[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-life-enthusiast-co-op-709315-08252025":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},682,"life-enthusiast-co-op-709315-08252025","Warning Letter","Life Enthusiast Co-op",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FOphthalmic Drug Products","2025-09-02","2025-08-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flife-enthusiast-co-op-709315-08252025","709315","Drugs","Via Email","Martin Pytela","\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\">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\">Martin Pytela\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>Life Enthusiast Co-op \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">711 S Carson Street Suite 4\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Carson City\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NV\u003C\u002Fspan> \u003Cspan class=\"postal-code\">89701\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:support@life-enthusiast.com\"> support@life-enthusiast.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>\u003Cu>WARNING LETTER\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>August 25, 2025\u003C\u002Fp>\u003Cp>RE: 709315\u003C\u002Fp>\u003Cp>Dear Martin Pytela:\u003C\u002Fp>\u003Cp>This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.life-enthusiast.com\u002F in May 2025. The FDA has observed that your website offers “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” for sale in the United States. Based on our review, these products are unapproved new drugs 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>Your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.\u003C\u002Fp>\u003Cp>You appear to be marketing your “MSM Gold Drops” as a dietary supplement. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “MSM Gold Drops” is intended for topical use. Therefore, your “MSM Gold Drops” product does not meet the definition of a dietary supplement under the FD&C Act.\u003C\u002Fp>\u003Cp>Based on a review of your website, your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 of claims from your websites that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>\u003Cu>Amazing Collyrio\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fwww.life-enthusiast.com\u002Fshop\u002Fww4112-amazing-colyrio-2190?category=125#attr=121:\u003C\u002Fp>\u003Cul>\u003Cli>“Alleviates Eye Irritations”\u003C\u002Fli>\u003Cli>“Relieves Tired, Strained Eyes”\u003C\u002Fli>\u003Cli>“Amazing Colyrio helps provide adequate oxygen to eye tissues. And helps restore the electrolyte balance of natural tears.”\u003C\u002Fli>\u003Cli>“Helps alleviate high pressure and pain. Provides a moisturizing and soothing effect within minutes.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Fulvic Eyes\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fwww.life-enthusiast.com\u002Fshop\u002Femgfe-fulvic-eyes-3181?category=125#attr=2576:\u003C\u002Fp>\u003Cul>\u003Cli>“STOPS RED EYES[,] ELIMINATES DRY EYES[,] RESTORES VISION”\u003C\u002Fli>\u003Cli>“This potent formula works to:\u003Cbr>o Aid cellular refreshment. . ..\u003Cbr>o Support efficient nutrient delivery to delicate eye structures. . ..\u003Cbr>o Assist the eyes in maintaining a healthy, comfortable state.”\u003C\u002Fli>\u003Cli>“Unique ingredient for gentle support. . ..\u003Cbr>o Promotes visual clarity.\u003Cbr>o Helps soothe and refresh dry-feeling eyes.”\u003C\u002Fli>\u003Cli>“Can be used topically in eyes, nose, ears, throat or other body parts to soothe irritation.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>MSM Gold Drops\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fwww.life-enthusiast.com\u002Fshop\u002Femsmg-msm-gold-drops-3261?category=125#attr=2461:\u003C\u002Fp>\u003Cul>\u003Cli>“MSM Gold Drops\u003Cbr>o Ease Irritations and Infections. [sic] in Eyes, Ears, Sinuses and Skin\u003Cbr>o Helps Relieve Eye Strain from Screens and Driving\u003Cbr>o Soothe Sensitive, Itchy Eyes”\u003C\u002Fli>\u003Cli>“Safe for topical use (on your skin) in your eyes, nose and ears. Consider using after removing your contact lenses.”\u003C\u002Fli>\u003Cli>“Supports Joint Comfort[,] Enhances Mobility[,] Aids Connective Tissue Health”\u003C\u002Fli>\u003Cli>“The silver and gold help fight infections. Zinc and copper speed repairs. Hyaluronic Acid builds flexibility”\u003C\u002Fli>\u003Cli>“Helps maintain comfortable movement and ease in your joints”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). 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). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>The violations cited in this letter are 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 fifteen working days of receipt of this letter, 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\u003C\u002Fp>\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “709315” in the subject line of the email.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>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>Food and Drug Administration\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\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMartin Pytela\n\nRecipient Title\n\nPresident\n\nLife Enthusiast Co-op\n\n711 S Carson Street Suite 4\n\nCarson City, NV 89701\n\nUnited States\n\nsupport@life-enthusiast.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\nAugust 25, 2025\nRE: 709315\nDear Martin Pytela:\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.life-enthusiast.com\u002F in May 2025. The FDA has observed that your website offers “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” for sale in the United States. Based on our review, these products are unapproved new drugs 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).\nYour “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.\nYou appear to be marketing your “MSM Gold Drops” as a dietary supplement. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “MSM Gold Drops” is intended for topical use. Therefore, your “MSM Gold Drops” product does not meet the definition of a dietary supplement under the FD&C Act.\nBased on a review of your website, your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 of claims from your websites that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\nAmazing Collyrio\nOn the webpage https:\u002F\u002Fwww.life-enthusiast.com\u002Fshop\u002Fww4112-amazing-colyrio-2190?category=125#attr=121:\n“Alleviates Eye Irritations”\n“Relieves Tired, Strained Eyes”\n“Amazing Colyrio helps provide adequate oxygen to eye tissues. And helps restore the electrolyte balance of natural tears.”\n“Helps alleviate high pressure and pain. Provides a moisturizing and soothing effect within minutes.”\nFulvic Eyes\nOn the webpage https:\u002F\u002Fwww.life-enthusiast.com\u002Fshop\u002Femgfe-fulvic-eyes-3181?category=125#attr=2576:\n“STOPS RED EYES[,] ELIMINATES DRY EYES[,] RESTORES VISION”\n“This potent formula works to:\no Aid cellular refreshment. . ..\no Support efficient nutrient delivery to delicate eye structures. . ..\no Assist the eyes in maintaining a healthy, comfortable state.”\n“Unique ingredient for gentle support. . ..\no Promotes visual clarity.\no Helps soothe and refresh dry-feeling eyes.”\n“Can be used topically in eyes, nose, ears, throat or other body parts to soothe irritation.”\nMSM Gold Drops\nOn the webpage https:\u002F\u002Fwww.life-enthusiast.com\u002Fshop\u002Femsmg-msm-gold-drops-3261?category=125#attr=2461:\n“MSM Gold Drops\no Ease Irritations and Infections. [sic] in Eyes, Ears, Sinuses and Skin\no Helps Relieve Eye Strain from Screens and Driving\no Soothe Sensitive, Itchy Eyes”\n“Safe for topical use (on your skin) in your eyes, nose and ears. Consider using after removing your contact lenses.”\n“Supports Joint Comfort[,] Enhances Mobility[,] Aids Connective Tissue Health”\n“The silver and gold help fight infections. Zinc and copper speed repairs. Hyaluronic Acid builds flexibility”\n“Helps maintain comfortable movement and ease in your joints”\nYour “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). 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). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nThe violations cited in this letter are 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 fifteen working days of receipt of this letter, 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “709315” in the subject line of the email.\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\nFood and Drug Administration","2026-08-19T16:27:11.762+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-09-02T04:00:00Z\">09\u002F02\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-08-25T04:00:00Z\">08\u002F25\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flife-enthusiast-co-op-709315-08252025\">Life Enthusiast Co-op \u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+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"]