EyeTech One, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your EYELIVIO lubricant eye ointment product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.

Passage 2

Your EYELIVIO lubricant eye ointment product is formulated with the active ingredients Mineral Oil, White Petrolatum, Aloe vera, Arnica montana, and Calendula officinalis. The botanical extracts (Aloe vera, Arnica montana, and Calendula officinalis) included in this formulation are not active ingredients permitted for ophthalmic emollient (lubricant) drug products under M018.14.

Passage 3

Additionally, your EYEVILIO lubricant eye ointment fails to include the amounts (concentrations) for the permitted active ingredients, mineral oil and white petrolatum, on the product label/labeling.

Passage 4

These labeled statements of protection of eyes, ocular surface, and providing anti-inflammatory benefits go beyond the general intended uses of topical OTC ophthalmic drug products set forth in M018.65(b).

Passage 5

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your EYELIVIO lubricant eye ointment drug product.

Passage 6

your EYELIVIO lubricant eye ointment drug product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.