Mel Honey US

WARNING LETTER Mel Honey US MARCS-CMS 709535 — August 25, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Josue Carias Recipient Title CEO Mel Honey US 152 Wapiti Loop Hyrum , UT 84319-2012 United States josuedcarias@gmail.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER August 25, 2025 RE: 709535 Dear Josue Carias: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://melhoney.us/ in June 2025. We have also reviewed your social media account at https://www.instagram.com/melhoney_us, which directs consumers to your above-mentioned website to purchase your product. The FDA has observed that your websites offer “Jimerito (Melipona) Honey” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Your “Jimerito (Melipona) Honey” product is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses. Based on a review of your websites, your “Jimerito (Melipona) Honey” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from your website https://melhoney.us/ that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following: “. . .Melipona honey is used as a natural remedy for eye infections, such as conjunctivitis, and for treating other eye issues like cataracts. Its antimicrobial properties help reduce infections, and it is said to promote clearer vision.” “ Experience natural relief with Melipona Honey Eye Drops When used as an eye drop, it serves as a natural moisturizer, providing relief for dry eyes and improving overall hydration and comfort. On the Instagram social media account https://www.instagram.com/melhoney_us/reels/: October 30, 2024, posting: o “Melipona honey contains natural enzymes and antioxidants that can soothe and protect your eyes, reducing irritation and promoting overall eye health. Try Mel Honey Eye Drops Today!” Your “Jimerito (Melipona) Honey” is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). 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). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). The violations cited in this letter are 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 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. 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 “709535” 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 Food and Drug Administration Content current as of: 09/02/2025 Regulated Product(s) Drugs