Food Allergen Labeling Checklist

Mondelez Global recently recalled some cartons of Ritz crackers sandwiches over erroneous labeling. Instead of being labeled "Peanut Butter variety," the 8-, 20-, and 40-pack cartons of Ritz peanut butter cracker sandwiches were labeled "Cheese variety." Because of unreported allergens, Trader Joe’s voluntarily recalled its Hot Honey Mustard Dressing earlier this year. No allergen callouts for wheat, peanuts, soy, or sesame were in the final packaging.

Food allergies can cause symptoms ranging from minor discomfort to hospital emergencies, so labeling an allergen is never an option. The U.S. Food and Drug Administration (FDA) has made it a mandate.

The Food and Drug Administration provides suggestions, industry guidelines, and federal mandates that carry serious consequences for non-compliance.

Any food manufacturer that discounts FDA regulatory provisions can face product recalls, plant closures, and exorbitant fines that can dilute its market position. The FDA enforcement has grown stronger over the past years, with audit teams inspecting plants more thoroughly and citing violations for breaches.

This checklist takes you through all the stages of allergen labeling governed under the two primary laws:

FALCPA: The Food Allergen Labeling and Consumer Protection Act
FSMA: The Food Safety Modernization Act

Before You Begin: What the FDA Expects from Food Allergen Labeling

The FDA keeps a close watch on how food allergens are handled. It includes:

01
Guidance Documents: Guidance documents provide information on allergens, allergy protections, and other ingredients that can trigger sensitivity.
02
Inspections: Facilities that produce, prepare, package, or store human food supplies are subject to FDA inspections. The agency considers allergen preventive controls to prevent cross-contact in manufacturing and packaging and the entry of undeclared allergens into the system.
03
Monitoring: The FDA monitors reports of food allergic reactions, as well as those on ingredients and food hypersensitivities. Every complaint is thoroughly researched to decide on the possible options of regulatory measures, communicating safety information, and/or withdrawing products from the market.
04
Testing: The FDA periodically surveys the public and assigns samples to determine the prevalence of unreported allergens that could endanger consumers.
05
Regulatory Action: The FDA takes several regulatory actions when:
- A food label lacks required allergen information for a food ingredient.
- A food product is found to contain a food allergen due to cross-contact.
- A food product does not qualify to be labeled as “gluten-free.”

Ensuring Compliance with FALCPA and FSMA Guidelines

Allergen labeling is just a print issue. Millions of people may be hospitalized due to skin irritation, throat swelling, or even death because of a snack that is mislabeled or contains a hidden ingredient. Because of this, the FDA has stringent requirements for allergen labeling. FALCPA forces companies to mention major allergens in their packaging. FSMA takes it further by ensuring allergens don’t sneak into food accidentally during production.

How to Use This Checklist

This checklist comprises different sections, each building on the previous one. Missing early steps creates more complex problems to fix later, so don’t skip any steps.

Apply this to everything. New products, reformulations, packaging changes, and supplier switches.
Make it part of your standard operating procedures.
Train every stakeholder involved in the labeling process: R&D team, procurement people, and even marketing and compliance teams.

Phase 1

Identify Major Allergens (FALCPA-covered)

The severity of food allergies ranges from minor symptoms like hives and lip swelling to severe, potentially fatal symptoms like shock and respiratory issues. The FALCPA lists nine main food allergens.

01
Check for the presence of any of these allergens:

Check for the presence of any of these allergens:

02
Map every ingredient back to its source and document all sources, including ingredients, additives, and processing aids.
03
Get written allergen statements from all suppliers.
04
Establish change notification procedures with suppliers. Reformulations happen constantly, and suppliers don't always notify customers about allergen changes.
05
Create traceability systems that quickly identify allergen sources when questions arise.

Phase 2

Verify Allergen Declaration Requirements

Food labels must declare the food source of all major food allergens following the ingredient's name or immediately after the ingredient list.

01
Ensure allergens are listed using plain language (e.g., “Contains milk”).
02
Clarify technical terms by adding the common name in parentheses: "albumin (egg)"
03
Choose the correct format; either include allergens in the ingredient list OR use a separate "Contains" statement immediately after ingredients.
04
Use consistent allergen terminology throughout packaging. Don't say "Contains milk" on one product and "Contains dairy" on another.

Phase 3

Verify Label Placement and Formatting

Perfect technical compliance means nothing if customers can't read your labels online or in grocery stores. Fluorescent lighting, cramped aisles, and hurried online shopping are the real conditions your labels must work in.

01
Place allergen statements on the principal display panel or information panel.
02
Ensure font size and style are legible and consistent with other ingredient declarations.
03
Allergen information must be prominent and unambiguous.
04
Test allergen labels under store lighting. Use sufficient contrast for colorblind customers.
05
Consider multilingual needs if you serve diverse communities.

Phase 4

Evaluate Voluntary Precautionary Allergen Labeling (PAL)

"May contain" statements are valuable but are also frequently misused. Overuse makes customers ignore them completely, which defeats the purpose. The key is balancing genuine safety warnings with practical usability. If there are too many warnings, customers may stop paying attention.

01
If products are manufactured via shared equipment or facilities, utilize PAL for potential cross-contact (e.g., “May contain peanuts”).
02
Consider additional allergens such as gluten, sulfites, and food coloring that may cause reactions to specific individuals.

Phase 5

Align with FSMA Preventive Controls

Food manufacturers must move beyond just labeling allergens to align with FSMA’s preventive controls for cross-contamination.

01
Analyze every process for allergen hazards, not just the final product.
02
Document preventive controls and specify the steps to prevent cross-contamination.
03
Maintain updated allergen control procedures in your Food Safety Plan.
04
Set up systems to ensure controls keep working overtime.
05
Train personnel on allergen handling and labeling protocols.

Alleviate Allergen Labeling Worries with ManageArtworks

Allergen labeling isn't a one-time project; it's a continuous process that needs persistent attention and regular updates. At the same time, manual allergen compliance checking is becoming impossible at scale. There are too many ingredients, too many suppliers, and too many opportunities for human error.

At ManageArtworks, we simplify your allergen review process by automating what’s often manual and repetitive. Our system uses a predefined list of ingredient-to-allergen mappings. For example, it knows to flag milk when it sees ghee, or soy when it sees miso or edamame. During label review, the platform checks the formulation and shows alerts if something on the list is missing or mismatched.

Alleviate Allergen Labeling Worries with ManageArtworks Allergen labeling isn't a one-time project; it's a continuous process that needs persistent attention and regular updates.

Final Thoughts

Allergen labeling is no longer an afterthought or a mere regulatory check; it has become a core business competency. Some companies take allergen labeling seriously because it protects their customers and profits; those that don't suffer increasingly grave consequences.

While this checklist serves as a guide, success remains elusive unless well-executed at every step. The only way forward is to make allergen compliance a matter of company culture rather than something your quality team handles.

There's no stopping the ever-changing regulatory landscape. Possibly, new allergens will be added to the significant list, and enforcement will become tighter. The sooner companies build a sturdy and flexible compliance mechanism, the sooner they will be geared for whatever lies ahead. And foremost, remember that behind every allergen labeling, a brave decision is being made about the health and safety of a human being, and they're relying on you to

Most importantly, remember that behind every allergen label, a real person is making real decisions about their health and safety. Their health and safety is your responsibility!

Food Allergen Labeling Checklist

USA (FALCPA + FSMA)

Before You Begin: What the FDA Expects from Food Allergen Labeling