easily affect the flavor either to be ‘too sweet’ or ‘not enough sweet.’ Having a diverse range of sweeteners can avoid the “too sweet” or “not enough sweet” challenge and help the finished products to maintain the ‘high return to flavor’ characteristic.”
Additionally, Zinwi’s flavoring team are some of the most experienced in the industry. Apart from flavorist’s own flavoring experiences, Zinwi’s flavoring team together has created over 50, 000 formulas, and hundreds more are added every day on average.
“Zinwi’s good flavor products are not attributed by one single factor,” said the spokesperson. “It is the combined factors including the raw materials selection, the self-developed e-liquid components such as nicotine salts and sweeteners, the quality control procedures and the well-trained flavoring team that guarantee the good flavor.”
Established in 2016 and headquartered in the Guangming District of Shenzhen, China, Zinwi Biotech is a high-tech company that specializes in providing integrated e-liquid solutions including R&D, production and sales services to global e-cigarette manufacturers and brands. Due to its strong R&D capabilities, stringent quality control procedures and premium client network, Zinwi has become the world’s leading integrated e-liquid solutions provider.
May 8, 2023
UK Prisoners Spend More Than $8.5 Million on Vapes

Credit: Methaphum
In the UK, campaigners say figures in a new report showed inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes.
The amount spent in canteens has risen every year since 2019 after a smoking ban was phased in by the government across closed jails in England and Wales.
In the previous financial year, inmates spent £7,655,766 on vapes and £7,930 on e-cigarettes — a three-year high overall, according to media reports.
Prisoners have already spent £6,730,176 of their own money on vapes alone in the current period up to January.
British American Tobacco (BAT) and Manchester-headquartered Supreme Imports Ltd. were named as suppliers of the products in the data released by the Ministry of Justice (MoJ).
May 8, 2023
Malaysia Urged to Restrict E-Juice to Sealed Bottles

Photo: José Rubén
The Malaysian Substance Abuse Council (Masac) has recommended that only locally made vape liquids in sealed glass bottles be allowed for sale in the country, reports The Star. Using glass bottles will minimize the risk of undesirable substances being added, according to Masac’s secretary-general Raja Azizan Suhaimi.
A joint study by Masac, the Asian Center for Research on Drug Abuse and Universiti Sains Islam Malaysia found that teenage girls are increasingly using vape liquids laced with psilocybin, a psychoactive compound found in fungi such as “magic mushrooms.”
Raja Azizan suggested that the age limit for vaping should be raised from 18 to 21 to minimize the abuse of vape liquids, which may contain drugs. So far, only 10 manufacturers producing liquid nicotine are registered with the Customs Department, despite the registration deadline ending on April 30, 2023.
Masac also suspects that the three 13-year-old girls who were allegedly gang-raped by four teenagers in Kota Kinabalu on April 26, 2023, may have been given a vape liquid laced with psilocybin. The Malaysian government attempted to regulate the use of vapes among youth in October 2022 through the Tobacco and Smoking Control Bill, but it was referred to a Special Parliamentary Select Committee for refinement.
Prime Minister Datuk Seri Anwar Ibrahim revealed during the revised Budget 2023 in February that vape liquids containing nicotine are still illegally sold in the country with estimated sales of MYR2 billion.
Meanwhile, Health Minister Zaliha Mustafa has stated that the Generational Endgame Bill—a piece of legislation that aims to gradually raise the smoking age until it covers the entire population—will be expedited and retabled.
May 8, 2023