Just as Congress is moving toward giving FDA explicit authority over non-tobacco nicotine products, Rob Jackler’s group at Stanford released a new report, “Marketing of ‘Tobacco-Free’ and ‘Synthetic Nicotine’ Products,” that details how these products are being promoted.
In 2009 Congress gave the FDA jurisdiction over consumer products “made or derived from tobacco,” which includes cigarettes, cigars, smokeless tobacco, e-cigarettes and a panoply of new products. While nicotine, the addictive drug in tobacco products, is present in other vegetables (including tomatoes, eggplant, and potatoes) the levels are so low that it has not been commercially viable to use them as a nicotine source. Thus, the law covered all practical sources of recreational nicotine.
The technology for genetically modifying these plants to increase nicotine yields, as well as the development of less expensive ways of synthesizing nicotine in the laboratory, has been rapidly evolving, and now several companies, most notably Puff Bar, are claiming that they are using synthetic or “non-tobacco” nicotine, thereby evading FDA Center for Tobacco Products regulation because they are not “made or derived from tobacco.” In particular, they have continued to sell flavored e-cigarettes that FDA has prohibited when the nicotine comes from tobacco.
While FDA the drug part of FDA could have banned these products as unauthorized drugs, they have not acted. Now the House has included language closing this loophole and allowed FDA to regulate synthetic and other non-tobacco sourced nicotine products. The Senate has yet to act, but this provision is in the giant bill to fund the federal government and likely to survive.
The new Stanford report shows how out-of-control the marketing of these products is and how the nicotine-addiction companies have used or created ambiguity about the source of nicotine to sidestep regulation.
In particular, the authors conclude
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.
While the pending legislation, if passed, will address this problem, it is still useful to have the compendium of information in the Stanford report because it shows the range of advertising and other claims that the companies are making that could guide FDA (and other regulators in other countries) to clamp down on these abuses.
The report also has an understandable discussion of the different molecular forms of nicotine, which is another important technical detail.
This knowledge should also guide localities, states and other countries to shift from regulating “tobacco” products to regulating “nicotine” products regardless of the source. The same is true for taxes, advertising, and clean indoor air laws.
The full citation for the report is: Divya Ramamurthi, Cindy Chau, Zhuojing Lu, Ilina Rughoobur, Keon Sanaie, Partha Krishna, Robert K. Jackler. Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products. White Paper. Stanford Research into the Impact of Tobacco Advertising. Published March 8, 2022. It is available for free here.