Why Are Allergy Drops Not FDA Approved?

The word Why? written on Post-It notes.

The FDA approves products. Though allergy drops may seem like a product, they’re a medical therapy personalized to each patient to treat the specific things that cause allergy symptoms. Because allergy drops are a therapy and not a product, the FDA will likely never approve multi-allergen allergy drop treatment.

Why are other allergy treatments, like allergy shots and sublingual tablets, approved? Because they’re technically approved to treat one allergen at a time. If you’re allergic to ragweed and take a ragweed immunotherapy tablet, it’s the same tablet that everyone else who is allergic to ragweed takes. Treating many allergies at once — whether through shots or allergy drops — is technically an off-label use of FDA approved products.

Allergy Drops Versus Allergy Shots


Personalized medicine

Allergy drops following the La Crosse Method™ Protocol are custom to your specific level of sensitivity and contain the allergens that you react to.

While multi-allergen allergy drop immunotherapy itself is not approved by the FDA, the ingredients used in the treatment are FDA approved. The same FDA approved extracts that are used in allergy shots are used in allergy drops in an off-label manner. Precise amounts of allergen extracts are added to a glycerin base to preserve the treatment; the amounts are based on how allergic you are, which is determined through allergy history, exam, and testing.

Off-label use of FDA approved products is safe, common, and done for many health conditions.

To learn more about how allergy drops may be right for you, find a provider near you that offers treatment following the La Crosse Method through our website or calling (866) 793-1680.