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September 13, 2020

Will Synthetic Nicotine Skirt FDA's Tobacco Authority?

Hangsen Technology, located in Shenzhen, China, is a division of Hong Kong-based Hangsen Holding Co., Ltd. The company has manufactured e-liquid in facilities around the world since 2009.

Hangsen will launch SYN NIcotine—which is created with lab chemicals, rather than extracted from tobacco plants—in North America soon. Synthetic nicotine is not a new concept; other companies also manufacture tobacco-free nicotine, and it has been used commercially in a few vaping products.

“SYN Nicotine is devoid of many of the harmful impurities that tobacco-derived nicotine contains and is an ideal alternative for manufacturers who may not wish to use pure nicotine derived from tobacco,” Hangsen’s executive director said in a statement.

The vast majority of e-liquid and prefilled vaping products use nicotine derived from tobacco, as do all pharmaceutical nicotine products. There is no evidence that USP-grade nicotine extracted from tobacco contains high enough levels of “harmful impurities” that they pose an actual health risk to users. Claiming health benefits for synthetic nicotine could itself lead to FDA enforcement.

Whatever actions are taken by the federal government, enforcement at the state level doesn’t depend on the Tobacco Control Act or Deeming Rule.

The Tobacco Control Act (TCA) gave the FDA regulatory authority over products containing “nicotine made or derived from tobacco.” The agency’s 2016 Deeming Rule applied that law to vaping products that contain nicotine and all components and parts of products containing tobacco-derived nicotine.

That’s how the FDA claimed authority over open-system (refillable) vaping products. Because they can be filled with tobacco-derived nicotine, the agency claims they are components or parts of a tobacco product, and therefore subject to the TCA. It is possible that the agency could deem tobacco-free nicotine and attempt to claim authority by describing it too as a component of a tobacco product.

Although the FDA may not currently have regulatory authority over synthetic nicotine, there is an active bill in the Senate (which already passed the House) that orders the FDA to regulate the substance. If the bill passes, or if the FDA decides on its own to address the issue, synthetic nicotine could be regulated as a drug rather than a tobacco product—a far more expensive and exacting process than tobacco regulation. Failing that, Congress could alter the Tobacco Control Act to include nicotine from any source—or the FDA could deem it to be a tobacco product, as described above.

Whatever actions are taken by the federal government, enforcement at the state level doesn’t depend on the Tobacco Control Act or Deeming Rule. As California vaping advocate Stefan Didak pointed out on Twitter, even if the FDA doesn’t claim regulatory authority over synthetic nicotine, individual states can include it in their own tobacco laws, and some already have.

A Hangsen spokesperson told Vaping360 that the company has “no intention or motivation to circumvent relevant FDA laws and regulations. We will abide by and obey relevant supervision.”

A similar Vaping360 article, published Sept. 11, described a sealed vaping device made by a Chinese company, which Hangsen had announced in a press release would be sold prefilled with e-liquid containing Hangsen’s new synthetic nicotine. Hangsen said it would be sold in North America.

Hangsen has since edited its press release to remove references to that company, and asked Vaping360 to edit our article. We have removed that article (and replaced it with this one), not because Hangsen requested it, but because the original story simply doesn’t make sense without the existence of the sealed, prefilled device that was originally described.

Hangsen explained by email that the press release description of the partnership with the second company was a “work error.” While this seems unlikely, we don’t wish to create problems for the other company if Hangsen’s explanation is indeed true. We will update this article if we receive further information.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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11 months ago

Unfortunately this does not help us here in Australia. Our laws cover the substances rather than the source, e.g. nicotine is covered as a substance no matter the source. This did lead to some issues trying to cover the sales of “bath salts” and synthetic cannabis/ecstasy/etc as the ingredients used can be completely random and not covered by the Therapeutic Goods Act.

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