The U.S. Food and Drug Administration (FDA) wants the U.S. public to know that cannabis bisphenol (CBD) is a non hallucinogenic component of cannabis plants, but perhaps the impact of CBD on health is not as magical as it is said.
FDA released its latest report on the official website (FDA. Gov) on July 17, discussing the popular cannabinoid, CBD, and trying to eliminate the concept of “zero risk pharmaceutical miracle” for consumers.
The FDA said it was collecting data from health professionals, hemp industry representatives and medical patients, hoping to learn more about how CBD can be used to treat various diseases. At present, there are many questions about the science, safety and quality of CBD products to be answered, the FDA wrote.
Studies have shown that CBD is at risk for liver dysfunction.
FDA acknowledges that it has not really understood the potential health risks and benefits of CBD. However, damage to the liver is one of the side effects found in limited research.
During the clinical trial of epidilex, an antiepileptic CBD drug approved by the FDA for the U.S. market in 2018, researchers found that the drug caused liver disease in some patients.
“We identified certain risks of CBD, including the possibility of liver injury,” the FDA wrote.
It is understood that Epidilex drugs are not pure CBD, and the concentration of CBD in FMCG in the US market is also different. According to GW pharmaceuticals, the prescription contains dehydrated alcohol, sesame seed oil, strawberry flavor and sucralose. However, almost 100% of CBD (98% pure oil soluble CBD extract) in this drug comes from cannabis plants, rather than what many people think is synthesized in the laboratory. It avoids the possibility of the negative impact of the synthetic CBD.
In addition to studies using epidiolex and the liver, other studies have found that high doses of CBD may cause damage.
Last month, Forbes published a study in medical science at the University of Arkansas that found that high doses of CBD can cause liver damage in mice within 24 hours. Many animals will die or near death within three to four days. The doses used in this study are indeed extreme – 615mg / kg is “scaling CBD to mice at the maximum tolerable dose”.
Although it is necessary to measure the amount of liver injury in mice, the amount of epilepsy patients in the United States is now worthy of vigilance. This is why doctors need to monitor the presence of enzymes in the liver of these patients based on Epidiolex‘s prescription information. In clinical trials, 5% to 20% of people had liver problems. Some patients were even permanently removed from the study to prevent further escalation of the damage.
According to a report from stat news, in Colorado, even if cannabis is now legalized, the use of medical marijuana in any case requires doctors to detect the level of enzymes in the liver of patients at any time.
Maybe the threat is real.
In addition, the US FDA wrote in a press release that common side effects associated with the CBD rich epidilex include drowsiness, loss of appetite, diarrhea, rashes, fatigue, weakness and so on. More serious side effects can even lead to suicidal thoughts, emotional agitation, depression and panic.
So what about CBD health care products derived from industrial hemp?
The CBD snacks, essential oil and other consumer products that Americans use now are unlikely to cause liver damage, because these products are lower than Epidiolex’s CBD content. But we are not sure whether the risk will increase when the measurement reaches a certain level. After all, there are many other herbal supplements on the market that do some damage to the liver.
CBD may not cure cancer
The FDA also wants U.S. consumers to know that many CBD products currently sold at grocery stores, gas stations, health food stores or medical marijuana dispensaries are not approved. CBD products sold by CVS or Walgreens are also not considered drugs.
Up to now, Epidiolex is the only CBD drug in the United States to obtain this privilege. GW pharmaceuticals has spent several years to prove to FDA that its drugs can safely and effectively control the frequency of epileptic seizures.
However, throughout the process, FDA can determine that Epidilex is only available for the treatment of two rare types of childhood epilepsy: Lennox Gastaut syndrome and Dravet syndrome. Other health implications are unclear.
Epidiolex is not a universal treatment even for epileptics. The drug is only effective in 32% of patients.
However, this does not prevent the industrial hemp industry from trying to convince the public that CBD can alleviate pain, get rid of anxiety and depression, bring a healthy heart and even protect against cancer. The U.S. FDA is concerned that all unconfirmed claims about how CBD can cure or alleviate various diseases will give consumers unrealistic hope.
FDA believes that misleading and false statements related to CBD products may lead consumers to miss the correct diagnosis, treatment and care. For some companies that sell CBD products and claim that they can prevent or treat cancer, Alzheimer’s disease, mental illness and diabetes, the FDA gives serious warnings.
FDA credibility
At the same time, consumers should also understand that the FDA is not infallible in its performance of protecting the public safety of food and drugs.
The agency approved several prescription drugs over the years and was recalled several years, or even decades later. For example, some opioid analgesics, ADHD drugs, cholesterol drugs and antihistamines are finally removed from the shelves after causing serious adverse reactions or even life-threatening.
A study published in 2017 found that nearly a third of all FDA approved drugs between 2001 and 2010 were relabeled as “unsafe.”
“A key issue for all new drugs and technologies is that the learning process will continue throughout the life cycle of the drug.” Dr Nicholas S. Downing, the author, told CNN.
According to the FDA, drugs can only be completely removed from the market “when the risk outweighs the benefit.” What is considered to be public safety today may also cause damage in the future. Maybe that’s why the latest poll shows that only 44% of the public approve of the FDA. Many Americans don’t even believe any medical evidence provided by the FDA.
On the other hand, we know little about CBD. More research is needed before we start to really weigh the advantages and disadvantages of CBD as a cannabinoid and measure its medicinal function.
For those considering using CBD to help them get rid of serious diseases, the best advice is to consult their family doctor, oncologist or other experts to ensure that they do not put their health at risk.
Instead of blindly following the trend to buy CBD.
Cannabis derivatives are safer than other drugs, but we still need to understand the cannabinoid, CBD, before we can say without doubt that CBD has been fully evaluated from safety to effectiveness, from pain relief to cancer treatment.
