The U.S. Food and Drug Administration envisions a harm reduction framework for CBD (cannabidiol, an active ingredient in cannabis that doesn’t make you high) through which consumers could make informed choices.
That’s the pathway described last week by Patrick Cournoyer, who heads the FDA’s Cannabis Product Committee, at the annual Food and Drug Law Institute (FDLI) conference.
In January, the FDA announced that it would not issue long-awaited guidelines for the inclusion of CBD in food and beverages, because the agency’s existing regulatory framework was not appropriate.
The FDA’s decision came nearly five years after the federal government legalized hemp-derived CBD containing less than 0.3 percent of the psychoactive compound Delta-9 THC via the 2018 Farm Act.
Concerns over the ingestion of CBD derive from the 2018 approval of the prescription drug Epidiolex, which contains CBD for the treatment of seizures associated with two forms of epilepsy.
Studies at the time showed a significant potential risk of liver disorder and other side effects from ingesting CBD.
Cournoyer shed more light on the FDA’s January decision by calling safety concerns regarding CBD in food and beverages “important toxicological red flags that are not typical for food ingredients,” as reported by Cannabis Wire.
“What’s envisioned here is really a harm reduction framework. The existing pathways that we have for foods and supplements don’t really allow for risk or harm. If it’s shown to be harmful or we can’t really show that it won’t be harmful, then it’s not allowed to be there,” Cournoyer said.
“What we’re proposing here is a more permissive category where it is acknowledged that there’s a risk here. We can’t eliminate it, but we would view that people can make an informed choice.”
He did not provide a timeline for the development of a harm reduction framework the FDA could develop in collaboration with the U.S. Congress.
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Earlier versions of the bills were filed last Congress and ultimately did not advance, but advocates and industry stakeholders feel that the U.S. Food and Drug Administration’s recent announcement that it wouldn’t be taking steps to regulate CBD will put pressure on lawmakers to act this time around.
The tobacco and nicotine product regulatory arm of the U.S. Food and Drug Administration has hired a senior advisor for health equity for the first time. The Center for Tobacco Products (CTP) announced Charlene Le Fauve will fill the role.
“Beginning today, she will join CTP’s Senior Leadership Team within the Office of the Center Director,” a release states. “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research. She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”
Most recently, Le Fauve served as the senior advisor to the Chief Officer for Scientific Workforce Diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research, according to the release.
Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of Disparities Research and Global Mental Health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.
“Diversity, Equity, Inclusion, and Accessibility (DEIA) are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the release states, “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”
A study conducted by University of North Carolina researchers and published in Tobacco Control found widespread uncertainty and misperceptions about the sources of nicotine in e-cigarettes among youth.
“An important contribution from this study is that adolescents don’t understand where nicotine in e-cigarettes comes from,” said first author Sarah Kowitt, assistant professor at UNC Family Medicine and UNC Lineberger Comprehensive Cancer Center, in a statement. “If youth don’t think e-cigarettes are tobacco products like cigarettes, that could increase the appeal of these products. The more youth associate e-cigarettes with cigarettes, the less youth like them.”
The study also found that while some youth were aware of e-cigarettes that contain synthetic or “tobacco-free” nicotine, most youth were unaware. Most importantly, Kowitt said that the experimental portion of the study revealed that describing synthetic nicotine as “tobacco-free nicotine” increased intentions to purchase e-cigarettes among youth who use e-cigarettes.
If youth don’t think e-cigarettes are tobacco products like cigarettes, that could increase the appeal of these products.
“To me, the big takeaway from our study is that the language that is used [to] describe e-cigarettes—on packaging and advertising—shapes adolescent users’ views of the products and their intentions to use them,” said senior author Seth Noar, professor at the UNC Hussman School of Journalism and Media and UNC Lineberger. “The industry has increasingly used the term ‘tobacco-free nicotine’ to describe synthetic nicotine products, and our data strongly suggest that this term may be misleading to youth in ways that increase the appeal of these addictive products.”
The study is the first to examine how youth understand e-cigarettes with synthetic nicotine. Its goal is to inform efforts by governments and regulatory agencies, including the U.S. Food and Drug Administration, to more effectively regulate the language used to describe synthetic nicotine products.
