How much politicians know about e-cigarettes and other novel tobacco products has a major effect on their perceptions of safety and risk, new research suggests.
A survey of members of the European Parliament (MEPs) found that those who were knowledgeable about novel tobacco products were far more likely than those with no knowledge to consider them less risky than smoking.
The survey conducted by ECigIntelligence and TobaccoIntelligence, independent data providers to the sector, found that:
A high proportion of MEPs have no knowledge about new nicotine products.
Views on risk seem linked to knowledge of the products. Those MEPs with knowledge of the products are more likely to consider the products less risky than smoking; those with no knowledge are more likely to consider the products the same or more harmful compared to smoking.
Most MEPs believe new nicotine products are likely to help existing smokers quit.
MEPs predominantly think that vaping is safer than smoking, but up to one in five think that some new nicotine products can be as risky as smoking.
The survey was carried out online and anonymously, and all data remains confidential other than in consolidated analysis. It was sent to all MEPs (from all member states and political parties), and responses were obtained from over 30 MEPs, representing nearly 5 percent of the European Parliament.
Jarvis Vaping Supply (JVS), parent to four of 21 Ohio-based Vapor Station vape shops, announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). James Jarvis, co-owner of JVS with his wife Gerri, announced the receipt of the acceptance letter on his Facebook page. The acceptance includes all 998 SKUs submitted to the FDA for authorization, James confirmed in a text.
“I’m so proud of my wife … she spent so many late nights, so many hours, frustration, stress and a lot of patience went into this,” James wrote. “She helped many others once she finished ours on top of this.”
JVS is a wholesale vaping supply store. Alongside the four Vapor Station retail stores in and around Columbus, Ohio, James also serves as president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.
Gerri and James Jarvis
While James continued to run the business, Gerri worked day and night over six months to fill out PMTAs for 998 products (SKUs). In the end, she dumped roughly 3 million pages off at the FDA. With just the help of a Facebook group called PMTA Sharing, Gerri was able to climb the PMTA mountain without any help from firms experienced in submitting PMTAs. The Jarvis’ were among 1,600 vapor company representatives who joined this and other private groups to help them navigate the PMTA process.
“With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could turn something in to the FDA,” Gerri said in a recent interview with Vapor Voice.
After submitting JVS PMTAs, Gerri then went on to help her friend Jason Gang of Westside Vapor as well as several other small companies negotiate the PMTA process, including Dripology, Vapor Generation, KL Labs and E Cig Cafe. Gerri said Westside Vapor’s PMTAs for its 1,800 products totaled over 6 million pages. Westside Vapor also received an acceptance letter according to James, but that has not yet been verified.
Innokin, a major China-based vaping hardware manufacturer, announced its partnership with Fourier Technology in the development of Sensis, the first vaporizer that uses 4th-generation vape technology. The new innovation, alternating current mode (ACM), is inspired by Nikola Tesla, according to an Innokin press release. Earlier generations of vaping hardware used a direct current to power coils in a single direction, while ACM sends electricity through the coil in both directions.
Sensis, Innokin’s 4th generation vaping hardware
The mission behind the development of the ACM technology is to provide vapers with a better experience and to provide the vaping industry with new ways to grow and improve, according to Meredith Zhao, chief technology officer at Fourier Technology.
“We are looking forward to working with experienced users to discover the full potential of this exciting new vape technology in the hope of working together to create a smoke-free future,” said Zhao. “Alternating current mode introduces waveform frequency control to vaping. Vapers can now adjust the hertz frequency waveforms as well as the wattage output.”
The upgraded output provides several advantages over previous generation single-direction current devices. By selecting different types of waveforms and adjusting the frequency, the full spectrum of flavors can be produced from e-liquids and specific flavors are enhanced, according to the release. ACM increases the efficiency of heat transfer between the coil and e-liquid, which also extends coil life. “Alternating Current Mode has been shown to help extend coil life by increasing coil saturation and reducing carbon buildup on coils,” Zhao said.
