For the first time since 2012, North Carolina’s state budget plan includes funds to help prevent young people from getting addicted to nicotine, reports NC Health News.
Much of that money comes from a $40 million settlement that State Attorney Josh Stein reached this summer with Juul Labs following a lawsuit over the e-cigarette maker’s alleged targeting of young people.
In 1998, North Carolina and 45 other states settled litigation with to recover healthcare cost incurred for treating sick smokers. The four largest U.S. tobacco companies agreed to pay $206 billion over 25 years, and part of that money was to be spent by the states on smoking-cessation programs.
In reality, however, many states have directed their Master Settlement Agreement funds to other priorities. In 2013, when Republicans held control of both the North Carolina General Assembly chambers and the governor’s office, money stopped flowing to programs targeted at young smokers and nicotine users.
The budget that Governor Roy Cooper signed into law on Nov. 18 transfers $2 million from the first $13 million allotment from the Juul settlement to the attorney general’s office to cover litigation costs.
Another $4.4 million will go to tobacco cessation media campaigns, resources and programs to help children in middle school, high school and young adults quit vaping and using tobacco products after becoming addicted.
The budget allocates $3.3 million for “evidence-based media and education campaigns” geared toward prevention of e-cigarette and tobacco use and $1.1 million for data monitoring to better understand how young people are exposed to such products and evaluate programs designed to help users quit.
Nationally, more than two million children in middle school and high school used e-cigarettes in 2021, according to North Carolina health director Elizabeth Cuervo Tilson. Almost half of those high school students used e-cigarettes frequently, for as many as 20 out of 30 days. In North Carolina, Tilson added, a third of people in that age group used tobacco products, most of which are e-cigarettes.
Knowledge Action Change (KAC) is looking for people to propose projects exploring their professional or personal interest in tobacco harm reduction (THR) for the next cohort of its Tobacco Harm Reduction Scholarship program (THRSP). Applications for the fifth year of the program close on Nov. 30, 2021, and successful applicants will receive a 12-month bespoke mentoring program and up to $10,000 in financial support.
According to Paddy Costall, a director at KAC, the THRSP is a crucial part of global efforts to communicate the benefits of safer nicotine products, helping to raise awareness about vaping, heated tobacco products, snus and nicotine pouches.
“The Tobacco Harm Reduction Scholarship program is the jewel in the crown for KAC,” he says. “When we were setting out on this journey, we wanted to attract a passionate and diverse group of new advocates into the tobacco harm reduction field from across the globe. We wanted to inspire them to take the movement into the future. We wanted to find the researchers of tomorrow, and with the THRSP that is exactly what we are doing.”
To further enhance the program’s status, KAC recently appointed Ethan Nadelmann, the founder of the Drug Policy Alliance, as the THRSP’s new patron. Nadelmann will be providing support to the recipients of these scholarships.
Launched in 2018, the program has supported 75 Scholars on six continents. Projects completed by THRSP participants include:
A short documentary film exploring attitudes on smoking and THR in Malawi
Novel scientific research in Romania showing that switching completely from combustible cigarettes to heated tobacco products can boost the oral health of smokers
The creation of a smoking and recovery toolkit in the U.S. to combat the high rates of smoking among people in recovery or seeking treatment for dependency on alcohol or other drugs
A study assessing the THR knowledge base of healthcare staff in Lithuania
A pair of studies that demonstrated the potential for safer nicotine products, such as vaping and Swedish-style snus, to help India’s smokers and smokeless tobacco users
The creation of THR Uganda, an organization set up to share accurate information on tobacco smoking and nicotine with its own dedicated website
A study on the effects of providing vapes to homeless smokers in Ireland
Australia’s Therapeutic Goods Administration (TGA) has fined four individuals and companies more than AUD170,000 ($122,740) for unlawfully advertising or importing vaping products, reports The Guardian.
