[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-mantroforce-729021-06172026":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":27,"updated_at":28},86,"mantroforce-729021-06172026","Warning Letter","MantroForce",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2026-06-23","2026-06-17","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmantroforce-729021-06172026","729021","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>MantroForce\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Room 701, Unit 127, 7\u002FF Tower B\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">New Mandarin Plaza\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Tsim Sha Tsui\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Hong Kong SAR China\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:info@mantroforce.com \"> info@mantroforce.com \u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">June 17, 2026\u003C\u002Fspan>\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cspan style=\"font-family:"Arial",sans-serif;\">Reference Number: 729021\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">To MantroForce:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Violations were identified and documented during a review of your website https:\u002F\u002Fmantroforce.com\u002Fen-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).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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\u002For 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:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cu>Passion Pro Endurance Delay Spray\u003C\u002Fu>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">On the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Flong-lasting-confidence-delay-spray:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Master Your Performance and Last 5x Longer Starting Tonight”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“IS PREMATURE EJACULATION DISRUPTING YOUR INTIMACY?”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“FOR LONGER LASTING PERFORMANCE”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Why Choose Biancat™ Passion Pro Endurance Delay Spray?\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">✓ Extended Pleasure\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">✓ Delayed Climax\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">✓ Premature Control\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">✓ Optimized Sensitivity\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">✓ Intense Satisfaction”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cu>Complex Men’s Nasal Inhaler\u003C\u002Fu>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">On the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Fmen-nasal-inhaler-get-a-rock-harderection-within-5-minutes-100-without-pills:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Designed to combat slow, weak erections and performance anxiety, it offers fast results, without pills or risks.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Men Nasal Inhaler Get a rock-hard erection within 5 minutes, 100% without pills!”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Experience the Powerful Erection Boost”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“APPLICABLE TO THE FOLLOWING GROUPS WITH MALE PROBLEMS. . .PREMATURE EJACULATION[,] DECREASED LIBIDO”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cu>ErectBoost Vitality Spray for Men\u003C\u002Fu>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">On the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Fvitality-spray-instant-power-get-a-rocksolid-erection-in-3-minutes-flat-copy:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“ErectBoost Explosive Performance and Rock-Solid Power in 3 Minutes Flat”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Discover the ultimate solution for impotence with Vitality Spray!”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Reignite your Passion\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Boost your Confidence\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Experience Lasting\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Stamina”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Images of male genitalia illustrating the before and after effect of using the product along with couples engaged in intimate interactions.\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cu>Prostate Care Gel\u003C\u002Fu>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">On the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Freliefpro-herbal-gel:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Reduce the urge to urinate”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Facilitating bladder emptying”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Better Sleep\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Reduces nighttime urges for uninterrupted rest.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Soothe pain\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Calms pelvic discomfort so movement hurts less.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“BENEFITS OF INJECTING THROUGH THE RECTUM. . .High local drug concentration”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cu>Prostate Patches\u003C\u002Fu>\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">On the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Fdaily-prostate-comfort-relief-patch:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Promote urine flow”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Enhance sexual function”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Better Sleep\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Reduces nighttime urgency so you sleep longer and wake refreshed.