Daily Archives: September 14, 2021

When a court-set deadline for "premarket" review of nicotine vaping products came and went on Thursday, the Food and Drug Administration (FDA) had received millions of applications but had not approved any. As a result, the agency says, every vaping product sold in the United Statesincluding myriad e-liquids, devices, and partsis now "subject to enforcement action at the FDA's discretion."

Seven years after the FDA officially declared its intention to regulate e-cigarettes as "tobacco products," in other words, the entire industry remains in legal limbo, existing solely thanks to the agency's enforcement discretion and limited resources. The FDA laughably maintains that it is bringing "regulatory certainty" to a market it concedes has great potential to reduce smoking-related disease and death. In reality, the agency, despite its promises of regulatory flexibility, is perpetuating a situation in which companies that tried to play by the rules have no idea whether they will still be in business next week, next month, or next year.

As of September 9, 2020, the deadline set by U.S. District Judge Paul Grimm in response to a lawsuit by anti-vaping groups, the FDA had received 6.5 million applications from more than 500 manufacturers of "new tobacco products," the vast majority of them vaping liquids or devices. That was a far cry from the 25 annual applications the FDA originally expecteda projection that suggested nearly all vaping companies would be deterred by the effort and expense required to comply with the agency's daunting regulations. Grimm gave the agency an additional year to act on those applications.

While the FDA brags that it has acted on "about 93% of the total timely-submitted applications," that number is highly misleading. Three-quarters of those actions involved 4.5 million applications from a single manufacturer, JD Nova, that the FDA deemed incompletein August because they did not include an "adequate Environmental Assessment" for each of the products, many of which had never actually been sold. In addition to seeking approval for hypothetical products, the company submitted a separate application for every flavor, strength, and size of its existing e-liquids, as required by the FDA.

As Filter's Alex Norcia noted at the time, the environmental assessment demanded by the FDA is "an onerous and complicated section that covers a product's environmental impact from the point of manufacture to disposal." Because JD Nova did not meet that requirement to the FDA's satisfaction, its applications were never formally filed. But later that month, the FDA issued its first "marketing denial orders" (MDOs), rejecting55,000 applications for "flavored" vaping products from three companies because they "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 FDA noted that the rejected products included "flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal." Acting FDA Commissioner Janet Woodcock said "flavored tobacco products are very appealing to young people," so "assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed."

For tobacco harm reduction advocates, that rationale is alarming because it suggests a bias against e-liquids in flavors other than tobacco, which are enormously popular among smokers who switch to vaping. It also implies that the FDA's requirements for overcoming that bias may be impossible to satisfy, especially for small businesses that could not afford to spend hundreds of thousands or millions of dollars on new research.

"Based on existing scientific evidence and the agency's experience conducting premarket reviews," the FDA said, "the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. Because this evidence was absent in these applications, the FDA is issuing MDOs."

Less than a week later, the FDA denied applications from three companies for about 800 other flavored products. It said it would "continue to review other premarket tobacco applications for non-tobacco flavored ENDS [electronic nicotine delivery systems] to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth." All told, the FDA says, it has issued "132 MDOs for more than 946,000 flavored ENDS products."

The FDA has yet to act on applications from major manufacturers such as Juul, which in 2018 preemptively stopped selling most of its flavors in response to the agency's concerns about underage vaping. "How the FDA could fail to make a decision on Juul products is beyond me," said Michelle Eakin, chair of the American Thoracic Society's Tobacco Action Committee, in a press release. "Juul has the largest share of the e-cigarette market and its products were a primary driver in the sky-rocketing rise in youth e-cigarette use. The FDA has delayed long enough. Until the agency addresses Juul, Puffbar and other companies that are driving the youth e-cigarette market, it is failing to do its job."

