Germaphobix

WARNING LETTER

January 09, 2026

CBER 26-720555

Dear Jon Tavarez:

The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Germaphobix, is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

FDA has reviewed your company’s website at https://germaphobix.com (last visited January 2026) and your firm’s responses to previous FDA correspondence. Based on our review of these materials, your firm offers a HIV DBS card self-collection kit for delivery to individuals and intends for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).

FDA has not authorized your HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.

In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. In your response dated April 18, 2025, you assert that you operate solely as a distributor and that the HIV dried blood spot tests offered on your website are Lab-Developed Tests (LDTs). On September 23, 2025, FDA notified you that HIV DBS card self-collection kits are not considered LDTs and that the distribution or causing the distribution of your HIV DBS card self-collection kit violates the FD&C Act. As noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for any use and to date, your firm has not submitted any premarket submission to FDA seeking authorization to market this kit.

Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.

The violations cited in this letter are not meant to be an all-inclusive list of violations. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.

Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

Dear Jon Tavarez:

The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated January 09, 2026, set forth in your correspondence dated January 20, 2026. Based on your representation that Germaphobix has removed all products, references, and content related to any HIV testing (including any at-home HIV tests, STD panels that include HIV, or similar self-collection kits) from your website and all sales channels, including through any third-party partners or affiliates, and will refrain in the future from offering or distributing any diagnostic devices or self-collection kits for serological testing without first obtaining required FDA marketing authorization, it appears that you have addressed the violation(s) contained in this Warning 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 an 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/
Melissa J. Mendoza, JD
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research