[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-psyched-wellness-ltd-730137-09292026":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},21922,"psyched-wellness-ltd-730137-09292026","Warning Letter","Psyched Wellness Ltd.",null,"Human Foods Program","Dietary Supplement\u002FAdulterated","2026-10-20","2026-09-29","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpsyched-wellness-ltd-730137-09292026","730137","Dietary Supplements","Via Email","Mr. Jeffrey Stevens","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Dietary Supplements                          \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>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv>Mr. Jeffrey Stevens\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv>CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Psyched Wellness Ltd. \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>36 Toronto Street, Ste 701\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Toronto\u003C\u002Fspan> \u003Cspan>ON\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Canada\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto: jstevens@psyched-wellness.com\">  jstevens@psyched-wellness.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Human Foods Program\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>September 29, 2026\u003C\u002Fp>\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>CMS #730137\u003C\u002Fp>\u003Cp>Dear Mr. Jeffrey Stevens:\u003C\u002Fp>\u003Cp>This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.psyched-wellness.com in May 2026 and has determined that you take orders there for various human food products, which you represent as containing \u003Cem>Amanita muscaria\u003C\u002Fem>. FDA has determined that your products, Calm, Calmer, and Santa, are adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(f)(1)(B). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Adulterated Dietary Supplements\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The labeling of your Calm, Calmer, and Santa products declares \u003Cem>Amanita muscaria\u003C\u002Fem> extract as a dietary ingredient. Based on a review of your product labeling, the \u003Cem>Amanita muscaria\u003C\u002Fem> extract in your Calm, Calmer, and Santa products is a “dietary ingredient” under section 201(ff)(1)(F) of the Act (21 U.S.C. 321(ff)(1)(F)). \u003Cem>Amanita muscaria\u003C\u002Fem>, A. muscaria extract, ibotenic acid, muscarine, and muscimol are new dietary ingredients under section 413(d) of the Act (21 U.S.C. 350b(d)) because, to the best of FDA’s knowledge, there is no information demonstrating that \u003Cem>Amanita muscaria\u003C\u002Fem> was marketed as a dietary ingredient in the United States before October 15, 1994.\u003C\u002Fp>\u003Cp>A dietary supplement is adulterated under section 402(f)(1)(B) of the Act (21 U.S.C. 342(f)(1)(B)) of the Act if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Based on our evaluation of the relevant safety evidence, there is inadequate information to provide reasonable assurance that Amanita muscaria does not present a significant or unreasonable risk of illness or injury. Therefore, your dietary supplements containing \u003Cem>Amanita muscaria\u003C\u002Fem> are adulterated under section 402(f)(1)(B) of the Act. The introduction of such adulterated dietary supplements into interstate commerce is prohibited under section 301(a) of the Act. Moreover, available information on the use of \u003Cem>Amanita muscaria\u003C\u002Fem> in products raises serious safety concerns.\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 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 adequately address this matter may result in legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Please notify FDA in writing, within 15 working days of receipt of this letter, 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 actions within 15 working days, 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 Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>Your written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE DietarySupplements@fda.hhs.gov. Please reference CMS #730137 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Maria Knirk, J.D., M.B.A.\u003Cbr>Director, Office of Enforcement\u003Cbr>Office of Compliance and Enforcement\u003Cbr>Human Foods Program\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nDietary Supplements\n\nRecipient:\n\nRecipient Name\n\nMr. Jeffrey Stevens\n\nRecipient Title\n\nCEO\n\nPsyched Wellness Ltd.\n\n36 Toronto Street, Ste 701\n\nToronto ON\n\nCanada\n\njstevens@psyched-wellness.com\n\nIssuing Office:\n\nHuman Foods Program\n\nUnited States\n\nSeptember 29, 2026\nWARNING LETTER\nCMS #730137\nDear Mr. Jeffrey Stevens:\nThis is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.psyched-wellness.com in May 2026 and has determined that you take orders there for various human food products, which you represent as containing Amanita muscaria. FDA has determined that your products, Calm, Calmer, and Santa, are adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(f)(1)(B). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.\nAdulterated Dietary Supplements\nThe labeling of your Calm, Calmer, and Santa products declares Amanita muscaria extract as a dietary ingredient. Based on a review of your product labeling, the Amanita muscaria extract in your Calm, Calmer, and Santa products is a “dietary ingredient” under section 201(ff)(1)(F) of the Act (21 U.S.C. 321(ff)(1)(F)). Amanita muscaria, A. muscaria extract, ibotenic acid, muscarine, and muscimol are new dietary ingredients under section 413(d) of the Act (21 U.S.C. 350b(d)) because, to the best of FDA’s knowledge, there is no information demonstrating that Amanita muscaria was marketed as a dietary ingredient in the United States before October 15, 1994.\nA dietary supplement is adulterated under section 402(f)(1)(B) of the Act (21 U.S.C. 342(f)(1)(B)) of the Act if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Based on our evaluation of the relevant safety evidence, there is inadequate information to provide reasonable assurance that Amanita muscaria does not present a significant or unreasonable risk of illness or injury. Therefore, your dietary supplements containing Amanita muscaria are adulterated under section 402(f)(1)(B) of the Act. The introduction of such adulterated dietary supplements into interstate commerce is prohibited under section 301(a) of the Act. Moreover, available information on the use of Amanita muscaria in products raises serious safety concerns.\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 requirements of federal law, including FDA regulations.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\nPlease notify FDA in writing, within 15 working days of receipt of this letter, 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 actions within 15 working days, 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 Act, include your reasoning and any supporting information for our consideration.\nYour written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE DietarySupplements@fda.hhs.gov. Please reference CMS #730137 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.\nSincerely,\n\u002FS\u002F\nMaria Knirk, J.D., M.B.A.\nDirector, Office of Enforcement\nOffice of Compliance and Enforcement\nHuman Foods Program","2026-10-27T01:19:12.206+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-10-20T04:00:00Z\">10\u002F20\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-09-29T04:00:00Z\">09\u002F29\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpsyched-wellness-ltd-730137-09292026\">Psyched Wellness Ltd. \u003C\u002Fa>","","2026-10-27T01:18:54.544251+00:00","2026-10-27T01:19:12.662122+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-10-26T02:00:44.031+00:00","2026-10-26T02:00:36.851+00:00","2026-10-26T02:00:41.561+00:00","2026-10-29T04:01:37.416+00:00","2026-09-07T05:17:28.839+00:00","2026-10-26T02:00:45.578+00:00","2026-10-27T01:19:46.805+00:00"]