I’ve heard that allergy drops are not approved by the FDA. Is that safe?

First, it’s important to understand that the antigens used in allergy drops are the same FDA-approved antigens used in allergy shots. The difference is how you take them — dispenser that delivers the antigen under the tongue versus a syringe injecting antigen into tissue.

The FDA does not approve therapies, they approve products, so it’s highly unlikely that the FDA will ever “approve” multi-antigen immunotherapy.

Antigens are labeled by the FDA for single use through injections and some for sublingual immunotherapy. Combining multiple FDA-approved antigens is considered off label use when delivered via sublingual immunotherapy as well as injection, and it’s a legal and highly common practice. Many drugs are prescribed in an off-label manner today, for example, blood pressure medications for migraines, montelukast for COPD, or arthritis drugs to treat shingles.