Tag: news

JVapes has PMTA Accepted by FDA for 992 SKUs
After submitting its premarket tobacco product application (PMTA) application to the U.S. Food and Drug Administration (FDA) on or before Sept. 9, 2020, Arizona-based JVapes announced that it had received a PMTA acceptance letter from the regulatory agency. The company submitted PMTAs for 992 SKUs of its JVapes e-liquids.
Credit: JVapes
The company now waits for a filing letter from the FDA. Following acceptance, applications undergo a more thorough review to determine if they include the data outlined in Section 910(b)(1) of the Tobacco Control Act (TCA). A filing status will only be received by brands that have submitted an application that contains all the necessary components with enough data included to justify a complete scientific review.
Filing is a critical milestone for a brand because once this status is reached, it is legal for products to remain on market till September 2021 while FDA completes its review.
During the substantive review phase of the PMTA process, FDA performs a detailed inspection of the documents and research that a brand has provided. This review considers whether or not an applicant product is safe for consumers and if it will be manufactured and marketed to FDA standards, with the ultimate goal of determining if a product is appropriate for the protection of public health.
Substantive review typically takes 90 days from notification of entering the review phase to receiving the first set of questions and comments from the FDA, according to the FDA. The majority of applications will receive follow-up questions and/or requests for additional data that may extend the timeline of the review phase.
June 5, 2021
Michigan to Formally Ban EVALI-Linked Additive
The additive that has been found as the source of THC vaping-related lung injuries and death would be formally banned in Michigan under legislation passed in the Michigan House this week. House lawmakers on Thursday approved a package of bills aimed at prohibiting the sale of tobacco and marijuana vaping products containing vitamin E acetate or other additives not approved by the Food and Drug Administration (FDA).
Credit: Spirit of America

The Centers for Disease Control has “strongly linked” THC products containing vitamin E acetate to 68 deaths — including three in Michigan — and more than 2,800 hospitalizations nationwide from a disease the CDC has called e-cigarette or vaping use-associated lung injury (EVALI), even though e-cigarettes had nothing to do with the diseases causes.
A processor or provisioning center found in violation of the ban would face a misdemeanor punishable by a fine of up to $10,000, according to M Live.
House Bills 4249 and 4250 passed the chamber with wide bipartisan support. The package now heads to the Senate for further review. The legislation is similar to bills introduced last session that also passed the House, but were never taken up for a vote in the Senate.
During a March 16 Regulatory Reform Committee hearing, one lawmaker said the harmful effects of vitamin E acetate were discovered in 2019 amid an “emergency when young people were dying after vaping.”
“This chemical is actually inserted in the vaping process and the manufacturing process, and there it was discovered that it was extremely dangerous to be inhaled,” they said at the time
The Marijuana Regulatory Agency in November 2019 created testing requirements banning the presence of vitamin E acetate in all marijuana vaping products and halted marijuana vaping sales until they could be tested for the presence of vitamin E acetate. In December 2019, the state recalled thousands of marijuana vaping products that tested positive for the additive.
Vitamin E acetate is safely consumed in food and applied to the skin in cosmetic products. When it comes to vaping, Vitamin E acetate can be used as a filler added to THC vaping cartridges – it’s a cheaper substance that dilutes potency.
The Centers for Disease Control and Prevention pointed to vitamin E acetate as a factor in many of the vaping-related deaths around the country, noting it “may interfere with normal lung functioning” when inhaled through a vaping product.
June 4, 2021
FDA Clarifies Purpose of PMTA Deficiency Letters
The U.S. Food and Drug Administration (FDA) has issued a statement that it has updated the language used in its deficiency letters. The new language is intended to clarify the purpose of the letters that are related to its premarket tobacco product application (PMTA) process. In an email on June 3, the FDA explained that such letters are only meant to communicate information gaps identified during review. The letter offers the applicant an opportunity to provide further information.
Credit: Araki Illustrations
“The language further clarifies that the letter is not intended to convey a list of concerns about the product, and a complete response to the deficiency letter does not guarantee that the applicant will receive a positive marketing order,” the agency states. “Importantly, a final decision regarding marketing of the product(s) will be made at the end of FDA’s scientific review. FDA will base the final decision on the applicable public health standard in the Federal Food, Drug, and Cosmetic Act after reviewing the totality of all the information included in the original submission and amendments.”
