E-cigarettes may help people decrease their dependence on combustible cigarettes without increasing their overall nicotine dependence, according to a recent Penn State College of Medicine study.
The researchers enrolled 520 participants interested in reducing their cigarette intake but with no plans or interest to quit smoking and instructed them to reduce their cigarette consumption over the six-month study period. Participants randomly received an e-cigarette that delivered 36, 8 or 0 mg/mL of nicotine, or a cigarette substitute that contained no tobacco, as an aid in their efforts to reduce their cigarette consumption.
At six months, all participants in the e-cigarette groups reported significant, decreased cigarette consumption, with those in the 36 mg/mL group smoking the least number of cigarettes per day. Those in the e-cigarette groups reported significantly lower dependence on the Penn State Cigarette Dependence Index than those in the cigarette substitute group.
“Our results suggest that using e-cigarettes or a cigarette substitute to reduce cigarette consumption can result in a reduction of self-reported cigarette use and dependence,” said Jessica Yingst, who directs the College of Medicine’s Doctor of Public Health Program. “Importantly, use of the high-concentration e-cigarette did not increase overall nicotine dependence and was associated with a greater reduction in cigarette smoking compared to the cigarette substitute.”
Smoore has opened China’s first non-clinical full-scale testing laboratory for U.S. premarket tobacco product applications (PMTA).
Operated by Smoore’s Analysis, Testing and Safety Assessment Center, the laboratory provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, hazardous components and potentially hazardous components (HPHC’s), and toxicology testing.
This is the first PMTA testing laboratory to open in China, and will allow Smoore to further improve the safety of its products, and help the brands they work with to successfully pass PMTA certification.
Prior to Smoore opening its new laboratory, vaping companies wanting to enter the U.S. would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, Smoore’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.
“The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for,” said Dr Long, the director of Smoore’s new Safety Assessment Center, in a statement. “Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances.”
According to Smoore, the laboratory tests against a world-leading new database of HPHCs, developed by Smoore and derived from international toxicity databases including those maintained by the U.S. Environmental Protection Agency (EPA).
Advanced computational toxicology software is also used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing Smoore’s safety assessments.
Since establishing its first research institute in 2017, Smoore has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical grade, and works to constantly review product safety.
A total of eight products have been approved for marketing by the FDA, many of which are manufactured by Smoore.
A new study led by researchers at the American Cancer Society (ACS) shows perceptions of e-cigarettes as being “more harmful” than cigarettes by adults in the United States more than doubled between 2019-2020 and perceptions of e-cigarettes as “less harmful” declined between 2018-2020.
The study also found that an increase in cigarette smoking prevalence (2019-2020) was restricted to those who perceived e-cigarettes as “more harmful” than cigarettes, while increases in prevalence of e-cigarette use was restricted to those who perceived e-cigarettes as “less harmful” than cigarettes, according to a press release.
Prevalence of dual use of both products increased only among those who perceived these products as equally or “as harmful”. The results coincide with the e-cigarette or vaping use-associated lung injury outbreak (EVALI) and the COVID-19 pandemic. The data was published today in the American Journal of Preventive Medicine (AJPM).
“While all tobacco products, including e-cigarettes, pose a risk to the health of the user, major health events, such as the EVALI epidemic in late-2019 and the COVID-19 pandemic in 2020, paved the way to new smoking/e-cigarette health risks,” the release states. “During this time, the quality and type of information individuals were exposed to may have shaped how they compare the potential harms of tobacco products, which in turn, may have altered tobacco use behaviors.”
How individuals perceive the harm of e-cigarettes vs. traditional cigarettes can predict their individual decision to use tobacco products, but according to the study authors, this is the first study to provide evidence this relationship translates to population-based prevalence changes.
“While this study showed sharp changes in public perceptions of e-cigarette vs. cigarette harms during EVALI and COVID-19, the more relevant finding for public health is that increases in cigarette smoking and e-cigarette use prevalence occurred primarily in individuals who perceived their preferred product as relatively less harmful,” said Priti Bandi, principal scientist, risk factors & screening surveillance research at the American Cancer Society and lead author of the study. “This suggests that public perceptions of e-cigarettes vs. cigarettes harms influences population tobacco use patterns.”
