Monthly Archives: September 2021

SALT LAKE CITY The Food and Drug Administration is slated to decide Thursday how or if e-cigarette companies can continue selling their products.

The agency is now reviewing millions of premarket tobacco product applications (or PMTAs) from e-cigarette companies.

Essentially, the companies are required to prove to the FDA that their products are safe enough to continue to be sold in the United States.

In recent years, the FDA has been under mounting scrutiny from policymakers and public health leaders after e-cigarettes grew more popular among teens and other youth groups.

Until now, companies have been able to sell and market their products under limited restrictions.

Elite Smoke & Vape In Murray is one business that could be impacted by the FDAs decision.

Owner Ryan Delahuerta speculated what could happen.

We are going to see our wall of e-juice shrink down to probably just a couple of brands, said Delahuerta.

He explained that his vaping inventory makes up 70 percent of his sales.

Delahuerta also told FOX 13 News that this change will reinforce the sale of e-cigarettes through alternative, shadier markets.

Youre already seeing a black market emerge on social media selling these, thats unregulated, and thats where teens can get ahold of them," he said.

Meanwhile, one medical professional told FOX 13 News that he considers this a step in the right direction.

Its a good part of public health strategy because it will probably limit the number of youths from using e-cigarettes, said Sean Callahan, a professor of medicine at the University of Utah.

He adds that some adults could be unhappy with the outcome because these vaping products have helped them with their smoke cessation efforts.

Just last week, CNN reported that the FDA blocked the sale of more than 55,000 flavored e-cigarette products.

It was the first ban on products of that kind since PMTAs had to be submitted in September 2020.

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FDA to decide fate of vape industry in US this week - fox13now.com

Now FDA is days away from a deadline that could signal how it will approach tobacco regulation for years to come. The agency has already said it is considering major changes. FDA announced in April that it planned to release a proposal within a year to ban menthol cigarettes and flavored cigars products disproportionately used by African Americans and teens. The agency is also reportedly considering whether to seek limits on nicotine levels in cigarettes to reduce their addictive potential. Similar concerns about addictive potential and risks to young people lie at the heart of FDAs imminent verdict on vapes.

FDA really is at a critical juncture, said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. In some critical ways how FDA will be perceived will probably be defined with what it does now with regard to pending applications.

In the meantime, the vaping industry is bracing for the possibility of major changes that could tilt the balance in favor of big tobacco companies who have expanded into the e-cig market.

Many vaping products are produced by smaller companies that dont have the resources to thoroughly answer FDAs scientific questions about safety, said Ken Warner, a professor emeritus of public health and tobacco control at the University of Michigan. Large companies such as Juul only sell a handful of types of e-cigarettes, but have the financial resources to stack their applications to make them more likely to be cleared by the agency.

FDA announced in April that it planned to release a proposal within a year to ban menthol cigarettes and flavored cigars. | Andrew Harnik/AP Photo

FDA, which has said it will likely miss the Sept. 9 deadline for some applications, is prioritizing its review queue based on applicants' market share. Juul alone controls over 40 percent of the e-cigarette market; its majority shareholder is Altria the parent company of Philip Morris USA.

FDA has not yet made decisions on applications submitted by the market's larger players, which account for only a handful of the submissions waiting for review. But the agency has already told some smaller companies to stop selling their products.

In some cases, FDA outright denied applications from these firms due to the nature of the e-cigarettes in question. These products, all of which were flavored, lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products, the agency stated.

In other cases, however, the agency has issued either Refuse to Accept or Refuse to File notices to smaller firms whose applications were incomplete or otherwise not meeting technical requirements. Those companies can refile their applications but cannot continue to sell affected products in the meantime.

Dave Morris, who owns a company called Vape Gravy Brands in Phoenix, Arizona, said that his initial application cost about $7,000 per flavor for 14 of the flavors he sells. Weve spent pretty much every penny we saved up on the last six years for this, he said. And with the uncertainty around FDAs decision, I dont know if Ill have a company in two weeks, he said, referring to the Sept. 9 deadline.

Morris and other small e-cigarette companies argue that their products including flavored ones are designed for adults who are looking to quit smoking cigarettes, not to entice new, young tobacco users.

I started smoking and then quit with vaping, said Victoria Drower, the owner of two small vape shops in southern California. I should be working myself out of a job that is my goal.

