Human studies on the microbiome and diet are feasible without FDA approval for drugs.

“We didn't have to apply for FDA approval for a drug before we could do a human study, we could just start doing human dietary interventions, longitudinally monitoring the immune system, and the microbiome, and starting to put the pieces together of what is it in diet that can change our microbiome in a healthy way, help us define what a healthy microbiome is, and monitor the immune system in great detail.”