RoyceDerm LLC

WARNING LETTER RoyceDerm LLC MARCS-CMS 734781 — October 01, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Over-the-Counter Drugs Recipient: RoyceDerm LLC 1309 Coffeen Avenue, Ste 3000 , WY Sheridan , WY 82801 United States service@roycederm.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States October 1, 2026 255 Primera Blvd, Ste 160 Lake Mary, FL 32746 WARNING LETTER Reference Number: 734781 To RoyceDerm LLC: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://roycederm.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. As discussed below, the “Herpes Relief Cream” product on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional. FDA Review Violations were identified and documented during a review of your website https://roycederm.com/ in July 2026. Based on our review, “Herpes Relief Cream” 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). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “Herpes Relief Cream” 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 from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following: In the name of the product – “Herpes Relief Cream” On the product label: “RoyceDerm Herpes Relief Cream is specially formulated to help relieve the symptoms of Herpes, rashes or blisters, redness & pain.” “HELPS RELIEVE THE SYMPTOMS OF RASHES OR BLISTERS, ITCHY, REDNESS, AND PAIN. o Fights outbreaks o Soothes & cools o Reduces recurrence” On the webpage https://roycederm.com/products/herpe-treatment-cream-herpe-treatment-for-women-natural-herpe-treatment-genital-gentle-cream-for-herpe-sufferers-genital-herpe-symptoms: “NATURAL GENTLE RELIEF CREAM FOR HERPES SUFFERERS” along with images of what appear to be a man and woman with their hands over their genital region and “before” and “after” images of what appears to be herpes lesions on the skin and no visible herpes lesions on the skin, respectively. “Herpes Relief Cream” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because 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 approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Conclusion As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number “734781” in the subject line of the email. Please note FDA posts warning letters on www.fda.gov. 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: Everymarket Inc. 2101 E Terra Ln O’Fallon MO 63366 cs@everymarket.com Content current as of: 10/06/2026 Regulated Product(s) Drugs Over-the-Counter Drugs