FDA Sued Over E-Cigarettes – Again

By Ricardo Carvajal –

Totally Wicked-E.Liquid (“TWI”), an importer and distributor of electronic cigarettes, filed suit to prevent FDA from regulating TWI’s electronic cigarettes as drugs, devices, or combination products, and from barring their importation into the U.S.  TWI claims that the nicotine in its product is derived from tobacco, and that the product is therefore subject to regulation as a tobacco product and not as a drug, device, or combination thereof – an issue that the D.C. Circuit Court of Appeals recently decided in industry’s favor.  TWI contends that “FDA’s actions in barring TWI’s imports, in addition to being ultra vires, are thus the very definition of ‘arbitrary and capricious.’”