[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-intermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024":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},1108,"intermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024","Warning Letter","Intermarket Industries Inc. dba Doc Ackerman Pet Products",null,"Center for Veterinary Medicine","New Animal Drug\u002FAdulterated","2025-01-07","2024-11-12","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fintermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024","696352","Animal & VeterinaryDrugs","Via Email","Greg Mongrain","\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 Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Animal & Veterinary\u003Cbr>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\">Greg Mongrain\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\">Vice President\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Intermarket Industries Inc. dba Doc Ackerman Pet Products\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1131 Industrial Ave\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Oxnard\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">93030\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:gmongrain@juno.com\"> gmongrain@juno.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 Veterinary Medicine\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>\u003Cp>November 12, 2024\u003C\u002Fp>\u003Cp>Re: 696352\u003C\u002Fp>\u003Cp>Dear Greg Mongrain:\u003C\u002Fp>\u003Cp>This letter concerns your firm’s marketing of an unapproved new animal drug Doc Ackerman's - Epilepsy & Seizure Formula, for the treatment of diseases in animals, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your firm’s Facebook account in October and November 2024 where you direct customers to your product on Amazon and Only Natural Pet Store and has determined that you offer your product for sale there.\u003C\u002Fp>\u003Cp>Based on our review of your Facebook account and third-party webpages, your product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (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 in animals and\u002For intended to affect the structure or any function of the body of an animal. This product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\u003Cp>You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.\u003C\u002Fp>\u003Cp>The intended use of your “Seizures” product is indicated by its name and is also shown by the claims you make for it. Examples of claims FDA observed on your product labelling, Facebook account and third-party webpages to which you direct your customers that show the intended use of your product include the following:\u003C\u002Fp>\u003Cp>From your Facebook post titled “\u003Cstrong>Doc Ackerman's Pet Products\u003C\u002Fstrong>” at the URL https:\u002F\u002Fwww.facebook.com\u002Fp\u002FDoc-Ackermans-Pet-Products-100057232281085\u002F?_rdr dated April 14:\u003C\u002Fp>\u003Cp>• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”\u003Cbr>• “… The Epilepsy and Seizure formula will be available at the end of April on Amazon and at Only Natural Pet Store.”\u003C\u002Fp>\u003Cp>From your product webpage “\u003Cstrong>Doc Ackerman's - Epilepsy & Seizure Formula\u003C\u002Fstrong>” on Amazon at the URL https:\u002F\u002Fwww.amazon.com\u002FDoc-Ackermans-Epilepsy-Seizure-Formula\u002Fdp\u002FB0002CGUP0:\u003C\u002Fp>\u003Cp>• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”\u003Cbr>• “EPILEPSY AND SEIZURE FORMULA for dogs and cats works as a calmative to help lessen the effects of nervous conditions.”\u003Cbr>• “…is an anti convulsant [sic] & antispasmodic herb … specifically for Epilepsy.”\u003Cbr>• “… help lessen the effects of nervous conditions while acting as a natural tranquilizer,…”\u003Cbr>• “… Safe for your pet …”\u003C\u002Fp>\u003Cp>From your product webpage “\u003Cstrong>DOC ACKERMAN'S EPILEPSY & SEIZURE FORMULA HERBAL REMEDY POWDER FOR DOGS & CATS - 10 OZ\u003C\u002Fstrong>” on onlynaturalpet.com at the URL https:\u002F\u002Fwww.onlynaturalpet.com\u002Fproducts\u002Fdoc-ackermans-epilepsy-seizure-formula-herbal-remedy-powder-for-dogs-cats:\u003C\u002Fp>\u003Cp>• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”\u003Cbr>• “… Epilepsy & Seizure Formula\u003Cbr>• “…\u003Cstrong>CAT AND DOG SEIZURE TREATMENT HOME REMEDY\u003C\u002Fstrong>…”\u003Cbr>• “… Epilepsy and Seizure Formula… provides dogs and cats relief from the effects of epilepsy...”\u003Cbr>• “… natural remedy for dog seizures… to treat epilepsy….”\u003Cbr>• “... natural remedy for dog seizures… safe for your pet and for the environment….”\u003Cbr>• “… seizure remedy comes in a convenient powder form…”\u003C\u002Fp>\u003Cp>This product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.