Broughton Nicotine Services has hired five additional toxicology specialists to strengthen its support for companies in the electronic nicotine delivery systems (ENDS) sector.
The new team members are: Yvonne Wilding (director, product safety and compliance), Emmanuel Minet and Frazer Lowe (principal scientists), Djeren Simitdjioglu (associate toxicologist) and Anais Kahve (toxicologist).
Wilding is a highly experienced toxicologist with more than 10 years’ broad regulatory toxicology experience and 20 years pharmaceutical research and development experience at companies such as GlaxoSmithKline and AstraZeneca.
‘’We’re delighted to welcome these highly experienced individuals to our existing team,” said Chris Allen, vice president of scientific and regulatory affairs at Broughton. “Toxicology is an essential element of the scientific and regulatory support we provide to ENDS companies submitting premarket applications in the UK, US and emerging markets.
“Having a large team of toxicologists in-house collaborating with our analytical team and external suppliers will help us leverage improved efficiencies for clients and accelerate compilation of scientific data for regulatory projects to advance a smoke free future.’’
The scientific evidence is clear that nicotine itself is not responsible for smoking-related diseases.
By Ian Jones
If you are as old as me, and happen to come from the U.K., you may recall Nick O’Teen, one of the central characters in an anti-smoking campaign run by the U.K. Health Education Council (HEC) in the early 1980s. With his cigarette-butt-shaped top hat and bright yellow teeth, O’Teen was the campaign’s arch villain and was regularly apprehended by the campaign’s hero, Superman.
Now, obviously, Nick O’Teen’s name is a play on the word “nicotine,” so it is reasonable to assume that people who saw the campaign in the 1980s concluded that nicotine in cigarettes is the direct cause of smoking-related illnesses. In fact, according to recent surveys, this is still a commonly held belief, not only in the U.K. but in several other surveyed countries. But, given what we know today, does nicotine deserve this reputation or, as Mitch Zeller, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products, the agency in the USA responsible for overseeing the implementation of tobacco product regulation, has previously asked, is it time for a “rethink within society on nicotine”?
Let’s start with the basics: What exactly is nicotine, and what does it do?
Nicotine is a chemical naturally found in tobacco and other related plants, in the same way that caffeine is naturally found in tea. Why does tobacco produce nicotine? Well, the commonly held belief is that nicotine helps protect the tobacco leaves from being eaten by insects and other predators. It does this in two ways.
First, nicotine has a bitter taste, so it could make the leaves unpalatable to some potential diners. Second, and of more relevance to its namesake Nick O’Teen, nicotine mimics one of the natural chemicals that cells in the nervous system of animals use to communicate with each other. Thus, eating nicotine-containing leaves could impact the normal working of the nervous system (in fact, this could even be fatal to some insects).
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Now, in you and me, the chemical that nicotine mimics, acetylcholine, is found throughout the nervous system and performs a myriad of functions. In the brain specifically, acetylcholine acts a bit like a volume control dial, turning up or turning down signals between brain cells. Which way the dial is turned depends on the brain region and the state of mind at the time.
This is why nicotine, by mimicking acetylcholine, is said to not only help with attention (volume up) but also relaxation (volume down). It also explains the addictive property of nicotine. In the part of the brain responsible for identifying enjoyable experiences, nicotine can turn the volume up, making the experience of smoking stronger.
Herein also lies a very important point; the addictive effects of nicotine are usually paired with a particular enjoyable experience. It explains why one of the common tests for tobacco addiction, the Fagerström Test for Nicotine Dependence, was renamed to the Fagerström Test for Cigarette Dependence; addiction to smoking is not solely due to the addictive nature of nicotine alone, but is a result of the interplay between nicotine, acting as volume up, and a series of sensory and other cues (smell, taste, ritual, etc.).
But hold on a minute; doesn’t nicotine cause cancer and other diseases associated with smoking?
This is one of the main misunderstandings about nicotine and the answer is simple—no. The scientific evidence is clear that nicotine itself is not responsible for smoking-related diseases. These are caused by other things in smoke, particularly chemicals formed when tobacco is burnt. Remember, tobacco-derived nicotine is an approved medicine and is even available without prescription in many countries.
This would not be the case if there were serious health risks associated with its use. Furthermore, the use of tobacco products that are not burned during use, such as Scandinavian snus—a tobacco product that is placed under the consumer’s lip—is associated with much lower risks of developing cancer compared to smoking, even though the product also delivers nicotine to the user. The FDA in the U.S. recently acknowledged this by approving modified-risk claims for certain snus products.
