Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?

Abstract

This article offers a thorough analysis of an important public health issue-the lack of regulation of companies selling direct-to-consumer (DTC) microbiome-based tests. These companies invite curious consumers and desperate patients to submit stool and/or vaginal secretion samples to them for analysis. Purchasers receive a report about the composition of their gut and/or vaginal microbiomes with recommendations to change their diet or take certain dietary supplements. The piece is grounded in a