Morris said that all of his products are designed to fill the large, tank-style e-cigarettes that teenagers often eschew in favor of vape pens. Even if they are flavored, he argued, that appeals to adult smokers, not only to teens.

A person uses an e-cigarette. | Tony Dejak/AP Photo

The vaping industry and some public health experts also argue that vaping can help wean smokers from cigarettes and other traditional forms of tobacco.

People who are trying to quit use more e-cigarettes than any other product, Warner said. In a recent paper published in the American Journal of Public Health, Warner and others argued that policies to reduce teen vaping may also help adults use e-cigarettes to quit smoking tobacco.

According to a CDC study, roughly 15 percent of adult smokers successfully quit smoking using e-cigarettes, compared to 3.3 percent who rely on non-cigarette tobacco products such as cigars or cigarillos. A study in the New England Journal of Medicine found that among smokers who quit, 18 percent remained cigarette-free after a year, compared to 9.9 percent who used nicotine-replacement therapies.

But e-cigarettes have still undoubtedly harmed public health. The focal point for most lawmakers and several public health advocacy groups has been vapes appeal to teens and even children. A 2020 CDC study found that nearly 20 percent of high school students and 5 percent of middle school students had vaped regularly, and mostly used flavored products.

Several lawmakers and state attorneys general have urged the FDA to ban all flavors of e-cigarettes, including menthol, because of their appeal to teens. Already, the agency has banned the sale of reusable flavored e-cigarettes, such as those once sold by Juul. But it still allows the sale of disposable flavored products.

But anti-vaping advocates argue that flavors are totally unnecessary to sell products to adults. Smokers are accustomed to tobacco-flavored products, said Dennis Henigan, the vice president for legal and regulatory affairs at the Campaign for Tobacco-Free Kids. Why in the world do they need strawberry-flavored e-liquids as opposed to tobacco-flavored products?

Others argue that even the smaller players in the e-cigarette industry arent as altruistic as they seem. It's hard to have sympathy for businesses that haven't even attempted to play by the rules, said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy.

No one has attempted to file applications or legally market these products [before now], no one has filed applications to make modified risk claims legally, he added. The whole idea that e-cigs are a cessation device why has no company filed a drug application to say it's a cessation device?

Still, most public health experts agree that there should be some kinds of e-cigarettes on the market to help wean adults from cigarettes, pipes and other smoked forms of tobacco.

If you have e-cigarettes on the market, that gives smokers a legal option to go to, said Eric Lindblom, a former official at FDA's Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center.

I personally would like to see more alternatives approved on the market for many different companies, said Mike Cummings, a professor of psychiatry at the Medical University of South Carolina. Alternatives that are acceptable for current smokers to use to stop smoking could be a public health tool. But, he said, you cant have willy-nilly [FDA] clearances.

No matter what FDAs ultimate decision is on e-cigarettes, some parties are going to be angry. I can't in my mind see the FDA threading a needle here that doesn't result in litigation from someone, Jenson said. It's kind of impossible.

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FDA nears day of reckoning on e-cigarettes - POLITICO

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After more than a year of online learning and social distancing from friends and peers, many teens are finally returning to school and their social circles this fall. But as students make plans for the new school year, we could also see the resurgence of another health crisis that was bad even before the COVID-19 shutdown: the youth e-cigarette epidemic.

In the early months of 2020, teen vaping was rampant in schools; 3.6 million kids, including 1 in 5 high school students, used e-cigarettes. Now, as students head back to school, they could again face the conditions that caused the vaping epidemic in the first place:the powerful influence of peer pressure and the widespread availability of e-cigarette products that lure kids with fun flavors and can quickly addict them with massive doses of nicotine. The industry knows full well that 83 percent of youth vapers use flavored products.

The return to school coincides with another critical date on the calendar: The Food and Drug Administration faces a Sept. 9 deadline for deciding which e-cigarette products can remain on the market. To truly protect kids and end the youth e-cigarette epidemic, the FDA must eliminate the flavored and high-nicotine products including the popular menthol flavor that have driven this crisis. Parents, educators and health advocates are counting on the FDA to take them off the shelves.

The evidence is clear that as long as any flavored e-cigarettes remain on the market, kids will get their hands on them. Last year, the FDA banned flavors other than menthol in cartridge-based products like Juul but left other flavored e-cigarettes widely available. What happened next was completely predictable: Kids migrated to the flavored products that were left. Use of disposable e-cigarettes like Puff Bar soared by an alarming 1,000 percent among high school students, and there was also a notable shift to menthol products, with over 1 million kids using them in 2020.

