Daily Archives: February 1, 2022

THURSDAY, Dec. 16, 2021 (HealthDay News) -- There may be a silver lining to the COVID-19 pandemic, with U.S. health officials reporting an "unprecedented" decline in teens' use of alcohol, marijuana, other illegal drugs and vaping.

"We have never seen such dramatic decreases in drug use among teens in just a one-year period," said Dr. Nora Volkow, director of the U.S. National Institute on Drug Abuse.

"These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents," she added in an institute news release.

From 2020 to 2021 the first year of the pandemic rates of past-year alcohol use fell from about 55% to around 47% among 12th graders, and from nearly 41% to around 29% among 10th graders. Eighth-grade drinking dipped from about 21% to just over 17%, according to the survey results.

Rates of past-year marijuana use also decreased, falling from around 11% to about 7% among 8th graders, and from 28% to 17% among 10th graders. Pot use dropped from around 35% to less than 31% among 12th graders, the findings showed.

The findings are from the University of Michigan's Monitoring the Future survey. It is given annually to students in grades 8, 10 and 12.

Vaping's popularity rates also fell after COVID-19's emergence. It remains the predominant method of nicotine consumption among young people, who may not recognize the risks associated with e-cigarettes.

Rates of past-year nicotine vaping fell from nearly 17% to 12% among 8th graders, from about 31% to less than 20% among 10th graders, and from roughly 35% to about 27% among 12th graders.

The 2021 decrease in vaping for both marijuana and tobacco was especially welcome, as it follows sharp increases in use between 2017 and 2019.

Still, more could be done to curb teen vaping, according to Matthew Myers, president of the advocacy group Campaign for Tobacco-Free Kids. In a statement, he said that "to end the youth e-cigarette epidemic for good, the FDA must clear the market of all flavored or high-nicotine e-cigarettes including menthol products and crack down on companies seeking to evade regulation with synthetic nicotine."

In another encouraging trend, past-year use of any illicit drug other than marijuana also fell across all three grades, declining to just under 5% in 2021 among 8th graders, to just over 5% among sophomores, and to a little more than 7% among high school seniors.

Significant declines in use were also reported across a wide range of drugs, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers and prescription opioids.

"Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use whether related to drug availability, family involvement, differences in peer pressure, or other factors and harness them to inform future prevention efforts," Volkow said.

This year, the survey also asked students about their mental health during the pandemic a subject of much interest nationally. Respondents in all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping and other negative mental health indicators.

The current survey included more than 32,000 participants at nearly 320 public and private schools nationwide. It was conducted from February through June 2021. About half the students identified as white, almost 17% as Hispanic, about 11% as Black, 5% as Asian and 0.9% as American Indian or Alaska Native. Almost 14% identified as multiple.

Richard Miech, the paper's lead author and survey team leader, said, "We knew that this year's data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents."

A follow-up survey of 12th graders who participated in the 2020 Monitoring the Future study was conducted in mid-July and mid-August 2020. It found their marijuana use and binge drinking did not significantly change during the first six months of the pandemic, despite record decreases in the substances' perceived availability.

The follow-up findings challenge the idea that reducing teen use of drugs can be achieved solely by limiting their supply, according to the paper.

More information

The Nemours Foundation has drug facts for teens.

SOURCE: U.S. National Institute on Drug Abuse, news release, Dec. 15, 2021; Campaign for Tobacco-Free Kids, statement

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Pandemic Saw Big Declines in Kids' Use of Drugs, Alcohol ...

The Fifth Circuit Court of Appeals listened to oral arguments on January 31 about a case that could help to determine the future of the US vape industry.

Eric Heyer, the lawyer for mid-sized e-liquid manufacturer Triton Distribution, argued that the Food and Drug Administration (FDA) acted arbitrarily and capriciously in denying his clients premarket tobacco product application (PMTA). All vapor manufacturers had to file PMTAs for each individual product by September 2020 to stay legally on the market. The FDA, in turn, had until September 2021 to determine whether more than 6 million submissions wereappropriate for the protection of public health (APPH)a standard now understood as a products likelihood of helping adult smokers switch to a safer alternative rather than introducing a new generation to nicotine.

