Warning Letter Record: Imu-Tek Animal Health, Incorporated (June 5, 2026) — Dietary Supplement/New Drug/Misbranded

FDA Warning Letter — Violations FDA cited at Imu-Tek Animal Health, Incorporated

WARNING LETTER Imu-Tek Animal Health, Incorporated MARCS-CMS 724610 — June 05, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Food & Beverages Recipient: Recipient Name Henry S. Dyjak, President/Co-Owner Recipient Title Susan A. Dyjak, Vice President/Co-Owner Imu-Tek Animal Health, Incorporated 3541 E. Vine Dr. Fort Collins , CO 80524 United States Henryd@Imutek.com Issuing Office: Human Foods Program United States June 5, 2026 WARNING LETTER CMS # 724610 Dear Mr. and Mrs. Dyjak: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 3541 E. Vine Dr., Fort Collins, CO 80524 from October 6 through October 14, 2025. Based on inspectional findings and our review of your website, www.Imutek.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov. At the conclusion of the inspection on October 14, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated October 29, 2025. Unapproved New Drugs FDA reviewed your website at the Internet address www.imutek.com in April 2026 and has determined that you take orders there for the products Colostrom-5 Capsules and Colostrom-5 Powder. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. An example that provides evidence that your products are intended for use as drugs include: “ImuTek Colostrum-5 Capsules and Powder. . . . has been shown to kill bacteria and viral invaders. It can also help correct bowel dysfunction by stimulating tissue repair.” Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner. Your products Colostrom-5 Capsules and Colostrom-5 Powder are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Colostrom-5 Capsules and Colostrom-5 Powder fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements The inspection of your facility from October 6 through October 14, 202