Category: Research

A Brighter Future
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Examining the impact of flavored e-cigarettes on adult smokers: insights from a three-month experimental study
By Jessica Zdinak
Much ink has been devoted to the dichotomy presented by electronic nicotine-delivery systems (ENDS)—are they a friend or a foe?
For several years now, we have seen a surge of a variety of different e-cigarette products, overrunning the U.S. commerce both legally and illegally. The question remains for some, including our regulator: Do they serve as an alternative to traditional combustible cigarettes, or do they serve as an initiator for youth and young adults? This dichotomy revolves heavily around the authorization of and use of flavored e-cigarette/e-liquid products.
Continuously, and in my opinion, rightfully so, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) presents manufacturers with marketing denial orders that state things like “… your PMTA lacks sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” To demonstrate this, a reliable and robust study must be conducted. “Reliable and robust” means different things with each of the different scientific areas contained within an application. For the behavioral sciences, it means using a design that inherently has a level of methodological and statistical control, such as a randomized control trial, known in our scientific area as a “between-subjects experimental design.”
To address the CTP’s concerns and gain a better understanding of the effects of flavored e-cigarettes, the research team at Applied Research and Analysis Company (ARAC) conducted a three-month randomized experimental study. This study was sponsored by Accorto Regulatory Solutions, in conjunction with Freenoms, an e-liquid manufacturer and subsidiary of Lotus Vaping Technologies, creator of the Nomenons e-liquid. In this article, we will explore the key findings and insights from this study, shedding light on how flavored e-cigarettes may influence adult smokers’ habits and vapes’ potential as a smoking cessation tool.
Study Context
The study, conducted by a team of experts led by ARAC Chief Research Officer Jessica Zdinak, was designed to provide evidence related to the public health impact of flavored e-cigarette products on adult smokers. The study’s design played a crucial role in ensuring the validity and reliability of the results. Expertise in behavioral science and research methodologies were instrumental in crafting the study’s plan, design and analysis. After a recent meeting with the CTP, it is acknowledged that ARAC’s key behavioral science framework meets the mark from a scientifically rigorous perspective. Here are just a few key aspects of ARAC’s study designs that underscore the importance of such expertise:
Statistical power: The study’s design took into account statistical power, ensuring that there were enough participants to detect significant effects should differences or effects exist and not to detect such differences or effects should they not exist. (Think, “Can you generalize your results?”)
Effect size considerations: Researchers considered effect size, an important factor in determining the practical significance of findings. (Think, “How generalizable are your results?”)
Hypothesis generation: The study involved the formulation of hypotheses that guided the research, enabling a systematic investigation of the impact of flavored e-cigarettes on smoking behaviors.
Awareness of behavioral factors: Researchers were keenly aware of the behavioral factors at play behind nicotine consumption, adding depth to the study’s approach.
Study Design
The study was conducted using a between-subjects randomized experimental design, which involved two conditions: one with flavored e-liquids and another with tobacco-tasting e-liquids. The primary dependent variables were cigarettes per day (CPD) and candidate product usage. The use of a randomized experimental design is a rigorous and reliable approach to investigate the effects of flavored e-cigarettes on smoking behaviors, as it minimizes bias and allows for causal inferences.

Following Institutional Review Board approval, participants were recruited from several locations across the U.S. They were then randomly assigned to one of two conditions: flavored candidate e-liquids or tobacco-tasting candidate e-liquids. Over a three-month time period, participants returned to facilities each month to select additional products as needed and to complete follow-up surveys. The follow-up surveys asked participants to specify their CPD over the past 30 days and the past 24 hours as well as their use of the candidate e-liquids. These responses were used for the primary analyses in which reduction and cessation were defined and analyzed as:
computed reduction of 50 percent or more of cigarette stick usage from baseline to follow-up
complete elimination of cigarette sticks
Results: Descriptive Insights
At the end of the three-month study, a total of 382 participants completed the final follow-up survey (n=181 in flavor condition; n=157 in tobacco-tasting condition). Using this data, we conducted both descriptive and inferential statistics. Coupled together, but with a focus on the inferential statistics, this study’s results offer valuable insights into the impact of flavored e-cigarettes on smoking behaviors.
Flavors over time: The study tracked how participants’ preferences for specific e-liquid flavors did (or did not) change over the three-month study period.
2. CPD between conditions over time: The results show the descriptive differences in cigarettes smoked per day between the flavored and tobacco-tasting conditions over the course of the study.