This is not to say, though, that nicotine is risk free. As mentioned above, it is addictive and can reinforce addiction to certain pleasurable behaviors. By mimicking acetylcholine, it can also affect certain biological processes such as the development of new blood vessels. There are also concerns about the potential effects of nicotine exposure in developing brains, an area that certainly deserves more research focus (as well as effective practical measures to prevent minors from accessing nicotine-containing products).
OK, so the science to date noes not support the notion that nicotine causes cancer, but what about nicotine salts? I hear they are even worse than nicotine.
I would contend that this is another misunderstanding, this time in part due to a lack of clear explanation by manufacturers as to what nicotine salts are when they first came onto the market. The key point to remember is that nicotine is nicotine, whether in salt form, nonsalt form (“nicotine base”), naturally derived or synthetic. Nicotine salts are simply nicotine attached to something else, in the same way that cooking salt is sodium attached to chloride (i.e. sodium chloride).
Whether nicotine attaches to something else is simply down to how acidic the environment is. In acidic environments (e.g. an acidic e-liquid), nicotine is in salt form. At the other end of the scale, in alkaline environments, it is in base form (not attached to anything). In the middle (neutral pH), as in our bodies, nicotine is in a mixture of salt and base forms. An interesting aside is that nicotine salts are therefore not a new discovery; historically, e-liquids have been around neutral pH, so they have in fact always contained some nicotine salts.
In any case, the fact that our bodies like to maintain a “just so” neutral pH means that, from a biological point of view, the form of the nicotine in the liquid does not really matter much as it will conform to a salt/base mix as soon as it comes in contact with the body. What nicotine salts (and acidic e-liquids in general) do is provide a different sensory experience, especially at higher nicotine levels, which some consumers may prefer.
So, back to Nick O’Teen. Does he deserve his reputation? In my opinion, he was an arch villain of his time. As we’ve gained more understanding over the intervening years about the effects of nicotine in the body, I think we can indeed rethink the role of nicotine in society, just as Mitch Zeller suggests. Nicotine is not risk free and is certainly not something that minors should ever consume given concerns about the impact on the developing brain.
Likewise, there are other susceptible groups of people, such as pregnant women, that either should not use nicotine-containing products or, at a minimum, seek medical advice before deciding whether to do so. For most adults, however, nicotine deserves acceptance of its new non-villainous persona as a cause of tobacco-related illness, and to be seen as an adult lifestyle choice, the same as many other adult consumer products.
Ian Jones
Ian Jones is the R&D principal scientist for Japan Tobacco International (JTI).
French researchers are planning to test nicotine patches on coronavirus patients and frontline workers following a study suggesting smokers are less likely to catch the virus according to The Guardian.
The Paris-based study suggests that something in tobacco helps prevent smokers from contracting the virus, but researchers say they are not encouraging people to take up smoking; cigarette smoke causes damage to the lungs, which can cause individuals who have contracted Covid-19 to suffer more severe symptoms.
Jean-Pierre Changeux, a renowned French neurobiologist, suggested nicotine may stop the virus from reaching cells in the body. Nicotine may also lessen the overreaction of the immune system that has been seen in the most severe Covid-19 cases.
The results coincide with a Chinese study showing that only 12.6 percent of 1,000 infected individuals were smokers whereas the national smoking rate is around 28 percent. In Paris, 8.5 percent of 11,000 Covid-19 patients were smokers while the total number of smokers in France is about 25.4 percent.
“Our cross-sectional study strongly suggests that those who smoke every day are much less likely to develop a symptomatic or severe infection with Sars-CoV-2 compared with the general population,” the report authors wrote. “The effect is significant. It divides the risk by five for ambulatory patients and by four for those admitted to hospital. We rarely see this in medicine.”
Anti-vaping activist groups continue to use the coronavirus crisis to advance their goal of restricting — or even completely banning — the use of vapor products. They argue that vapers are at higher risk of harm from COVID-19.
However, the available evidence indicates the opposite: If they had worked to convince more smokers to switch to e-cigarettes, there might be fewer coronavirus-related deaths today, according to a story on insidesources.com.
That’s the view of Dr. Michael Siegel, professor of community health sciences at the Boston University School of Public Health.
“It’s absolutely true that if more public health activists had embraced e-cigarettes instead of opposing them and more smokers had been encouraged to switch, there would be less mortality from COVID-19 today,” Siegel told InsideSources. An estimated 2.5 million smokers have given up traditional cigarettes for vaping and other similar technologies.
Siegel has spent much of his career working to reduce smoking and is no friend of Big Tobacco. At the same time, he embraces the “mitigation over prohibition” model for reducing tobacco use. Anti-tobacco prohibitionists — hoping to get every smoker to “just say no” — are fighting an unwinnable battle, Siegel said, according to the story.
