FDA Posts Small Entity Guidance

Published in Tobacco E-News

Document to help small businesses with FDA cigarette warning compliance

ROCKVILLE, Md. -- FDA posted a guidance titled "Small Entity Compliance Guide" 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;
  • In which language warnings must appear on packages and advertisements;
  • How to reference a smoking cessation assistance resource in all required warnings.

Click here to access the new guidance.

For questions regarding the guidance, contact the Center for Tobacco Products (CTP) at 1-877-CTP 1373, or by emailing AskCTP@fda.hhs.gov.