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Новости/Аналитика

FDA officially declares the insecurity of using cannabidiol extracts

15.11.2019

Studies in laboratory animals have identified the risks of reproductive toxicity in men associated with the use of CBD extracts and the birth of healthy offspring in women.

The pages of the profile electronic publication of Ukrainian hemp breeders have repeatedly described the situation in which the Food and Drug Administration (FDA) requires business entities to remove products from retail and wholesale who include extracts of drug-free cannabinoids , primarily cannabidiol. The FDA does not only prohibit this kind of activity. The above-mentioned state structure is constantly studying this issue, for which it collects expert opinions, expert round tables, finances special studies for studying this issue, etc. Why exactly the Office is so aggressively opposed to the products of companies containing CBD and what arguments it holds for this, we are trying to understand in more detail.

In an update for consumers posted on the official electronic resource of this government agency, it is reported that at the moment only one drug, Epidiolex, is approved by the FDA to treat patients with two rare forms of epilepsy. The use of this therapeutic agent was rather simply approved in June 2018 after the drug showed a statistically significant decrease in the frequency of epileptic seizures compared with the initial level in patients with two rare types of “epileptic”. However, during an appropriate FDA audit, Epidiolex was found to be potentially harmful to the liver. For this reason, in the United States, the use of Epidiolex is currently permitted exclusively during the treatment of two types of rare forms of epilepsy, and medical personnel are instructed to warn patients and their relatives about the negative effect of the drug on the patient's internal organs.

In all other cases, the negative consequences of using the above pharmacological preparation may exceed the treatment potential that it can provide. In particular, it states that “the FDA is concerned that consumers may mistakenly believe that attempting to use a product containing cannabidiol“ cannot harm ”. The department explains that the department’s specialists saw extremely limited data on the safety of cannabidiol extract, and they indicate real risks that consumers of this kind of product need to consider. ”

On the official website of the Office, it is noted that at the moment it is forbidden to add cannabidiol extract to food products or to label products containing CBD as food additives . Among other things, the FDA describes in detail the individual risks of using CBD extracts that have been discovered as a result of scientific research, including the possibility of liver damage and the inability to interact with other drugs. In addition, experts from the above-mentioned government department claim that studies on laboratory animals of products with CBD extract revealed the risks of reproductive toxicity in men associated with the use of CBD extracts and the birth of healthy offspring in women. This was clearly manifested in a decrease in testicle size, inhibition of sperm growth and development and a decrease in blood circulation in the urogenital system of the animals studied. 

Specialists of the Department say that cannabidiol extract, which is a part of food , cosmetics or biologically active additives, can provoke pain, and if this substance accumulates in the body, the negative effect on the body can have a long-term effect.

Cannabidiol extract can cause side effects that the consumer may not even feel at the initial stage. After the cessation of food intake, which includes cannabidiol extract or a significant reduction in the amount of its use, the above negative effects gradually disappear.

There are a huge number of negative aspects associated with the use of CBD extract which are currently not fully understood. The basis of all FDA studies is the fact that cannabidiol extract cannot be considered a safe remedy. As a result of using various kinds of groups of products containing cannabidiol extract, the liver is damaged, and in addition, significant side effects regularly occur, which in some cases have a much greater negative effect on the human body than the advertised properties of cannabidiol extract.

The FDA officially warns consumers of CBD products that products containing cannabidiol extracts are sold with unproven medical properties and can also be produced in non-sterile manufacturing facilities.

Another area of ​​use of CBD extracts, which is negatively perceived by the representatives of the Office, is their presence in the composition of pet food formulations . 

The U.S. Food and Drug Administration has once again detailed its concerns regarding the safety of cannabidiol by warning 15 companies that, in the opinion of the aforementioned government agency, illegally sell various commodity items containing cannabinoids. In its press release, the FDA announced that it had sent letters to the next 15 firms whose management warned that they were selling CBD products in violation of the Federal Food , Drugs and Cosmetics Act (FD & C Act). In particular, the Office officially announced that the above companies illegally sell products containing cannabidiol extracts, including adding the above drug-free cannabinoid to food products , labeling CBD products as food additives or advertising products containing CBD extracts as an effective means of healing properties.

The FDA has officially announced that the experts of the structure “based on the available data cannot conclude that cannabidiol extract can be considered a safe tool for its use as one of the ingredients commonly used in food or animal feed .”

In particular, according to FDA First Deputy Commissioner Amy Abernathy, “The Administration will continue to monitor the market and, as necessary, take measures against companies that violate the law in such a way as to draw public attention to emerging health problems caused by the negative effect on the body of cannabidiol extract ".

Commentary of the Ukrainian Technical Hemp Association

The growing scandal in the USA related to the negative experience with the use of cannabidiol extracts in electronic cigarettes does not add optimism to FDA specialists . The investigation revealed that about 2,300 people were injured and 40 people died as a result of using vapes , which included cannabidiol extract. It is unlikely that Office staff will be less careful about products containing CBD extract, while at the same time endangering US public health . The aforementioned scandal will clearly complicate the entry into the market of a number of brands that specialize in promoting various types of food products or cosmetics , which include extracts of various cannabinoids.

The position of the US Food and Drug Administration is in tune with similar structures in the European Union that have already adopted the relevant EU Directive . According to the provisions of the above document, products that include cannabidiol extract are classified as “new foods ”. It remains to draw parallels with the Ukrainian market and admit that in our country there are no studies conducted at all regarding the safety of using extracts of drug-free cannabinoids. This begs the question, how without holding the appropriate type of research can promote the adoption of relevant legislation and most importantly who is advantageous to impose the Ukrainian consumer products , cosmetic and pharmaceutical preparations , which with great skepticism are in the EU , US and Canada . Maybe our market is once again preparing in order to become a “drain” of all “biological trash” that cannot be sold in economically developed countries , in which the corresponding state structures are engaged in their direct functional duties.

During the round table " The use of cannabinoids in the treatment of severe / chronic diseases ", held as part of the " Hemp University ", listeners and everyone will be provided with relevant information on how to maximize the use of drug-free cannabinoids of plant origin in Ukraine under the current legislation of our country The facts of using the leaves and inflorescences of varieties of technical hemp of a therapeutic orientation for the treatment of pain will be clearly demonstrated. sensations, autoimmune, oncological, neurodegenerative and other diseases.

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