Delivery Method: Via Email Product: Drugs Recipient:
Recipient Name
Alvaro E. Arenas, AMBR
EyeTech One, LLC
8833 Cypress Preserve PL
Fort Meyers, FL 33912
United States
(b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 9, 2025
RE: 712438
Dear Mr. Arenas:
This letter is to advise you that on September 26, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address, www.eyelivio.com, where your EYELIVIO lubricant eye ointment product is available for purchase in the United States without a prescription. We also reviewed your social media on Instagram at www.instagram.com/eyelivio/, which directs consumers to your website to purchase your product(s).
Based on our review, your EYELIVIO lubricant eye ointment is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
Unapproved New Drug and Misbranded Drug Violations
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.
Examples of claims from the EYELIVIO lubricant eye ointment product labeling, your website and your Instagram site listed above, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product include, but may not be limited to, the following:
“LUBRICANT EYE OINTMENT” [from principal display panel on product carton labeling]
“DRY EYE RELIEF” [from product carton labeling]
“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.” [from Drug Facts panel on product carton labeling]
“lubricant ointment that helps reduce discomfort caused by dry eye symptoms.” [from product label]
“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.” [from your home website page www.eyelivio.com (last visited August 2024)]
“EYELIVIO Dry Eye Relief Ointment 5gr is a specially formulated product designed to provide long-lasting relief for individuals suffering from dry eye symptoms.” [from your website page https://eyelivio.com/product/eyelivio-ointment-5-gr/ (last visited August 2024)]
“DRY EYE SYMPTOMS
Ocular Discomfort
• Feeling sensitive to light
• Gritty, sandy feeling
• Painful or sore eyes
eyelivio PREVALENCE: Based on data from the national Health and Wellness Survey, 6.8 percent of the United States adult population…have been diagnosed with Dry Eye Disease. Follow us for more information EYELIVIO Ointment 5gr …” [from your Instagram webpage www.instagram.com/p/CmrT2jrOV6_/ (last visited September 2024)]
Unapproved New Drug Violations
Based on the above evidence of intended use, your EYELIVIO lubricant eye ointment is intended for use as an ophthalmic emollient (lubricant) drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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.
Your drug product is marketed as an ophthalmic demulcent drug product and is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which generally governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your EYELIVIO lubricant eye ointment, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here OTC Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).1 However, your EYELIVIO lubricant eye ointment drug product does not conform to the conditions specified in M018 for the reasons described below.
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. 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. Specifically, the final rule requires that mineral oil be present at up to 50 percent, in combination with another permissible emollient agent, such as white petrolatum, up to 100 percent; see M018.14(b).
We also note statements made on your website that make claims for indications that are not consistent with the permitted indications in M018. For example, your website states, “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.” and “The EYELIVIO Ointment combines lubrication and protection with natural anti-inflammatory benefits…” 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).
Thus, your EYELIVIO lubricant eye ointment drug product does not comply with the applicable conditions specified in M018 and has not otherwise been found GRASE.2 Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
Additionally, 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.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “712438” in the subject line of your email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_______________________
1 M018 reflects the conditions as set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000023, available at FDA’s website OTC Monographs@FDA.
2 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that the EYELIVIO lubricant eye ointment drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).
