WASHINGTON -- The Food & Drug Administration (FDA) has posted a guidance report titled “Small Entity Compliance Guide” intended to help small businesses understand and comply with the 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 use 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.
This Small Entity Compliance Guide is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.
Click here to view the complete guidance report.
For questions regarding the guidance, contact the Center for Tobacco Products (CTP) at 1-877-CTP 1373, or by emailing AskCTP@fda.hhs.gov.
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