Category: Nicotine

  • Biden Administration Presses Ahead With Low-Nicotine Rule

    Biden Administration Presses Ahead With Low-Nicotine Rule

    Photo: Jaroslaw Grudzinski

    The U.S. government is moving ahead with a plan to mandate significant reductions of nicotine levels in cigarettes, reports The Wall Street Journal. Proponents believe the measure, which was unveiled this week as part of the government’s regulatory agenda, will prompt millions of Americans to quit smoking and prevent countless of others from taking up the habit. The administration decided to embrace the reduced-nicotine policy as part of President Biden’s Cancer Moonshot initiative, which aims to reduce the cancer death rate by at least 50 percent over the next 25 years.

    Implementation, however, is likely still years away. The FDA plans to publish a proposed rule in May 2023, after which it would invite public comments before publishing a final rule. Tobacco companies could then sue, which could further delay the policy’s implementation.

    The policy would apply to all cigarettes sold in the U.S. Imports of cigarettes with “normal” nicotine levels would be barred but multinational tobacco companies could continue to sell full-nicotine cigarettes in other countries. New Zealand’s Ministry of Health also has proposed a reduction of nicotine in cigarettes to very low levels as part of a broader plan to curb smoking.

    Health advocates have long pushed for lower nicotine levels, arguing that it would prevent future generations from becoming addicted to cigarettes, and prompt current smokers to quit. In 2009, the Family Smoking Prevention and Tobacco Control Act authorized the Food and Drug Administration to mandate such a change—with the stipulation that the policy be based on scientific evidence.

    Research funded by the FDA and National Institutes of Health has shown that when nicotine was nearly eliminated in cigarettes, smokers were more likely to quit or seek their nicotine fix from less harmful alternatives such as e-cigarettes or gum compared with smokers who continued using cigarettes with normal nicotine levels.

    According to estimates published in the New England Journal of Medicine, mandating a reduction of nicotine levels in cigarettes to very low levels would prompt an additional 5 million adult smokers to quit within a year of implementation.

    According to an FDA study published in 2018, such a rule would prompt an additional 13 million adult smokers to quit within five years of implementation.

    “Nicotine is powerfully addictive,” said FDA Commissioner Robert M. Califf  in a statement. “Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives. The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit.”

    Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit.

    Robert M. Califf, Commissioner, FDA

    Not everybody is convinced of the wisdom of a low-nicotine policy. Critics, such as Counterfactual Director Clive Bates, have cautioned that a reduced-nicotine mandate is unlikely to achieve its objectives. Some have suggested that the measure could lead people to smoke more, rather than less, because smokers would need a larger number of cigarettes to satisfy their nicotine cravings. This, in turn, would cause them to inhale more of the cancer-causing substances generated by combustion. Critics have also warned that requiring low-nicotine cigarettes would boost the illicit tobacco market.

    Cigarette companies also say it would take years for them to develop a very low-nicotine cigarette and that it wouldn’t be feasible to manufacture at scale. In the past, tobacco companies have made low-nicotine cigarettes by stripping nicotine from the tobacco leaf. Some technologies rely on chemicals while others use microwaves to extract nicotine.

    22nd Century Group, a biotechnology company, uses genetic engineering to grow tobacco with about 95 percent less nicotine than a typical tobacco plant for a cigarette brand called VLN. In December 2021, the FDA authorized the marketing of 22nd Century Group’s VLN King and VLN Menthol King cigarettes as modified risk tobacco products.

    In a press release, the president of 22nd Century Group’s tobacco programs, John Miller, said the company was delighted by the Biden administration’s decision to move forward with the reduced nicotine mandate. “The FDA requiring tobacco companies to reduce the nicotine content in all cigarettes sold in the United States has long been seen as the most powerful tool in the fight to reduce smoking and its grave health effects on citizens,” he said.

    22nd Century has repeatedly said it is willing to partner with other cigarette companies to provide tobacco seeds.

    Tobacco Reporter profiled 22nd Century Group in its June 2022 issue (See “In the Catbird seat“).

