Robert Califf vowed to close the synthetic nicotine loophole if appointed commissioner of the U.S. Food and Drug Administration, according to a report by Vaping360.
During Califf’s nomination hearing on Dec. 14, Wisconsin Senator Tammy Baldwin expressed concern over reports that companies are switching to making flavored synthetic nicotine products in the wake of FDA marketing denial orders.
“As FDA commissioner, how would you work to address the rise in youth use of synthetic nicotine, and will you commit to working with Congress to ensure that the FDA has the authorities and resources it needs to crack down on these products?” Baldwin asked.
In response, Califf first noted that is crucial to appoint the right person to succeed Center for Products Director Mitch Zeller, who plans to retire in April 2022.
“Secondly,” Califf continued, “this is not limited to children. I may have some family members using synthetic nicotine, I learned as I was going through the paces here. And what people don’t realize is that there are two enantiomers of nicotine—one of which is not occurring in nature—that are in this product, and its properties are not known.
“So we’ve got to close this loophole,” Califf added, “so that we make sure that we understand the risks and benefits, and particularly deal with the issues in children.”
The Senate Health, Education, Labor & Pensions Committee will vote soon on whether to recommend Califf’s nomination to the full Senate. If the committee approves him, the former commissioner can expect full Senate confirmation to be the new commissioner soon, probably in January.
Kanabo today announced that its unique CBD and nicotine formula for help in quitting both e-cigarettes and traditional cigarettes has moved from the Patent Cooperation Treaty (PCT) phase to National Phase in the U.S., U.K., and E.U. countries. It’s the last phase before becoming an internationally approved patent.
Credit: Kanabo
One of Europe’s fastest-growing medical cannabis and R&D companies that focuses on the distribution of cannabis-derived products for medical patients, and wellness CBD consumers, Kanabo’s says the smoking cessation market is expected to reach £50 million within a few years. “Kanabo’s unique, high potency CBD and nicotine and standalone CBD formulas, delivered by their proprietary cartridges and VapePod, can be used to treat nicotine and tobacco addiction, with evidence so far suggesting the program significantly reduces physical and psychological nicotine withdrawal effects,” a press release states.
Covered under the Kanabo patent application is a new formula development of specific naturally derived terpenes to allow the application of a “very consistent and reproducible, high concentration of CBD throughout the life of the Kanabo cartridge.” Initially, CBD is combined with nicotine, which is then reduced over several weeks until there is zero Nicotine presence. Tests with a small group of volunteers cigarette smokers that participated in Kanabo’s trial showed an “average reduction of 70 percent in their cigarette consumption” and did not experience physical or psychological withdrawal effects
“Our unique patent pending CBD formulations and controlled and consistent delivery device, the VapePod, represents an excellent opportunity for governments to quickly end the reliance on tobacco for millions of citizens worldwide,” said Avihu Tamir, CEO for Kanabo. “Our tests show a dramatic reduction in nicotine consumption, whether in cigarettes or e-cigarettes, which can only be good news for health services around the world.”
Aurora Cannabis together with 22nd Century Group announced a three-way nonexclusive agreement to license biosynthesis intellectual property to Cronos Group, intended to assist in the advancement of research and development on the biosynthesis of cannabinoids.
“We are deeply interested in the evolution of cannabinoids, and this is a promising step toward the commercialization of cannabinoid products using biosynthesis,” said Miguel Martin, CEO of Aurora. “The long-term potential for rare cannabinoid molecules produced through biosynthesis is incredibly promising given their efficient production methods and potential therapeutic benefits and utility in health, wellness and consumer products.”
“This license combines the resources and intellectual property of all three companies in this agreement intended to facilitate the commercial success of a biosynthetic approach, which complements the disruptive plant-based advancements 22nd Century and Aurora continue to develop to bring more consistent and higher yields to the hemp and cannabis industry,” said James A. Mish, CEO of 22nd Century Group, in a statement. “We believe that the availability of both plant-based and biosynthetic cannabinoids will be important to the commercial success of our industry, and this agreement positions 22nd Century, Aurora and Cronos Group with an important role in each approach.”
