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

Source: https://www.keypedia.com/records/warning_letter/boiron-inc/0d417bb4-64c3-414b-b6b6-642b25ad840b

> FDA WARNING_LETTER for Boiron, Inc. on September 12, 2023. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Boiron, Inc.
- Inspection Date: 2023-09-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/jill-p-furman/984bfbfc-3f4e-46bc-8d3b-3d82e56c6ac9)

Company: https://www.keypedia.com/companies/boiron-inc/e7f42559-5061-40d8-b7f2-d7fd9928adb0

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c