Since October, Australian vapers have been required to obtain a doctor’s prescription for nicotine-containing e-cigarettes and liquids. Doctors are supposed to prescribe the products only as a last resort when more proven quit treatments fail. The law changes were prompted by concerns about the health impacts of vaping, and data showing children are increasingly using the products.
In response to the new rules, companies have set up websites offering to link vapers to a health practitioner authorized to prescribe the products. But the law allows only pharmacies and pharmacy-marketing groups to advertise in a limited way. Non-pharmacy websites that advertise vaping products or links to online suppliers are likely to be noncompliant with the nicotine advertising permissions.
The fined companies are Mason Online, RV Global Ecommerce, Vapespot and a Melbourne-based individual.
Maurice Swanson, chief executive of the Australian Council on Smoking and Health, said he was pleased with the TGA’s actions.
“We welcome the strong monitoring of illegal advertising which doesn’t meet the guidance provided by the TGA,” he said. “The TGA’s advertising guidelines have been well-known and well-promoted, so companies can’t claim not to have known about it.”
Confusion about smokefree alternatives is preventing many smokers from quitting smoking according to a global survey, reports Arab News.
Commissioned by Philip Morris International and conducted by Povaddo, the study surveyed nearly 30,000 people in 26 countries. The researchers found that many adult smokers remain unaware that alternatives to cigarettes exist, are unable to access them, or are confused by conflicting information that prevents them from making an informed choice.
The survey showed that despite the science backing up smokefree alternatives, there was public confusion surrounding these products, such as heated tobacco products or e-cigarettes.
Thirty-three percent of the respondents cited a lack of information about how these products differ from cigarettes and 35 percent said they were unsure about the science behind these new products.
The survey found that 32 percent of smokers have easier access to cigarettes and so don’t switch to alternatives.
“The findings of the survey show there is confusion about smokefree products. For those adults who would otherwise continue to smoke cigarettes, having access to evidence-based information about smoke-free products is critical,” said Tarkan Demirbas, area vice-president for the Middle East at PMI.
According to the World Health Organization, there are more than 1 billion smokers in the world today, and this number is expected to stay steady until 2025.
Puff Bar rose to prominence in early 2020 after the Food and Drug Administration banned candy and fruit-flavored e-cigarettes because of their youth appeal but continued to permit the sale of flavored single-use devices like Puff Bar because they were not yet very popular.
Today, Puff Bar is the most popular e-cigarette brand among high school and middle schoolers. Nielsen reports that store sales of Puff Bar in the United States topped $150 million last fiscal year, but much of that is believed to be counterfeit product.
Puff Bar has operated in the shadows for most of its existence. It listed its mailing address first to a shuttered storefront on skid row in Los Angeles and more recently to a P.O. box. The company appeared to relish its obscurity. Last year, its website read “Who Makes Puff Bar? Everyone wants to know.” Minas and Beltran say the brand was originally developed in China, where it continues to be manufactured.
In 2020, the FDA ordered Puff Bar off the market amid lawsuits and a widening public outcry about youth appeal. The company pulled its products but later reintroduced redesigned versions using synthetic nicotine, which some believe remains outside of the FDA’s remit.
Four states have banned the product. It also faces a probe in the House of Representatives and lawsuits in at least three states. Recently, North Carolina’s attorney general launched an investigation.
In early November U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, wrote a letter to Minas and Beltran requesting information about its sale of synthetic nicotine products.
Minas and Beltran, both 27, are childhood friends from Southern California who said they are now the sole owners and co-CEOs of Puff Bar. During the CBS interview, Beltran said they wanted to speak out to “build trust” with their consumers.
“We’re aware that there is a lot of mystery and there was a lot of shadowiness before. Us being here right now, talking with you guys [CBS News] is our first step in kind of really, like, building the trust with our consumers,” he said.
The FDA declined to speak to CBS News about Puff Bar. In a statement, the agency said it was aware that companies have publicly announced strategies to switch to synthetic nicotine in an attempt to evade FDA jurisdiction, adding that it is investigating the issue.