  • Industry Braces for Reduced Nicotine Policy

    Industry Braces for Reduced Nicotine Policy

    Photo: chones

    The Biden administration intends to pursue a policy requiring tobacco companies to reduce the nicotine in all cigarettes sold in the U.S. to minimally or nonaddictive levels, reports The Wall Street Journal, citing people familiar with the matter. The policy could be announced as early as this week.

    Health advocates have long pushed for lower nicotine levels, arguing that it would prevent future generations from becoming addicted to cigarettes, and prompt current smokers to quit. In 2009, the Family Smoking Prevention and Tobacco Control Act authorized the Food and Drug Administration to mandate such a change—with the stipulation that the policy be based on scientific evidence.

    Research funded by the FDA and National Institutes of Health has shown that when nicotine was nearly eliminated in cigarettes, smokers were more likely to quit or seek their nicotine fix from less harmful alternatives such as e-cigarettes or gum compared with smokers who continued using cigarettes with normal nicotine levels.

    According to estimates published in the New England Journal of Medicine, mandating a reduction of nicotine levels in cigarettes to very low levels would prompt an additional 5 million adult smokers to quit within a year of implementation.

    The tobacco industry has cautioned that a reduced-nicotine mandate will lead people to smoke more, rather than less, because smokers would need a larger number of cigarettes to satisfy their nicotine cravings. This, in turn, would cause them to inhale more of the cancer-causing substances generated by combustion. Critics have also warned that requiring low-nicotine cigarettes would boost the illicit tobacco market.

    If the low-nicotine policy is indeed announced this week, it will still take several years to come into force. The FDA first must publish a proposed rule, then invite public comments before publishing a final rule. Tobacco companies could then challenge the rule in court, which could further delay the policy’s implementation.

  • In the CatBird Seat

    In the CatBird Seat

    Photo: 22nd Century Group

    A pioneer in nicotine reduction technology, 22nd Century Group is well-positioned as the FDA mulls a mandate for minimally addictive cigarettes.

    By Taco Tuinstra

    22nd Century Group appears to be a company whose time has come. With a fresh modified-risk tobacco product (MRTP) marketing order for its VLN (very-low-nicotine) cigarettes—the only such authorization granted to a combustible tobacco product to date—and a profound understanding of nicotine reduction technologies, the company is well positioned to benefit from the U.S. Food and Drug Administration’s plan to require tobacco companies to reduce the nicotine in their cigarettes to minimally addictive levels.

    22nd Century Group’s hemp/cannabis business, too, has been on a roll, boosted by spreading legalization of the product and new acquisitions. Tobacco Reporter spoke with John Pritchard, 22nd Century Group’s vice president of regulatory science, about the MRTP process, the company’s plans for VLN cigarettes and the company’s views on tobacco harm reduction.

    Congratulations on the MRTP marketing orders for your VLN cigarettes. What steps have you taken to commercialize the product since December? Please comment on your plans for the United States and South Korea. Why did you choose South Korea as your first foreign market? And what have you learned from your pilots in the U.S. and South Korea thus far?

    Since April 2022, we have launched our VLN cigarettes in 159 Circle K stores as part of a pilot program. Here, we can test our marketing mix to understand what the most effective way to reach adult smokers with our authorized product claims. Based upon the results of the pilot market here in the United States, we will be working closely with Circle K, our launch partner in the convenience channel, to further develop how to take the brand nationally and best appropriately service the 68 percent of adult smokers who want to smoke less.

    I am happy to report that some early learnings include: 1) A measurable percentage of VLN purchases are in the carton format, even within a high tax state. We believe this is because adult smokers who are committed to smoking less are believing in the brand proposition, understand the claims the FDA authorized VLN with and how the product can help them. 2) For many years, mainstream news publications have typically not or desired not to cover tobacco and nicotine products in their publications. However, given the unique proposition of VLN, it has received widespread coverage in the Chicago Tribune, Crain’s Chicago Business, Fox 32 Chicago, WBEZ and many other local publications. We were even acknowledged by the Chicago Medical Society’s president as a product that due to the FDA’s authorization and review of our materials is something doctors should be taking seriously with their patients.

    Our introduction to the South Korean market was centered around a variety of commercial and demographic criteria where one in three adult men are smokers. This market is in its early phases, and I look forward to providing detail as we move ahead.

