Regulation of Vaginal Secretions as a Drug or Tissue and the Implications for Women’s Autonomy

The use of vaginal microbiota transplantation and vaginal seeding, respectively, as a potential therapy for bacterial vaginosis and preventive measure for allergies, asthma and obesity associated with c-section delivery, has recently come to light. Although the U.S. Food and Drug Administration has not made a public pronouncement about whether or how it would regulate this new application of vaginal secretions, such a decision is likely the next frontier in the regulation of microbiome-based therapies. If the agency follows the approach it has taken with fecal microbiota transplantation it will regulate vaginal secretions as a drug, medicalizing and shifting decision-making about their use from women and their physicians to the administrative state and the pharmaceutical industry. The decision to regulate these intimate bodily secretions as drugs rather than as the practice of medicine has profound implications for access to the secretions by women for therapeutic purposes.