First-generation vape technology was basic, where direct power output to the coils could not be adjusted. With the push of a button, or by simply inhaling, the battery heated coils, changing the e-liquid into vapor to deliver nicotine and flavors. Second-generation vape technology introduced variable voltage and variable wattage, where adjusting the power output to the coils increases or decreases heat to personal taste. Third-generation technology used temperature control with advanced chipsets and new types of coil materials.
ACM technology allows vapers to customize their vaping experience, according to the Fourier’s website. “ACM equips you with adjustable frequency and selectable AC wave-forms, which create a unique output curve,” the company states. “Power output repeatedly pulses the coil in both directions, heating e-liquid more efficiently, in a way that can be fine-tuned at any time.”
Turning Point Brands has appointed Chief Business Development Officer Louie Reformina, as the company’s new chief financial officer, effective May 1, 2021. Reformina is replacing Bobby Lavan, who will step down after first quarter earnings to pursue a new opportunity. In addition, Brian Wigginton, Turning Point Brands’ chief accounting officer, has been promoted from vice president to senior vice president.
“I would like to thank Bobby for his unceasing commitment to the company,” said Larry Wexler, Turning Point Brands’ president and CEO, in a statement. “Bobby played a major role in improving Turning Point Brands’ capital structure, streamlining the business, making accretive acquisitions and investments and positioning the Company for the growth that we are experiencing today.
“I look forward to tracking his future progress. Additionally, Louie has played an important leadership role in the company by pivoting our focus to higher growth opportunities in cannabis-related and other branded consumer product industries. I am excited to see him expand his responsibilities as we accelerate our growth trajectory.”
“Turning Point Brands is one of the most innovative and well-capitalized companies in the high-growth cannabis-related accessories market,” said Reformina. “Our iconic brands and market-leading distribution platform set us apart in this rapidly evolving space. In addition, our New York Stock Exchange listing helps to provide deep access to the capital markets, which allows us to opportunistically take advantage of acquisition opportunities that are beyond the reach of many competitors.
I look forward to continuing to work with the team to reinvest our substantial free cash flow in high-growth branded consumer products, expand our distribution infrastructure and strengthen our capital position.
“As CFO, I look forward to continuing to work with the team to reinvest our substantial free cash flow in high-growth branded consumer products, expand our distribution infrastructure and strengthen our capital position.”
“I would like to thank Larry and the management team at Turning Point Brands for the opportunity to work with them on the Company’s continued evolution,” said. Lavan. “I have been working closely with Louie since he first joined the Company and am confident that his elevation to CFO will help to ensure a seamless transition, while continuing the Company’s focus on growth.”
Reformina joined Turning Point Brands in 2019 and has more than 20 years of financial experience. He previously served in investment roles at Point72 Asset Management, Waterfront Capital Partners, Perella Weinberg Partners and Vestar Capital Partners. He began his career as an investment banker at Goldman Sachs & Co. and received his MBA from the Stanford University Graduate School of Business, as well as his B.S. in electrical engineering from Cornell University, where he graduated summa cum laude.
Turning Point Brands estimates that net sales for the first quarter of 2021 will be at the high end or above the previous guidance of $97 million to $102 million provided during the presentation of its full-year and fourth-quarter 2020 results on Feb. 10, 2021.
A new study from Italy has found that 40 percent of participating adults with schizophrenia spectrum disorders stopped smoking traditional cigarettes after 12 weeks of using Juul products. These findings are significant because smoking prevalence among people with schizophrenia is at 60 to 90 percent.
“Smoking is the primary cause of the 15-25 years mortality gap between users of mental health services and the general population,” said Riccardo Polosa, one of the lead researchers. “This study demonstrates that switching to high-strength nicotine e-cigarettes is a feasible, highly effective smoking cessation method for smokers who have schizophrenia. And it improves their quality of life too!”
The study—conducted in collaboration with the University of Stirling, City University of New York and Weill Medical College of Cornell University, and published in the journal Nicotine & Tobacco Research—enrolled 40 adult smokers with schizophrenia spectrum disorders, as reported on filtermag.org.
Aged between 22 and 65, the participants all said at the outset that they did not intend to quit or reduce their smoking. They were each given a free starter kit—containing one Juul device with a 5 percent nicotine tobacco flavored pod and a charger. In addition, participants were asked to maintain a daily diary to record product use, number of tobacco cigarettes smoked and any adverse side effects.