\u003C\u002Fp>\u003Cp>To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and\u002For injunction.\u003C\u002Fp>\u003Cp>Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 696352” in the subject line of your email.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Neal Bataller, ME, DVM\u003Cbr>Director\u003Cbr>Division of Drug Compliance\u003Cbr>Office of Surveillance and Compliance\u003Cbr>Center for Veterinary Medicine\u003C\u002Fp>\u003Cp>cc: grgmeister@aol.com\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 Email\n\nProduct:\n\nAnimal & Veterinary\nDrugs\n\nRecipient:\n\nRecipient Name\n\nGreg Mongrain\n\nRecipient Title\n\nVice President\n\nIntermarket Industries Inc. dba Doc Ackerman Pet Products\n\n1131 Industrial Ave\n\nOxnard, CA 93030\n\nUnited States\n\ngmongrain@juno.com\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nWARNING LETTER\nNovember 12, 2024\nRe: 696352\nDear Greg Mongrain:\nThis letter concerns your firm’s marketing of an unapproved new animal drug Doc Ackerman's - Epilepsy & Seizure Formula, for the treatment of diseases in animals, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your firm’s Facebook account in October and November 2024 where you direct customers to your product on Amazon and Only Natural Pet Store and has determined that you offer your product for sale there.\nBased on our review of your Facebook account and third-party webpages, your product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (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 in animals and\u002For intended to affect the structure or any function of the body of an animal. This product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\nYou can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.\nThe intended use of your “Seizures” product is indicated by its name and is also shown by the claims you make for it. Examples of claims FDA observed on your product labelling, Facebook account and third-party webpages to which you direct your customers that show the intended use of your product include the following:\nFrom your Facebook post titled “Doc Ackerman's Pet Products” at the URL https:\u002F\u002Fwww.facebook.com\u002Fp\u002FDoc-Ackermans-Pet-Products-100057232281085\u002F?_rdr dated April 14:\n• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”\n• “… The Epilepsy and Seizure formula will be available at the end of April on Amazon and at Only Natural Pet Store.”\nFrom your product webpage “Doc Ackerman's - Epilepsy & Seizure Formula” on Amazon at the URL https:\u002F\u002Fwww.amazon.com\u002FDoc-Ackermans-Epilepsy-Seizure-Formula\u002Fdp\u002FB0002CGUP0:\n• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”\n• “EPILEPSY AND SEIZURE FORMULA for dogs and cats works as a calmative to help lessen the effects of nervous conditions.”\n• “…is an anti convulsant [sic] & antispasmodic herb … specifically for Epilepsy.”\n• “… help lessen the effects of nervous conditions while acting as a natural tranquilizer,…”\n• “… Safe for your pet …”\nFrom your product webpage “DOC ACKERMAN'S EPILEPSY & SEIZURE FORMULA HERBAL REMEDY POWDER FOR DOGS & CATS - 10 OZ” on onlynaturalpet.com at the URL https:\u002F\u002Fwww.onlynaturalpet.com\u002Fproducts\u002Fdoc-ackermans-epilepsy-seizure-formula-herbal-remedy-powder-for-dogs-cats:\n• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”\n• “… Epilepsy & Seizure Formula\n• “…CAT AND DOG SEIZURE TREATMENT HOME REMEDY…”\n• “… Epilepsy and Seizure Formula… provides dogs and cats relief from the effects of epilepsy...”\n• “… natural remedy for dog seizures… to treat epilepsy….”\n• “... natural remedy for dog seizures… safe for your pet and for the environment….”\n• “… seizure remedy comes in a convenient powder form…”\nThis product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.\nTo be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\nConclusion\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and\u002For injunction.\nWithin fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\nPlease direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 696352” in the subject line of your email.\nSincerely,\n\u002FS\u002F\nNeal Bataller, ME, DVM\nDirector\nDivision of Drug Compliance\nOffice of Surveillance and Compliance\nCenter for Veterinary Medicine\ncc: grgmeister@aol.com","2026-08-19T17:05:57.419+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-01-07T14:20:00Z\">01\u002F07\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-11-12T05:00:00Z\">11\u002F12\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fintermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024\">Intermarket Industries Inc. dba Doc Ackerman Pet Products\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+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"]