FDA: A Draft Guidance on Mandatory Recall Authority

With an abundance of information shared on the web and available at our fingertips, it’s easier than ever to receive information about things that affect our health and the health of our families.

The FDA is now reaching out to the public regarding its protocols, and the way information is obtained and shared.

The FDA has the capability to force an organization to recall food if there is reasonable suspicion that food, the consumption, use of, or exposure could result in adverse health consequences. A recently published notice, “A draft guidance for industry on mandatory food recalls” is meant to strengthen food safety enforcement measures.

As of Thursday, May 7th the draft was available for public comment. According to the FDA, all comments will be considered prior to completion.

“This list of Questions and Answers is intended to provide answers to common questions about the mandatory recall provisions in section 423 of the FD&C Act and FDA’s current thinking regarding their implementation” says the FDA.

The draft details the following:

  • Why is mandatory food recall authority important?
  • What foods are subject to FDA’s mandatory food recall authority?
  • What is a responsible party under section 423 of the FD&C Act?
  • What are the criteria for a mandatory recall?
  • What is the process FDA must follow for a mandatory recall?
  • When is a food considered adulterated under Section 402 of the FD&C Act?
  • When is a food considered misbranded under 403(w) of the FD&C Act?
  • What evidence might FDA consider when deciding to move forward with a mandatory food recall under Section 423?
  • How will FDA publicize information about the mandatory recall?
  • When would user fees to cover food recall activities be assessed, to whom, and for what activities? What are the costs of the fees? Can civil money penalties be assessed for not complying with a recall order?

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