04 Aug FDA Warning Plan Requirements: IPCPR Guidance for Retailers
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 guidance for retailers and an associated template on what situations they will need to submit a warning plan for, how to fill out a plan and how to submit it to the FDA. We strongly advise you read the guidance and determine how best to proceed for you and your store. The guidance provides information on the following:
- What information do warning plans require,
- Definition of a “Cigar Brand” vs. “Cigar Company” and what that means for warning plans,
- Covering “all brands” of cigars in future advertisements with a single plan,
- How and where to submit the plan to the FDA.
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 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 retailers.
For additional information or any questions, please contact Daniel Trope, IPCPR Director of Federal Affairs at email@example.com.