How worried should e-cigarette manufacturers and tobacco harm reduction proponents be about FDA’s review of new product applications?
13:35 - 13:50
Tobacco Control, Industry & Regulation
Every e-cigarette on the U.S. market is currently illegal and will ultimately need a permissive new-product order from FDA to stay on the market legitimately. And no new or substantially changed e-cigarettes can legally enter the market without a permissive new-product order. What standards must and could FDA apply to manufacturers’ applications for new-product orders? Will politics come into play? Is helpful product innovation being stalled? Can it be encouraged? So far, applications to get permissive orders have consisted of hundreds of thousands of pages and many months of back-and-forth revisions and review. Is there an easier way?
- Eric N. Lindblom, JD Director, Tobacco Control and Food & Drug Law - O'Neill Institute for National and Global Health Law, Georgetown Law
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