EyeTech One, LLC
FDA issued a warning letter to EyeTech One, LLC (doing business as EYELIVIO) on July 9, 2025, citing its EYELIVIO lubricant eye ointment as an unapproved new drug and misbranded drug sold via its website and Instagram. The product's formulation includes botanical active ingredients (Aloe vera, Arnica montana, Calendula officinalis) not permitted under OTC Monograph M018 for ophthalmic emollients, and its labeling makes claims for anti-inflammatory benefits and ocular surface protection that exceed permitted OTC indications. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within 15 working days.
Flagged claims (7)
EYELIVIO Dry Eye Relief Ointment 5gr is a specially formulated product designed to provide long-lasting relief for individuals suffering from dry eye symptoms.
Uses … May be used as temporary relief of burning, irritation, and discomfort due to dryness of the eye(s) and relief of dry eye symptoms.
This lubricating, preservative-free ointment is formulated with soothing ingredients that directly target dry eye symptoms. EYELIVIO harnesses the power of natural ingredients to enhance eye health.
lubricant ointment that helps reduce discomfort caused by dry eye symptoms.
DRY EYE RELIEF
The EYELIVIO Ointment combines lubrication and protection with natural anti-inflammatory benefits…
This delicate, nourishing formula, enriched with plant-based properties, offers a unique approach to soothing and protecting your eyes. It provides superior lubrication and protection for the ocular surface and delivers natural anti-inflammatory benefits.
Required actions (2)
Please notify FDA in writing, within 15 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.
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