On September 28, a string of mainstream public health organizations including the American Lung Association and the American Heart Association, together with the Campaign for Tobacco-Free Kids (CTFK), sent a letter to Janet Woodcock, acting commissioner of the Food and Drug Administration (FDA).
Aside from its actual substance—a predictable demand that all flavored vaping products, including menthol, be removed from the market—the letter hit some rare notes of agreement with tobacco harm reductionists: urging the agency to expedite its long-awaited review process and panning the accompanying lack of transparency.
Because of a lawsuit filed and won by most of the signatories, the FDA had until September 9 to authorize or deny the marketing applications that vape manufacturers had to submit a year prior. Many of those premarket tobacco product application (PMTA) submissions have already received marketing denial orders (MDOs) from the agency, meaning those products can no longer be sold. But the largest companies, most of which make pod-based e-cigarettes, remain in a regulatory limbo.
The FDA has stated it needs more time to go over the corresponding science, an excuse that has been met with vitriol from all sides: Small- and medium-sized vape producers have essentially concluded that the industry will transform into an oligopoly of well-financed brands; prohibitionists aren’t thrilled that the agency has yet to target the most influential players.
Alex Norcia – FilterMag – 2021-09-29.