Food products are recalled from the North American market for various reasons, but historically the vast majority of recalls are attributed to public health hazards. A review of food recall data reported by the U.S. Food and Drug Administration, USDA Food Safety and Inspection Service, and the Canadian Food Inspection Agency revealed annual trends in the reasons for North American food recalls. In particular, the review confirmed the majority of food recalls in recent years were due to food allergens and microbial hazards. Following is a summary of recent trends in recalls attributed to food allergens, including product types, root causes and related regulatory issues.

Allergens have persisted as a leading reason for food recalls due in part to the implementation of allergen labeling rules in the US and Canada, which led to greater regulatory scrutiny and enforcement.  The trend is likely to continue in the US as the FDA prepares a final allergen guidance and develops new allergen controls requirements as mandated by the Food Safety Modernization Act (FSMA).  Moreover, the long-awaited FDA rule for gluten-free labeling took effect last August, which is likely to prompt future recalls of FDA-regulated food products due to gluten labeling errors.  In Canada, the latest food allergen labeling regulations took effect in August 2012 mandating new requirements for specific priority allergens, gluten sources, and added sulfites in prepackaged 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 U.S., the “Big 8” allergens (wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans) account for approximately 90 percent 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.

The annual number of FDA food recall events due to allergens steadily increased between the years 2006 and 2012. While allergen recalls declined slightly in 2013, recalls due to the Big 8 allergens accounted for 34 percent of all FDA food recalls in 2014 and were the leading reason for recalls of FDA-regulated food products last year. Microbial contaminants were identified as the reason for 30 percent of FDA recalls in 2014.

The USDA Food Safety and Inspection Service (FSIS) is the federal agency responsible for ensuring the safety of meat, poultry and egg products.  Undeclared allergens have been the leading reason for recalls of FSIS-regulated products since 2011. In comparison to the previous year, FSIS recalls due to undeclared allergens during 2014 increased approximately 30 percent, but recalls due to microbial hazards declined by more than 50 percent last year. Allergens were responsible for nearly half of all FSIS recalls in 2014.

In Canada, a review of public food recall warnings issued by the Canadian Food Inspection Agency (CFIA) revealed a steady upward trend from 2007 until 2011.  Despite a slight decline in allergen-related recalls after 2011, undeclared allergens were responsible for more than half of all CFIA high-risk food recalls in 2013, and the majority of more than 300 high-risk food recalls during 2014.   In Canada, food allergens include: coconut, crustacean/shellfish, egg, fish, gluten, milk, mustard, peanut, sesame seeds, soy, sulfites, tree nut and wheat.

Food products & allergens
Bakery products, snack foods, chocolate confectionery products, dairy products and dressings are most commonly involved in allergen-related recalls, but any food with multiple ingredients has the potential to contain allergens. The allergens most commonly identified in FDA food recalls last year included milk, nuts (peanuts and tree nuts), wheat and soy.  In Canada, the top five allergens named in food recalls during 2014 were: milk, mustard, wheat, peanut and egg.

Reasons for recalls
Improper or ineffective Good Manufacturing Practices (GMPs) are the underlying reason for the vast majority of food recalls.  The FDA has defined 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.

FSMA, preventive controls, and industry guidance
As mandated by FSMA, the FDA proposed rule for preventive controls for human food included a proposed revision of the existing requirements of the current Good Manufacturing Practices (cGMPs).  The proposed rule recommended several revisions of the existing GMP requirements (21 CFR 110), including actions to ensure protection of allergen cross-contact during manufacturing.

Under the May 2014 FDA draft guidance entitled, ‘Food Allergen Labeling Exemption Petitions and Notifications’, food manufacturers could request an allergen labeling exemption. FDA would consider an exemption from the FALCPA labeling requirements if the petitioner can confirm a food or ingredient would not provoke an allergic response. Clinical data from an oral food challenge and risk modeling data would be considered.  Moreover, FDA would evaluate the identity and intended use of the ingredient as well as the analytical methods.

Addressing the rise in recalls of meat and poultry products due to allergens, FSIS issued compliance guidelines for allergens last year, 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 millions of consumers worldwide.   To reduce the risk of an allergen-related food recall, food manufacturers must understand current and emerging regulations in order to be prepared for the increased scrutiny of food regulatory agencies in the U.S. and Canada.

Effective employee training and best practices are essential for food companies to ensure the integrity of their product, protect their company from damaging liability claims and minimize the risk of costly recalls. Download our food allergens brochure to learn more!

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