A US public health expert has accused the Food and Drug Administration of botching the cost-benefit analysis of its electronic cigarette deeming regulations.
In a blog, Dr. Michael Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said the FDA had drastically underestimated the costs of the regulations and not attempted 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,’ he wrote.
Siegel made his assessment after reviewing the declaration of Nicopure Labs’ CEO Jeff Stamler in the company’s lawsuit against the FDA,
‘In its declaration, Nicopure reveals that it has 2,400 stock keeping units (SKUs), including e-liquids, vaporizers, and component parts,’ Siegel said. ‘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.’
Siegel’s blog, The Rest of the Story, is at: http://tobaccoanalysis.blogspot.co.uk/.