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“Delays, delays, delays. While the FDA has rejected millions of products from the market, those products together represent only a fraction of total e-cigarette sales. In fact, the FDA has asked for yet another extension to make decisions on the most popular e-cigarette brands available on store shelves today. Admittedly, the PMTA process is complex and is inadvertently shutting small vape companies out of the market. A key part of this process requires significant data to indicate whether a product is appropriate for the protection of public health. The process is also expensive, with the FDA estimating an average cost between $200k-500K per application, but the costs are actually much higher. In a lawsuit against the FDA by two vapor companies that received marketing denials, costs incurred for a handful of the required tests ballooned to over $300,000 for just one e-liquid product.”
ARTICLE LINK: Tobacco control is not a zero-sum game
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