Cannabidiol (CBD) Oil comes from hemp plants, and especially the one we know as marijuana, Cannabis sativa. Because it comes from Cannabis, many have lots of questions about safety related to this material. On the other hand, many use it daily – so much so that several Pharmacists we know say they have a hard time keeping it in stock.
Is it Safe?
First, CBD is safe. It is purified from hemp plants in a similar way to how corn oil comes from corn. It belongs to a chemical group called phytocannabinoids. These are all chemicals that are purified from various members of the hemp plant family. You have heard of marijuana, which is probably the most famous member of this family. According to the FDA, marijuana has over 80 active chemicals in it. Its primary active ingredient is called THC or tetrahydrocannabinol. Others are CBN, CBG, THCV, CBDV, and CBC. Of these, CBD appears to be the safest. However, industrial hemp plants do not contain significant amounts of THC, and therefore are a good, legal source of CBD.
The World Health Organization (WHO) is an international organization like our FDA. WHO recently released a report saying that CBD is safe and non-habit forming, or non-addictive. The Critical Review Report (1) was issued at the Fortieth meeting of the Expert Committee on Drug Dependence which met in Geneva in June 2018. After studying use in animals and humans, the conclusion was that there were no safety concerns. Additionally, because of the lack of addictive potential, they recommended delisting it in terms of being a controlled substance. They also stated that CBD is well tolerated and has a very good safety profile. There is no evidence of any public health or safety issues related to CBD use according to this report. They also stated that no conversion of CBD to THC occurs in humans who received an oral dose. They cited several studies where oral CBD administration resulted in no circulating THC in participants. Reviews of toxicology studies also showed no significant issues.
WHO also listed several diseases that CBD can treat. One of these is epilepsy. Others were listed in varying degrees of potential treatment including Alzheimer’s, cancer, Parkinson’s and several more. Other serious research organizations have also claimed that CBD is very helpful in relief of pain and swelling, and various psychological issues such as anxiety.
The report also reviews several clinical trials that are ongoing. Currently, there are several pure CBD products being tested by Pharmaceutical companies. Epidiolex was recently approved by the FDA for treatment of Epilepsy in children. Arvisol is being studied in the Netherlands in Phase 1 trials for treatment of various neurological disorders including schizophrenia and epilepsy. There is also a gel form (ZYN002 by Zynerba Pharmaceuticals) being tested as a transdermal gel to treat Fragile X and other developmental epilepsy related syndromes. This product is currently in Phase 2 trials. Insys Pharma has a Phase 2 pure CBD oil to treat childhood absence seizures, and also a Phase 3 trial for infantile spasm-like seizures. Phytotech Therapies has put pure CBD in a gelatin matrix and significantly increased bioavailability.
With so many Pharma companies studying potential applications and many showing safety in human subjects along with no addictive issues, CBD, as WHO states, is safe for human use.
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What does the FDA say about CBD?
The FDA has approved a few drug products that contain CBD. Epidolex was recently approved for Epilepsy treatment in children. In 2015, the FDA also gave fast-track approval to an intravenous CBD treatment from GW Pharmaceuticals for treatment of perinatal asphyxia.
The FDA has issued two types of warning letters related to CBD products. (2) The first was against companies who were marketing with unsubstantiated claims. This is a common problem for new products coming on the market. Companies advertise dozens of claims that have not been demonstrated for their specific product. This is a requirement for drugs and supplements and requires clinical studies to support the claims. The other letter was against companies selling CBD products which when tested have no CBD in them at all. These are the worst kinds of companies – those trying to make a quick buck by selling fake items.
The only other thing the FDA has said is that CBD is considered as other supplements and drugs. It requires small clinical trials to make claims (as a supplement) and cannot be product specific (applies to all CBD, not that CBD). For drugs, as mentioned above, a full clinical trial needs to verify that the proposed treatment is supported by the clinical data.
What does the US National Institute of Health (NIH) have to say about CBD safety?
In June 2017, NIH issued a comprehensive review of clinical data and relevant animal studies as relate to CBD. (3) NIH reported that most studies were performed for treatment of epilepsy and psychotic disorders. Primary reported side effects included tiredness, diarrhea, and loss in appetite/weight. The main potential issue discussed was that of drug interactions. Because CBD (and many drugs and other chemicals) are processed heavily by the liver, there is a potential for drug interactions if the person is taking other prescription drugs. This will sound familiar to people taking cholesterol drugs and are told not to drink a lot of grapefruit juice. Grapefruit juice inhibits enzymes in the liver that process drugs. CBD acts on similar enzymes to slow them down. In both cases the amount of the other drugs circulating is likely higher than intended (the processing and removal by the liver is slowed down which results in “backing up” in the blood system). Adjusting the amount of CBD generally is able to take care of this problem should it arise.
What do other countries think about CBD Safety?
Canada recently legalized marijuana altogether. The government suggests that people should first seek out products that are high in CBD and low in THC (or at least of roughly same amounts) until they know how they are impacted by THC. This speaks to their level of comfort as relates to CBD. Australia recognizes that CBD is not psychoactive, addictive, and is generally safe. Ireland similarly treats cold-pressed CBD oils as fully safe foods. Because of suppliers making wild claims and the lack of testing standards for CBD, many countries are looking at imposing some basic requirements along the lines of what the FDA has stated: there must be CBD in the product, and there should be research to back up claims made. Switzerland has taken the stance that CBD cannot be a controlled substance since it does not produce a psychotropic effect.
China has a long history of using hemp and its various products. CBD oils were first referenced being used in China dating back to 2900 BC. They used it to treat many things including gout, muscle spasms, joint pain and many other things. Today, China has a robust CBD industry. They have a large on-line store that sells many CBD related products legally. They focus on providing access to people with epilepsy, Alzheimer’s, and cirrhosis of the liver among other things. They obviously are not concerned about safety issues related to use of CBD.
If it comes from marijuana, why don’t you get high?
Just like any plant, there are many different chemicals in plants from the hemp family. The one that is recognized by all as the psychotropic chemical is THC and this is in high concentration in the marijuana plant. This is the chemical that causes people to get “high”. CBD oil contains little to no THC. During the purification process, the little amount of THC in industrial hemp goes one way and the CBD goes another. This is why taking quality CBD does not lead to any issues with “getting high”. As noted above, studies have shown conclusively that there is no converting CBD into THC in the human body, so again, there is no concern about “getting high” from CBD.
Is it Legal?
CBD Oil is legal in the 30 states that have made medical or medicinal marijuana legal according to Governing Magazine. In addition, Prevention Magazine says that 17 states have added CDB-specific laws on the books. This means that purchase of CBD oil is legal in 47 of the 50 states. The cannabis industry has long claimed that if CBD oil contains less than 0.3% THC it is regulated by federal law as hemp and is therefore legal. Additionally, the Farm Bill of 2014 made CBD cultivated under state law “in which such institution of higher education or state department of agriculture is located, and such research occurs” is legal. However, in 2016 the DEA said that “cannabinoids derived from any plant of the genus Cannabis” is a Schedule 1 controlled substance. In spite of this murky legal status, sales of CBD continue to explode.
While some may consider CBD a little risky, it is in reality a very safe material. There are no addictive properties, and it appears to potentially have many positive impacts on humans. The only consideration is for those taking prescription drugs that are processed in the liver – they need to consider adjusting CBD dosing to not impact those prescription drugs. This is true for many drugs and supplements on the market.
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