The House passed a $1.5 trillion federal spending bill that includes language that gives the U.S. Food and Drug Administration power over synthetic nicotine. The bill now moves to the Senate and, if passed, will require a presidential signature to become law.
Not long after the 2,700-page spending bill was released early Wednesday and just hours before a scheduled vote, a number of Democrats privately registered their dismay with party leaders, raising the prospect that the entire package could collapse for lack of support. The dispute froze activity on the floor for hours as top Democrats rushed to salvage the spending measure, according to the New York Times.
By midafternoon, Speaker Nancy Pelosi of California notified Democrats in a brief letter that the coronavirus money would be dropped.
If the synthetic nicotine language remains in the bill and clears the Senate, Biden is expected to sign the measure. The rule will then become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotinefrom any source, that is intended for human consumption.”
Update: At 2:56 pm the House went into recess, to presumably make amendments to the bill. Media outlets have reported it is to remove some Covid-19 related measures (30 states at risk of losing Covid relief funding previously promised). Currently, the vote on the omnibus appropriations bill is expected to occur this evening or late tonight.
It is possible that the omnibus appropriations bill vote is delayed. In case Congress does not complete work on the omnibus by the end of the week, the House is also expected to vote on a CR through March 15 today to allow time for Senate passage and signing by the President.
If the synthetic nicotine language remains in the bill, the rule will become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
The U.S. House of Representatives is expected today to vote on an omnibus appropriations bill (page 1,870) that includes language that would give the U.S. Food and Drug Administration the power to regulate synthetic nicotine . Lawmakers have said some add-ons have already been agreed to, such as a package of health care provisions including Medicare program extensions and eliminating the synthetic nicotine loophole.
The House is planning to vote sometime today before going to Philadelphia for its annual issues conference. The bill must clear the Senate before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
House Appropriations Chair Rosa DeLauro was adamant after a private House Democratic Caucus meeting Tuesday morning the omnibus would be ready for the House to pass on Wednesday, according to RollCall.
“It’s not going to get delayed. We’re going to vote tomorrow,” she said.
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotinefrom any source, that is intended for human consumption.”
Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
Amanda Wheeler
Yaël Ossowski, deputy director of the Consumer Choice Center, said the legislation will actively harm adults who want to quit smoking. He says that the method of “fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits,” is shameful in a modern American Republic.
“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.
“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
Yaël Ossowski
Ossowski said he hopes elected representatives reject the synthetic nicotine inclusion and “go back to the drawing board” to offer a more permanent policy.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
The regulation of synthetic nicotine has been a recent focus for many U.S. states. If a yet-to-be unveiled budget bill is passed, it is expected to include giving the U.S. Food and Drug Administration new powers to regulate synthetic nicotine, a lawmaker confirmed on Tuesday. The omnibus appropriation bill is slated to be passed in the next few days.
Language included in the omnibus spending package bill to fund the government through September would give the FDA the authority to regulate products that contain nicotine but aren’t derived from tobacco, such as synthetic nicotine, according to a document obtained by Bloomberg.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
The change will stop “bad actors attempting to evade FDA regulation and hook a new generation of young people into a lifetime of nicotine addiction,” Pallone said.
Public health groups have been warning that synthetic nicotine e-cigarettes such as Puff Bar have grown in popularity among teens while skirting FDA oversight. The FDA has authority to regulate natural tobacco products, but it’s unclear if that extends to lab-made nicotine.
More than a quarter of middle and high school e-cigarette users reported using Puff Bar as their usual brand, according to a survey from the Centers for Disease Control and Prevention. Puff Bar didn’t immediately respond to a request for comment.
The same survey found brands that use traditionally derived nicotine, such as those sold by Vuse, SMOK, and JUUL Labs Inc., are also popular among teens, even though people under age 21 can’t purchase them legally.
The U.S. state of Mississippi’s House of Representatives Thursday passed legislation that would require sellers of any type of alternative nicotine and marijuana products and package retailers to have a third-party age verification service.
Nick Bain
HB 976, authored by State Rep. Nick Bain (R), revises the provisions of law that regulate alternative nicotine products such as an electronic cigarette, any other product that consists of or contains nicotine that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling or by any other means, according to Y’All Politics. The rules would include synthetic nicotine products.
The bill also amends Section 67-1-81 of Mississippi Code to, “require holders of a package retailer permit to have an independent, third-party age verification service available on the property of the location in which alcoholic beverages are sold; and for other related purposes.”
The legislation says that before selling alternative nicotine products, the person or business must verify that the individual is at least 21 years of age by performing an age verification through a third-party verification service that obtains the purchasers full name, date of birth, and residential address and compares the information available from public records to the personal information entered.
In accordance with national standards, the third-party verification system used must have at least a 95% accuracy rating in order to be in compliance with the identification requirements listed in the bill.
An amendment was added that would require medical marijuana dispensaries to be included in this bill.
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.
A new research paper attempts to clarify the confusion surrounding nicotine consumption and the role it plays in the diseases caused by smoking. The paper, released by the Consumer Choice Center, outlines six main reasons why the “war on nicotine is pointless” and should end.
Credit: kues1
“Instead of celebrating declining numbers of smokers and far fewer deaths, many governments, public health agencies and anti-smoking activists have been on the hunt for new enemies,” the researchers wrote. “They decided to scapegoat nicotine, and as a result, the fight against smoking gradually transformed into a fight against nicotine. Such an approach has dire consequences: fewer people switching to less harmful alternatives.”
