We write to express our deep concern over the failure of the Food and Drug Administration, and the Center for Drug Evaluation and Research (CDER) in particular, to assert its drug jurisdiction over marketers of synthetic nicotine products, and to commence enforcement actions against marketers of such products as illegal, adulterated drugs. CDER’s inaction is undermining FDA regulation of nicotine products under the Federal Food, Drug and Cosmetic Act (FDCA), including the agency’s regulation of tobacco products pursuant to the Family Smoking Prevention and Tobacco Control Act (TCA). As we explain below, as FDA denies marketing applications for e-cigarettes, manufacturers are exploring using Synthetic Nicotine in order to continue marketing their products while avoiding FDA regulation.

This development makes it even more imperative that FDA take immediate action against illegal, Synthetic Nicotine products, Public health groups have written to FDA twice about the Synthetic Nicotine issue (in November 2018 and again in March 2021). These letters were prompted by statements by manufacturers of Synthetic Nicotine, and manufacturers of e-cigarette products using Synthetic Nicotine, suggesting that these products are not subject to FDA regulation of any kind because synthetic nicotine is not “derived from tobacco,” and thus does not fall within the definition of “tobacco product” under the TCA.

Those letters demonstrated that Synthetic Nicotine products, if they are not “tobacco products,” clearly fall within the FDCA’s definition of “drug,” and therefore within FDA’s jurisdiction to regulate drugs. Thus, Synthetic Nicotine products currently on the market without drug authorization are illegal, adulterated products. Yet CDER continues to do nothing to assert its regulatory authority over these products and to pursue appropriate enforcement actions against them.

This inaction harms the public health and must be remedied without further delay. As a threshold matter, and as explained in detail in our prior letters, synthetic nicotine products easily meet the “structure/function” prong of the definition of “drug” because they are intended to affect the structure or function of the human body. 21 U.S.C. §321(g)(1). FDA has recognized the effects of nicotine on the human body, including satisfaction of addiction, stimulation, sedation, and appetite suppression. In addition, the statements and actions of manufacturers of Synthetic Nicotine products show that the manufacturers intend these physiological effects.

For example, manufacturers of e-liquids containing Synthetic Nicotine know of nicotine’s extensively-documented pharmacological effects; know that consumers use nicotine-containing e-liquids to get those effects; add Synthetic Nicotine to their e-liquids to produce those effects; and make statements to consumers promoting the biological impact of nicotine. Under the FDA’s longstanding and current view, FDA determines “intended use” based not just on the manufacturer’s claims about the product; rather, FDA can discern intended use from the “design or composition of the article, or by the circumstances surrounding the distribution of the article.” See FDA, Final Rule, “Regulations Regarding ‘Intended Use,’” 86 Fed. Reg. 41383 (Aug. 2, 2021). FDA has previously stated that “the mere presence of a pharmacologically active ingredient could make a product a drug even in the absence of explicit drug claims. In these cases, the intended use would be implied because of the known or recognized drug effects of the ingredient.” 59 Fed. Reg. 5226, 5227 (Feb. 3, 1994).

That is plainly the case here, and FDA must not allow makers of e-cigarette and e-liquid products to evade agency oversight required by the FDCA and FDA regulations, simply by using Synthetic Nicotine instead of tobacco-derived nicotine. It is now apparent that FDA’s failure to assert drug jurisdiction over these products threatens to undermine the agency’s regulation of nicotine products. Three years ago, the Campaign for Tobacco-Free Kids wrote FDA about a Synthetic Nicotine manufacturer aggressively promoting its product as “not subject to regulation.” In March of this year, our organizations wrote FDA about the reemergence of the Synthetic Nicotine version of PuffBar, a disposable e-cigarette product marketed with kid-appealing flavors.

PuffBar had previously been the subject of an FDA warning letter for its sale as a tobacco product without the required marketing order. It is a product that could not possibly meet the public health standard to stay on the market as a tobacco product with tobacco-derived nicotine. Consequently, it was reintroduced with Synthetic Nicotine in a blatant attempt to avoid any FDA regulation at all, with its website stating that “All PuffBar products listed on this website contain nicotine but do not contain tobacco or anything derived from tobacco.” We are not aware of any response by FDA to PuffBar’s transparent tactic to market an illegal drug product.

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We write to express our deep concern over the failure of the Food and Drug Administration, and the Center for Drug Evaluation and Research (CDER) in particular, to assert its drug jurisdiction over marketers of synthetic nicotine products, and to commence enforcement actions against marketers of such products as...