British American Tobacco on Monday officially launched its synthetic nicotine-based liquid e-cigarette, Nomad Sync 5000, in South Korea, the first market in the world to release the product.
The Nomad Sync 5000, available in sweet “Purple” and refreshing “Cold” flavors, offers up to 5,000 puffs with a liquid capacity of 10 milliliters and a nicotine concentration of 0.9 percent. Priced at around 17,000 won ($12), the product is now available at vape shops nationwide.
BAT Rothmans, the company’s Korean subsidiary, attributed the product’s Korean debut to the country’s regulatory framework, according to media reports.
“South Korea is the only OECD country where synthetic nicotine products are governed separately from natural nicotine products,” a BAT Rothmans official said. “This unique distinction provides a favorable environment for innovation and allows us to responsibly introduce products that meet high industry standards.”
Under Korea’s current tobacco laws, only products derived from tobacco leaves are classified as tobacco, leaving synthetic nicotine products exempt from taxes, health warning labels, advertising restrictions, and sales restrictions to minors.
Despite this regulatory gap, BAT Rothmans emphasized its voluntary compliance with local standards, including displaying health warnings and ensuring branding avoids youth appeal.
The government of South Korea aims to regulate synthetic nicotine as tobacco, reports the Yonhap News Agency.
The Ministry of Health and Welfare and the Ministry of Economy and Finance want to revise the Tobacco Business Act to include synthetic nicotine in the definition of tobacco.
Tobacco in South Korea is governed by the National Health Promotion Act, under the jurisdiction of the health ministry, and the Tobacco Business Act governed by the finance ministry.
The current rules define tobacco as a product “manufactured in a state suitable for smoking, sucking, inhaling steam, chewing or smelling, by using tobacco leaves as all or any part of the raw materials.”
That language fails to capture e-cigarette liquids made with synthetic nicotine, which is created in a laboratory rather than from tobacco leaves. As a result, vapes are not subject to product requirements, such as health warning labels, age restrictions and tobacco taxes, in South Korea.
The push for new legislation follows an announcement by British American Tobacco that it is mulling the launch of a new synthetic nicotine product in the country. South Korea is reportedly the only nation where the tobacco giant is considering a synthetic nicotine product.
“We have decided to push for the revision of the Tobacco Business Act when the 22nd National Assembly opens,” an official at the health ministry was quoted as saying. “We will provide necessary materials to the finance ministry and there is already an abundance of evidence proving that synthetic nicotine is tobacco.”
The consumption of e-cigarettes has been rising steadily in South Korea, reaching 16.9 percent of tobacco sales in 2023.
As consumer demand for healthier and more environmentally friendly alternatives to combustible cigarettes increases, we should expect greater focus on the benefits of this man-made alternative.
By Derek Yach
Tobacco-derived nicotine has been the sole source of nicotine used by pharmaceutical and tobacco companies until recently. The naming of the sector (tobacco sector), the naming of companies (British American Tobacco for example) and the framing of public health policies as tobacco control all show how pervasive and deeply embedded the word tobacco has become despite its scientific name being Nicotiana.
The dominance of tobacco plants started to wane when pharmaceutical companies developed nicotine-replacement therapies (NRTs) as cessation products. That highlighted the fact that while nicotine is addictive, it is not the source of death and disease caused by the products of combustion. The advent of a wide range of consumer-facing products that also use nicotine (especially e-cigarettes and nicotine pouches) to help smokers switch and/or quit has further increased the focus on nicotine.
Initially, there was no debate about the source of nicotine since it was assumed to come from the plant. In recent years, several companies have started using patented laboratory processes to develop nicotine from scratch. Many, like Zanoprima, use green chemistry to convert plant-based molecules into synthetic nicotine. Other companies, such as Contraf-Nicotex-Tobacco (CNT), begin with plant-based molecules used in cosmetics and derived from vitamin B.
Nicotine, like many molecules, exists in two orientations: S-nicotine and R-nicotine; however, nicotine that occurs naturally in the tobacco plant is entirely S-nicotine. Prior to the popularization of synthetic nicotine, this distinction had not been of great practical importance due to its naturally occurring form. Pharmaceutical-grade synthetic nicotine manufacturers such as CNT and Njoy therefore treat R-nicotine as a byproduct of the S-nicotine manufacturing process while Zanoprima’s patented process does not produce R-nicotine at all. Other manufacturers may use methods that may well not meet the high-quality standards of the pharmaceutical industry.