The paper was co-authored by Michael Landl, director of the World Vapers’ Alliance, and Maria Chaplia, research manager at the Consumer Choice Center This six reasons listed to stop the war against nicotine the paper recommends are:
People consume nicotine, but they die from smoking
Nicotine in patches and gums is not a problem — it is neither (a problem) when vaped nor in a pouch
Addiction is complex and not solved by a war on nicotine
Nicotine makes some people smarter, stronger and more attractive
Misconceptions about nicotine are hindering progress
Prohibition never works
“Put practical solutions first: to reduce smoking rates, public health needs to make use of all available possibilities. People who cannot quit smoking should be encouraged to switch to less harmful alternatives. Nicotine is not the main problem when it comes to smoking, the toxins are,” the researchers recommend to policy makers. “Regulation must be drafted according to the actual risk of a product. Vaping or snus are less harmful than smoking, hence must be treated differently. Nicotine doesn’t become a poison when delivered through vaping. When nicotine isn’t a problem in gums and patches, it can’t be a bigger problem in vaping. The moral panic when it comes to nicotine must end.
“Addiction is complex and is not solved with a war on nicotine. When it comes to addiction, public health policies should not single out a single substance. Potential benefits of nicotine must be explored and unbiased scientific endeavors must be ensured. Public policy must accept that many people use nicotine recreationally. A war on nicotine will fail like the war on drugs or alcohol prohibition failed. Public misconceptions about nicotine must be fought. They discourage people from switching to less harmful alternatives and therefore hurt public health.”
This year’s Global Tobacco and Nicotine Forum (GTNF) focused on innovation and sustainability in the ENDS industry.
By Vapor Voice staff
The Global Tobacco and Nicotine Forum (GTNF) has been one of the most insightful conferences over the past decade, especially in its embracing of electronic nicotine-delivery systems (ENDS) and their potential for harm reduction. During this year’s event, held in London from Sept. 21-23, speakers were challenged to focus their insights on this year’s theme: Continuing Change: Innovation & Sustainability. Below, we have provided session overviews of the many keynote speeches and panel discussions that centered on ENDS products. Next year’s GTNF will be held in Seoul, Korea on Sept. 20-22.
GTNF Fireside Chat with Todd Cecil, FDA
The U.S. FDA insists its banning of all flavored e-liquids other than tobacco is not a de facto ban on the products.
By VV staff
When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.
Credit: Malcolm Griffiths
At least four companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.
When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.
“The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”
Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.
“We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”
The FDA has also been facing an unprecedented amount of scrutiny on its handling of the regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.
“We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those … scientifically or make a determination based upon that science.”
Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.
“We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”
Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”
The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”
GTNF Panel: The Fork in the Road: What is Next for Tobacco and Nicotine
Regulators must remember the vaping industry began with hobbyists and enthusiasts who built their own devices.
By VV staff
The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).
Credit: Malcolm Griffiths
One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.
All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.
While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.
Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.
“Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”
GTNF Panel: Consumers: The Key Stakeholders
Harm reduction should empower individuals to make their own choices about what products they consume.
By VV staff
For many people, the threats they face in day-to-day life are far more immediate than their long-term health. The mission of harm reduction should be to empower people to make their own choices about what products they consume and their own health decisions, even if those decisions don’t align with what public health experts would say is optimal. This was the general focus during a plenary panel discussion at the GTNF called Consumers: The Key Stakeholders.
Credit: Malcolm Griffiths
Most of the session centered consumers standing up and advocating for the industry, the global attacks on flavored e-liquids and growing threats from the World Health Organization (WHO), which remains suspicious of tobacco harm reduction. Panelists agreed that while some consumers prefer to remain on the sidelines, many others are willing to get organized and campaign for tobacco harm reduction and the vaping industry. “The consumer voice is very powerful,” a panelist said.
A major concern for the vaping industry is the concerted campaign against flavors. Flavors, according to one panelist, are used to by the industry’s enemies to redirect the conversation toward children. “They’ll say vaping flavors attracts children, and then they get us to play in their playground,” he said. “It’s very different. You [consumers] have got to keep asserting that adults use flavors.”
The WHO is a threat no matter what, the panel agreed. The global health body is now even talking about redefining smoke to include anything that’s heated and emits a vapor. “This means that any customizability of a product will be restricted and have limits on it, which basically means all the vape products will be the same,” explained one panelist. “These [recommendations] have to be resisted. The WHO doesn’t make laws, but it’s very influential, and these things can’t just be waved away.”
The scientific studies the WHO uses to justify its negative view toward next-generation products as tools for harm reduction are “fantasy and cherry-picked” studies, according to another speaker. “The people who are against harm reduction will never sleep. They’re always working, and they’re highly funded,” a panelist said. “[Consumers] have to stay alert, and they have to stay organized because, at the end of the day, there are more consumers than there are activists against harm reduction, and we’ll vote. So, consumers really have a big role to play.”
Consumers are the key stakeholders. However, when talking about consumers, regulators must acknowledge that not every smoker is the same, according to the panel. Many smokers don’t want to quit combustibles. “The important thing is to understand why and respect their choice,” a panelist said.
One speaker said that the industry also needs more responsible vape reviewers on YouTube because the current ones “are absolutely appalling.” The speaker urged consumers to make their voices heard in politics. “You’ve got to have somehow to get ahold of your Parliamentarians or your politicians in your country and get them to campaign on your behalf because there are many, many consumers, but you haven’t got great voice in government, and that’s what you really need to try and get,” he said.
