How Government Agencies Notify the Public About Which Foods Not to Eat 

By Gary C. Smith and Keith E. Belk, Colorado State University 

Food safety oversight by FSIS-USDA, FDA-USDHHS, and State/Local Health Departments (S/LHD) includes “notifications of the public that certain food products are potentially or actually dangerous, unsafe, adulterated, misbranded, and/or mislabeled.”^1,2,3 So, how does the government inform customers and consumers that a potentially dangerous or unsafe food product has slipped through the net and entered commerce (i.e., the buying or selling of a commodity)?  

• FSIS and FDA regulate the safety of food in interstate and foreign commerce. 
• S/LHDs regulate the safety of food in intrastate commerce.⁴   

S/LHDs Food Safety Oversight and Public Notifications 

S/LHDs follow Food Code regulations, routinely audit cafes, restaurants, supermarkets, schools, etc.; and then go public by revealing the results publicly. A typical “call out” lists sites (by name and address) and specific shortcomings; for example, “evidence of insects/rodents”, “poor hygienic practices”, and “failure to keep food at 41°F or less”.⁵ Periodically, S/LHDs issue “Voluntary Recalls” via collaboration with either FSIS or the FDA.⁶ FSIS notifies the public media by issuing “Voluntary Recalls” and “Public Health Alerts”.⁷ The FDA notifies the public media by issuing “Voluntary Recalls”, “Allergy Alerts”, and “Outbreak Advisories”.⁸ 

Notable Foodborne Illness Outbreaks (1993–2013) 

The era of high-profile foodborne illness outbreaks (1993 – 2013) included:  

1. Jack-In-The Box, beef 
2. Odwalla, apple juice 
3. Schwann’s, ice cream 
4. Sara Lee, luncheon meat 
5. Malt-O-Meal, toasted oats 
6. Jewel Dairy, milk 
7. Jalisco, cheese 
8. Dole Foods, fresh spinach 
9. Con/Agra, peanut butter 
10. Swift & Company, beef 
11. Peanut Corporation Of America, peanuts 
12. DeCoster Egg Farms, shell eggs 
13. Jensen Farms, cantaloupe 
14. Chamberlain Farms, cantaloupe^3,4  

The biggest of these were:  

1. Peanut Corporation Of America recalled more than 3,200 different peanut-containing products.  
2. DeCoster Egg Farms recalled 380 million eggs.  
3. Jensen Farms caused 35 deaths.  
4. Chamberlain Farms sickened more than 200 people in 21 states, hospitalized 62 people, and caused 2 deaths.
5. Worldwide, Fenugreek Sprouts sickened more than 4,000 people and killed more than 50 people.⁹ 

In all the aforementioned foodborne illness outbreaks, “Voluntary Recalls” played an integral role in quelling public fear of personal danger regarding what they eat. By design, governmental notification actions are intended to protect the public and to shame those members of the supply-chain that might not be as conscientious as they should be.  

The Role of Voluntary Recalls in Foodborne Illness Management 

One of the most devastating things that can happen to a food manufacturing plant and/or company is to have a “Recall”; the costs – to human health, product value, and brand reputation – can be substantial.¹⁰  

Given that there is no such thing as a “Mandatory Recall”, and that companies often find themselves at an extreme disadvantage when dealing with government officials, it is remarkable how quickly the food industry responds when something goes wrong and the product has already entered commerce.¹¹ 

FSIS Detection of Adulterated or Misbranded Products 

FSIS may become aware of adulterated or misbranded product in commerce via: 

1. The company that manufactures, distributes, or receives the product. 
2. Test results from FSIS sampling. 
3. Observations gathered by FSIS personnel. 
4. Consumer complaints reported through the FSIS Consumer Complaint Monitoring System or other sources. 
5. Epidemiological, informational, or laboratory data from local, State, Federal, or foreign-inspection authorities.¹²  

It is the firm’s decision to recall product at the firm’s or the Agency’s recommendation; FSIS notifies the public about Class I and Class II Recalls through press releases.¹² The FDA becomes aware of such need, and reacts in a similar manner. ^2,3 

FSIS and the FDA announce, in a press release, that a certain company in a certain city/state is voluntarily recalling approximately a certain number of pounds of product(s) that may contain a certain hazard.^2,3  

What Constitutes a Class I, II, and III “Health Risk” During a Recall? 

