Allergen Labeling Compliance: Best Practices for Food Brands

If you’re a food brand looking to enter or expand in the U.S. market, allergen labeling isn’t just a checkbox—it’s a critical responsibility that affects consumer safety, your brand’s reputation, and your ability to clear customs without delays. One mislabeled product can trigger a recall, land you in regulatory hot water, or worse, harm someone who trusts your packaging to tell the truth.

Let’s walk through what actually works when it comes to allergen labeling compliance, from understanding the regulations to implementing systems that keep you ahead of issues before they become problems.

Understanding Allergen Regulations

Know the Laws

The FDA doesn’t leave much room for interpretation when it comes to allergen labeling requirements. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), food manufacturers must clearly identify the presence of major food allergens. This applies whether you’re manufacturing domestically or importing products into the United States.

The big nine allergens you need to watch for are:

• ✔️ milk
• ✔️ eggs
• ✔️ fish
• ✔️ crustacean shellfish
• ✔️ tree nuts
• ✔️ peanuts
• ✔️ wheat
• ✔️ soybeans
• ✔️ sesame (added as of January 1, 2023)

These account for the vast majority of serious allergic reactions and must be declared on every label.

If you’re exporting to multiple countries, regulations vary. The UK through the FSA has its own list that includes celery and mustard. Canada adds sesame and mustard seeds. When you’re dealing with international distribution, understanding allergen labeling laws means knowing exactly which markets you’re serving and what each requires.

Common Allergens

Not all allergens are created equal in terms of prevalence or severity, but FDA allergen labeling requirements treat the major nine with equal seriousness. Peanuts and tree nuts tend to cause the most severe reactions, but milk and egg allergies are more common, especially in children. Fish and shellfish are separate categories—a person allergic to shrimp isn’t necessarily allergic to salmon, but your label needs to specify which type you’re using.

Here’s what catches brands off guard: “tree nuts” is an umbrella term, but you must specify which ones are in your product. “Contains almonds and cashews” is compliant. “Contains tree nuts” without specifics? That’s a problem waiting to happen during an FDA inspection.

Accurate Labeling

Ingredient Disclosure

When it comes to how to label allergens for food products, clarity beats creativity every time. You have two compliant ways to declare allergens: within the ingredient list using parenthetical statements (e.g., “whey [milk]”), or in a separate “Contains” statement immediately after the ingredient list.

Most brands use both. Why? Because parents scanning labels in a grocery store aisle or consumers with severe allergies don’t have time to decode ingredient lists. A clear “Contains: Milk, Eggs, Wheat” statement in bold type removes ambiguity.

One common mistake: assuming consumers know that whey, casein, or lactose means milk. They might not. The FDA requires plain language—use the common allergen name, not just its derivatives. This is where consulting for FSVP compliance becomes valuable. An expert review catches these gaps before your product reaches port.

Cross-Contamination Information

Shared equipment is one of the biggest gray areas in allergen labeling. The FDA doesn’t require “may contain” statements for potential cross-contact, but many brands include them voluntarily. Here’s the reality: if your facility processes peanut butter and granola on the same line, even with cleaning protocols, trace amounts can remain.

Advisory statements like “manufactured in a facility that also processes peanuts” provide transparency, but they’re not substitutes for good manufacturing practices. The key is documenting your allergen control plans and validating your cleaning procedures. If you can’t guarantee zero cross-contact, the label should reflect that possibility.

Clear and Consistent Communication

Use Simple Language

Technical accuracy matters, but if a consumer can’t understand your label in three seconds, it fails its most important test. Avoid terminology like “albumin” when “egg” is clearer. Don’t hide allergens in fine print or use fonts smaller than the rest of your ingredient list—the FDA has specific readability requirements, and inspectors check them.

This becomes especially important for import food allergen labeling USA requirements. If your product was originally labeled for another market, direct translations might not cut it. “E120” might be a recognized code elsewhere, but in the U.S., you need “cochineal extract (color)” with a note that it’s derived from insects if relevant to allergen-sensitive consumers.

Consistency Across Products

Once you establish a labeling format, stick with it across your entire product line. Consumers who trust your brand develop pattern recognition. If your “Contains” statement appears in a yellow box on one product, changes locations on another, and disappears entirely on a third, you’re creating confusion and risk.

Consistency also helps during audits. When inspectors review your product portfolio, standardized formats demonstrate systems-level compliance rather than product-by-product scrambling.

