09 Aug FDA Warning Plan Requirements: IPCPR Guidance for Manufacturers (Updated)
On August 10th, manufacturers and retailers alike will be subject to FDA’s new warning plan requirements for advertising and packaging. What does this mean?
- Manufacturers & some* retailers must submit a plan to FDA on how it will randomly display and distribute six required warning statements on their packaging and advertising,
- These warning statements will be required as of August 10, 2018,
- Warning plans must be submitted 12 months before implementation.
IPCPR has provided updated guidance for manufacturers that covers:
- What is a warning plan,
- What are the six required warnings,
- What should a warning plan look like,
- Warning plans and advertisements, and
- How to submit a warning plan.
FDA’s recent roll out of its new comprehensive approach to tobacco regulations was a positive development for premium cigar retailers and manufacturers. For the first time since 2014, FDA is acknowledging at-least the potential for a definitive difference in premium cigars vs. other cigar products. However, until delays or changes to upcoming compliance deadlines are implemented, IPCPR will continue to advise our member retailers on FDA compliance requirements and best practices for manufacturers.
For additional information or any questions, please contact Daniel Trope, IPCPR Director of Federal Affairs at email@example.com.