The U.S. Food and Drug Administration (FDA) recently published finalized guidance on the Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, available here. This guidance falls under FDA’s Foodborne Illness Outbreak Response Improvement Plan, initiated in December 2021, and applies to voluntary recalls of all products subject to FDA jurisdiction, including human and animal food, drugs, and others. The guidance is directed at all firms in product distribution chains.

Initiation of Voluntary Recalls contains nonbinding recommendations on how firms should prepare voluntary recall processes, including recommended procedures. It also discusses steps that firms should take if there is an indication of an issue with a distributed product, how a firm should initiate a voluntary recall, and how FDA can support firms in the timely execution of voluntary recalls.

In the guidance, FDA urges all firms in the product distribution chain to be “recall ready.” General suggested preparations include:

  • Identifying appropriate personnel and their recall responsibilities
  • Training personnel on their responsibilities
  • Establishing a recall communications plan
  • Identifying FDA reporting requirements for distributed products
  • Using adequate product coding
  • Maintaining distribution records.

Initiation of Voluntary Recalls also includes recommended procedures for initiating a recall and executing specific procedures related to recall initiation, such as ceasing distribution and sales of affected products, developing a recall strategy, notifying direct accounts of the recall and suggesting actions, notifying the public, and crafting effective electronic communications for the recall.

When a firm decides to initiate a voluntary recall, the guidance suggests prompt communication about the recall and execution of the procedures in its recall plan, without waiting for FDA to review its recall strategy and communications. FDA also assures its commitment to cooperative collaboration with recalling firms by detailing who to contact within the regulatory body and what information to prepare.