Is A Placenta a Drug?  Our thoughts on Health Canada's Recent Guidelines

In response to Health Canada’s recent recommendations and attempted regulation of this service, I thought that I would write my thoughts to help our clients make an informed decisions if this service is right for them.


The Case

Health Canada is following the footsteps of the America Centre for Disease’s recommendation for the practice of placenta consumption to stop. Their recommendation follows their study of one infant that got sick. Please read the story here: https://www.cnn.com/2017/07/02/health/placenta-pills-infant-strep-infection/index.html


After birth, the infant tested positive for GBS and was treated in hospital. GBS can be passed from mother to baby during the normal birth process, and this is why usually the mother is treated with antibiotics in labour.  Five days later, the infant fell ill with GBS again and was admitted to the hospital for treatment. The hospital was confused as to where the GBS has come from, so they tested the mother’s milk (which came back as negative). They did not test the mother or the other family members to see if they were the carriers of the infection. Instead, they tested the encapsulated placenta, which came back positive, nearly matching the same bacteria from the infants 2 blood samples (one from initial infection, one from secondary infection).


My question is how did the infant catch the secondary infection from the pills that the mother was reportedly taking? It could not have been transferred to her breastmilk as it tested negative, as well the acid in the stomach would have killed any and all bacteria.


The article even states “This led the doctors to believe that the placenta pills were likely responsible for the infection -- though they could not definitively rule out that the infection could have come from another of the baby's family members.” Say what?!? You are only blaming the placenta for causing the secondary infection even though there is not link to how the infant would come into contact with the encapsulation, and you didn’t test the family members who would have been in direct contact with the infant? Or maybe, the first infection wasn’t cleared up with your initial treatment, and got ‘re-sick’ from the primary infection (how many times have we had to take a second round of anti-biotics for a persistent infection?). Instead of looking in the obvious, direct transmission routes, let’s instead attack the ‘hippy’ practice that we do not understand and wish to regulate.


The Regulation

So this moves me onto the regulation of placenta encapsulation. Those that know me know that I do have a wee bit of a conspirator complex. If placenta encapsulation does have all the benefits that people claim they do, how can governments and drug companies get their hands on it? Short answer, they can’t. unless they shut us all down. And this is exactly what I think they are trying to do.


You can read Health Canada’s statement here: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/68368a-eng.php

First they say that: “There is currently no scientific evidence that supports claims of health benefits associated with consuming human placenta.” Ok, so if you choose to do it, there is no guarantee that it will work.


Later, they say: “Placenta products prepared by a third party are considered drugs and therefore subject to the requirements of the Food and Drugs Act and Regulations. Information about the safety and efficacy of the product must be submitted to Health Canada for review and obtain approval before they can be sold.” They are calling a placenta a drug? What is there definition of a drug? From another government webpage (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products.html), I found “Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims…When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.” So first they are saying that it does not have any health benefits, but they wish to classify it as a drug because it treats and prevents diseases or symptoms. Which is it? So are you telling me that chamomile tea, which we all know has a soothing effect, must be sold as a drug because it alleviates symptoms? What about all those doTerra people selling essential oils, are they regulated as drugs? Let’s do down the rabbit hole further and are all the CBD oil people registered as selling drugs?? No, they are not. This is the only way for the government to try to stop families from making fully informed decisions about their health care.


The Science

Ok, so let’s move onto there being ‘no studies done on human consumption of placenta’ or ‘no health benefits. A quick google search brought up this meta-analysis of several studies from the US National Library of Medicine National Institutes of Health. (www.ncbi.nlm.nih.gov/pmc/articles/PMC6138470/). They reviewed many studies, and even found the same flaws as I did with the one case of infant illness stating:


A single case published by the American Center for Disease Control describes a late-onset infection in a neonate from group B streptococci (GBS) 32 . The mother had consumed her own placenta post partum in the form of capsules. Group B streptococci were identified both in the dried placental tissue and the blood of the newborn infant, but not in the breast milk. In case of maternal, oral ingestion it is assumed that the stomach functions as a barrier against bacteria, including streptococci. The maternal intake of placenta as a route for infection is therefore debatable. Prenatal transmission of bacteria, colonization of the maternal gastrointestinal tract with GBS, and transmission due to close postpartum contact between mother and child, can more likely be assumed in this case.


