Boiron, Inc.

Warning LetterOpen

Janick Boudazin Boiron, Inc. 4 Campus Boulevard Newton Square , PA 19703 United States info@Boiron.comFEI 2027549Issued Sep 11, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2027549.

Violations2

Issue DateSep 11, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Boiron, Inc.
Location: Janick Boudazin Boiron, Inc. 4 Campus Boulevard Newton Square , PA 19703 United States info@Boiron.com
FEI Number: 2027549
Country: United States
Issue Date: September 11, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Boiron, Inc. was cited for distributing "Optique 1 Eye Drops" as an unapproved new drug in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company marketed the product through its website and social media platforms (Facebook and Instagram) with claims indicating drug use, including "eye irritation relief" for dry eyes, allergies, and eyestrain, without obtaining FDA approval. The FDA emphasized that ophthalmic products pose heightened public health risk due to direct eye administration, which bypasses natural body defenses.

Boiron, Inc. FDA Warning Letter, September 11, 2023