[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-supply-center-usa-710859-08252025":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":17,"recipient_name":8,"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},680,"supply-center-usa-710859-08252025","Warning Letter","Supply Center USA",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\u002Fsupply-center-usa-710859-08252025","710859","Drugs","Via Email","\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>\u003C\u002Fdd>\n                    \n            \u003Cdd>Supply Center USA\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">30 N Gould St Ste R\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Sheridan\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">WY\u003C\u002Fspan> \u003Cspan class=\"postal-code\">82801\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@supplycenterusa.com\"> info@supplycenterusa.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:support@supplycenterusa.reamaze.com \"> support@supplycenterusa.reamaze.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>\u003Cp>August 25, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">RE: 710859\u003C\u002Fp>\u003Cp>Dear Supply Center USA:\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\u002Fsupplycenterusa.com in May 2025. The FDA has observed that your website offers “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” 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 unapproved “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” drug 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>Based on a review of your website, your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” 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 website https:\u002F\u002Fsupplycenterusa.com 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>Similasan Allergy Eye Relief (all variations)\u003C\u002Fu>\u003Cbr>On the webpages https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-allergy-eye-relief-eye-drops-20-sterile-single-use-droppers-0-014-fl-oz-0-4-m and https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-allergy-eye-relief-sterile-eye-drops-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“[T]emporarily relieve minor allergy symptoms such as:\u003Cbr>Itching\u003Cbr>Burning\u003Cbr>Excessive watering\u003Cbr>Redness of eye and lids”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Similasan Complete Eye Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-complete-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“When your eyes need multi-symptom relief reach for Similasan Complete Eye Relief sterile eye drops. It stimulates the body's natural ability to temporarily relieve and address eye symptoms like dryness, burning, watering, grittiness, irritation, and redness.”\u003C\u002Fli>\u003Cli>“Uses: According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as:\u003Cbr>Redness of eyes and eye lids\u003Cbr>Dry eye\u003Cbr>Reflex watering secondary to dry eye\u003Cbr>Sensation of grittiness\u003Cbr>Sensation of burning”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Similasan Computer Eye Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-computer-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:\u003Cbr>Aching eyes\u003Cbr>Burning\u003Cbr>Redness\u003Cbr>Strained eyes (Computer, TV, reading, driving)”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Similasan Pink Eye Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-pink-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“Use As Often As Needed\u003Cbr>Redness\u003Cbr>Burning\u003Cbr>Watery Discharge\u003Cbr>Sensation of Grittiness”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Similasan Redness & Itchy Eye Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-redness-itchy-eye-relief-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms such as:\u003Cbr>itching\u003Cbr>redness of eyes and lids\u003Cbr>excessive watering\u003Cbr>burning\u003Cbr>stinging\u003Cbr>irritation”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Similasan Stye Eye Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-stye-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:\u003Cbr>Redness\u003Cbr>Burning\u003Cbr>Eyelid Redness\u003Cbr>Tearing”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Similasan Aging Eye Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-aging-eye-relief-0-33-fl-oz-10-ml:\u003C\u002Fp>\u003Cul>\u003Cli>“Uses: According to homeopathic principles, the active ingredients in this medication help temporarily relieve minor symptoms such as:\u003Cbr>Dryness\u003Cbr>Burning\u003Cbr>Irritation\u003Cbr>For protection against further irritation”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Boiron Optique 1 Eye Irritation Relief\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fboiron-optique-1-eye-irritation-relief-30-doses-0-013-fl-oz-each:\u003C\u002Fp>\u003Cul>\u003Cli>“Uses:\u003Cbr>Temporarily relieves minor eye irritation due to fatigue or airborne irritants such as ragweed, other pollens and dust\u003Cbr>Soothes red, dry, itchy, gritty, burning or tired eyes”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” products 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>We recognize that your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” products are labeled as homeopathic drugs with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.\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. You should also refer to the FDA warning letters previously sent to Similasan AG\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> and Boiron, Inc.\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> about these unapproved ophthalmic drug products.\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 “710859” 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>\u003Cp>____________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> See the Warning Letter issued to Similasan AG on September 11, 2023.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> See the Warning Letter issued to Boiron, Inc. on September 11, 2023.\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\nSupply Center USA\n\n30 N Gould St Ste R\n\nSheridan, WY 82801\n\nUnited States\n\ninfo@supplycenterusa.com\n\nsupport@supplycenterusa.reamaze.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\nAugust 25, 2025\nRE: 710859\nDear Supply Center USA:\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fsupplycenterusa.com in May 2025. The FDA has observed that your website offers “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” 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 unapproved “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” drug 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.\nBased on a review of your website, your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” 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 website https:\u002F\u002Fsupplycenterusa.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\nSimilasan Allergy Eye Relief (all variations)\nOn the webpages https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-allergy-eye-relief-eye-drops-20-sterile-single-use-droppers-0-014-fl-oz-0-4-m and https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-allergy-eye-relief-sterile-eye-drops-0-33-fl-oz-10-ml:\n“[T]emporarily relieve minor allergy symptoms such as:\nItching\nBurning\nExcessive watering\nRedness of eye and lids”\nSimilasan Complete Eye Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-complete-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml:\n“When your eyes need multi-symptom relief reach for Similasan Complete Eye Relief sterile eye drops. It stimulates the body's natural ability to temporarily relieve and address eye symptoms like dryness, burning, watering, grittiness, irritation, and redness.”\n“Uses: According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as:\nRedness of eyes and eye lids\nDry eye\nReflex watering secondary to dry eye\nSensation of grittiness\nSensation of burning”\nSimilasan Computer Eye Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-computer-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml:\n“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:\nAching eyes\nBurning\nRedness\nStrained eyes (Computer, TV, reading, driving)”\nSimilasan Pink Eye Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-pink-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml:\n“Use As Often As Needed\nRedness\nBurning\nWatery Discharge\nSensation of Grittiness”\nSimilasan Redness & Itchy Eye Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-redness-itchy-eye-relief-0-33-fl-oz-10-ml:\n“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms such as:\nitching\nredness of eyes and lids\nexcessive watering\nburning\nstinging\nirritation”\nSimilasan Stye Eye Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-stye-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml:\n“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:\nRedness\nBurning\nEyelid Redness\nTearing”\nSimilasan Aging Eye Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fsimilasan-aging-eye-relief-0-33-fl-oz-10-ml:\n“Uses: According to homeopathic principles, the active ingredients in this medication help temporarily relieve minor symptoms such as:\nDryness\nBurning\nIrritation\nFor protection against further irritation”\nBoiron Optique 1 Eye Irritation Relief\nOn the webpage https:\u002F\u002Fsupplycenterusa.com\u002Fproducts\u002Fboiron-optique-1-eye-irritation-relief-30-doses-0-013-fl-oz-each:\n“Uses:\nTemporarily relieves minor eye irritation due to fatigue or airborne irritants such as ragweed, other pollens and dust\nSoothes red, dry, itchy, gritty, burning or tired eyes”\nYour “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” products 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).\nWe recognize that your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” products are labeled as homeopathic drugs with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.\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. You should also refer to the FDA warning letters previously sent to Similasan AG1 and Boiron, Inc.2 about these unapproved ophthalmic drug products.\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 “710859” 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\n____________________\n1 See the Warning Letter issued to Similasan AG on September 11, 2023.\n2 See the Warning Letter issued to Boiron, Inc. on September 11, 2023.","2026-08-19T16:27:30.352+00:00",[22,23,24,9,10,25,25,25],"\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\u002Fsupply-center-usa-710859-08252025\">Supply Center USA\u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+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"]