IPCPR Provides Guidance on Warning Plans and Labeling for Manufacturers

The FDA deeming rule installed new requirements for warning plans for advertising and labeling of regulated products. Unsurprisingly, the rule has left many manufacturers and retailers in the dark regarding their new obligations over the multi-year implementation of the labeling and advertising requirements. The first deadline under these requirements is fast approaching. To assist our industry with upcoming compliance obligations and challenges, IPCPR has drafted a guidance document overviewing the warning plan, warning label and timing requirements in the deeming rule.

Click HERE¬†for IPCPR’s guidance document.

The document reviews the following:

  • Warning Plans
    • What is a warning plan,
    • What are the six required warnings, and
    • When is a warning plan required for advertising.
  • Warning Labels
    • Deadlines for sale of non-labeled products.

For any additional questions or further discussions on the new requirements for manufacturers or retailers, please contact Daniel Trope, IPCPR Director of Federal Government Affairs at Daniel@ipcpr.org.