MantroForce — FDA Warning Letter, June 17, 2026: Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at MantroForce

WARNING LETTER MantroForce MARCS-CMS 729021 — 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: MantroForce Room 701, Unit 127, 7/F Tower B New Mandarin Plaza Tsim Sha Tsui Hong Kong SAR China info@mantroforce.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 WARNING LETTER Reference Number: 729021 To MantroForce: 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://mantroforce.com/en-us in May 2026. Based on our review, “Passion Pro Endurance Delay Spray,” “Complex Men’s Nasal Inhaler,” “ErectBoost Vitality Spray for Men,” “Prostate Care Gel,” and “Prostate Patches” are unapproved new drugs 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 allinclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “Passion Pro Endurance Delay Spray,” “Complex Men’s Nasal Inhaler,” “ErectBoost Vitality Spray for Men,” “Prostate Care Gel,” and “Prostate Patches” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 these products as drugs include, but may not be limited to, the following: Passion Pro Endurance Delay Spray On the webpage https://mantroforce.com/en-us/products/long-lasting-confidence-delay-spray: “Master Your Performance and Last 5x Longer Starting Tonight” “IS PREMATURE EJACULATION DISRUPTING YOUR INTIMACY?” “FOR LONGER LASTING PERFORMANCE” “Why Choose Biancat™ Passion Pro Endurance Delay Spray? ✓ Extended Pleasure ✓ Delayed Climax ✓ Premature Control ✓ Optimized Sensitivity ✓ Intense Satisfaction” Complex Men’s Nasal Inhaler On the webpage https://mantroforce.com/en-us/products/men-nasal-inhaler-get-a-rock-harderection-within-5-minutes-100-without-pills: “Designed to combat slow, weak erections and performance anxiety, it offers fast results, without pills or risks.” “Men Nasal Inhaler Get a rock-hard erection within 5 minutes, 100% without pills!” “Experience the Powerful Erection Boost” “APPLICABLE TO THE FOLLOWING GROUPS WITH MALE PROBLEMS. . .PREMATURE EJACULATION[,] DECREASED LIBIDO” ErectBoost Vitality Spray for Men On the webpage https://mantroforce.com/en-us/products/vitality-spray-instant-power-get-a-rocksolid-erection-in-3-minutes-flat-copy: “ErectBoost Explosive Performance and Rock-Solid Power in 3 Minutes Flat” “Discover the ultimate solution for impotence with Vitality Spr