Ninety minutes ago, the FDA released its long-awaited electronic cigarette deeming regulations.
Sadly, the “deeming regulations” would better be called “The Cigarette Smoking Promotion Regulations of 2016.” They regulate tobacco-free and smoke-free electronic cigarettes much more stringently than real tobacco cigarettes, which the agency knows kills more than 400,000 Americans each year. And by essentially decimating the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these much safer products from competing with cigarettes – the deadliest consumer product on the market.
I will have much to say about the regulations in the coming days, but for now, I want to outline the three major provisions of the regulations and discuss their impact on public health.
1. Pre-Market Tobacco Applications
SUMMARY
As expected, the regulations require virtually every manufacturer of a vaping device and/or e-liquid to submit a burdensome and costly pre-market tobacco application (PMTA) for each of its devices and products. The FDA established a grandfather date of February 15, 2007, meaning that unless your product was already on the market in 2007, you must submit a PMTA. Although the FDA allows a pathway for products that are “substantially equivalent” (SE) to predicate products that were on the market in 2007, virtually none (if any) existing products are substantially equivalent to products on the market in 2007.
Dr. Michael Siegel – The Rest of the Story – 2021-05-05.
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