Life Enthusiast Co-op

WARNING LETTER Life Enthusiast Co-op MARCS-CMS 709315 — August 25, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Martin Pytela Recipient Title President Life Enthusiast Co-op 711 S Carson Street Suite 4 Carson City , NV 89701 United States support@life-enthusiast.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER August 25, 2025 RE: 709315 Dear Martin Pytela: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.life-enthusiast.com/ 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). 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. 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. 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/or 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: Amazing Collyrio On the webpage https://www.life-enthusiast.com/shop/ww4112-amazing-colyrio-2190?category=125#attr=121: “Alleviates Eye Irritations” “Relieves Tired, Strained Eyes” “Amazing Colyrio helps provide adequate oxygen to eye tissues. And helps restore the electrolyte balance of natural tears.” “Helps alleviate high pressure and pain. Provides a moisturizing and soothing effect within minutes.” Fulvic Eyes On the webpage https://www.life-enthusiast.com/shop/emgfe-fulvic-eyes-3181?category=125#attr=2576: “STOPS RED EYES[,] ELIMINATES DRY EYES[,] RESTORES VISION” “This potent formula works to: o Aid cellular refreshment. . .. o Support efficient nutrient delivery to delicate eye structures. . .. o Assist the eyes in maintaining a healthy, comfortable state.” “Unique ingredient for gentle support. . .. o Promotes visual clarity. o Helps soothe and refresh dry-feeling eyes.” “Can be used topically in eyes, nose, ears, throat or other body parts to soothe irritation.” MSM Gold Drops On the webpage https://www.life-enthusiast.com/shop/emsmg-msm-gold-drops-3261?category=125#attr=2461: “MSM Gold Drops o Ease Irritations and Infections. [sic] in Eyes, Ears, Sinuses and Skin o Helps Relieve Eye Strain from Screens and Driving o Soothe Sensitive, Itchy Eyes” “Safe for topical use (on your skin) in your eyes, nose and ears. Consider using after removing your contact lenses.” “Supports Joint Comfort[,] Enhances Mobility[,] Aids Connective Tissue Health” “The silver and gold help fight infections. Zinc and copper speed repairs. Hyaluronic Acid builds flexibility” “Helps maintain comfortable movement and ease in your joints” 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). 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. 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 “709315” 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 Content current as of: 09/02/2025 Regulated Product(s) Drugs