Critics like Eakin think the FDA should ban all non-tobacco-flavored vaping products, despite the fact that former smokers overwhelmingly prefer them, because they also appeal to teenagers. Under the Family Smoking Prevention and Tobacco Control Act, the 2009 statute that the FDA used to assert authority over e-cigarettes (even though legislators did not contemplate that product category when they wrote the law), the agency is supposed to consider a product's impact on "the population as a whole," which includes underage vaping. But that collectivist calculus also includes reductions in smoking facilitated by vaping products. If banning flavored options makes these products less appealing to current and former smokers, that policy could perversely lead to more tobacco-related deaths than would otherwise occur.

"There is robust evidence that non-tobacco-flavored e-cigarettes help adults quit smoking," notes Competitive Enterprise Institute senior fellow Michelle Minton. "It seems their availability in non-tobacco flavors is, in fact, a major reason why e-cigarettes are at least twice as effective for smoking cessation as other nicotine replacement therapies."

Because of the standard set by the Tobacco Control Act, it is not enough for a manufacturer to show that its products are much less hazardous than combustible cigarettes. Nor is it enough to plausibly project that more vaping will mean less smoking (among teenagers as well as adults) and therefore fewer premature deaths. A manufacturer also has to persuade the FDA that the "public health" benefit from allowing its product to stay on the market outweighs the potential cost of vaping by teenagers who otherwise never would have used nicotine.

As a general matter, that should not be difficult, since the health hazards of nicotine itself are minimal compared to the hazards of cigarette smoking, the vast majority of teenagers who vape frequently are current or former smokers, and there is little evidence that vaping products are a "gateway" to smoking among teenagers. To the contrary, recent trends suggest the availability of these products has accelerated the downward trend in adolescent smoking, and there is reason to think that banning flavored e-liquids would have the opposite effect.

But if every manufacturer has to present "product-specific," "robust and reliable" evidence that the benefits of each variation it sells will outweigh the costs, that is a recipe for eliminating all but the biggest, wealthiest companies. Even a manufacturer that presents a "randomized controlled trial" or "longitudinal cohort study" indicating that flavored vaping products play an important role in reducing smoking has to contend with speculation about "the impact of potential or actual youth use."

Since 2015, Minton notes, the FDA "has approved new tobacco products from three companies, including flavored tobacco." Those products included "eight varieties of Swedish Match North America's snus, the heated tobacco product, IQOS, made by Philip Morris, and combustible cigarettes with reduced nicotine made by 22nd Century Group." In those cases, "the FDA was happy to accept more general evidence about the product category's appeal to adults and youth, as well as their general risks to public health." But when it comes to flavored vaping products, the FDA seems to be demanding more.

"America's tobacco and nicotine regulatory system is broken beyond repair," says Gregory Conley, president of the American Vaping Association, which supports vaping as a harm-reducing alternative to smoking. "It is absolutely absurd that the same agency that found time to ban over six million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares. Even worse, after spending five-plus years peddling false hope to businesses across America, the FDA now can't even be bothered to grant formal extensions to the remaining pending applicants. This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers."

Norcia reports that some manufacturers, having concluded that satisfying the FDA is impossible, are shifting toward synthetic nicotine, which is not derived from tobacco and therefore is arguably not subject to the agency's jurisdiction under the Tobacco Control Act. Assuming that legal strategy is successful, there could be many vaping products that are not even notionally subject to FDA regulation. And if the FDA refuses to approve flavored products, vapers who prefer them will still find lots of black-market alternatives, which likewise will be completely unaffected by government-prescribed standards. Given the recent experience with lung injuries caused by black-market THC vapes, that is a situation a public health agency should be keen to avoid.

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Since the FDA Has Not Approved Any Vaping Products, All of Them Are Now 'Subject to Enforcement Action' - Reason

Tour extended into last week of the election to give a voice to the 1,000,000 Canadian vapers besieged by federal and provincial regulations

Vigil planned for September 16 to honour those Canadians who have died from smoking-related illnesses

Vaping is a proven less-harmful alternative to smoking

TORONTO and QUEBEC, Sept. 13, 2021 /CNW/ - The biggest mobilization of Canadian vapers continues this week with a blitz through Toronto and the Greater Toronto Area that will include a vigil for the hundreds of Canadians who have died from smoking-related diseases since the start of the election campaign.

http://www.rights4vapers.com (CNW Group/Rights 4 Vapers)

The tour encourages vapers to speak out against the Liberal's proposed regulations that will ban all flavours, except tobacco, mint and menthol. It also wants to educate non-vapers on the realities of vaping as a tobacco harm reduction tool.