    What other markets are you considering internationally? For example, are you eyeing New Zealand, which plans to mandate lower nicotine levels in cigarettes?

    We have currently launched VLN in South Korea. We absolutely commend the progress of the New Zealand government and their plans to reduce the harm caused by smoking as well as the wider initiatives they are pursuing. While no cigarette is a safe cigarette, VLN contains 95 percent less nicotine, the addictive component of cigarettes, and our proprietary tobacco genetics ultimately make possible New Zealand’s forward-thinking approach to harm reduction as well as compliance with such product standards there or elsewhere.

    That said, we are taking an iterative approach to our commercial expansion and [remain] focused on the importance of the U.S. pilot. Beyond that, we have identified numerous international markets that we are continuing to evaluate; at this point, we will not comment in detail about them just yet. We will, however, be attending the Intertabac Tradeshow in Dortmund, Germany, this fall and are looking forward to meeting with specialty tobacco distributors in attendance who would like to diversify their portfolio of products with a product authorized by the United States FDA to help adult smokers smoke less.

    You had been anticipating MRTP designation for some time. What actions did you take in the run-up to authorization to prepare for increased production and sales? Please comment on the expansion of your low-nicotine, tobacco growing operations, the installation of new testing equipment, partnerships with retailers and your move to a new headquarters.

    We were always highly confident that we would secure an FDA authorization, given the comprehensive scientific evidence base that has been established, both from our own research and the decades-long interest and clinical studies by health agencies and public health researchers. Moreover, we have established a strong regulatory and compliance function that has been fully supported by our executive team and board.

    Drawing closer to the final marketing granted orders, we built out our commercial team, bringing on board highly experienced individuals with a unique blend of knowledge of the tobacco sector and emphatic support for how the product could help adult smokers. These hires include industry experts and disrupters for our commercialization team, including John J. Miller, previously with Swisher International and UST; John Ellegate, previously of Kretek International and R.J. Reynolds; and Sam Morales, previously [of] Cannadips, Swisher International and Drew Estate.

    On the operations side, we’ve planted a record crop acreage this year to be able to support our national launch plans. We have also made substantial investments elsewhere in our manufacturing base. Our factory, for example, utilizes state-of-the-art manufacturing equipment, robust manufacturing processes and quality measures to be able to produce VLN reduced-nicotine tobacco cigarettes at the same speed and scale as conventional high-nicotine cigarettes.

    Please describe your experience going through the MRTP process. What was good about it, and what parts need improvement? What would you advise other players considering an MRTP application?

    Well, it wasn’t particularly easy—a classic British understatement—as those whom I worked with on the MRTP project know only too well. The modified-risk tobacco product application process is certainly the most rigorous and scientific process I’ve ever been a part of in my tobacco career. While it is a long and multistep process, we acknowledge that FDA had a vast amount of scientific literature to review—much of which was done whilst FDA managed the needs and disruption caused by Covid. This attention to detail and thorough review is essential because it allows the industry, the trade and—with product introduction—the adult consumer to have confidence and trust in the statements authorized by the FDA and how we describe our product.

    Since launching, we’ve seen numerous points of view published by the trade in regard to our product and its proposition to adult smokers—the rigor of the MRTP application process is incredibly important because it allows the FDA to have the loudest voice in the room, so to speak, and helps trade partners and adult smokers receive and understand messages which are truly based in science. I particularly enjoyed working with a range of subject matter experts and seeing their shared enthusiasm for what we were working to achieve. The profound public health impact of cigarette addiction in the U.S. and elsewhere was and remains a significant motivation for me and for the team.

    As for advice to other companies, I remain fully committed to reducing the harm caused by smoking, and [I] encourage all companies with appropriate products to utilize the MRTP application pathway. We are not a large company when compared to most U.S. tobacco interests and yet were able to navigate the complexities and challenges to bring something new and needed to adult smokers. Adults need access to and choice of alternative products that are supported by a robust evidence base, and we believe that having more MRTP-authorized products in the market will enable the industry to more rapidly move adult smokers to smoking less or to switch to using less harmful products [and] thus ultimately help end cigarette addiction.