At the end of the session, an audience member asked the panel if it could see a situation where consumers would sue regulators over counterproductive rules, such as flavor bans. “I have mentioned the fact that it would be interesting if someone could do a test case, but I don’t know whether that someone could come from the consumer side and sue [over regulatory action],” the panelist said. “It’s also expensive, and someone will end up having to pay if you lose.”
GTNF Panel: Science Driving Innovation
The nicotine delivery of products and being conscience of the environment are key points in innovation.
By VV staff
Regulators globally are becoming more understanding of what they expect next-generation tobacco products to accomplish. Regulators want manufacturers to demonstrate, on a product-specific basis, whether the vaping products are a benefit to combustible cigarette smokers. More importantly, manufacturers must ensure that vulnerable populations such as youth are not using these products.
Credit: splitov27
During the lunchtime GTNF panel “Science Driving Innovation,” one speaker also mentioned that manufacturers must be more conscious about the environmental impacts of vaping products too. The environment is a big issue in the minds of governments, regulators and society as a whole. The panelists agreed that vaping manufacturers should produce products that are environmentally sustainable.
“Think about all the batteries that go to waste every time an e-cigarette is disposed of. What are we doing as an industry to address the fundamental questions that society and regulators are concerned about?” a panelist asked. “We need to start thinking about what views of science we need to really put our investments in [and start] focusing on going into the future.”
Another major industry concern that should be addressed through innovation is youth initiation. One panelist said this topic should be a primary focus of scientific efforts relating to vaping products. Reduced-risk products must exist for adult smokers, so it’s imperative that the industry proactively addresses the underage use issue. “If we don’t, others will try to do it for us, and then collectively, we will all compromise the potential that [we are focusing on during the conference] today,” one panelist said. “It’s a critical balance. It’s important that we offer adult smokers an alternative, and we can also combat underage use. We can do both, and we must because there’s too much at stake if we don’t.”
Another speaker discussed her company’s global retailer compliance monitoring program. The company sends thousands of “mystery shoppers” into U.S. retail outlets that sell its vaping products and collects data around whether the retailers are abiding by federal age verification laws and/or other local policies.
“What we found is that retailers need help. There’s a lot going on in this world. We help them by providing information on how they’re performing, education and training, and we can also assist in changing their existing point-of-sale technology,” she said. “It can actually prompt the clerks to check ID when they’re selling an interesting new product. And it alleviates the mental burden on their end.”
Another concern for the industry that can be addressed through innovation is improving nicotine delivery and satisfaction. That satisfaction delivered by products today is not enough to sustain the large number of people we want to see switching from cigarettes to electronic nicotine-delivery systems.
“To achieve meaningful harm reduction, we need these products to appeal to and be affordable to most adult cigarette smokers. Which means those consumers would need to like the product and be able to afford the product,” a speaker said. “They need to be able to trust these products, and it requires a significant investment in innovation if you want to do it properly.”
GTNF Plenary Panel: Innovation as the Path to Progress
The more freedom the industry has to innovate, the more likely smokers are to transition away from combustibles.
By VV staff
Innovation is grounded in regulation. Regulators can either embrace innovation as a tool to support harm reduction, or they can regulate them to the point that any innovation is impossible to bring to market. During the GTNF panel Innovation as the Path to Progress, one speaker explained that the U.S. Tobacco Control Act was written with the goal that the state of public health will change over time. The idea is that as smokers quit and product standards are implemented, many may migrate to products lower on the risk continuum. As a result, as the state of public health changes, the products that the U.S. Food and Drug Administration determines to be appropriate for the protection of the public health (APPH) will also change.
Credit: Urupong
“If you think about the significance of the innovation of the e-cigarette, today we have major companies that are in the tobacco space talking about eliminating combustion altogether,” a panelist noted. “We have companies giving up their entire combustible segments, and that would not have happened, in my opinion, had it not been for the innovators.”
Making innovative progress in the vapor industry is measured by transitioning adult smokers to noncombustible products, according to the panel. However, there are many avenues to accomplish this goal as well as numerous obstacles. One speaker offered the audience three focus areas that he described as the pillars of innovation. The first pillar is product innovation. “If the product is not satisfying, people are not going to switch,” the speaker said. “In order to get there, we will need a very disciplined, science-based approach in understanding some of the questions underlying satisfaction. As we think about innovation and product innovation, it’s important for smokers to have a range of products to choose from.”
The second pillar is scientific innovation. There must be a comprehensive assessment of science to demonstrate that a product is APPH, and while all novel products tobacco products must be held to this high standard, it is rigorous and takes time. There are innovations in scientific methodologies that must be made, the speaker explained.
The speaker cited dissolution methods to understand nicotine release profiles and computation of toxicology as examples of tools that can help accelerate this pathway for getting products in the market. “Along with that, I think that regulators have an opportunity to create some innovative processes,” the speaker said. “For example, establishing product standards that will hopefully help these products be reviewed in an expedited manner, and most importantly, get them in the hands of consumers.”
The third pillar is communication. The industry needs to make clear the benefit to smokers by switching to noncombustible products. The industry needs to address the misperceptions surrounding nicotine and the wrong assumption nicotine causes cancer. “This clouds the decision-making process of adult smokers,” the speaker said. “As manufacturers in the U.S., we have to seek FDA authorization before we can communicate a modified-risk or modified-exposure order. That, too, is important but time-consuming and resource intensive. This is a responsibility for everybody to explore innovative communication approaches that can address these misperceptions.”
Another area ripe for innovation in the electronic nicotine-delivery system industry is environmental sustainability. For example, e-cigarette batteries contain heavy metals. The industry must innovate battery technology that will reduce their products’ environmental impact. Responsible disposal of any product is important. Regulation can also impact environmental issues. In the U.K., for example, requiring 10 mL bottles instead of larger bottles creates more waste.
