⚖️FDA Guidance on Evaluating Food Allergen Public Health Importance
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Interested Parties; Availability
Summary
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
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This guidance directly impacts businesses producing or labeling food products, as they must comply with safety and labeling regulations concerning allergens not classified as major allergens. Failure to meet these requirements could result in misbranding and regulatory consequences.