Tag: news

FDA Issues its 69th Vapor PMTA Warning Letter This Year
The US Food and Drug Administration (FDA) issued three more warning letters to vapor industry companies on March 19. The latest announcement total brings the count to 69 letters this year for companies selling vapor products without gaining regulatory approval through the agency’s premarket tobacco product application (PMTA) process, according to the agency’s website.
The latest letters were issued to Arizona-based Vapor Outlet, Vapor Tech Hawaii and the Vaporium in Illinois. In its letter to Vaporium, the FDA stated that the company continues to “manufacture, sell, and/or distribute to customers in the United States The Vaporium 6mg Red White and Blue 70/30 30 ML e-liquid product” without a marketing authorization order.
“Your firm is a registered manufacturer with 19,860 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states. “Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
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.
Many of the FDA’s letters so far have gone to local vape shops that manufacturer their own e-liquid in the store. For example, Vapor Tech Hawaii’s letter states that the FDA has determined that it “manufacture, sell, and/or distribute to customers its Vapor Tech Hawaii Waikikiwi 100ML 3mg e-liquid product” without a marketing authorization order. On March 16, the company issued three letters to stores owned by the Louisiana-based Little Town Vaping for selling house brand e-liquids.
March 22, 2021
Legal THC Vape Pens Enter Missouri Marijuana Market
Eight Missouri medical marijuana dispensaries, including three in the Kansas City area, started selling THC vape pens and cartridges for the first time last week. Store owners say customers have clamored for them for some time, despite varying opinions on their safety.
Credit: Clear Cannabis
The potential dangers of vaping nicotine and black market THC have been studied. The U.S. Centers for Disease Control and Prevention (CDC) hasn’t updated reports on a lung injury associated with black market THC vaping products since the start of the Covid-19 pandemic, but in February 2020 it reported 2,800 hospitalized cases of EVALI and 68 deaths since August of 2019. The CDC has stated that vitamin E acetate in illegal THC vape pens was to blame for the lung disease.
“Vaping products are “by far our No. 1 request,” Greenlight CEO John Mueller said, according to an article in Newsbreak.
Last week, medical marijuana vape pens were delivered to Greenlight’s dispensaries in Kansas City, Independence and Harrisonville. It’s the first time the products have been available in the state because it took time for cultivators to extract trim material down to a distillate form that could be vaporized.
“It’s an exciting day for the industry,” Mueller said, opening the first box.
March 22, 2021
Oscar Health Executive Joel Klein Joins Juul Labs Board
Joel Klein, a top executive at health insurer Oscar Health, has joined the board of directors of Juul Labs, one of the largest e-cigarette companies in the world.
Joel Klein, Credit: NYT
Klein is the chief policy and strategy officer at Oscar, which went public earlier this month in an IPO that valued the company at $8.6 billion, according to Business Insider. He previously spent eight years as the chancellor of New York City public schools under former Mayor Michael Bloomberg. Politico first reported Klein’s appointment.
“I believe the company must continue to play a critical role in reducing the devastating harm caused by smoking,” Klein said in a statement emailed to Insider. “To accomplish that paramount goal, Juul Labs must, first and foremost, continue preventing underage use of its products.
Oscar declined to comment on Klein’s appointment.
March 22, 2021
Cambodia Cracks Down on Heated-Tobacco Products