Among the study’s key findings:
Researchers observed [either] an overall, sustained 50 percent reduction in smoking or complete smoking abstinence in 92.5 percent of participants at the end of 12 weeks.
Researchers observed an overall 75 percent reduction in median daily cigarette consumption, from 25 to six, by the end of the 12 weeks.
After six months, 35 percent of participants had completely stopped smoking conventional tobacco cigarettes, while continuing to use e-cigarettes.
After six months, 57.5 percent of participants reduced their cigarette usage by over 50 percent.
Participants’ mean blood pressure, heart rate and weight measurably decreased between the start of the study and the 12-week follow up.
Positive and negative symptoms of schizophrenia were not significantly different after using e-cigarettes throughout the duration of the study.
At the end of the study 61.9 percent of participants reported feeling more awake, less irritable, and experiencing greater concentration and reduced hunger.
These findings are remarkable and should give hope to the international mental health community that has essentially given up on helping smokers with schizophrenia.
The power of vaping is that the enjoyable and comforting rituals remain, while the dangers of combustion are eliminated.
Eastern Co. is studying electronic cigarettes as an alternative to traditional combustible products, reports Egypt Today.
In a statement to the Egyptian Exchange (EGX), Eastern Co. said it consulting with manufacturers of electronic cigarettes in preparation for putting them on the market after obtaining the necessary licenses.
The move is in line with the company’s strategy to expand and diversify its products.
Earlier in March, Eastern Co. announced that it is studying several new investment projects that will enhance its position in the field of smoking and tobacco alternatives.
Eastern Co. operates within the food, beverage and tobacco sectors. It was established in July 1920 and currently holds a monopoly in the domestic tobacco market.
Egypt has invited tobacco companies to bid for a license to manufacture cigarettes in the country, a move that could reduce Eastern Co.’s dominance of the local market.
In 2018, the U.S. Food and Drug Administration (FDA) and then-Surgeon General Jerome Adams declared a so-called youth vaping epidemic. Lawmakers across the country, from city council members, to state leaders, to Congress, have been attempting to reduce youth use of e-cigarettes and vaping products ever since, Lindsey Stroud wrote for Inside Sources. Addressing youth use of any age-restricted product is laudable, but it should not come at the expense of adult users of such products. And all policies introduced by well-intended lawmakers threaten adult access either through bans, arduous regulations, or unfair taxation.
A quick glance at existing data on youth e-cigarette use finds many of these “solutions” fail to address the real reason why youth use e-cigarettes. Officials completely disregard that youth smoking rates are at all-time lows. Such legislation threatens adult access to tobacco harm reduction products and is unlikely to reduce youth e-cigarette use.
Take, for example, the impending ban on mailing vapor products. Crammed into the 5000+ pages of the December 2020 COVID-19 relief bill was an amendment to include electronic cigarettes in the Prevent All Cigarette Trafficking (PACT) Act. Not only will the new regulation ban the shipment of e-cigarettes in USPS mail it will also require retailers to register with the Bureau of Alcohol, Tobacco, Firearms and Explosives, as well require sellers, to submit monthly reports to the state agency that handles tobacco taxes in all states where their products are sold.
Lindsey Stroud
The amendment was introduced by Sen. Dianne Feinstein (D-CA), who erroneously claimed “[b]uying e-cigarettes online is one of the easiest ways for children and teens to get their hands on these harmful products.”
Several state-based youth surveys have shown youths are not relying on the internet to obtain e-cigarettes. For example, in 2019, in Vermont, among current e-cigarette users, only three percent of high school students under 18 years of age reported buying vapor products online. Conversely, 52 percent of minors reported borrowing e-cigarettes. In aggregate data of all students from five different state high school surveys including Arkansas, Maryland, Montana, New Hampshire, and Rhode Island, only 0.9 percent of high school students reported purchasing vapor products from online retailers. With very few youths using the internet and mail to obtain e-cigarettes, a ban on the shipment of such products is highly unlikely to reduce underage e-cigarette use.