Finally, synthetic nicotine also offers innovative advancements for next-generation products. “I think that when we talk about moving away from combustion, that is one thing, but when we talk about moving away from tobacco—in other words, giving consumers a truly tobacco-free option—that’s where science comes in,” a panelist explained. “The promise that is involved with synthetic nicotine is significant. They need to research it closely and recognize that it does provide certain benefits that perhaps the tobacco-derived nicotine does not.”
GTNF Keynote: Frank Han
The leader of FEELM said that exciting innovations are happening every day in the vaping industry.
By VV staff
During a keynote address for GTNF, Frank Han, senior vice president of Shenzhen SMOORE Technology Co. and CEO of its FEELM business division, said that there are exciting innovations—big and small—happening every day in the vaping industry. Vaping products using FEELM atomization technology have now reached millions of users in more than 50 countries.
Credit: Malcolm Griffiths
“Vaporization technology is still just at the beginning; we could welcome the opportunity for innovation to create a better life together … Basic Science Innovation has been the cornerstone for sustainable growth; it is the science of atomization that we need to build as the foundation supporting the industry,” he said, speaking through an interpreter. “As a firm believer of innovation, SMOORE has integrated disciplines like engineering thermodynamics and biomedical sciences into our atomization research.”
SMOORE has been actively learning to understand and assess the long-term health effects of vaping, according to Han. The company currently has seven research centers between the U.S. and China, “bringing in global talents” from different backgrounds. In addition to in-house R&D resources and efforts, SMOORE is also focused on partnering with leading universities to transform the company’s scientific discoveries into applied technologies. “The way vape products are manufactured is also constantly evolving; more effectively and definitely more environmentally friendly,” said Han.
SMOORE had begun operations using the first fully automated pod production line in the world. Each new manufacturing (single) line can produce 7,200 standard vaporizers per hour, double the previous generation’s output. “We have been working with business partners to improve sustainable practices in all stages of product development, especially manufacturing with the common goal of reducing carbon footprint,” said Han.
SMOORE is currently evaluating the underlying technology of atomization for its potential applications in other fields. “With one direction of our R&D focus on the atomization application in healthcare, I am proud that SMOORE has made progress on the research of atomized medication, along with partners from different sectors,” Han said. “The initial results are all positive. We are hoping in the near future, more and more people might be able to inhale medicines or even vaccines with atomization devices.”
Looking ahead at the vaping industry overall, Han said that policymakers and NGOs must be inclusive. Regulation has been a heated topic recently in both the U.S. and China, and while institutional innovations to promote healthy industry development and more balanced regulations are needed, regulators must also embrace vaping as a strategy to improve public health while safeguarding against youth initiation, he said.
“The global media must also be inclusive. We must value the media that report from an unbiased perspective, involving more people in the public dialogue on vaping, discussing the pros and cons and discovering the truth,” said Han. “I’d like to share an old Chinese saying here: ‘Though the road ahead is dangerous and difficult, we can only achieve our goals with constant efforts.’ We must press ahead with a sense of perseverance to expect a better future.”
Amanda Wheeler: NO SURRENDER
Her dreams and business crushed by a marketing denial order, Amanda Wheeler vows to continue the fight for vaping.
By Timothy S. Donahue
Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis at age 19, she was unable to quit smoking for another 11 years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.
Credit: Malcolm Griffiths
The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy. She joined several support organizations, including Arizona Smoke Free Business Alliance, Vaping Advocates of Oklahoma, Rocky Mountain Smoke Free Alliance, Smoke Free Alternatives Trade Association, American E-Liquid Manufacturing Standards Association and Vapor Technology Association.
In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.
Wheeler and the AVM assisted 230 e-liquid manufacturers that submitted PMTAs for more than 1.7 million products following a plan she developed with Azim Chowdhury, a partner with the law firm Keller and Heckman and a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation.
The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. The agency’s deadline to decide on all the applications was Sept. 9, 2021. When Wheeler’s application was accepted, she felt confident that her business could survive and that the industry had a future.
As the deadline approached, however, Wheeler became anxious. The FDA was slow to release information before the deadline. Then, on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the small company she and her husband had built, along with the industry she passionately defended, out of business.
That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.
That’s how Wheeler found herself on the global stage, sharing her story with some of the largest players in the nicotine industry at the recent GTNF conference in London.
“[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”
Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.
“My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler. “Their freedom as Americans no longer includes the right to use a product with none of the well-established, deadly effects of those other substances, and which has undoubtedly saved the lives of countless former smokers.”
Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.
She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said. “In this malign effort, those activists had enthusiastic help from nearly the whole of the national news media. By focusing on the messaging of Bloomberg dark money NGOs [nongovernmental organizations] and beneficiaries of MSA funds, our media and political class have criminally neglected the harm reduction aspects of vaping under the guise of moral virtue. The years added to their lives by our products are never mentioned.”
The misinformation plaguing the vapor industry has been around since Hon Lik introduced e-cigarettes to a mass market in 2006. TheWall Street Journal, for example, recently ran a gushing story about a Truth Initiative advertising campaign that misleadingly asserts that vaping nicotine “can worsen symptoms of anxiety and depression.” There is no evidence to support the claim. According to Wheeler, the statement is also contradicted by studies on the Truth Initiative’s own website. The Journal article even quoted a Truth Initiative executive admitting that “it is unknown whether a causal link exists” between nicotine and those symptoms.
