United States: FDA’s Mandatory Recall Draft Guidance: What, When, Why, How And Who Pays!

Last Updated: May 8 2015
Article by Michael A. Walsh

On May 7, 2015, the Food and Drug Administration (FDA) published its draft Guidance for Industry Questions and Answers Regarding Mandatory Food Recalls and opened its docket [No. FDA-2015-D-0138] seeking comments. The Food Safety Modernization Act of 2011 (FSMA) granted the FDA extensive new power to require recall for food products (including finished products and ingredients). FDA required recalls can occur when there is a "reasonable probability" that the product is adulterated or misbranded (e.g. contains unlabeled allergens or added ingredients from food contact substances) and if exposure to the food will cause serious adverse health consequences or death to humans or animals (SAHCODHA pronounced "sa-coda").

In February 2015, the FDA issued its annual report to Congress on its use of its recall authority and advised Congress that it had exercised its authority for only the second time since enactment of FSMA. FDA's second recall involved products from dietary supplement manufacturer USPlabs, LLC for its OxyElite Pro branded products after an outbreak of acute non-viral hepatitis involving at least 47 hospitalizations, 3 liver transplants, and 1 death between April 10, 2013 and October 24, 2013.

Who pays? Last things first:

In its Draft Guidance, the FDA makes clear that if the "responsible party" for a domestic or foreign facility refuses to comply with any aspect of a recall order it will be liable for both its own costs of a voluntary recall and for recall costs incurred by the FDA. "Refusal" includes:

  • Not initiating a recall as ordered by the FDA;
  • Not conducting the recall in the manner specified by the FDA in the recall order; or
  • Not providing the FDA requested information regarding the recall.

The FDA recoverable costs include costs arising from:

  • Time spent by the FDA conducting food recall activities;
  • Retained technical assistance;
  • Follow-up effectiveness checks; and
  • Public notifications.

What can be recalled?

All food items that are manufactured, processed, packed, or held at a food facility that is required to register (including dietary supplements but excluding infant food) are subject to the FDA's mandatory recall authority.

Who may be ordered to make a recall?

The FDA's authority extends where the "responsible party" refuses to voluntarily recall the product or follow the FDA's order concerning how to conduct the recall. A responsible party is any party required to register with the FDA. The Food Drug and Cosmetic Act (FDCA) defines a responsible party as a "person who submits a registration." The FDCA definition of "person" includes individuals, partnerships, corporations, and associations. The owner, operator, or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring the recall is performed.

What are the mandatory recall criteria?

  • There must a be a "reasonable probability that the food is adulterated or misbranded"; and
  • The FDA must determine that exposure to the food will cause serious adverse health consequences or death (SAHCODHA).

Adulteration: The FDA Draft guidance goes further and defines when a product is deemed adulterated citing, in part, 21 USC § 342.

  • If the food bears or contains any poisonous or deleterious substance which may render it injurious to health; consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food; or has been prepared, packed, or held under insanitary conditions whereby it may be rendered injurious to health;
  • If the food is a dietary supplement or contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling; if the food is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; or if the food is a dietary supplement declared by the Secretary to pose an imminent hazard to public health or safety.

Misbranding ("Major Food Allergens"): The Draft Guidance sets out the circumstances for when misbranding will result in a mandatory recall.

  • When a major food allergen is unlabeled and exposure to the product is deemed an article that will cause serious adverse health consequences or death and is subject to FDA recall authority.
  • Major food allergens are defined as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and any food ingredients that contain a protein derived from these foods.

What facts does FDA consider?

The FDA will make its SAHCODHA determination by evaluating "all applicable evidence" including:

  • Observations made during inspections;
  • Results from sample analyses;
  • Epidemiological data;
  • Reportable Food Registry data; and
  • Consumer and trade complaints.

What happens next? FDA recall chronology and notification directives:

The FDA provides written notice "using an expeditious method" providing a time frame and method for the recall and an opportunity for a hearing. The notice can place additional requirements on the responsible party including ceasing distribution and providing notice to others in the distribution chain. The FDA will also require publishing a press release regarding the recall. When appropriate in the FDA's discretion, alerts and public notices may be required to provide additional notice to consumers and retailers.


It is a well-founded truism for the food industry that it is not a matter of if you will have a recall but when. Congress granted the FDA significant new and expanded powers in FSMA and the FDA has indicated that it is taking its responsibility seriously and will impose significant costs on those who refuse to obey its edicts. It is also a well-founded truism that lack of planning distinguishes a problem from a crisis. More than ever, having a recall response team and procedures in place before you need them should be the first order of business.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Michael A. Walsh
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