FDA Rule Stifles E-Cigarettes' Harm Reduction Role With Grandfather Date, Application Costs

Most electronic nicotine-delivery devices that some consumers use for smoking cessation, even though the devices are not approved for the indication, likely will be unavailable starting in three years without a change to the grandfather date in a final rule adding the products to FDA's regulatory oversight.

While makers and marketers of e-cigarettes and other types of what FDA terms "electronic nicotine-delivery systems" look to Congress for help on allowing products already available when FDA published the rule to remain available without pre-market approval, some also will challenge the regulation in court