SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has revised its deeming guidance for tobacco products to reflect recent court decisions on premium cigars and warning and labeling requirements for cigars and pipe tobacco.
The FDA was granted authority over e-cigarettes, cigars and hookah products when the deeming rule took effect on Aug. 8, 2016. The administration issued a compliance policy to provide manufacturers of deemed products that met the definition of a new tobacco product and were on the market as of that date time to submit their applications for authorization. Those premarket tobacco applications (PMTAs) were due on Sept. 9, but cigars have some exceptions.
On Aug. 19, the U.S. District Court of the District of Columbia prohibited FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the agency considers developing a streamlined substantial equivalence process specifically for those products.
Premium cigars are defined, in part, as cigars that are wrapped in whole tobacco leaf, contain a 100% leaf tobacco binder, are handmade or hand rolled and do not have a characterizing flavor other than tobacco.
The court on Sept. 11 also vacated health warning requirements for cigars and pipe tobacco, remanding the issue back to the FDA so it can more closely consider whether the health warnings would likely affect the number of cigars and pipe tobacco users.
Due to these court rulings, the FDA updated its Small Entity Compliance Guide, which helps small businesses understand and comply with the FDA’s deeming rule.