What Is Allergen Declaration?

Why It Matters for Supplement Brands

Incorrect or missing allergen declarations can trigger product recalls, FDA enforcement, and — most critically — pose genuine health risks to consumers with severe allergies. Allergen compliance is non-negotiable for supplement brands.

How It Works

Under the Food Allergen Labeling and Consumer Protection Act (FALCPA, 2004) and the FASTER Act (2021), supplement labels must declare the presence of these major allergens:

1. **Milk** (including casein, lactose, whey) 2. **Eggs** 3. **Fish** (must name the species) 4. **Crustacean shellfish** (must name the species) 5. **Tree nuts** (must name the type: almonds, walnuts, etc.) 6. **Peanuts** 7. **Wheat** (and other gluten-containing grains) 8. **Soybeans** 9. **Sesame** (added by the FASTER Act, effective January 1, 2023)

Allergens can be declared either in a 'Contains:' statement below the ingredient list or in parentheses within the ingredient list itself.

'May contain' or 'processed in a facility that also processes' statements are voluntary and address cross-contact risk — they are not substitutes for mandatory allergen declarations.

Common Mistakes to Avoid

• ✗Not auditing raw material suppliers for allergen cross-contact risks in their facilities
• ✗Forgetting to declare sesame (added as a major allergen in 2023 under the FASTER Act)
• ✗Using 'may contain' statements as a substitute for proper allergen control and prevention
• ✗Not re-evaluating allergen declarations when changing suppliers or formulation ingredients

Related Terms

See It in Action

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