“Cronos Group has successfully commercialized the first cultured cannabinoid product in Canada. Licensing this intellectual property provides us with a component of the process that could allow for increased speed and efficiency in the development and commercialization of cultured cannabinoids,” said Kurt Schmidt, president and CEO of Cronos Group.
Denver, Colorado Mayor Michael Hancock issued a veto Friday on a flavored vaping and tobacco ban approved by city council on Dec. 6. Approved in an 8-3 vote, the ban was slated to begin in 2023, pending Hancock’s signature.
“I want the public to understand I share the same objective that this bill promoted, but to do it in Denver, it would have only been, in my eyes, symbolic,” Hancock told Denver’s Fox31 news.
Credit: Daniel Jędzura
“Kids could have still crossed the street to Aurora and purchased the product. Businesses were going to be hurt because people would go across the street to procure the product, as opposed to coming into their store where it would be banned, and that to me is just not responsible legislation.”
The measure’s main sponsor, Councilwoman Amanda Sawyer, said she had been hearing about the potential for a veto.
“Disappointed, yes, but surprised, no,” Sawyer said. “When I spoke to the mayor earlier today, he and I talked about the potential for other options moving forward. And although we’ve been working on this for a year or so, you know some of those options could have absolutely been pursued by now and haven’t been, but I’m hopeful that we’ll be able to find a good partnership moving forward.”
Hancock said he isn’t sure what will happen Monday, where the City Council will have the decision to override his veto. The council will need 9 votes to do so.
China’s domestic e-cigarette market is going to look very different next year. Draft rules governing e-cigarettes were issued on Dec. 2 by the country’s tobacco regulator, the State Tobacco Monopoly Administration (STMA). While the entirety of China’s new draft rules for the regulation of vaping products are vague and still being reviewed by interested parties, the included standards for the manufacturing of vapor products do open a window into the future of China’s domestic vapor market.
The National Standards of the People’s Republic of China for e-cigarettes allows only for closed pod systems with tobacco-derived nicotine and tobacco-derived nicotine salts. Flavors will be allowed and cartridges can’t leak, according to a translated copy of the proposed rules.
Unlike other countries, China will only allow tobacco-derived nicotine. The rules do not allow for a synthetic nicotine. “Nicotine extracted from tobacco should be used, and the purity should not be less than 99 percent,” the standards state. “Benzoate, tartrate, lactate, levulinate, malate and citrate of nicotine are allowed, and nicotine for preparing the above nicotine salts shall meet the requirements of [the previous statement].”
However, synthetic nicotine will still be allowed in products for export. What isn’t clear is if that synthetic nicotine must be shipped into China premixed in PG and/or VG and held in bond or if a pure synthetic can be imported. “There’s no legal imports of nicotine as far as we can tell. There’s seems to be no leeway for legal imports of a pure synthetic nicotine. However, we think if people import e-liquids with nicotine as a certain percent of that, that’s okay,” an industry representative told Vapor Voice and asked not to be named because they didn’t have permission to speak on the matter. “We don’t know if it’s 10 percent or 20 percent and it can only be brought into the country to be manufactured for re-export, that appears to be okay. That is just how we are interpreting the rule though, maybe someone else is seeing it differently.”
It also seems that the proposed rules also do not allow for a company to import finished vaping products into China and then sell them domestically without having a license and being registered with STMA (local companies will also need licenses). However, the country will continue to encourage exports, and wants domestic manufacturers to develop markets overseas.
“What they’ve really done is they’re clamping down on anything that is destined for the domestic market,” the source said. “They’ve also tapped into the tax department. Any time a manufacturer wants to manufacturer an e-cigarette or parts for an e-cigarette, they have to have a local representative from the taxation bureau there. And each day’s production that they run, they have to pay tax on those products at the end of that day. They’re clamping down in terms of what people can do as well as trying to ensure that they collect relevant taxes from all the manufacturers.”