    What, if anything, did you learn from the experiences of PMI and Swedish Match in the wake of their IQOS and General Snus MRTP authorizations? Will you market your product differently?

    In considering other MRTP applications, it was apparent that while there are statutory requirements that are cross-cutting for all applications, each individual product that has been authorized or that is currently under review by FDA raised different public health and scientific questions. To that end, it was important to recognize what FDA’s concerns were or could be and ensure that we responded earnest[ly] and fully to these with appropriate evidence.

    At the same time, we are grateful to the many researchers and experts within health agencies and academia for their meticulous work that contributed to the evidence base for our product, with many of such studies addressing key public health questions relating to reduced-nicotine content products.

    As I am sure you have seen recently, PMI has made an offer to acquire Swedish Match, including both the innovative modern oral ZYN brand and the heritage General Snus brand—this leaves 22nd Century Group as the only other company in the world with an MRTP authorization from the FDA. The opportunity between General Snus versus VLN is entirely different. General Snus provides an offramp for interested adult smokers to continue with their nicotine consumption but changes their form factor or modality greatly, thereby reducing their exposure to combustion.

    VLN provides a complete offramp from nicotine since each cigarette does not contain enough nicotine to create or sustain addiction, allowing the adult smoker to make the switch to VLN and to reduce their daily cigarette consumption. So in this regard, we do not see other MRTP products as direct competition so much as representing wider industry progress toward a future where cigarette addiction is no longer a public health disaster.

    Where do you see VLN in the constellation of reduced-risk products? How will VLN cigarettes help reduce the public health toll of smoking?

    It’s important to first understand that the industry has failed many adult smokers through its innovation to date. “But what about …?” I hear you say. Well, “one swallow does not a summer make,” and with over a billion smokers globally, there is clearly much to be done before the industry congratulates itself just yet.

    Moreover, much innovation is sold to wealthy countries and excludes poorer countries where some companies seem entirely content to aggressively market highly addictive cigarettes. While product innovations containing nicotine—including vapor, pouches, gum, lozenges—and other modern oral products have gone some way to reducing smoking, general mistrust of the industry, contradictory corporate activity as well as willful misrepresentation of the science by some well-known anti-tobacco groups all work against the consumer and by extension the public health interest.

    I am fully in favor of whatever means an adult smoker utilizes to help them reduce or cease their consumption of highly addictive combustible products. We should acknowledge that all responsible industry members share a similar end goal, but the path we take with our adult customers is demonstrably different; there is no “one size fits all.” I believe it is important that all product solutions that are backed by science and appropriately regulated must be made available to adult smokers to reduce the harm caused by cigarette addiction.

    Some tobacco harm reduction advocates contend that VLN’s MRTP diverts smokers from better choices, stating that “people smoke for the nicotine but die from the tar.” What is your response to such criticism?

    It’s always painful to see the industry as a whole posture and seek to create black and white narratives around an issue that is everything but binary. Nicotine gum was developed back in the 1970s and has doubtless helped many smokers even with the low efficacy of the product—and yet there are still more than $700 billion a year worth of cigarettes sold globally. The same can be said of vape technology, which has existed in multiple formats for over a decade. While millions have switched to vape, tens of millions of Americans still smoke highly addictive cigarettes.

    So for us, VLN addresses a unique adult smoker need, which is not asking the adult smoker to switch to a new form factor or modality in their journey but simply asking them to make a switch to [a] product that contains significantly less of the addictive substance in cigarettes. With over 50 clinical studies, and now the authorization by the FDA that VLN helps adult smokers smoke less, it is quite clear to me that the criticism is not based on the science of our product.

    Criticism of our product approach or other options by some industry voices or their familiars may play well with the gallery at conferences or other echo chambers but does not serve the interests of the individual smoker and so is ultimately self-defeating, despite their self-styled tobacco harm reduction approach. You know who you are.

    I would encourage all adult smokers to use whichever product or products they feel will best help them end their use of highly addictive cigarettes and, as always, people concerned about their cigarette addiction should speak with their healthcare providers – as they can provide access to a range of other Rx product options. Our goal is simple: to make VLN available as a choice to adult smokers alongside other appropriately regulated alternative products that make up the MRTP set; people want and deserve options not dogmatic opinions.

