Tag: synthetic nicotine

  • Into the Void

    Into the Void

    Credit: Billion Photos

    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.

  • Zanoprima Begins Commercial Production of SyNic

    Zanoprima Begins Commercial Production of SyNic

    Zanoprima Lifesciences announced the commercial production of its SyNic brand of synthetic (S)-nicotine. The company said SyNic is produced using a patented process that does not involve the use of tobacco or any synthetic racemic mixture. The company manufactures “high purity (typically 99.9 percent), synthetic (S)-Nicotine for commercial use” that is free of tobacco-specific nitrosamines(TSNAs), toxins, carcinogens, odor and harsh taste.

    “This is a landmark development for the trillion-dollar tobacco industry and its 1.3 billion consumers as it heralds the arrival of a superior, substantially lower-risk, cost-effective, and greener alternative to a global industry that is arguably the single biggest avoidable cause of death globally, a press release states. “SyNic Protonated (S)-Nicotine e-liquid for e-cigarettes is without any potentially harmful ingredients such as organic acids and propylene glycol. It is pure, stable and has a long shelf life. E-cigarettes that use SyNic offer a smooth taste and enhanced nicotine experience, a distinct advantage given the nicotine limit guidelines/rules in e-liquids in the EU and other geographies.”

    SyNic (S)-nicotine conforms to and exceeds European Pharmacopeia (EP) and United States Pharmacopeia (USP) specifications. The company states that its “Green Chemistry” principles compliant production process minimizes the environmental impacts of nicotine production. Applications include:

    Zanoprima owns patent applications or registration for its revolutionary manufacturing process in several countries, including the United States, Europe, Great Britain, Australia, China, India and others, according to the release.

    SyNic is also available in products such Znus, a tobacco-free white snus that is completely sodium and tobacco-free and next-generation chewing gum and lozenges that “contain a new proprietary nicotine complex with superior bioavailability and taste,” according to the release.

    The company has also announced it will soon release tobacco-free heated nicotine products unlike existing tobacco-based heat-not-burn products and skin-friendly transdermal patches for use with Alzheimer’s and dementia patients. As a responsible synthetic nicotine (SyNic) manufacturer Zanoprima will distribute SyNic in strict compliance with regulations in each of its markets, globally.

    “Zanoprima offers the entire range of products including SyNic (S)-nicotine bitartrate (Nicotine Bitartrate Dihydrate), SyNic (S)-Nicotine polacrilex resin/Nicotine resinate and its novel proprietary (S)-Nicotine complex,” the release states.

  • Bidi Vapor Wants FDA to Ban Synthetic Nicotine Products

    Bidi Vapor Wants FDA to Ban Synthetic Nicotine Products

    Photo: Andrii

    Bidi Vapor is pushing for a ban on the marketing and distribution of synthetic nicotine in the United States, the company’s exclusive distributor, Kaival Brands Innovations Group, reported in a press release. The company, which manufactures a synthetic nicotine based smokeless pouch, insists synthetic nicotine should be classified as an unapproved drug and thus be subject to applicable Food and Drug Administration drug regulations.

    Bidi Vapor appears to be betting that a ban on synthetic nicotine pouches will benefit sales of its tobacco-derived nicotine pouch, which will be subject to the FDA premarket tobacco product application (PMTA) process before it can be distributed in the U.S. The reviewing process will further delay the launch of the tobacco-derived nicotine pouch, which had already been postponed due to Covid-19, according to Bidi Vapor.

    Following the FDA’s rejection of numerous PMTA’s earlier this month, many companies have set their sights on synthetic nicotine, a legal grey area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product”—a position suggesting that synthetic nicotine remains outside its remit.

    Bidi Vapor is now taking the opposite approach.

    “We believe that the delay in the distribution of the Bidi Pouch in the U.S. will lower revenues in the short term. However, we believe that in the longer term, the removal of all synthetic nicotine products in the U.S. market could prove to be a positive event for us,” the company wrote.