3. CPD between conditions over time: The results show the inferential statistics assessing the experimental effect of flavors on CPD compared to tobacco-tasting. Specifically, the study found that the portfolio of flavored e-liquids led to a significant reduction in CPD compared to tobacco-tasting products. This suggests that flavor plays a role in encouraging smokers to cut down on their cigarette consumption.

4. Switching rates: The research examined the rates at which participants switched from smoking cigarettes to using e-cigarettes, with specific attention to the flavored e-liquids, which led to a higher quit/cessation rate than tobacco-tasting e-liquids.

5. Individual flavor assessments: The study explored how individual flavors affected CPD reduction and cessation, providing insights into the specific flavors that had the most significant impact. Specifically, different flavors had varying effects on CPD reduction and cessation, with some flavors showing statistically significant differences. This highlights the complexity of the relationship between flavor and smoking behaviors, such as reduction in CPD and cessation of combustible cigarettes.
Summary of Findings
In summary, the study found that flavored e-liquids had a positive impact on smoking behaviors among adult smokers. Specific findings include:
CPD reduction: The portfolio of flavored e-liquids were associated with a statistically significant reduction in cigarettes smoked per day compared to tobacco-tasting products, suggesting that flavors encourage smokers to cut down on their cigarette consumption.
Variability among flavors: The impact of flavored e-liquids on CPD reduction and smoking cessation varied among different flavors. Certain flavors had a more pronounced effect, highlighting the need to consider the specific flavor profiles when evaluating their impact on smoking behavior.
Preference changes over time: Some participants’ preferences for specific flavors changed throughout the study, indicating that flavor appeal may evolve and influence its effectiveness in encouraging smokers to switch to e-cigarettes.
Qualitative insights: Open-ended questions provided valuable qualitative insights into how flavors influenced participants’ perceptions and decisions to quit or reduce cigarette consumption. These insights offer a more comprehensive understanding of the relationship between flavor and smoking behavior.
Overall, the study’s findings underscore the complex interplay between flavored e-cigarettes and smoking behaviors among adult smokers. While some flavors show promise in reducing cigarette consumption and promoting switching, there is no one-size-fits-all approach, and individual preferences and perceptions play a significant role.
One of the most powerful aspects of science is replicability. If industry is serious about getting new products, including flavors, authorized for market, replicability of studies such as this one is fundamental to success. Let’s hope this study is just the first of many at building that library of rigorous scientific evidence that the CTP has been looking for.
Jessica Zdinak is a U.S. Eastern Shore Virginia native with almost 20 years’ experience leading psychological research across a variety of domains, including a decade of which serving in tobacco harm reduction. She leads a team focused on product development and behavioral science consumer research supporting innovation, “next-generation” products and regulatory applications, including investigational tobacco products, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications. Zdinak has substantial experience within the U.S. federal government sector, leading research evaluation teams with a focus on the Centers for Disease Control and Prevention, the National Institutes of Health, the National Science Foundation, the Food and Drug Administration, and other large-scale grants and projects.
January 2, 2024
Conditional Approval for Redwood Studies

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Redwood Scientific Technologies has secured conditional approval from the Institutional Review Board (IRB) and Central Institutional Review Board to study nicotine addiction in vape devices.
The conditional IRB approval not only paves the way for the study on Redwood’s product for nicotine addiction in vape devices but also extends to a study on TBX Free, the company’s primary product designed to combat nicotine addiction in traditional cigarettes.
“It has been a long road for us, and we are working around the clock to get these products on the market as fast as possible,” said Redwood CEO Jason Cardiff. “We understand the urgency for help when it comes to the addiction of nicotine in vapes.”
November 15, 2023
More Waste From Toys Than Vapes: Study

