Author: Staff Writer

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
Kaival Brands Reaches $100 Million in Revenue
Kaival Brands Innovations Group reported significant revenue and profitability milestones in the quarter ended Jan. 31, 2021. The company achieved a cumulative $100 million in revenues since it commenced business operations in March 2020, despite revenue slowdowns during the fourth quarter of 2020 due to packaging and labeling updates.
During the fourth quarter of 2020, the company and Bidi Vapor made the decision to wash out inventory and repackage the entire product line in an effort to go “above and beyond” U.S. Food and Drug Administration packaging and labeling guidelines.
First quarter 2021 revenues were $37.3 million, compared to revenues of $0 in the first quarter of 2020. “Given the significant expenses associated with infrastructure, start-up costs, marketing, legal and many other business necessities, we are proud of our ability to reach profitability so early on in our development,” said Niraj Patel, Kaival’s president and CEO, in a statement.
“The gross profit number provides a glimpse into our future net profits as we continue to scale the business in a smart and efficient operational manner.”
The gross profit number provides a glimpse into our future net profits as we continue to scale the business in a smart and efficient operational manner.
Niraj Patel, president and CEO, Kaival
From a revenue perspective, February and March have benefited from the company’s new distribution partnerships as well as the rollout of the Bidi Pouch. As such, the company expects revenues to increase during the second fiscal quarter ending April 31, 2021. “Given our current visibility, we remain very confident in our full-year fiscal 2021 revenue guidance of $400 million to $450 million,” Patel said.
March 18, 2021
Borgwaldt KC Presents New Vaping Machine

Photo: Borgwaldt KC
Borgwaldt KC has launched the NGX10, a 10-port linear vaping machine for next-generation products.
Exceeding ISO 20768 and CRM 81 specifications with gas analyzer options to match the specifics of these products, the NGX10 is a new, professional, flexible, efficient and reliable member of Borgwaldt KC’s well-known analytical vaping machines.
The NGX10 incorporates all the design and feature improvements specific to the emission testing of next-generation products.
The machine can handle all device sizes and shapes. For more information, visit www.borgwaldt.com.
March 18, 2021
Irvine: Health Canada’s Nicotine Cap is Deadly Decision
If Health Canada has its way, this year vaping will be dealt three knockout blows that will see, not just the end of the business as we know it, but an increase in smoking-related deaths nation-wide, says Ian Irvine, a professor of economics at Concordia University.
Ottawa is recalibrating the delicate equilibrium between harm reduction and youth use of nicotine. It plans to introduce a mandatory limit on nicotine concentration in e-cigarettes and to ban most flavours. Maximum permissible content is currently at 66 milligrams per millilitre; the new limit will be 20. Eventually, we will see strike three: excise taxes.
Ian Irvine, courtesy Concordia University
Harm reduction tries to induce smokers to switch to nicotine products with greatly reduced toxins, particularly if they are habituated or even addicted to nicotine. Public Health England has repeatedly stated that the toxins in e-cigs are at most five per cent of those in regular cigarettes. The toxins that cause cancer come from the burning of tobacco at 700 degrees Celsius. But vaping devices heat rather than burn. Nicotine is not the health demon. It does cause habituation. But it’s the burning that shortens lives.
In an article for the Regina Leader-Post, Irvin explains that e-cigarettes are not harmless. The health problem vaping poses is that between five and 10 per cent of teens are regular vapers and nicotine is bad for the developing brain. But while a pack-a-day smoker will on average lose 10 years of life, an equally indulgent vaper might lose just one. Most adults who drink moderately, gamble, like sugar too much, or exercise insufficiently might think one year off a normal lifespan a reasonable price to pay to indulge a passion or need.
As for adult smokers, people considering a transition from smoking to vaping require a product yielding enough nicotine to satisfy their craving. Many potential switchers will not make the transition — and will end up dying prematurely — if they cannot get a strong enough nicotine substitute for their cigarettes. Canada has about 40,000 smoking-related deaths per year, so if even a small percentage of smokers don’t transition because of insufficient nicotine, that will mean thousands more deaths annually.
If Health Canada succeeds in introducing both a nicotine cap and a flavour ban on vaping, smoking rates will continue to be higher than necessary and many thousands of unnecessary deaths will folllow.
The entire opinion can be read here.
March 16, 2021
Greenrose Buys 4 Cannabis Companies for $210 Million
Greenrose Acquisition Corp said it would buy four private companies to build a cannabis cultivation, distribution and retail network across seven U.S. states. Greenrose will buy Shango Holdings Inc, Futureworks LLC, Theraplant LLC and True Harvest LLC at an initial deal value of $210 million and a maximum earnout of $110 million, it said on Monday.
“The companies we are bringing to market fully align with Greenrose’s core objectives,” CEO Mickey Harley said. “We are targeting strategic assets in several key states that present opportunities for further consolidation as we seek to deepen our presence, particularly in the West.”
The acquisitions will give Greenrose, a special purpose acquisition company, legal-weed operations in seven states – Arizona, California, Colorado, Connecticut, Michigan, Nevada and Oregon. Greenrose said in a statement that the acquisitions will create “a vertically integrated and cash flow positive platform positioned for significant growth.”
Media reports say Greenrose is betting on the nation’s pot industry opening up soon. According to Sharik Khan with Reuters, dealmaking in the U.S. cannabis industry has surged in recent months on expectations that President Joe Biden’s administration will relax federal prohibition and make it easier for companies to operate similarly to rivals in the alcohol or tobacco industries.
The combined company will have nine dispensaries and over 300,000 square feet of cultivation space, Greenrose said. Greenrose said it expects to temporarily move from the Nasdaq to over-the-counter trading because companies growing or selling marijuana in the U.S. cannot list on major stock exchanges.
The company also plans to list on Canada’s NEO exchange after the deal closes, though there is still a chance it may not have to leave the Nasdaq, Harley told Reuters.
March 16, 2021
First Tennessee Vapor Shipping Reports Due May 10
Tennessee has announced the starting date for its PACT Act requirements. The state’s Department of Revenue states that beginning May 10, 2021, and the 10th of every month thereafter, any entity shipping electronic nicotine-delivery systems (ENDS) or related products into Tennessee from another state is required to report all such shipments to the department.
It is expected that all states will require PACT Act reporting to begin on May 10. Effective March 28th, 2021, recipients of all vaping products purchased online will be required to present ID and sign for their delivery. The United States Postal Service mail ban on vaping products will go into effect on April 27th, 2021. After this date, customers will no longer be able to receive vaping products by way of USPS delivery.
The amended PACT Act provides that any person who sells, transfers, or ships for profit ENDS in interstate commerce, or who advertises such products for sale, must register with the tobacco tax administrator of the state into which the shipment is made. The company must also file monthly reports with the tobacco tax administrator no later than the 10th day
of each month.
Under the PACT Act, a delivery seller faces violations that may result in civil penalties of up to
$5,000 for the first violation, $10,000 for the second violation, or 2percent of the gross sales during the prior 12 months. Additionally, there are penalties for common carriers or other persons providing delivery services of up to $2,500 for a first violation or $5,000 for any other violation within one year of a prior violation.
March 16, 2021
Global Consumer Group Wants Sensible THR Policies
An international consumer group released a position paper today that claims blanket bans on vaping and heated tobacco products (HTPs) are a detriment to low- and middle-income countries (LMICs). The International Network of Nicotine Consumer Organisations (INNCO), a global advocate for sensible tobacco harm reduction (THR) says bans on electronic nicotine delivery systems (ENDS) are an overly simple solution that make the problems that come with combustible cigarette use far worse.
“The hundreds of millions of people who smoke in these countries should have the ability to make decisions about safer nicotine products, particularly when their own health is on the line,” said Samrat Chowdhery, president of INNCO’s governing board. “Overly simplistic policy solutions, such as proposed bans on all ENDS and THR products by the Bloomberg Philanthropies-funded The Union, are being offered as a blunt and impractical tool for a situation that requires pragmatism and nuance, making meaningful and sustainable change more difficult.”
Samrat Chowdhery
The report, “10 Reasons Why Blanket Bans of E-Cigarettes and HTPs in low- and middle-income Countries (LMICs) Are Not Fit for Purpose,” sends a strong warning to organizations and governments that limiting options to reduce harm will only increase the number of people smoking tobacco, inevitably leading to illicit markets and increases in crime. The paper lists the Top 10 reasons the bans don’t work as the following:

