According to the Food and Drug Administration (FDA), millions of Americans have food allergies. While most reactions are mild, some people experience severe or even life-threatening symptoms. FDA’s Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF) Rule (21 CFR Part 117) requires domestic and foreign food facilities that manufacture human food develop and implement a Food Safety Plan that includes an Allergen Program to address this concern.

Eight Becomes Nine

While many different foods can cause many different types of reactions and symptoms, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified what has commonly been known as the “Big 8” major allergens:

1. Milk
2. Eggs
3. Fish (e.g., bass, flounder, or cod)
4. Crustacean shellfish (e.g., crab, lobster, or shrimp)
5. Tree nuts (e.g., almonds, pecans, or walnuts)
6. Wheat
7. Peanuts
8. Soybeans

Sesame was added as the ninth major food allergen when the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act became effective on January 1, 2023. FALCPA requires that food labels clearly identify the food source names of any ingredients that are a major food allergen or contain protein derived from a major food allergen. The intent of FALCPA is to help allergic consumers identify foods or ingredients that they should avoid to prevent an allergic or other reaction due to hypersensitivities.

New Guidance

On the heels of the FASTER Act’s effective date, FDA recently published draft guidance for Food Allergen Programs in September 2023. This is part of the Agency’s ongoing updates to its Draft Hazard Analysis and Risk-Based Preventive Controls for Human Foods Guidance for Industry. Comprised of 16 chapters, FDA has been releasing new chapters since the guidance was announced in 2016 as they are developed to help facilities develop a Food Safety Plan in accordance with regulatory requirements. The most recent guidance published includes Chapter 11: Food Allergen Program.

Chapter 11 focuses on developing a Food Allergen Program to ensure finished food is properly labeled for major food allergens and, even more so, to protect food from major food allergen cross-contamination. According to FDA, “Some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate presence, rather than taking appropriate measures to minimize or prevent cross-contact.” Through the new guidance, FDA is encouraging industry to prevent allergen cross-contamination rather than intentionally adding sesame (or other major allergens) to products and then labeling them to comply with the law.

FDA recognizes the challenges of ensuring products are allergen-free, and the guidance is intended to help companies find solutions to meet the needs of consumers with food allergies. Chapter 11 explains how to develop and implement a Food Allergen Program by providing detailed recommendations for each aspect of the Program. It offers multiple examples for illustrative purposes that demonstrate ways to significantly minimize allergen cross-contact and undeclared allergens using cGMPs and preventive controls.

Labeling errors are the major reason for most FDA food allergen recalls. As such, the new chapter also offers guidance on how to monitor and verify that food allergies are properly declared and correctly labeled. In addition, the guidance addresses what facilities can do when allergen presence due to cross-contact cannot be completely avoided, including using allergen advisory statements.

Previously Published Guidance

The comprehensive Draft Guidance for Industry remains a work in progress. In addition to Chapter 11: Food Allergen Programs, the following draft chapters are currently available:

• Chapter 1: The Food Safety Plan
• Chapter 2: Conducting a Hazard Analysis
• Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food
• Chapter 4: Preventive Controls
• Chapter 5: Application of Preventive Controls and Preventive Control Management Components
• Chapter 6: Use of Heat Treatments as a Process Control
• Chapter 14: Recall Plan
• Chapter 15: Supply-Chain Program for Human Food Products
• Chapter 16: Acidified Foods

FDA plans to still publish the following chapters as they are developed:

• Chapter 7: Use of Time/Temperature as a Process Control
• Chapter 8: Use of Product Formulation or Drying/Dehydrating as a Process Control for Biological Hazards
• Chapter 9: Validation of a Process Control for a Bacterial Pathogen 
• Chapter 10: Sanitation Controls
• Chapter 12: Preventive Controls for Chemical Hazards
• Chapter 13: Preventive Controls for Physical Hazards
• Chapter 17: Classification of Food as Ready to Eat or Not Ready to Eat

Whether for allergen management or other identified hazards, taking a systematic approach to establishing risk-based preventive controls helps protect food products—and the consumer—from biological, chemical, and physical risks. FDA’s guidance can provide an excellent resource for meeting regulatory requirements and protecting consumers.