The U.S. Food and Drug Administration (“FDA”) draws its authority from the Food Drug & Cosmetic Act (“FD&C Act”), whereas the Alcohol Tobacco Tax and Trade Bureau (“TTB”) is authorized under the Internal Revenue Code (“IRC”). Each of these laws has different definitions of “tobacco products” for different purposes. FDA’s Deeming Rule has no effect on TTB’s jurisdiction over tobacco products, and vice versa. While the FDA has deemed certain products to be “tobacco products” under the FD&C Act, some deemed products do not meet the definition of “tobacco products” under the IRC.
For example, the FDA has deemed e-cigarettes to be included in the definition of “tobacco products” under the FD&C Act. The FDA has extended its authority to all tobacco products except accessories of newly deemed tobacco products. Despite this, e-cigarettes are not within the jurisdiction of TTB. There is no federal excise tax (“FET”) imposed on e-cigarettes or e-liquids. As a result, there is no FDA user fee at this time for e-cigarettes or e-liquids. FET payments are the current methodology for figuring the FDA user fees for tobacco products.
Beginning August 20, 2016, domestic manufacturers and importers of cigars and pipe tobacco must report data concerning volume and FET paid in the previous quarters for cigars and pipe tobacco, to enable FDA to calculate FDA user fees for these product lines.
For example, since there is no FET assessed for e-cigarettes, the FD&C Act provision extending user fees to cigars and pipe tobacco is not currently extended to e-cigarettes.