“It’s natural, so it must be good for us” is a belief many of you who are reading this blog potentially share. While it’s true that many prescribed medicines found their origin in nature, including opiates, aspirin and some cold remedies to name just a few, then it’s not all natural remedies that are completely safe, as they may interact with prescribed medication or have side effects. However, this is not a reason to wipe herbal remedies from the face of our medicine cabinet. So, let’s take a look at some key botanically-based substances that run the risk of being either outlawed internationally or controlled by the pharmaceutical industry.
Based on the system of ‘like for like’ when treating illnesses, homeopathy uses natural substances that are similar to the symptoms of the disease it is treating. However, these substances have been so highly diluted that when examined, no actual trace is found. This is because according to homeopathy, a minimum dose is thought to stimulate a healing response in the body.
In the scientific community, homeopathy is often viewed as pseudoscience and its users are derided for trusting a system based on quack principles. It should come as no surprise that for regulatory bodies with a Modus Operandi to protect the public against false medical claims and dangerous, unregulated substances, homeopathy finds itself facing a potential clamp down from the FDA.
December 2017 saw the FDA release a statement announcing its plan to “protect consumers from potentially harmful, unproven homeopathic drugs.” In particular, it came down hard on any companies claiming their products could cure serious illnesses, as well as warning against any homeopathic remedies that might contain dangerous substances or that fail to meet good manufacturing practices.
FDA Commissioner Scott Gottlieb, M.D. said: “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”
However, the FDA position will never lead to a satisfactory outcome for the homeopathy community.
Amongst the thousands of individual homeopathic remedies on the market, several contain substances that if they were not used at homeopathic levels, would be toxic to the body. We’re talking here the likes of belladonna and Nux Vomica, which in homeopathy are both prescribed for nausea and vomiting.
Only thanks to the theory of minimum dose, most homeopathic products in fact contain imperceptible amounts of these substances. So in effect, no true homeopathic remedy could be considered toxic or dangerous, because their only active ingredient is sugar (although speak to any homeopath and they would say they are water structures that mimic the original molecules).
Not only that, from a modern, conventional medicine perspective, it’s inconceivable that something that has no active ingredient can potentially bring about health improvement in patients (this would of course make it little more than a placebo).
So in effect, there will never be any happy meeting place between the defenders of public health and the homeopathic community. It also means that anyone who chooses to believe in a paradigm different to that upheld by the FDA, and its international equivalents, will most likely be denied legal access eventually.
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Stevia, a plant found in South America and used for hundreds of years to sweeten teas and medicines, has also found itself to be the focus of attention for the FDA and other international regulatory agencies.
Scientists have isolated key molecules in Stevia that act as sweeteners known as glycosides. One in particular, rebaudioside, has been extracted, purified and made into the branded sweeteners Truvia (developed by Coca-Cola) and PureVia (developed by Pepsi). Hailed as healthier sugar alternatives suitable for diabetics, these Stevia derivatives have been deemed safe as a food additive by the FDA and the EU. But guess what, the whole plant has not.
This has led to the absurd situation that farmers can supply companies using glycosides to make sweeteners, but cannot sell the whole plant to herbalists.
However, by being denied the whole plant, some key potential health benefits are being lost. The entourage effect - the synergy between all the compounds in a plant commonly used in reference to the cannabis plant - can also be applied to Stevia. So whereas the processed variant will perform no other role apart from sweetening your tea, the whole plant has been seen to have potential therapeutic benefits for conditions like obesity, cancer, diabetes, high blood pressure, and cholesterol.
One man in particular, the Catalan Josep Pamies has devoted his life to freeing Stevia from its regulatory shackles, writing the book “The Sweet Revolution” as well as generally promoting the traditional use of medicinal herbs.
3. St John’s Wort
Also known by its latin name Hypericum, St John’s Wort is a powerful plant with proven pharmacological effects. While its use for treating low moods dates back to antiquity, studies have shown St John’s Wort to be superior to placebo and as effective as commonly prescribed antidepressants in treating mild to moderate depression.