“Just last month, FDA records gathered by Freedom of Information Act laws revealed that America’s most preeminent news organization, the New York Times, would send its articles in their entirety and before publication, to FDA officials for review and feedback. Neither that reporter, Sabrina Tavernise, nor her editors have summoned the integrity to offer any explanation,” Wheeler said. “Remember, these are publications and outlets that routinely praised and awarded themselves for taking on Big Tobacco. And yet on a decision that has given Big Tobacco exactly what they wanted—a monopoly—they are silent. Marching arm in arm with the very businesses they once excoriated as merchants of death.”
The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.
“We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”
In the wake of marketing denial orders, many U.S. e-liquid manufacturers are turning to synthetic nicotine.
By Timothy S. Donahue
In 2015, Mitch Zeller, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), was asked what the FDA’s position was on synthetic nicotine. “I’ll let you figure that one out for yourselves,” he said, hinting that the agency would regulate it as a drug. Today, vaping products, especially disposable devices, using tobacco-free nicotine (TFN) are one of the fastest-growing segments on the market.
After the FDA began issuing marketing denial orders (MDOs) to companies whose premarket tobacco product applications (PMTAs) failed to satisfy the agency’s concern about youth use, many rejected applicants hinted that they would start using synthetic nicotine—nicotine made in a lab and not derived from tobacco—in their flavored e-liquids.
Vapor Salon, for example, announced on Facebook that it would be switching to synthetic nicotine less than 24 hours after the FDA ordered the company to remove its products from the market.
“The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement, which takes full effect on Sept. 9, 2021, with needing an approved PMTA or your product can no longer be sold,” the company wrote.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice after receiving a warning letter from the FDA. However, the brand resumed sales on its website in February of this year with an altered product. To get around the ban on its products, Puff Bar began using tobacco-free nicotine. As of this writing, Puff Bar continues to hawk its products both on its website and in convenience stores around the U.S.
Meanwhile, the popular online vaping retail website Element Vape.com has at least 11 brands offering several synthetic nicotine e-liquids in different flavors, including fruits, cereals and candies. Pioneer e-liquid manufacturer Five Pawns reformulated its vape juice using synthetic nicotine even before the Sept. 9, 2020, PMTA submission deadline.
“Synthetic nicotine products still must abide by nationwide age restrictions, but the Center for Tobacco Products lacks the ability to regulate them as ‘tobacco products,’” said Greg Conley, president of the American Vaping Association. “Unless and until the FDA authorizes a sufficient number of flavored products to keep current ex-smokers off of cigarettes, we will support efforts by small businesses to keep offering their products to adult customers.”
Tony Abboud, executive director of the Vapor Technology Association, said that synthetic nicotine has been available and on the market since as early as 2014, and while the FDA and U.S. Congress could have elected to regulate synthetic nicotine at any time, they have chosen not to confront the issue.
“If it wasn’t for the innovation of the vapor industry, cigarette companies would not today be saying, ‘We want to get rid of combustibles.’ Synthetic nicotine is simply the next level of innovation, and it’s not surprising the government is behind it. The [U.S.] government is always behind companies in any industry that is technological and that innovates,” explains Abboud. “There’s no surprise here. There’s no loophole here. There’s no evasion here. The marketplace is what the marketplace is. It’s up to the government to figure out if and how it wants to catch up.”
Credit: Myvisuals
Anti-tobacco groups, by contrast, vowed to halt the spread of synthetic nicotine. In a recent letter to the FDA, the Campaign for Tobacco-Free Kids (CTFK), the American Academy of Pediatrics and the American Lung Association, among other organizations, argued that e-cigarette manufacturers are using “a loophole” to avoid government regulations.
“As FDA denies marketing applications for e-cigarettes, manufacturers are exploring using synthetic nicotine in order to continue marketing their products while avoiding FDA regulation,” the letter states. “This development makes it even more imperative that FDA take immediate action against illegal, synthetic nicotine products.”
Matthew Myers, president of CTFK, said synthetic nicotine is not a safer product, and his organization has sent at least three letters since 2018 to the FDA concerning synthetic nicotine products, none of which has received a response from the regulatory agency. “It is totally designed to circumvent government regulation,” he said. “The companies that have used nicotine derived from tobacco to [now] nicotine made in a laboratory are the companies whose products have been denied because of their appeal to youth and their lack of evidence that they actually help smokers quit.”
Conley said that there is a reason the CTFK’s and other letters have gone unanswered through two different presidential administrations. “Tobacco-free nicotine was invented to eliminate trace levels of impurities that are present in traditional nicotine sources, not to evade regulation. Rather than expanding the futile war on drugs to nicotine, we believe all nicotine products should be regulated as consumer products and sold only to adult consumers 21 years and over.”
Defining tobacco products
Whether the FDA will allow products with synthetic nicotine to stay on the market remains to be seen. Despite its growing popularity, the category current operates in a regulatory void. Because the product is not derived from tobacco, it does not necessarily fall under the 2009 Family Smoking Prevention and Tobacco Control Act or meet the requirements of the Federal Food, Drug and Cosmetic Act’s definition of a tobacco product.
When synthetic nicotine first appeared on the market in 2016, the product was marketed as a way to circumvent the FDA’s proposed deeming rule for next-generation tobacco products by at least one company. The FDA’s definition of “tobacco product” includes any product made or derived from tobacco [that is intended for human consumption], including any component, part or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to the FDA’s tobacco control authorities, according to the agency.