    22nd Century has repeatedly said it is willing to license its reduced-nicotine tobacco technology to other cigarette manufacturers. Has the industry expressed interest?

    You’ll appreciate that at this time, I will not be sharing specific details. What I can say is that since the FDA has announced its intention to ban menthol cigarettes along with flavors in other tobacco products, we have had an incredible amount of outreach from the industry and trade. It’s really exciting to see new participants, such as convenience chains, drug stores and grocery stores, from across the United States paying attention to the FDA, the FDA’s goals and ultimately products like ours that align with the FDA’s goals as well as their corporate ethos. We are committed, as ever, that when the United States and other countries bring in limits for nicotine content in cigarettes, we will license our tobacco genetics to the industry to enable their compliance with such requirements.

    After announcing its intention to reduce nicotine levels to minimally addictive levels in 2017 and again referring to the concept when it first announced plans to ban menthol in the spring of 2021, the FDA appears to have gone quiet on the plan again. Do you expect the FDA to enact a nicotine standard in the near future, and how important is such a standard to the success of VLN cigarettes?

    While I cannot speak directly or indirectly for the FDA, I believe the FDA is taking the appropriate steps by focusing its efforts on the ban of high-nicotine menthol cigarettes. While some parts of industry will doubtless challenge this, they should recall that their own actions have led to the need for such regulation to be considered in the first place.

    I believe the elimination from menthol in highly addictive cigarettes is an important step to reducing the attractiveness of highly addictive tobacco or nicotine to youth, a view which should be shared by industry participants as a key concern as it is for the FDA.

    I am confident that we will see a nicotine standard in the coming years as appropriately regulated alternative products become increasingly available as well as a shift in public health messaging relating to such products. At this juncture, we see that our genetics and intellectual property are uniquely able to support such forward-thinking and pioneering harm reduction effort, which will save millions of lives, and we are excited to play our part in this vast public health opportunity.

    In a press note dated April 29, 22nd Century Group said it expected its VLN Menthol King reduced-nicotine cigarette to be exempted from the FDA’s proposed ban on menthol cigarettes. Please explain why you expect this to happen.

    We expect that the FDA will allow for a reduced-nicotine menthol cigarette to stay on the market in order to provide an offramp for adult smokers who currently use menthol cigarettes. In authorizing our MRTP applications, FDA was clear that such products have a role to play in both menthol and nonmenthol product styles to reduce their consumption of nicotine-containing products. With so many individuals smoking menthol cigarettes, we think it is prudent for the FDA to allow those smokers more options and not less to help reduce their exposure to nicotine and products containing nicotine.

    Where do you see 22nd Century Group five years from now? What are the challenges that need to be overcome to achieve that vision?

    Most people know the company for its leadership in reduced-nicotine tobacco technology; however, this is only one part of our business. Recently, we acquired GVB Biopharma, a contract development and manufacturing organization. GVB is one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage. GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas and cultivation capabilities at Needle Rock Farms. The combination with 22nd Century establishes a global one-of-a-kind company to serve the rapidly growing hemp/cannabis ingredient market.

    Taco Tuinstra is Tobacco Reporter’s editorial director.Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors.On his watch, Tobacco Reporter has won several awards for editorial excellence.Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.
  • VTA and FDA Discuss Synthetic Nicotine

    VTA and FDA Discuss Synthetic Nicotine

    Photo: pressmaster

    The Vapor Technology Association (VTA) met with officials of the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) on May 2 to help clarify issues relating to synthetic nicotine. Premarket tobacco product applications (PMTAs) for synthetic products are due on May 14.

    “We presented a thoughtful case for synthetic nicotine products that, to our knowledge, had not yet been made to any policy maker,” the VTA wrote in a press note.

    During the meeting, scientists explained how synthetic nicotine is manufactured and how it differs from tobacco-derived nicotine. Expert speakers included Bill Jackson, (organic chemistry), David Johnson (physical analytical chemistry), Ray McCague, (organic chemistry), and Willie McKinney (inhalation toxicology).

    This is the VTA’s second meeting with the FDA following the signing into law of new legislation governing synthetic nicotine. While pleased with the level of engagement from the CTP, the VTA stressed its work continues.

