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FDA ‘clarifies’ stance on synthetic nicotine as a tobacco product
Monday 30 January 2017 - Comments
Posted by Matt Rowland
When the FDA deeming regulations were first announced in May of 2016, the vaping industry was shocked to learn that the agency considers e-cigs and vaping technology to be classified as “tobacco products.” While many of the flavored e-liquids used in these devices happen to contain nicotine, they are also 100% tobacco-free. And nicotine is not necessarily synonymous with tobacco.
Lots of other plants contain nicotine, including eggplant, potatoes, and tomatoes. So, one forward-thinking company named Next Generation Labs decided to test the FDA’s logic.
What if they created a synthetic nicotine made from tomatoes rather than the tobacco plant? And what if they sold this synthetic nicotine to e-liquid manufacturers nationwide? Would the related e-cigs, e-liquids, and vaping gear still be classified as tobacco products?
The FDA publishes an official response regarding synthetic nicotine
The FDA has a section of their website specifically devoted to “Commonly Asked Questions: About the Center for Tobacco Products.” And last week, the site was updated with new information. About midway down the page, the question of synthetic nicotine is addressed.
“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
“A: The 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 FDA's tobacco control authorities.
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. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
The second paragraph is the most important. It appears as if the FDA’s current opinion on synthetic nicotine is that it should not be regulated by the FDA. But is this reason enough for the vaping industry to jump for joy in celebration?
No so fast. The very last line also says that the FDA intends to review each product on a “case-by-case basis,” leaving the door wide open for FDA regulation in the future.
Next Generation Labs issues a response
The new clarification by the FDA regarding synthetic nicotine is still very positive news. At least the agency did not attempt to offer some “alternative facts” to support an outlandish claim that products made from tomato nicotine are somehow, magically “tobacco products.” And the Vincent Schuman, CEO of Next Generation Labs, strongly agrees, as is evident in a published statement on the company website.
“The FDA is slowly revealing its stance on regulating synthetic nicotine and while this latest update is a welcome one, we fully anticipate further clarification from the FDA as the August PMTA deadline approaches. All indications from the FDA confirm our long-held position: TFN Nicotine products cannot be regulated under the Deeming Rule as they are not tobacco products, and we continue to believe that an open or closed system device for use with a choice of synthetic nicotine products will qualify as a non-tobacco product.”
To those vapers who wonder if synthetic nicotine will taste just as good as the real thing, Next Generation Labs seems to believe that consumers will like the synthetic stuff even better. According to the website, “TFN® Nicotine is virtually tasteless and odorless, (and) dramatically improves e-juice flavors.” The vaping industry might have just found a legal loophole to bypass the FDA deeming regulations.
Lots of other plants contain nicotine, including eggplant, potatoes, and tomatoes. So, one forward-thinking company named Next Generation Labs decided to test the FDA’s logic.
What if they created a synthetic nicotine made from tomatoes rather than the tobacco plant? And what if they sold this synthetic nicotine to e-liquid manufacturers nationwide? Would the related e-cigs, e-liquids, and vaping gear still be classified as tobacco products?
The FDA publishes an official response regarding synthetic nicotine
The FDA has a section of their website specifically devoted to “Commonly Asked Questions: About the Center for Tobacco Products.” And last week, the site was updated with new information. About midway down the page, the question of synthetic nicotine is addressed.
“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
“A: The 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 FDA's tobacco control authorities.
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. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
The second paragraph is the most important. It appears as if the FDA’s current opinion on synthetic nicotine is that it should not be regulated by the FDA. But is this reason enough for the vaping industry to jump for joy in celebration?
No so fast. The very last line also says that the FDA intends to review each product on a “case-by-case basis,” leaving the door wide open for FDA regulation in the future.
Next Generation Labs issues a response
The new clarification by the FDA regarding synthetic nicotine is still very positive news. At least the agency did not attempt to offer some “alternative facts” to support an outlandish claim that products made from tomato nicotine are somehow, magically “tobacco products.” And the Vincent Schuman, CEO of Next Generation Labs, strongly agrees, as is evident in a published statement on the company website.
“The FDA is slowly revealing its stance on regulating synthetic nicotine and while this latest update is a welcome one, we fully anticipate further clarification from the FDA as the August PMTA deadline approaches. All indications from the FDA confirm our long-held position: TFN Nicotine products cannot be regulated under the Deeming Rule as they are not tobacco products, and we continue to believe that an open or closed system device for use with a choice of synthetic nicotine products will qualify as a non-tobacco product.”
To those vapers who wonder if synthetic nicotine will taste just as good as the real thing, Next Generation Labs seems to believe that consumers will like the synthetic stuff even better. According to the website, “TFN® Nicotine is virtually tasteless and odorless, (and) dramatically improves e-juice flavors.” The vaping industry might have just found a legal loophole to bypass the FDA deeming regulations.
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