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A primary line of defense against food safety hazards to protect consumers' health



When a company initiates a voluntary food recall, the company will usually first notify either the U.S. Department of Agriculture (USDA)’s Food Safety and Inspection Service (FSIS) or the U.S. Food and Drug Administration (FDA), whichever agency is responsible for regulating the food.

FSIS or FDA will help inform the public about the recall by posting a notice on its website and sending an email to those who have signed up to receive recall information. The recalling company might also set up a webpage of their own with information about why they are recalling the food and what resources the company offers the consumers impacted by the recall. The company will also take the problematic food off of store shelves and stop selling it.

What is a Food Recall?

The U.S. Department of Agriculture (USDA)’s Food Safety and Inspection Service (FSIS) defines a voluntary food recall as an “action by a manufacturer or distributor to protect the public from products that may cause health problems or possible death.”

Similarly, under the U.S. Food and Drug Administration (FDA)’s regulations, a voluntary food recall is an “action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.”

FSIS’s food safety authority comes from the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. However, FDA’s food safety authority comes from the Federal, Food, Drug, and Cosmetic Act, as amended by the Food Safety Modernization Act (FFDCA/FSMA).

Furthermore, the Food Safety and Inspection Service (FSIS) regulates meat, poultry, and egg products while the Food and Drug Administration (FDA) regulates all other food products (around 80% of the food supply).

Finally, FSIS conducts continuous inspections in the facilities which process food under its jurisdiction. This means that FSIS inspects meat, poultry, and egg products that are sold across state lines. FSIS also approves labels on these products before the products are marketed.

On the other hand, FDA inspects the food facilities under its jurisdiction only once every three to five years but does not conduct pre-market approval of food labels.

FSIS does not have the authority to conduct mandatory recalls, however, companies can voluntarily recall FSIS regulated food.  Meanwhile, recalls of FDA regulated food can be either voluntary or mandatory.

If a recall falls under Class I, then there is a reasonable probability that the food will cause serious adverse health consequences or death to humans or animals.

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Foodborne Disease Outbreaks

A foodborne outbreak occurs when two or more people get the same illness from the same contaminated food or drink.

The Centers for Disease Control and Prevention (CDC) posts food safety alerts and investigation notices for multistate foodborne disease outbreaks. When multiple people get sick around the same time from bacteria with the same DNA fingerprint, that indicates a possible outbreak.

CDC’s investigators use three types of data (epidemiologic, traceback, and laboratory data) to identify the source of an outbreak. A multistate outbreak source is considered confirmed if it has epidemiologic and at least one other type of data to support it as the source.

Each year in the United States, Salmonella, Shiga toxin-producing E. coli (STEC), and Listeria cause an estimated 1.49 million illnesses, 28,000 hospitalizations, and 700 deaths, at an estimated cost of more than $6 billion. These three germs are the leading causes of multistate foodborne outbreaks.

Germs causing foodborne disease in 2023 include:

Salmonella Enteritidis.

Salmonella Infantis.

Hepatitis A.

Listeria monocytogenes.

Report a Problem with Food Products to the U.S. Food and Drug Administration

FDA 24-hour Emergency Number for Food-borne Illness: 301-443-1240.

Complete an electronic Voluntary MedWatch form online.

Saving Lives

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