    “These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs,” the VTA wrote.

    “If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.”

  • 22nd Pilots its Low-Nicotine Brand in Illinois

    22nd Pilots its Low-Nicotine Brand in Illinois

    Photo: 22nd Century Group

    22nd Century Group’s VLN cigarettes are now available through a national pilot in select Chicagoland Circle K stores, the company announced in a press release.

    Containing 95 percent less nicotine than conventional cigarettes, VLN cigarettes in December 2021 became the first combustible cigarettes to receive authorization from the U.S. Food and Drug Administration to be marketed as modified-risk tobacco products.

    When choosing Chicagoland for the pilot, 22nd Century noted smokers are found within every segment of the population, many of whom are looking for alternatives. The Centers for Disease Control estimates 15.5 percent of Illinois adults aged 18 years or older smoke cigarettes, higher than the national average of 12.5 percent, according to 2018 state and 2020 national statistics.

    A pack of VLN cigarettes will be similarly priced to full nicotine premium brands, approximately between $9 and $12, depending on tax. Illinois is the second most expensive cigarette retail market in the United States.

    The three- to six-month pilot will be the first U.S. sales of VLN King and VLN Menthol King cigarettes. 22nd Century is also launching VLN cigarettes in South Korea, its first international market. Following the pilot, 22nd Century and Circle K intend to expand sales nationwide to more than 7,000 stores in 48 states.

    On April 4, 2022, the Illinois Attorney General’s Tobacco Enforcement Bureau added 22nd Century Group’s VLN cigarettes to the Illinois Directory of Participating Manufacturers listing. The registration was the final step before 22nd Century could begin distribution.

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  • Synthetic Nicotine Applications Due Soon

    Synthetic Nicotine Applications Due Soon

    Photo: Brian Jackson

    Premarket tobacco product applications (PMTAs) for nontobacco nicotine products are due May 14, the U.S. Food and Drug Administration announced on its website.

    Legislation enacted on March 15 empowers the FDA to regulate tobacco products containing nicotine from any source.

    Effective April 14, not new nontobacco nicotine products may enter the market, as portions of  the new law take effect.

    The May 14 deadline applies to applicants using the FDA’s electronic submission process. Hardcopy applications must be received by FDA no later than 4 p.m. EDT on May 13.

  • What’s Next for Synthetic Nicotine

    What’s Next for Synthetic Nicotine

    Nveed Chaudhary (Photo: Broughton)

    Broughton’s Nveed Chaudhary explains how the FDA’s new powers to regulate synthetic nicotine will impact the industry.

    Contributed

    In mid-March, the U.S. Congress moved to close the loophole on the use of synthetic nicotine in electronic nicotine-delivery systems (ENDS) in the United States, bringing it into line with tobacco-derived nicotine products. In this article, Nveed Chaudhary, chief scientific and regulatory officer at Broughton, an independent life sciences contract research organization, explains what this regulatory change means for the next-generation nicotine-delivery industry in the U.S. market.

    What has happened in the U.S., and when will the changes take effect?

    The U.S. Congress has extended the Food and Drug Administration’s authority over tobacco products to include synthetic nicotine in products such as vapes, heated products and oral nicotine pouches. This will bring these products into line with tobacco-derived nicotine next-generation nicotine-delivery products. The new regulation was passed as part of a U.S. lawmaker’s long-term spending bill signed into law by President Joe Biden on March 15. It takes effect immediately, and manufacturers of synthetic nicotine vapes and oral nicotine pouches have 60 days from March 15 to submit a premarket tobacco product application (PMTA) dossier to keep their products on the U.S. market.  

    Was the industry expecting this regulatory change?

    The ENDS industry had been watching U.S. regulators with interest around this issue for some time and expected a change to come at some point. The speed with which it has been passed took the industry by surprise. It was included in a long-term spending bill that contained hot-button issues like funding for Ukraine, Covid support and regular government running expenses, enabling it to be passed without debate or amendment. That being said, U.S. lawmakers would possibly argue that ENDS manufacturers have had almost two years since the PMTA regulations were published to start collecting data on their products.

