FDA WARNING_LETTER - Boiron, Inc. - September 12, 2023

On September 11, 2023, the FDA issued a Warning Letter to Boiron SA following a July 2023 review of their websites (boironusa.com, facebook.com/BoironUSA, instagram.com/boironusa/). The FDA found that Boiron SA offers "Optique 1 Eye Drops" for sale in the U.S., which is deemed an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a).

The product is considered a drug under section 201(g)(1) of the FD&C Act due to claims on their websites indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or affecting body structure/function. Examples of claims include "EYE IRRITATION RELIEF," "Dry Eyes ● Allergies ● Eyestrain," and soothing red, dry, itchy, gritty, burning, or tired eyes from various irritants.

The FDA states that "Optique 1 Eye Drops" is not generally recognized as safe and effective (GRASE) for its claimed uses, making it a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Introducing or delivering this product into interstate commerce without an FDA