"We've been on the road for almost a month. We felt we needed to come back to the GTA to push home our message of tobacco harm reduction. The Liberal government will have no choice but to hear our voices. In the past, we have been silenced and marginalized. This tour will show candidates in this election that vapers will no longer be ignored. This is the fight for our lives," said Maria Papaioannoy, spokesperson for Rights4Vapers one of Canada's vapers' rights organizations.

Vaping is a proven less harmful alternative to smoking. Public health authorities around the world have made it clear that vaping can be an effective tool to help smokers quit smoking. But only if the right regulatory and societal frameworks are in place.

"If regulated appropriately vapour products have the potential to help millions of smokers quit smoking. Isn't this what the government wants?" said Ms. Papaioannoy. "Instead, the Liberals are threatening to remove flavours from the market. If the government is successful with this draconian regulation, it will drive thousands of current vapers back to smoking and stop millions of smokers from trying vapour products."

Story continues

Flavours are an important component to the vaping experience for adult smokers. Flavours help smokers migrate from traditional cigarettes to vapour products. In 2019, Parliament conducted hearings on amendments to the Tobacco Act (Bill S5). Experts told the federal government that flavoured vapour products are important. It's time that all governments listen.

"Since the start of the election over 3000 Canadians have died from smoking related illnesses. No one has died from vaping. We want to honour the lives of those who died with a vigil in downtown Toronto. Who is to say that with progressive regulations, truth and science based information, and accessibility to vapour products, some of these Canadians may still be alive today," said Ms. Papaioannoy.

Vapour products are the best hope for hundreds of thousands of Canadians who smoke and are looking for an alternative to cigarettes. Earlier this year, Public Health England released its latest review of vapour studies. It found that "the best thing that a smoker can do is to stop smoking completely and the evidence shows that vaping is one of the most effective quit aids available, helping around 50,000 smokers quit a year."

According to research published by the Consumer Choice Center, there are upwards of 1.5 million adult Canadian vapers in Canada. Approximately 955,000 of those adult consumers currently use flavoured vape products. A full ban on vaping flavours would likely push most of those consumers back to smoking.

Vape Tour 2021 will reach out to the forgotten 1,250,000 Canadian vapers. More and more regulations at both federal and provincial levels are threatening the access, availability, and affordability of vapour products. Vape Tour 2021 will bring the truth about vaping to towns and cities across Quebec and Ontario and mobilize vapers. It's time to save vaping. It's time to save lives.

Event Schedule:What: Vigil for those who have died from smoking related illnessesWhen: Thursday September 16Time: Begins at 6:30 p.m.Where: March starts at Yonge and Adelaide and will culminated in a silent vigil at Yonge and Dundas Square

SOURCE Rights 4 Vapers

Cision

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2021/13/c7837.html

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Vape Tour 2021 Arrives in the Greater Toronto Area - Yahoo Finance

A new study finds health concerns that vaping raises the risk of blood clots, high blood pressure, high heart rate, and damaged arteries in youths. These vaping risks are startlingly similar to the risks associated with smoking cigarettes, leading researchers to warn people that their vaping habit may not be so safe.

Study author Gustaf Lyytinen, a clinician at Helsingborg Hospital and researcher at the Karolinska Institute in Stockholm, said, Our results suggest that using e-cigarettes. That contains nicotine has similar impacts on the body as smoking traditional cigarettes. This effect on blood clots is important because we know that in the long-term, this can lead to clogged-up and narrowed blood vessels, and that, of course, puts people at risk of heart attacks and strokes.

