This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market.

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