“What people need to understand is that smoking is such an addictive behavior, and it’s not just the nicotine. It’s the psychology as well. In the middle of a pandemic when people are under so much stress, asking these people to just quit cold turkey is ridiculous,” Siegel said.
Pointing to claims that smoking and vaping can make coronavirus symptoms worse, some anti-tobacco activists are advocating limits, or even outright bans, on vaping products.
Earlier this month, Rep. Raja Krishnamoorthi, chairman of the House Subcommittee on Economic and Consumer Policy, sent a letter to the Food and Drug Administration (FDA) asking the agency to “clear the market of e-cigarettes for the duration of the coronavirus pandemic.”
The New York State Academy of Family Physicians has joined the call for a vaping ban, while other anti-tobacco groups like the Campaign for Tobacco-Free Kids and the Truth Initiative have been advocating restrictions on e-cigarettes for years, according to the story.
Their efforts create the impression that the risks from traditional cigarettes and e-cigarettes are comparable. And that, Siegel argues, is a dangerous message.
“There is no evidence for the claim that e-cigarette use has a significant impact on coronavirus patients, that’s just speculation,” Siegel said.
Dr. Sally Satel, a visiting professor at Columbia University’s Irving Medical Center, agrees. “There is no evidence that vaping causes ‘interstitial lung disease,’ or fibrous scarring. Hundreds of thousands of former smokers have been vaping for at least 10 years to date without evidence of meaningful injury to their lungs,” she writes. “Over the longer-term, it must be said, vaping might cause impairment in lung function — though surely less injury than had vapers continued to smoke.”
Even supporters of vaping restrictions acknowledge that there is little research involving the novel coronavirus.
When NYC Mayor Bill de Blasio said “smoking or vaping” contribute to the impact of the coronavirus, Italian medical researcher and former president of the Italian Anti-Smoking League Riccardo Polosa tweeted, “Where is the evidence? Stop placing smoking and vaping on the same level. Get your facts straight, Mayor!”
Conflating the risks of smoking and vaping is both bad science and discourages smokers from making the switch, health professionals like Siegel argue, according to the story.
“The impact of smoking on the body’s ability to heal is so significant that most surgeons insist their patients quit prior to surgery because they know that smoking inhibits healing and increases the susceptibility to infection,” Siegel said. There’s no evidence of any similar health impact from vaping.
If anti-tobacco groups are right about the deadly impact of coronavirus on smokers, then their goal should be to get as many smokers to stop as possible. And a CDC study found that “substituting some cigarettes with e-cigarettes was used by a greater percentage of smokers than the nicotine patch, nicotine gum, or other FDA-approved cessation aids.”
Siegel makes the case more starkly: “In retrospect, the focus on fighting against e-cigarettes looks terrible. Imagine if, instead of 2.5 million former smokers who made the switch, we were in this coronavirus pandemic with 3 million, 4 million, 5 million ex-smokers. There’s no doubt we would be in better shape today.”
Reynolds American Inc. (RAI) has submitted two new premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). RAI is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow these products to remain on the market after the FDA’s deadline for PMTAs for electronic nicotine-delivery systems.
The applications include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks. Though the PMTAs themselves are considered commercially proprietary and are thus confidential, the data and information submitted to the FDA include the results of product analyses, nonclinical health risk information and human health and population information, including the impact to both users and nonusers of tobacco products.
According to RAI, the results of these studies demonstrate that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health. The FDA s expected to extend the PMTA deadline to from May 12 to Sept. 9.
“I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA’s May deadline for ENDS products,” noted Reynolds’ executive vice president and head of scientific and regulatory affairs, James Figlar.
The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.
The U.S. Food and Drug Administration modified its stance on Covid-19 and vaping, saying it has an unknown effect on the risk of the new coronavirus, while warning that smoking can create worse outcomes, according to Bloomberg News.
“E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of Covid-19 is not known,” the agency said Wednesday in an emailed response to a question from Bloomberg News.
The agency had said late last month that vapers and smokers with underlying health conditions might be at higher risk from complications.
Its description of cigarettes’ risks also differed from its earlier statements. “Cigarette smoking causes heart and lung diseases, suppresses the immune system, and increases the risk of respiratory infections,” FDA spokeswoman Alison Hunt said. “People who smoke cigarettes may be at increased risk from Covid-19, and may have worse outcomes from Covid-19.”
The new statement comes as the disease afflicts young people in some countries at rates that are surprising, given initial data out of China, and some health experts speculate as to whether vaping could play a role, the article states.
‘Especially Serious’
Other U.S. agencies have issued mixed warnings on both smoking and vaping. Nora Volkow, director of the National Institute on Drug Abuse, wrote a recent blog post warning that the coronavirus “could be an especially serious threat to those who smoke tobacco or marijuana or who vape.”