The mail ban isn’t the only flawed “solution” proposed by lawmakers. Many localities and states have banned, or are attempting to ban, the sale of flavored vapor products. Yet again, the data overwhelmingly indicate youth use e-cigarettes because of “other” reasons and because friends and family members use them. For example, in the aforementioned Vermont survey, when asked about the “primary reason” for using e-cigarette products (among current users) only 10 percent reported “flavors,” compared to 51 percent who cited “other,” and 17 percent who cited friends and family. This data is similar to other states including Connecticut, Hawaii, Maryland, Montana, Rhode Island, and Virginia.
Again, banning flavors is unlikely to reduce youth use of e-cigarettes and it may also have adverse effects. In San Francisco, which banned the sale of flavored e-cigarettes in 2018, youth vaping still increased after the ban, but so did youth smoking rates. In fact, current combustible cigarette use among high school students increased from 4.7 percent of San Francisco high school students in 2017, to 6.5 percent in 2019.
In order to protect adult access, youth use of e-cigarettes and vapor products must be addressed, but bans are ineffective measures and ultimately punish adults. States do have one solution in place, borne by the pockets of the very smokers that are trying to quit by using flavor vapor products: the monies received from tobacco taxes and settlement payments.
Each year, states allocate a pitiful amount of existing tobacco dollars towards tobacco control measures, including cessation, education, and youth prevention. In 2019, states collected an estimated $16.7 billion in cigarette taxes and $6.2 billion in tobacco settlement payments, yet spent only $655 million in state funding on tobacco control programs. This is a paltry 3 percent.
Given the lack of funding dedicated towards programs to help smokers quit, policymakers should embrace e-cigarettes as they have been more effective at reducing smoking than the insufficiently-funded tobacco control programs.
As a tool that has helped millions of American adults quit smoking, lawmakers must avoid policies that preventing adult access to e-cigarettes and vapor products. They must also rely on existing data on why youth are using e-cigarettes when putting forth policies to limit youth e-cigarette use. To fail to do so harms millions of American adult smokers – and former smokers – and fails to reduce youth use.
Lindsey Stroud is the creator and manager of Tobacco Harm Reduction 101 (www.thr101.org), a website that provides analysis and insight on tobacco and vapor products.
The China Patent Office has approved Next Generation Labs’ (NGL) patent application covering the process for the preparation of R-S [synthetic] nicotine, issue number 201580069647.2.
The approval will give NGL the ability to better enforce its intellectual property rights. NGL is the world’s largest manufacturer of S-isomer, R-S isomer and R-isomer synthetic nicotine sold under the registered brand name TFN.
According to NGL, the U.S. and Korean markets have been inundated with dozens of fake synthetic nicotine products and brands, and many manufacturers have misleadingly labeled bulk pure nicotine, bulk vape liquid mixtures and vaping and oral nicotine products as made with TFN. In many instances, the nicotine contained in these products is not synthetic, tobacco-free or non-tobacco, but is in fact derived from tobacco sources.
For almost a decade, NGL has spent considerable effort establishing a strong global intellectual property portfolio that has become distinctive of the company’s goodwill and of the high-quality adult consumers expect of TFN-branded nicotine.
NGL now intends to fully enforce its rights against many of these so-called synthetic nicotine brands.
NGL has been taking direct action in the United States and through its sole South Korean distribution partner NextEra to limit the misleading claims of unscrupulous sellers of pseudo-synthetic nicotine, and against manufacturers and brand owners who misrepresent that their product contains TFN branded synthetic non-tobacco-nicotine.
“With the assistance of the Chinese authorities, NGL now intends to fully enforce its rights against many of these so-called synthetic nicotine brands at their point of manufacture, and will take the lead with national customs agencies to limit the flow of fake synthetic nicotine products at trade exit and entry points in China, the U.S., EU, UK, South Korea, India, Canada, and Australia,” the company wrote in a press release.
As the Biden administration engages the COVID-19 pandemic, a public tug-of-war has emerged over who should be nominated to run the Food and Drug Administration, a pivotal participant in the effort, write Henry I. Miller and Jeff Stier for Issues & Insights. An analysis of the two perceived front-runners illustrates that neither would likely introduce the kinds of reform needed at the agency.
