FDA Botched Cost-Benefit Analysis of Its E-Cigarette Deeming Regulations

After reviewing the declaration of Nicopure Labs'  CEO Jeff Stamler in its lawsuit against the FDA, I have concluded that the FDA completely botched its cost-benefit analysis of the e-cigarette deeming regulations, drastically underestimating the costs of the regulations and without even attempting to quantify the benefits.As such, this represents a violation of the Administrative Procedures Act, providing strong grounds for the D.C. District Court to overturn the regulations.In its declaration, Nicopure reveals that it has 2,400 stock keeping units (SKUs), including e-liquids, vaporizers, and component parts. This means that in order to keep its products on the market, Nicopure will have two years to complete 2,400 pre-market tobacco applications (PMTAs), each of which is estimated by the FDA itself to cost approximately $300,000 and to require 1,500 hours to complete.Nicopure estimates the actual cost of each PMTA to be between $3 million and $5 million. But even if we use FDA's more conservative estimate, it would cost Nicopure $720,000,000 ($720 million) to keep its products on the market. The company estimates that at very best, it could complete PMTAs for 12 of its products. Thus, the regulations - if not overturned - will decimate the overwhelming majority of Nicopure's offerings to vapers.The Rest of the StoryThe FDA estimated that it would receive only 750 PMTAs. So one of two things must have occurred:1. The FDA grossly underestimated the number of regulated pr...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs