Of poops and parasites: unethical FDA overregulation

Food Drug Law J. 2014;69(4):555-74, ii.


Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.

MeSH terms

  • Animals
  • Biological Therapy / methods*
  • Feces / microbiology*
  • Government Regulation*
  • Humans
  • Hygiene Hypothesis*
  • Personal Autonomy
  • Professional Autonomy
  • Therapy with Helminths*
  • United States
  • United States Food and Drug Administration