In this study, researchers analyzed data from the National Cancer Institute sponsored Health Information National Trends Survey collected from more than ten-thousand U.S. adults from 2018 – 2020. The results showed perceptions of e-cigarettes as “more harmful” than cigarettes doubled each year, increasing most between 2019-2020 (2018: 6.8%, 2019: 12.8%, 2020: 28.3%), while uncertainty (responses of “don’t know”) in relative harm declined (2018: 38.2%, 2019: 34.2%, 2020: 24.7%). “Less harmful” relative perceptions declined (2018: 17.6%, 2019: 15.3%, 2020: 11.4%), while “as harmful” perceptions remained steady (2018: 37.4%, 2019: 37.7%, 2020: 35.6%).
Exclusive cigarette smoking increased between 2019-2020 among those who perceived e-cigarettes as relatively “more harmful” (2018: 18.5%; 2019: 8.4%; 2020: 16.3%), exclusive e-cigarette use increased linearly among those who perceived them as relatively “less harmful” (7.9%; 15.3%, 26.7%), and dual use increased linearly in those who perceived them “as harmful” (0.1%, 1.4%; 2.9%).
“It is challenging for individuals to make conclusions about the short- and long-term health effects of tobacco products without clear, effective, and ongoing communication from public health authorities, especially when new contextual events that change health harms happen,” said Bandi. “There is a need for behavioral interventions to encourage individuals to be informed consumers of available scientific findings and appreciate that while no tobacco products is safe, there are inherent differences between relative and absolute harms between tobacco products that can influence behavior. In turn, public health education campaigns must facilitate informed decision making by translating emerging scientific evidence accurately to appropriate audiences.”
Errors are disturbingly common in e-cigarette research, resulting in misinformation and distortion of scientific truth, according to a new study.
Under the guidance of Cother Hajat of the United Arab Emirates University and Riccardo Polosa, founder of the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) at the University of Catania, a team of international researchers examined the 24 most frequently cited vaping studies published in medical journals.
The researchers found almost all of the examined studies to be methodologically flawed. Among other shortcomings, the studies lacked a clear hypothesis, used inadequate methodology, failed to collect data relevant to the study objectives and did not correct for obvious confounding factors.
“Most of the included studies utilized inappropriate study design and did not address the research question that they set out to answer. In our paper we offer practical recommendations that can massively improve the quality and rigor future research in the field of tobacco harm reduction,” said Hajat.
Riccardo Polosa
“Systematic reiteration of the same errors that result in uninformative science is the new pandemic,” said Polosa. “I’m astounded that such low-quality studies have made it through editorial review in prestigious scientific journals. The credibility of tobacco control scientists and their research is on the line.”
The findings are concerning, according to the academics, because without methodologically valid scientific research, it is impossible to generate balanced and accurate information for the adoption of more effective tobacco control policies and healthier lifestyles. “The dissemination of inaccurate information about combustion-free alternatives in the news media contributes to public skepticism and uncertainty, particularly among smokers,” the center wrote in a press release. “Many smokers may be discouraged from switching to less harmful nicotine delivery products as a result of this.”
This investigator-initiated study was sponsored by ECLAT, a spin-off of the University of Catania, with the help of a grant from the Foundation for a Smoke-Free World, which in turn is backed by Philip Morris International.
An industry-leading risk assessment laboratory for compliance of the European Union Tobacco Product Directive (TPD) has been launched by one of China’s largest vapor manufacturers. Shenzhen-based Smoore has become China’s first company capable of providing vaping products with a one-stop TPD risk assessment service, according to a company press release. A division of Smoore’s fundamental research center, the laboratory will be a hub to empower more vaping brands to comply with the safety standards of TPD.
“This laboratory has begun operation in the first half of 2021, and already completed 52 product tests for several world-leading vape brands. As China’s first corporate TPD-compliant risk assessment laboratory, it can generate test reports within 5 working days,” the release states. “Its laboratory equipment is benchmarked against those in world-class analytical testing laboratories, such as Labstat and Enthalpy.”
Smoore’s fundamental research center has developed a comprehensive analytical testing and risk assessment system, covering PMTA non-clinical testing and health risk assessment. Accredited by China National Accreditation Service for Conformity Assessment (CNAS) in 2019, the lab is capable of up to 149 CNAS tests, involving the chemical analysis of e-liquids and aerosols, electrical safety, material safety and battery safety.
With only one e-cigarette approved by the U.S. Food and Drug Administration through the premarket tobacco product application (PMTA) pathway to date, more and more vape brands are aiming for expansion in the European market. Smoore states that the EU is a “relatively friendly regulatory environment and significant market potential.”
