Warnings on hold

The US Food and Drug Administration has issued a new guidance about how it intends to comply with a recent court order by not enforcing the warning statement requirements for cigars and pipe tobacco products until 60 days after the final decision of the Plaintiffs’ appeal.
In addition, the guidance, Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco, states that the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) of the Food, Drug, and Cosmetic Act for cigars and pipe tobacco while the injunction remains in effect. During this time, however, cigar and pipe tobacco firms may add the warnings and make these labeling changes.
In a note issued through its Center for Tobacco Products, the FDA said it had revised also the following guidance documents to reflect the compliance policy outlined above:

• Submission of Warning Plans for Cigars
• FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
• Compliance Policy for Required Warning Statement on Small-Packaged Cigars
• Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule
• Tobacco Retailer Training Programs

The note drew attention also to a new tobacco compliance webinar, Retailer Requirements: New Warning Statement Requirements for Certain Tobacco Products. The webinar is said to address the addictiveness warning statement requirement and which tobacco products it applies to, and to answer some frequently asked questions from tobacco retailers about the warning statement requirements.
The FDA said it had created too several visual examples of the required addictiveness warning statement on different tobacco product packaging, and that it had developed a side-by-side product and warning statement chart.