FDA WARNING_LETTER - 4U Health - March 01, 2026

The FDA issued a Warning Letter to 4U Health on March 17, 2026, concerning the unauthorized sale of its human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit. The FDA"s review, including the company"s website (last visited March 2026) and prior communications, confirmed 4U Health"s offering of these kits for at-home sample collection and subsequent HIV testing.

The core violations are under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The HIV DBS kit is classified as a medical device and found adulterated due to the absence of required marketing authorization, specifically an approved premarket approval application (PMA) or an investigational device exemption (IDE). Additionally, the device is misbranded because 4U Health failed to provide notification of its intent to commercially distribute the device, a requirement of the FD&C Act.

Despite 4U Health"s claims of merely facilitating medical services rather than selling kits, FDA evidence contradicted this. The agency clarified that even with "physician consultants" or preliminary results, the kits are devices subject to regulation. Without proper authorization, the safety and effectiveness of the HIV DBS kit cannot be guaranteed.

4U Health is mandated to immediately cease all activities causing the misbranding or adulteration of its HIV DBS card self-collection kit. A written response outlining specific corrective actions and preventative measures is required within fifteen working days. Non-compliance could result in further regulatory actions like seizure or injunction.