Despite all the evidence indicating the relative safety and effectiveness of e-cigarettes as smoking cessation tools.
Yet while this evidence is as strong as that for the other new tobacco products recently approved for sale by the Food and Drug Administration (FDA), PMTAs for the former are being rejected by the thousands.
On August 31st, the FDA rejected approximately 800 PMTAs for vaping products from three e-liquid manufacturers, on grounds that these failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.” The agency added that such evidence, “would likely be in the form of a randomized controlled trial or longitudinal cohort study,” though it leaves room for other types of evidence “if sufficiently robust and reliable.”
Diane Caruana – Vaping Post – 2021-09-10.
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