Abstract

Aims: To characterize the scope and scale of “tobacco-free” and “synthetic nicotine” products on the market and their regulatory implications. Design: Survey of nicotine products offered for sale online which claim either to be made from “synthetic nicotine” or that they are “tobacco-free.” Analyze the extent to which these novel products circumvent governmental regulations, tobacco taxation, and tobacco sales bans of major online marketplaces. Findings: As the deadline for FDA authorization of novel tobacco products approached, a rapidly increasing number of brands assert that their products are not derived from tobacco and thus are exempt from the Agency’s regulations. Six manufacturers offer synthetic nicotine while others that claim to be “tobacco-free” use a purified form of tobacco derived nicotine. “Tobacco-free” labeling conveys advantages to the seller beyond exemption from tobacco regulation and taxation. Major online marketplaces, which prohibit both sales and paid advertising of tobacco products, allow them for brands claiming to be “tobacco-free.” Conclusions: There is no rationale for products using non-tobacco sourced nicotine to be exempt from regulation. As nicotine is highly addictive, this regulatory loophole needs to be closed by designation as either a drug or tobacco product. These brands assert that they are not tobacco products, and many make reduced harm and even therapeutic claims. Logically, they are unauthorized drugs and should be removed from the market pending new product application. Those products claiming to be “tobacco-free,” which use highly purified tobacco-derived nicotine, are subject to existing FDA tobacco regulations.