    “Based on the FDA’s PMTA decisions related to disposable ENDS products, we anticipate that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s PMTA process. Conversely, we believe that many other ENDS manufacturers are utilizing synthetic nicotine as a loophole to avoid the rigorous PMTA process and that if synthetic nicotine is deemed to be an unapproved drug, the FDA will need to regulate synthetic nicotine products as unapproved drugs, or remove them from the market, in order to enforce and bolster compliance requirements.”

  • Firms Embrace Synthetic Nicotine After FDA Rejections

    Firms Embrace Synthetic Nicotine After FDA Rejections

    Photo: Martinmark – Dreamstime.com

    Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.

    The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.

    “VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “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 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”

    According to Filter, more manufacturers have begun looking at the possibility of synthetic nicotine as a way to avoid having to comply with FDA regulations.

    The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

    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 tobacco product or push for synthetic nicotine to be regulated like any other drug.

    Because synthetic nicotine is more expensive than the natural variety, a switch would likely result in higher prices for consumers. Vapor Salon indicated that many of its redesigned products will now have “an upcharge,” according to Filter.

  • Australian Patent for Next Generation’s Synthetic Nicotine

    Australian Patent for Next Generation’s Synthetic Nicotine

    Image: Zerbor

    Next Generation Labs has received an Australian patent for its innovative use of combinational ratios of synthetic R- and S-isomer nicotine in tobacco cessation products.

    “This patent gives Next Generation Labs additional IP protection as the company pursues its international effort to encourage the adoption and use of novel synthetic combinational R-S isomer nicotine, to assist consumers in their desire to break away from tobacco use and their long-term dependence to the reportedly highly addictive S-isomer nicotine,” the company wrote in a statement.

    Next Generation Labs started producing bulk synthetic nicotine in 2014, at a time when there was no commercial availability of isolated R- and S-isomer nicotine. Given that both isomers can be produced in abundance by Next Generation Labs at relatively low cost, industry partners can now access separated isomers for commercialization into products that may aid cessation, enhance quit success rates and moderate overall tobacco use, according to the company.

    “Next Generation Labs believes future combinational R- and S-isomer nicotine formulations may prove to be less addictive than natural or biosimilar standalone S-isomer nicotine, and could potentially help achieve the broader public health goal of providing adult consumers with a satisfying, but non-addictive form of nicotine to replace current products,” the company wrote. “These new variable isomeric ratios of synthetic nicotine products may ultimately assist adults in quitting or reducing their overall dependence on current tobacco, vape and nicotine products that deliver only the purported highly addictive ‘S’ form of nicotine.”

    The granting of the Australian TFN R-S nicotine cessation patent is in addition to existing Next Generation Labs patents that have been issued in China, South Korea, Japan, Canada, Europe and the United States.

  • Next Generation Labs Receives European Patent

    Next Generation Labs Receives European Patent

    Photo: tashatuvango

    Next Generation Labs has received a European Patent (No. 3209653), for its proprietary technology related to the preparation of R-S isomer nicotine.

    “This patent grant by the European Patent Office is a significant milestone for Next Generation Labs, as it solidifies our tobacco-free synthetic nicotine intellectual property portfolio across a number of European countries, allowing the company to better enforce its rights against violators and counterfeiters of its industry leading TFN branded synthetic nicotine,” Next Generation Labs wrote in a statement.

    “Alongside our announcement of patent grants in China, Australia, and Canada, and the enforcement efforts of our strategic partner NextEra in South Korea, we are now even better positioned to take direct action against companies violating our patented nicotine production process in an additional 38 countries.”

    Next Generation Labs says it was the first company to successfully scale the bulk manufacture of non-tobacco synthetic nicotine for use in novel non-tobacco products, such as vape liquids and pens, in heat-not-burn devices and in many modern oral nicotine products, as well as in innovative pharmaceutical nicotine cessation products.

    “Our company believes that consumers have a right to access non-tobacco derived nicotine as a matter of choice,” Next Generation Labs wrote.

    “There are many adult consumers who wish to enjoy nicotine, but want to do so without the lingering and potentially detrimental effects of long-term tobacco use. The introduction of TFN branded synthetic nicotine has created a liberating opportunity for consumers, who as a result of Next Generation Labs nicotine technology, are now able to achieve a complete break from tobacco as they enjoy many of the leading brands available on the market today that use TFN.”