Both FSIS and the FDA characterize each Recall by the “health risk” as a Class I, II, or III.^1,2,3,12 The FSIS Recall Classifications (effective Dec. 19, 2023) are:  

• Class I: This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.  
• Class II: This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.  
• Class III: This is a situation where the use of the product will not cause adverse health consequences or the risk is negligible.¹²  

The FDA uses essentially the same classification system.² FSIS notifies the public of all Class I and Class II Recalls;¹² the FDA notifies the public of all Class I and some Class II Recalls.² 

The Importance of Recall Plans and Traceability 

Each establishment that harvests, produces, or processes foods regulated by FSIS or the FDA must have a Recall Plan; and, the key to its success is backward and forward traceability.³  

In FSIS HACCP, “Traceability and Recall” is a prerequisite program: All raw material and finished products should be lot-coded and a Recall System should be in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary.⁴ Effective January 2026, FDA PCHF will require manufacturers, processors, and those who pack or hold foods on the “Food Traceability List” to maintain “Key Data Element” records for “Critical Tracking Events” in a product’s journey through the supply chain.^13,14 

Evolving Focus of Recall Programs Over the Decades 

Over the last three decades, the focus of Recall programs has shifted. In the early 1990s, the FDA, FSIS, and food companies, reacting to outbreaks associated with foodborne pathogens in ground beef, peanuts, and leafy greens, believed they were issuing Recalls at a rate of 94% biological hazards, 4% chemical hazards, and 2% physical hazards.⁴  

By CY-2010, the FDA issued 97 Recalls (related to at least 2,000 human illnesses) of which 73% were for Salmonella and Listeria monocytogenes, while FSIS issued 23 Recalls (related to at least 100 human illnesses) of which 61% were for E.coli, Salmonella, and Listeria monocytogenes.¹⁵  

Since then, two things changed the 94%-4%-2% hazard ratio:  

1. Greater emphasis on undeclared allergens (as a chemical cause of foodborne illness). 
2. Increased pressure for companies to issue Recalls based on consumer complaints about foreign/extraneous materials.^16,17 

Trends in FDA and FSIS Recalls 

Combined FDA and FSIS Recalls soared from a total of 120 in CY-2010 to an all-time high of 801 Recalls in CY-2016, due, in large part to:  

1. Consumers, media, and lawmakers are increasingly demanding safer food. 
2. There is less tolerance for foreign/extraneous material in food.¹⁸  

In 2017, there were 439 Recalls of FDA- and USDA-regulated food products; 49.5% of them were for “presence of undeclared allergens and/or misbranding”, 42.0% were for biological hazards, and 8.5% were for physical hazards.¹⁹ In 2019, the “FSIS Guideline For Industry Response To Consumer Complaints” was released to help the meat/poultry/egg products sector respond to the inundation of foreign materials complaints,²⁰ and the FDA revamped its “Guidance On Voluntary Food Recalls” to improve its protocols for public notification.²¹ 

Trends in FSIS and FDA Recalls (2020–2022) 

In CY-2020, FSIS Recalls dropped precipitously to a total of 47, while FDA spiked a YOY 700% to 417.^22,23 Top 2022 FSIS Recalls were for:  

1. “Contamination with foreign/extraneous materials” (the largest being 148,000 pounds of chicken patties after consumer complaints of pieces of clear plastic). 
2. “Produced without inspection”. 
3. “Undeclared allergens”.^23,24,25  

Top 2022 FDA Recalls were for:  

1. “Pathogenic bacteria” (the largest being in fresh leafy greens, infant formula, cantaloupes, and cereal grains). 
2. “Undeclared allergens”. 
3. “Contamination with foreign/extraneous material”.^16,26,27  

Recall statistics over the last 10 years (FY 2013 through FY 2022) show an average of 613 Recalls of FSIS-regulated plus FDA-regulated food products each year.²⁸ Every year, on average, 49% were for “undeclared allergens”, 26% were for “harmful pathogens”, 12% were for “contamination with foreign/extraneous material”, and 13% were for “all other reasons”.²⁸  

In the last 26 years, our belief is that the Hazards creating foodborne illness has shifted from 94-4-2 percentages for biological-chemical-physical, to 20-67-13.  

Essential Information in a Voluntary Recall 

Information provided in a Voluntary Recall includes:  

• Name of the company voluntarily issuing the Recall (e.g., Quaker Oats Company, Hillshire Farms). 
• Product descriptor (e.g., ground beef, cantaloupe). 
• Amount of product (e.g., 75,398 pounds). 
• Problem (e.g., may be contaminated with E. coli 0103). 
• Date of production. 
• Packaging size and material 
• Brand name. 
• Lot code. 
• Establishment number. 
• Destination to which product was distributed. 
• How the Agency found there was a problem 

Whether or not people who ate the product were sick or died.^29,30,31  

Some are brief (e.g., especially those from FDA).³² Some are long and detailed; including advice about how to handle, cook, or return the product, and who to contact at the company or Agency about it.³¹ Some are written in Spanish.³³  

Common Causes for Voluntary Recalls 

Voluntary Recalls are initiated by the FDA and/or FSIS for the following problems:  

1. Undeclared allergens 
2. Made or stored under insanitary conditions 
3. Not presented for reinspection 
4. Contaminated with a pathogen 
5. Fake inspection legend 
6. Choking hazards 
7. Misbranding 
8. Foreign/extraneous materials 
9. Not presented for re-inspection 
10. Mislabeling 

