On November 16, North Carolina Attorney General Josh Stein spear a survey of electronic cigarette maker Puff Bar and others, citing concerns about flavors appealing to young people, youth marketing and poor age verification. In a statement, Stein said, “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 make sure they don’t benefit children.
The move marks the final regulatory review of Puff Bar, which was recently investigated by the US House Oversight Committee on Economic and Consumer Policy. The November 8 subcommittee letter alleges that Puff Bar reformulated its products in the summer of 2020 to replace tobacco-derived nicotine with synthetic nicotine in an attempt to boost sales, while avoiding the scrutiny of the Food and Drug Administration (FDA) of United States.
In the letter, the subcommittee appeared concerned that Puff Bar was trying to avoid the application of the Federal Food, Drug and Cosmetic Act (FDCA) because the law defines “tobacco product.” as “any product manufactured or derived tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product. 21 USC § 321 (rr) (1) (emphasis added). As the FDA concedes on its website, “It is possible that a disposable closed system device containing an e-liquid with truly zero nicotine (or synthetic nicotine) is not regulated by the FDA as a tobacco product. “
Puff Bar’s synthetic nicotine shield against FDA scrutiny, however, could be short-lived for two reasons. First of all, in addition to the state and federal investigations mentioned above, 31 state and territory attorneys general sent a letter to the FDA on Aug. 18, urging the agency to take action on flavored electronic cigarettes. Notably, this bipartisan group of states and territories – led in part by North Carolina – singled out disposable Puff Bar e-cigarettes and urged the FDA to regulate them as a “drug” if not a “tobacco product.” “. Since the FDCA defines drugs, among other things, as “articles (other than food) intended to affect the structure or any function of the body,” 21 USC § 321 (g) (1), synthetic nicotine could be considered a drug subject. for FDA oversight as it is intended to affect a consumer’s body.
Second, we expect the North Carolina Attorney General’s investigation to be based on alleged violations of North Carolina consumer protection laws, which the Attorney General has the authority to enforce. The North Carolina Attorney General has used the same state laws against manufacturers and retailers in previous enforcement actions related to the use of e-cigarettes and against other industries primarily regulated in Canada. federal level.
Whether the FDA acts on synthetic nicotine or not, the scrutiny of e-cigarette manufacturers like Puff Bar could foreshadow renewed regulatory interest from the FDA, and possibly even federal legislation, expanding the definition of “product. tobacco”. If such a step is not taken at the federal level, the action of the North Carolina attorney general indicates that the states are ready to take matters into their own hands. Stay tuned.