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). 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, “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 Spray!” An image of a physician next to the product with the testimonial: “As a urologist, I recommend Vitality Spray because of its immediate and long-lasting effect. The powerful formula stimulates blood circulation and supports a firm, stable erection.” “Reignite your Passion Boost your Confidence Experience Lasting Stamina” Images of male genitalia illustrating the before and after effect of using the product along with couples engaged in intimate interactions. Prostate Care Gel On the webpage https://mantroforce.com/en-us/products/reliefpro-herbal-gel: “Reduce the urge to urinate” “Facilitating bladder emptying” “Better Sleep Reduces nighttime urges for uninterrupted rest.” “Soothe pain Calms pelvic discomfort so movement hurts less.” “BENEFITS OF INJECTING THROUGH THE RECTUM. . .High local drug concentration” Prostate Patches On the webpage https://mantroforce.com/en-us/products/daily-prostate-comfort-relief-patch: “Promote urine flow” “Enhance sexual function” “Better Sleep Reduces nighttime urgency so you sleep longer and wake refreshed.” “Improve prostate health and reduce uncomfortable symptoms” “Enhance urinary function and promote smooth urination.” “Improves your bladder and urinary tract system” “Helps maintain normal prostate function and relieve prostate-related discomfort.” “Reduce frequent waking up at night, improve urine flow” “Passion Pro Endurance Delay Spray,” “Complex Men’s Nasal Inhaler,” “ErectBoost Vitality Spray for Men,” “Prostate Care Gel,” and “Prostate Patches” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their 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 these products. Accordingly, these products are unapproved new drugs. 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 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. Identify your response with reference number “729021” in the subject line of the email. 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. 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 Content current as of: 06/23/2026 Regulated Product(s) Drugs