Following last year’s Sept. 9 PMTA deadline for most deemed new tobacco products, including vapor and e-cigarette products, that are currently on the market, the FDA’s job is to process, review, and take action on as many applications as possible before September 9, 2021, according to the agency. The substantive review process is the longest and most thorough phase of FDA’s review. Substantive review includes the evaluation of the scientific information and data in an application and often includes identification of follow-up questions for the applicant.
Before a final decision is made based on substantive review, the FDA generally sends a deficiency letter, which allows one opportunity for applicants to provide any additional information that the FDA needs to continue its scientific review. The agency typically allows 90 days for an applicant to respond to a deficiency letter.
June 4, 2021
FDA Issues 3 Warning Letters for PMTA Violations
The U.S. Food and Drug Administration (FDA) has issued three more warning letters for illegal e-liquids. The regulatory agency issued the letters on May 28 and June 3 and posted them to its website on the same days. Companies that received the latest round of letters have a combined 750 products registered with the FDA. The agency has now issued 123 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Chris Titze Imaging
North Carolina-based Asheville Vapor received letter on May 28 (50 registered products), while Kansas-based Tiger Vapes (100) and New York-based The Vapor Shop received the letters on Thursday, June 3.
In May, the FDA issued a total of 19 warning letters to firms who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S.
While each of these 19 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively those firms have listed a combined total of more than 378,000 products with the FDA, according to an email from the agency.
Since January 2021, FDA has issued a total of 123 warning letters to firms selling or distributing more than 1,280,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline.
The FDA recently released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
June 4, 2021
RLX Stock Jumps 29% on Week, Q1 Revenue up 48%
RLX Technology shares took a tumble back in March after China announced it would soon start regulating e-cigarettes, falling more than 40 percent. Over the past week, on expected high earnings, the company’s stock began to recover and was at $11.93 pre-market today after seeing a low $7.89 in March. Today, the company announced its unaudited financial results for the first quarter ended March 31, 2021.
Kate Wang / Credit: RLX
Net revenues were RMB2.4 billion ($366.1 million), up 48.2 percent from RMB1.62 billion in the fourth quarter of 2020. Gross margin was 46 percent, compared to 42.9 percent in the fourth quarter of 2020. GAAP net loss was RMB267 million, compared with RMB236.7 million in the 2020 fourth quarter. Non-GAAP net income was RMB610.5 million, representing an increase of 45.6 percent from RMB419.3 million in the fourth quarter of 2020.
“2021 began, on a solid note, with strong growth in key performance metrics of our business,” said Ying (Kate) Wang, co-founder, chair of the board of directors and CEO of RLX Technology, in a press note. “Specifically, our expansion in distribution network fueled a strong sequential growth, further demonstrating sustained user demand for our e-vapor product portfolio.”
“As the go-to brand of e-vapor products in China, we remain dedicated to investing in deepening our scientific research, improving our technology and product development, expanding our distribution network and retail outlets as well as enhancing supply chain and production capabilities.
“In the first quarter, we opened our Quality Lab to further strengthen our quality assurance and control capabilities, and started developing our second and third exclusive production plants to enhance our production capabilities. We believe we are well positioned to further capture the growth potential in the e-vapor industry in China,” Wang concluded.
During an early morning earnings call, RLX CFO Chao Lu said the company is dedicated to investing in deepening its scientific research, improving its technology and product development, expanding its distribution network and retail outlets, as well as enhancing supply chain and production capabilities.
“Our robust results in the first quarter of 2021 exemplify our strong capabilities in meeting user demands for reliable, innovative and trustworthy products,” said Chao Lu, who joined the company in February. “Building on rapid revenue growth and continued efforts in improving operating leverage, our gross margin and non-GAAP net margin have remained steady in the first quarter. We will continue to pursue user value creation by enhancing our suite of product offerings and strengthening our brand leadership in the market.”
For the second quarter of 2021, RLX Technology expects net revenues to exceed RMB2.85 billion, and expects non-GAAP net income to exceed RMB720 million. The company’s expected GAAP net income will include share-based compensation expenses which depend on the company’s share price. The company currently also expects gross margin to remain steady.of
June 2, 2021
Poda and Eson Pursue Europe, Asia Partnership

Photo: Poda Lifestyle and Wellness
Poda Lifestyle and Wellness and Shenzhen Eson Technology Co. have signed a binding letter of intent to facilitate a joint development agreement, whereby Poda will join Eson’s existing distribution network in Europe and Asia where Eson is currently selling over 50 million units per month.