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New research from the United Nations suggests that toys are a much larger contributor to electronic waste than vaping products, according to New Scientist.
The Waste Electrical and Electronic Equipment (WEEE) Forum recently collaborated with the United Nations Institute for Training and Research to quantify how much electronic waste the world disposes of without realizing it has the potential to be recycled.
According to the analysis, 9 billion kg of so-called “invisible” e-waste, worth nearly $10 billion, is thrown away yearly. Around one-third of this waste comes from children’s toys containing some 3.2 billion kg of hidden electronics.
Toys contribute 77 times more to the world’s invisible e-waste than vapes, which account for 42 million kg annually. The U.N. estimates that 844 million vapes are thrown away every year.
“Electronic waste is our fastest-growing waste stream,” says Oliver Franklin-Wallis, the author of Wasteland, a book on waste disposal. “It’s also by far our most valuable waste stream when it comes to household waste.”
However, very few people realize that many common items they dispose of contain e-waste. Magdalena Charytanowicz, at the WEEE Forum, highlighted that this was the purpose of the research.
“We’re trying to make people understand that the items they may not suspect are electronics actually do contain a lot of precious materials, like copper and lithium,” Charytanowicz said.
November 10, 2023
Cyprus: One in Three Smokes

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About one-third of Cyprus residents smoke, according to statistics from Marc, a research company, reports The Cyprus Mail.
Marc interviewed 801 households across Cyprus, finding that 30.1 percent of respondents are smokers. The research was done on behalf of Philip Morris Cyprus.
The number of smokers last year was 31.3 percent.
Though the number of smokers remains high, about 90 percent of respondents said they are concerned about the health effects of smoking, and 80 percent of smokers said their main motivation for quitting would be the impact quitting would have on their health and physical condition. Only 22 percent of smokers stated that they are fully informed about available alternatives, and 81 percent said information should be available to them.
November 7, 2023
Japan: Smoking Rates Continue to Decline

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Smoking rates for men and women in Japan continued to decline in 2022, according to health ministry survey data, reports Kyodo News.
The male smoking rate fell 3.4 percentage points compared to 2019 data, and the female smoking rate fell 1.1 percentage points.
The survey classified smokers as respondents who said they either “smoke every day” or “sometimes have days where I smoke.” The rate of tobacco use was highest among men in their 40s (34.6 percent) followed by men in their 50s (32.6 percent) and men in their 30s (29.9 percent). The rate of tobacco use among women was highest for those in their 50s (12 percent) followed by those in their 40s (11.6 percent) and those in their 30s (9 percent). Almost all age groups showed a drop in usage from the 2019 data.
In April 2020, the revised health promotion law came into effect in Japan, banning smoking indoors at many locations and requiring businesses that allow indoor smoking to install separate spaces for smokers.
August 11, 2023
Tobacco Used to for Cancer Antibodies

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Thailand researchers have successfully used tobacco plants to develop antibodies that have inhibitory effects on the growth of cancer cells in laboratory animals, according to News-Medical.
“Our research team has developed the technology and system to produce plant proteins to make antibody drugs, with the hope to help reduce the cost of drug production so that cancer patients in the country can access drugs more easily and widely,” said Waranyoo Phoolcharoen, associate professor in the Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences at Chulalongkorn University, where the research is taking place.
The potential of the research was recognized with a 2023 research award from the National Research Council of Thailand.
The researchers are using an Australian species of Nicotiana benthamiana.
“We use plants as factories to produce the proteins we need,” said Phoolcharoen. “We insert antibody-producing genes into tobacco plants in order for the tobacco plants to produce the antibodies (drugs) we need. The extracted protein (antibody) is then purified. We found that the antibodies produced by the plants can bind to proteins on the surface of immune cells.”
“The antibodies that the research team produced from plants can inhibit the growth of cancer cells in laboratory animals,” Phoolcharoen said. “The size of the tumor cells in mice decreased. This ability to make cells shrink in size is comparable to that of the drugs used in the market.”
The next steps in the research are testing for safety and toxicity and studying the structure of the drug.
“If this research is successful, we will be able to produce our own medicines locally, reducing the cost of drug production and lowering medicinal expenses. More people will then have access to cancer medicines,” said Phoolcharoen.
The technology used in this research could also be used to produce antibodies to develop drugs or vaccines for many other diseases.
Phoolcharoen has also been involved in a venture to produce a Covid-19 vaccine using tobacco plants.
August 11, 2023
Vaping Could Save U.K. Half A Billion Pounds