What Benefits Does It Bring to Consumers and the Environment?
Consumers increasingly demand information about the supply chain of end products. Leading food companies have led in being transparent about the source of all ingredients in their products with a shift toward those where labor conditions on the farm are known, addition of chemicals are reported, water and greenhouse gas use associated with products are made public and the traceability of food product ingredients is independently audited. Investors are more likely to invest in companies with sound records on these issues.
So it will be for all future nicotine products.
For many combustible users, the incentive to switch to a reduced-risk product usually starts with a desire to lower health risks. But for a considerable number, environmental issues are fast becoming reasons to switch, often independent of their health concerns. Again, this has its analogy in the food sector, where companies like Whole Foods have built their main value proposition on an environmental benefit, with health credentials being dubious.
The tobacco industry emits 84 million metric tons of carbon dioxide (CO2) a year, which is equivalent to 0.2 percent of global CO2 emissions, according to researchers at Imperial College London. Of the total, 20.87 million tons of CO2 come from cultivation, and 44.65 million tons of CO2 come from curing, together amounting to 78 percent of all tobacco industry emissions. Synthetic nicotine has the potential to virtually eliminate these.
Synthetic nicotine brings tangible benefits to consumers: A better sensorial experience, assurances about the absence of contaminants and a stamp of quality good enough for pharmaceutical companies, to name a few.
The recent World Health Organization report Tobacco: Poisoning Our Planet paints a vivid picture of the harms of tobacco farming, curing and processing for the environment. More recently, the Foundation for a Smoke-Free World provided a qualitative summary of the potential sources of environmental harm associated with reduced-risk products. Both the WHO and the foundation advocate for the reduction in global tobacco farming, outlining the harms caused by tobacco growth and cultivation on arable land, workers’ rights and malnutrition. It is likely that products created with synthetic nicotine can mitigate many concerns in the product lifecycle. And as companies selling clean nicotine push harder to ensure their products are recyclable and/or reusable, the overall negative environmental footprint will decline further.
Where Is It Likely to Grow Fastest?
Today, synthetic nicotine is used in next-generation nicotine products by emerging nicotine pouch companies like NIIN and by mainstream vape companies like Njoy. This trend is set to continue and will gain traction as e-cigarettes and nicotine pouch companies seek medical licensing using synthetic nicotine.
One example is SMOOD, an up-and-coming next-generation e-cigarette and NRT company based in New York City. SMOOD creates its products as a comprehensive approach to address both health and environmental issues simultaneously. Synthetic nicotine, recyclable hardware and design features to support smokers to quit may well be a signal of what is to come. “We always used nontobacco nicotine due to the absence of minor tobacco alkaloids and metals, both of which are inherent in agricultural production,” says Martin Steinbauer, chief engineer of SMOOD. “Together with repeatable pharmaceutical production processes, nontobacco nicotine improves the toxicological safety of our devices and eliminates carbon emissions, water use and deforestation from tobacco growing. Most importantly, it offers a clean break of nicotine from tobacco finally.”
Snus and heated-tobacco products are unlikely to shift away from tobacco in the medium term but are lowering the health risks of the tobacco they use through processing changes in the case of snus and by eliminating combustion in the case of heated-tobacco products. For decades to come, tobacco plants will be used in these products as well as in combustibles like cigarettes and cigars where a significant demand from consumers is likely to remain even as overall demand declines.
Most major tobacco companies already support farmers to diversify. It will be interesting to watch the dynamic within companies with large and growing reduced-risk portfolios who will continue to sell combustibles even as they shift to reduced-risk products to a greater extent in later numbers for several decades. Altria’s purchase of Njoy, Philip Morris International’s acquisition of Swedish Match and BAT’s dominance in the U.S. vape space all signal that these companies will take a twin track approach to nicotine sourcing.
Who Makes It and How Do They See the Future?
CNT has stated that synthetic nicotine is currently a niche product with enormous potential. “We see enormous demand there and the capacity for the synthesis of chemical is unlimited.”
Zanoprima, the only company to use myosmine as the starting material believe that in time synthetic nicotine will become the main source of nicotine in pharmaceutical products as well as in products likely to be sold as both medically approved cessation products, and as recreational products for ex-smokers to use.
Isn’t It Expensive To Use?
No—prices have been dropping recently and will continue to do so as demand increases.