“As the industry’s harm reduction and quality benchmark, Smoore complies with its in-house Smoore 3.0 safety standards. Based on the risk assessment guidance of U.S. Environmental Protection Agency and PMTA, Smoore 3.0 covers all of the PMTA vapor safety tests and Harmful and Potentially Harmful Constituents (HPHCs) listed by U.S. FDA,” the release states. “In addition to vapor safety, Smoore 3.0 also involves extractable and leachable substances of medical-grade atomization materials.”
Since FEELM, Smoore’s flagship atomization technology brand, entered the EU market in 2018, Smoore has been in partnership with several leading vape brands in this EU region, including Vuse, HEXA, Innocigs and Alfapod. To date, vaping products loaded with FEELM technologies have been exported to Belgium, Netherlands, Estonia, and Romania, with market leadership in the UK, Germany and France, the release states.
Broughton is establishing a U.S. subsidiary to enhance its presence in the region. Leading the U.S. team will be Tony Jones, who joins Broughton as managing consultant. Jones has extensive experience in toxicology and risk assessment.
“I am delighted to be spearheading this exciting next stage of the development of Broughton in the U.S. market,” said Jones. “I’m looking forward to introducing the full lifecycle development services offered by the Broughton team to U.S. clients across pharmaceuticals, nicotine and cannabinoids to help the company support their clients to accelerate innovation to market and improve health outcomes.”
Along with the appointment of Jones, Broughton has strengthened its consultancy team with several new members.
Libby Clarke and Carol Beevers have joined the company’s toxicology team. Clarke is a European registered toxicologist and has substantial experience devising toxicology testing strategies and compiling submissions to regulatory bodies, such as the U.S. Food and Drug Administration and Health Canada. Beevers is a genetic toxicology specialist and has contributed to more than 20 papers in peer-reviewed journals. She is a member of the U.K. Committee on Mutagenicity and several international working groups on genotoxicity testing.
In recognition of the growing importance of behavioral science in regulatory submissions, Broughton has also strengthened its in-house team with the appointment of Oliver Knight-West. Knight-West has conducted multiple behavioral and clinical studies into next-generation nicotine products and pharmaceuticals for dossier submission to the FDA, the U.K. Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency.
He has published many scientific papers in several highly cited publications.
To complement the appointment of Paul Hardman in 2021, Malcolm Saxton has joined the chemistry consultancy team. Saxton will help ensure that Broughton remains at the forefront of the industry in terms of novel method development aligned with evolving market and regulatory needs.
‘’Since 2006, our focus has always been to help our clients succeed,” said Broughton CEO Chris Allen. “With a passion for enhancing societal health and wellbeing, the establishment of a North American subsidiary is a natural next step to enable us to better partner with our customers in the region.”
There may be no industry with more misinformation than vaping. The American Council on Science and Health (ACSH) today published a list of many of the vaping and e-cigarette related studies that involved “junk science.”
Credit: Kraken Images
“The media reports the results of sloppy vaping research, then quickly forgets them. We do not,” writes Cameron English for the pro-industry advocacy organization founded in 1978. “What follows is a list of many of the low-quality studies that have investigated the alleged health risks of e-cigarette use. We’ll regularly update this catalog of bad studies as necessary.”
“The past year has seen the publication of many studies alleging that e-cigarette use (vaping) carries very serious health consequences, everything from depression to erectile dysfunction and higher stroke risk,” English writes. “Each paper generated widespread media coverage, usually one news outlet duplicating the uncritical coverage of the last, giving consumers the false impression that vaping poses a greater health threat than it actually does. When we examined these studies in more detail, we identified their serious flaws and reported them to our readers.”
English also suggests that health reporters tend to obsess over a topic for a few days then forget it entirely, quickly moving on to the next exaggerated study. This means the public often only hears the information relayed from the faulty study and is never informed that the information isn’t sound.
A recent study that found that vaping doesn’t prevent smokers from relapsing to cigarettes has a major flaw, according to Cameron English, writing for the American Council on Science and Health. The results seem to undermine the efficacy of e-cigarettes as smoking-cessation tools—”until you take a closer look at the definition of relapse.”
At first glance, the study seems to undermine the case for e-cigarette use as a smoking cessation tool. But first glances, as we all know, rarely tell the whole story, according to English. A closer look at the paper indicates that its authors improperly assessed how smokers utilize e-cigarettes, thus generating results that don’t reflect reality.
