Allergenics are any substance capable of causing an allergic reaction.
The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.
Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Currently, there are two types of licensed allergen extracts: injectable and sublingual
1. Injectable allergen extracts can be used for both diagnosis and treatment. They are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. There are 2 subcategories within the injectable allergen extracts – standardized, for products that have an established method to determine the potency (or strength) of the product on a lot-by-lot basis, and non-standardized – for injectable allergen extracts with no measure of potency.
2. Sublingual allergen extract tablets are used for treatment only. They are also derived from natural substances known to elicit allergic reactions in susceptible individuals and are intended for the treatment of allergic rhinitis with or without allergic conjunctivitis. Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by healthcare providers to determine the specific cause 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. Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.