Photo: IRIS AO from Pixabay
Cambodia’s National Authority for Combating Drugs (NACD) has instructed all relevant ministries and institutions to take immediate action to stop the use and commercialization of heated tobacco products (HTPs), reports The Phnom Penh Post.
“All forms of trafficking, trading and importation of HTPs must be stopped and information on import restrictions must be disseminated to all vendors and the public,” the NACD stated in a directive.
Citing the World Health Organization, the NACD said the use of cigars, electronic nicotine delivery devices (ENDS) and HTPs can lead to serious lung disease and even death. The announcement further said that using these products is also a motivating factor for people to use other illegal drugs.
Cambodia has restricted ENDS since February 2014, but its guidelines did not cover newer HTPs.
Deputy National Police chief Mak Chito said that in the past the authorities had confiscated many of these products. He said that although some other countries consider the use of these products legal, Cambodia does not allow it.
“In Cambodia, there are also bad people who are cheating by using methamphetamines or marijuana [with these devices],” he said.
March 22, 2021
Kaival Brands Appoints New Board Members Ahead of IPO
Kaival Brands Innovations Group has appointed Paul Reuter, Carolyn Hanigan and Roger Brooks to its board of directors.
In addition to gaining the experience and judgment that the new members will bring to the board, their appointments are intended to ensure the company complies with certain corporate governance rules ahead of its planned Nasdaq uplisting.
“We are very pleased that Paul, Carolyn and Roger have agreed to join us as new members of the board,” said Niraj Patel, CEO of Kaival Brands, in a statement. “Coming off a remarkable year that demonstrated the strength of our team and products, these three individuals are joining the company at an exciting time. We look forward to benefiting from their diverse backgrounds and respective expertise.”
Reuter brings nearly five decades of industry experience in small box retail as a journalist, editorial director, entrepreneur and speaker. He has launched two businesses, including MidWest Retail Group, where he served as chairman and founding partner from April 2013 through June 2019. He is also the founder of Kreative Collaborations, an industry consultancy.
Prior to her retirement, Hanigan was the president of Reynolds American Innovation Co., an operating company of Reynolds American Inc. (RAI). Hanigan led the global vapor collaboration with British American Tobacco (BAT) up until RAI was acquired by BAT in 2017.
Coming off a remarkable year that demonstrated the strength of our team and products, these three individuals are joining the company at an exciting time.
Niraj Patel, CEO, Kaival Brands
She was the architect of RAI’s U.S. reduced-risk products strategic direction to further the vision of transforming tobacco. Under her leadership, RAI prepared both the U.S. commercial execution and regulatory applications for the Glo tobacco-heating products, the Velo nicotine pouches, and the Alto, Ciro, Vibe and Solo nicotine vaporizers.
Brooks is currently the chairman, treasurer and co-founder of Abierto Networks. Prior to his roles at Abierto Networks, from 1998 to 2008, Brooks was the lead independent director and member of the compensation and audit committees for Moldflow Corp. From 2017 to 2019, Brooks served as an independent director of Lytron Incorporated.
Kaibal Brands recently reached $100 million in revenues.
March 22, 2021
Philippine House Committees Endorse Vapor Rules
In the Philippines, three committees of the House of Representatives have endorsed to the plenary the approval of a measure that will regulate all vapor products, whether they contain nicotine or not. The rule will also apply to heated tobacco products (HTPs).
House Committees on Trade and Industry, on Health and on Appropriations has submitted Committee Report 873 for the proposed Non-Combustible Nicotine Delivery Systems Regulation Act (House Bill 9007), according to politics.com.ph. The rule applies to electronic nicotine- and non-nicotine-delivery systems (ENDS/ENNDS).
The measure provides that the allowable minimum wage to purchase, sale and use ENDS/ENNDS or HTPs shall be 18 years old, although there is debate to raise that age to 21 or even 25. The seller would also be required to verify the age of the buyer by requiring any valid government-issued identification card bearing the picture, age or date of birth.
“It shall not be a defense for the person selling or distributing that oneself did not know or was not aware of the real age of the purchaser. Neither shall it be a defense that oneself did not know nor had any reason to believe that the product was for the consumption of a person below 18 years old,” the committee report read.
The use of ENDS/ENNDs or HTPs will be banned in all enclosed public places except in designated vaping areas if passed, and the use of product will be prohibited in schools, hospitals, government offices and facilities intended particularly for minors. The bill prohibits the sale or distribution of ENDS/ENNDS or HTPs within 100 meters from a school, playground or other facility frequented by minors.
It also prohibits manufacturers of ENDS/ENNDS or HTPs from sponsoring any sport, concert, cultural or art event, as well as individual and team athletes or performers where such sponsorship shall require or involve the advertisement or promotion of the products.
Violators of the proposed law will be fined P500,000 for the first offense and P750,000 for the second offense. On the third offense, a fine of P1 million and/or imprisonment of not more than six years. The business permit and licenses of the company will also be revoked or cancelled.
If the offender is a foreign national, they will be deported only after serving their sentence.
March 19, 2021
Becerra Confirmed Secretary of Health And Human Services

