The U.S. Food and Drug Administration recently issued a guidance entitled “Small Entity Compliance Guide” that is intended to help small businesses understand and comply with FDA’s regulations regarding the required warnings on cigarette packages and in cigarette advertisements.

The guidance addresses questions such as:
•    How required warnings must appear on packages and in cigarette advertisements, including size and location, rotation and irremovable or permanent warnings;
•    How to obtain and utilize electronic files for the required warnings; and
•    In which language warnings must appear on packages and advertisements

According to the new Tobacco Control Act, these warning labels will be required on Sept. 22, 2012.  However, a lawsuit filed by five tobacco manufacturers seeking preliminary injunction against the implementation of the FDA’s new text and graphic picture warning labels for cigarette packages and cigarette advertisements must still be ruled on and AWMA will advise members on any new developments on this issue.

The link to the new FDA Guidance may be found here:  www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm276626.htm