The deeming rule applies only to e-cigarettes that contain nicotine “made or derived from tobacco.” In the last few years, however, over a dozen e-cigarette brands have begun to sell products containing Synthetic Nicotine, developed in a lab without the use of tobacco plants. This product is chemically identical to the nicotine found in tobacco plants—and similarly addictive—but falls outside of the FDA’s tobacco-related authority.

Sellers of Synthetic Nicotine products claim they are an important advance, because tobacco-derived nicotine inevitably also contains some contaminants—including potentially carcinogenic ones—from tobacco plants, whereas synthetic nicotine is “pure.” For the same reason, they contend that Synthetic Nicotine products offer a “comparatively clean flavor” when used in e-liquids.

Although the technology to create Synthetic Nicotine has existed since the 1940s, the high cost of production has limited its commercial use in products intended for human consumption. Now, however, more efficient production methods seem to have been developed, and some companies are selling synthetic nicotine products (or, at least, products that sellers claim contain synthetic nicotine) at prices comparable to other e-liquids. For example, we observed that one company sells 60 mL of its “mangolito” flavor e-juice with tobacco-derived nicotine for $24.99, and it sells the same amount of the same flavor e-juice with Synthetic Nicotine for $27.99. Moreover, although the market for products containing Synthetic Nicotine currently appears to be dominated by e-liquids, Synthetic Nicotine could be used as an ingredient in any product in which a seller wants to include nicotine. For example, one seller has announced plans to launch a gum that contains Synthetic Nicotine, and before the TCA was enacted, companies (unsuccessfully) attempted to market water that contained tobacco-derived nicotine as a dietary supplement.

One company asked the FDA for clarification on whether Synthetic Nicotine products would fall within the deeming rule’s scope. Although the FDA explained that Synthetic Nicotine products must be evaluated on a “case-by-case basis,” it also acknowledged that “it’s possible [such products] would not be regulated by the FDA as [] tobacco product[s].”  Indeed, we think it clear that e-cigarettes and other products that use only Synthetic Nicotine – which, by definition, is not “made or derived from tobacco”– are not tobacco products under the TCA. Thus, these products are not subject to any of the deeming rule’s regulations – no premarket approval requirements, no warning labels, no prohibition on health-related claims, and so forth. This is, we believe, a problematic regulatory gap. As discussed in the following section, however, the FDA has a viable option for closing it: classifying Synthetic Nicotine products as drugs.

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The deeming rule applies only to e-cigarettes that contain nicotine “made or derived from tobacco.” In the last few years, however, over a dozen e-cigarette brands have begun to sell products containing Synthetic Nicotine, developed in a lab without the use of tobacco plants. This product is chemically identical...