Xavier Becerra (Photo: State of California Department of Justice)
The U.S. Senate on Thursday narrowly confirmed Xavier Becerra as President Biden’s secretary of Health and Human Services (HHS), reports The New York Times.
Becerra will take charge as the Biden administration is working to lead the nation out of the coronavirus pandemic.
Biden’s selection of Becerra was a surprise, and it set off an immediate debate over whether, as a lawyer, he was the correct choice to lead a department that oversees high-profile medical agencies, including the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. Republicans argued he was unqualified.
Democrats argued that Becerra had deep expertise in health policy. As California’s attorney general, he led 20 states and the District of Columbia in a campaign to protect the Affordable Care Act from being dismantled by his Republican counterparts. He has also been vocal in the Democratic Party about fighting for women’s health, including access to contraceptives and abortion.
In a tweet earlier this year, Derek Yach, president of the Foundation for a Smoke-Free World, described the nomination of Becerra as a “serious missed opportunity.”
“At a time of public health crisis, deep expertise in public health, medicine and science should matter,” Yach wrote. “Sadly, this is not apparent in the pick of the lead cabinet health voice.”
James A. Mish, CEO of 22nd Century Group, welcomed Becerra’s appointment, citing his leadership in tackling cigarette addiction.
According to Mish, Secretary Becerra is a long-time proponent of a reduced nicotine cap for cigarettes and tougher regulation for the tobacco industry. While serving as the attorney general of California in 2018, Becerra and five other attorneys general wrote a letter in response to the FDA’s Advance Notice of Proposed Rulemaking, strongly supporting a tobacco product standard for the nicotine level of combusted cigarettes.
“We look forward to joining Secretary Becerra, the HHS and the FDA on tackling the pressing public health tragedy caused by addictive cigarettes that is costing millions of Americans’ lives and billions of dollars each year,” said Mish in a statement.
March 19, 2021
Nicopure’s Halo PMTAs Move on to Substantive Review
The U.S. Food and Drug Administration has accepted all of Nicopure Labs’ Halo products’ premarket tobacco product applications (PMTA) for the substantive scientific review phase.
Just over six months after submission, Nicopure Labs’ PMTAs for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit and all supporting consumable components have been accepted and advanced to the final phase, substantive scientific review, by the FDA. Halo FDA accepted premarket tobacco product applications include:

Halo Tribeca Tobacco e-liquid

Halo SubZero Menthol e-liquid

Halo Turkish Tobacco e-liquid

Halo Fusion Unflavored Tobacco e-liquid

Halo Triton II Starter Kit (and supporting consumable components)

Halo ZERO Starter Kit (and supporting consumable components)
Halo’s first round of products was accepted and advanced three days after submission.
“Halo’s more than 12 years of commitment to producing the highest quality vaping products available for adult consumers has been our organization’s mission for more than a decade,” said Jeffrey Stamler, co-founder of Nicopure Labs, in a statement. “We believe in science, and we believe in transparency; we are honored to continue to work with the FDA, and as always, in the best interest of the industry and the most important thing of them all, our loyal customers.”
March 19, 2021
Montana State Bill Aimed at Preventing Local Vape Laws
The Montana Senate heard a measure to limit local government and the Department of Public Health and Human Services from regulating vaping products this week. Bill sponsor Rep. Ron Marshall (R-Hamilton) says vaping and alternative nicotine products are meant to get people away from tobacco.
Proponents say House Bill 137 would keep small businesses open by stopping counties from introducing flavor bans on vape products, according to NBCMontana. Opponents say these products aren’t any less dangerous than cigarettes and are too easily accessible to minors.
The bill Marshall proposed is House Bill 137. According to the official legislation, House Bill 137 will prevent and stop any further regulation on nicotine and vapor products by local and county governments. Health Boards and the Montana Department of Public Health and Human Services are also prohibited from further regulating flavored e-cigarettes and vapor products unless the policies match entirely different regulatory standards that deal with non-tobacco and non-combustible nicotine-containing products.
Marshall, a vape shop owner, and his business partner are former members of the Montana Smoke-Free Association. This bill moves to executive action, when the committee will vote whether to send it to the Senate floor.
March 19, 2021
Swisher and E-Alternative Solutions Expand Partnership

Photo: EAS
Swisher and E-Alternative Solutions (EAS) have expanded their partnership to support the marketing, sales and distribution of EAS’s Leap and Leap Go vapor brands. Both companies will remain separate entities with EAS benefitting from the additional support and strength of Swisher’s world-class sales and marketing organization.
Jeffrey Brown, formerly vice president of sales for EAS, has been named general manager of EAS, and will take the lead in the evolution of the partnership.
“Jeff is a well-respected leader with more than three decades of industry experience, and as general manager, he is the natural choice to take the EAS business to the next level and drive our respective brand expansion goals,” said John Miller, president and chief executive officer of Swisher, in a statement. “In the short term, the expanded partnership between EAS and Swisher will remain transparent to our valued customer base, and we will be following up with additional details as they become available.”

I look forward to working with the Swisher sales and marketing teams and taking the Leap and Leap Go brands to the next level.
Jeffrey Brown, general manager, EAS
“I couldn’t be more excited about this arrangement and look forward to working with the Swisher sales and marketing teams and taking the Leap and Leap Go brands to the next level,” said Brown. “EAS was built from the ground up to prosper in the highly regulated tobacco environment, and with the bench strength of the Swisher sales and marketing teams, we have the power to broaden our reach and expand the distribution of these great brands,” he added.
Over the past several years, Swisher has continued to expand its offerings to include smokeless tobacco products, premium cigars, and modern oral nicotine products to appeal to diverse and changing consumer tastes. Broadening its strategic partnership with EAS is another step toward becoming a more consumer-centric company.
March 19, 2021