Boiron, Inc.
FDA issued a warning letter to Boiron, Inc. on September 11, 2023, regarding their homeopathic 'Optique 1 Eye Drops' product sold via their website and social media channels. FDA determined the product is an unapproved new drug under section 505(a) of the FD&C Act because it is marketed with drug claims (treating eye irritation, dryness, allergies, and eyestrain) without an approved application, and is not generally recognized as safe and effective for those uses. The agency flagged the product as especially concerning due to the ophthalmic route of administration, which bypasses natural bodily defenses. Boiron was directed to respond within 15 working days and warned that failure to comply could result in seizure, injunction, or import detention.
Flagged claims (8)
Boiron Optique 1 relieves minor eye irritation due to airborne irritants, such as dust, ragweed, and other pollens.* These homeopathic eye drops also refresh fatigued eyes from long hours at a computer.*
Optique 1 Eye Drops relieve itchy, red, dry, tired, or burning eyes from allergies, computer eyestrain, and sensitivity to light and glare. . . . soothing relief for sore eyes.
Struggling with dry, irritated eyes? If you're on the East Coast, the current poor air quality could be the culprit. Optique 1 eye drops offer soothing relief for red, dry or itchy eyes triggered by airborne irritants.
Temporarily relieves minor eye irritation such as dry, red, itchy, and burning eyes due to: eyestrain and fatigue light and glare digital displays airborne irritants (pollens and dust)
Soothes red, dry, itchy, gritty, burning or tired eyes.*
EYE IRRITATION RELIEF
Optique 1 relieves minor eye irritation due to airborne irritants, such as dust, ragweed, and other pollens. . . . refresh eyes that are tired and overworked from long hours at a computer.
Dry Eyes ● Allergies ● Eyestrain
Required actions (3)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination.
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