Allergen Testing Requirements for Plant-Based Foods

Allergen Testing Requirements for Plant-Based Foods

Plant-based foods are gaining market share across dairy alternatives, meat analogs, snacks, and prepared meals; often marketed as cleaner, simpler, or safer alternatives. Conventional foods and plant-based products follow the same FDA allergen requirements; however, the ingredients and production methods used in many plant-based foods can increase allergen risk and testing complexity. 

FDA Allergen Labeling Basics

Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), foods regulated by the U.S. Food and Drug Administration must clearly disclose the presence of major food allergens. These currently include: milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. 

Any ingredient derived from one of these allergens must be clearly identified in the ingredient statement or in a “Contains” declaration. Plant-based labeling terms such as dairy-free, vegan, or plant-based do not replace allergen disclosures and do not reduce testing obligations.

Why Allergen Testing is More Complex for Plant-based Products

Plant-based product development relies heavily on ingredients that are either major allergens themselves or closely related to allergenic food groups. This creates unique allergen testing challenges that are less common in many animal-based products.

High Use of Allergenic Plant Proteins

Plant-based formulations frequently include:

• Soy protein and soy lecithin
• Pea protein and other legume-based proteins
• Tree nuts such as almonds, cashews, walnuts, and coconut
• Wheat-derived binders and texturizers
• Sesame seeds, tahini, or sesame oil



These ingredients often appear together in a single formulation, increasing the number of allergens that must be tested and declared.

Increased Risk of Allergen Cross-Contact

Many facilities producing plant-based foods handle multiple allergenic ingredients across shared equipment. Even products formulated without a specific allergen may be at risk of cross-contact if robust sanitation and verification programs are not in place.

Novel Ingredients and Processing Methods

Emerging plant proteins may behave differently during processing, affecting allergen detectability. This makes method selection and validation especially important for reliable allergen testing results.

Key Differences Between Plant-Based and Conventional Allergen Testing

While the core allergen testing methods are the same for conventional and plant-based foods, plant-based products often require a broader and more frequent testing approach. Unlike traditional products that rely on standardized dairy or egg ingredients, plant-based formulations commonly use blends of protein concentrates, isolates, and functional ingredients that can vary by supplier and by lot, increasing variability and allergen risk. As a result, manufacturers may need more frequent finished product verification testing to confirm labeling accuracy, especially when making allergen-free or free-from claims. This added complexity also raises regulatory and legal exposure, as plant-based consumers tend to rely heavily on allergen statements when making purchasing decisions.

Allergen Tests Needed for Accurate FDA-Compliant Labeling

A strong allergen control program for plant-based products typically includes multiple layers of testing.

Ingredient-Level Allergen Testing

Testing raw materials helps verify supplier documentation and identify unexpected allergen presence before production. This is especially important for:

• Protein powders and isolates
• Flours and starches
• Spices, flavors, and seasoning blends

Finished Product Allergen Testing

Finished product testing confirms that allergen declarations are accurate and that unintended allergens are not present at detectable levels. Common FDA-accepted testing methods include:

• ELISA allergen testing for specific proteins
• PCR-based testing when protein detection is challenging
• Rapid lateral flow devices for in-process verification

Environmental and Equipment Swab Testing

Environmental monitoring identifies allergen residues on shared equipment and food contact surfaces. Routine swab testing supports sanitation validation and changeover effectiveness.

Support for Allergen-Free Claims

Although claims such as dairy-free, soy-free, or nut-free are not formally defined by FDA regulation, they must be truthful and not misleading. Consistent allergen testing data, supported by sanitation controls and documentation, is critical to defend these claims.

Labeling Accuracy Is a Brand Protection Strategy

For plant-based products, allergen labeling accuracy is more than a regulatory requirement. It is a consumer safety issue and a brand integrity issue. FDA expectations for allergen disclosure are the same regardless of whether a product is plant-based or conventional, but the complexity of plant-based formulations increases the need for thorough testing and verification.