Those of us working in schools and caring for students health and well-being remember what it was before classrooms were shuttered. Juul and other e-cigarettes were everywhere, and traces of mint- and fruit-scented aerosol lingered in hallways and bathrooms as teens attempted to discreetly satisfy their dangerous nicotine addictions. Educators even smelled it in classrooms. Nurses, teachers and administrators were constantly confiscating devices, with piles of Juuls filling their desk drawers. Some schools had to take the doors off bathroom stalls to stop kids from trying to vape in secret. The percentage of high school e-cigarette users reporting frequent or daily use has risen steadily, to a high of nearly 39 percent in 2020. Thats not surprising, because e-cigs like Juul contain as much nicotine as a whole pack of cigarettes.

The U.S. Surgeon General has found that nicotine use in any form by young people is unsafe, causes addiction and can harm the developing adolescent brain, impacting learning, memory and attention. Studies indicate that young people who use e-cigarettes are more likely to go on to smoke regular cigarettes, and nicotine use during adolescence can increase risk for future addiction to other drugs.

With COVID-19 cases surging once again because of the Delta variant, it is more important than ever to keep kids lungs healthy by preventing young people from smoking or vaping. For school nurses, that means this academic year will bring even more challenges. On top of navigating COVID-19 and the mental health fallout from the pandemic, they will have to redouble their efforts to educate teens about the risks of vaping.

Teachers and parents will also need to learn anew how to recognize the signs of e-cigarette use and addiction. E-cigs can be hard to identify because of their sleek and inconspicuous designs that resemble flash drives or pens. If teens are spending more time alone than usual, coming up with excuses to step away frequently or have a sweet smell on their clothes or in their rooms, these could be signs of vaping. Others include an unexplained cough or increased thirst, increased irritability and mood swings.

But nurses, educators and parents alone cannot combat youth vaping. More than anything, we need the support of the FDA and other policymakers, who are the only ones with the power to eliminate the flavored products driving this epidemic.

As the new school year begins, wed all like to start fresh. But until the FDA takes action, we will face more of the same. Its time for the agency to stop playing whack-a-mole and eliminate all flavored e-cigarettes.

Laurie Rubiner is executive vice president, domestic programs, at the Campaign for Tobacco-Free Kids. Linda Mendonca is president of the National Association of School Nurses and an assistant professor at the Rhode Island College School of Nursing. She was a school nurse for two decades.

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Rubiner & Mendonca: Schools and Parents Alone Can't Stop Kids from Vaping. To Head Off This Epidemic, the FDA Must Ban All Flavored E-Cigarettes -...

After a misstep, it's about to become illegal to import e-cigarettes without a prescription, which means that, for most Australians, it'll become all but impossible to vape from October 1.

The misstep tells us a lot about how the Australian government works behind the scenes most of it good.

Mid last year, Health Minister Greg Hunt announced plans to ban the import of nicotine-containing e-cigarettes and refills without a doctor's prescription. Border Force would be checking parcels.

To Hunt, the decision made sense. It was already illegal to buy and sell such products without a prescription in every Australian state and territory, and it was illegal to possess them without a prescription in every state but South Australia.

All Hunt was doing was closing a (very wide) loophole.

Government backbenchers revolted, Hunt pointed to a doubling of nicotine poisonings over the past year and the death of a toddler, the Prime Minister offered less than complete support, saying he was keeping an "open mind", and Hunt put the idea on the backburner.

That's the way it played out in public.

But beneath the surface, something impressive was swinging into gear. It's called the Office of Best Practice Regulation OBPR, an apolitical body nestled within the prime minister's department.

ABC News

So what did this little-known part of the government do that will effectively stamp out vaping from next month? Its executive director, Jason Lange, revealed the back story at an Economic Society of Australia meeting in Canberra earlier this year.

Set up during the 1980s to ensure government decisions didn't needlessly tie up business in red tape, the office gradually was given other things to consider, including the effect of government decisions on citizens, on the environment and on the distribution of burdens throughout society.

Then in 2013 Prime Minister Tony Abbott moved it out of the Department of Finance into his own department: Prime Minister and Cabinet.