Chinese vapor manufacturers are still waiting to understand what needs to be done officially for a company to produce vaping products for the international and/or domestic market. “We’re still waiting on that. The important piece isn’t the product standards,” the source said. “What I’m really interested in is the registration process, who’s allowed to do what, who has to issue licenses, because now there’s an emergency management bureau involved, not just STMA, so it’s a lot of people. We’re also trying to figure that piece out.”
China’s product standards do clarify what types of products China will allow domestically. The country will only allow closed-pod systems to be sold, stating that “devices and cartridges using e-liquid should have a closed structure to prevent artificial filling.” Additionally, flavors will be allowed for now, but flavors are only approved under a “temporary permit for additive in e-vapor matter” and any substance or flavor not listed “shall be used only after being proved to be safe and reliable by risk assessment,” the standards state. The listed additives include numerous flavoring extracts such as coffee, cocoa, prune and vanilla bean.
The standards only allows for a maximum amount of nicotine of 20 mg per milliliter (mL). The source also said that the way he interprets the rules is that vape symposiums, such as the recently held 2021 IECIE Shenzhen eCig Expo (held Dec. 6-8), wouldn’t make sense to be held in China anymore.
2021 IECIE Shenzhen eCig Expo (Credit: IECIE)
“I can’t imagine, if they’ve really taken bookings and got one on the cards currently, that they will cancel it, but we’ll see shortly,” the source said. “The Chinese domestic market is off limits to outsiders now. Moving forward, I don’t see a place for [trade shows] in this market anymore.”
For China’s domestic manufacturers the outlook is grim. While international players will still survive, they are still confused about what will be expected when the rules are finalized. Stock shares for RLX, China’s largest domestic brand, fell by more than 16 percent after the SMTA released the proposed rules. In Shenzhen, the capital of global vapor manufacturing, the industry is in a state of shock, according to the source.
“Everybody, from big to small, is scrambling to try and find out how this relates to them,” the source said. “They all have to register immediately with State Tobacco Monopoly to continue doing business. They have to register what they’re going to be manufacturing, what their exports are, where they are going. It’s a complete disaster.”
A more detailed version of this story will appear in the next issue of Vapor Voice.
Now-defunct e-cigarette retailer Eonsmoke and its co-owners have settled a lawsuit with the state of Massachusetts for selling nicotine vaping products to minors. Attorney General Maura Healey today announced that Eonsmoke has agreed to a settlement amount of $50 million, and owners Gregory Grishayev and Michael Tolmach will pay a total of $750,000. The terms of the consent judgment, pending court approval, orders Eonsmoke to end all sales, distribution, marketing, and advertising of any tobacco products to consumers in Massachusetts, according to a press release.
The settlement, filed today in Suffolk Superior Court against Eonsmoke, LLC and Grishayev and Tolmach, resolves allegations that the defendants directly targeted young people for sales of its vaping products through marketing and advertising intended to appeal to youth. Healey’s office also alleged that Eonsmoke failed to verify the age of online purchasers of its products—including electronic nicotine devices, e-liquids, and nicotine pods—and failed to ensure shipments of the products were received by a person 21 years or older, the state’s minimum legal sales age for smoking products.
“Eonsmoke coordinated a campaign that intentionally targeted young people and sold dangerous and addictive vaping products directly to minors through their website,” said Healey. “We were the first to take action against this company and its owners, and today we are holding them accountable and permanently stopping them from conducting these illegal practices in our state.”
Eonsmoke has agreed to a settlement amount of $50 million, and Grishayev and Tolmach will pay a total of $750,000. Eonsmoke ceased all operations and dissolved in 2020. According to the Healey’s complaint, filed in May 2019 and amended in November 2020 to include Defendants Grishayev and Tolmach, the defendants “willfully and repeatedly violated the state’s consumer protection law by using a marketing campaign that directly targeted underage consumers.”
Healey alleges that the defendants directly marketed “Eonsmoke vaping products to young people through social media sites such as Instagram, Snapchat, and YouTube, and included youth popular culture references, social media influencers, celebrity endorsers, cartoons, and internet memes that intentionally minimized or omitted the fact that the vaping products contained nicotine.”