    What is synthetic nicotine?

    Synthetic nicotine, also called tobacco-free nicotine, is a synthesized form of nicotine produced via a chemical process instead of extraction from tobacco. Recent improvements in manufacturing processes have enabled producers to mimic the enantiomeric ratio of tobacco-derived nicotine. Synthetic nicotine is not new, with it first synthesized in 1904, but the production on a mass scale is relatively recent. Most e-cigarette manufacturers do not use synthetic nicotine because it tends to be more expensive than tobacco-derived nicotine. There is also far less infrastructure to create synthesized nicotine from scratch than the well-established facilities for harvesting nicotine from tobacco plant materials.

    Why have U.S. regulators chosen to close the synthetic nicotine loophole now?

    Previously, the FDA defined “any product made or derived from tobacco and intended for human consumption, including any component, part or accessory of a tobacco product” as a tobacco product. Under this description, e-cigarettes containing tobacco-derived nicotine e-liquids were subject to the PMTA regulatory framework while those containing tobacco-free nicotine were not. However, some U.S. lawmakers and nonprofit organization lobbyists have long discussed closing this loophole because it enabled manufacturers to introduce tobacco-free nicotine products to the market without regulatory oversight. Following the publication of the recent National Youth Tobacco Survey (NYTS) data, there is particular concern about the youth usage of synthetic nicotine disposable vape products, e-liquid flavors and marketing, which the FDA has had no authority to challenge. As we saw with tobacco-derived nicotine ENDS products, there is rightly intense scrutiny around products that are found to be attractive to youth, and this has become an area of significant political focus in the U.S. The fact that it appeared that some manufacturers were using the loophole to get around regulatory control is likely to have increased the speed with which lawmakers felt they had to act.

    What can synthetic nicotine manufacturers do now?

    If a product is already on the market in the U.S., manufacturers have 60 days to file a PMTA. If a manufacturer was in the process of commercializing a new synthetic nicotine product in the U.S., they have a 30-day window to launch the product and then 30 days to file their PMTA. This 60-day deadline for data submission will be very challenging for most tobacco-free nicotine ENDS manufacturers to meet but may not be impossible. At Broughton, we are currently in discussions with several clients about the regulation and what they will need to do to submit a PMTA within the timeframe allowed.

    Is it possible to prepare a PMTA dossier within this short timeframe?

    We believe it is, but manufacturers need to act immediately, and there are no guarantees of success. Especially as many of the manufacturers who submitted PMTA dossiers for their tobacco-derived nicotine ENDS products still don’t know if they have passed the FDA requirements to be awarded a marketing authorization. The first question is how much data a synthetic nicotine ENDS manufacturer already has available about their product and then to build analytical studies to fill gaps to file an adequate submission in the timeframe available. There is always a possibility that the FDA wants to close this NGP (next-generation product) market area completely, but that seems unlikely. It’s more likely they want to ensure that tobacco-free nicotine products are regulated in the same way tobacco-derived nicotine products are. Responsible manufacturers should welcome this opportunity to prove their product’s quality, safety and efficacy in relation to tobacco harm reduction objectives.

    What will be the long-term impact of FDA authority over synthetic nicotine products?

    The industry has been debating how governments will respond to regulating synthetic nicotine products for some time. It isn’t made from tobacco, but how else could lawmakers regulate it? It’s a classic dilemma for regulators; needing to respond to a technical innovation quickly, having less information than the industry it’s regulating, and then relying on existing regulation to act quickly and fill the gap. This has been the problem for the entire next-generation product category. We believe that all nicotine-containing products, regardless of tobacco-derived nicotine or synthetic-derived nicotine, should be treated in the same way. Regardless of where the nicotine comes from, the impact on population health needs to be measured in a consistent way. Synthetic nicotine is still not cost-effective to manufacture, and only a few companies currently produce synthetic nicotine due to patents around the manufacturing process. It’s estimated that synthetic nicotine is up to 13 times more expensive to manufacture than tobacco-derived nicotine. It will be interesting to see if ENDS manufacturers now abandon using synthetic nicotine because of the regulatory change or stick with it. A large part of this may be decided by how the FDA evaluates the PMTA submissions they receive and if there appears any difference in how synthetic nicotine and tobacco-derived nicotine PMTA applications are evaluated.

