Zdrowie i gospodarka · 25/09/2017

Compliance Policy for Required Warning Statements on Small-Packaged Cigars; Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Compliance Policy for Required Warning Statements on Small-Packaged Cigars." The guidance is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in FDA's regulations deeming other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.