Why the FDA doubts the therapeutic properties of cannabidiol extract
During the extraction of cannabinoids, up to 90% of the therapeutic potential of cannabis is destroyed, and in the case of chemical types of extraction, the solvents remaining in the final product can have an extremely negative effect on the patient's body.
On the pages of a specialized electronic publication of Ukrainian hemp growers, attention was focused on how " US government structures protect consumers from low-quality cannabinoid products ." Why in the most economically developed country of the world there is a situation in which state structures doubt the therapeutic properties of cannabidiol extract and what this leads to, let's try to understand this material.
The US Food and Drug Administration (FDA) wants the American public to know that cannabidiol (CBD) may not be as safe and effective for the human body as everyone says. . On its website (FDA.gov), the Office recently published public information for consumers, which focuses on numerous complaints about products containing this drug-free cannabinoid. In these materials, FDA employees are trying to dispel the idea imposed on American society that a CBD is some kind of harmless miracle cure.
Despite the fact that the FDA is currently collecting the necessary data for a full-scale study from medical professionals, representatives of the canna industry, as well as patients in the hope of obtaining complete and reliable information on how CBD can be used to treat various diseases, from the staff of the above mentioned state structures appear more and more questions that currently remain unanswered. Questions from representatives of the US specialized agency related to the scientific base, confirming the therapeutic properties of CBD, the quality of products manufactured with cannabidiol, as well as the safety of its use.
The FDA wants to clarify several critical points related to cannabidiol before more and more consumers face problems related to the negative effects on the body of products that contain cannabidiol.
Studies show that CBD causes liver damage.
FDA experts recognize that they do not have a clear understanding of potential health risks or positive manifestations associated with the use of cannabidiol in various products. In spite of this, it is argued that liver damage is the factor that stops the Office’s staff from “deifying” this drug-free cannabinoid.
For example, during clinical trials of the drug Epidiolex, manufactured on the basis of cannabidiol, which was approved for the US market only in 2018, researchers found that this pharmacological agent in certain patients adversely affects the functioning of the liver. FDA staff were forced to determine safety risks, including determining the parameters of liver damage in patients who took Epidiolex. Studies of the effects of using the drug Epidiolex confirm the fact that its use in large doses leads to tissue damage and liver function.
An earlier study by specialists from the University of Arkansas (University of Arkansas) suggests that high doses of CBD cause damage to the liver in mice for 24 hours. Many rodents died or were close to death during the 3-4 days of the experiment. Including this study is the reason that patients receiving Epidiolex are required to control the enzymes of the patient's baking. In the conducted tests, from 5 to 20% of patients experienced various kinds of liver problems, as a result of which individual patients were finally removed from the process of conducting experiments to prevent further damage to treatment using the above-mentioned preparation based on CBD.
The FDA in a published press release indicates the following most common side effects associated with using Epidiolex: drowsiness, sedation, and lethargy; an increase in liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disturbance and poor sleep quality; various infections that appear without cause in patients as a result of taking the drug. More serious side effects are “launching thoughts of suicide”, suicidal attempts, the emergence of feeling or aggravated depression, aggression, and panic attacks. Therefore, FDA employees want US citizens to understand that none of the products containing cannabidiol and sold in grocery stores, health food selling points or medical cannabis dispensaries are not a medicine.
Until now, Epidiolex is the only cannabidiol-based drug in the United States, which has been granted the privilege of being classified as a drug. It took its manufacturers (GW Pharmaceuticals) several years to prove to the FDA that this drug can safely and effectively control the frequency of epileptic seizures. However, throughout the entire testing process, the FDA determined that Epidiolex is really useful only for treating children suffering from two rare forms of epilepsy: Lennox-Gastaut syndrome and Drave syndrome. In addition, even in cases of use of the drug by patients with epilepsy, it is not a reliable means - the drug is recognized as an effective tool in only 32% of patients.
The above facts do not stop the hemp industry from trying to convince the public that cannabidiol can eliminate pain, help with anxiety, remove patients from depression, improve cardiovascular muscle, and even protect people from cancer. FDA experts are concerned about the unfounded claims that CBD can alleviate or even cure all types of diseases that give consumers a false sense of hope.
The Office claims that “Misleading labeling of goods containing CBD may lead to consumers postponing the possibility of obtaining the necessary medical care, timely and proper diagnosis of the disease, as well as the implementation of quality treatment using traditional medical methods.” That is why the FDA has warned companies selling cannabidiol products, which in advertising leaflets and labels claim that they are intended to diagnose, prevent, prevent, and treat such serious diseases as cancer, Alzheimer's disease, mental disorders and diabetes, so that they remove this information with their products.
Commentary of the Association "Ukrainian technical hemp"
It should be noted that Epidiolex, which has been registered in the US market, is not pure cannabidiol. According to GW Pharmaceuticals, Epidiolex is a solution that can only be available by prescription from a doctor who, in addition to CBD (purified 98% oil-based CBD extract), contains dehydrated alcohol, sesame oil, strawberry flavor and sucralose. It is quite fantastic to say that some other components of the drug can cause damage to the liver tissue, since each of the ingredients in its composition is present in large quantities in other products that do not have this kind of side effects.
During his speech at the round table “Nutrition and Hemp”, Candidate of Medical Sciences, Associate Professor, President of the Association of Nutritionists of Ukraine O.V. Shvets. during his report, he not only described the peculiarities of using CBD in food products in the USA, but also focused attention of the students at Hemp University and guests at the event on the same problems that are described in this article. At the round table “Cannabinoid therapy”, several speakers immediately stated that synthetic cannabidiol is extremely cardio-and neurotoxic. In addition, during the extraction of cannabinoids, up to 90% of the therapeutic potential of cannabis is destroyed, and in the case of chemical types of extraction, the solvents remaining in the final product can have an extremely negative effect on the patient's body.