The vapor industry has experienced growth after Covid-19 lockdowns sent many back to cigarettes.
By Timothy S. Donahue
After declines in 2019 and 2020, the vapor industry has grown 10-15 percent in 2021. Don Burke, senior vice president of Management Science Associates, speaking on a panel during the first day of TMA’s “From Chance to Change” webinar on No. 17, said that he expects the industry to continue its growth into 2022.
“Vapor cartridges were up by 18.5 percent. Over … 2019 going into 2020, we were seeing some declines in vapor. One of the things to keep in mind is at the end of 2019 was that illegal THC vaping [EVALI] crisis,” said Burke. “That turned a lot of people off of vapor, even though it was only an illegal product that caused the issues. No legitimate product caused any problems. It’s about a year-and-a-half now since that occurred … because of that, consumers are starting to forget, vapor is coming back.”
Burke said disposables, because they’re allowed to have flavors, were up 28.9 percent and all-in-one kit volumes are growing (up 2.9 percent). He said vape shop and tobacco outlet sales are also on the rise after many closed or limited hours due to the Covid pandemic. He said his research includes approximately 300,000 stores. It does not include vape shop sales.
“We’re looking at distributor to shipment retail data. In many cases, that’s important because a lot of the convenience stores and some tobacco outlets do not collect their data and, therefore it’s very difficult to get a clean read,” he said. “The convenience channel – because they were considered essential businesses in most parts of the US – managed to survive the pandemic and in fact, now are a larger percentage of stores in the US. Also, 71 percent of tobacco volume goes through convenience stores.”
Burke said pods for closed-pod systems (cartridges) are up 6 percent in the most recent quarter. He said that during the third quarter of 2021 disposables continue to have strong sales, rising by 21 percent and he expects those trends to continue. E-liquid distribution fell by 49.6 percent through 2020 and into current 2021 and sales fell nearly 15 percent, mostly due to recent regulatory action in the US.
Burke also said cannabis sales grew significantly during 2020 and into 2021, but he didn’t elaborate.
For more on this session from TMA 2021 read the next issue of Vapor Voice coming in mid-December.
New research suggests that flavored vaping products are much less harmful to young people than combustible cigarettes. They also have the potential to help current teen cigarette smokers quit.
Credit: Haiberliu
A new study from researchers at the University of East Anglia (UEA) reported the views and experiences of more than 500,000 youth under the age of 18. Lead researcher, Caitlin Notley, from UEA’s Norwich Medical School, said the study was conducted because there was a lot of concern that young people may start vaping because they are attracted to e-liquid flavors, and that it could potentially lead them to start smoking tobacco.
“We wanted to find out more about the links between vape flavors, the uptake of vaping among young people, and whether it leads to regular vaping and, potentially, tobacco smoking,” she said in a statement, adding that he research team studied all available evidence (58 studies) on the youth use of e-liquid flavors. “We found that flavored e-liquids are an important aspect of vaping that young people enjoy. This suggests that flavored products may encourage young people to switch away from harmful tobacco smoking towards less harmful vaping.”
Flavored vaping products also did not cause vapers to move on to combustible products, according to the study. may be an important motivator for e-cigarette uptake – but we found no evidence that using flavored e-liquids attracted young people to go on to take up tobacco smoking. “And we also found no adverse effects or harm caused by using liquid vape flavors,” Notley said. “However, there is also a need to monitor flavor use to ensure that young people who have never smoked are not attracted to taking up vaping.”
The team found that the overall quality of the evidence on use of e-cigarette flavors by young people was low. In particular, many studies did not clearly define e-liquid flavors and could not therefore be included within the review. The study was led by UEA in collaboration with researchers at University College London, the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust.
The US House of Representatives has passed the portion of the Build Back Better Act that includes a controversial nicotine tax. The legislation will now head for the Senate. If passed, the bill would go to President Biden’s desk.