Jeff Stier / senior fellow at the Consumer Choice Center
One candidate is acting Commissioner Dr. Janet Woodcock, a long-serving top FDA official with widespread institutional respect, both inside and outside the agency.
To her (far) left is Dr. Joshua Sharfstein, who served briefly as deputy commissioner of the FDA in the Obama administration, and who formerly was the secretary of the Maryland Department of Health, as well as the health commissioner in Baltimore. Earlier in his career, Sharfstein was the health policy adviser to influential, liberal Congressman Henry Waxman, D-Calif. He is currently the vice dean for Public Health Practice and Community Engagement at the Johns Hopkins Bloomberg School of Public Health.
Woodcock’s strength is her extensive background in pharmaceutical regulation. However, some perceive her to be overly sympathetic to industry. Woodcock has been at the FDA for 35 years, and would be a sober, steady influence at a time that cries for stability at the agency.
But her institutionalism is also a weakness; all is not well at the FDA. As former Commissioner Frank E. Young quipped, “dogs bark, cows moo, and regulators regulate.” Consistent with that propensity, the FDA often exceeds its congressional mandate. Regulators have concocted additional criteria for marketing approval of a new drug beyond the statutory requirements for demonstrating safety and efficacy— requirements that sometimes inflict significant but obscure damage on both patients and pharmaceutical companies.
For example, regulators have arbitrarily demanded that a new drug be superior to existing therapies, although the Food, Drug and Cosmetic Act requires only a demonstration of safety and efficacy. And in a classic case of regulatory mission creep, Phase 4 (post-marketing) studies are now routine, whereas the FDA used to reserve them for rare situations, such as when there were subpopulations of patients for whom data were insufficient at the time of approval.
The effects of FDA regulators’ self-aggrandizing, excessively risk-averse actions range from the creation of disincentives to research and development (which inflates costs) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.
Another egregious example of the impact of excessive risk-aversion is the saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been judged to be safe and effective and marketed in Europe, Japan, Canada, and China. (This deadly delay occurred on the watches of both Woodcock and Sharfstein.) As a result, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.
The agency’s handling of e-cigarettes over the last two administrations is a sorry illustration of how regulatory dilly-dallying undermines public health. The agency’s mealy-mouthed endorsement of vaping as only a “potential” tool for tobacco harm reduction for adult smokers failed to sufficiently encourage smokers to make the switch away from consuming nicotine in its deadliest form, the cigarette. As a result, not enough smokers have been using them, while too many kids have.
Contrast this with Public Health England’s clear endorsement of using e-cigarettes to quit smoking, which has led to a sharp reduction in smoking without an epidemic of youth vaping. Woodcock would be unlikely to break the FDA’s mold in this space, while Sharfstein’s blind opposition to private sector-driven innovative solutions would likely shift e-cigarettes from a highly regulated marketplace to an illicit market like the one that caused the outbreak of pulmonary illnesses related to THC-vaping in 2019.
The agency has become extremely top-heavy, with ever more boxes appearing at the top of the organizational chart, even though the vast majority of day-to-day oversight and regulatory actions are taken at the level of FDA’s various “centers” – Woodcock’s longtime perch, the Center for Drug Evaluation and Research, the Center for Food Safety and Nutrition, the relatively new Center for Tobacco Products, and so on. The FDA needs to be put on an organizational diet.
If Woodcock is the institutional pick, Sharfstein would be the Ralph Nader pick. In fact, Sharfstein’s affiliation with failed nanny-state presidential candidates is more current than that. His academic affiliation with the Bloomberg School of Public Health is no coincidence. An outspoken advocate for expanding the scope of the FDA, which already regulates 20 cents of every consumer dollar, Sharfstein would have been the obvious pick for FDA commissioner, or even secretary of the Department of Health and Human Services, if former New York Mayor Michael Bloomberg’s multi-million-dollar presidential campaign had prevailed. Far from putting the agency on a diet, Sharfstein would instigate a regulatory feeding frenzy.
What’s needed are structural, policy, management, and cultural changes that create incentives for the FDA to regulate in a way that is evidence-based and imposes the minimum burden possible. A number of possible approaches and remedies to accomplish that have been described, but neither Woodcock nor Sharfstein is likely to embrace any of them.