The question before the court concerns how exactly the FDA ended up denying Tritons PMTAwith potential implications for comparable applications by many other denied companies.

So far, the FDA has authorized a single vaping product and two tobacco-flavored e-liquid cartridges, punted on the players with the largest market share and denied thousands of less well financed applications.

The question before the court concerns how exactly the FDA ended up denying Tritons PMTAwith potential implications for comparable applications by many other denied companies.

The agencys process, Heyer argued, set Triton up for failure: Because only after the PMTA deadline had passed did the FDA indicate that successful applications would likely need two types of long-term studiesrandomized controlled trials (RCTs) and longitudinal cohort studiesto demonstrate comparative efficacy. In lay terms, these analyses needed to conclude that products helped smokers quit, not only that they were safer than cigarettes.

There were early signs that the court would agree with Heyers logic: At the end of October, the Fifth Circuit granted Triton a full stay, allowing the manufacturer to continue selling its products as the lawsuit snaked its way through the judicial system. Along with that decision, three judgesAndrew Oldham, Cory Wilson and Jennifer Elrodissued a scathing opinion, stating that the FDA simply ignored Tritons [marketing] plan and pull[ed] a surprise switcheroo by demanding long-term studies the companies did not anticipate.

As Filter reported, in memos made public from those court filings, the FDA appeared to resort to a Fatal Flaw, checklist-like process that looked for the inclusion of RCTs or longitudinal cohort studies in an application andsummarily denied it if those werent present. The FDA has maintained that it later rescinded this method, around two weeks before the September 2021 decision deadline. Todd Wages, a partner at Triton, told Filter that the company informed the FDA that it would complete those studies but would need time to do so.

The FDA has enforcement discretion to act on any vapor manufacturer but has effectively allowed companies with pending PMTAs to keep selling their products as they remain under considerationunlike those that have already received denials.

Heyer essentially claims that the FDA formed a new standard after the PMTA deadline, likely to dig itself out of mounds of paperwork. He argued on January 31 that the agency should have considered the whole PMTAincluding Tritons marketing plan and survey data that showed youth did not use the companys vaping productsbut did not, instead relying on that Fatal Flaw rejection strategy. He has asked the court to vacate Tritons denial.

Should that happen, the Fifth Circuit judges on the caseEdith Jones, Gregg Costa and Catharina Haynes, not the three behind the October opinioncould create a precedent for the dozens of similar lawsuits, potentially leaving the FDA to re-review thousands of PMTAs.

Basically, there are three possible outcomes: The court upholds the FDAs denial; allows Triton some time to complete long-term studies; or court vacates the denial.

But thats far from certain. There might be some type of relief for Triton, but what that means is the big question I think the court will struggle with, a vaping industry insider, who requested anonymity so as not to affect the PMTA process, told Filter. Telling the FDA they screwed up isnt a meaningful or helpful remedy with ramifications that force a policy change, they continued. So what the court is able to do, and what that means for anyone else, is so up in the air. Im sure the FDA is confident theyll be unscathed, which is why they fought this and other cases.

If the court disagrees with him, Heyer has requested that the judges enjoin FDA from taking further adverse action on the Petitioners PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy, according to legal documents.

Basically, there are three possible outcomes: The court upholds the FDAs denial, and Triton can no longer sell its products; the court allows Triton some time to complete long-term studies (and could potentially keep selling its products in the meantime); or the court vacates the denial, putting the PMTA back under review tobe reevaluated over an indeterminate period.

Either way, itll end up back in the hands of the FDAin a system that many in the industry maintain is broken. A win for Triton, in other words, might not necessarily be a win.

Its like going to a general practice doctor for a complex cardiac issue.

