Food safety in the United States is regulated by two agencies. 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 78% of the food supply). This split in federal food safety jurisdiction stems from the legislation that grants these agencies their food safety authority. FSIS’s food safety authority comes from the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. FDA’s food safety authority comes from the Federal, Food, Drug, and Cosmetic Act, as amended by the Food Safety Modernization Act (FFDCA/FSMA). In 2021, there were 281 recalls on food and beverage products. Of these recalls, 47 products were regulated by FSIS, while the other 234 products were regulated by FDA.
Food recalls play a key part in ensuring the American public has the knowledge they need to avoid adulterated and mislabeled food. This blog post explains what food recalls are and how they work in the United States.
Food Recalls Generally
Generally, a food recall happens when a company or the government informs the public that a food item is adulterated or mislabeled. When a product is recalled, the recalling entity informs the public of a specific issue with the product, such as foodborne illness contamination, glass or metal contamination, or undisclosed allergens. Also, the recalling company or government agency usually tells the public to avoid consuming the product and how best to dispose of it.
Some recalls are more severe than others. Both FSIS and FDA classify food recalls under the same system. Under this system, there are three classifications:
- Class I: this is the most severe class. 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. FDA sometimes refers to these recalls using the acronym “SAHCODHA”.
- Class II: a food recall that is classified as Class II means that there is a remote probability of adverse health consequences.
- Class III: under these recalls, the recalled food will not cause adverse health consequences, but the food nonetheless violates a food safety law or regulation.
See 21 C.F.R. § 7.3(m).
FSIS provides classification data on the recalls that fall within its food safety jurisdiction. Of the 2021 food recalls under FSIS’s jurisdiction, 38 were Class I, 9 were Class II, and 0 were Class III. FDA does not provide similar data for the food recalls under its jurisdiction.
FSIS v. FDA
Although FSIS and FDA have similar recall processes, there are a few differences. These differences primarily stem from the fact that the agencies have different inspection processes. 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, under the FFDCA/FSMA, FDA inspects the food facilities under its jurisdiction only once every three to five years. See 21 U.S.C. § 350j(2). Further, FDA does not conduct pre-market approval of food labels.
Because most of the food under FDA’s jurisdiction hits store shelves without first being inspected and FDA does not pre-approve food labels, FDA does not have the same ability as FSIS to catch adulteration and mislabeling before products enter the stream of commerce. This difference in inspection authority has led to a difference in FSIS’s and FDA’s recall authority. 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.
Voluntary v. Mandatory
Voluntary Recalls
Any food manufacturer can voluntarily recall an adulterated or mislabeled food product currently in commerce. As FSIS explains, a voluntary food recall is an “action by a manufacturer or distributor to protect the public from products that may cause health problems or possible death.” Similarly, FDA’s regulations explain that 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.” 21 C.F.R. § 7.40(a).
When a company initiates a voluntary food recall, the company will usually first notify either FSIS or 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.
If FSIS or FDA learn of a food safety risk, but the responsible company has not initiated a voluntary recall, FSIS or FDA can request the company to do so. Although companies are usually willing to proceed with a voluntary recall, if the company refuses, FSIS or FDA can detain and seize the food at issue. However, when FSIS or FDA detains and seizes food without the responsible company initiating a recall, the general public is less likely to learn about the food safety risk.
Because FSIS inspects both food products and product labels before they are marketed, problematic foods are usually caught early on. This means that for FSIS regulated food, the voluntary recall process serves as a backup for the food safety hazards that fall through the cracks. However, because FDA does not conduct pre-market food or label inspections of every product, the voluntary recall process serves as a primary line of defense against food safety hazards for FDA regulated food. To help increase FDA’s ability to protect the public from food safety risks, Congress passed FSMA in 2011. FMSA, among many things, granted FDA mandatory food recall authority.
Mandatory Recalls
Under FSMA, FDA can use its mandatory recall authority if it determines “that there is a reasonable probability that an article of food (other than infant formula) is adulterated [as defined by the FFDCA] or misbranded [as defined by the FFDCA]”. 21 U.S.C. §305l(a). Additionally, FDA can use its mandatory recall authority only if “the use of or exposure to such food will cause serious adverse health consequences to humans or animals”. Id. This is the definition of a Class I recall, so this means that FDA can only use its mandatory recall authority for Class I recalls.
There are several steps FDA must take when conducting a mandatory recall, which include:
- FDA must provide the company primarily responsible for the adulterated or mislabeled food an opportunity to stop distributing the food and to conduct a voluntary recall. FDA must give the responsible company notice that it is giving the company this opportunity.
- If the company does not stop distributing the problematic food or does not conduct a voluntary recall after receiving notice from FDA, then FDA may order the company to stop distributing the food and order the company to notify others (such as distributors, processors, or grocers) to stop distributing the food.
- When FDA orders a company to stop distributing food, it must offer the company a hearing where the company can learn why FDA ordered it to stop distributing the food and the company can offer defenses against a mandatory recall.
- After the hearing, FDA will determine whether a mandatory recall is necessary.
When FDA decides to go forward with a mandatory recall, it publishes a press release and alerts the public of the recall. The press release gives consumers the information they need to avoid the adulterated or mislabeled food. 21 U.S. C. § 350l(g). FDA also sets up an “incident command operation” that ensures there is timely and coordinated communication to the public about the recall. 21 U.S.C. § 350l(j).
Conclusion
FSIS and FDA regulated food can be recalled; however, only FDA has mandatory food recall authority. Even though FDA has mandatory food recall authority, it can only exercise the authority on adulterated and mislabeled foods subject to Class I recalls. Additionally, before FDA can exercise its mandatory recall authority, it must complete a series of steps which includes giving the responsible company the opportunity to be heard. Both voluntary and mandatory recalls help reduce the risks adulterated and mislabeled foods pose to the public because the goal of a recall is to inform the public about certain food safety risks and how to dispose of potentially hazardous foods.
For more National Agricultural Law Center resources on food safety, visit the food safety reading room, here.
To learn how FSIS defines food adulterants, click here.
To learn how FDA defines food adulterants, click here.
**This article was written by former NALC Staff Attorney Jana Caracciolo.