In the past few months there has been quite a stir in the placenta encapsulation (PE)community about where the best place is to encapsulate a placenta–in the client’s home, or in the specialist’s dedicated workspace? People on each side of the debate vehemently defend their position. Those on the “in the client’s home” side state that this ensures that the client knows there is no mix up with other placentas and allows the client to observe the encapsulation process to make sure they feel comfortable with it. Those on the “in the specialist’s dedicated work space” say that the potential for mix up is very low, point out that the can begin the process before the client is home from the hospital when they use their own space, and mention concerns about what might be happening to the placenta while they leave it dehydrating in a client’s home for 12-24 hours outside of the specialist’s control.

At Knitted in the Womb we don’t really have skin in this game since we do not offer this service. But do I (Jenn) have an opinion? Yes, I do.

I think that for all practical purposes, either preparation space is fine. I think that an individual placenta encapsulation specialist is going to be just as careful about technique in either setting, so getting well prepared capsules really comes down more to picking the specialist more than picking the “right” location. One client may like having the ability to oversee the process and interact more personally with her specialist, while another values her privacy in her home. We routinely consume food prepared for us by friends and relatives in their kitchens without much of a thought about contamination, though I will acknowledge that the placenta capsules pose a special concern that is different from a meal because they are stored for weeks or even months after the birth, so any failure to follow sanitary procedures could allow microbes to grow for a long time in the capsules.

But practical purposes and government regulations aren’t always the same. I believe that what placenta encapsulation specialists are doing is in violation of regulations for production of consumable products.

Many specialists will tell you that they are following all OSHA regulations applicable to PE.  I worked as an employee safety specialist/manager for almost 8 years, which included getting a ton of OSHA training. I worked at a facility that was an “OSHA Voluntary Protection Star” site–which meant we actually invited OSHA in to do inspections every 3 years (with the agreement that they would let us fix any deficiencies without fines), which meant that we really had to be on our toes when it came to following OSHA rules.

OSHA rules are about protecting the worker, not the customer,
though of course there is some over lap.

So I get a bit confused when people say they are following OSHA rules in their placenta prep business, and this is somehow supposed to protect the client.  

What OSHA standards are they following? If they are abiding by the Blood Borne Pathogens standard that is great–they should be! But that standard is about protecting the specialist, as the person handling potentially infectious materials, not about protecting the product, and by extension the customer. I’m not aware of any OSHA standards that apply to preparation of consumable products in a manner that addresses safety of the product. For example, they have a great e-Tool for youth who are employed in restaurants–it really could be used by anyone employed in restaurants–and it doesn’t have a single word in it about food safety other than talking about employees avoiding burns from hot foods, liquids, and steam; or avoiding cutting themselves when cutting up foods.

The bottom line is that OSHA is not the regulatory agency that ensures the safety of placenta capsules for the consumer.

Encapsulated placenta would be considered a “dietary supplement.” The FDA says that dietary supplements are considered food products, which would put them under the jurisdiction of both the FDA and each state’s agency that governs commercial food production–in Pennsylvania that is the Department of Agriculture (DoA).

As far as the FDA regulations for dietary supplements go, the agency is unable to do much monitoring of producers of supplements, but instead relies on producers to report adverse effects to them. They do not pre-approve supplements for sale in the same way that medications are pre-approved. In keeping with that, the FDA states that food supplements can not be “labeled” as a treatment, cure or prevention for any disease, because that would then mean that they are actually medications. “Labeling” includes any marketing materials used to promote the product–including websites. Most placenta encapsulation specialists state that consumption of your placenta can reduce the incidence of postpartum depression.–a claim that got a birth center in Florida investigated by the FDA and the Florida Department of Health. Though I can’t find any on-line resource that tells how that case was resolved, I do find it noteworthy that the website for the center no longer mentions placenta encapsulation at all, even in their FAQs.

I believe that the state agencies that regulate commercial production of consumable products would be more likely to get involved with a placenta encapsulation specialist than the FDA. While the definition of “food” by the DoA might seem to exempt supplements, the FDA regulations do call supplements “foods,” and thus the DoA could easily choose to take a regulatory stance on placenta encapsulation. I do believe as the practice becomes more widespread, this is going to inevitably happen.

Looking at it from that perspective, we can quickly find several areas where placenta encapsulation in the specialist’s home does not meet DoA rules.

  • During the processing time (which is well over 12 hours, possibly over 24 hours), the kitchen being used for the processing can not be used for personal food preparation.
  • The placenta can not be stored in the same refrigerator as personal food is stored, and it especially should not be stored in a refrigerator in a break room at work.

    You thought I was kidding about a placenta in a non-birth related break room, didn't you?

    You thought I was kidding about a placenta in a non-birth related break room, didn’t you?

  • No pets can be in the house. Ever.
  • Children can not be in the same space as the placenta is being processed. Remember that this will take over 12 hours, possibly over 24.
  • The placenta, being a “meat,” would be considered a “potentially hazardous food” (PHF), and thus can’t be processed in a kitchen that is EVER used for personal use. An entirely separate kitchen must be used, with its own entrance to the house. The placenta is not even allowed to pass through the house on its way to that kitchen.

Regardless of where the placenta is being prepared, the specialist may be required to take a supervisory course in food safety, at the very least a course on safe food handling. Beyond that, I can’t find any regulations in Pennsylvania that would restrict placenta preparation in the client’s home, so in that regards, the choice to encapsulate in the client home may be the better one.

The regulatory concerns with placenta encapsulation is enough to keep me out of this line of business, however I have other reasons as well.

My primary reason is that there are NO research studies that
support any benefit for ingestion of the placenta.

To be fair, there are also no studies that say that ingestion of the placenta does not work. I have read the theory behind why it might work, and I find it to be interesting. If a woman wants to ingest her placenta, I don’t think there is anything ethically wrong with it. I simply can’t offer a service that costs several hundred dollars that has no research supported benefits. Some specialists are able to offer it based on it being a service that people desire and find value in, and I have no problem with referring clients to those specialists as long as I have confidence in their technique. I hope some day that there will be research evidence one way or the other, because I have plenty of clients who are interested in this service.