“However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product if it is not intended or reasonably be expected to be used in such a fashion,” the FDA states on its website. “[The] FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
In late 2016, Next Generation Labs (NGL), the maker of proprietary TFN Nicotine—nontobacco derived synthetic nicotine liquid and crystals—noted court statements made by the FDA in the NicoPure Labs LLC v. U.S. Food & Drug Administration that seemed to confirm that products not made or derived from tobacco fall outside of the FDA’s deeming rule.
Credit: NDABCREATIVITY
TFN claimed that in a response brief to the court dated Nov. 1, 2016, the FDA had stated that not all nicotine-free e-liquids (NFLs) were subject to the deeming rule. “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’—that is, if it is ‘intended or reasonably expected’ either … (1) to alter or affect [a] tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product; and is not an accessory,” the FDA was quoted as having said.
Experts have also said that the FDA could potentially assert jurisdiction over synthetic nicotine as a tobacco product and argue that, when the legislation was written, nobody had the foresight to think about synthetic nicotine. Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
Congress could eventually pass a nationwide ban on synthetic nicotine. A more likely scenario, however, according to industry insiders, is that individual states ban the sale of synthetic nicotine products. On May 17 of this year, the governor of Alabama signed into law Act No. 2021–453, which was backed by Altria, with that purpose in mind.
The legislation, which went into effect Sept. 1, states that “no e-liquid, e-liquid in combination with an electronic nicotine-delivery system, or alternative nicotine product that, in the case of any such product, contains synthetic nicotine or nicotine derived from a source other than tobacco may be sold or otherwise distributed” in Alabama if products have not been approved by the “FDA for sale as a drug, device or combination product.”
Abboud says vapor companies may not want to face the drug regulatory pathway. “Drug protocols are absurd, and if companies cannot even survive this PMTA process, then how would they ever possibly survive the other one?” he questioned. “Are you going to blame a company that spent millions of dollars trying to comply with [the] FDA’s opaque regulatory process, find that the FDA changed the rules at the last moment after the fact, and then and you’re going to criticize that company for doing something that’s currently lawful?”
For the time being, synthetic nicotine e-liquids will likely keep flavored e-liquids on the market despite the FDA’s efforts to remove them. However, Conley warned manufacturers against publicly advertising or celebrating their decision to switch to synthetic nicotine.
“A note to manufacturers planning to use TFN—don’t make public pronouncements about what you’re planning to do over the next month. Just do it,” he tweeted. “[The] FDA may have no respect for you, but there’s no need to blast them publicly. Plenty of harm reduction advocates can handle that.”
Sidebar
What is synthetic nicotine?
A major argument for synthetic nicotine is that it is safer than tobacco-sourced nicotine. The synthetic nicotine has no tobacco-specific nitrosamines (TSNAs), the harmful, cancer-causing chemicals found in combustible tobacco products. TSNAs are formed when tobacco leaves are grown, cured, aged and processed.
Research has shown that all nicotine is highly addictive, and regardless of the form, should be consumed with caution. However, the chemical does not directly cause cancer, which instead results from inhaling the byproducts of combustion.
Whether manufactured naturally or artificially, the nicotine molecule has the same chemical structure, C10H14N2, meaning that it comprises 10 carbon atoms, 14 hydrogen atoms and two nitrogen atoms. What makes it special, independent of its origin, is that it is a “chiral” molecule: It has two stereoisomers that are mirror images of each other.
The most prevalent form is (S)-nicotine, the physiologically active variant. Its mirror isomer, (R) nicotine, also occurs in plant-derived nicotine in small amounts but is considered physiologically ineffective. Synthetic nicotine is made with a combination of niacin, ethanol, sulfuric acid and a few other chemicals.
Traditionally, a problem for the producers of synthetic nicotine has been that the production process is both complicated and expensive. As a chiral molecule, nicotine is far easier to produce as a synthetic nicotine with equal amounts of both (R) isomers and (S) isomers compared to a nearly pure (S)-nicotine.
Naturally derived nicotine and synthetic nicotine are identical on a molecular level. The differences are the individual or potential impurities. Nicotine derived from tobacco can contain potentially harmful impurities. Purification can be difficult and costly because the impurities appear structurally very similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning, and none of the impurities are carcinogenic.
Currently, two types of synthetic nicotine are on the market: an (S) only synthetic nicotine and a 50 percent (S) and 50 percent (R) synthetic nicotine. In the early years of the vaping industry, the cost of the process to produce synthetic nicotine was prohibitively expensive when compared to tobacco-derived nicotine extraction methods.
Today, that’s no longer the case. Synthetic nicotine can be purchased for nearly the same price as tobacco-derived nicotine and in some instances for even less. This is due to advancements in the commercially scaled bulk production of synthetic nicotine for use in the tobacco, vaping, pharmaceutical and scientific research industries.
In November 2020, eLiquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), released its recently patented SyNic synthetic (S)-nicotine. Because SyNic has greater than 99.7 percent (S), an e-liquid needs only half the amount of SyNic to create the same effect for users as current 50/50 synthetic nicotine offerings on the market.
When it comes to government regulation, it’s sometimes hard to get the details right, according to Steven Greenhut in an opinion hew wrote for InsideSources. He says that the Utah Department of Public Health’s proposed new rules that would reduce the amount of nicotine that sellers and manufacturers can include in their “closed-system” electronic cigarettes derail harm reduction efforts.
Two years ago, the agency adopted a compromise that capped the amount of nicotine in closed vaping products at 5 percent. That 2019 rule attempted to protect consumers from the over-consumption of nicotine. But the 5 percent cap still enabled vape users to consume a sufficient amount of nicotine to satisfy their cravings. However, the newly proposed regulation would reduce the nicotine cap to 3 percent.