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The U.K. National Health Service (NHS) could save over GBP500 million ($636.9 million) annually if half of England’s adult smokers switch to vaping, according to a Brunel University London report.
“If smokers transitioned to RRPs [reduced-risk products], it would significantly reduce the pressure on the NHS and free up much-needed hospital resources for other treatments,” said Francesco Moscone, professor and business economics expert at Brunel University London and study author. “Under a 50 percent conversion scenario, with half of smokers turning to RRPs, the NHS would save an estimated [GBP]518 million in an average year. If the conversion rate was just 10 percent, the NHS would save [GBP]103 million.”
“We are delighted that this new research from Brunel University London reinforces the findings of our own economic impact report,” said John Dunne, director general of the U.K. Vaping Industry Association, in a statement. “The potential savings to the NHS from smokers switching to vaping are enormous, and at a time when the NHS is desperately crying out for more funding and government budgets are squeezed so tightly, this is an opportunity we cannot afford to miss.
“I sincerely hope that these two reports will give the government more impetus to really push the positive impacts that vaping has for the health of our nation and the finances of our country.
“Only last week, ASH [Action on Smoking and Health] revealed shocking data, which showed that four in 10 smokers wrongly believe vaping is as or more harmful than smoking—up from one in five in 2019.
“Misinformation in the mainstream media about the relative health risks of smoking and vaping was one of the reasons given for this increasing lack of knowledge, and unless the government acts to educate smokers about the real risks, then lives will continue to be needlessly lost.”
“Cancer, heart disease, stroke, chronic bronchitis and emphysema are the five main disease categories caused by smoking cigarettes. Such illnesses put significant burdens on the NHS, which we know is already under increasing pressure,” said Moscone. “Although the long-term effects of RRPs are still unknown, we know from previous research that alternatives to traditional cigarettes result in a 90 percent reduction in the exposure to chemicals that are major contributors to health risks.”
The study was published in the British Journal of Healthcare Management.
August 9, 2023
Retracted Study Links Vapes and Liver Disease

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A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research after the authors failed to reply to concerns about the researchers’ methods and findings, reports Filter.
The retraction stated that “concerns have been raised regarding the article’s methodology, source data processing, including statistical analysis, and reliability of conclusions.” The study was published in June 2022.
A letter was sent to the editor raising concerns, and the authors were given time to respond but failed to do so. “As is our journal and publisher’s policy, because there was no response or rebuttal from the authors, the manuscript was retracted, and the letter to the editor was not published,” said Robert Wong, editor-in-chief of Gastroenterology Research. “Typically, if there is an author response or rebuttal, we publish both the letter to the editor and the response.”
“This is a greater problem than just one study,” said Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, noting a 2020 retraction by the Journal of the American Heart Association of a study connecting vaping to heart attacks. The 2020 retraction letter to the journal was made public, but the issue with the Gastroenterology Research paper is less clear because “there is silence around why it was retracted,” said Conley.

It’s gratifying that the journal took the step to retract the paper. There’s just a lot of things going on with this study that make it seem kind of weird.
Ray Niaura, epidemiology professor at New York University’s School of Global Public Health
The 13 co-authors of the study drew from the National Health and Nutrition Examination Survey and analyzed participants’ responses for associations between liver disease and the use of cigarettes or vaping products.
They claimed the results showed “e-cigarette users … were associated with higher odds of having liver disease compared to nonsmokers.”
“I already have a bunch of questions just off the top of my head, basically, just looking at this paper,” said who studies tobacco dependence and treatment. He said there were issues with the data, noting that the only survey question on vaping is broad, asking “Have you ever used an e-cigarette?” Questions on combustible tobacco included “Do you now smoke cigarettes?” and if someone has smoked “at least 100 cigarettes” in their life.
“That’s kind of a weak variable,” Niaura said. “What does it mean? It doesn’t mean much.”
The data also didn’t allow for analysis around timing, which means it’s not possible to tell whether liver disease was developed before or after smoking/vaping. “What’s the resolution of the information in studies like this?” Niaura asked. “It’s tricky.”
“It’s gratifying that the journal took the step to retract the paper,” he said. “There’s just a lot of things going on with this study that make it seem kind of weird.”
July 24, 2023
Labstat Opens Greensboro Location