The research was done with women and men from the ages of 18 to 45. The research showed that those who vaped had higher blood pressure and heart rate afterward. They also showed a 23% increase in blood clots. High tech visualization using laser technology was used to study the changes in small blood vessels of the participants, showing that the small vessels temporarily became narrower.

Patricia Folan, who directs the Center for Tobacco Control at Northwell Health in Great Neck, N.Y. said, E-cigarettes in their many forms were brought to market without proper regulation. Their safety and effectiveness in assisting smokers to quit were not proven or demonstrated with supporting research.

This research proves that vaping is not much of a safer alternative to smoking, as it also comes with its own health concerns.

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Study Reveals the Serious Health Concerns Behind Vaping - One Green Planet

About 20% of LSU students are regular or social vapers, while 86% have vaped at least once, according to a survey conducted by Manship School of Mass Communication professor Judith Sylvester.

Sylvester conducted two surveys to gauge how many LSU students and college students across the country are using e-cigarettes.

Sylvester is the founder of the SmokingWords program, which has been advocating for smoking cessation on college campuses since 2000. With many people turning to vaping as an alternative to cigarettes, Sylvester and SmokingWords latest battle has been getting the word out about the dangers of e-cigarette usage.

Although the U.S. Food and Drug Administration eliminated most flavoring in e-cigarettes and raised the legal tobacco purchasing age to 21, these measures resulted in only 28% of survey respondents quitting vaping. About 46% of respondents said they had vaped THC, the psychoactive compound found in marijuana.

Almost all of these devices are manufactured in China and you dont know whats in them, Sylvester said. I just want students to be aware of how dangerous it is, and how connected it is with COVID and EVALI.

The Centers for Disease Control named vitamin E acetate, associated with unregulated THC vaping products, as the most likely additive causinge-cigarette or vaping use-associated lung injury, or EVALI. Over 70% of EVALI cases reviewed by the CDC and FDA were connected to vaping THC; however, they have not confirmed this additive to be the sole cause of EVALI. The CDC halted research on EVALI in February 2020 as fighting COVID-19 took priority.

Sylvester stressed the connections between the COVID-19 pandemic and the explosion of vaping popularity, both because many students turn to vaping to beat isolation boredom and the social aspect of people sharing devices as a cause of virus transmission. Her survey found that over 70% of students who vape named boredom or stress as a contributing factor to increased use.

Her greatest concern, though, is the similarity in symptoms between EVALI and COVID-19. Variants of the virus that are particularly hostile to young people are a major cause for worry, as those who vape may be more susceptible to the severe lung complications associated with the worst COVID cases. Even with EVALI being more connected to vaping THC than nicotine, a Stanford Medical School survey found those who vaped in the last month are five times more likely to exhibit COVID symptoms.

Theres been no tracking of whether the people that got the sickest from COVID were vaping or smoking, Sylvester said. That connection has just been lost.

Logan Montalbano, a junior chemical engineering major, said he's not too concerned about what is in vaping products, but acknowledged the role that the isolation of the pandemic plays into the habit for himself and others.

Being stuck at my house without as much to do made me do it more because I thought about it more, Montalbano said. Whenever youre out and about, you dont think about hitting your vape as much, but when you have nothing to do, its just there and you want to do it.

Noah Carges, a sophomore mechanical engineering major, said he does remembers receiving some anti-tobacco resources from the university at the start of his freshman year, but has not received any material since and did not consider the education to be effective, as he began vaping at the start of college amid the boredom of pandemic life.

I dont really mind whats in it, because I know its not particularly good for you, but Im willing to take the risk of it, Carges said. It started off as boredom, but it kind of just grew into a habit.

The university implemented a tobacco-free campus policy in 2014, which includes e-cigarettes and chewing tobacco. A strict enforcement of this policy, however, remains to be seen, as only 6% of students in the LSU survey said they had never seen vaping or tobacco use on the campus. Sylvester said shed like to see the LSU administration enforce the policy more strictly.

For whatever reason, theyve absolutely refused to speak out about it, she said. Theres been no statement from a president ever, from a provost ever. Weve had a couple statements come in from the student life vice president in 2014 and 2015, and that has been it.

