Supply Center USA

WARNING LETTER Supply Center USA MARCS-CMS 710859 — August 25, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Supply Center USA 30 N Gould St Ste R Sheridan , WY 82801 United States info@supplycenterusa.com support@supplycenterusa.reamaze.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER August 25, 2025 RE: 710859 Dear Supply Center USA: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://supplycenterusa.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). 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. 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/or intended to affect the structure or any function of the body. Examples of claims from your website https://supplycenterusa.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following: Similasan Allergy Eye Relief (all variations) On the webpages https://supplycenterusa.com/products/similasan-allergy-eye-relief-eye-drops-20-sterile-single-use-droppers-0-014-fl-oz-0-4-m and https://supplycenterusa.com/products/similasan-allergy-eye-relief-sterile-eye-drops-0-33-fl-oz-10-ml: “[T]emporarily relieve minor allergy symptoms such as: Itching Burning Excessive watering Redness of eye and lids” Similasan Complete Eye Relief On the webpage https://supplycenterusa.com/products/similasan-complete-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml: “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.” “Uses: According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as: Redness of eyes and eye lids Dry eye Reflex watering secondary to dry eye Sensation of grittiness Sensation of burning” Similasan Computer Eye Relief On the webpage https://supplycenterusa.com/products/similasan-computer-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml: “Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: Aching eyes Burning Redness Strained eyes (Computer, TV, reading, driving)” Similasan Pink Eye Relief On the webpage https://supplycenterusa.com/products/similasan-pink-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml: “Use As Often As Needed Redness Burning Watery Discharge Sensation of Grittiness” Similasan Redness & Itchy Eye Relief On the webpage https://supplycenterusa.com/products/similasan-redness-itchy-eye-relief-0-33-fl-oz-10-ml: “Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms such as: itching redness of eyes and lids excessive watering burning stinging irritation” Similasan Stye Eye Relief On the webpage https://supplycenterusa.com/products/similasan-stye-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml: “Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: Redness Burning Eyelid Redness Tearing” Similasan Aging Eye Relief On the webpage https://supplycenterusa.com/products/similasan-aging-eye-relief-0-33-fl-oz-10-ml: “Uses: According to homeopathic principles, the active ingredients in this medication help temporarily relieve minor symptoms such as: Dryness Burning Irritation For protection against further irritation” Boiron Optique 1 Eye Irritation Relief On the webpage https://supplycenterusa.com/products/boiron-optique-1-eye-irritation-relief-30-doses-0-013-fl-oz-each: “Uses: Temporarily relieves minor eye irritation due to fatigue or airborne irritants such as ragweed, other pollens and dust Soothes red, dry, itchy, gritty, burning or tired eyes” 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). 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. 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. 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 1 and Boiron, Inc. 2 about these unapproved ophthalmic drug products. 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. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office 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. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration ____________________ 1 See the Warning Letter issued to Similasan AG on September 11, 2023. 2 See the Warning Letter issued to Boiron, Inc. on September 11, 2023. Content current as of: 09/02/2025 Regulated Product(s) Drugs