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Labstat has opened a new laboratory in Greensboro, North Carolina, USA.
“The expansion of our network into the U.S. significantly benefits our customers,” said Michael Bond, Labstat president, in a statement. “It allows us to provide our premium services to a larger client base, ensuring faster turnaround times, simplified logistics and exceptional scientific support locally. With our new Greensboro lab, customers can look forward to receiving our consistent, high-quality services in a more efficient and convenient manner.”
The Greensboro laboratory will commence operations in fall 2023. As the lab’s capabilities evolve, it will handle an increasing variety of testing projects and formats.
“We’re committed to best-in-class technical expertise and service for our customers within their region,” said Amanda Bosse, CEO of Certified Group. “Our network expansion in the U.S. amplifies Labstat’s global footprint and, at the same time, opens new opportunities for our team to help advance scientific progress in this industry.”
Labstat provides testing and research services to the tobacco, nicotine, cannabis and hemp industries.
July 21, 2023
Call for Proposals to Help Doctors With THR

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The Foundation for a Smoke-Free World (FSFW) has issued a call for proposals to further analyze the findings of its Sermo survey on doctors and propose programs that would help improve doctors’ fluency about smoking cessation and tobacco harm reduction (THR), according to a press release.
The FSFW funded research carried out in 2022 by Sermo, an independent platform and leader in actionable healthcare professional insights that surveyed more than 15,000 doctors online in 11 countries, including China, Germany, Greece, India, Indonesia, Israel, Italy, Japan, South Africa, the United Kingdom and the United States. A significant majority of the surveyed doctors mistakenly attributed the negative health effects of smoking to nicotine.
An average of 87 percent of doctors agreed, at least moderately, that helping patients quit smoking is a priority; however, 74 percent mistakenly believe nicotine causes a range of illnesses, including lung cancer and chronic obstructive pulmonary disease (COPD).
The misperception about nicotine could account for an average of 55 percent of the doctors recommending over-the-counter nicotine-replacement therapies to help patients reduce or quit smoking.
“It is imperative that doctors get the proper training to learn the facts about nicotine and tobacco harm reduction options that can help their smoking patients quit,” said Muhammad Ahmed, director of health and science research at the FSFW. “With more than 7 million smokers dying annually from smoking-related diseases worldwide, many lives can be saved if doctors become more knowledgeable about the cessation tools available.”
“Patients look to doctors for trusted health advice,” said Jed Rose, president and CEO of Rose Research Center and co-inventor of the nicotine patch. “Therefore, it is vital that doctors provide accurate, current advice to smokers about the health risks of smoking cigarettes compared to using products that deliver nicotine without combustion.”
The survey on doctors showed that 74 percent of doctors on average at least moderately agree that nicotine causes lung, bladder and head/neck/gastric cancer; in the United States, this figure is 70 percent; in Germany, this figure is 78 percent; in China, this figure is 86 percent; in Japan, this figure is 85 percent; 78 percent of doctors on average at least moderately agree that atherosclerosis is caused by nicotine; and 76 percent of doctors on average at least moderately agree that COPD is caused by nicotine.
On average, 81 percent of the physicians surveyed are at least moderately interested in training focused on smoking cessation and tobacco harm reduction.
The survey also found that while doctors’ conversations with patients who smoke focus on the health benefits of cutting down or quitting (73 percent on average globally) and the health risks of continuing (73 percent on average globally), a comparatively small number of physicians—just over half (56 percent on average globally) on average—recommend cutting down on the amount of smokable tobacco products, and less than half of doctors (48 percent on average globally) help patients develop a plan to quit.
Researchers interested in submitting a proposal to further analyze these findings should contact support@smokefreeworld.org.
July 20, 2023