At the hearing, Fifth Circuit Judges Jones, Costa and Haynes did not appear to be subject-matter experts. When Heyer presented a variety of different vaping products, Jones asked how to ignite them. And for whatever reason, Costa believed that the FDA had already authorized tobacco-flavored vaping products across the board.

Its like going to a general practice doctor for a complex cardiac issue, another vaping industry insider, who also requested anonymity so as not to affect the PMTA process, told Filter.

But while the judges also harped on a supposed youth vaping crisis despite youth vaping rates substantially waning in recent years, they did not let the FDA off the hook. Jones in particular grilled the FDAs counsel, Noah Katzen, about why the agency did not appear to evaluate Tritons marketing plan and if the FDA was, in fact, applying a de facto blanket flavor ban without saying so.

FDA ought to say, since the state of the science is inconclusive whether flavored products assist smokers in stopping to smoke in a robust way that overbears the attractiveness to youth, then we are not going to approve any applications, Judge Jones said during the oral arguments, wondering if the agency was indirectly instituting a flavor ban. If FDA is going to rely on inconclusiveness, then youre making thousands of these producers waste thousands and thousands of dollars on what is a fruitless exercise. Or a flavorless exercise.

Triton now awaits the courts decision, which could take weeks or months.

Photograph by John via Flickr/Creative Commons 2.0

Read more from the original source:

US Vaping's Future Could Hinge, in Part, on the Triton Case - Filter

Marcus

Ive been reading a 309-page story that could become a delightful movie about corporate deceit and anti-social behavior.

The managers of JUUL would be hilarious, if played by the Marx brothers. Sadly, those managers caused widespread teen addiction and added costs for our schools.

Remember when cigarette smoking was readily accepted in public places? When the U.S. Surgeon General submitted a report in 1964 on the link between cancer, heart disease and cigarettes, we increased regulations on coffin nails. Twenty years later, smoking was banned from public areas including airplanes, hospitals, and restaurants.

In the 1990s, Attorneys General across America sued tobacco companies and won massive awards for the states in compensation for health care provided to smokers. Since 1999, Indiana has received $2.9 billion for smoking cessation and related programs, including $146 million in 2021.

Then, along came vaping, the process of heating a chemical solution producing a gas which, like cigarettes, contains nicotine and can be inhaled. Quickly, JUULs products captured the market. This was achieved by targeting children in junior and senior high schools.

Although JUUL denies such targeting, its use of social media, packaging and flavor additives made it cool for those 13 to 23. A steady and growing stream of health problems among the young led to many studies and even a Congressional hearing about vaping.

JUUL products deliver more nicotine than cigarettes in a single puff, speeding the process of nicotine addiction. Whereas cigarettes burn out, ending the intake of nicotine, JUUL delivers its higher volume nicotine long after any cigarette might last.

In 2018, the JUUL Labs, Inc. (JLI) sold a 35% interest in itself to Altria, the former Philip Morris mega-corporation, for $12.8 billion. Armed with the experience of Altria in selling tobacco to the youth market, JUUL expanded the market for nicotine addiction. Originally promoted as a convenient, reliable way to quit smoking, JUUL and other e-cigarette producers knew early addiction promotes long-term sales.

As young people became addicted to e-cigarettes, school counselors and teachers had to contend with increased disruptive behaviors and new health issues of students. Critical time lost to education and guidance was a real cost not reported in annual financial statements.

Today, a multistate lawsuit representing over 250 school districts is progressing. Yet only 15 are from Indiana. Why so few? There are no financial risks, no fees to pay for the school districts. All they have to do is answer a questionnaire which is mainly Yes/No.

From my reading of the submission on behalf of the Carmel Clay Schools, the blatant deceit of JLI management will be exposed and a good financial boost for the schools realized. Why arent the school boards in Columbus, Chesterton, and West Lafayette participating? Are they so blessed that they have no vaping epidemic and no use for added funds?

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Morton Marcus: Hoosier schools leaving vaping money on the table - Daily Journal

MIDDLETOWN, Conn. (WTNH) In a few days, students will return to Wesleyan University and find a major change. Smoking and vaping will no longer be allowed on campus.