In a 220 to 213 vote, the House predictably voted mostly along partly lines for the legislation that has often been compared to the New Deal. Biden signed the second piece of his domestic agenda, a $1.2 trillion package focused on infrastructure improvements, into law earlier this week. He is expected to sign the social spending section if its passed by the Senate.
Democrats are planning on using a special budgetary process known as “reconciliation” to avoid the 60-vote filibuster threshold and pass the bill on a party-line vote, according to news reports.
The vote was delayed last night after the record for the longest speech in the US House of Representatives was broke by Kevin McCarthy, which went on until early Friday morning. The speech surpassed eight hours of continuous floor time. Towards the end of the speech, McCarthy joked that “my one minute is almost up,” noting that “personally I didn’t think I could do that long.” He then spent some time asking those around him to confirm that he had beaten the record.
In a release, Biden said for the second time in just two weeks, the House of Representatives has moved on critical and consequential pieces of his legislative agenda. “Now, the Build Back Better Act goes to the United States Senate, where I look forward to it passing as soon as possible so I can sign it into law,” he stated.
Court records show the FDA failed at reviewing submitted PMTA data as required and only looked for specific studies.
By Timothy S. Donahue
The term “fatal flaw” was used by the U.S. Food and Drug Administration for premarket tobacco product application (PMTA) submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
In court records reviewed by Voice Voice submitted in the Triton Distribution v. U.S. FDA case requesting a stay of the marketing denial order (MDO) the e-liquid manufacturer received from the FDA, the regulatory agency submitted an administrative record for the review of Triton’s PMTA that shows the agency did not fully review all PMTA data submitted, as required by law, but instead only looked for specific studies relating to flavors and youth use.
A memo dated July 9, 2021, written by Anne Radway, the associate director of the FDA’s Center for Tobacco Products’ Office of Science, states that “based on the information available to date, FDA has determined this evaluation requires evidence that can demonstrate whether an applicant’s new non-tobacco flavored product(s) will provide an incremental benefit to adult smokers relative to the applicant’s tobacco-flavored product(s). In particular, the evidence necessary for this evaluation would be provided by either a randomized controlled trial (RCT) or a longitudinal cohort study. The absence of these types of studies is considered a fatal flaw, meaning any application lacking this evidence will likely receive a marketing denial order.”
Radway goes onto explain that due to the large number of PMTAs received, the agency would only conduct a Fatal Flaw review of PMTAs for non-tobacco flavored ENDS products.
“The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” Radway states. “To decrease the number of PMTAs without final action by September 9, 2021, [Office of Science] used a database query to identify the top twelve manufacturers with the largest number of pending PMTAs [in the substantive review stage of the process] … Following completion of filing those applications that are filed will immediately initiate Fatal Flaw review.”
Radway also states that for the remaining PMTAs not in [substantive review] for non-tobacco flavored e-liquid products, FDA will send a “General Correspondence letter requesting the applicant to confirm if their PMTA contains such evidence and, if so, to direct FDA to the location in the application where the studies can be found.”
During the first day of TMA’s “From Chance to Change” webinar on Nov. 17, panelists were disturbed by the findings that the agency, rather than reviewing a submission on its merits, simply searched for the presence or absence of certain studies.
Brittany Cushman
Brittani Cushman, senior vice president, general counsel and secretary at Turning Point Brands said that the “idea that so many of the applications were reviewed with an eye toward this so-called fatal flaw analysis” didn’t “feel like the right direction” for the PMTA review process.
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. The FDA then rescinded TPB’s MDO and placed its applications back into substantive review. The agency has since rescinded or a court has stayed MDO’s for 10 companies and the agency is currently facing at least 45 lawsuits for it handling of the PMTA process. This is in addition to the dozens of requests for supervisory review.