We need significant legislative changes, or just conscientious congressional oversight, to disrupt the agency’s built-in bias for overregulation, but political realities make that unlikely anytime soon.
Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. A 15-year veteran of the FDA, he was the founding director of the agency’s Office of Biotechnology. Jeff Stier is a senior fellow at the Consumer Choice Center. Please follow them on Twitter at @henryimiller and @JeffAStier.
China’s Ministry of Industry and Information Technology (MIIT) and the State Tobacco Monopoly Administration announced today the Chinese government’s intent to overhaul rules governing the vapor and electronic nicotine-delivery systems (ENDS) market. The news started a swift downfall of shares of RLX Technology, parent to RELX, China’s largest e-cigarette brand, on the New York Stock Exchange. At 2:45pm today, RLX was down nearly 45 percent to $10.69 per share after recent high of $19.46 per share on March 19.
Credit: RLX Technology
Draft regulations posted online by MIIT suggest it will seek to regulate these products similarly to ordinary cigarettes. The ministry is seeking public comments on the draft regulations until April 22. The implications of the draft regulations could be wide-ranging as, with an estimated 300 million smokers, China is considered the world’s largest market for tobacco product.
“In order to implement the decision-making and deployment of the CPC Central Committee and the State Council, further strengthen the supervision of new tobacco products such as e-cigarettes, and safeguard the legitimate rights and interests of consumers, we have drafted the Decision on Amending the Regulations on the Implementation of the Tobacco Monopoly Law of the People’s Republic of China,” the rule states. “The amendment is mainly to implement the requirements of the CPC Central Committee and the State Council on promoting the rule of law in the supervision of e-cigarettes , to clarify the legal basis for the supervision of new tobacco products such as e-cigarettes , and to do a good job in connecting with laws and regulations such as the Law of the People’s Republic of China on the Protection of Minors, so as to play an important role in strengthening the rule of law , stabilizing expectations and promoting the long-term.”
RLX Technology raised $1.4 billion during its initial public offering (IPO) in January this year. It sold 116.5 million shares with a target price of between US$8 and US$10 a share. Its successful market debut turned its 39-year-old founder, Wang Ying, into a billionaire overnight with an estimated net worth of $24.8 billion.
In its prospectus, RLX stated that vaping products only have a 1.2 percent penetration rate in China, compared with 32.4 percent in the U.S. According to the China-based Electronic Cigarette Industry Committee, China’s 2020 e-cigarette sales were an estimated 14.5 billion RMB yuan ($2.2 billion), an increase of 30 percent from 2019 (11.2 billion RMB yuan). According to Grandview Research, the US e-cigarette market in 2019 and was valued at $5.34 billion and is expected to reach $6.50 billion in 2020.
RELX recently announced its partnership with 110 authorized distributors to supply its products to over 5,000 RELX-branded partner stores, and over 100,000 other retail outlets nationwide, covering over 250 cities in China, according to its prospectus. Revenue for the company nearly doubled in the nine months ended September 30, 2020 to $324 million, with a net income of $16 million, the latest figures available at the time of this writing.
But tobacco companies are increasingly facing scrutiny from regulators in China. Currently, the only regulatory actions taken by Chinese authorities are in 2018, the country made it a crime to sell a vapor product to anyone under 18 years of age and then, in November 2019, an online sales ban was implemented in order to further prevent youth initiation. In 2020, the country passed the Law of the People’s Republic of China on the Protection of Minors. That law is aimed at preventing parents or other guardians from “indulging or instigating minors” to smoke or vape.
CNTC is a source of major funding for the Chinese government. Its contribution accounted for an estimated 5.45 percent of the country’s tax revenue in 2018. That amounts to 10.8 trillion yuan ($1.5 trillion), according to media reports. If CNTC were to enter the vapor market, the monopoly’s existing 5 million domestic retail outlets could present a major challenge for private vape shop owners.
Wang told Reuters in a recent news article that she’s “not worried” about the government’s impact on the sector. The products will continue to remain available, she said, “as long as there’s proof that this is a good solution for smokers.”
