FDA Allergens | What Food Businesses Need to Know

1. What are allergens

- Allergens are substances that can cause an excessive immune reaction in some people, leading to symptoms ranging from mild such as rash and hives to severe such as anaphylactic shock, and even death.

- Food allergy is a public health issue that is receiving increasing attention worldwide, especially in the United States – where the U.S. Food and Drug Administration (FDA) has very strict regulations on the disclosure and control of FDA allergens.

2. List of FDA allergens

Under current regulations of FDA (Food and Drug Administration), there are 9 main allergen groups that must be clearly declared on food packaging labels:

- Milk

- Eggs

- Fish

- Crustacean shellfish (such as shrimp, crab, scallops)

- Tree nuts (such as walnuts, pecans, almonds)

- Peanuts

- Wheat

- Soybeans

- Sesame (added to the official list from 1/1/2023 under the FASTER Act (Food Allergy Safety, Treatment, Education, and Research).

These are the FDA allergens that are highly likely to cause severe allergic reactions and account for more than 90% of food allergy cases in the United States.

3. FDA allergen labeling regulations

The FDA requires all foods produced in or imported into the United States to clearly state allergen information on the product label. This information must:

- Be written in English

- Be clear and easy to read

- State the specific allergen name (for example "contains milk", contains peanut allergens)

- In addition, in the case where a product may be cross-contaminated with allergens during production, businesses should also use warnings such as: "may contain...", "produced on a line that also processes..."

4. Why compliance with FDA allergen regulations is important

Failure to fully disclose FDA allergens can have serious consequences:

- Consumer health impact: especially for people with severe allergies

- Legal violations: may lead to product recalls, fines, loss of brand reputation

- Financial damage: from product recalls, litigation and loss of consumer trust

5. Methods for detecting allergens in food

Currently, to help businesses test and control FDA allergens, many testing laboratories and manufacturers use modern methods such as:

- ELISA (Enzyme-linked Immunosorbent Assay): Quantitative detection of allergenic proteins with high sensitivity

- PCR (Polymerase Chain Reaction): Detection of the DNA of the allergenic agent

- Rapid test (Lateral Flow Test): Used for quick testing on site or on the production line

These methods help ensure that the final product is safe for consumers and compliant with FDA allergen regulations.

-> Refer to the article Which testing methods should you choose to control allergens in food?

6. Conclusion

Compliance with FDA allergens is not only a mandatory requirement but also an ethical responsibility of food manufacturing and trading businesses. Proactive testing, complete labeling and transparency will help improve product quality, build consumer trust and protect public health.

-> Please refer to the food allergen test kits we provide here.