Allerdrops are a mixture of preservative free allergy serum and distilled water. The FDA has approved the serum for injection. The FDA has not been asked to approve the serum for Allerdrops.

The FDA only responds to a manufacturer's request for product approval. Since allergy serum is already approved for use in medicine, and is used in sublingual therapy, there isn't an obvious need for a company to seek additional approval. The FDA does not regulate medical practice; instead it regulates medications, devices, and equipment used in medical practice. The FDA only responds to a manufacturer's request.

Mounting evidence continues to lend support for Allerdrops becoming the standard allergy therapy. A study involving children under age 5 revealed no adverse reaction to Allerdrops with 39,000 individual doses.