Well, I guess this could be good news or bad news or both. The FDA has sniffed the winds of microbiome studies and decided that it wants some more regulation on fecal transplants (aka fecal bacteriotherapy). See for example Fecal Transplant: FDA Wants Regulation. Fecal transplants are spreading like crazy these days and every where I go in real life and online I hear and see more about them. For more on fecal transplants see some of my previous posts such as More (you know you wanted it) on fecal transplants and the microbiome and Fecal transplants in the news and Transfaunation and Fecal Transplants: What Goes Around Comes Around, Literally and Figuratively.
I guess the FDA feels like they have to do something given the spread of FT. Given how many scam artists and oversellers of the microbiome are out there I think some sort of increased protection or regulation is probably a good thing. But I am not sure what the best way to do this is. Clearly some are unhappy with the FDA sticking their noses into fecal transplants (e.g., see here). But given how little we know about FTs other than as treatment for Clostridium dificile infections it seems like one could make a reasonable argument for more regulation or caution. It seems strange though that we can do just about anything and everything we want to kill all the microbes around us with very little regulation and yet attempting to manipulate the microbes in and on us or add a few here and there is being regulated more.
What do others think? Do we need more regulation from the FDA on fecal transplants?
UPDATE – some links to other discussions of this:
- The kibosh (from Controversies in hospital infection prevention)
- Fecal transplants to treat C. diff now need FDA approval
- FDA halts US poop transplants pending further review (Raw Story).
- FDA: Fecal Transplants Need Investigational New Drug Application … (JWatch blog)
- Oversight for Fecal Transplants | The Daily Scan | GenomeWeb
- Many Years Young: Fecal Transplant: FDA Wants Regulation
- FDA Declares Stool a Drug — Not kidding! @ TigerDroppings.com
- Fecal Transplant: FDA Wants Regulation – Digestive Health Center – Everyday Health – EverydayHealth.com