The EU and Canada have basic regulatory reporting requirements for cigars, however, with Deeming, the U.S. Food and Drug Administration (FDA) has pushed the cigar regulatory framework into an entirely new level of intensive rigor. However, in July, the FDA announced their new strategy which aims to start "striking the right balance between smart regulation and encouraging innovation of satisfying, less harmful products" while making sure any product standard is "steeped in science" and is made with "robust" participation from stakeholders” - Mitch Zeller, CTP, NATO Conference, Denver, CO, DDAug2017, but is the new FDA strategy appropriate for cigars?

The right balance is indeed difficult to achieve when a regulator’s mission is to decrease combustible tobacco use while encouraging adult consumers to transition to satisfying, less harmful products. The FDA’s Family Smoking Prevention and Tobacco Control Act states it cannot ban an entire category of tobacco products, such as cigars. So how can a regulator best navigate this terrain while ensuring that regulations do not negatively impact customer satisfaction by means of less desirable products, higher costs and/or less access?

This presentation will look at the building blocks of a regulated product and briefly cover why cigars pose a unique challenge to the regulators and to tobacco product registration applicants seeking a license to sell high quality and cost appropriate products to informed adult consumers.