In the United States, the electronic cigarette industry is going through a tumultuous period, marked by rigorous regulation and contested legal decisions. The American health regulatory agency (FDA) faces criticism for its management of applications for approval of vaping products, with an extremely low approval rate and decisions often deemed biased by the courts.
The FDA, which was not initially hostile to vaping, has hardened its position following the controversies surrounding the Juul e-cigarette. It approved a very limited number of products, mainly tobacco-flavored electronic cigarettes from the tobacco industry, effectively excluding a wide variety of flavors. This strict stance has led to marketing bans for certain flavors, including menthol, on the grounds that manufacturers have not demonstrated sufficient benefits for adult smokers.
However, American justice has contradicted the FDA several times, overturning its decisions to refuse marketing for reasons considered arbitrary or capricious. American e-liquid manufacturers thus won their case, forcing the agency to reconsider its bans.
Despite these legal setbacks and administrative delays, the vaping market in the United States has partly moved underground, with an increase in sales of products not approved by the FDA. These “illicit” products continue to flow in, taking advantage of regulatory gaps and the agency’s inability to effectively control the market. Delays in processing permission applications are exacerbating the problem, with broken promises to finalize outstanding assessments.
The legal market, for its part, is dominated by a few tobacco-flavored products, which struggle to attract consumers. The combined sales of these authorized products represent a tiny fraction of the total vaping market, highlighting the failure of the current regulatory strategy to meet the needs of adult smokers seeking alternatives to tobacco.
This situation highlights the challenges faced by vaping players in the United States, between regulation perceived as punitive and the need to provide effective cessation solutions. The FDA's decisions, often criticized for lacking scientific basis, have caused some to ignore or circumvent regulations, fueling a growing black market and calling into question the repressive approach to vaping.