Conclusion
Health and environmental consumer demand combined with benefits in terms of quality and safety, suggest that synthetic nicotine is set to meet its potential in the coming years.
A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
The U.S. Food and Drug Administration has updated its definition of “tobacco products” to include nontobacco nicotine products.
In response to the increase of nontobacco nicotine in popular tobacco products, Congress passed a federal law that went into effect on April 14, 2022, granting the FDA authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. This new law extended the tobacco product requirements in the Federal Food, Drug and Cosmetic Act to manufacturers, importers, retailers and distributors of nontobacco nicotine products. Previously, the FDA’s tobacco product authority only extended to tobacco products that contain nicotine made or derived from tobacco.
Under this legislation, the definition of “tobacco product” in the FDA’s regulations and guidances has been considered to be amended since April 14, 2022. The FDA has now issued two notices in the Federal Register updating the definition of “tobacco product” in its existing regulations and guidances.
In addition, the agency has also posted the following nine revised guidances to the FDA’s website: Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers (Revised); Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order (Revised); Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products (Revised); Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug and Cosmetic Act Requirements to Vape Shops (Revised); Listing of Ingredients in Tobacco Products (Revised); Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (Revised); The Prohibition of Distributing Free Samples of Tobacco Products (Revised); FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised); and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3).
The U.S. Food and Drug Administartion today announced that, as of Oct. 7, the agency has issued refuse to accept (RTA) letters for more than 889,000 products in premarket tobacco product applications (PMTAs) that do not meet the criteria for acceptance.
The agency also announced it FDA has accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products.
“While the application review is ongoing, FDA remains vigilant in overseeing the market and will continue to use our compliance and enforcement resources to curb the unlawful marketing of [non-tobacco nicotine] NTN products. To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar,” the FDA stated in a release. “The manufacturer warning letters include those for products for which an application had been submitted but where the agency has taken a negative action, such as a [RTA].”
The FDA has also issued over 300 warning letters to retailers for violations in relation to their sale of NTN products to underage purchasers, and imposed civil money penalties against two retailers for sales of NTN products to underage purchasers.
“To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action,” the FDA stated. “It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty.”
The U.S. Food and Drug Administration is understating the number of non-tobacco nicotine (NTN)-related premarket tobacco product applications (PMTAs) it has accepted for review in order to avoid criticism from tobacco control groups that seek prohibition of all vaping products, reports Vaping360, citing American Vapor Manufacturers Association (AVM) President Amanda Wheeler.
On Sept. 8, the FDA announced it has accepted over 350 PMTAs (out of nearly 1 million applications) for NTN products. Wheeler insists that AVM member companies alone have received acceptance letters for 4,700 PMTA submissions.
“Once again the FDA and its Center for Tobacco Products are misleading the public and press on crucial data and methods in its approval process for vaping products,” Wheeler said in a statement. “The figures stated in its press release today on synthetic nicotine applications are demonstrably inconsistent with FDA letters to our own members indicating many thousands more applications successfully filed than FDA now claims.”
An acceptance letter indicates that the application has met the basic requirements to move forward in the review process. It does not authorize the applicant to market the product.
The AVM also says the FDA altered required PMTA forms close to the submission deadline to disqualify already-submitted applications. According to Wheeler, the application forms were “abruptly altered” without public notice, “apparently as a means to disqualify wide swaths of already-filed applications.”
In March, U.S. President Joe Biden signed legislation authorizing the FDA to regulate synthetic nicotine products. Manufacturers had until May 14 to submit PMTAs, and were given two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement.
The U.S. Food and Drug Administration has sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine (NTN) products since President Joe Biden signed legislation authorizing the agency to regulate tobacco products containing nicotine from any source. Additionally, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage purchasers.
In an update, the agency detailed what it described as “significant progress” in processing and reviewing premarket tobacco product applications for synthetic nicotine products.
On March 15, 2022, a new federal law gave the FDA the authority to regulate tobacco products containing nicotine from any source. This law took effect April 14, 2022, and after July 13, 2022, any new NTN product that has not received premarket authorization from the FDA cannot be legally marketed.
The FDA says it received nearly 1 million NTN applications from more than 200 companies. To date, all applications submitted by May 14 have been processed, and more than 85 percent have been reviewed to determine if they meet the minimum requirements to be accepted for further review, according to the agency. In total, the FDA has issued refuse to accept (RTA) letters for more than 800,000 NTN products in applications that do not meet the criteria for acceptance.