Prime Minister and Cabinet is the traffic cop: it decides what gets put forward for cabinet to decide, and when. So suddenly the office was working at the centre of government decisions, getting to view every one of the 1,800 or so things put to senior ministers to decide each year.

For the few hundred proposals it thinks might have significant unintended impacts, the office demands an impact statement.

It doesn't tell the department or authority putting forward the idea what to put in the statement. But as Lange explained, it "marks the homework". The proposals behind any statements that aren't good enough are harder to bring to cabinet.

Hunt's decision on e-cigarettes wasn't accompanied by an impact statement the first time around. Lange's office made sure it was on the second.

Each OBPR analysis has to address seven questions.

The first is what problem the agency is trying to solve. Maybe it's not really a problem. Merely working that out puts what follows into focus.

The second is why government action is needed. Maybe the problem isn't very big, or maybe it will solve itself.

The third is what options the agency is considering. The agency has to put forward at least three options, including one that isn't a regulation. In the case of e-cigarettes, that option was a public awareness campaign.

Then it has to estimate the likely benefits and costs of each option, including the costs to people the option wasn't intended to hit, such as under-the-counter retailers and people using vaping to give up smoking.

The fifth question is the range of people and organisations to be consulted (which is a way of making sure it happens). The sixth is to identify the best option from the list, which includes making no regulation whatsoever.

The seventh is the means by which the measure would be implemented and (importantly) later evaluated.

Once in, and usually after being sent back for further work, the analysis is graded on a scale from "insufficient" to "adequate" to "good practice" to "exemplary".

Very few are graded exemplary, and very few that we know about are graded inadequate, because if such a proposal does get adopted by cabinet, the impact statement gets published along with the grade and a statement that describes its failings a "nuclear option" Lange says can be deeply embarrassing.

All impact statements attached to proposals the government adopts get published along with its OBPR rating. It is often the best opportunity the public has to read about the thinking behind the proposal.

Tellingly, only about 80 of the hundreds of impact statements started each year get to decision makers, which means the process itself knocks out poorly thought out proposals.

But if an idea has merit, as did the ban on importing nicotine-containing e-cigarettes without a prescription, the 180-page impact statement can make all the difference.

It sets out the problem clearly, sets out a number of possible solutions and identifies the winners and losers from each, and shows how they were consulted.

It demonstrates someone in the government has thought it through clearly, and provides material for the government to use when selling its decision.

On the Office of Best Practice Regulation website are hundreds of impact analyses on topics as diverse as food standards, protection for car dealers, and the redress scheme for child sexual abuse.

That's why from October 1 it will become illegal to import without a prescription nicotine-containing e-cigarettes, and illegal to supply any liquid nicotine that isn't in child-resistant packaging.

Behind the scenes, the government got it right.

Peter Martin is visiting fellow at the Crawford School of Public Policy, Australian National University. This article originally appeared on The Conversation.

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From October, it will be all but impossible for most Australians to vape largely because of the homework police - ABC News

A researcher holding various vape pens.Photo: Craig Mitchelldyer (AP)

A new, international survey of experts found wide agreement that vaping devices like e-cigarettes are safer than traditional tobacco products. But the experts also expressed that vaping products should only be sold in specialized stores and shouldnt be used inside public spaces. The findings come just before the Food and Drug Administration is preparing its final decisions this week on the state of the vaping market in the U.S.

E-cigarettes and heated tobacco products are marketed as better and safer alternatives to cigarette smoking. E-cigarettes work by vaporizing nicotine-filled fluid that can then be inhaled, while heated tobacco products are supposed to heat-not-burn the tobacco inside, in theory leading to fewer harmful emissions. Vaping devices can also be used to consume other drugs, namely cannabis or its active ingredient THC.

The FDA is set to issue its first major regulations concerning the industry by September 9, which will include its final decision on millions of applications from e-cigarette companies. The agency has said that it will deny products that fail to show they are appropriate for the protection of public health. In recent weeks, it has already pulled over 55,000 flavored products from three small companies from the market, perhaps signaling that very few of these products will survive the cull.

In a new study published in BMJ Open, researchers in France and Switzerland decided to poll public health specialists around the world about their opinions on the future of e-cigarettes and heated tobacco products. They used a method known as a Delphi survey, which uses a series of detailed questionnaires and feedback to help determine a consensus among experts on a specific topic (in other words, the survey isnt intended as just a simple question-and-answer poll).