Read the original:

Survey: 20% of LSU students vape regularly or in social settings; only 14% have never vaped - The Reveille, LSU's student newspaper

Reproductive biologist Dr. Ali Honaramooz and his research team, are designing an experiment allowing researchers to identify and study the effects of e-cigarette use on the health and development of testis tissue, in detail. Inspired by figures released by Health Canada in 2020, claiming that teen vaping tripled between 2014 and 2019, the study aims to look into the the effects of vaping on teenage reproductive health development.

I usually look for important, everyday applied or clinical questions that can be answered using my specialty and the study tools that we have at our disposal, said Honaramooz. As a father of three teenagers, I feel this research may help shed light on some aspects of e-cigarettes that are not sufficiently studied and may help to inform young individuals and their parents, as well as practitioners and policy makers.

The researcher said that expectant mothers tended to defend their use of these products as a healthy alternative to conventional cigarettes in their survey responses. However he added, the use of the word healthier in this context, as if it is synonymous with less harmful, is misleading if not deceitful. In the absence of evidence, the premise for claiming e-cigarettes as being less harmful than smoking is shaky.

Meanwhile, contradicting Honaramoozs claims, there are actually countless peer reviewed studies indicating that e-cigarettes are significantly less harmful than combustible tobacco products. Infact, a recent report by Public Health England (PHE) not only reaffirmed that vaping is relatively safer, but also that it is a gateway out of smoking.

However Honaramooz says that since unlike other vital body systems that are fully developed at birth, the reproductive system remains purposely underdeveloped until puberty, it is left susceptible to interference by carcinogens. In order to determine any possible negative effects via vaping, the biologist and his team have regenerated functional testis tissue from stem cells by modifying the testis cell aggregate implantation technique.

Subsequently, they plan to introduce a number of possible carcinogens, a plan which includes exposing the cells to e-cig vapour in order to study its effects on the live tissue directly and in real time. You see, toxicology is all about dose. At reasonably relevant doses, I probably expect to see subtle changes such as in gene expression and possibly cell behavior, said Honaramooz. Again, the effects do not necessarily have to be significant or visible to cause major functional consequences. [Even subtle differences] can lead to carcinoma and germ cell testicular cancer.

In the meantime, Honaramooz warns consumers to be wary of products marketed as healthy, especially where common sense suggests otherwise. My own advice is to stick with what has worked over millions of years of evolution: the basic, unaltered primary food and drink items in their natural and non-modified formjust as we follow manufacturers instructions in choosing the fuel for our cars.

Read Further: MedicalXpress

Smoke Exposure During Pregnancy Can Have Damaging Effects Lasting Generations

Originally posted here:

Looking Into The Effects of Vaping on Reproductive Health - Vaping Post

The paper titled, Money up in smoke: The financial benefits of smoking cessation may be more motivating to people who are homeless than potential health gains, rightly pointed out that smoking among disadvantaged groups such as people who are homeless or living in temporary accommodation, increases the likelihood of poor health outcomes and financial disadvantages.

The survey conducted by the research team looked into the smoking and quit attempt history of the participants, perceptions about smoking cessation and cessation tools. The researchers also inquired about the levels of awareness of the Intensive Quit Support program, a free local government-funded smoking cessation initiative.

The researchers found that participants reported a high level of interest in e-cigarettes as a cessation aid. On the other hand, there was a low level of awareness but moderate level of interest in the Intensive Quit Support program.

The participants reported spending a high proportion of their income on cigarettes, and while the most commonly reported perceived benefit of smoking cessation was improved health, more participants (twice as many) were interested in a campaign promoting the financial savings of quitting, rather than the health benefits. To this effect concluded the researchers, more emphasis needs to be put on the financial gains of quitting cigarettes in most campaigns.

Read Further: NIH

A Self-Help Smoking Cessation Intervention Designed for Dual Users

Read more from the original source:

The Financial Benefit of Smoking Cessation For The Homeless - Vaping Post