The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule Tomorrow, May 18, 2023, from 9 a.m. to 2 p.m.
The proposed rule is open for public comment until Sept. 6, 2023.
The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.
Pinney Associates has announced a new leadership team.
Joe Gitchell recently assumed the role of CEO, Lucy Owen is its new president, Judy Ashworth has been promoted to senior vice president, and Robyn Gougelet has been promoted to vice president, health policy and regulatory strategy.
In their new roles, they provide strategic advice and tactical support to help clients reduce regulatory risk and achieve regulatory approval across our four practice areas. Pinney Associates helps clients switch prescription medications to over-the-counter status, supports the clinical and regulatory development of central nervous system-active medications, advises on the development and commercialization of dietary ingredients and supplements, and advances research and policies to minimize the death and disease caused by smoking cigarettes.
Owen guides clients through the complex and dynamic Rx-to-OTC switch regulatory process and specializes in developing and executing science-based regulatory strategies. Ashworth guides the clinical development of CNS-active drugs in a challenging and rapidly evolving regulatory environment.
Gougelet advises clients on public health legislative and regulatory policy efforts, as well as regulatory submissions to the U.S. Food and Drug Administration.
“We are thrilled to have promoted these talented individuals to our leadership team,” said John Pinney, founder and chair of Pinney Associates, in a statement. “Each of them brings unique skills and experiences that will help us continue to deliver exceptional value to our clients and better public health.”
“For over thirty years, Pinney Associates has worked hand-in-hand with our clients to overcome their regulatory and policy challenges by identifying root causes and developing innovative solutions based on medical and behavioral science and public health. We look forward to future collaborations with clients to increase access to products that advance individual and public health,” said CEO Joe Gitchell.
Pinney Associates is a science-based health consulting firm with resources and experience in scientific, medical, public health, regulatory and commercial aspects of prescription and consumer healthcare products.
A recent study comparing lung inflammation between smokers and nonsmokers does not prove any causality between the use of e-cigarettes and lung damage, according to researchers from the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) in Catania, Italy.
A recently published study by a team of American researchers compared the scans of the lungs of five electronic cigarette users, five tobacco cigarette smokers and five subjects who never smoked or vaped. Data suggested preliminary evidence that e-cigarette users had greater pulmonary inflammation than cigarette smokers and never smoke/vape controls, implying even a greater damage to health.
In a letter to the editor of The Journal of Nuclear Medicine, the CoEHAR researchers expressed their concern about the study. “The very small sample size and low reproducibility of the tests does not allow us to give a precise and scientific answer on pulmonary inflammation caused by vaping because it does not take into consideration fundamental factors, such as the prior exposure to tobacco smoking,” said CoEHAR founder Riccardo Polosa in a statement.
“The very small sample size and low reproducibility of the tests does not allow us to give a precise and scientific answer on pulmonary inflammation caused by vaping because it does not take into consideration fundamental factors, such as the prior exposure to tobacco smoking.
Because it is impossible to decouple the health impact of e-cigarette aerosol emissions from prior tobacco smoke exposure, only long-term follow-up of exclusive vapers who have never smoked can verify potential harm caused by electronic cigarettes use.
CoEHAR stresses the need to develop and adopt shared scientific research standards and a greater control of publication processes: “We often opposes poor quality designed scientific results that are published in prestigious journals without proper scrutiny: researches that only feed an unfounded anti-vape rhetoric based on preconceptions that try to dissuade smokers from making choices that are less harmful to their health,” said Polosa.
The innovative new disposable vaping system FEELM Max was launched during the UK Vaper Expo in Birmingham on May 13.
The FEELM Max is now available in the UK and EU markets. The event was attended by many top-level e-cigarette industry representatives and FEELM clients, including BAT, RELX International, Totally Wicked and KIWI.
A subsidiary of Smoore Technology, the world’s largest vaping company, FEELM says the FEELM Max brings three major breakthroughs to vaping, including the advanced heating technology of the Ceramic Coil S1, a constant power control system and “mindful design,” according to a press release.
“The FEELM Max uses the new Ceramic Coil S1, which is designed to deliver a superior vaping experience” and offers an increased puff count that sets a new benchmark in the market, according to the release.