However, in an age when most people take some kind of prescription medication, caution is issued as St John’s Wort can interfere with certain drugs, such as the contraceptive pill, selected cancer medications and the blood thinner, Warfarin.
While the FDA seems to have a more hands off approach when it comes to St John’s Wort, classing it as a dietary supplement, other countries have taken more concrete steps to regulate its use. Back in 1999, Ireland banned the herb from over the counter sale, leaving an estimated 75,000 people without access unless it was prescribed through a registered medical herbalist.15 years on, St John’s Wort became available again on prescription as the standardised drug, Pacifica.
Kratom, the tropical tree traditionally used in South East Asia as a pain reliever, a stimulant and an aid to opiate withdrawal, has also had its fair share of run-ins with regulatory bodies.
It’s thought that in the US alone approximately 5 million people use Kratom in some way. Back in 2016, the DEA tried to put Kratom into a Schedule 1 category and a huge public outcry ensued. Just two months later, it was removed from the list pending further investigations thanks to public pressure and lobbying from politicians.
However, it ain’t over until the fat lady sings, and it’s quite possible Kratom users may have another fight on their hands.
In November 2017, FDA Director Commissioner Scott Gottlieb issued a public health advisory on Kratom outlining concerns about its “deadly risks.” He warns that the FDA will be intercepting and destroying Kratom shipments in the future.
It may come as little surprise to hear that pharmaceutical companies are in the process of developing their own synthetic versions of the active alkaloids found in Kratom. One can’t help but wonder whether it is just coincidence then that the FDA is about to come down hard once more on Kratom?
5. CBD Oil
Last but not least, let’s look at CBD oil.
CBD, or cannabidiol, is a compound known as a cannabinoid found in the cannabis plant. In scientific research, CBD is shown to have anti-inflammatory effects, reduce seizures, lower anxiety, and has, in studies on animal models, even displayed anti-tumoral properties.
In the US, the DEA has recommended that, as a derivative of the cannabis plant, CBD should be considered a Schedule 1 substance, effectively making it illegal.
However, most CBD products available worldwide contain Cannabidiol, plus other ingredients such as minor cannabinoids, terpenes and flavonoids. As such they are considered nutritional supplements and CBD companies must therefore refrain from making any medical claims about their products. This is partly because whole plant CBD oil has not been through the rigorous research necessary to deem a substance a medicine.
Flouting this ruling runs the risk of punishment by regulatory bodies, such as the FDA in the US, MHRA in the UK or their equivalents elsewhere.
Such was the case in the US last year, when several CBD companies were hauled across the coals by our old friend Scott Gottlieb from the FDA. He said: “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”
The FDA was also concerned about a general lack of quality control or regulation whereby some CBD oils contain next to no CBD at all.
We at Endoca are proud to say that our CBD oil products come with Good Manufacturing Practice (GMP) certification, as well as lab reports proving cannabinoid content. Lab reports also show whether a CBD product contains any pollutants, heavy metals or mold.
But what about Big Pharma and CBD?
Well, 2018 is going to be the year when the first CBD drug gets FDA approval. Epidiolex, a pure CBD medication developed for rare forms of epilepsy by British company GW Pharma, is set to hit the global market. Many fear this will have dire consequences on the sales of CBD oil as a dietary supplement. But only time will tell.
If you’re familiar with Endoca, you will know our company motto is ‘unlocking the secrets of nature.’ And for us, this must be extended beyond hemp and cannabis to all medicinal plants.
The challenge then is to find a new approach that incorporates the requirements of evidence based medicine, while maintaining our right as human beings to benefit from the gifts nature has given us.
Could this be possible? We believe it is. But perhaps we will need to create a new model in order to make it happen. But as the Old English proverb says: ‘Necessity is the mother of invention.’ And now more than ever, change is needed.