Greenhut states that the proposed rules could make consumers vape more than they do now, switch to open systems that allow the use of higher-nicotine liquids or even mix their own e-liquid recipes, raising a host of troubling health concerns. Some might even return to cigarette smoking.
“Regulators, at the behest of anti-smoking activists, are missing the forest for the trees—or at least overlooking the 7,000 carcinogenic chemicals that make traditional cigarette smoking so detrimental while focusing on one highly addictive but not particularly dangerous substance,” he states. “Many public-health advocates take a zero-tolerance approach toward anything tobacco or nicotine-related. They seek to ban—or overly regulate—e-cigarettes as a means to reduce availability. Their goal is abstinence, although they often support the use of Food and Drug Administration (FDA)-approved smoking-cessation products, such as patches and gum, that contain some nicotine.”
In their zeal to quash the use of vape and other lower-risk nicotine products, health advocates are endangering public health, explains Greenhut. “One needn’t be a health expert to realize that if nicotine-addicted people can’t get enough nicotine to fulfill their needs, they will try alternatives,” he states. “Utah already adopted a defensible approach to nicotine regulation. Maybe now, the best approach is to leave well enough alone.”
Steven Greenhut is Western Region director for the R Street Institute.
If you are struggling to work out whether you and your fellow human beings will be able to save the only planet on which we can live from being made uninhabitable by climate change, it is possibly because you are looking in the wrong direction for the answer—you are looking at the data, which, because it comprises complex inputs from many interacting sciences, is impossible for a layperson to interpret.
But never mind; I have cut through all this data for you and come to a conclusion that I believe is rock solid. No, we won’t save the world.
And to become a fellow believer, you need look no further for evidence than the existence of the powered leaf blower. That people, with the possible exception of the disabled, buy these things rather than brooms during a climate emergency engendered largely by the overuse of unrenewable energy provides indisputable evidence that humans refuse to engage their brains and, therefore, won’t—and probably shouldn’t—survive.
There is a man of my acquaintance who uses a powered blower to corral the leaves in his garden, which is the size only of one of those large, starched napkins beloved, for good reason, of spaghetti eaters, and at the front of his house, including the pavement, which forms a larger area.
It is fascinating to watch him because, like a dog rounding up sheep, he has to keep going back for stragglers, which are often stragglers only because they have been hit by a puff of wind, possibly caused, in part, by climate change, which, in turn, is being exacerbated by the use of the leaf blower …
But his offense is worse than this because, after corralling his leaves, he gets into his car, which is not much smaller than a bus capable of carrying half a dozen people and all their worldly goods, and drives off, alone, to the gym, contributing as he goes to the already high and probably illegal levels of pollution we happily maintain in these parts.
Credit: Good Ideas
He could have obtained a good level of exercise by wielding a broom at those leaves, but no, he prefers to burn fossil fuels driving down to the gym where he mounts an exercise machine manufactured using huge amounts of energy and materials dug out of the ground or manufactured so as to be, like Tithonus, cursed with an immortality not mitigated by eternal youth.
At least you would think that the machine he mounts would be connected to the gym’s power supply so that the work he does has some purpose. But no, this is a lesson in entropy, so the work he does is converted into heat that causes the gym’s air-conditioning system to kick in, burning more energy …
And as my acquaintance works on his machine, happily watching his pain and discomfort reflected back at him by giant mirrors, keenly monitoring on his wrist-mounted electronic device the state of organs whose position in his body he couldn’t identify, and listening distractedly to music delivered through sweat-encrusted headphones, his wife is vacuuming the house—getting rid of the dust that, in no small part, comprises small leaf particles created and driven into the air by the actions of her husband and his leaf blower.
Is this sensible? Of course, I admit that, even though there are a lot of people like my acquaintance and his wife, to a certain extent, what individuals can do to help ameliorate the climate emergency is a drop in the ocean compared with what could be done by businesses, industries and governments, but I think the situation would be helped if individuals showed a greater awareness of the problems we face and the sorts of actions that are plain stupid if the aim is to save the planet.
In that way, perhaps, they would be in a better position and more likely to put pressure on businesses, industries and governments to take action. After all, it would be awful to go out with a whimper.
There is no point in expecting politicians to act logically without their being pressured to do so because, as somebody nearly once said, people are governed by parliaments, not by logic. Unfortunately, we in the tobacco and nicotine industries are similarly governed—not by logic, but by governments largely swayed by half-baked ideas delivered by lobbyists, broken economic systems and pollsters, not to mention great dollops of hypocrisy.
So my eye was caught recently by the heading of a May 7 story by Sarantis Michalopoulos for EURACTIV.com based on an interview with Michele Rivasi, who was described as a French EU lawmaker from the group of the Greens/European Free Alliance (Europe Ecologie) of the European Parliament, MEP: E-cigarettes have a place in the EU Cancer Plan, but we must remain vigilant. Given this was a report based on an interview with a Green politician, I was keen to read it because I am interested in the environmental credentials of e-cigarettes, a subject that doesn’t seem to attract enough debate.
However, I was disappointed. This was another of those fence-sitting exercises in which the risk-reduction characteristics of e-cigarettes are acknowledged but in which it is said that nothing should be done to encourage their use, which seems to miss the point that if their use isn’t encouraged, then their risk-reduction potential remains hanging in limbo.
