Testing Researchers call for regulation of direct-to-consumer microbiome tests. The DTC microbiome testing industry needs more regulation (Mar 2024)

Michael Harrop

Active member
Jul 6, 2023

"There is a perception among consumers that these products will give them a real medical diagnosis and a way to treat an 'unbalanced' microbiome,"

"There is no scientifically agreed-upon definition of a 'healthy' microbiome; the microbiome is dynamic and changes frequently; there is no clinical proof that these products work; and no standardization in the processes involved."

For consumers—who often suffer from diseases such as inflammatory bowel disease (IBD) or bacterial vaginosis (BV)—that means shelling out a lot of money for a test without a guarantee of useful or actionable medical information—and then often further investing in what companies tell them will help improve their microbiome, such as nutritional supplements including probiotics and prebiotics, or special diets. None of these interventions have been clinically validated or had their claims evaluated by the U.S. Food and Drug Administration (FDA).

"In addition to the cost, these tests could do real harm by convincing a person to delay medical care and substitute supplements for prescription medications,"


A growing body of research has suggested the potential for improving human health by better understanding the human microbiome. This research has led to the emergence of a global industry selling direct-to-consumer (DTC) microbiome testing services. Regulation of this industry has been generally ignored despite its having made a mark on the lifestyle health and wellness market. Yet companies’ claims of having the ability to detect “abnormal” microbiomes are not substantiated by research; the testing processes lack analytical validity, and the results have no demonstrated clinical validity. As a result, consumers may be financially exploited or harmed by inappropriate use of test results that neither they nor their doctors understand. To address concerns over such potential harms, we conclude that regulators should develop requirements for the industry to document and demonstrate the consistency and validity of methods and claims.
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