In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. Food allergen labeling is not optional — and the rules have gotten stricter. Let’s talk about whether your labels are compliant.
Under the Food Allergen Labeling and Consumer Protection Act, or FALCPA, food manufacturers must declare the presence of the eight major allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. The FASTER Act, signed into law in 2021, added sesame as the ninth major allergen, effective January 1, 2023.
Allergen declarations can be made in two ways: either within the ingredient list itself — using common names like “milk” or “wheat” in parentheses after the ingredient name — or in a separate “Contains” statement immediately after or adjacent to the ingredient list.
Cross-contact is a separate issue. If your facility processes products that contain allergens and those allergens could inadvertently end up in products not intended to contain them, you need to evaluate whether voluntary advisory statements like “may contain” are appropriate. But these are voluntary — they don’t substitute for mandatory allergen labeling.
Allergen labeling errors are one of the leading causes of food recalls. A mistake here doesn’t just create regulatory risk — it creates serious consumer safety risk. Review your labels carefully and get them verified before your next production run. We can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.