Food allergen recalls have surged in recent years, making them one of the most common causes of food product recalls in North America. In 2023 alone, the FDA and USDA recalled hundreds of products due to undeclared allergens—mistakes that can cost companies millions and put consumers at risk.

Why Are Allergen Recalls Increasing?
Several documented factors contribute to the rise in allergen recalls:

• Labeling and packaging errors, especially following ingredient, recipe, or supplier changes
• Expanded regulatory oversight, including the addition of sesame as the 9th major allergen under U.S. law in 2023
• Stronger detection, audits, and enforcement by FDA and USDA

These trends highlight the importance of robust allergen controls and careful label management.

Regulatory Requirements: FALCPA vs. FSMA
It’s important to distinguish between allergen labeling and preventive allergen management:

• FALCPA (Food Allergen Labeling and Consumer Protection Act, 21 U.S.C. 343) regulates the accurate declaration of major allergens on food labels. The top nine allergens in the U.S. are:

•Milk
•Eggs
•Fish
•Crustacean shellfish
•Tree nuts
•Peanuts
•Wheat
•Soybeans
•Sesame (effective January 1, 2023)

• All allergens must be declared in plain language when present as ingredients. Advisory “may contain” statements are voluntary and should only be used based on documented risk—not as a substitute for preventive controls.
• FSMA (Food Safety Modernization Act, 21 CFR 117.135) does not regulate label declaration. Instead, it requires food facilities to implement preventive allergen controls to manage cross-contact and ensure products are properly labeled.

Together, FALCPA and FSMA provide a comprehensive framework for preventing allergen-related hazards.

How to Prevent Allergen Labeling Errors
1.- Validate your ingredient suppliers
Confirm allergen content at the source with Certificates of Analysis (COAs) and specifications.
2.- Implement robust change control
Ensure that any changes to ingredients, packaging, or suppliers trigger a formal label review process.
3.- Audit your label approval workflow
Every product label should be reviewed by QA before printing or release.
4.- Segregate allergenic ingredients
Use color-coded containers, designated storage areas, and cleaning protocols to prevent cross-contact.
5.- Leverage expert labeling support
Partnering with professional teams, such as Go HACCP, can help design and review labels to meet FALCPA requirements and stay compliant with FSIS and FDA guidance.

Enforcement and Recalls
Incorrect allergen labeling can lead to:

• Class I recalls (immediate danger to public health)
• FDA warning letters
• Lawsuits and reputational damage

To stay informed about recent allergen-related recalls and enforcement actions, consult:

• FDA Recalls, Market Withdrawals, & Safety Alerts
• FSIS Recall Case Archive (USDA)

Final Thoughts
Allergen labeling errors are preventable with proper controls, staff training, and expert support. As regulatory scrutiny grows and consumer expectations rise, food manufacturers must prioritize allergen management—not only to protect their brand but also to safeguard the lives of their customers.