CASAA Call to Action: Ahlusion creates and sells ejuice. A small Mom and Pop operation. Imagine my surprise and delight when they posted the best explanation of “The Cost of FDA Regulation” I have ever read. All the angles in great detail. Footnotes included. Written in an easy to understand fashion by a very talented employee named Lindsay. A few snippets for your reading pleasure:
“Even though the e-cigarette market has expanded rapidly in the last couple of years, it is unclear how many companies would commit to the industry by submitting premarket tobacco applications to the FDA. The agency optimistically suggests that without the inclusion of costly clinical trials, the market will justify the cost of submitting this application for many companies, although they do anticipate some product consolidation, reduction, or exit (FDA Economics Staff 36). However, the upper end of the cost estimate for this process, divided by the number of new products anticipated, still leaves an estimated cost of $333,554 per product application (FDA Economics Staff 36). This is far too expensive for many small businesses, meaning that the majority of the market will be left to large companies or to the Big Tobacco companies that are rapidly buying into the industry”
“The numbers for the total estimated costs of implementing this proposal are staggering. The up-front costs for full regulation, which does not exempt premium cigars, range from $74.3 to $347 million, with a primary estimate of $171.1 million (FDA Economics Staff 8). The costs in subsequent years are estimated to range from $20.8 to $49.0 million, with a primary estimate of $30.6 million (FDA Economics Staff 8). The primary estimate for the present value of total quantified costs over 20 years is approximately $592.0 million at a 3 percent discount rate and $467.6 million at a 7 percent discount rate (FDA Economics Staff 8). However, the upper estimate for the present value of total quantified costs over 20 years is approximately $1,010.1 million at a 3 percent discount and $810.2 million at a 7 percent discount (FDA Economics Staff 8). Given the possibility that the FDA underestimated the number of e-cigarette products on the market, these upper estimates may be closer to the actual cost.”
Please read The Cost of FDA Regulation
Disclosure: I am a customer of Ahlusion and enjoy their creations. I was NOT paid and or incentivized to make this post. I did not receive nor will I ever accept any “in kind” and or considerations to make this post or any post on this Blog. Thank you ~ Steve