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WARNING LETTER

October 9, 2025

RE: 717968

Dear Mr. Moloney:

This letter is to advise you that on September 10, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address melcare.com where your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products are available for purchase in the United States without a prescription. We also reviewed your social media site on YouTube https://www.youtube.com/watch?v=W0nofWh_uGU&t=12s, which is listed on your website.

Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products are unapproved new drugs 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), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded 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

Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body.

Examples of claims from the Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops labeling, including on your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

Optimel Manuka+ Forte Eye Gel

“DRUG FACTS…USES…▪for the temporary relief of irritation due to dryness of the eye. ▪ for use as a protectant against further irritation or to relive dryness of the eye.” [from the Drug Facts panel on product carton labeling]

“Suitable For: ▪Aqueous tear deficiency ▪ eye discomfort ▪ eye lid irritation [from your product website at https://melcare.com/product/optimel-manuka-forte-eye-gel/]

“Melcare’s Optimel Manuka+ Forte Eye Gel contains a standardised [sic] medical grade Manuka honey developed from Leptospermum spp. and is preservative free for moderate to severe dry eye” [from your product website at https://melcare.com/product/optimel-manuka-forte-eye-gel/]

“Albietz and Lenton also reported that the application of medical grade Leptospermum spp honey (Manuka) was associated with signficant [sic] clinical improvements in dry eye and meibomian gland dysfunction” [from your product website at https://melcare.com/product/optimel-manuka-forte-eye-gel/]

“Indications…Optimel Manuka+ Forte Eye Gel containing 98% honey with increased viscosity is preservative free, and is also available for more difficult conditions from your eye care specialist.” [from your product website at https://melcare.com/product/optimel-dry-eye-drops/]

Optimel Manuka+ Dry Eye Drops

“DRUG FACTS…USES… ▪for the temporary relief of irritation due to the dryness of the eye. ▪ for use as a protectant against further irritation or to relieve dryness of the eye.” [from the Drug Facts panel on product carton labeling]

“Suitable For: ▪Chronic dry eye ▪ Eye discomfort ▪ Sore, irritated eyes and eyelids” [from your product website at https://melcare.com/product/optimel-dry-eye-drops/]

“About the Product…Albietz and Lenton also reported that the application of medical grade Leptospermum spp honey (Manuka) was associated with signficant [sic] clinical improvements in dry eye and meibomian gland dysfunction.” [from your product website at https://melcare.com/product/optimel-dry-eye-drops/]

Multiple products

“At Melcare, we are experts in the therapeutic use of honey in products to help relieve some of the symptoms associated with chronic disease. Honeys from Australian and New Zealand Leptospermum spp, commonly called Manuka, a small native tree is favoured because of its well-studied composition and antibacterial activity.” [from your product website at https://melcare.com/about-us/]

YouTube video posted on your website created on June 18, 2020 that includes statements by Melcare’s President, Anthony Maloney, emphasizes the use of honey and it’s benefits in drug products. For example, Mr. Maloney states in the video, “We developed a range of products that use and leverage off the therapeutic efficacy of honey that is in wound care, eye care, skin care, and throat care.” [from your YouTube video on your product website at https://www.youtube.com/watch?v=W0nofWh_uGU&t=12s]

Unapproved New Drug Violations

Based on the above labeling evidence, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops are intended for use as ophthalmic demulcent (lubricant) drug products. As described below, these drug products are unapproved new drugs 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for any of the product identified above.

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 Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops, in order to be GRASE and not new drugs, these products 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 Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products do not conform to the conditions specified in M018 for the reasons described below, and thus cannot be legally marketed under section 505G.

Specifically, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops products are formulated with honey (from Leptospermum spp.). Although you identify honey as an inactive ingredient on the product label, statements on your website show that honey is presented as an active ingredient, because it is intended to furnish pharmacological activity for the treatment of a disease or condition.² However, honey is not an active ingredient permitted for OTC monograph ophthalmic demulcent drug products under M018.12. Examples of you labeling statements presenting honey as an active ingredient include, “Optimel Manuka+ Forte Eye Gel contains a standardised medical grade Manuka honey developed from Leptospermum spp. and is preservative free for moderate to severe dry eye,” “The application of medical grade Leptospermum spp honey (Manuka) was associated with significant clinical improvements in dry eye and meibomian gland dysfunction,” and “We are experts in the therapeutic use of honey in products to help relieve some of the symptoms associated with chronic disease.” Additionally, a YouTube video created on June 18, 2020 and posted on your website includes statements by Melcare’s President, Anthony Maloney, describing the medical benefits of honey. For example, Mr. Maloney states, “We developed a range of products that use and leverage off the therapeutic efficacy of honey that is in wound care, eye care, skin care, and throat care.” Thus, honey is used in your product as an active ingredient and, because it is not an active ingredient permitted under M018.12, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops products do not conform with the conditions for lawful marketing of an OTC ophthalmic demulcent or vasoconstrictor drug product as set forth in M018.

Therefore, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products do not comply with the applicable conditions specified in M018. In addition, these products have not otherwise been found GRASE.³ Accordingly, these products are new drugs 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 these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, these products are unapproved new drugs.

The introduction or delivery for introduction into interstate commerce of these unapproved new drug products 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 Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are 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

This letter is not intended to be an all-inclusive statement 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 products are 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 15 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 717968 in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Cc: (b)(4)

__________________

1 M018 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000023, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.

2 See21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”

3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops products are GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).