Allergy drops, a form of treatment for allergic conditions, are administered under the tongue to alleviate symptoms. These treatments, known medically as sublingual immunotherapy (SLIT), manage allergies. Many people considering this treatment often wonder about its regulatory status, particularly regarding approval by the U.S. Food and Drug Administration (FDA).
Understanding Allergy Drops
Allergy drops are a type of immunotherapy designed to modify the body’s immune response to allergens. Small, controlled doses of allergens, such as pollen or dust mites, are placed under the tongue. These are absorbed through the mucous membranes, gradually exposing the immune system to these substances.
Over time, this repeated exposure helps the immune system build tolerance. This desensitization occurs as specialized immune cells reorient the body’s response, shifting from an allergic reaction to a more tolerant one. The goal is to reduce the severity of allergic symptoms and potentially decrease the need for symptom-relieving medications.
FDA-Approved Allergy Drops
Some specific allergy drops have received FDA approval as sublingual immunotherapy (SLIT) tablets. These standardized tablets are approved for treating certain allergens, including specific grass pollens (like Timothy grass), ragweed pollen, and house dust mites. Examples include Oralair, Grastek, Ragwitek, and Odactra.
It is important to distinguish these FDA-approved SLIT tablets from “compounded” allergy drops. Compounded allergy drops are custom-mixed liquid formulations prepared by pharmacies, often containing multiple allergens. These compounded liquid formulations are generally not FDA-approved, as their safety, effectiveness, and consistency have not been formally evaluated.
Why FDA Approval Matters for Your Health
FDA approval means the product meets stringent standards for safety, effectiveness, and manufacturing quality. Extensive clinical trials demonstrate the drug’s benefits outweigh its risks. FDA oversight also ensures consistent production, controlled ingredients, and predictable dosage and purity.
Products not undergoing FDA approval lack this assurance. Without this review, their precise dosage, potential side effects, and effectiveness are less certain. Unapproved treatments may introduce unpredictable outcomes or risks, lacking the same scientific scrutiny as approved medications.
Consulting Your Healthcare Provider
Choosing an allergy treatment, including sublingual immunotherapy, requires careful consideration and personalized medical guidance. An allergist can assess an individual’s specific allergies and overall health. They determine the most appropriate and safe treatment.
A doctor can discuss the advantages and disadvantages of various allergy treatments, including both FDA-approved and other available approaches. They provide insights into expected outcomes, helping you make an informed decision about managing allergies.