Previously, it was 20 feet from a door, now theyre just not allowed on the grounds or green of campus, September Johnson, Wesleyan Universitys Alcohol and Other Drug Specialist.

Anyone, students, faculty, or staff who still wants to smoke or vape will have to go out the public sidewalks of Middletown. The hope is, however, that they will quit entirely. Johnson is offering to help.

We are providing nicotine replacement therapy for those who are trying to get through a craving while on campus, Johnson said. We have quit kits. Theyre able to meet with me. Im a tobacco treatment specialist as well.

This decision did not suddenly happen all at once. There have been committees talking about going tobacco-free for years. When the university came out of its COVID lockdown, that is when it really gained momentum, partly because of the COVID pandemic. We know that smokers are more vulnerable to infections in general. Respiratory infections like COVID especially.

It kind of just jump-started that conversation again for us to make sure that we are promoting the health and wellness of everybody in our Wesleyan community, but also the overall community of Middletown, Connecticut in general, Johnson said.

Wesleyan joins some 2,000 other universities in going tobacco-free. The University of New Haven and Yale made that switch more than six years ago. Quinnipiac did the same three years ago.

We know its going to take time, and its an environmental change that were all working towards, and were excited to see it, said Johnson. We know that its going to benefit the health of our community now and for years to come.

She says the majority of that community is all for it.

See the rest here:

Wesleyan University announces smoking, vaping banned on campus - WTNH.com

Of some 200 open system brands available today, only about 30 have filed PMTAs, and even if all these are approved, that disparity implies that about 85% of open system hardware brands will soon be removed from the market.

A release by E-CigIntelligence who analysed data from over 6 million submissions received by the FDA, highlighted that this analysis shows that there were hundreds more applications for the simpler disposable and cigalike devices, than for open system hardware. These type of products tend to come from large companies such as tobacco manufacturers, while open systems are produced by smaller specialist businesses.

Of some 200 open system brands available today, only about 30 have filed PMTA applications to the FDA. Even if all these are approved, that disparity implies that about 85% of open system hardware brands will soon be removed from the market. This may indicate the discouragement that non-tobacco companies face when applying for PMTA approval, said ECigIntelligence managing director Tim Phillips.

Meanwhile, a renowned and well meaning vape shop owner, has been forced to close her small family run business. Skip Murray, a passionate vape advocate and former smoker who managed to quit smoking thanks to e-cigarettes, alongside her son, has been forced to close down her small vape shop, Lakes Vape and Rec Supply in Brainerd, Minnesota.

Filter revealed that Murray has updated a Twitter thread every time a vape shop closed down. Sadly, on December 31st, she added her own. Given the smoking cessation success her son and herself experienced via vaping, Murrey tried to remain optimistic. Realistically, I knew this was going to happen, she said as quoted by Filter. But I kept hoping that somethingsomethingwould change. I was holding out hope that the world would come to its senses.

To the surprise of many, Avail Vapor which is actually a major brand has also decided to close shop and has been dismantling its business to avoid disaster. AVAIL Vapor LLCs specialized brick-and-mortar shops and website, were started by James Xu in 2013 and grew to over 100 retail stores in 12 states, 400 employees and a manufacturing facility in Chesterfield County. However, given the current hostile regulatory environment, Xu saw that the brand was entering 2022 with essentially zero business, hence decided to dismantle everything. Right now, we are unwinding everything, said Xu as quoted by The News and Advance.

The founder explained that like other vape businesses, the brand is finding it impossible to meet the FDAs unrealistic regulatory requirements. Under this environment, we cannot operate a legitimate business, Xu said. Our biggest problem was we tried to believe in the FDA that one day it would regulate this market with common sense.

Uncovered FDA Memos Reveal Murky Strategy to Reject PMTAs

Read more:

Post PMTA Predictions Suggest That Only Big Vape Brands Will Survive - Vaping Post