[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-amcyte-pharma-inc-623474-01032022":3,"fda-latest-sync-dates":28},{"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":8,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},2940,"amcyte-pharma-inc-623474-01032022","Warning Letter","Amcyte Pharma, Inc.",null,"Center for Drug Evaluation and Research | CDER","Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)","2022-01-04","2022-01-03","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Famcyte-pharma-inc-623474-01032022","623474","Drugs","Gustavo Mahler","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\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>\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\">Gustavo Mahler\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Amcyte Pharma, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">5400 Carillon Point\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Kirkland\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">WA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">98004\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:info@nasitrol.com\"> info@nasitrol.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 class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Date: January 3, 2022\u003C\u002Fp>\n\n\u003Cp>RE: Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)\u003C\u002Fp>\n\n\u003Cp>This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fnasitrol.com\u002F on December 20, 2021. The FDA has observed that your website offers Nasitrol for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).\u003C\u002Fp>\n\n\u003Cp>There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.\u003Csup>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.\u003C\u002Fp>\n\n\u003Cp>Some examples of the claims on your website, https:\u002F\u002Fnasitrol.com\u002Fscience\u002F, that establish the intended use of your product and misleadingly represents it as safe and\u002For effective for the treatment or prevention of COVID-19 include:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“\u003Cstrong>In vitro study of Iota carrageenan in SARS-CoV-2\u003C\u002Fstrong> . . . This study performed at the University of Tennessee provides evidence of the inhibitory effect of Iota Carrageenan on the propagation of SARS-CoV-2 in a call [sic] based assay.”\u003C\u002Fli>\n\t\u003Cli>“\u003Cstrong>A Nasitrol clinical trial ICU hospital personnel exposed to SARS-CoV-2\u003C\u002Fstrong> . . . An independent, double-blinded, placebo controlled multicenter clinical trial providing evidence of the protective effect of Nasitrol in doctors and nurses highly exposed to SARS-CoV-2 (personnel dedicated to the COVID-19 ICU) during a period of one month.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>You should take immediate action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. \u003Cstrong>Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov\u003C\u002Fstrong> describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.\u003C\u002Fp>\n\n\u003Cp>FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and\u002For effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-covid-19-products\">http:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-covid-19-products\u003C\u002Fa>. Once you have taken actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.\u003C\u002Fp>\n\n\u003Cp>Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Donald D. Ashley\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\u003C\u002Fp>\n\n\u003Cp>__________________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at \u003Ca href=\"https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx\">https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx\u003C\u002Fa>.\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at \u003Ca href=\"https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F\">https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Product:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nGustavo Mahler\n\nAmcyte Pharma, Inc.\n\n5400 Carillon Point\n\nKirkland, WA 98004\n\nUnited States\n\ninfo@nasitrol.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nDate: January 3, 2022\n\nRE: Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)\n\nThis is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fnasitrol.com\u002F on December 20, 2021. The FDA has observed that your website offers Nasitrol for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).\n\nThere is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.2 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.3 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.\n\nSome examples of the claims on your website, https:\u002F\u002Fnasitrol.com\u002Fscience\u002F, that establish the intended use of your product and misleadingly represents it as safe and\u002For effective for the treatment or prevention of COVID-19 include:\n\n“In vitro study of Iota carrageenan in SARS-CoV-2 . . . This study performed at the University of Tennessee provides evidence of the inhibitory effect of Iota Carrageenan on the propagation of SARS-CoV-2 in a call [sic] based assay.”\n\n“A Nasitrol clinical trial ICU hospital personnel exposed to SARS-CoV-2 . . . An independent, double-blinded, placebo controlled multicenter clinical trial providing evidence of the protective effect of Nasitrol in doctors and nurses highly exposed to SARS-CoV-2 (personnel dedicated to the COVID-19 ICU) during a period of one month.”\n\nYou should take immediate action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.\n\nFDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and\u002For effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-covid-19-products. Once you have taken actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.\n\nThis letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nIf you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.\n\nPlease direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov\n\nSincerely,\n\n\u002FS\u002F\n\nDonald D. Ashley\n\nDirector\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\n__________________________\n\n1 As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\n\n2 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\n\n3 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F.","2026-08-20T02:17:31.407+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2022-01-04T15:00:00Z\">01\u002F04\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-01-03T05:00:00Z\">01\u002F03\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Famcyte-pharma-inc-623474-01032022\">Amcyte Pharma, Inc.\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"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"]