Study Identifies Regulatory Gap in Direct-to-Consumer Microbiome Testing

In a newly published study in the Journal of Law and the Biosciences, we examine whether the current U.S. regulatory framework adequately protects consumers using direct-to-consumer (DTC) microbiome-based tests. These tests—often marketed directly to consumers without involvement from healthcare providers—claim to provide personalized health insights based on analyses of the gut or vaginal microbiome.

This work is the result of a long-standing, interdisciplinary collaboration with Dr. Diane Hoffmann, Professor of Health Law at the University of Maryland Francis King Carey School of Law in Baltimore, whose expertise in health law and regulation was central to the study.

Based on a detailed analysis of company websites, testing practices, and federal regulatory pathways, we find that many DTC microbiome tests lack demonstrated analytical and clinical validity and are frequently marketed in ways that may mislead consumers. We identify significant gaps in oversight, including limited requirements under the Clinical Laboratory Improvement Amendments (CLIA) and minimal regulation by the U.S. Food and Drug Administration (FDA), despite the potential for medical, economic, privacy, and dignitary harms. These harms can include unnecessary fear or stigma when individuals are told they have an “unhealthy” microbiome, distress or shame linked to vaginal test results that may be misinterpreted as reflecting hygiene or sexual behavior, and loss of control over deeply personal biological data that may be reused or shared without meaningful consent.

We argue that many of these tests are inappropriately characterized as low-risk “wellness” products and therefore escape meaningful regulatory scrutiny. As microbiome science continues to advance and commercial testing proliferates, we highlight the need for clearer regulatory standards, greater transparency around test performance, and stronger consumer protections to ensure that innovation in this space proceeds responsibly and ethically.

Reference

Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?
Hoffmann DE, Langel FD, von Rosenvinge EC, Palumbo FB, Roghmann MC, Ravel J.
J Law Biosci. 2025. 12(2):lsaf024. doi: 10.1093/jlb/lsaf024. PMID: 41450770