One of my fears in advance of the release of the regulations was that they would require substantial equivalence determinations for most products currently on the market an would pull some products from the market pending such determinations. Instead, the agency decided to allow all existing products to remain on the market, giving them two years to apply for FDA approval. In addition, new products can enter the market for the next two years without pre-approval from the agency.

The FDA's Center for Tobacco Products simply does not have the capacity to review 22,000 new product applications. After all, it has taken more than 4 years for the agency to even begin to process the more than 3,500 substantial equivalence applications submitted by tobacco companies, and as of this date, there are still thousands of those applications pending. It is easy to see that the proposed deeming regulations would create a bureaucratic nightmare.

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