In August of 2020, the Arizona Attorney General’s Office (AGO) obtained a $22.5 million judgment and a permanent injunction against the New Jersey-based vapor company Eonsmoke. The ruling could set a precedent for other states suing vapor companies over marketing practices.
Juul sued Grishayev and Tolmach for trademark infringement in 2018 claiming Eonsmoke illegally marketed its vaping pods as “Juul compatible,” complete with packaging that looked eerily similar to Juul’s. Rather than settle the case, Grishayev and Tolmach were accused of quietly stashing millions in corporate funds out of Juul’s reach — despite a federal judge having warned them last year not to touch the money “outside the ordinary course of business,” according to the New York Post.
“While purposefully using JUUL branding to confuse customers that its illicit products were somehow related to Juul Labs, Eonsmoke flooded the market with pods featuring inappropriate flavors and packaging made with unknown ingredients under unknown quality standards,” said Juul spokesperson Austin Finan at the time. “We will continue to enforce against illegal actors like Eonsmoke to help ensure the vapor category is comprised of companies focused on transitioning adult smokers from combustible cigarettes while following regulations and combatting underage use.”
The Spanish government has taken control the country’s sales and distribution of vaping products. Authorities say the move was needed because there is currently no clear and effective system of control regarding the sale of e-cigarettes.
Credit: Oleksii
The Ministry of Health has a new objective: to reformulate the anti-smoking legislation that was approved by José Luis Rodríguez Zapatero in 2006, according to Euro Weekly. The Spanish government’s new proposal aims to restrict the use of e-cigarettes, as the government says that they cause “harmful short-term effects”.
Fernando Fernández Bueno, surgical oncologist at the Gómez Ulla Military Hospital and member of the Platform for the Reduction of Harm caused by Tobacco, explained that “vaping is 95 percent less harmful than traditional tobacco because e-cigarettes do not emit the carcinogens that tobacco does.” He added, “some people still say that vaping is worse than smoking. But there is nothing worse than smoking.”
The government’s greatest concern is that these devices could “encourage experimentation in young people and non-smokers”, who may be drawn to smoking e-cigarettes due to the “colors of the vaporizers or the flavors used.”
The Ministry of Health, headed by Carolina Darias, has manifested concern regarding the sale of these devices, explaining that “there is a large number of websites where nicotine-based devices can be bought online, and the methods for preventing access to minors are neither sufficient nor effective”.
The government’s goal is to prevent the sale of e-cigarettes online and support the sale of vaping products only in specialized tobacco shops, according to the story. The government also warned vapers that the new rules will raise e-cigarette prices when they go into effect.
A proposal to impose U.S. federal taxes on vaping has been removed from the Democrats’ healthcare, education and climate change bill, reports The Wall Street Journal, citing people familiar with the matter. Nevada Senator Catherine Cortez Masto, a Finance Committee member in a tough re-election race, reportedly pushed to remove the tax and helped force its deletion.
The removed provision would have levied a tax on vaping products designed to parallel the existing federal cigarette tax rate of $1.01 per pack.
The move comes just days after the Vapor Technology Association (VTA) released a report that concluded the tax would cost thousands of jobs. “We have been meeting with numerous members of the House and Senate, and the Administration, to explain the absurdity of this tax, giving them multiple public health and economic reasons to strip it out of the bill,” said Tony Abboud, head of the VTA. “A tax can always come back, but if it does I doubt it will be as poorly considered as this one. There are much better alternatives.”
The tax had draw considerable criticism from vapor industry representatives and tobacco harm reduction advocates, who said it would in some cases make e-cigarettes more expensive than combustible cigarettes—a perverse outcome, given that vaping is widely believed to be less harmful than smoking.
Critics also noted the tax would be regressive. According to a recent Gallup poll, Americans with an annual household income of less than $40,000 are significantly more likely to vape than higher-income groups.
Vaping advocates welcomed the decision. “The evidence is clear that imposing a new excise tax on vaping products will discourage adults from quitting smoking and shut down small businesses already dealing with industry-crushing federal regulations,” Gregory Conley, president of the American Vaping Association, was quoted as saying by The Wall Street Journal.
