Tag: vaping

Kaival Expands Distribution for Bidi Stick to 46,000 Stores
Kaival Brands has three new distribution partners for its Bidi Vapor products: Smoker Friendly International, Avail Vapor and Hilmes Distributing. These three additional distributors push the potential U.S. store count for Bidi Vapor products above 46,000, up from 10,000 in 2020.
According to Bidi Vapor, distributor interest in its products has increased greatly following its receipt of a premarket tobacco product application filing letter from the Food and Drug Administration. As the company’s product moves into the substantive review phase, Bidi Vapor anticipates it will continue to update investors on additional new distribution agreements.
“These new partners will become a large new revenue stream for Bidi and Kaival,” said Niraj Patel, CEO of Kaival Brands, in a statement. “It is important to note our 2020 sales of just under $100 million were achieved with a distribution network of 10,000 stores and in less than 10 months of operation.
“Today’s new distribution partner announcements bring our network to over 46,000 store locations. The strength and breadth of these partnerships fuels our confidence in our ability to meet or exceed our 2021 projection of $400 [million] to 450 million in sales.”
March 1, 2021
U.S. Senator Romney Calls for Federal Flavor Ban
Utah Sen. Mitt Romney on Thursday pushed for flavored vaping products to be pulled from shelves across the United States. Romney introduced legislation in Sept. 2019 that would have banned the sale of all flavored vape products except tobacco flavors, but it was never taken up for a vote.
Credit: Office of Mitt Romney
Romney’s comments during the confirmation hearing for President Joe Biden’s nominee for surgeon general, Vivek Murthy, echo similar statements the senator has made in the past, according to kutv.com.
“The analysis shows that nearly one fourth of high school kids are vaping on a regular basis — tobacco products — and in many cases marijuana, as well,” Romney said, adding that the government needs to do everything it can to stop the sale of flavored vaping products and implement a robust public education campaign to warn kids about the dangers of vaping.
In Oct. 2019, the Utah Department of Health issued an emergency order banning the sale of flavored vape products in Utah, which was met swiftly with a lawsuit from tobacco retailers. The products remain available for sale today.
In 2019, the legal age to purchase tobacco products in the U.S. was raised from 18 to 21.
February 26, 2021
Vermont Revives Bill to Ban Flavored Vape Products
The U.S. state of Vermont is once again floating the idea of proposing legislation that seeks to ban the sale of flavored vaping products. Support for the bill is gaining traction in the state’s senate and would also ban flavored combustible tobacco, including menthol cigarettes.
The ban was originally proposed in early 2020 as a way to prevent youth use, but was sidelined after the Covid-19 pandemic began to impact the country. Ginny Lyons, chair of the Senate Committee on Health and Welfare, said in an interview this week that she’d like the Senate to pass the bill, S.24, “as quickly as possible.” She said use of nicotine products by young people has increased during the Covid-19 pandemic, according to vtdigger.com
If Vermont approved a ban on flavored e-cigarettes, it would be the third state to do so. Massachusetts banned flavored vapes and tobacco products in 2019, and California followed suit last year. However, California’s law was blocked after the tobacco industry moved successfully to have voters decide on the ban in a statewide referendum next year.
“During the pandemic, we’ve seen a real fallback from all the progress we’ve made on limiting youth access to tobacco and other flavored products, so it seems more important than ever to move forward with this bill,” Lyons said. “If we were only to eliminate all the other flavors and leave menthol on the market, we would see a transition of people to those menthol products, and we would be backsliding again.”
February 25, 2021
UK Health Group: Vapor Works as Quit-Smoking Aid

Photo: Marc Bruxelle | Dreamstime.com
Nicotine vaping products were the most popular quit-smoking aids (27.2 percent) in England in 2020, according to Public Health England’s (PHE) seventh independent report on vaping, carried out by researchers at King’s College London. Using a vaping product as part of a quit attempt in local stop smoking services had some of the highest quit success rates—between 59.7 percent and 74 percent in 2019 and 2020. An estimated 50,000 smokers stopped smoking with the aid of a vaping product in 2017.
Despite these trends, 38 percent of smokers in 2020 believed that vaping is as harmful as smoking; with 15 percent believing that vaping is more harmful
The coronavirus pandemic is likely to have had an impact on smoking and vaping behaviors in both adults and young people. However, it is still too early to assess the full effect of the pandemic, with much of the data examined in this report being pre-pandemic.
Vaping has plateaued in adults and young people since the last PHE report in March 2020. Around 4.8 percent of young people (aged 11 to 18 years) reported vaping at least once a month—the same as last year—and most of these were either current or former smokers (only 0.8 percent of young people who had never smoked currently vape). Smoking prevalence among young people, including those who smoked sometimes or more than once a week, was 6.7 percent in March 2020, similar to March 2019, at 6.3 percent.
Similar to last year, around 6 percent of adults are current vapers, equating to about 2.7 million adult vapers in England. Smoking prevalence continues to fall and is between 13.8 percent and 16 percent depending on the survey. Vaping prevalence was between 17.5 percent and 20.1 percent among current smokers, around 11 percent among former smokers and between 0.3 percent and 0.6 percent among those who have never smoked. The proportion of vapers who also smoke, or “dual users,” has declined since 2012.