Poda has developed and patented a heat-not-burn (HNB) platform while Eson has developed a patented proprietary blend of tobacco-free products that it currently sells through the brand Neafs.
“We are incredibly excited to partner with Eson, who is recognized as one of the leading manufacturers of electronic cigarette devices, and more recently as one of the global leaders in tobacco-free heat-not-burn products” said Ryan Selby, CEO of Poda, in a statement.
“Daniel Chen and his team at Eson are currently filling and distributing millions of Neafs products per month into the Chinese market, providing us with tremendous opportunities to scale. There are over 400 million adult smokers in China, and we believe that this partnership with Eson will provide us with a fast-track opportunity to rapidly develop our market share in the Chinese market,” said Selby.
Eson has designed numerous electronic nicotine delivery systems and has licensed its IP to some of the biggest tobacco companies in the world. In addition, Eson has served as an original equipment manufacturer for some of the biggest tobacco companies globally, including Japan Tobacco International, Imperial, British American Tobacco, Godfrey Philips India, Philip Morris International and China National Tobacco.
Eson has designed numerous electronic nicotine delivery systems and has licensed its IP to some of the biggest tobacco companies in the world. In addition, Eson has served as an original equipment manufacturer for some of the biggest tobacco companies globally, including Japan Tobacco International, Imperial, British American Tobacco, Godfrey Philips India, Philip Morris International and China National Tobacco.
This partnership will provide us with a fast-track opportunity to rapidly develop our market share in the Chinese market.
Ryan Selby, CEO, Poda
“Poda has developed an incredible HNB platform, and their zero cleaning pods offer consumers a hassle-free HNB product that delivers consistently great results, day after day” said Daniel Chen, CEO of Eson. “Additionally, the vapor is flavorful and robust, offering cigarette-like satisfaction to discerning adult smokers.
“We are already selling over 50 million Neafs stick per month and are currently expanding our production facilities to produce over 250 million Neafs sticks per month, which should be completed within the next 60 days. Since we launched the Neafs products in October 2020, the demand for Neafs products has been overwhelming. We are extremely excited to offer the Neafs by Poda products to our existing distribution channels, and we anticipate tremendous success with the Neafs by Poda products.”
June 2, 2021
Despite Regulatory Challenges, Vapor Retail Rises
Regulatory challenges have had a major impact on the vaping industry. Premarket tobacco product applications (PMTAs), along side recent shipping changes have been testing the markets as of late. However, according to IRI Total U.S. Convenience data, for the latest four weeks ending April 18, 2021, electronic smoking devices saw a 19.9 percent increase in dollar sales and a 24.5 percent increase in unit sales. And for the latest 52 weeks, the category saw a 10.5 percent increase in dollar sales and a 17.7 percent increase in unit sales.
Credit: Auremar
Rick Staley, merchandising manager for Nashville, Tenn.-based Tri Star Energy’s Twice Daily stores, noted its numbers are overall in line with IRI’s, according to CStore Decisions. “At Twice Daily, customers are looking for alternative tobacco products,” he said. “We’ve noticed that nicotine pouches and vapor are both doing very well.”
And at ARKO Corp.’s GPM Investments, the vape subcategory is doing “extremely well,” said Kaitlyn Meara, GPM’s tobacco category manager, adding that customers are looking for variety in nicotine delivery, flavors and price points. The Richmond, Va.-based chain operates or supplies stores in 33 states and Washington, D.C., including both its 1,350 company-operated stores and approximately 1,600 dealer sites. “Like in most other CPG categories,” Meara said, “we saw an increase in baskets due to customers making fewer trips.”
Now that people are starting to return to their routines and to more traditional work environments, much remains unknown about the way that consumers’ habits will shift moving forward.
Meara noted it’s extremely hard to predict the tobacco category as a whole, but she’s “excited about the innovation in the category with nicotine pouches and IQOS.”
June 1, 2021
Australian Retail Group Shames Medical Group With Award
The National Retail Association (NRA) has created the inaugural ‘Dirty Mirror Award’ and bestowed it on the Australian Medical Association (AMA) for its “breathtaking hypocrisy in public affairs”. NRA CEO Dominique Lamb said the AMA deserved the award for its efforts to protect the monopoly over nicotine vaping enjoyed by doctors and pharmacists.