    This article was contributed by Broughton, an independent life sciences contract research organization.

  • E-LiquiTech: Synthetic Nicotine in Stock

    E-LiquiTech: Synthetic Nicotine in Stock

    Photo: Tobacco Reporter archive

    E-LiquiTech says it has large quantities of Zanoprima’s SyNic in stock to help companies introduce new products to the U.S. market ahead of the mid-April deadline imposed by a new law.

    On March 15, 2022, President Joe Biden signed into law a spending bill that includes a provision to regulate products containing synthetic nicotine the same as products containing tobacco-derived nicotine. This means that companies selling products containing synthetic nicotine will be required to file a premarket tobacco product application in order to keep their product(s) on the market. The deadline for filing such applications is less than 60 days away.

    According to E-LiquiTech, SyNic is the same chemical composition of (S)-nicotine as natural tobacco-derived nicotine but without any of the impurities. Specifically, SyNic achieves a purity profile of 99.9 percent and is devoid of tobacco-specific nitrosamines, heavy metals and other impurities that are present in tobacco-derived nicotine.

    SyNic is manufactured through a patented process in a cGMP facility approved by the U.S. Food and Drug Administration and meets or exceeds the U.S. Pharmacopeia monograph, making SyNic a 1-to-1 replacement for tobacco-derived nicotine and enabling manufacturers to use it as a CAS number substitute, according to E-LiquiTech.

    The company says all of the scientific data that is applicable to tobacco-derived nicotine is equally applicable to SyNic. The manufacturing process is replicable from batch to batch, and every batch of SyNic is fully trackable and traceable.

    Earlier this month, Zanoprima filed a patent lawsuit against Hangsen International in the U.S. District Court for the Western District of Texas to enforce Zanoprima’s patented process for manufacturing (S)-nicotine, demonstrating its long-term commitment to the U.S. market.

  • FDA Gets Authority Over Synthetic Nicotine

    FDA Gets Authority Over Synthetic Nicotine

    Photo: The White House

    U.S. President Joe Biden on Tuesday signed into law a spending bill that gives the Food and Drug Administration authority over synthetic nicotine.

    The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

    The amendment comes into effect 30 days after the bill’s enactment. Manufacturers of products made with synthetic nicotine will then have an additional 30 days to submit a premarket tobacco product application (PMTA) to the FDA. If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market.

    According to Bryan Haynes, a partner with Troutman Pepper, the measure could amount to an effective ban on synthetic nicotine products. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years,” he wrote on the law firm’s blog.

    April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA) suspects the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill—and others like it—aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.

    “The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”

    The FDA appears keen to crack down on synthetic nicotine. During his Senate confirmation hearing, FDA Commissioner Robert Califf vowed to close what he described as the synthetic nicotine “loophole.”

  • Synthetic Nicotine Rule Clears Senate

    Synthetic Nicotine Rule Clears Senate

    Photo: lazyllama

    Synthetic nicotine products will soon require U.S. Food and Drug Administration marketing approval. The U.S. Senate approved a $1.5 trillion spending bill that includes language that changes the definition of a tobacco product to include synthetic nicotine. The legislation now heads to President Joe Biden, who looks forward to signing it into law, according to White House spokesperson Jen Psaki.

    Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal gray area, and many companies started using it after their natural nicotine products were denied market access by the FDA. 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 Food, Drug and Cosmetic Act, which includes the 2009 Tobacco Control Act, defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).”

    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.

    Amanda Wheeler, president of the American Vapor Manufacturers Association

    Proponents of the policy change refer to it as closing a loophole. “By using synthetic nicotine, e-cig companies are avoiding public health protections for flavored tobacco products and still hooking teens,” tweeted billionaire philanthropist Michael Bloomberg. “With millions of kids still using e-cigs, we must get synthetic nicotine products off the market.”

    Critics contend that, given the flaws and deficiencies in the FDA approval process, the new rules will likely result in the prohibition of products that smokers have been using to quit cigarettes.

    Amanda Wheeler, president of the American Vapor Manufacturers Association, said banning synthetic products will 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.