Tag: Next Generation Labs

Lawmaker Scrutinizes Synthetic Nicotine

Raja Krishnamoorthi
U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, has sent letters to two companies that manufacture or sell synthetic nicotine products, requesting information about the companies and their sale of these products.
One letter was addressed to Next Generation Labs, the self-declared market leader in the production and sale of synthetic nicotine. The company claims its unregulated synthetic nicotine is used in more than 60 products and projects its sales to increase by 1,800 percent this year.
Synthetic nicotine has been gaining popularity among vapor companies after the FDA denied hundreds of thousands of marketing applications for products made with conventional nicotine.
“In response, some e-cigarette and e-liquid manufacturers, banned from legally selling their products, reportedly plan to switch to synthetic nicotine in an effort to avoid FDA regulation,” Krishnamoorthi wrote in his letter to Next Generation Labs.
“Next Generation Labs appears to support this approach, with its co-founder, Ron Tully, offering the following thoughts on the FDA laws and regulations governing nicotine: ‘If the statute has been ill-conceived, and the regulation has been ill-drafted, it is not the responsibility of the industry to conform to some kind of idea that you can’t innovate in those spaces where the legislation doesn’t occur.’”
Krishnamoorthi also sent a letter to Puff Bar, whose products have replaced Juul as the vape of choice for many young people after Juul Labs discontinued certain flavored products. In 2020, the Food and Drug Administration ordered Puff Bar to pull its products from the market. Earlier this year, the company introduced new versions of its products using synthetic nicotine.
In a recent profile by The Wall Street Journal, Puff Bar co-CEO Patrick Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice. Because the Tobacco Control Act specifically gives the FDA authority to regulate nicotine “made or derived from tobacco,” most people believe the agency’s Center for Tobacco Products cannot regulate products that use synthetic nicotine—at least not without serious legal challenges, according to Vaping360.
“You have apparently made the vile decision to continue enriching yourselves by poisoning children,” Krishnamoorthi wrote in his letter to Puff Bar. “Puff Bar’s meteoric rise in popularity among kids resulted in $156 million in sales in 2020 alone. Puff Bar should not be allowed to continue harming children due to FDA’s failure to regulate synthetic nicotine, and I intend to put an end to your predatory practices.”
In his letter to Next Generation Labs, Krishnamoorthi requested information regarding the company’s sales and new business. In his letter to Puff Bar, Krishnamoorthi requested information regarding the company’s ownership and operations as well as support for the company’s assertion that it is using synthetic nicotine and requested the company’s co-CEOs appear for transcribed interviews.
Greg Conley, the president of the American Vaping Association, said Krishnamoorthi lacked evidence that the targets of his investigation have broken any laws. “As per the usual, he is playing politics, and we are hopeful the demands specified in his letter will be resisted,” Conley told Filter.
“With youth vaping numbers and the associated moral panic continuing to decline,” he continued, “it remains to be seen whether Representative Krishnamoorthi’s primary goal—getting media attention focused on Representative Krishnamoorthi—will actually be met with this campaign.”
November 9, 2021
Next Generation Nixes Kaival Patent Deal

Photo: sorapop
Next Generation Labs, which manufactures and markets bulk R-S, R- and S-isomer synthetic nicotine under its TFN brand, has terminated its Sept. 28, 2020, patent contribution agreement with Kaival Brands Innovation Group and Kaival Labs.
The Patent Contribution Agreement related to the acquisition and commercial exploitation by Kaival of Next Generation Labs’ IP portfolio on combinational use of synthetic R- and S-isomer nicotine ratios in tobacco cessation products.
In a press note, Next Generation Labs said Kaival Labs had published inaccurate and misleading statements relating to the use of patented synthetic nicotine for tobacco cessation products on its website. “Next Generation Labs wants to clarify that as a consequence of Kaival’s failure to perform its obligations under the Patent Contribution Agreement, all rights to the R-S synthetic nicotine cessation patent portfolio fully reverted to Next Generation Labs in May 2021,” Next Generation Labs wrote.
Additionally, Kaival executed a confirmatory transfer agreement with Next Generation Labs relinquishing all rights to the Next Generation Labs patent portfolio for the commercialization of combinational TFN R-S nicotine relating to tobacco cessation products. Kaival is not an authorized agent of Next Generation Labs nor is it authorized to use Next Generation Labs’ name, intellectual property or its TFN trademark on its products, in its product marketing or in any financial prospectus to investors, according to Next Generation Labs.
July 26, 2021
Australian Patent for NGL’s Synthetic Nicotine