The researchers analyzed data on 3,578 previous-year smokers who had recently attempted to quit and 1,323 recent former smokers from the Population Assessment of Tobacco and Health (PATH) Study between 2017-2019. Participants self-reported their use of e-cigarettes or other products to quit cigarettes. The researchers then investigated who among the study participants had abstained from smoking or any tobacco products in 2019.
Credit: Aleksej
“The significance of this study is limited by the same flaw we found in an earlier paper by two of the same authors: relapse to tobacco use was measured by the question ‘In the past 12 months, have you smoked a cigarette/(used product), even one or two puffs/times?’ Using this metric, an individual who has almost entirely quit smoking, save for “even one or two puffs” of a cigarette, and someone who has gone back to smoking a pack a day would be counted as having relapsed,” English writes.
“This definition ignores the fact that many smokers gradually switch from combustible cigarettes to their electronic counterparts. This is known as ‘dual-use,’ and properly designed epidemiological studies (even those based on PATH data) and clinical trials try to account for this behavioral shift, correctly noting that replacing even some cigarette smoking with vaping is desirable because vaping is the far safer option.”
Additional high-quality research would be very helpful, but “preventing relapse” is an all but useless outcome, states English. “Unless the researchers evaluate how e-cigarettes are used in the real world, the only thing their next paper will confirm is that asking the wrong question inevitably leads to the wrong answer, he writes.
In the wake of marketing denial orders, many U.S. e-liquid manufacturers are turning to synthetic nicotine.
By Timothy S. Donahue
In 2015, Mitch Zeller, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), was asked what the FDA’s position was on synthetic nicotine. “I’ll let you figure that one out for yourselves,” he said, hinting that the agency would regulate it as a drug. Today, vaping products, especially disposable devices, using tobacco-free nicotine (TFN) are one of the fastest-growing segments on the market.
After the FDA began issuing marketing denial orders (MDOs) to companies whose premarket tobacco product applications (PMTAs) failed to satisfy the agency’s concern about youth use, many rejected applicants hinted that they would start using synthetic nicotine—nicotine made in a lab and not derived from tobacco—in their flavored e-liquids.
Vapor Salon, for example, announced on Facebook that it would be switching to synthetic nicotine less than 24 hours after the FDA ordered the company to remove its products from the market.
“The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement, which takes full effect on Sept. 9, 2021, with needing an approved PMTA or your product can no longer be sold,” the company wrote.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice after receiving a warning letter from the FDA. However, the brand resumed sales on its website in February of this year with an altered product. To get around the ban on its products, Puff Bar began using tobacco-free nicotine. As of this writing, Puff Bar continues to hawk its products both on its website and in convenience stores around the U.S.
Meanwhile, the popular online vaping retail website Element Vape.com has at least 11 brands offering several synthetic nicotine e-liquids in different flavors, including fruits, cereals and candies. Pioneer e-liquid manufacturer Five Pawns reformulated its vape juice using synthetic nicotine even before the Sept. 9, 2020, PMTA submission deadline.
“Synthetic nicotine products still must abide by nationwide age restrictions, but the Center for Tobacco Products lacks the ability to regulate them as ‘tobacco products,’” said Greg Conley, president of the American Vaping Association. “Unless and until the FDA authorizes a sufficient number of flavored products to keep current ex-smokers off of cigarettes, we will support efforts by small businesses to keep offering their products to adult customers.”
Tony Abboud, executive director of the Vapor Technology Association, said that synthetic nicotine has been available and on the market since as early as 2014, and while the FDA and U.S. Congress could have elected to regulate synthetic nicotine at any time, they have chosen not to confront the issue.
“If it wasn’t for the innovation of the vapor industry, cigarette companies would not today be saying, ‘We want to get rid of combustibles.’ Synthetic nicotine is simply the next level of innovation, and it’s not surprising the government is behind it. The [U.S.] government is always behind companies in any industry that is technological and that innovates,” explains Abboud. “There’s no surprise here. There’s no loophole here. There’s no evasion here. The marketplace is what the marketplace is. It’s up to the government to figure out if and how it wants to catch up.”
Credit: Myvisuals
Anti-tobacco groups, by contrast, vowed to halt the spread of synthetic nicotine. In a recent letter to the FDA, the Campaign for Tobacco-Free Kids (CTFK), the American Academy of Pediatrics and the American Lung Association, among other organizations, argued that e-cigarette manufacturers are using “a loophole” to avoid government regulations.