Food-safety oversight by FSIS-USDA, FDA-USDHHS, and State/Local Health Departments include “notification of the public that certain food products – currently in commerce –are potentially or actually dangerous or unsafe.” S/LHDs report results of Food Code audits to the media (print, radio, television, e-commerce) to “shame” food outlets.³⁴ FSIS notifies the public media, and other parties, by issuing “Voluntary Recalls’, “Public Health Alerts”, and “Import Refusals”.^7,35,36 The FDA notifies the public media, and other parties, by issuing “Voluntary Recalls”, “Urgent Food Recalls”, “Allergy Alerts”, “Consumer Alerts”, and “Outbreak Advisories”.^8,37,38,39 

FSIS and FDA External Recall Notifications 

For external notification, an FSIS “Recall Release” is distributed to:  

1. Media wire services. 
2. Media outlets in areas that received recalled products. 
3. The FSIS email subscription service for recalls. 
4. FSIS-affiliated social media outlets. 
5. FSIS website.⁴⁰  

For external notification, an FDA “Recall Release” is distributed to:  

1. Its Reportable Food Registry electronic portal for industry to report all Recalls. 
2. Federal and State Recall coordinators. 
3. Customers and consumers (about how to identify, return, or dispose recalled food). 
4. The public and social media. 
5. FDA Website.⁴¹  

Contact Information in Recall Press Releases 

In some FSIS and FDA Recall press releases and on their websites, contact information is provided. For example, FSIS uses these:  

1. Consumers with food safety questions can call the toll-free USDA Meat and Poultry hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHHotline@usda.gov.  
2. Consumers can report problems with a meat, poultry, or egg product to the online Electronic Consumer Complaint Monitoring System at https://foodcomplaint.fsis.usda.gov/eCCF/.  
3. Consumers can browse food safety messages at AskUSDA.⁴²  

Prime-time public media seldom cover food recalls but there are exceptions. CNN covered the fact that a supermarket chain, Trader Joe’s, had just issued its sixth food Recall in a two-month period; those included metal, rocks, allergens, etc. in tamales, crackers, soup, falafels, etc.⁴³ 

Criticism and Reactions to Government Food Safety Efforts 

Critics of the government (FSIS, FDA, and S/LHDs) on the handling of food safety issues abound. For years, skeptics have doubted that very many citizens actually kept tabs on Recall announcements, that the Agencies don’t act quickly enough to withdraw suspect foods from commerce, that we have too many serious foodborne illness outbreaks every year, and that the Agencies have woefully inadequate traceability.^{13,14,44,45,46,47}  

FSIS reacted to some of those things by launching an Application Programming Interface to transform the way the public can benefit from this critical and timely public health information⁴⁸, and by issuing new Guidance on public notification procedures.¹² The FDA reacted by developing a Food Traceability List and the FSMA 204 regulation.^13,14  

Several handlers of FDA-regulated food, including URM Stores Inc., Associated Grocers, Capitol Sausage and Provisioners, and Sysco plus 5,000 retail stores, 1,500 suppliers, and 25 distribution centers are already affiliated with two traceability companies, ReposiTrak® and iFoodDS®, preparing for the enaction of FSMA 204.^{14,49,50,51,52,53} 

Economic Impact of Increased FSIS Recalls 

The four-fold increase in FSIS Recalls from 120 (in CY-2010) to 499 (in CY 2023)⁵⁴ has some critics claiming there is federal government overreach. For example, on average, the cost of a Recall ranges from $10 million to $30 million, and some exceed hundreds of millions of dollars.⁵⁵  

Hillshire Farms recently recalled 15,876 pounds of meat and poultry sausage after a single (one person) consumer complaint, to the company, saying that he/she had found some bone fragments in one package of the product.⁵⁶  

Kraft Heinz recalled 83,800 cases of Kraft American Cheese slices because a strip of plastic film might stick to the slice after the wrapper has been removed; the FDA said that “could be unpleasant and could potentially cause a gagging or choking hazard.”⁵⁷ 

Litigation Costs and Media Coverage of Recalls 

And, it’s not just the monetary value of the recalled food products that have to be reworked or destroyed, and the loss of market-share due to public humiliation of “the brand”, it’s the cost of litigation when a consumer files a lawsuit against the grower, manufacturer, or retailer.  

ConAgra recalled 245,366 pounds of frozen chicken strips after a consumer (one person) was injured (orally) by a piece of plastic in a strip.⁵⁸ One week later, the injured consumer filed a class-action lawsuit against ConAgra seeking $5 million in damages.⁵⁹  

A journalist wrote, “The lawsuit is unnecessary and absolutely excessive, predator litigation lawyers are in action; unless there was gross negligence on the part of ConAgra, the damages should be limited to medical bills and a reasonable amount of money for ‘suffering’.”⁶⁰  

Another journalist said, “Consumers need to know there are two kinds of Recalls. Too often, the media fails the general public, scaring people or demeaning the food industry, by not differentiating foods that are unfit for consumption versus those that are unsafe for consumption.⁶¹ 

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