Johnny Zhang, assistant president at FEELM
“Benefitting from its cotton-free design and the resulting improvement of e-liquid utilization, the FEELM Max is able to boost puff count by more than 30 percent compared to cotton coil disposable solutions, providing 800 more puffs and setting a new benchmark for 2ml (e-liquid volumes),” said Johnny Zhang, assistant president at FEELM. “This innovation allows products using the FEELM Ceramic Coil S1 to offer increased puff counts while remaining totally compliant with all local regulations.”
Additionally, the new S1 coil decreases the number of impurities created in the heating process by 78 percent, resulting “in fresher breath and no unpleasant aftertaste.”
The new system also has several technological innovations. The FEELM Max solution uses a constant power energy management system for stable vaping. This technology improves taste consistency by 35 percent, which further enhances the user experience, according to the release.
FEELM Max products have a transparent e-liquid tank for both aesthetics and user convenience that allows consumers to easily see how much e-liquid is left in the device.
The first industrial whole-chain recycling program was also introduced by FEELM during the UK event. Collaborating with RELX International in the UK, FEELM has “taken the responsibility for implementing a scheme that will facilitate vape recycling to a fuller extent, thereby minimizing the environmental impact.”
Bing Du, the CEO and founder of RELX International stated at the event: “Thanks to the groundbreaking technology of FEELM Max, and driven by our legendary partnership with FEELM, RELX International is on course to revolutionize the vaping experience across the globe.”
The company’s commitment to making recycling more accessible demonstrates its dedication to environmental sustainability, according to the release. As the initiative gains traction, it could serve as a model for other industries looking to implement eco-friendly practices and engage adult customers in sustainability efforts.
FEELM intends to continue pushing the boundaries of what’s possible in vaping technology, while keeping its commitment to sustainability and compliance at the heart of its operations, according to the release. “The company’s mission to shape a better vaping industry, not only for today but for generations to come, remains stronger than ever,” Zhang said.
The U.S. Food and Drug Administration says it is on track to finish reviewing premarket tobacco product applications (PMTAs) for the most prevalent e-cigarettes by the end of the year, reports CSP.
The FDA has reviewed 52 percent of covered applications as of March 31. Covered applications are for new tobacco products on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and sold under the brands Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar and reach 2 percent or more of total retail sales volume per NielsenIQ reports, according to CSP.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
What makes the FAV different is both its new wicking technology and its state-of-the-art microchip technology.
A new vaping product is slated to offer the cigarette-like flavor of combustibles with the ease of vaping.
By Timothy S. Donahue
It might be the most “wicked” thing to ever happen in the vapor industry. A new vaping device will enter the U.K. market this summer that brings together the taste and aroma of heat-not-burn products with the ease of use, mouthfeel and lowered risk offered by liquid-based vaping products. Developed by Avail Vapor founders James Xu and Donovan Phillips, the new FAV system hopes to be the ultimate transition device to trend combustible smokers toward less risky electronic nicotine-delivery system products.
Xu and Phillips co-founded FAV Tech Hong Kong Limited with a leading Chinese hardware manufacturer to launch this new hybrid product, the FAV. What makes the FAV different is both its new wicking technology and its state-of-the-art microchip technology. Xu said the wicking is the first of its kind in the industry to use real tobacco leaf in the wick to help produce the tobacco flavoring in the atomized vapor. Xu uses proprietary patented technology to “sandwich” a layer of tobacco particulate in the cotton wicking used to absorb the e-liquid into the coil. The liquid is then atomized, and the heat releases the natural tobacco’s essence into the vapor as flavoring.
National data shows that at least two-thirds of combustible smokers try to quit each year. During his time with Avail, Xu said that shopper survey data showed that of those two-thirds of users, only six percent converted completely to vapor. That left 94 percent that continue to use traditional tobacco cigarettes. There had to be a better way to transition combustible smokers.
“It’s a scary experience for them to quit smoking because it’s a habit they form over many years. Any reason that they [combustible smokers] could find not to switch, such as it’s too complicated to use, it leaks or the flavor’s not there … They walk away from it or any other less harmful product,” explains Xu. “From the early days, we could see that there were certain ‘boxes’ that had to be checked to convert smokers. A convenient form factor, ease of use, but the one thing that was the most important was flavor.”