“As FDA denies marketing applications for e-cigarettes, manufacturers are exploring using synthetic nicotine in order to continue marketing their products while avoiding FDA regulation,” the letter states. “This development makes it even more imperative that FDA take immediate action against illegal, synthetic nicotine products.”
Matthew Myers, president of CTFK, said synthetic nicotine is not a safer product, and his organization has sent at least three letters since 2018 to the FDA concerning synthetic nicotine products, none of which has received a response from the regulatory agency. “It is totally designed to circumvent government regulation,” he said. “The companies that have used nicotine derived from tobacco to [now] nicotine made in a laboratory are the companies whose products have been denied because of their appeal to youth and their lack of evidence that they actually help smokers quit.”
Conley said that there is a reason the CTFK’s and other letters have gone unanswered through two different presidential administrations. “Tobacco-free nicotine was invented to eliminate trace levels of impurities that are present in traditional nicotine sources, not to evade regulation. Rather than expanding the futile war on drugs to nicotine, we believe all nicotine products should be regulated as consumer products and sold only to adult consumers 21 years and over.”
Defining tobacco products
Whether the FDA will allow products with synthetic nicotine to stay on the market remains to be seen. Despite its growing popularity, the category current operates in a regulatory void. Because the product is not derived from tobacco, it does not necessarily fall under the 2009 Family Smoking Prevention and Tobacco Control Act or meet the requirements of the Federal Food, Drug and Cosmetic Act’s definition of a tobacco product.
When synthetic nicotine first appeared on the market in 2016, the product was marketed as a way to circumvent the FDA’s proposed deeming rule for next-generation tobacco products by at least one company. The FDA’s definition of “tobacco product” includes any product made or derived from tobacco [that is intended for human consumption], including any component, part or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to the FDA’s tobacco control authorities, according to the agency.
“However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product if it is not intended or reasonably be expected to be used in such a fashion,” the FDA states on its website. “[The] FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
In late 2016, Next Generation Labs (NGL), the maker of proprietary TFN Nicotine—nontobacco derived synthetic nicotine liquid and crystals—noted court statements made by the FDA in the NicoPure Labs LLC v. U.S. Food & Drug Administration that seemed to confirm that products not made or derived from tobacco fall outside of the FDA’s deeming rule.
Credit: NDABCREATIVITY
TFN claimed that in a response brief to the court dated Nov. 1, 2016, the FDA had stated that not all nicotine-free e-liquids (NFLs) were subject to the deeming rule. “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’—that is, if it is ‘intended or reasonably expected’ either … (1) to alter or affect [a] tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product; and is not an accessory,” the FDA was quoted as having said.
Experts have also said that the FDA could potentially assert jurisdiction over synthetic nicotine as a tobacco product and argue that, when the legislation was written, nobody had the foresight to think about synthetic nicotine. Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
Congress could eventually pass a nationwide ban on synthetic nicotine. A more likely scenario, however, according to industry insiders, is that individual states ban the sale of synthetic nicotine products. On May 17 of this year, the governor of Alabama signed into law Act No. 2021–453, which was backed by Altria, with that purpose in mind.
The legislation, which went into effect Sept. 1, states that “no e-liquid, e-liquid in combination with an electronic nicotine-delivery system, or alternative nicotine product that, in the case of any such product, contains synthetic nicotine or nicotine derived from a source other than tobacco may be sold or otherwise distributed” in Alabama if products have not been approved by the “FDA for sale as a drug, device or combination product.”
Abboud says vapor companies may not want to face the drug regulatory pathway. “Drug protocols are absurd, and if companies cannot even survive this PMTA process, then how would they ever possibly survive the other one?” he questioned. “Are you going to blame a company that spent millions of dollars trying to comply with [the] FDA’s opaque regulatory process, find that the FDA changed the rules at the last moment after the fact, and then and you’re going to criticize that company for doing something that’s currently lawful?”
For the time being, synthetic nicotine e-liquids will likely keep flavored e-liquids on the market despite the FDA’s efforts to remove them. However, Conley warned manufacturers against publicly advertising or celebrating their decision to switch to synthetic nicotine.
“A note to manufacturers planning to use TFN—don’t make public pronouncements about what you’re planning to do over the next month. Just do it,” he tweeted. “[The] FDA may have no respect for you, but there’s no need to blast them publicly. Plenty of harm reduction advocates can handle that.”
