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E-Cigarette or Drug-Delivery Device? Regulating Novel Nicotine Products

On April 25, 2011, the Food and Drug Administration (FDA) announced its intention of regulating “electronic cigarettes” as tobacco products, having failed in its initial attempt to regulate them as drug-delivery devices. Previously, products delivering refined nicotine had either been regulated as pharmaceuticals (and subjected to the “safe and effective” standard used in drug approvals) or swiftly removed from the market to protect public safety. The FDA’s decision came after the courts blocked the agency from regulating these products as drug-delivery devices, holding that under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), products containing nicotine derived from . . .

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