Training and Education

Staff Training

Your warehouse staff, quality assurance team, and even sales representatives need to understand allergen risks. The person receiving ingredients should verify supplier certifications. The line operator should know which allergen-containing products run before and after each batch. The customer service rep should be able to answer basic allergen questions without guessing.

Training isn’t a one-time orientation. It’s an ongoing process that includes scenario testing. What happens if a supplier substitutes an ingredient? What’s the protocol if someone spots an unlabeled allergen? These aren’t hypotheticals—they’re situations that have triggered major recalls for established brands.

Ongoing Education

Regulations evolve. Sesame becoming the ninth major allergen in 2023 caught some brands flat-footed, especially those with tahini, hummus, or products using sesame oil. Staying current means monitoring FDA guidance documents, participating in industry associations, and working with compliance partners who track regulatory changes as part of their core business.

This matters particularly for food brand FSVP services. Brands operating internationally need partners who understand multiple jurisdictions and can flag changes before they cause shipment holds.

Monitoring and Review

Regular Audits

Schedule quarterly label reviews at minimum. Check every product variant, especially seasonal or limited editions that might not get the same scrutiny as your core line. Look for changes in supplier ingredient formulations—manufacturers reformulate products constantly, and what was allergen-free six months ago might contain soy lecithin today.

Document these audits. If the FDA questions your due diligence during an inspection, contemporaneous records showing systematic reviews carry significant weight.

Consumer Feedback

Some of your best quality control comes from customers who contact you with questions or concerns. Create easy channels for consumers to report potential allergen labeling mistakes to avoid, and treat every inquiry seriously. A consumer asking “Does this contain dairy?” might be pointing to unclear labeling that affects thousands of others who simply avoid your product instead of asking.

Technological Support

Labeling Software

Managing allergen declarations manually across multiple SKUs, markets, and ingredient suppliers is asking for trouble. Modern labeling software links to ingredient databases, flags potential allergens automatically, and updates labels when formulations change.

These systems become essential when you’re dealing with allergen labeling for dietary supplements, where products might contain dozens of ingredients and multiple potential allergens. The software doesn’t replace human oversight, but it catches what tired eyes miss during the tenth label review of the day.

Barcode Scanning Systems

When a recall happens—and statistically, if you’re in this business long enough, you’ll face one—traceability systems that use barcode scanning determine whether you can identify affected lots in hours or weeks. The faster you pinpoint which products contain the mislabeled allergen, the more targeted your recall and the less damage to your brand.

These systems also help during import inspections. When customs asks for documentation proving your allergen controls, having digital records accessible through barcode queries demonstrates sophistication that inspectors appreciate.

Transparency with Consumers

Engaging Communication

Your website should provide detailed allergen information for every product, ideally in a searchable format. Some brands create dedicated allergen guides or PDF downloads showing their entire product line’s allergen profile. This transparency builds trust and reduces customer service burden.

Consider going beyond minimum requirements. Some brands voluntarily test for gluten content and share those results, or provide detailed information about their cleaning procedures between allergen runs. This level of openness differentiates you in a crowded market.

Allergen Resources

Providing resources on allergen management shows you understand the daily reality of consumers living with food allergies. Links to organizations like FARE (Food Allergy Research & Education), clear explanations of your allergen control procedures, and contact information for specific questions all signal that safety is genuinely important to your brand, not just a compliance requirement.

Taking the Next Step

Getting allergen labeling right the first time saves money, protects consumers, and keeps your products moving smoothly through customs. But compliance isn’t static—it requires expertise in current regulations, attention to manufacturing details, and systems that catch problems before they reach consumers.

If you’re preparing to export food products to the U.S. market or reviewing your current labeling practices, having experienced eyes on your labels and compliance procedures makes the difference between smooth sailing and costly delays. Whether you need support with FDA registration, FSVP agent services, or a comprehensive label compliance review, working with specialists who understand both the regulatory requirements and the practical realities of food importing helps you avoid the common pitfalls that trip up even established brands.

Global Import Agent specializes in FDA compliance and U.S. import approvals for international food, beverage, and dietary supplement companies. Our team of PCQIs and FDA legal experts provides affordable, technology-enabled solutions including label compliance reviews, FSVP compliance, and market entry strategy. We’ve helped hundreds of brands successfully navigate U.S. allergen labeling requirements and avoid detention at ports. Contact us today for a free quote and ensure your products are export-ready and fully compliant.