Credit: Belyay
“Doctors are set to make a lot of money from prescribing nicotine products for vaping, and then sending customers on to pharmacies so they can get a slice of the vaping action,” Lamb said, according to Convenience and Impulse Retailing.
“The only businesses in the equation who are not making money from nicotine vaping are Australian retailers. So, it’s understandable that in its public positioning the doctors’ union has sought to protect that monopoly at all costs.
“In doing so, they have attacked mum and dad retail businesses who would like to transition away from selling cigarettes and move to vaping, which has been recognised by the World Health Organisation as a less harmful alternative to smoking.
“So, for using anti-tobacco day to stop Australian businesses reducing their reliance on tobacco; for happily agreeing that GPs and chemists should take money for vaping but no-one else; and for all-round extraordinary hypocrisy, we happily nominate the AMA for the Dirty Mirror Award.
“In fact, the self-interest is so breathtaking, we wonder if the AMA has taken a Hypocritic Oath.”
June 1, 2021
Harm Reduction Advocates Ready for World Vape Day
May 30 is World Vape Day. The theme for 2021 is “Go The Extra Mile” which is meant to encourage vapers to go just a little bit further to support and promote vaping. World Vape Day is a celebration of vapers making the choice to make the switch to a healthier, smoke-free lifestyle.
“On World Vape day we’re gathering vapers from around the world to celebrate this amazing innovation that changed our lives for the better,” said Michael Landl, the director of the World Vapers’ Alliance (WVA). “We’re doing it under the motto ‘Go The Extra Mile’ because I can’t think of a single person who took up vaping who didn’t benefit from it, go further and improve their lives in the process.”
The World Vape Day website is operated by the International Network of Nicotine Consumer Organisations (INNCO)—an alliance of dozens of vaping and tobacco harm reduction (THR) organizations around the world. The site is packed with THR information, resources, testimonials from vapers and other nicotine users, as well as a list of events vapers can take part in on May 30. Samrat Chowdhery, president of INNCO and founder-director of Association of Vapers India (AVI) said World Vape Day is important to promote the harm reduction offered by reduced risk products.
“Smoking disproportionately affects the disadvantaged. Vaping helps address these inequalities by giving those who can least afford medical treatment a means to prevent harm. In India where access to public healthcare is low, a 100 million people smoke, of whom a million die from smoking-related causes every year, harm reduction is vital,” he said. “And yet, sale of vaping products was banned last year. On World Vape Day, about a million of us vapers in India will celebrate our win over smoking and also demand our and smokers’ rights to health and choice.”
May 29, 2021
Review of 10 Years of Vaping Science Published by BAT
A comprehensive review of the scientific evidence for vaping products, their potential health effects and their role in tobacco harm reduction by BAT as World Vape Day sets to be celebrated on May 30.
Credit: Coloures Pic
This review shows that, over the past decade, the number of people who incorrectly believe vaping is as harmful or more harmful than smoking conventional cigarettes has risen in the UK, Europe, and the U.S., according to a press note. This is despite several scientific reviews published in the same period showing that vaping products manufactured in accordance with quality standards present less risk to health than combustible cigarettes.
According to population modelling studies cited in the review, a significant reduction in premature deaths could be achieved if current smokers switched exclusively to vaping rather than continuing to smoke. These modelling studies use population data and simulations to project the health-related outcomes associated with the long-term risks of smoking versus vapour use over time.
David O’Reilly, Director of Scientific Research at BAT, said the paper is a comprehensive summary of more than 300 peer-reviewed scientific papers and other evidence published by an estimated 50 institutions over the past decade.
“The scientific evidence is clear – but consumer misperceptions remain. In England and the United States, only one in three adults is aware that there is scientific evidence available, including from leading public health authorities, that supports the conclusion that vaping is less harmful than smoking,” O’Reilly said. “The reality is that many leading public health authorities have reported that vaping is less harmful than smoking, and that this harm reduction potential can be maximized if those smokers who would otherwise continue to smoke switch exclusively to using vapor products.”
The review highlights that vaping products can effectively compete with combustible cigarettes by providing nicotine and the sensorial enjoyment sought by smokers, according to the press note.
May 28, 2021