FDA Warning Letter to Wild Arabic Herbs (June 17, 2026) — Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at Wild Arabic Herbs

WARNING LETTER Wild Arabic Herbs MARCS-CMS 729192 — June 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Wild Arabic Herbs Albania arabicnaturalcare@live.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 WARNING LETTER Reference Number: 729192 To Wild Arabic Herbs: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations 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 violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. FDA Review Violations were identified and documented during a review of your website https://wildarabicherbs.com/ in May 2026. Based on our review, “Edral-17t” 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 these products 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). 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, your “Edral-17t” product 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: On the webpage https://wildarabicherbs.com/products/edral-17t-desert-herbs-formula-for-prostate--testicles-cancers-90-capsules: “Edral-17t – Desert Herbs Formula for Prostate & Testicules [sic] Cancers” “[S]pecifically designed to support patients suffering from prostate cancer, testicular malignancies, and other severe conditions of the male reproductive system.” “Anticancer and antiproliferative effects – inhibits uncontrolled cell division, blocks the cell cycle, promotes differentiation, and induces apoptosis.” “Anti-metastatic effects – suppresses malignant angiogenesis, prevents cell migration, and blocks metastasis.” “Anticancer and selective cytotoxicity – effective against prostate, testicular, colon, liver, breast, kidney, and lung cancers.” “Helps prevent the spread of malignant cells within the body.” “Edral-17t” 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 th