4U Health

CLOSEOUT LETTER 4U Health MARCS-CMS 720527 — June 16, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Biologics Drugs Recipient: Recipient Name Alfred Caminos Recipient Title Co-Founder and Managing Director 4U Health 71 Lighthouse Road, Suite 220 Hilton Head Island , SC 29928 United States help@4uhealth.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Secondary Issuing Offices United States Dear Alfred Caminos: The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated March 17, 2026, set forth in your correspondence dated April 23, 2026. Based on your representation that 4U Health “has discontinued direct-to-consumer marketing on 4uhealth.com of professional HIV medical screening services, pertaining to the physician ordering and medical oversight of self-collected dried blood spot specimens”, it appears that you have addressed the violation(s) contained in this Warning Letter. While we acknowledge that you no longer offer HIV DBS card self-collection kits for sale on your website, we note that your website still states “HIV” under the “Shop Our Tests” drop-down menu within the “STD/STI tests” section. As it appears based on your representations noted above you have discontinued marketing tests for HIV and do not intend to resume doing so, please remove references to HIV tests from your website and confirm completion of this action within 15 business days of receipt of this letter. Future FDA surveillance and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If you have any questions regarding this letter, please contact the Division of Case Management, CBERDCMRecommendations@fda.hhs.gov. Sincerely, /S/ Vincent Amatrudo Acting Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research Content current as of: 06/23/2026 Regulated Product(s) Biologics Drugs