Image: Zerbor
Next Generation Labs has received an Australian patent for its innovative use of combinational ratios of synthetic R-isomer 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-isomer 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-[isomer] 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 nonaddictive 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.
July 23, 2021
Next Generation Labs Receives Patent

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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 nontobacco synthetic nicotine for use in novel nontobacco 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 nontobacco-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.”
June 29, 2021
China OKs Synthetic Nicotine Patent

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 nontobacco 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 nontobacco 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, U.K., South Korea, India, Canada and Australia,” the company wrote in a press release.
March 23, 2021
Next Generation Assigns Patent

Photo: Martinmark – Dreamstime.com
Next Generation Labs (NGL), the world’s largest manufacturer of TFN R-S, S and R isomer nicotine, has assigned the rights of its Republic of Korea R-S nicotine manufacturing patent to NextEra Co.
NGL said it has taken this step “to help strengthen direct in-market enforcement efforts by NextEra against unscrupulous manufacturers who have attempted to ship unauthorized synthetic, nonsynthetic and, in some instances, counterfeit or mislabeled TFN synthetic nicotine vape products into the South Korea market.”
NextEra is NGL’s exclusive TFN partner and is the largest flavor formulator and distributor of synthetic nicotine vape products in South Korea. Under the assignment, NextEra products containing TFN will continue to be sold, and NextEra will use all means available to protect the market and prohibit violative brands from entering South Korea.
“This is a strategic patent assignment that will give NextEra the full freedom to use all legal means at its disposal to seek enforcement of existing intellectual property rights related for TFN recreational nicotine in the market,” NGL wrote in a statement
“Next Generation Labs fully expects NextEra to immediately take action against violators and utilize all necessary legal remedies against any business seeking to either: divert R-S nicotine product sales into South Korea from other markets, attempt to sell mislabeled tobacco-derived nicotine as a synthetic product, or to sell counterfeit TFN products in South Korea,” the company added.
The terms of the patent transaction have not been made public, and the transaction will not impact Next Generation Labs’ other patents in South Korea or impact control of patents in any other jurisdiction worldwide.
January 25, 2021
Next Generation Labs Expands its TFN Brand

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.

December 18, 2020
Partnering for Synthetic Nicotine Pouches

Photo: Martinmark – Dreamstime.com
Next Generation Labs has entered an exclusive manufacturing arrangement with Dholakia Tobacco to produce synthetic non-tobacco nicotine moist white portion products for the modern oral nicotine (MON) pouch market.
Combining Next Generation Labs TFN synthetic nicotine technology with Dholokia’s expertise in the manufacturing of herbal non-tobacco smokeless portion pouch products, this new partnership offers new opportunities for alternatives to nicotine portion pouches containing tobacco-derived nicotine.
Under the terms of the agreement, Next Generation Labs and Dholakia are offering private-label development and manufacturing services to companies seeking to bring to market white portion pouch products that incorporate TFN tobacco-free synthetic nicotine in non-tobacco white portion pouch brands around the world.
“While many portion pouch brands claim to use tobacco-free nicotine, they are in fact exclusively using tobacco-derived nicotine, and are labeled and marketed with claims such as ‘tobacco-leaf free,’ ‘tobacco-dust free’ or ‘free of tobacco residuals’,” Next Generation Labs wrote in a press release.
“Almost all of these products continue to use nicotine extracted from the tobacco plant, and as such, they are not tobacco-free nicotine products,” the company wrote. “The TFN-based portion pouches made by Next Generation Labs and Dholakia can legitimately make the claim to be the only 100 percent tobacco-free nicotine pouches available to adult consumers today.”
As the global market for synthetic nicotine grows, Next Generation Labs and Dholakia anticipate significant market growth opportunities for TFN-based tobacco-free smokeless nicotine products.

October 13, 2020
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.
September 18, 2020