Bans are an overly simplistic solution to a complex issue and will not work.

Prioritizing the banning of reduced harm alternatives over cigarettes is illogical.

Reduction and substitution are valid goals for smokers in LMICs.

People who smoke have the right to choose to reduce their own risk of harm.

Reduced harm alternatives can significantly contribute to the aims of global tobacco control.

Lack of research in LMICs is not a valid reason to ban reduced harm alternatives.

The prohibitionist approach in LMICs is outdated, unrealistic and condescending.

Bans will lead to illicit markets with increases in crime and no tax revenue.

Banning reduced harm alternatives leads people back to smoking and greater harm.

• Blanket bans in LMICs are a form of “philanthropic colonialism.”
INNCO estimates that that there are scores of LMICs in jeopardy of increasing the number of people who smoke cigarettes in their countries unless pragmatic approaches to tobacco harm control are adopted, including the availability of a wide selection of safer nicotine products. Leveraging the paper’s findings, INNCO states that it will work with its global membership to inform policy makers in developing nations to help achieve risk-relative regulations and access to safer THR products, according to a press release.
“Africa is home to some of the highest-ranked smoker countries on the planet,” said Joseph Magero, chairman of Campaign for Safer Alternatives, a pan-African non-governmental member organization dedicated to achieving 100 percent smoke-free environments in Africa. “While improving overall public health has made great strides in these regions, efforts to directly address smoking cessation and harm reduction strategies have lagged due to limited or no access to safer, non-combustion nicotine products. By denying smokers access to much safer alternatives while leaving cigarettes on the market, policymakers would leave only two options on the table – quit or die.”
Several other THR groups also agree with the paper’s position. Nancy Loucas of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, a grassroots alliance of THR advocacy organizations, said a blanket ban in LMICs is a form of philanthropic colonialism, suggesting that these countries and their citizens cannot be trusted with any level of self-determination. “Inhabitants are treated as second-class citizens, which is offensive,” she said. “There is no benefit in limiting choice of safer nicotine products, but only the potential for increasing harm.”
Francisco Ordóñez of the Asociación por la Reducción de daños del Tabaquismo Iberoamérica, a network of consumer organizations in Latin America, says that very few low- and middle-income countries have adopted even the most basic prevention measures suggested by the World Health Organization (WHO).
“Policymakers should embrace harm reduction as a valid goal, particularly in LMICs where access to cessation programs is extremely limited,” said Ordóñez. “Replacing combustible tobacco with alternative nicotine products can significantly reduce the risk of harm by at least 95 percent. It works in industrialized nations and can do the same in LMICs.”
The paper can be found on the INNCO website.
March 16, 2021