Mitch Zeller, the director of the Food and Drug Administration’s Center for Tobacco Products, plans to retire in April 2022 after serving in the post since 2013, reports The Washington Post. In a letter to staff, acting FDA Commissioner Janet Woodcock praised his work as “invaluable and instrumental” to advancing “numerous historic public health milestones in tobacco regulation.”
A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the human resources and intergovernmental relations subcommittee of the House of Representatives’ government operations committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then FDA Commissioner David Kessler. What began as a two-week assignment by Kessler to examine the practices of the tobacco industry led to his serving as associate commissioner and director of the FDA’s first Office of Tobacco Programs. Instrumental in crafting the agency’s 1996 tobacco regulations, Zeller also represented the FDA before Congress, federal and state agencies. Zeller also served as an official U.S. delegate to the World Health Organization working group for the Framework Convention on Tobacco Control.
In 2000, Zeller became executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and, in 2002, creating the foundation’s first Office of Policy and Government Relations. That year, Zeller joined PinneyAssociates, where, as senior vice president, he provided strategic planning and communications advice.
He left PinneyAssociates in 2013 to begin his second stint at the FDA.
A new report finds that combustible cigarettes will become less expensive than vaping products and nearly 43,000 jobs would be lost if the proposed nicotine tax contained in the Build Back Better bill (HR 5376) were to become law. The Vapor Technology Association (VTA) funded study, The Negative Economic Impacts of the New Nicotine Tax Imposed Only on Vapor Products In the Reconciliation Bill, conducted by economist John Dunham & Associates, is being billed as a comprehensive analysis of the negative effects that the proposed tax will have on smokers, the industry and the economy.
“Our analysis finds that the bill would not create anything close to parity with cigarette taxes but, rather, would tax vapor products at a much higher rate – up to nine times higher – than the tax on a pack of cigarettes,” the report states. “The proposed nicotine tax in the Reconciliation Bill would lead to a net price increase on vapor products at retail of about 53 percent (21.2 percent for a standard two-pack of closed-system pod products and 73.5 percent for a standard 60 milliliter bottle of open system e-liquid), while the price of cigarettes and other tobacco products would remain unchanged as they would not be subject to any additional federal tax.”
The study also concludes that the proposed nicotine tax would lead to a reduction of nearly 42,800 full-time equivalent jobs and the loss of $2.2 billion in wages and benefits, negatively impact the size of the overall economy which would fall by about $7 billion and would result in states and their localities losing $620 million in taxes while the federal government attempts to generate revenues.
“A pack of cigarettes contains approximately 204 milligrams of nicotine (10.2 mg/cigarette x 20 cigarettes per pack). Applying the proposed nicotine tax of 2.78-cents per milligram to cigarettes, means that the tax on a pack of cigarettes should be $5.41, not $1.01,” the study states. “Viewed another way, the federal tax on cigarettes, if applied to their nicotine content, would only amount to less than half a penny per milligram, not the 2.78-cents Congress seeks to impose on e-cigarettes ($1.01 per pack / 204 mg of nicotine per pack).”
As defined in the bill, the proposed tax would be equal to about $2.22 on the standard closed system nicotine vapor product (such as a two pack of JUUL pods), and a $10.01 on the standard average 60 milliliter bottle of nicotine containing e-liquid used in an open system vapor device,” according to the study.
If passed, the proposed tax would also lead to a loss of about 31.9 percent of vapor product sales or 3.7 million milliliters of e-liquid consumed. Of this loss, 61.2 percent would be the result of consumers switching to other tobacco products, including combustible cigarettes. An additional 18.5 percent of these lost sales would move to the black market, according to the study.
“Modeling suggests that a large portion of consumers would react by purchasing unregulated products over the black market or make their own e-liquids,” according to the study. “These figures (which reflect a price increase resulting from the tax of 53 percent) are conservative and are not out of line with other studies examining the substitution of vapor products and combustible cigarettes when taxes are imposed.”