  • Synthetic Nicotine Patent Approved in China

    Synthetic Nicotine Patent Approved in China

    Photo: Michal Jarmoluk from Pixabay

    The China Patent Office has approved Next Generation Labs’ (NGL) patent application covering the process for the preparation of R-S [synthetic] nicotine, issue number 201580069647.2.

    The approval will give NGL the ability to better enforce its intellectual property rights. NGL is the world’s largest manufacturer of S-isomer, R-S isomer and R-isomer synthetic nicotine sold under the registered brand name TFN.

    According to NGL, the U.S. and Korean markets have been inundated with dozens of fake synthetic nicotine products and brands, and many manufacturers have misleadingly labeled bulk pure nicotine, bulk vape liquid mixtures and vaping and oral nicotine products as made with TFN. In many instances, the nicotine contained in these products is not synthetic, tobacco-free or non-tobacco, but is in fact derived from tobacco sources.

    For almost a decade, NGL has spent considerable effort establishing a strong global intellectual property portfolio that has become distinctive of the company’s goodwill and of the high-quality adult consumers expect of TFN-branded nicotine.

    NGL now intends to fully enforce its rights against many of these so-called synthetic nicotine brands.

    Next Generation Labs

    NGL has been taking direct action in the United States and through its sole South Korean distribution partner NextEra to limit the misleading claims of unscrupulous sellers of pseudo-synthetic nicotine, and against manufacturers and brand owners who misrepresent that their product contains TFN branded synthetic non-tobacco-nicotine.

    “With the assistance of the Chinese authorities, NGL now intends to fully enforce its rights against many of these so-called synthetic nicotine brands at their point of manufacture, and will take the lead with national customs agencies to limit the flow of fake synthetic nicotine products at trade exit and entry points in China, the U.S., EU, UK, South Korea, India, Canada, and Australia,” the company wrote in a press release.

  • Next Generation Labs Expands Synthetic Nicotine Distribution

    Next Generation Labs Expands Synthetic Nicotine Distribution

    Photo: Martinmark – Dreamstime.com

    Next Generation Labs, the developer of the patented pure synthetic nicotine sold under the TFN brand, has expanded sales and distribution of its S, R-S and R isomer synthetic nicotine products to vape, oral smokeless and tobacco product manufacturers internationally.

    “TFN non-tobacco derived synthetic nicotine has increasingly become the industry benchmark for both quality and consumer acceptance in many branded nicotine alternative products in the U.S. market, select European countries, and in emerging novel-nicotine markets in Asia,” Next Generation Labs noted in a press statement

    “We are actively developing customized formulations of TFN S, R-S and R isomer nicotine for vaping products, nicotine portion pouch and novel reduced risk products such as herbal non-tobacco-alternatives and heat-not-burn products,” the company stated.

    In association with strategic partners in key markets, Next Generation Labs has also recently expanded availability of its isomeric TFN nicotine formulations direct to customers, or via certified compounding and formulating companies, both in bulk diluted freebase nicotine, or in nicotine salt formulations specific to individual market or brand owner requirements.

    In China, Next Generation Labs is working closely with vape device manufacturers, such as ITSUWA, to deliver authorized TFN formulations into vape devices for sales worldwide. In the USA, America Juice Co, has become a key formulator and shipper of customized TFN liquids to Chinese manufacturers of vape products. In India, Dholakia is formulating TFN nicotine into manufactured white label nicotine portion pouch products for customers in the USA and Europe. In South Korea, the EU and U.K., Next Generation Labs is direct shipping nicotine to formulators who onward sell to brand owners in their respective markets.

     

  • Disruptive Science

    Disruptive Science

    Credit: TTI

    A new version of synthetic nicotine eliminates the cancer-causing impurities in leaf-derived nicotine.

