Food products are recalled from the North American market for various reasons, but historically, the vast majority of them are attributed to public health hazards. A review of reports from U.S. and Canadian regulatory agencies revealed that the majority of food recalls are due to undeclared allergens and microbial hazards. 

Sometimes, increased regulation can actually lead to more recalls. Allergens have persisted as a leading reason for food recalls due to the implementation of labeling rules in the United States and Canada, which leads to greater regulatory scrutiny and enforcement. In the United States, the trend is likely to continue, as the FDA prepares a final allergen guidance and evaluates allergen controls mandated by the Food Safety Modernization Act (FSMA). Moreover, labeling errors associated with the 2014rule for gluten-free labeling could prompt additional recalls. In Canada, food allergen labeling regulations implemented in August 2012 mandate new requirements for specific priority allergens, gluten sources and added sulfites in pre-packaged foods sold in Canada.

Recent trends in food recalls
Undeclared allergens can have serious public health implications for susceptible individuals, and are an important reason for a food safety recall. In the United States, the “Big 8” allergens (wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans) account for approximately 90% of all food allergy reactions.Since the implementation of the Food Allergen Labeling and Consumer Protection Act (FALPCA) in 2006, allergens have triggered more FDA recalls than any other reason.

For calendar year 2015, the total number of FDA recall events due to undeclared allergens reached a historic level and exceeded the total for all previous years. Since FALCPA was introduced, there has been an upward trend in recalls due to undeclared allergens. The Big 8 allergens triggered 34% of all FDA food recalls in 2014. Last year, undeclared allergens were identified as the reason for over 250, or 45%, of all FDA recall events. Overall, the leading reasons for FDA recalls last year were undeclared allergens (45%), microbial agents (29%), non-allergen labeling errors (9%), foreign matter (7%) and quality issues due to improper GMPs (4%).

USDA’s Food Safety & Inspection Service (FSIS) is responsible for ensuring the safety of meat, poultry and egg products in the United States. Undeclared allergens have been the leading reason for recalls of FSIS-regulated products since 2011. FSIS recalls due to undeclared allergens during 2014 increased approximately 30%, as recalls due to microbial hazards declined by more than 50% during the same period. During 2015, the leading reasons for the nearly 150 FSIS recalls were undeclared allergens (40%), microbial contaminants (15%), mislabeling (10%) and foreign matter (8%). A lack of FSIS inspection or import inspection was named in roughly 20% of FSIS recalls last year.

In Canada, a review of CFIA food recall reports revealed a general upward trend since 2006, and an unexpected decline in recalls from 2014-2015. While undeclared allergens were responsible for the majority of CFIA food recalls in recent years, the annual total of recalls due to microbial contaminants has declined each year since 2012. 

Last year, the leading reasons for CFIA food recalls included undeclared allergens (44%), microbial contaminants (31%), foreign matter (10%), quality issues (5%) and non-allergen labeling errors (2%).

Causes and controls
Improper or ineffective good manufacturing practices (GMPs) are the underlying reason for the vast majority of food recalls. The FDA defines GMP-related issues as any problem that could be avoided through the use of preventive measures, including employee training, proper equipment sanitation, labeling reviews and maintenance of processing equipment. Cross-contact during processing, ineffective sanitation, incorrect terminology and the failure to properly declare allergens from all ingredients are common reasons for allergen-related recalls.

It would be of great benefit for both industry and regulators to have more information as to the actual root causes of recalls. Although it may be known that a recall occurred due to an undeclared allergen, it would also be valuable to know if this happened due to a mix-up in label application, poor sanitary design or sanitation practices, a change in an ingredient from a supplier without proper communication, etc. A compilation of root causes would allow better management of the issue and could eventually lead to fewer recalls.

During the first six months of 2015, undeclared allergens triggered more than half of all food recalls recorded within the FDA Enforcement Report, and the vast majoritywas attributed to undeclared peanut or almond in imported cumin or products containing cumin. The initial spike in cumin-related recalls subsided in February, but later resurged between April and June. The majority of recalls of cumin or products containing cumin were due to the potential presence of an allergen, but not necessarily the detection of an allergen.

FSIS recall reports from 2015 reveal a surge in recalls due to a lack of FSIS inspection and/or import inspection. Moreover, the total number of recalls due to undeclared allergens and labeling errors increased last year in comparison to recent years. 

As mandated by FSMA, the final rule for preventive controls for human food includes updated requirements for the current GMPs. The rule revised long-standing GMP requirements, including actions to ensure protection of allergen cross-contact during manufacturing and employee training.

To address the rise in recalls of meat and poultry products due to allergens, FSIS issued compliance guidelines for allergens in 2014, which provided best practice recommendations for establishments to ensure product labels declare all ingredients and products do not contain undeclared allergens or other undeclared ingredients of public health concern.   

Luck favors the prepared
Food allergens are a leading cause of product recalls in North America and a prevalent health concern for consumers worldwide. To reduce the risk of an allergen-related food recall, manufacturers must understand current and emerging regulations to be prepared for the increased scrutiny of food regulatory agencies.

Effective employee training and best practices are essential to ensure product integrity, protect companies’ damaging liability claims and minimize the risk of costly recalls.