How Will Synthetic Nicotine Change the Vaping Industry?
The key to what makes Synthetic Nicotine interesting for the vaping industry is the language that nations such as the United States and the United Kingdom use when regulating vaping products. Regulations such as the Family Smoking Prevention and Tobacco Control Act in the United States and the Tobacco Products Directive in the United Kingdom and Europe use the same phrase when referring to vaping products – they call those products “tobacco products.”
The phrase “tobacco product,” however, assumes that the e-liquid in an e-cigarette contains nicotine derived from tobacco. Do those same regulations apply to vaping products that contain no tobacco or tobacco derivatives? That’s what the makers of Synthetic Nicotine vaping products aim to find out.
The FDA’s answer to that question is vague – perhaps intentionally so. The website of the FDA says it’s “possible” that a closed-system vaping device using only Synthetic Nicotine may not meet the legal definition of a tobacco product and therefore would not be regulated by the FDA as such. The FDA says that it will evaluate Synthetic Nicotine vaping products on a “case-by-case basis.”
If a vaping product with Synthetic Nicotine falls outside the FDA’s jurisdiction, then it would be possible for companies to release new closed-system vaping products without going through the cumbersome and expensive premarket application process that essentially functions as a cost barrier preventing new companies from entering the American vaping industry. Such a product would have to be completely proprietary, however, thus preventing people from using that product with any e-liquid containing tobacco-derived nicotine.
If a company does attempt to release such a product without going through the premarket application process, however, that company will almost certainly need to battle the FDA in court. Litigation could prove to be just as costly as going through the premarket application process, so any company that plans to introduce a new Synthetic Nicotine vaping product in the United States will need to consider its options carefully before doing so.
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