Did you know that 33 million Americans, according to FARE (Food Allergy Research & Education), have food allergies?

FDA Compliance for Allergen Testing

With the Faster Act (Food Allergy Safety, Treatment, Education, and Research Act) in 2023, the FDA updated the original eight food allergies to nine major allergens referred to as the “Big 9” to be declared on food and supplement labels. These include milk, eggs, fish, crustacean, tree nuts, peanuts, wheat, soybeans, and sesame.

To comply with FDA regulations, manufacturers are required to have allergen control programs per Title 21 of CFR Part 117. These requirements are for preventing cross-contact during production, implement labeling controls to avoid undeclared allergens, and use validated testing methods to detect allergens in raw materials, finished products, and production environments.

One of the most trusted tests to detect food allergens is the ELISA Kits. At Ara Testing Labs, we specialize in helping food and dietary supplement companies meet FDA requirements using ELISA kits. ELISA, the enzyme-linked immunosorbent assay, detects and quantifies the amount of a target antigen, which is very consistent for reproducible results.