01 Background

Food allergies affect millions of Americans and their families due to a complex mix of genetic and environmental factors. Food allergies usually occur when the body's immune system reacts to certain proteins in foods. Food allergic reactions can vary in severity, from mild symptoms such as hives and swollen lips, to severe, life-threatening symptoms (often called anaphylactic shock). The widespread presence of these food allergens in foods exposes consumers to potential risks when purchasing and consuming them. Since there is no very effective treatment for food allergies, avoiding food containing allergens is the only viable way to prevent allergic reactions. To protect people with food allergies, the Food and Drug Administration enforces relevant provisions that require enterprises to list allergenic ingredients on package.

02 Relevant regulations

The U.S. government passed the 2004 Food Allergen Label and Consumer Protection Act (FALCPA), identifying eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. On April 23, 2021, the Food Allergy Safety, Treatment, Education and Research (FASTER) Act designated sesame as the ninth major food allergen in the United States, which took effect on January 1, 2023.

03 Labeling methods and location

The labeling of allergens comes in two forms. One is in parentheses after the name of raw material, such as "lecithin (soy)", "flour (wheat)" and "whey (milk)".

The other is directly marked below or next to the ingredients list with "contains" as the guide word, and the font should not be smaller than that of the ingredients list, as shown below:

In addition, for the three categories of fish, crustacean shellfish and nuts, the regulations stipulate that specific species must be marked, such as "allergens: fish (bass), crustacean shellfish (crabs), nuts (almonds)".

04 FAQs

Q1: If there are co-linear allergens, do they need to be mandatorily marked on the label?

A: There are no mandatory regulations for labeling when allergens are introduced on the production line. However, to avoid risks, most enterprises will provide a warning. Generally, for co-linear allergens, the phrase "may contain" or a complete description such as "This production line also produces products containing xx, xx" are used.

Q2: Is allergen required when fish collagen is used in the ingredients?

A: It is recommended to mark, as similar products on the market have labels indicating fish allergens.

Q3: Can "Allergen" be used as a guide word?

A: No, simply start with "Contains".

If you have any questions or need any assistance with U.S. food regulation consulting, U.S. food compliance audits, please feel free to contact us.

Source: Antion

Note: This article is compiled by Antion. Please indicate the source for reprint.