“The way the review process has played out this far, really, feels like the incentive structure in the nicotine industry has been placed on its head,” explained Cushman. “It seems that the lower-risk products are receiving heightened scrutiny, kind of an opaque direction as to what’s sufficient. And it just doesn’t feel like these products are getting a kind of equitable treatment in the space.“
Triton Distribution had their MDO stayed by the 5th Circuit Court of Appeals with the court holding that Triton is likely to succeed on the merits of its case because the FDA “changed its regulatory requirements” and that this “switcheroo” to now require a randomized controlled trial and/or a longitudinal cohort study – which the Agency previously stated on numerous occasions would not be required – was arbitrary and capricious under the Administrative Procedure Act.
The court stated that the FDA failed to “reasonably consider the relevant issues and reasonably explain” the MDO. The Court further noted that FDA failed to consider Triton’s marketing plan, surveys, and evidence of potential benefits of flavored e-cigarettes. FDA also “failed to consider the company’s legitimate reliance interests, as Triton relied on FDA’s statements made in numerous public meetings, guidance documents and rulemakings” that it did not expect applicants would need to conduct long-term studies to support their PMTAs.
Cushman told webinar watchers that, at the end of the day, the FDA’s regulatory treatment of the various product categories is to the detriment of the adult smoker.
“We’re all down in the weeds of this. But it’s difficult to see how we ended up at this point. And it certainly can’t be where anyone wanted this process to play out,” she said. “I think this has led to a lot of detrimental outcomes. You have adults seeing a large number of vapor products being deemed as not appropriate for the protection of public health while seeing no change in [combustible] cigarette offerings in their local C-store … This is being celebrated not only by those who are ignorant to the science, but more perversely, those [who understand the science and should] know better.”
For more on this session from TMA 2021 read the next issue of Vapor Voice coming in mid-December.
The record for the longest speech in the US House of Representatives was broke by Kevin McCarthy early Friday morning, surpassing eight hours of continuous floor time. Towards the end of the speech, McCarthy joked that “my one minute is almost up,” noting that “personally I didn’t think I could do that long.” He then spent some time asking those around him to confirm that he had beaten the record.
The speech was centered around the vote of Biden’s Build Back Better (BBB) Act, which includes a controversial tax on next-generation nicotine products.
Americans For Tax Reform (ATR) called on House legislators to accept the science as detailed in extensive reports commissioned by the National Institutes of Health (NIH) and the U.S. Food & Drug Administration and vote against the BBB Act (H.R. 5376) due to “its disastrous impact on public health.” H.R. 5376 is expected to be voted on today.
Credit: Dave Newman
“It is mind-boggling that in the midst of a global pandemic, Nancy Pelosi is pushing a tax hike on people trying to save their lives, just to pay for a tax-cut for the ultra rich” said Tim Andrews, director of Consumer Issues at Americans for Tax Reform. “The science is crystal clear: This bill is a public health disaster. The tax hikes on people trying to quit smoking contained in H.R. 5376 would lead to more people millions more Americans smoking – and dying as a result. “With millions of lives on the line, it’s time for Congressional Democrats to listen to the science – and reject Nancy Pelosi’s desperate SALT pay-for cash grab which seeks to raise revenue at the expense of human lives“
HR 5376 includes a new tax of $50.33 per 1,810 mg of nicotine contained in next generation electronic nicotine delivery systems such as e-cigarettes. These funds would be used to help pay for SALT provisions for the ultra-wealthy, which the Congressional Joint Committee on Taxation has stated would give two-thirds of people making more than a million dollars a tax cut, according to a ATR statement. Of the 2.5 million additional smokers the Act would create, it is estimated that two thirds – or over 1.6 million -would die as a result.
“Nancy Pelosi’s Build Back Better Act places a small amount of revenue as more important than saving over 1.5 million lives. We call upon all Democrats to follow their conscience, and do the right thing by their constituents, and vote against this deeply unethical and immoral blood tax,” said Andrews. “To increase taxes on poor Americans trying to quit smoking just to pay for tax cuts for multi-millionaires is morally reprehensible … To condemn so many lives to pay for tax breaks for multi-millionaires is one of the most morally bankrupt actions ever undertaken by a government.”