    By Timothy S. Donahue

    No tobacco-specific nitrosamines (TSNAs). A new synthetic nicotine coming to market has none of the possible cancer-causing impurities that are found in traditional leaf-derived nicotine. In November, eLiquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), will release its newly patented SyNic synthetic (S)-nicotine. The announcement has the potential to revolutionize next-generation tobacco products, such as electronic nicotine-delivery systems (ENDS), oral nicotine-delivery systems and heat-not-burn (HnB) products.

    SyNic USP/EP, SyNic nicotine bitartrate and SyNic polacrilex resin are manufactured in U.S. Food and Drug Administration (FDA)-registered facilities using current good manufacturing practices (cGMP). These products have confirmed purity levels of more than 99.9 percent, (S) levels of more than 99.7 percent and are free of TSNAs and carcinogens, according to eLiquiTech CEO George Cassels-Smith. “What is the value of noncarcinogenic nicotine base to any tobacco product manufacturer?” he asks. “What is a noncarcinogenic tobacco product portfolio worth to the tobacco consuming public? But high-purity, pedigreed natural nicotine will continue to have a large seat at the table nevertheless.”

    SyNic got its start seven years ago when e-LiquiTech began working with U.K.-based Zanoprima Lifesciences with the goal of developing a unique and patented portfolio of synthetic nicotine products. The group wanted those products to cover the entire nicotine value chain with a focus on next-generation tobacco products.

    E-LiquiTech, through TTI, is committed to Zanoprima to serve as SyNic’s global distributor and the manufacturer of record for synthetic nicotine bitartrate and synthetic nicotine polacrilex resin as well as proprietary SyNic e-liquid formulas. “Ensuring that synthetic nicotine is readily available is the right thing to do for our industry—and now also is the right time to do it,” said Cassels-Smith.

    Zanoprima holds the patent and eLiquiTech maintains the exclusive rights for global distribution to the tobacco and ENDS industries, but the product won’t be available to everyone, according to Cassels-Smith.

    “This will not be available directly to the consumer market. We will soon post a set of standards online that manufacturers must meet to purchase our synthetic nicotine,” he says. “This product is not intended to circumvent the rules governing the tobacco and ENDS industries nor evade regulation. We will not sell it to companies that have that intent.”

    SyNic will refrain from entering the highly contentious U.S. vapor market until its potential customers can show they have an accepted for review premarket tobacco product application (PMTA) submitted to the FDA’s Center for Tobacco Products. “Our objective is to work with the FDA, not around it,” says Cassels-Smith.

    When synthetic nicotine first appeared on the market in 2016, the product was marketed as being a potential way to circumvent the FDA’s proposed deeming rule for next-generation tobacco products. The FDA’s definition of “tobacco product” includes any product made or derived from tobacco, 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.

    Cassels-Smith says that Zanoprima has filed multiple global patents for its technologies and has also begun the process of filing drug master files with the FDA for SyNic nicotine, SyNic bitartrate and SyNic polacrilex resin. “Coupled with e-LiquiTech’s exclusive distribution, competitive pricing and carrying the e-LiquiTech guarantee, these products will be available only to responsible partners operating within the regulatory guidelines of the global tobacco industry,” said Cassels- Smith. “The synthetic nicotine is cleaner than naturally derived nicotine because it has no TSNAs. These nitrosamines have the potential to turn into carcinogens. SyNic will not have any nitrosamines and is 100 percent carcinogenic-free by design.”

    E-LiquiTech’s synthetic nicotine resembles its naturally derived cousin. Like a naturally derived liquid nicotine, e-LiquiTech’s new synthetic nicotine is more than 99 percent pure (S)-nicotine. This purity of (S)-nicotine has a better effect on the body, and SyNic carries fewer impurities than naturally derived nicotine that comes from leaf tobacco.

    “Nicotine exists in nature in two forms, (R) isomer and (S) isomer. One is basically a mirror image of the other, but the nicotine desired by vapers and smokers alike is the (S)-nicotine alone. Naturally grown tobacco contains over 99 percent (S)-nicotine, and the rest is very little (R),” says Cassels-Smith. “The body considers (R)-nicotine a filler with substantially less physiological effect. It’s considered a waste product, and [the body] does not absorb it. SyNic is slightly superior to the (S)-nicotine content found in a naturally derived nicotine because of its higher levels of (S)-nicotine with qualified and quantified impurities.”

