FDA has finalized its labeling rules for foods containing allergens—including common types such as milk, eggs, peanuts and shellfish—which allows food manufacturers to qualify for a labeling exemption if they can prove an ingredient is modified so that it no longer presents a risk to allergic consumers.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires food labels to identify products containing major food allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans). But manufacturers have proven to be able to modify these ingredients in a way that would neutralize any threat. These modifications may provide consumers who have a specific allergy with more foods to choose from, without fear of inducing an allergic reaction.

Under FALCPA, manufacturers who want to obtain an exemption from the labeling requirement for a specific ingredient must submit:

-a petition that provides scientific information demonstrating that an ingredient derived from a major food allergen “does not cause an allergic response that poses a risk to human health”


-a notification providing scientific information demonstrating that the ingredient “does not contain allergenic protein” (or providing information that that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health)

FDA says the final guidance describes the types of submissions that will help the agency evaluate ingredients to see if they meet the standards in the FALCPA. Manufacturers that can demonstrate to FDA that an ingredient qualifies for an exemption will not need to place an allergen declaration on the food label for that ingredient.

 The final guidance can be found here