[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-energetic-essences-llc-dba-pet-essences-696395-11122024":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},1106,"energetic-essences-llc-dba-pet-essences-696395-11122024","Warning Letter","Energetic Essences, LLC dba Pet Essences",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\u002Fenergetic-essences-llc-dba-pet-essences-696395-11122024","696395","Animal & VeterinaryDrugs","Via Email","Polly Fox","\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\">Polly Fox\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\">President\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Energetic Essences, LLC dba Pet Essences\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">(b)(6)\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:help@petessences.com\"> help@petessences.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: CMS Case # 696395\u003C\u002Fp>\u003Cp>Dear Polly Fox:\u003C\u002Fp>\u003Cp>This letter concerns your firm’s marketing of an unapproved new animal drug for the treatment of seizures in animals, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fpetessences.com\u002F in October to November 2024 and has determined that you offer this product for sale there.\u003C\u002Fp>\u003Cp>Based on our review of your website at the internet address https:\u002F\u002Fpetessences.com\u002Fproducts\u002Fseizures, 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, prevention of disease, 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\u003Cbr>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 website and product labeling that show the intended use of your product include, but are not limited to the following:\u003C\u002Fp>\u003Cp>From your home website titled “\u003Cstrong>Seizures\u003C\u002Fstrong>” at the URL \u003Ca href=\"https:\u002F\u002Fpetessences.com\u002Fproducts\u002Fseizures:\">https:\u002F\u002Fpetessences.com\u002Fproducts\u002Fseizures:\u003C\u002Fa>\u003C\u002Fp>\u003Cp>• “Our Seizures formula is designed to help reduce the frequency, severity, and duration of seizures in animals.”\u003Cbr>• “We recommend administering it to your pet 2 to 4 times a day to help prevent seizures from occurring.”\u003Cbr>• “…this formula can also be used to manage seizures as they occur.”\u003Cbr>• “…certain physical symptoms like shaking, drooling, and lack of control can be addressed with our formula.”\u003C\u002Fp>\u003Cp>On your home webpage titled “\u003Cstrong>Formulas\u003C\u002Fstrong>” at the URL \u003Ca href=\"https:\u002F\u002Fpetessences.com\u002Fpages\u002Fformulas?_pos=2&_sid=9eb800182&_ss=r:\">https:\u002F\u002Fpetessences.com\u002Fpages\u002Fformulas?_pos=2&_sid=9eb800182&_ss=r:\u003C\u002Fa>\u003C\u002Fp>\u003Cp>• “At the time of a seizure, use Emergency to help the animal recover. Then use Seizure Prevention to help ease the emotional stress associated with seizures. Use it daily…”\u003Cbr>• “Our Seizures formula is designed to help reduce the frequency, severity, and duration of seizures in animals. We recommend administering it to your pet 2 to 4 times a day to help prevent seizures from occurring. However, this formula can also be used to manage seizures as they occur… certain physical symptoms like shaking, drooling, and lack of control can be addressed with our formula….”\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. 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 correct 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 products are 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 “CMS Case #696395” in the subject line of you\u003Ca href=\"#696395”\">r email.\u003C\u002Fa>\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: help@petessences.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\nPolly Fox\n\nRecipient Title\n\nPresident\n\nEnergetic Essences, LLC dba Pet Essences\n\n(b)(6)\n\nUnited States\n\nhelp@petessences.com\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nWARNING LETTER\nNovember 12, 2024\nRe: CMS Case # 696395\nDear Polly Fox:\nThis letter concerns your firm’s marketing of an unapproved new animal drug for the treatment of seizures in animals, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fpetessences.com\u002F in October to November 2024 and has determined that you offer this product for sale there.\nBased on our review of your website at the internet address https:\u002F\u002Fpetessences.com\u002Fproducts\u002Fseizures, 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, prevention of disease, 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\nwww.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 website and product labeling that show the intended use of your product include, but are not limited to the following:\nFrom your home website titled “Seizures” at the URL https:\u002F\u002Fpetessences.com\u002Fproducts\u002Fseizures:\n• “Our Seizures formula is designed to help reduce the frequency, severity, and duration of seizures in animals.”\n• “We recommend administering it to your pet 2 to 4 times a day to help prevent seizures from occurring.”\n• “…this formula can also be used to manage seizures as they occur.”\n• “…certain physical symptoms like shaking, drooling, and lack of control can be addressed with our formula.”\nOn your home webpage titled “Formulas” at the URL https:\u002F\u002Fpetessences.com\u002Fpages\u002Fformulas?_pos=2&_sid=9eb800182&_ss=r:\n• “At the time of a seizure, use Emergency to help the animal recover. Then use Seizure Prevention to help ease the emotional stress associated with seizures. Use it daily…”\n• “Our Seizures formula is designed to help reduce the frequency, severity, and duration of seizures in animals. We recommend administering it to your pet 2 to 4 times a day to help prevent seizures from occurring. However, this formula can also be used to manage seizures as they occur… certain physical symptoms like shaking, drooling, and lack of control can be addressed with our formula….”\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. 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)].\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 correct 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 products are 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 “CMS Case #696395” 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: help@petessences.com","2026-08-19T17:05:36.767+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\u002Fenergetic-essences-llc-dba-pet-essences-696395-11122024\">Energetic Essences, LLC dba Pet Essences\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"]