“Our report draws together findings from randomized controlled trials, stop-smoking services and population studies and concludes that nicotine vaping products are an effective way of successfully quitting smoking,” said Ann McNeill, professor of tobacco addiction at King’s College London.
“What is concerning is that smokers, particularly those from disadvantaged groups, incorrectly and increasingly believe that vaping is as harmful as smoking. This is not true and means fewer smokers try vaping.
“The goal for 2030 is to be smokefree in England. The development of a new Tobacco Control Plan and this year’s review of the Tobacco and Related Products Regulations 2016 is an opportunity to ensure that the regulations around vaping are appropriate. The regulations are also hoped to help smokers to quit, while not attracting people who have never smoked.”
February 25, 2021
Bidi Vapor PMTA Moves to Substantive Review Phase
Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.
Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.
“Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”
Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.
“We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”
While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.
February 24, 2021
CVA Asks for Meeting With Nova Scotia Government
A Canadian vapor trade group extended an open invitation to Nova Scotia’s new government. The Canadian Vaping Association (CVA) letter to Premier Iain Rankin and 16 cabinet ministers stated that the organization wants to “work with industry to repair the destructive vaping legislation implemented by the previous administration.”
Credit: Toptop54
The Canadian province’s current legislation prohibits all flavored vaping products excluding tobacco and has a .50 cent per/ml tax. The policies have resulted in a drastic increase in traditional cigarette sales, as confirmed by the Atlantic Convenience Store Association and Abacus Data finding 30 percent of adult vapers are at risk of returning to smoking, according to the letter.
“Vaping has conclusively shown to be less harmful than smoking, and as such, vaping regulation must balance adult smokers’ constitutional right to life, liberty, and the security of the person with youth protection. In acting to protect youth, Nova Scotia has overcorrected to the detriment of public health,” the letter states.
The flavor ban has resulted in the closure of over 85 percent of Nova Scotia’s specialty vape retailers, job losses and broken lease agreements. The regulation has also strengthened illicit marketing of the products.
“The CVA has developed solutions to balancing youth use with adult harm reduction that have been successful within Ontario and British Columbia,” said Darryl Tempest, executive director of the CVA. “We continue to work to seek solutions to prevent use with youth and never smokers. The CVA asks for the opportunity to meet with the new administration to discuss solutions and present the science.”
February 24, 2021
Vapor Advocates Welcome PHE Evidence Review

Photo: Chris Dorney – Dreamstime.com
Public Health England’s (PHE) latest evidence review reinforces vaping’s role in smoking cessation as well as the low rate of use among underage never-smokers.
As the U.K. prepares to reevaluate its Tobacco & Related Products Regulations following Brexit, the report shows great successes in harm reduction and smoking cessation linked to vaping products.
In every region of the country, quit rates among adult smokers were found to be higher with the use of vaping than with other products, ranging from 49 percent success in the South West to 78 percent in Yorkshire and the Humber.
PHE states that the use of nicotine-replacement therapies (NRT) among long-term former smokers is declining while the use of vaping products is increasing. Citing data from Action on Smoking and Health, the review highlights that the most common reasons given for vaping were to quit combustible cigarettes (29.7 percent), stay off cigarettes after quitting (19.4 percent) and to reduce tobacco consumption (11.2 percent).
Flavors remain an important driver for those using vaping products, with 31.6 percent of vapers reporting fruit flavors to be their preference.
Uptake among “never-smoker” youth remains very low, between 0.8 percent and 1.3 percent, with PHE confirming that this rate has not increased in recent years.
John Dunne
“This a defining moment for the vaping sector and truly shows the considerable progress it has made against a backdrop of significant misinformation around the industry, with Public Health England once again stating that perceptions of the harm caused by vaping compared with smoking are increasingly out of line with the evidence,” said John Dunne, director general of the U.K. Vaping Industry Association (UKVIA).
“This latest data, which the review is based upon, provides incontrovertible evidence as to the importance of vaping to successful smoking cessation and the nation’s public health.”
Dunne also pointed to challenges that need addressing by the industry and policy makers.
“Despite the many positives in this report, a great deal remains to be done,” he said. “Action on Smoking and Health, for example, has found that just 11 percent of local authority stop-smoking services are offering vaping products to some or all of those trying to quit smoking. With the clear efficacy of vaping evidenced in this report, we must ensure this figure grows.
“As an industry, we also share PHE’s views on stronger enforcement in preventing underage sales. In our response to the government’s TRPR consultation, which we will be publishing shortly, we call for fully funded regional and national test purchasing schemes to better understand compliance and to help educate retailers on their legal requirements. The UKVIA has already published the first ever Preventing Underage Sales Guide for vape shops and online retailers, which has been supported by Trading Standards.
“The review’s finding that more than 50 percent of people believe vaping to be as harmful or more harmful than the use of combustible cigarettes means we need to keep educating smokers about the fact that vaping is a fraction of the harm of smoking, has literally changed the lives of former smokers for the better and is acknowledged as one of the best ways to quit conventional cigarettes.”
