Real medicine has to be researched and tested for many years before reaching approval by the regulatory agencies. It usually starts with biochemical research measuring different chemical parameters of a substance or selecting agents based on already known parameter data. It then moves on to cell and tissue cultures and if they are still considered promising, it can move on to animal testing.
If it passes that hurdle, it can move on to testing on humans in different stages. All relevant documents should be submitted to regulators that then scrutinize the findings. If found to be safe and effective, the product can be approved. Despite approval, research still continues to ensure that the treatment continues to be safe after approval. If something happens, regulators can recall the product. For supplements, complementary and alternative medicine (SCAMs), the story is very different.
Often, they do not need any evidence for efficacy, but may need evidence for safety depending on the country. In some countries, it is enough that they contain substances that are generally regarded as safe. Usually, quacks are not allowed to make radical health claims on their products implying that it treats or cures things that it does not actually work for, but they try to get around that by using weasel words or different kinds of warnings.
However, because SCAMs are often produced by unscrupulous manufacturers and pushed by equally uncaring sellers, it is not unusual for them to be contaminated or contain very different amounts of ingredients than declared on the label. Their products typically have no evidence for efficacy and do not work.
What is PureCare Herbal Cream?
It is an alternative medicine cream that claims to be beneficial for “extremely dry skin”. In reality, that is just the current label. In the past, labels have advertised it as an “herbal cream for eczema, psoriasis & dry skin”, which is very likely a unscientific claim supported by no evidence.
The change probably happened to avoid the fury of health regulators since they are pushing a substance that is probably not safe and effective for such allergic reactions or autoimmune conditions. The product is not made in Canada, but imported by the company behind it (named PureCare Herbal Cream Ltd.). In particular, it is marketed to babies and children and has not been approved for those conditions by the Canadian health authorities.
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What was PureCare Herbal Cream contaminated with?
According to an advisory issued by Health Canada on March 27, their testing procedures found that the products were contaminated by clobetasol propionate and phenoxylethanol. None of these were reported on the label of the product.
What is clobetasol propionate? Turns out that this is a prescription corticosteroid that is normally used to treat inflammatory skin diseases and related itching. It is considered to be highly active and have a “super-high” potency compared with other similar products. As such, it is not recommended for children under the age of 12. This means that PureCare Herbal Cream Ltd. was selling their contaminated herbal cream to a vulnerable group that should not be exposed to it. Psoriasis is skin condition that is sometimes localized, but some people with it can have it all over their body. Because it can be absorbed directly through the skin, a parent applying the herbal cream to a child with lots of affected skin can cause systemic absorption of the corticosteroid. This can in turn cause suppression of the HPA axis, high blood sugar, high blood pressure and symptoms of Cushing’s syndrome. If the corticosteroid use suddenly stops, it can cause adrenal insufficiency as a withdrawal effect. Children have a higher risk for systemic absorption than adults because they have more surface area per unit volume than adults. To convince yourself of this latter fact, try calculating the surface area and volume of cubes with increasingly larger sides.
What is phenoxylethanol? This is an phenol-derivative used to prevent the establishment and growth of bacteria and some yeasts. Health Canada highlights the fact that ingestion of phenoxylethanol could lead to difficulty breathing, vomiting, diarrhea, and dehydration. It can be used safely at appropriate dosages and methods of administration, but the Health Canada alert does not state any concentrations.
However, they do note that the contaminats “may pose serious health risks”, which makes it likely that the concentrations where high enough to be of concern. It can also be the case that the concentration of the contaminants varied widely, which indicates a severely flawed manufacturing process. Health Canada also explicitly states that the product should not be used and told the company to recall it from the market.
How did the company behind PureCare Herbal Cream react?
When confronted with evidence that their products are contaminated and/or potentially dangerous, some sellers of quack treatments refuse to do anything, dismiss the scientific findings and even use conspiracy theories attack the regulators as corrupted.
This time, however, it was different. PureCare Herbal Cream Ltd. closed down their webshop and issued a “public announcement and correction notice” on their Facebook page. Their notice said that they have “ceased all sales and have instituted a recall action plan” and that “already contacted the manufacturer of the product regarding this Health Canada concern and is following up with the manufacturer regarding this new information”.
Or was it really different? Their notice further claims that they were “always expressly informed by the manufacturer that the product was all natural and free from any drugs or parabens and this information was passed on to its retail customers and end users.” and that they do “not believe that past use of this product would have caused any damage or injury to any of its users”. In other words, they blame it all on an unnamed manufacturer outside of Canada and dismisses concerns that their products could have caused harm to people who used it.
Earlier versions of their website cannot be found using any online archival service and their Facebook page was started in 2016 and appears to only post sporadic updates once in a while.
What they should have done
However, the company should have made sure using their own testing procedures or that of an external and independent contractor to make sure that their products contain the ingredients stated on their labels and nothing else. There are many documented cases of unregulated or unapproved products that are contaminated with heavy metals and pesticides. If they want to keep their customers safe, they must test their products. Blaming it all on the manufacturer is no excuse. They are selling the stuff and thus have a responsibility to ensure that their products are safe.
In fact, a common tendency among manufacturers of fake treatments is to include the corresponding real medication. For instance, some “natural” products designed to treat erectile dysfunction (ED) are contaminated with prescription medication approved for the use against ED. This could very well be done intentionally and a tacit admission that the only way their products could work is to include real medication. There are reasons to suspect that the contamination of clobetasol propionate was not merely a random accident.
Contamination is fake treatments are likely due to the fact that many manufacturers do not care about good manufacturing practices (GMPs) and might see it as an unnecessary expense. Also, if a manufacturer does not have a problem pushing fake treatments, then that manufacturer might not be trusted with following GMPs either.
Don’t use PureCare Herbal Cream. In fact, toss out most of your supplements and alternative medicine unless you have a medically diagnosed deficiency or other real medical needs for them that have been established my scientific research. You will save money and avoid the risk from using contaminated products in these categories.