Why Are Allergy Drops Not FDA Approved?

Allergy drops, also known as sublingual immunotherapy, have garnered significant attention as an innovative approach to allergy treatment. Despite their increasing popularity and evidence suggesting their effectiveness, a critical question remains: Why are allergy drops not FDA approved? This blog post aims to shed light on the regulatory processes that govern allergy treatments in the U.S. and discuss the reasons behind the non-FDA-approved status of allergy drops.

The FDA Approval Process

Understanding the FDA's role is key to grasping why allergy drops lack FDA approval. The agency's rigorous approval process is designed to ensure the safety, efficacy, and security of drugs and medical treatments. This process involves multiple stages, including preclinical research, clinical trials, and thorough reviews of manufacturing practices. The standard set by the FDA for approving any medical treatment is high and requires substantial evidence of a treatment's safety and effectiveness.

Allergy Drops and FDA Regulation

  1. Off-Label Use: Allergy drops are commonly used in what's known as "off-label" practice. This means that while the ingredients used in allergy drops are FDA-approved, the specific use of these ingredients as sublingual treatments for allergies is not. This off-label use is a common practice in medicine and is not inherently unsafe, but it does mean that the specific treatment hasn't undergone the FDA's comprehensive approval process.
  2. Clinical Trials and Evidence: The path to FDA approval is paved with extensive and expensive clinical trials. These trials must meet rigorous standards and provide substantial evidence of a treatment's efficacy and safety, which can be a significant hurdle for any new therapy.
  3. Comparisons to Allergy Shots: Allergy shots, an older form of immunotherapy, have received FDA approval. However, allergy drops, which involve a different method of administering allergens, haven't been subjected to the same level of FDA review. This difference in regulatory status is often a point of confusion and concern for patients and healthcare providers.

The Current State of Allergy Drops

  1. Widespread Use in Europe: In contrast to the U.S., allergy drops have been widely accepted in Europe for many years. European regulatory agencies, like the EMA, have approved various formulations of sublingual immunotherapy, demonstrating a differing approach to regulation compared to the FDA.
  2. Growing Research and Acceptance: Despite the lack of FDA approval, there's a burgeoning body of research in the U.S. supporting the effectiveness and safety of allergy drops. This growing acceptance is seen both within the medical community and among patients seeking alternative allergy treatment options.

Navigating the Use of Allergy Drops

  • Consultation with Specialists: For individuals considering allergy drops, it's crucial to consult with an allergist knowledgeable in sublingual immunotherapy. These specialists can offer informed advice on the use of allergy drops, addressing concerns related to their non-FDA-approved status.
  • Understanding the Risks and Benefits: Patients need to have a comprehensive discussion with their healthcare provider about the potential risks and benefits of allergy drops. This conversation should consider the current regulatory landscape, the latest scientific research, and individual patient needs.


The question of FDA approval for allergy drops is entangled in complex regulatory and scientific considerations. While they remain non-FDA-approved, allergy drops offer a promising alternative for allergy sufferers. The landscape of allergy treatment is continually evolving, and with ongoing research, the regulatory status of allergy drops may change, offering new possibilities for those seeking different treatment methods.Interested in exploring allergy drops as a part of your allergy treatment strategy? Reach out to us for a comprehensive evaluation and expert guidance on this innovative treatment option, tailored to your specific needs and informed by the latest in allergy care.

Frequently Asked Questions About Allergy Drops and FDA Approval

Why aren't allergy drops FDA approved if they are effective?
The FDA approval process for any medical treatment is rigorous and requires extensive clinical trials and evidence of safety and efficacy. While allergy drops have shown effectiveness, they have not undergone the comprehensive approval process required by the FDA, often due to the high costs and complexities of such trials.

Does the lack of FDA approval mean allergy drops are unsafe?
Not necessarily. The lack of FDA approval for allergy drops primarily reflects the regulatory process rather than a definitive statement on their safety. Allergy drops are widely used and considered safe, especially given their long history of use in Europe.

Are the ingredients in allergy drops FDA approved?
Yes, the individual extracts used in allergy drops are FDA-approved. The off-label use of these extracts as sublingual therapy for allergies is what lacks specific FDA approval.

Can I still get allergy drops in the United States?
Yes, allergy drops are available in the United States. Many allergists offer them as a treatment option, but it's important to consult with a healthcare provider who is experienced in this form of therapy.

How do European regulations on allergy drops differ from the FDA’s?
In Europe, various forms of sublingual immunotherapy (allergy drops) have been approved by regulatory agencies like the European Medicines Agency (EMA). This reflects a different regulatory approach compared to the FDA in the United States.

Will allergy drops ever be FDA approved?
It's possible that allergy drops could receive FDA approval in the future, especially as more research is conducted and submitted for review. However, this process can be lengthy and depends on a range of factors.

Are there any alternatives to allergy drops that are FDA approved?Yes, allergy shots, also known as subcutaneous immunotherapy, are an FDA-approved alternative to allergy drops. They have been used for decades and have a well-established safety and efficacy profile.