February 23, 2021
FDA ‘Public List’ of Products has Critical Flaws
By Bryan Haynes, Troutman Pepper
On February 16, 2021, the Food and Drug Administration (FDA) published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020.
The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States. However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
The initial version of the list includes cigar, pipe tobacco and waterpipe tobacco products that were the subject of substantial equivalence (SE) or exemption from substantial equivalence (EXSE) applications filed by September 9, 2020. However, the list expressly does not include any submissions for electronic nicotine delivery systems (ENDS), apparently because FDA has not yet completed its intake review of the thousands of Premarket Tobacco Applications (PMTAs) submitted for ENDS products.
This omission is striking, given what appears to be the plethora of ENDS products that are currently on the market and for which no PMTA was submitted by the manufacturer or importer. Although FDA has issued a few warning letters to sellers of these unauthorized products, it appears that these warning letters have only scratched the surface of unauthorized products.
The “public list” is also underinclusive in that it does not contain “deemed” products that are grandfathered from the premarket review process. Under the Family Smoking Prevention and Tobacco Control Act, products sold in the US as of February 15, 2007 (and unchanged since then) are not subject to premarket review. There are thousands of grandfathered deemed products that are not subject to premarket review.
Although FDA has published a separate database of products that have received standalone grandfather determinations, industry stakeholders are rightly concerned that distributors and retailers may conclude a product is not legally marketed if it does not appear on the “public list.” Distributors and retailers would need to separately consult the grandfather database, which is itself underinclusive because there are many grandfathered products that have not received formal FDA determinations.
The “public list” is also underinclusive in that it does not contain “deemed” products that have actually received FDA marketing authorization. For that, stakeholders would need to consult separate databases of products that have received either SE, EXSE or PMTA marketing orders. However, those databases are not current. Indeed, to our knowledge, there are scores of deemed products that obtained FDA marketing authorization months ago, and those products have not been identified in any of FDA’s databases.
The “public list” was ostensibly designed to be a tool for stakeholders to understand products that can, and cannot, be legally marketed in the United States. In order to better advise the public as to which products can legally be sold, FDA will need to expedite the inclusion of ENDS products on the list, as well as consider better ways to advise the public of products that are exempt from premarket review or that have obtained marketing authorization.
The above opinion may not be the same as Vapor Voice or it’s staff. Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
This article first appeared on tobaccolawblog.com.
February 23, 2021
RLX Technology Hires Citigroup Dealmaker as CFO
The China-based vapor company RLX Technology Inc. has hired Lu Chao, Citigroup’s top Asia health-care investment banker, as its chief financial officer, according to people with knowledge of the matter.
Credit: RLX Technology
Lu, a managing director and head of Asia health-care investment banking at Citi, is expected to join the U.S.-listed e-cigarette maker as soon as March, the people said. Lu will help RLX Tech to identify expansion and investment opportunities in the health care industry that could apply its vaping technology, said the people, who asked not to be named as the information is private. He will still be based in Hong Kong, they said, according to an article by Bloomberg.
Lu, a Princeton University graduate, joined Citi in December 2013, according to his LinkedIn profile.
The company, which is known for its RELX-branded devices, raised about $1.4 billion in an initial public offering in the U.S. last month, according to data compiled by Bloomberg. Lu was a lead banker on the deal, the people said, as Citi and China Renaissance Holdings Ltd. arranged the offering.
Shares in RLX Tech have risen more than 75 percent since its January debut, giving the company a market value of about $32.7 billion.
Representatives for Citi and RLX Tech declined to comment.
February 22, 2021
Utah Lawmakers Want Control of Nicotine Limits
The a new bill in the U.S. state of Utah seeks to un-do some vaping restrictions in the state. S.B. 134 would raise the standard of 24 mg/ml to 65 mg/ml if passed. Senator Curtis Bramble, the lawmaker behind the bill, says that the current standard bars 70 to 80 percent of all vape products on the market.
Credit: Tyler Moore
“We’ve done everything prudent to limit access of these products to youth; the question is if these are legal products in the US, should it be by administrative rule that they are prohibited or should it by an affirmative vote of the legislature that we limit the market?” Senator Bramble asked during a senate committee.
Over the last few years, Utah’s state legislature has given the Utah Department of Health (UDH) the power to limit nicotine sales and quantities in Utah. Beginning in 2020, UDH set a standard of 24 mg/mL of nicotine in vaping products sold in the state.
Beyond raising the nicotine standards, the law would also strip UDH of the ability to create these kinds of limits. Opponents to S.B. 134 say the more limits to nicotine the better, no matter where those limits are coming from.
“We have a youth addiction problem with nicotine; we have 30,000 youth in Utah vaping. Why on earth would the legislature want to increase the amount of nicotine?” asked Walter Plumb, the president of Drug Safe Utah, said, according to a story on abc4.com.
The bill has passed in a Senate committee and is waiting for a vote by the full Senate.
February 22, 2021