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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently two types of allergenic products licensed for use: allergen patch tests and allergenic extracts. 

Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by physicians to determine the specific causes of contact dermatitis, and are manufactured from natural substances or chemicals (such as nickel, rubber, and fragrance mixes) that are known to cause contact dermatitis.

Allergenic extracts are used for the diagnosis and treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Allergenic extracts are injectable products that are manufactured from natural substances (such as molds, pollens, insect venoms, animal hair, and foods) known to elicit allergic reactions in susceptible individuals. Food extracts are only used to diagnose food allergies, but other allergenic extracts may be used for both diagnosis and treatment of allergic disease.




Antigen Skin Tests


Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448