They conducted two rounds of the survey, with the first involving 92 experts and the second involving 55. These participants came from 15 countries, including the UK, Sweden, Finland, France, and the U.S., and they all had experience in tobacco control or smoking cessation research.

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For e-cigarettes, the team found consensus (at least 70% agreement on yes-no questions, for instance) that all ingredients of an e-liquid should be listed on the product; that there should be a maximum concentration of nicotine in an e-liquid; and that products should come with a warning label noting the limited evidence on their long-term outcomes, including their safety and addiction potential. E-cigarettes, they also agreed, shouldnt be sold at general stores, only at specialized vaping stores or other places where tobacco products are sold, like pharmacies with sale restrictions for minors. Heated tobacco products should considered as addictive as traditional cigarettes and should come with the same warnings and taxes attached to cigarettes, the surveyed experts said.

A majority of experts did agree that e-cigarettes are safer than cigarettes and less addictive than heated tobacco products, and that vaping should be offered as one of many cessation aids for quitting smoking. But most also believed that people are more likely to use e-cigarettes and cigarettes at the same time, rather than use vaping as a way to quit cigarettes permanently. The majority similarly agreed that neither e-cigarettes nor heated tobacco products should be allowed indoors in public spaces and that they shouldnt be advertised to non-smokers.

The study, while meant to be the first international survey of its kind, does have its caveats. Namely, the low response rate, with only 34% of eligible participants responding to the initial survey and only slightly more than half returning for the second round. So the findings may not be generalizable to all relevant experts around the world, the researchers warn. They also noted that the second round of the survey took place after the epidemic of lung illness among some vaping users in the U.S. in 2019, which could have affected some peoples opinions (the crisis, while used as justification by some states to further crack down on the industry, was traced to black market THC products, not legally sold e-cigarettes).

Some countries, particularly the UK, seem to have a much more favorable opinion of e-cigarettes than others. Public health experts there widely support its use as a cessation aid for smokers, and its leading public health agency argues that vaping is at least 95% less harmful than smoking. There are also some scientists in the U.S. who have been very critical of their fellow vaping researchers and who have argued that policies like banning flavored products could be counterproductive and actually increase the risk of teen smoking.

The authors of the new study do point out the ongoing debates over vaping and the passionate responses expressed by experts on various sides. But they also hope that their results may be useful for health authorities, decision makers and researchers of the tobacco use and cessation field.

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Experts Call for More Regulation of E-Cigarettes Ahead of Major FDA Decision - Gizmodo

The campaign encourages adolescents to dispose of their e-cigarettes with the goal of collecting a total of 500 devices.

The campaign encourages adolescents to dispose of their e-cigarettes at any of the White, Greer & Maggard Orthodontics 20 locations, with a goal of collecting a total of 500 devices. While vaping might seem safer than smoking cigarettes, the nicotine in vape pods can cause an increase in blood pressure and heart rate, and a narrowing of the arteries, as well as irritability, mood swings, anxiety, impulsivity and learning difficulties. That is why White, Greer & Maggard Orthodontics is working alongside the American Heart Association to educate people throughout Central Kentucky on the harmful effects of vaping, said Dr. Stan Ferguson of White, Greer & Maggard Orthodontics.

The AHA has also recently launched a youth-driven Tobacco Endgame site which also features the personal experiences of young vapers but also gives teens the opportunity to connect directly with policymakers, learn how they can create healthier communities by taking charge and speaking up.

Meanwhile, the American Lung Association (ALA) has launched a a similar campaign with the aim of offering a more productive alternative than school suspensions for students caught vaping on campus.

Amongst the Vape-Free Schools Initiatives goals, is providing educators with more effective strategies than suspensions in handling teens caught vaping in schools. The reason we want an alternative to suspension program is because if you suspend kids for using a very addictive substance, then they are more likely to stay home and vape and theyre missing out on educational opportunities, says Ellen Penrod, Executive Director of the American Lung Association in Colorado, where high school tobacco use rates are at 28%. T

The programme, includes a ten-week program that takes students caught vaping through the entire quitting process and costs $400 per school to get these programs set up. To this effect the AHA has launched the Vape-Free Schools Scholarship Fund, which aims to raise $400,000 to serve 1,000 schools by the end of 2021. Any school can apply to receive the funding. To donate, visit Lung.org/scholarship.

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American Heart Association Launces New Campaign to Combat Teen Vaping - Vaping Post