But e-cig companies will also incur great costs in both time and expense in complying, if they're even able to do so. The FDA itself admits it could take as many as 5,000 hours to complete the necessary paperwork and cost "only" several hundred thousand dollars per product. Industry estimates, however, run orders of magnitude higher, between $3 million and $20 million per product. Plus applications have to be submitted for everything a manufacturer wants to do. New product design? Submit an application. Make a health claim? Submit an application. Register with the agency? Application. Introduce ingredients? Application.
It's obvious the only e-cig companies that will be able to afford such time-consuming and costly processes, even at the decidedly lowball figures offered by the FDA, are the established players in the industry: the tobacco giants that have their own e-cig and vapor products on the market. The many thousands of smaller players that currently populate the market will find those costs impossible to pay. Instead they'll be driven from the market by the ruinous costs. If they're lucky they may be bought up by Altria or Reynolds, which will further solidify Big Tobacco's dominance.