[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-bioactive-services-usa-llc-herstat-inc-734784-10012026":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":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},21689,"bioactive-services-usa-llc-herstat-inc-734784-10012026","Warning Letter","Bioactive Services USA, LLC \u002F Herstat Inc.",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs","2026-10-06","2026-10-01","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbioactive-services-usa-llc-herstat-inc-734784-10012026","734784","Drugs Over-the-Counter Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","Kevin Aspinall Nessling","\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                          \u003Cbr>Over-the-Counter Drugs\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>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Kevin Aspinall Nessling\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Bioactive Services USA, LLC \u002F Herstat Inc. \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1309 Coffeen Ave, STE 1200\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Sheridan\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">WY\u003C\u002Fspan> \u003Cspan class=\"postal-code\">82801\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\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:contact@herstat.com\"> contact@herstat.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>October 1, 2026\u003C\u002Fp>\u003Cp>Herstat (USA) Inc.\u003Cbr>680 S Cache Street\u003Cbr>Suite 100 – 10219\u003Cbr>Jackson, WY 83001\u003Cbr>United States\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference Number: 734784\u003C\u002Fp>\u003Cp>To Kevin Aspinall Nessling:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites, https:\u002F\u002Fdrsosnowski.com\u002F and https:\u002F\u002Fwww.herstat.com\u002F, 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 violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>As discussed below, the “Herstat GST” product on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and\u002For 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.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of your websites, https:\u002F\u002Fdrsosnowski.com\u002F and https:\u002F\u002Fwww.herstat.com\u002F in July 2026. We have also reviewed your Facebook and Instagram accounts at https:\u002F\u002Fwww.facebook.com\u002FDoctorSosnowski and https:\u002F\u002Fwww.instagram.com\u002Fdrsosnowskis\u002F where you direct consumers to your website to purchase your products. Based on our review, “Herstat GST” 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).\u003C\u002Fp>\u003Cp>This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>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\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Based on a review of your website, “Herstat GST”\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> 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\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 this product as a drug include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fdrsosnowski.com\u002Fproducts\u002Fherstat-gst:\u003C\u002Fp>\u003Cul>\u003Cli>On product label: “Genital Sore Treatment”\u003C\u002Fli>\u003Cli>“Herstat GST provides rapid and targeted relief of genital sores at tingle, blister or scab, getting to work from 1st use at any stage of an outbreak”\u003C\u002Fli>\u003Cli>“The formula is dual action, designed to provide effective relief of symptoms (itching, pain, irritation) and aid healing of skin during outbreaks by calming inflammation and balancing PH”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>On the webpage https:\u002F\u002Fwww.herstat.com\u002Fproducts\u002Fherstat-genital-sore-treatment?variant=52463728689494:\u003C\u002Fp>\u003Cul>\u003Cli>“Dr Sosnowski’s Herstat GST is formulated to provide effective relief from the symptoms of genital sores.”\u003C\u002Fli>\u003Cli>“The carefully balanced formula of GST helps to soothe and calm the symptoms of genital sores and provides temporary relief of pain, itching and inflammation.”\u003C\u002Fli>\u003Cli>“Effective for the treatment of genital sores”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>On an October 12, 2022 post on your Facebook and Instagram page https:\u002F\u002Fwww.facebook.com\u002FDoctorSosnowski and https:\u002F\u002Fwww.instagram.com\u002Fdrsosnowskis\u002F respectively:\u003C\u002Fp>\u003Cul>\u003Cli>On product label: “Genital Sore Treatment”\u003C\u002Fli>\u003Cli>“Herstat GST provides rapid, targeted relief from the symptoms of genital sores.”\u003C\u002Fli>\u003Cli>“[P]rovides targeted pain relief . . . soothing relief to calm the discomfort associated with genital sores.” . . . \u003C\u002Fli>\u003Cli>“[A]nalgesic action . . . penetrate deep into the epidermis.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>“Herstat GST” 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>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 “734784” in the subject line of the email.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.fda.