    Traditionally, a problem for the producers of synthetic nicotine has been that the entire 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. “(R)-[nicotine]/(S)-nicotine requires additional refining processes, which [are] time consuming and expensive to convert it to a true synthetic (S)-nicotine,” explains Cassels-Smith. “Also, because (R)-nicotine has substantially [fewer] physiological properties, it takes twice as much 50/50 synthetic nicotine in an e-liquid to achieve parity with SyNic. Because SyNic has greater than 99.7 percent (S), it only needs half the amount of SyNic to create the same effect for users as current synthetic nicotine offerings on the market.”

    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 if it is not purified sufficiently. That can be very 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 are carcinogenic.

    SyNic, by design, carries no heavy metals and contains no residual pesticides. Additionally, unlike tobacco-derived nicotine that uses harsh acids and chemical solvents in its process, SyNic, is produced using a “green chemistry” method. “Its manufacturing is environmentally friendly, and any solvent used is recovered completely before being recycled for future use,” explains Cassels-Smith. “The SyNic process makes the tobacco-derived nicotine process appear dirty by comparison.”

    SyNic will help manufacturers meet the FDA’s goals by consistently creating high-quality nicotine to deliver to the consumer without the possibility of potential carcinogens, according to Cassels-Smith. “We will allow vaping products to have the cleanest delivery and the best delivery,” he says. “That isn’t going to happen with the old technology. SyNic is a new frontier and a perfect tool for this industry to reinvent itself. It is constantly developing and reinventing itself. This product can help make all tobacco products better.”

    Because of its unique patented process, Cassels-Smith says SyNic can achieve price parity with tobacco-derived nicotine. He adds, however, that this synthetic product will always be marketed at a higher cost than naturally derived nicotine to ensure there will always remain a naturally derived pedigreed nicotine market where the tobacco farmer can sell his crops.

    “We have a lot of respect for the natural product and foresee our synthetic nicotine being a compliment to those that wish to remain all natural. There is enough room in the market for everybody. SyNic, with its known qualities, will have a place at the table alongside pedigreed natural tobacco-derived nicotine. But there are issues with nicotine sourced from scrap and dust as traceability is impossible and controlling pesticide and heavy metal contamination is problematic,” Cassels-Smith explains. “I foresee a future requiring the tracing of [natural] nicotine’s origin from the seed and soil through the extraction process and also quantifying impurities, all in cGMP facilities.”

    SyNic’s potential is unlimited in the number of products in which it could be used. Cassels-Smith says that he cannot think of a single nicotine product that could not benefit from SyNic. In a heat-not-burn product, for example, during the rod-making process, SyNic could augment the prevalent nicotine source—or even be the sole source.

    “Zanoprima has adapted their SyNic technology and patented an extremely unique and stable nicotine salt that does not use organic acids and retains pH stability,” he says. “SyNic also has the potential for being associated with superior purity and shelf life stability in all tobacco products of the future. SyNic will raise the bar, and we are just scratching the surface. It is a great tool that emerges at the perfect time for every tobacco product designer. The portfolio of potential products that can utilize SyNic is infinite.”

  • Warning Against Fake Synthetic Nicotine

    Warning Against Fake Synthetic Nicotine

    Photo: Liliya623 | Dreamstime.com

    Next Generation Labs, a producer of synthetic nicotine, is advising the vape industry to be wary of recent claims by numerous Chinese manufacturers regarding the availability of synthetic nicotine for use in recreational adult vaping and other nicotine containing products.

    According to Next Generation Labs, many of these brands are potentially violating the company’s nicotine manufacturing process patent or trademarks, or are counterfeit, fake, mislabeled, or are potentially misrepresenting their synthetic base material as being “not made or derived from tobacco leaf, stem, stalk, root, flowers or waste,” when they actually are tobacco-derived.

    Over the past six years, Next Generation Labs has invested heavily in strengthening its intellectual property worldwide. In a press note, the company said it will act against any company that may violate its process patents for the manufacture of synthetic nicotine.