The debate about whether prenatal vitamins are a medical food seems to have been clearly addressed once and for all in a revised Question and Answers Guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition” (here).  Among other issues addressed in the Q&A document, FDA clearly states its position that prenatal vitamins are not considered to be medical foods.  The points relative to this conclusion include the fact that FDA states:

  • pregnancy is not considered a disease
  • there are no distinctive nutritional requirements associated with pregnancy
  • FDA would generally not consider a product labeled for pregnancy a medical food
  • medical foods do not require a prescription
  • medical foods would be considered to be misbranded if they contained the “Rx Only” or “Rx” symbol
  • medical food would be misbranded it they contained a NDC number as those numbers are reserved for drug products only

This debate has been lingering for as long as I remember being a pharmacist but now it appears that FDA has definitively spoken on the issue.  FDA has been skirting the status of prescription prenatal vitamins for years; however, conventional wisdom is that FDA enforcement action is not likely until FDA definitively decides how to regulate these products.  Clearly, the medical community would go apoplectic if FDA removed the products from the marketplace.  But, for now at least, the medical food argument for fitting prenatal vitamins under the regulatory umbrella has closed.