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003Cbr>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs and Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>______________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> The permitted indications under OTC Monograph M017: External Analgesic Drug Products for OTC Human Use (M017) are for the treatment of pain, itching, and minor skin irritation generally and for the prevention of premature ejaculation. The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application. (see https:\u002F\u002Fwww.accessdata.fda.gov\u002Fdrugsatfdadocs\u002Fomuf\u002Fmonographs\u002FOTC%20MonographM017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).\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\nOver-the-Counter Drugs\n\nRecipient:\n\nRecipient Name\n\nKevin Aspinall Nessling\n\nRecipient Title\n\nCEO\n\nBioactive Services USA, LLC \u002F Herstat Inc.\n\n1309 Coffeen Ave, STE 1200\n\nSheridan, WY 82801\n\nUnited States\n\ncontact@herstat.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 1, 2026\nHerstat (USA) Inc.\n680 S Cache Street\nSuite 100 – 10219\nJackson, WY 83001\nUnited States\nWARNING LETTER\nReference Number: 734784\nTo Kevin Aspinall Nessling:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites, https:\u002F\u002Fdrsosnowski.com\u002F and https:\u002F\u002Fwww.herstat.com\u002F, 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 violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\nAs discussed below, the “Herstat GST” product on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and\u002For 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.\nFDA Review\nViolations were identified and documented during a review of your websites, https:\u002F\u002Fdrsosnowski.com\u002F and https:\u002F\u002Fwww.herstat.com\u002F in July 2026. We have also reviewed your Facebook and Instagram accounts at https:\u002F\u002Fwww.facebook.com\u002FDoctorSosnowski and https:\u002F\u002Fwww.instagram.com\u002Fdrsosnowskis\u002F where you direct consumers to your website to purchase your products. Based on our review, “Herstat GST” 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).\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, “Herstat GST”1 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\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 this product as a drug include, but may not be limited to, the following:\nOn the webpage https:\u002F\u002Fdrsosnowski.com\u002Fproducts\u002Fherstat-gst:\nOn product label: “Genital Sore Treatment”\n“Herstat GST provides rapid and targeted relief of genital sores at tingle, blister or scab, getting to work from 1st use at any stage of an outbreak”\n“The formula is dual action, designed to provide effective relief of symptoms (itching, pain, irritation) and aid healing of skin during outbreaks by calming inflammation and balancing PH”\nOn the webpage https:\u002F\u002Fwww.herstat.com\u002Fproducts\u002Fherstat-genital-sore-treatment?variant=52463728689494:\n“Dr Sosnowski’s Herstat GST is formulated to provide effective relief from the symptoms of genital sores.”\n“The carefully balanced formula of GST helps to soothe and calm the symptoms of genital sores and provides temporary relief of pain, itching and inflammation.”\n“Effective for the treatment of genital sores”\nOn an October 12, 2022 post on your Facebook and Instagram page https:\u002F\u002Fwww.facebook.com\u002FDoctorSosnowski and https:\u002F\u002Fwww.instagram.com\u002Fdrsosnowskis\u002F respectively:\nOn product label: “Genital Sore Treatment”\n“Herstat GST provides rapid, targeted relief from the symptoms of genital sores.”\n“[P]rovides targeted pain relief . . . soothing relief to calm the discomfort associated with genital sores.” . . .\n“[A]nalgesic action . . . penetrate deep into the epidermis.”\n“Herstat GST” 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product 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 future and 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. 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 “734784” in the subject line of the email.\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\n______________________\n1 The permitted indications under OTC Monograph M017: External Analgesic Drug Products for OTC Human Use (M017) are for the treatment of pain, itching, and minor skin irritation generally and for the prevention of premature ejaculation. The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application. (see https:\u002F\u002Fwww.accessdata.fda.gov\u002Fdrugsatfdadocs\u002Fomuf\u002Fmonographs\u002FOTC%20MonographM017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).","2026-10-14T12:32:49.157+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-10-06T04:00:00Z\">10\u002F06\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-01T04:00:00Z\">10\u002F01\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbioactive-services-usa-llc-herstat-inc-734784-10012026\">Bioactive Services USA, LLC \u002F Herstat Inc. \u003C\u002Fa>","","2026-10-14T12:31:16.41489+00:00","2026-10-14T14:44:01.489557+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-10-12T02:00:50.914+00:00","2026-10-12T02:00:38.521+00:00","2026-10-12T02:00:45.002+00:00","2026-10-14T04:02:53.8+00:00","2026-09-07T05:17:28.839+00:00","2026-10-12T02:00:52.377+00:00","2026-10-14T14:44:02.318+00:00"]