Credit: Balint Radu
“E-cigarettes ‘undoubtedly’ reduce risks compared to traditional cigarettes and have a place in the EU’s plan to fight cancer,” Michalopoulos quotes Rivasi as saying. “However, these products should not enjoy ‘lighter’ regulation, and Europe should treat them with the same vigilance as tobacco products. I see no reason why the electronic cigarette and its products should benefit from tax reductions or exemptions.”
What is being said here? Well, as I read it, nothing helpful or rational. Rivasi seems to be saying that traditional cigarettes and e-cigarettes are, at one and the same time, different but the same. These products are so different that e-cigarettes can be seen as part of the weaponry with which to fight cancer, whereas traditional cigarettes comprise part of cancer’s own armory. But, at the same time, they are so similar that they should be treated the same when it comes to regulations and taxes.
You have to wonder what Rivasi believes smokers will make of such a stance, if indeed it can be regarded as a stance. Most smokers, I imagine, make some kind of compromise in moving from traditional cigarettes to e-cigarettes, perhaps in respect of satisfaction, taste, convenience … Even so, in the early days of e-cigarettes, it was probably relatively easy to get smokers to convert because many of them were willing to make compromises simply on the basis that they were moving to a less risky product.
Now, in those countries where a significant level of conversion has taken place, it becomes necessary to try to reduce the compromises that must be made and, in this way, encourage more-committed smokers to convert. Tobacco and nicotine businesses tend to do this simply because they are in competition; they want their products to be more satisfying, tasty and convenient than those of their competitors.
But an important way of reducing the compromises that have to be made is through price—i.e., tax—differentials or through regulation, such as that allowing the use of e-cigarettes in at least some public places where traditional cigarettes may not be smoked. Lumping together traditional cigarettes and e-cigarettes in respect of taxation and regulation is simply ridiculous if the aim is to get smokers to transition to vaping. It sends out a signal that e-cigarettes do not offer a real health benefit.
Rivasi has more to say on products that to her way of thinking are similar. “For us, the Greens, if the use of electronic cigarettes is claimed to be an alternative to tobacco [use], as a substitute product or as a way of reducing the ravages associated with conventional cigarettes … we need to consider electronic cigarettes as a medical device in the same way as gum or patches are pharmaceutical products,” Michalopoulos reports Rivasi as saying.
I’m not sure whether a distinction is being made here between a medical device and a pharmaceutical product, but I assume not. So what seems to be being said is that if e-cigarettes are claimed to be a substitute for or alternative to traditional cigarettes, they should be treated as if they are nicotine-replacement products (NRTs), an idea that seems to ignore the fact that NRTs are not consumer products and therefore cannot be seen as substitutes for or alternatives to traditional cigarettes.
Again, the lack of logic drives you to impossible places. If, as above, it is claimed that NRTs are the same as e-cigarettes, which are the same as tobacco products, you have to assume that all three should be taxed at the same level and subject to the same regulations. So, for instance, people shouldn’t be allowed to wear nicotine patches in enclosed public places.
Quite clearly, this would be ludicrous for a number of reasons, and the problem stems from trying to pretend that different things are the same. Traditional cigarettes and e-cigarettes are two similar but different consumer products, whereas NRTs are medical devices, even though, in the U.K., for instance, they have been licensed for harm reduction rather than just cessation.
During the interview, we get much else that seems to discourage the use of e-cigarettes. We get the EVALI (e-cigarette or vaping use-associated lung injury) distraction and a totally unconvincing passage about what Rivasi sees as the gateway vaping provides to smoking.
Credit: Aleksej
Later, she is quoted as saying the shortcomings of legislation concerning heated tobacco and electronic cigarettes are known. “We need better regulation of sales and advertising, a thorough analysis of additives and their cocktail effect, a ban on flavorings and mandatory health warnings to alert nonsmokers to the risks, as is the case for traditional cigarettes,” she is reported as saying.
These are just throwaway lines. What does it mean to talk of “better regulation”? Better regulation to somebody steeped in tobacco harm reduction is going to look a lot different to better regulation as seen by those supporting a quit-or-die agenda while goodness knows what better regulation looks like to somebody perched on the fence.
And what is the point, apart from providing cover for science departments to carry out pointless “research,” in calling for a thorough analysis of additives while at the same time calling for a ban on flavors, which make up a huge proportion of those additives?
Towards the end of the reported interview, Rivasi moves to a favorite of politicians: the attribution to a group of a claim that the group has not made and then the condemnation of that claim. “The electronic cigarette is undoubtedly a product that can reduce risks, but it is not the panacea its followers—and the companies behind them—would have us believe,” she is quoted as saying.
I have never heard people who promote e-cigarette use over traditional cigarette use claiming such a move is a panacea. The panacea quip is another throwaway line and one that needs to be thrown away. Indeed, Rivasi knows as much. Earlier in the interview, she is quoted as saying, “The industry itself acknowledges its ignorance and wants to know more about the real impact of its products.” That doesn’t sound to me to be an industry claiming to have already developed a panacea.
There is something odd here. As I mentioned above, there is no mention in the interview of the area of the e-cigarette debate to which Rivasi could, I assume, make a valuable contribution. How do you compare the environmental impacts of traditional cigarettes, e-cigarettes, other new generation products and NRTs?
The major problem is that politicians often believe they need to fuss around tidying up the lives of smokers and nicotine users without considering the wider picture. They are like my acquaintance and his use of the leaf blower. In fact, I would much sooner hear Rivasi talking about leaf blowers and patio heaters … There is no point in extending by a few years the lives of some smokers if we’re all going to die prematurely of pollution and the effects of climate change.