Notice that last sentence. So it is more probable that close contact between the mother and infant was the more likely cause, not the placenta.

If you read the whole NCIB article (which was published in September 2018, and the Health Canada ‘recommendation’ was passed down in November 2018), it states:


The risk associated with ingesting oneʼs own placenta following a spontaneous, non-interventional delivery without long-term pharmacological treatment during pregnancy is relatively low…. Placental tissue is a source of natural hormones, trace elements and essential amino acids – the ingestion of raw or dehydrated placenta could influence postpartum convalescence, lactation, mood and recovery.


The risk of intoxication from individual intake appears to be low in terms of microbiological contamination and the content of potentially toxic trace elements. However, the mother should be advised that the processing and use of the placenta is her responsibility and that the transmission of infections cannot be ruled out.


Further studies focusing on the bioavailability of the hormones after oral ingestion and their potential physiological effect are necessary to evaluate the use of placental preparations. Patients with an interest in placentophagy should be informed about the potential risks and effects.


We always take the stance of Informed Consent; if you do not know your options than you don’t have any. The above potential benefits were included for families to make decisions that are best for them; they can decide if they feel that the potential benefits outweigh the potential risks.


Where We Stand

We have never claimed that placenta consumption will cure you of anything, and any one that has had a consult with Lindsay knows that she says ‘even if the effect is purely placebo, what harm has it done?’ A simple cup of chamomile tea has calming effects, where is that line that distinguishes what is a drug, and what is not. A placenta is not a drug as it does not fit Health Canada’s definition, nor does it fall within the guidelines of the Natural Health Product Regulation. We are not charging you for your placenta, we are not selling you back your placenta, we are not making any health claims that placentaphagy will cure you of anything. Our fee is for the preparation of your placenta, something that you could easily do yourself. We are not selling you a product, but rather offering you a service.


Our contract clearly states:


Bellies2Babies Doula Services (hereinafter referred to as B2B) is not a pharmacy, pharmaceutical representative, holistic practitioner, herbalist, or medical doctor. Benefits of placentophagy are supported by ongoing research but have not been evaluated by Health Canada. Placentophagy, (as it pertains to this contract agreement, is for natural nutritional supplementation and is intended solely for ingestion by the mother who has birthed the placenta(s) and not for her family members, friends, or other individuals), is a natural nutritional supplement and as such cannot be guaranteed to produce specific results.

I will stand by to say that it has not been evaluated by Health Canada because they have not evaluated it yet! They are moving forward on this ban out of fear and ignorance.


The Food and Drugs Act states:

drug includes any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying organic functions in human beings or animals, or

(c) disinfection in premises in which food is manufactured, prepared or kept; 


As we make no health claims that placentaphagy will cure, treat or prevent any thing (and Health Canada agrees that there are no scientific evidence to support it), we are not manufacturing a drug.


We are not selling encapsulated placentas to anyone; the placenta that you give us, we charge a fee for processing it, and we give it back to you.


Conclusion

Health Canada is trying to have the situation both ways; they will not say that placenta encapsulation has any health benefits but are trying to classify it as a drug when it does not fit into either the Food or Drug Regulations, or as a Natural Health Product. They have not demonstrated why a placenta fits into the ‘drug’ category aside from simply stating that it is.


Placenta Encapsulators are not ‘selling’ a food, drug, or natural health product. We are providing a service for a fee, and the government does not have an avenue to stop people from providing a service for a fee. This is a can of worms that they cannot open and fight, so they resorted to trying to classify a placenta as a drug.