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FDA Guidance on Mandatory Recall Authority, Granted by FSMA

On May 6, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding mandatory food recalls.  FDA was granted its mandatory recall authority by the Food Safety Modernization Act (FSMA) in 2011.  All food, beverages, and dietary supplements (other than infant formula) from facilities that require an FDA food facility registration are subject to FDA’s mandatory recall authority.

According to the guidance, FDA can order a mandatory recall when it determines there is a reasonable probability that

1)      an article of food is adulterated under section 402 or misbranded under section 403(w) of the Food, Drug, and Cosmetic Act (FD&C Act), and

2)      exposure to such food will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

Among other things, a food may be considered adulterated under section 402 if it contains poisonous or deleterious substances that may render it injurious to health; contains a filthy, putrid, or decomposed substance; or has been prepared, packed, or held under insanitary conditions.  A food may be considered misbranded under section 403(w) if it contains a major food allergen that is not identified on its label.  An October 2014 FDA Consumer Update stated that undeclared allergens are the leading cause of food recalls requested by FDA.

Before FDA orders a mandatory recall, it must provide the responsible party with an opportunity to voluntarily recall the food.  If the responsible party fails to do so within the time provided by FDA, FDA may then order the responsible party to cease distribution, notify other parties to cease distribution, and give the responsible party an opportunity for an informal hearing.  If after these steps FDA still feels it is necessary, it may order the mandatory recall.

FDA is authorized to collect fees from domestic facilities and importers for noncompliance with a food recall order. According to the guidance, noncompliance may include the following:

  1. Not initiating a recall as ordered by FDA
  2. Not conducting the recall in the manner specified by FDA in the recall order
  3. Not providing FDA with requested information regarding the recall

The recall noncompliance fee for fiscal year (FY) 2015 is $217/hour for domestic facilities and $305/hour for foreign facilities.  FDA may charge this fee for every hour spent conducting food recall activities, including technical assistance, follow-up effectiveness checks, and public notifications.

The FDA Commissioner is the only person with the authority to order or rescind a mandatory recall. According to FDA’s Annual Report to Congress on the Use of Mandatory Recall Authority, FDA issued one Notification of Opportunity to Initiate a Voluntary Recall letter and three public health advisories in FY 2014.

Recalls can be time consuming, expensive, and damaging to a company’s reputation.   Registrar Corp can help food companies comply with FDA regulations to help prevent costly recalls.   As part of our Food Safety Services, we can assist companies in the review or development of HACCP, Food Safety, or Food Defense plans, as well as conduct a mock facility inspection to help a company prepare for an FDA food facility inspection.

For questions regarding FDA’s mandatory recall authority or Registrar Corp’s food safety services, contact us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.