On November 16, North Carolina Attorney General Josh Stein launched a probe into e-cigarette maker Puff Bar and others, citing concerns of youth-appealing flavors, youth marketing, and poor age verification. In a statement, Stein announced, “We are actively investigating Puff Bar and other companies at all stages of the distribution chain, from manufacturers to retailers and everything in between to ensure they are not profiting off kids.”
The move marks the latest regulatory scrutiny for Puff Bar, which recently received an investigatory inquiry from the U.S. House Oversight Committee’s Subcommittee on Economic and Consumer Policy. The November 8 subcommittee letter alleges that Puff Bar reformulated its products in summer 2020 to replace tobacco-derived nicotine with synthetic nicotine in a bid to restart sales, while avoiding scrutiny from the U.S. Food and Drug Administration (FDA).
In the letter, the subcommittee appeared concerned that Puff Bar is attempting to avoid application of the Federal Food, Drug, and Cosmetic Act (FDCA) because the statute defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” 21 U.S.C. § 321(rr)(1) (emphasis added). As the FDA concedes on its website, “it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product.”
Puff Bar’s synthetic nicotine shield from FDA scrutiny, however, might be short-lived for two reasons. First, in addition to the state and federal inquiries noted above, 31 state and territories attorneys general sent a letter to the FDA on August 18, urging the agency to act on flavored e-cigarettes. Notably, this bipartisan group of states and territories — led in part by North Carolina — singled out Puff Bar’s disposable e-cigarettes and encouraged the FDA to regulate them as a “drug” if not a “tobacco product.” Because the FDCA defines drug, among other things, as “articles (other than food) intended to affect the structure or any function of the body,” 21 U.S.C. § 321(g)(1), synthetic nicotine could qualify as a drug subject to FDA oversight to the extent it is intended to affect a consumer’s body.
Second, we expect that the North Carolina attorney general’s investigation will be based upon alleged violations of North Carolina consumer protection laws, which the attorney general is empowered to enforce. The North Carolina attorney general has utilized the same state statutes against manufacturers and retailers in previous enforcement actions related to e-cigarette use and against other industries that are primarily regulated at the federal level.
Whether or not FDA acts on synthetic nicotine, the mounting scrutiny of e-cigarette makers like Puff Bar could foreshadow renewed regulatory interest on the part of FDA, if not federal legislation, expanding the definition of “tobacco product.” If such action is not taken at the federal level, the North Carolina attorney general’s action signals that the states are willing to take matters into their own hands. Stay tuned.