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When the consumption or exposure to such food will cause serious adverse health consequences or death to humans or animals (SAHCODHA)


FDA Mandatory Food Recalls

The mandatory food recall authority went into effect when the FDA Food Safety Modernization Act (FSMA) was enacted on January 4, 2011.

The agency can since then, order a responsible party to recall an article of food where the FDA determines that there is a reasonable probability that the product (other than infant formula), is adulterated or misbranded, and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

What Foods are subject to the FDA’s Mandatory Recall Authority?

Food products (other than infant formula) must be  manufactured, processed, packed, or held at a food facility that is required to register. Infant formula is not covered because it has its own recall requirements. The term “food” here, includes dietary supplements.

What is a Responsible Party under the Federal Food, Drug, and Cosmetic Act (FD&C Act)?

Owners, operators, or agents in charge of a facility and its registration, are also responsible for implementing and assuring the recall is performed, if so ordered.

What are the Criteria for a Mandatory Recall?

▪ Reasonable probability that the article of food is adulterated.

▪ Reasonable probability that the article of food is misbranded.

▪ Reasonable probability that the use of or exposure to such food will cause SAHCODHA.

FDA Process for a Mandatory Recall

Once the FDA has determined that the criteria for a mandatory recall have been met, the responsible party will be notified in writing using an expeditious method of delivery, and will be provided an opportunity to voluntarily cease distribution and to recall the article of food.

If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing to be held not later than 2 days after the issuance of the order.

Following these steps, the FDA Commissioner may order a recall taking into account:

▪ Significant food safety observations made during establishment inspections.

▪ Results from sample analyses, which may include those for raw materials or finished food products, and certain sample swabs from the food facility manufacturing environment.

▪ Epidemiological data (food borne outbreak data directly related to the food product that suggest disease or injuries have already occurred from the consumption of/exposure to the product).

▪ Vulnerability of the population that normally consumes or is exposed to the food product (infants, toddlers, the elderly, pregnant women, medically compromised individuals, certain pets, young livestock).

▪ Nature of the food product (Ready-to-eat food, raw, cooked).

▪ Reportable Food Registry data.

▪ Consumer and trade complaints.

▪ Whether the responsible party has failed to initiate a voluntary recall.

Below are examples of circumstances that could result in mandatory Class 1 recall authority, besides Listeria monocytogenes (Lm) or Salmonella spp. in ready-to-eat foods, certain undeclared allergens in food products, E. coli O157:H7 in leafy greens, and botulinum toxin found in food products:

▪ Peanut butter, alfalfa sprouts, and deli products found to be contaminated with salmonella.

▪ Under-processed canned chili that contains clostridium botulinum toxin.

▪ Smoked salmon and pumpkin seeds found to be contaminated with listeria monocytogenes.

▪ Products containing undeclared allergens such as milk, peanuts or eggs.

▪ Baby food that poses a choking hazard.

▪ Horse feed contaminated with elevated levels of monensin.

▪ Pet foods contaminated with elevated levels of melamine and cyanuric acid, or contaminated with salmonella or listeria monocytogenes.

▪ Sheep feed containing elevated levels of copper.

Then, the FDA ensures that a press release, alerts and public notices are published regarding the recall. Furthermore, the agency sends a notification to affected consumers and retailers.

Report a Problem with Food

For Meat, Poultry and Egg Products

▪ Call the toll-free U.S. Department of Agriculture (USDA) Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854).

Report the complaint online.

You must have:

  1. The original container or packaging
  2. Any foreign object that you might have discovered in the product
  3. Any uneaten portion of the food (refrigerate or freeze it)

Restaurant food safety is covered by local public health authorities. Call the Health Department in your city, county or state.

Other food products? Then, contact the FDA Consumer Complaint Coordinator for the state in which you reside.

Report finds an increase in the number of food items recalled in 2022.

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