Public Health Groups Sue FDA for Delaying E-cigarette Legislation
In late March, several public health organizations and medical groups filed suit against the U.S. Food and Drug Administration (FDA) for its decision to delay FDA review of e-cigarette products. The controversial decision pushed the deadline for e-cigarette product approval applications to August of 2022 relieving the vaping industry of strict compliance under FDA product standards.
The plaintiffs argue the decision was improper under law, puts public health at risk, and leaves young people vulnerable to the negative effects of nicotine and tobacco addiction. The suit also claims the FDA’s decision prevents access to scientific information about the health effects of vaping.
In August 2016, the FDA announced its “Deeming Rule” expanding regulatory oversight to include e-cigarettes. Among other things the new rule included product application requirements for e-cigarette products. When the open comment period on the rule ended, the FDA reversed its decision to implement product reviews and instead announced a five-year delay before enforcing the application process.
According to plaintiff press releases, the FDA exceeded its authority under the Family Smoking Prevention and Tobacco Control Act when it delayed the proposed regulation. The lawsuit also claims the decision violated the Administrative Procedure Act because “the FDA did not give the public an opportunity to comment” on the change and did not provide factual justification for the delay.
The FDA’s public position is that it continues to fight nicotine addiction and protect children from the hazards of smoking.
In late May, FDA Commissioner, Scott Gottlieb, MD., tweeted an assurance that the FDA “takes use of e-cigs by youth very seriously,” and will “continue to enforce laws, including those aimed at preventing inappropriate targeting of kids, and prohibiting retailers from selling tobacco products, including e-cigs, to minors.” As tweeted by Gottlieb, these rules are enforced. However, enforcement over e-cigarettes will not extend to FDA product reviews until the 2022 extended deadline.
The lack of serious e-cigarette product regulation, including the effects of the delay in formal FDA product approval, is a concern for many health advocates including those bringing the recently filed lawsuit. It is particularly concerning because of the growing body of research showing e-cigarettes cause serious health issues.
The 2016 Surgeon General’s report cited evidence that nicotine, in addition to being highly addictive, causes damage to the brains of adolescents. Additional research shows that e-cigarettes also cause lung and cell damage similar to that of combustible cigarettes. The plaintiffs in the lawsuit include heavy hitter public health agencies like the American Lung Association. It also includes the American Academy of Pediatrics, American Cancer Society Cancer Action Network; American Heart Association; Campaign for Tobacco-Free Kids; Truth Initiative; and five pediatricians. (American Academy of Pediatrics v. Food and Drug Administration, U.S. District Court, District of Maryland, No. 18-cv-00883.)
The results of the lawsuit, which was filed in federal court in Maryland, may change the implementation date of FDA product approval,l but that decision may be a long time coming. In the meantime, consumers must stay vigilant about safety when choosing to use e-cigarettes and the nicotine liquids used in the product.