In total, the FDA has accepted over 350 applications for NTN products, with the vast majority being for e-cigarette or e-liquid products. The agency stresses that acceptance is not a determination about the products’ authorization status. “Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review,” the FDA wrote in its update.
More information about the FDA’s premarket review progress and compliance and enforcement actions is available at the agency’s NTN product webpage.
Under the new law governing synthetic nicotine products signed on March 15, 2022, Congress imposed a short 60-day deadline for companies to file premarket tobacco product applications (PMTAs) and declared that if such applications were not approved within 120 days (the Act) they would be “in violation of” the Federal Food Drug & Cosmetic Act’s (FDCA) PMTA requirement.
Since no authorizations have been granted as of today, the question is will FDA use its enforcement discretion to continue reviewing PMTAs, or will it precipitously declare that all synthetic nicotine products must be removed from the market after July 13, 2022?
There is no question that the FDA should use its enforcement discretion. In a series of direct engagements with FDA since the Act’s passage, the Vapor Technology Association (VTA) has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process.
However, some have suggested that Congress mandated all products be removed from the market this week if they are not approved by FDA. But a close review of the Act reveals that the opposite is true: Congress did not require synthetic nicotine products with pending PMTAs to be removed from the market after July 13.
In interpreting laws, a court will first look to the plain language of the Act and, only if there is an ambiguity, will it look to Congressional intent to resolve such a question. Here, both support the FDA’s continued use of enforcement discretion for pending PMTAs.
The Plain Language Supports Enforcement Discretion
There are four relevant sections of the Act. First, under Section (d)(2)(A), Congress expressly stated that “as a condition to market” all manufacturers wishing to continue selling their products must file a PMTA no later than May 14, 2022.
Tony Abboud
Second, under Section (d)(2)(B), Congress expressly stated that companies which filed PMTAs “may continue to market” their products during what the Act calls a “transition period.”
Third, under Section (d)(2)(C), Congress expressly required that if a company did not file a PMTA for its synthetic products by May 14, 2022, that company is “not eligible for continued marketing.” In each of these sections, Congress expressly uses some variation of the term “market” to articulate its direction on what may (not) be marketed and when.
However, in the operative Section (d)(3), which addresses what happens after July 13, 2022, Congress makes no statement regarding marketing at all. Instead, it states that products with pending PMTAs not yet approved would be “in violation of…section 910” of the FDCA (21 USC 387g).
When presented with this question, a court likely would rule that because Congress did not expressly state that pending applicants are “not eligible for continued marketing” or that they “may not market” after July 13, as it clearly said in the immediately preceding sections, Congress did not require the removal of products with pending PMTAs.
This places synthetic nicotine products with pending PMTAs in precisely the same position as all other products with pending PMTAs which, for years, FDA has made clear are “illegal” (i.e., in violation of section 910) but are allowed to remain on the market at FDA’s enforcement discretion.
Even if a court finds that Section (d)(3) is ambiguous, there is nothing in Congressional intent that would lead to the conclusion that Congress intended for products with pending PMTAs to be removed from the market.
First, Congress could have banned synthetic nicotine products, if that is what it intended, but it did not do so. To the contrary, Congress expressly authorized manufacturers to bring new products to market after the Act’s passage. Thus, it would be folly to suggest that Congress intended all synthetic nicotine products be removed from the market without PMTA review.
Second, Congressional intent is generally divined by on the record statements made in committee hearings and in floor debate (not from press releases or media statements). But there is little to nothing which a court could rely on [with] this question because the provision was quietly slipped into the Ukraine-omnibus spending bill with no relevant hearing or floor debate.
Third, Congress was fully aware that FDA could not review PMTAs within 180 days (as required under the FDCA). In fact, the FDA told a court it will not be finished reviewing tobacco derived PMTAs until June of 2023. Thus, no one could suggest that there ever was any reasonable expectation or intent that the FDA would rule on synthetic nicotine PMTAs in 60 days.
Hence, the only reasonable conclusion that can be drawn from the plain language and Congressional intent is that Congress did not require removal of products with pending PMTAs but, rather, expected the FDA to continue to use its discretion in enforcing its PMTA regulation after July 13.
Congress did, however, expressly state that products for which no PMTA was timely filed have no continuing ability to market, authorizing the FDA to take immediate action. VTA has repeatedly communicated to the FDA the need for it to aggressively remove all tobacco products from the market for which no PMTA has been filed and to publish a list of all products covered by a synthetic nicotine PMTA so that retailers know which products can be sold.