The coronavirus presents a new challenge for the tobacco industry, which for years has faced lawsuits and higher taxes due to links between smoking and higher rates of lung disease. E-cigarette maker Juul Labs Inc. was already under fire for allegedly marketing its product to teenagers, and an amended complaint filed in San Francisco district court this month includes claims that vapers suffer a greater risk of more serious coronavirus complications.
Before the outbreak of the coronavirus, the vaping industry had drawn scrutiny and restrictions from federal and state governments amid a series of deaths and illnesses that were linked to faulty cannabis products.
Michael R. Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. He is the majority owner of Bloomberg LP, the parent company of Bloomberg News.
The Campaign for Tobacco-Free Kids (CTFK) is sending out email blasts urging for a “Call to Action” to pressure U.S. President Donald Trump to label vape shops as non-essential businesses.
“In a new low, vape shops are lobbying the Trump Administration to be declared “essential businesses” so they can stay open during the COVID-19 crisis. This is ludicrous and we need your help to stop it,” the email begins. “It is the height of disgrace for the vaping industry to argue that e-cigarettes, which damage the lungs, should be considered essential during a lung disease pandemic. It has never been more urgent for us to protect our kids and their health, not vape shops.”
Some states have labeled vape shops as non-essential businesses. In states such as Ohio, vapor advocacy groups such as the Ohio Vapor Technology Association (OHVTA) have asked its members to close their doors during the pandemic. Ohio, however, allows online sales. Many US states do not.
Gas stations and convenience stores, where the majority of combustible cigarettes are purchased, are labeled essential businesses. CTFK does not make any mention of asking for businesses that sell deadly cigarettes to be closed.
In response to requests from the public, FDA is extending the comment period for a request for information (RFI) seeking data and information related to the use of vaping products that are associated with lung injuries.
The RFI, initially published in the Federal Register on Feb. 18, responds to direction from Congress to gather additional information that could help identify and evaluate additional steps that could be taken by the agency to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.”
States with laws legalizing recreational marijuana had fewer cases of e-cigarette/vaping-related lung injury (EVALI) than states without such policies in 2019, researchers reported.
In states that had legalized recreational marijuana, the EVALI case rate averaged 1.7 per million population (95% CI 0.3-3.1), far lower than states where it’s legal only for medical purposes (8.8 per million, 95% CI 5.1-12.5) or completely illegal (8.1 per million, 95% CI 4.1-12.0), reported Alex Hollingsworth, PhD, of Indiana University in Bloomington, and colleagues, according to an article on medpagetoday.com.
Moreover, the number of cases was significantly lower in states with legal recreational marijuana compared to those where it was not after adjusting for vaping rates (difference 7.2 cases per million, 95% CI -11.8 to -2.6, P=0.003), they wrote in a JAMA Network Open research letter, according to the story.
“It appears states that have legal access to marijuana have lower rates of EVALI cases, which is consistent with the hypothesis that people have demand for marijuana products, and in states where they don’t have access to them in this regulatory fashion, they end up purchasing them elsewhere,” Hollingsworth told MedPage Today.
Philter Labs, a San Diego-based technology company that produces micro-sized air filters to help reduce the impacts of secondhand smoke, announced it has received $1 million in new investments.
The capital will be used for research and development, building out an extensive product roadmap, and launching what the company says will be first-of-its-kind personal filtration products, according to an article on Benzinga.com.
This new round of funding brings Philter’s total to $3 million. Bravos Capital and Explorer Equity both participated in the effort.
Philter Lab’s patented zero-5 technology utilizes a five step filtration process that manipulates smoke and vapor at the molecular level to dissipate up to 97 percent of emissions and dissolve harmful particulates and pollutants. Also unique to Philter is it’s pocket-sized design, allowing for ease of use and portability.
For over 20 years, the team behind Philter has been working to solve major medical problems, and identify consumer-centric solutions for common issues. Philter also aims to help re-frame popular associations behind controversial human behaviors, according to the article.
Philter’s technology encourages consumers to practice responsible vaping and empowers them to protect those they love, and the environment, by drastically reducing harmful emissions and airborne contaminants. The company’s overarching mission is to change the way people perceive vaping tobacco and cannabis.
CEO Christos Nicolaidis told Benzinga the goal at Philter Labs is to eliminate the impacts of secondhand smoke and harmful emissions while empowering consumers to vape responsibly, according to the article.
“This new series of funding builds on our momentum and will allow us to expand on our scientific research and launch new innovative, cutting-edge filtration products,” Nicolaidis said. “We want to lead the charge on a cultural shift for cleaner air and a better environment — and hopefully change the way people vape for the better.”