Sidebar
What is synthetic nicotine?
A major argument for synthetic nicotine is that it is safer than tobacco-sourced nicotine. The synthetic nicotine has no tobacco-specific nitrosamines (TSNAs), the harmful, cancer-causing chemicals found in combustible tobacco products. TSNAs are formed when tobacco leaves are grown, cured, aged and processed.
Research has shown that all nicotine is highly addictive, and regardless of the form, should be consumed with caution. However, the chemical does not directly cause cancer, which instead results from inhaling the byproducts of combustion.
Whether manufactured naturally or artificially, the nicotine molecule has the same chemical structure, C10H14N2, meaning that it comprises 10 carbon atoms, 14 hydrogen atoms and two nitrogen atoms. What makes it special, independent of its origin, is that it is a “chiral” molecule: It has two stereoisomers that are mirror images of each other.
The most prevalent form is (S)-nicotine, the physiologically active variant. Its mirror isomer, (R) nicotine, also occurs in plant-derived nicotine in small amounts but is considered physiologically ineffective. Synthetic nicotine is made with a combination of niacin, ethanol, sulfuric acid and a few other chemicals.
Traditionally, a problem for the producers of synthetic nicotine has been that the production process is both complicated and expensive. As a chiral molecule, nicotine is far easier to produce as a synthetic nicotine with equal amounts of both (R) isomers and (S) isomers compared to a nearly pure (S)-nicotine.
Naturally derived nicotine and synthetic nicotine are identical on a molecular level. The differences are the individual or potential impurities. Nicotine derived from tobacco can contain potentially harmful impurities. Purification can be difficult and costly because the impurities appear structurally very similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning, and none of the impurities are carcinogenic.
Currently, two types of synthetic nicotine are on the market: an (S) only synthetic nicotine and a 50 percent (S) and 50 percent (R) synthetic nicotine. In the early years of the vaping industry, the cost of the process to produce synthetic nicotine was prohibitively expensive when compared to tobacco-derived nicotine extraction methods.
Today, that’s no longer the case. Synthetic nicotine can be purchased for nearly the same price as tobacco-derived nicotine and in some instances for even less. This is due to advancements in the commercially scaled bulk production of synthetic nicotine for use in the tobacco, vaping, pharmaceutical and scientific research industries.
In November 2020, eLiquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), released its recently patented SyNic synthetic (S)-nicotine. Because SyNic has greater than 99.7 percent (S), an e-liquid needs only half the amount of SyNic to create the same effect for users as current 50/50 synthetic nicotine offerings on the market.
Broughton has unveiled a rebrand that reflects its evolving service offerings to support clients through their whole product life cycle journey. The company states that it is on a mission “to help our clients deliver life-enhancing products to market, by providing the most trusted integrated services in the world.”
Building on years of experience in the pharmaceutical and next generation nicotine products space, Broughton offers its clients fully integrated scientific and regulatory consultancy, combined with comprehensive in-house laboratory services. The launch coincides with the announcement that the business is expanding its services into the rapidly evolving cannabinoids industry.
Moving forward the company will focus on accelerating life-enhancing products to market within strategic markets including pharmaceuticals, nicotine and cannabinoids. Its combined expertise in formulation science, device technology, software applications and aerosol science makes Broughton the ideal strategic outsourcing partner to support client pipeline portfolios of future next generation products.
“The launch of the Broughton brand formalizes our rapidly developing position as a full-service solutions provider to the life sciences sector,” said CEO Paul Moran, who founded Broughton Laboratories in 2006. “We will continue our commitment to investing further into global operations delivering scientific and regulatory consultancy combined with comprehensive product development and laboratory services.
“This next phase of our expansion is a natural evolution to grow capacity and capabilities into the broad life sciences sector as technologies improve to target unmet market needs.”
“One exciting aspect of this change is that it facilitates the expansion of our existing pharmaceutical quality and product stability services to support providers of pharmaceutical inhalation products,” said Broughton Chief Scientific Officer Chris Allen. “With expertise in device optimization, human factor studies, navigating complex regulatory pathways for combination products and a track record of quality compliance, our broad expert team can support device development from concept to commercialization.’’
“The expanding team at Broughton hold extensive knowledge of their specialist fields,” said Moran. “This rebrand brings together this expertise with a fresh focus on the journey of our clients’ products to meet an unmet market need. This is an exciting time for the business that will enable us to continue to innovate as we contribute to global health and wellbeing.”