A Careful and Complete Evaluation of Synthetic Nicotine PMTAs is Required
We live in a world that remains captive to [combustible] cigarettes. Congress won’t ban them and Congress has prevented the FDA from doing so. While electronic nicotine-delivery system (ENDS) products offer a technological solution to delivering nicotine in a substantially less harmful way, synthetic nicotine now represents the first technological innovation in nicotine itself.
Synthetic nicotine uniquely offers consumers the cleanest and purest form of nicotine with numerous benefits, i.e., the absence of heavy metals, nitrosamines, and pesticides. Synthetic nicotine uniquely offers consumers the opportunity to break free from the last remaining vestige of the tobacco plant.
Synthetic nicotine uniquely offers the FDA unprecedented product constituent clarity, replicability, and traceability down to the batch level. Not only does synthetic nicotine offer companies the opportunity to change the dynamics regarding total reliance on tobacco-derived nicotine for all tobacco and pharmaceutical nicotine products, but it also provides companies the ability to address their ESG [sustainability] goals and take a significant step to ameliorate the adverse environmental impacts of tobacco.
Our message to the FDA has been constructive and clear: it is critical to the adult smoker that FDA takes aggressive steps to create an orderly and regulated marketplace with a diversity of desirable nicotine alternatives.
Given recent history with tobacco derived PMTAs, the best way for FDA to realize that objective now is to avoid the blanket denial mistakes of the past which have mired the agency in protracted litigation. Such litigation will only delay the time until we achieve an orderly and regulated marketplace.
Instead, we have asked the FDA to work companies which timely filed synthetic nicotine PMTAs – the good actors – through the PMTA scientific process and provide them the requisite time and guidance to fulfill FDA’s requirements.
At the same time, we have asked the FDA to aggressively enforce against the non-compliant companies that have refused participate in the PMTA process – the bad actors – by interdicting such products at the border and removing such products from the market Congress has clearly required.
In the end, it is incumbent on the new FDA leadership to use its power to create an orderly marketplace by embracing scientific innovations, stimulating additional financial investment, accelerating authorizations of pending tobacco-derived PMTAs, and ensuring that synthetic nicotine products which now contain the cleanest and purest form of nicotine that science has created are available to adult smokers.
Tony Abboud serves as president for Strategic Government Solutions, Inc., and executive director of the Vapor Technology Association (VTA).
A bipartisan coalition of 31 attorneys general are calling on the U.S. Food and Drug Administration to reject marketing authorization for all non-tobacco nicotine products, which are currently being sold without regulation of their contents, manufacturing, health effects, required warning labels or marketing claims.
In a letter to the agency, the coalition argues that these products currently don’t meet the FDA’s public health standard, and the regulatory agency should not gamble on the unknown effects of the products. The letter specifically calls for the FDA to reject a request by product manufacturers to grant marketing authorization for non-tobacco nicotine products.
The letter also insists that if the agency does grant marketing authorizations for these products, it imposes the same restrictions required of tobacco-derived nicotine products including a ban on all products with a flavor other than tobacco and strict regulatory requirements regarding their contents, manufacturing, and effect on users’ health.
Products should carry warnings concerning their addictiveness, and manufacturers should be required to validate health claims made about their products, including claims that a product is safer than tobacco.
“E-cigarettes containing synthetic nicotine and other synthetic nicotine products are putting our kids’ health at risk,” said North Carolina Attorney General Josh Stein. “The FDA has the power to do more to protect them, and I hope it takes action to prohibit manufacturers and retailers from marketing and selling to young people, using youth-friendly flavors, and putting exorbitant amounts of nicotine in these products, especially because we don’t yet know how dangerous these products are. I appreciate that the FDA has started taking some steps, but it must do more to rein in this industry and keep our kids safe.”
Time is running out for companies that want to keep their synthetic nicotine products on the market. Manufacturers of non-tobacco nicotine (NTN) products on the market as of April 14, 2022 that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.
The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13.
The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first premarket tobacco product application (PMTA) status reports required by the Court’s revised remedial order on April 29.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.
The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse to file or marketing denied order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from FDA.
Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022 without an FDA marketing granted order are in violation of section 910 of the FD&C Act and may be subject to FDA enforcement.
For products not on the market on April 14, 2022, a PMTA must be submitted to FDA and marketing authorization received before the product can be sold in the United States.