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Improve prostate health and reduce uncomfortable symptoms”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Enhance urinary function and promote smooth urination.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Improves your bladder and urinary tract system”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Helps maintain normal prostate function and relieve prostate-related discomfort.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“Reduce frequent waking up at night, improve urine flow”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">“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).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">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.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Please note FDA posts warning letters on www.fda.gov.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Sincerely,\u003C\u002Fspan>\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Tina Smith, M.S.\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Captain, U.S. Public Health Service\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Director\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Office of Unapproved Drugs and Labeling Compliance\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Office of Compliance\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">Center for Drug Evaluation and Research\u003C\u002Fspan>\u003Cbr>\u003Cspan style=\"font-family:"Arial",sans-serif;\">U.S. Food and Drug Administration\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\nMantroForce\n\nRoom 701, Unit 127, 7\u002FF Tower B\n\nNew Mandarin Plaza\n\nTsim Sha Tsui\n\nHong Kong SAR China\n\ninfo@mantroforce.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nJune 17, 2026\nWARNING LETTER\nReference Number: 729021\nTo MantroForce:\nThis 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.\nFDA Review\nViolations were identified and documented during a review of your website https:\u002F\u002Fmantroforce.com\u002Fen-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).\nThis review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe 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.\nUnapproved New Drug Violations\nBased 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\u002For 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:\nPassion Pro Endurance Delay Spray\nOn the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Flong-lasting-confidence-delay-spray:\n“Master Your Performance and Last 5x Longer Starting Tonight”\n“IS PREMATURE EJACULATION DISRUPTING YOUR INTIMACY?”\n“FOR LONGER LASTING PERFORMANCE”\n“Why Choose Biancat™ Passion Pro Endurance Delay Spray?\n✓ Extended Pleasure\n✓ Delayed Climax\n✓ Premature Control\n✓ Optimized Sensitivity\n✓ Intense Satisfaction”\nComplex Men’s Nasal Inhaler\nOn the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Fmen-nasal-inhaler-get-a-rock-harderection-within-5-minutes-100-without-pills:\n“Designed to combat slow, weak erections and performance anxiety, it offers fast results, without pills or risks.”\n“Men Nasal Inhaler Get a rock-hard erection within 5 minutes, 100% without pills!”\n“Experience the Powerful Erection Boost”\n“APPLICABLE TO THE FOLLOWING GROUPS WITH MALE PROBLEMS. . .PREMATURE EJACULATION[,] DECREASED LIBIDO”\nErectBoost Vitality Spray for Men\nOn the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Fvitality-spray-instant-power-get-a-rocksolid-erection-in-3-minutes-flat-copy:\n“ErectBoost Explosive Performance and Rock-Solid Power in 3 Minutes Flat”\n“Discover the ultimate solution for impotence with Vitality Spray!”\nAn 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.”\n“Reignite your Passion\nBoost your Confidence\nExperience Lasting\nStamina”\nImages of male genitalia illustrating the before and after effect of using the product along with couples engaged in intimate interactions.\nProstate Care Gel\nOn the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Freliefpro-herbal-gel:\n“Reduce the urge to urinate”\n“Facilitating bladder emptying”\n“Better Sleep\nReduces nighttime urges for uninterrupted rest.”\n“Soothe pain\nCalms pelvic discomfort so movement hurts less.”\n“BENEFITS OF INJECTING THROUGH THE RECTUM. . .High local drug concentration”\nProstate Patches\nOn the webpage https:\u002F\u002Fmantroforce.com\u002Fen-us\u002Fproducts\u002Fdaily-prostate-comfort-relief-patch:\n“Promote urine flow”\n“Enhance sexual function”\n“Better Sleep\nReduces nighttime urgency so you sleep longer and wake refreshed.”\n“Improve prostate health and reduce uncomfortable symptoms”\n“Enhance urinary function and promote smooth urination.”\n“Improves your bladder and urinary tract system”\n“Helps maintain normal prostate function and relieve prostate-related discomfort.”\n“Reduce frequent waking up at night, improve urine flow”\n“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).\nConclusion\nAs 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.\nSend 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.\nIf 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.\nPlease note FDA posts warning letters on www.fda.gov.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration","2026-08-19T04:34:01.894+00:00",[22,23,24,9,25,26,26,26],"\u003Ctime datetime=\"2026-06-23T04:00:00Z\">06\u002F23\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-06-17T04:00:00Z\">06\u002F17\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmantroforce-729021-06172026\">MantroForce\u003C\u002Fa>","Unapproved New Drugs\u002FMisbranded\u003Cbr \u002F>\r\n\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]