In April, Sunrise Hospital reported me to the Southern Nevada Health District the same day that they told Anne Swanson she could not have her baby’s placenta without a court order. SNHD, in turn, reported me to the FDA.
I had been on the phone with various departments within the FDA back in January, trying to find out what sort of regulation placenta encapsulation would fall under. I basically hit a brick wall, as I was passed from one department to another, then finally the person I was supposed to talk with next just never responded to my inquiries. I went down to the SNHD main office a short while later to speak with health officials there, and to get my Safe Food Handlers card required by anyone preparing food for others in Southern Nevada. I explained what I was doing, namely providing encapsulation services for women who did not want to prepare their own placenta. While they had their concerns, they were just not sure which department or agency would oversee my activities.
So I had already tried to get squared away with these agencies when Anne Swanson delivered her baby at Sunrise and started the firestorm of publicity and sudden interest in what exactly it was that I was doing with women’s placentas.
Since a state agency contacted the FDA, they were suddenly willing to speak with me about this. I spoke with a very nice woman who was apparently designated to be in charge of my case, and she said that since I am working with human tissue, that my activities would have to be regulated by the FDA. She was very interested in the research I had gathered, the history of encapsulation, and the fact that this is more common in countries other than the US. She asked to see my Standard Operating Procedures, which describe everything I do in explicit detail, as well as the scientific research. I was happy to comply with her request, and sent everything off to her in early July.
As of this writing, I have not heard back from them. Other than the quote in the USA Today article referencing my website, PlacentaBenefits.info: “Spokeswoman Kris Mejia says the FDA considers that some statements on the website are making medical claims and will be looking more carefully into the matter.” Interesting. I have tried to make the site as informational as possible, sharing the personal experiences of women who have taken the capsules. I am not sure how that constitutes medical claims, but then, I am not a lawyer nor a government entity. My only hope is that they will point out any issues they have and give me the chance to make changes before… doing whatever it is that they do.
Until I hear otherwise, I continue to provide my encapsulation services to interested women as a personal service in their home. It is something that has been done for women, by women, for generations. I am not the first, and I will most certainly not be the last.
