Can we have a formulation of ClearDrops® as a nasal spray or a mouth spray?

In the United States, dietary supplements are regulated by the Food and Drug Administration (“FDA”).

A “Dietary Supplement” designation is limited to products that: (1) are intended for ingestion in tablet, capsule, powder, softgel, liquid or certain other forms; (2) are not represented as conventional food or as the sole item of a meal or of the diet; and (3) are labeled as dietary supplements.

The “certain other forms” cannot include sublingual or topical/transdermal products intended to enter the body through the skin or mucosal tissues.

Therefore, a nasal spray or a mouth spray cannot be lawfully marketed as a dietary supplement in the United States.

If a product is intended for nasal absorption (like a nasal spray) or for sublingual absorption (like a mouth spray), this product is classified by the FDA as a pharmaceutical product and cannot, lawfully, be sold as a dietary supplement.

The FDA sends Warning Letters to companies that advertise their products as “dietary supplements” and marketed for nasal or sublingual absorption.