This knowledge sent Xu and Phillips on their journey to develop the FAV. Heated-tobacco products offered the touch and feel of combustibles, but they were complicated to use, and many users rejected the flavor. E-cigarettes were easier to use, but none offered the combustible cigarette flavor profile that nearly mimicked traditional tobacco cigarettes. The industry often said that if such a device was ever marketed, it could be the missing piece to the puzzle of tobacco harm reduction.
The chip embedded in FAV pods will not allow the device to be used without being activated at the store from which it’s purchased.
“When the smoker is first attempting to quit, it needs to be a lateral move. Something that tastes like combustible cigarettes,” said Xu. “For the smoker, taste is very important.”
Xu said the lightbulb moment happened when he was in China exploring factories with representatives of a global leaf supplier that explained how recon tobacco was created and used. Also known as homogenized tobacco recon (RTL), it was developed in the 1950s to save valuable raw material by combining remnants of virgin tobacco during production. RTL is a paper-like sheet approaching the thickness of tobacco laminae.
“They explained how they make recon paper. And that’s when we began to wonder if we could use recon paper near the heating coil so it can release the aroma. We later started to research how we could incorporate pure leaf into the cotton wicking existing in e-cigarette coils,” Xu said. “We devoted the last 12 months to perfect the process. We use real tobacco particulate. We can make infinite combinations to mimic all the different cigarette blends by using different leaves. It’s an extremely difficult and unique process to blend tobacco with cotton. The tobacco is ‘sandwiched’ in between the cotton fiber.”
The heat from the coil then releases the tobacco aroma into the vapor produced by the e-liquid passing through the cotton wicking and heating coil. The tobacco never burns, it just “heats” to release the flavor in the leaf blend mixed into the wicking. Xu said the concept is simple. To make it work, however, is quite the process.
“This wasn’t something we could do ourselves. We needed the assistance of scientists to help us be able to identify what particle size and layering process would actually work,” Xu said. “This is a specialized, unique and proprietary process.”
Technical response
An exceptional quality of the FAV is that the e-liquid used in the device contains only 3 percent tobacco essence boosters. Typical disposable vaping products contain between 20 percent and 36 percent flavoring. Xu didn’t disclose what flavoring was used, only saying it had no added sugars and only “enhanced” the flavor produced by the tobacco in the FAV’s wicking. Xu said the added flavoring “mimics other aspects of a combustible cigarette’s flavoring.”
Xu said that another innovation offered by the FAV is its microchip enhancement technology developed over many years with their Chinese partner. The chip embedded in FAV pods will not allow the device to be used without being activated at the store from which it’s purchased. This prevents any use unless the seller verifies the purchaser is of legal age to consume tobacco products. Xu acknowledges that there is little a manufacturer can do if devices are purchased by an adult, then given to an underage user (straw purchase). The technical enhancements, however, are aimed at combating underage nicotine consumption.
“The device can’t be stolen from a store and then used. It also prevents counterfeit products from becoming available. Only legitimate FAV pods work with the FAV battery device. The cartridge (pod) comes in the factory setting but can be modified by the user. Some users may want the wattage a little higher to squeeze out that last little bit of e-liquid. They have that ability to do that but within certain limits,” Xu explains. “Because many app platforms don’t allow tobacco product apps, users will have to initially connect the device to their computer to alter any settings.”
The device can also program puff counts for users who may be using the device to wean themselves off nicotine entirely. Xu said that the first version of the FAV will have a very limited set of options for users. “It’s going to be very limited because we need regulatory approvals on some options. However, the sky is the limit with the chip,” he said. “But if you tell me you want to quit smoking or vaping, we can program that. Today, you can have 100 puffs, tomorrow, 99; the day after tomorrow, 98. Everything can be stored in the chip.”
The FAV device has also performed better on toxicology testing than other heated-tobacco products. Xu said the FAV is equal to if not better than typical e-liquids as well because of the lack of flavoring and sugars in the e-liquid. There is little introduction of tobacco-specific nitrosamines (TSNAs) (which comprise one of the most important groups of carcinogens in tobacco products) or harmful and potentially harmful constituents (HPHCs) that are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers.
The device can also program puff counts for users who may be using the device to wean themselves off nicotine entirely.
