On May 10, 2016, the U.S. Food and Drug Administration published the final tobacco deeming regulations, a 499-page document that accompanies this article. Under the deeming regulations, the FDA has expanded its regulatory authority to include premium cigars, domestic cigars, pipe tobacco, e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, electronic pipes, hookah tobacco, dissolvable tobacco products, and nicotine gels.
Generally, the deeming regulations go into effect on August 8, 2016, but the FDA has various compliance periods for different regulations. Also, the FDA prohibits retailers from selling the deemed tobacco products (including over the Internet) to individuals under 18 years of age. It is important to note that state and local lawmakers have the authority to adopt a higher minimum age to purchase tobacco products.
The manufacturers of the deemed tobacco products must comply with several FDA regulations including: (1) submission of ingredient lists for each deemed tobacco product and reporting of harmful or potentially harmful constituents (HPHCs); (2) registration of tobacco product manufacturing facilities and a list of all tobacco products manufactured; (3) removal of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) from products, and (4) filing substantial equivalency (SE) or pre-market tobacco applications (PMTA) for products introduced in the marketplace after February 15, 2007, which is known as the predicate or grandfather date.
A manufacturer can submit a SE application if a product introduced to the market after February 15, 2007 is substantially similar to a product that was already on the market on or before February 15, 2007. A substantially similar product is known by the FDA as a “predicate product”. If there were no substantially similar predicate products for a manufacturer to rely on, then the manufacturer would need to file a PMTA with the FDA.
According to the FDA, the final deeming regulations differ from most public health regulations in that they are enabling regulations. In addition to directly regulating the newly deemed tobacco products, the deeming regulations enable the FDA to issue further regulations related to tobacco products that are appropriate to meet the agency’s standard of protecting the public health.
Specifically, to address concerns with the growing flavored cigar market and its impact on youth and young adult initiation with tobacco products, the FDA states in the deeming regulations that it intends to issue a proposed product standard that, if finalized and adopted, would eliminate characterizing flavors in all cigars including cigarillos and little cigars.