“There are minute TSNAs or HPHCs present. FAV tests better than heat-not-burn by a significant amount and surpasses most vapor product testing because our cartridges/e-liquid use little flavoring. Additionally, the amount of tobacco equivalent to a pack of cigarettes is 12.4 grams for [an estimated] 300 puffs,” explained Xu. “We use 0.05 grams of tobacco in our wicking. It’s only a small fraction of real tobacco compared to a pack of cigarettes that’s needed to give that authentic taste.”
Xu said the FAV is expected to hit the European market this summer. The FAV is already TPD certified. The device has a 2 mL capacity with a 20 mg nicotine e-liquid mixed in a PG/VG base. It will come in three different tobacco flavors, and each flavor will have a menthol counterpart. Xu said he has submitted the FAV to Canadian authorities as well and expects to be able to enter that market sometime this year.
Concerning the world’s largest vaping market, Xu said he does want to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration. He does, however, want to wait until the FDA gets the PMTA process in order and is clearer on what it expects from a vaping product to receive marketing approval. Xu said the FDA’s failure is costing the U.S. economy, limiting the technology of less risky tobacco products in the U.S. market and, most importantly, costing the lives of millions of smokers who want to quit but are unclear of the benefits of using less risky products.
“We identified the European market for our initial product launch. The FDA has this ludicrous regulatory environment. Initially, we were thinking about releasing FAV in the U.S. and manufacturing it in the U.S. This would have brought jobs and the first vaping hardware production to the Unites States,” said Xu. “We just couldn’t make it work because of the U.S. regulatory landscape. Because of the uncertainty with FDA regulation, we had no other choice but to choose production outside the U.S.”
There is one problem, however, that Xu hopes will never be solved: Focus group test panels seem to love the FAV. “The biggest problem we have right now is when we do a focus group test panel, and our testers are actual current combustible cigarette smokers, they don’t want to give me the FAV back,” he joked. “They just keep telling me, ‘This is exactly what we’ve being looking for.’ That’s a good problem; those individuals smoking combustible cigarettes don’t want to give it back. Maybe this is the unicorn device that makes the transition to less risky products easier.”
The trial of the San Francisco Unified School District’s lawsuit against Marlboro maker Altria continues this week. At the end of the first week, jurors heard testimony that use of vape pens by students had declined before more than doubling from 2017 to 2019.
Only a little more than 7 percent of students throughout the district had reported using vape pens in 2017, former district health administrator Erica Lingell testified Friday. By 2019, she said, that figure had more than doubled to 16 percent.
Lingell said students were using Juul and the district was scrambling to build support systems and give guidance to teachers and staff about them, according to Courthouse News.
“We didn’t have anything for this new substance that the kids were using,” Lingell said in answer to questioning by the school district’s attorney Dena Sharp. “We didn’t have lessons. We didn’t have enough research except for what experts were telling us.”
The school district was building systems to combat Juul from scratch, the attorney claimed. Even after the San Francisco Board of Supervisors banned the sale of e-cigarettes in the city — the corporate home of Juul Labs — in 2019, youth use continued.
For school district officials, it was a scramble to pull together the resources needed to combat Juul’s growth among students. “It was like flying the plane while we were building it,” said Lingrell.
For other substance use issues in the district, there were materials lesson plans, and support groups in place to help teachers tackle the problem. Students leaving class to smoke would interfere with teaching time for the rest of the kids, she said. “Teachers have an incredibly hard and busy schedule already. One kid being gone affects everybody.”
Much of the school district’s argument in its case against Altria involves the distraction which occurred when vaping became “endemic,” interfering not only with teachers’ abilities to control their classrooms but nearly all levels of student life.
The bellwether trial forces Altria to publicly defend itself solo for the first time as it faces thousands more cases that were brought against the company and Juul. In December, Juul Labs agreed to pay more than $1.2 billion to settle more than 5,000 suits blaming the company for a youth vaping epidemic across the U.S.
Juul and Altria defended the first trial that started in March over a case brought by Minnesota over deceptive marketing of e-cigarettes. The companies last month settled the state’s case, though details are yet to be disclosed.
In April, Juul agreed to pay $462 million to six states and the District of Columbia to resolve lawsuits and investigations into the marketing of addictive vaping products to children.
