FDA status on CBD products

Good day and thanks for taking a look at today’s blog.

First off, please be advised that this message is simply intended to inform you about some recent actions in regards to CBD and Hemp derived products. It is not intended to make statements as to the medical effectiveness nor healing properties. When writing about these products, one has to be careful about the content of the article and wary of making claims that can be considered false or non-confirmable based on FDA guidelines.

Since the signing of the Farm Act in 2018, which legalized the production of CBD and Hemp related products, little has been done to fully test and confirm these products and their proposed healing properties.

Short of the FDA approval of the drug Epidiolex and a few others, testing into the possible benefits has been held in “limbo”. While the FDA admittedly recognizes the potential opportunities that cannabis and cannabis derived compounds containing cannabidiol may offer, they are also aware that some of these products contain cannabis and cannabis containing compounds that violate The Federal Food, Drug and Cosmetics Act, which was signed into law in 1938.

The full-scale FDA approval of the drug Epidiolex, which contains a purified form of CBD and has been successful in the treatment of Lennox-Gastaut syndrome or Dravet syndrome has answered the question as to whether CBD has medicinal value and is safe and effective for its intended use. In fact, companies are now advocating that the FDA remove CBD from the label of a controlled substance and allow cannabis and hemp products to be researched and tested without restrictions. If this should happen, we may well be on our way to determining and understanding CBD’s proposed therapeutic benefits.

 In addition, The FDA has also approved the compounds Marinol and Syndros as therapeutic uses in the treatment of anorexia associated with weight loss in AIDS patients. As well, they approved the drug Casamet which contains the active ingredient nabilone, which is synthetically derived and similar to THC.

One questioned that is most asked is, what is the difference between cannabis CBD and Hemp CBD?  First, let’s look at the physical difference in the two plants. Hemp plants tend to be tall and very fibrous while Marijuana plants tend to be stubbier and much shorter, almost bush like. Hemp, unlike CBD, contains less than .3% THC or none at all. Unlike Marijuana Hemp CBD, with no THC, does not cause a “high”.

From a legal standpoint, all forms of cannabis are considered as a schedule one narcotic and illegal at the federal level. As of January 1, 2020 eleven states have legalized marijuana for adults over twenty-one and thirty-three states have legalized, Doctor prescribed medical cannabis. If you live in one of these states, you have the ability to purchase hemp and cannabis CBD oils and related products. Obviously, CBD products with higher than .3@ THC cannot be legally purchase in the rest of the states but, CBD oil from hemp is a different story.  Due to the signing of the updated U.S. Farm Bill back in 2018, hemp is now a commercially legal crop in the U.S.A.

To be clear, as you read this, be advised that CBD oil is not an FDA approved medication except for two forms of intractable epilepsy Lennox-Gastault syndrome and Dravet syndrome. As such, CBD cannot be considered as a cure for other medical ailments and cannot be considered as a medical drug. However, there has been a great deal of non-FDA supported studies of CBD and its effects on other health related conditions. While research shows potential that the plant-based compound may help with associated symptoms, further study and clinical trials must be carried out in order for CBD to be considered a practical medicine.

Some of the conditions where CBD oil is thought to be able to help with are:

1)      Symptoms related to cancer treatment

To be clear, CBD should not be considered a cure for cancer nor are we implying otherwise, regardless of what you may have heard on an infomercial or read on-line. However, several studies have shown CBD contains properties that may be beneficial in relieving symptoms such as pain and nausea.

2)      Epilepsy and other neurological disorders.

To re-state what we noted earlier. Epidiolex is the first FDA approved drug as of June 25^th, 2018 that contains a purified drug substance derived from marijuana. It is also the first FDA approved drug for the treatment of Davet syndrome.

3)      Anxiety and depression

Although psychiatric disorders cannot be specifically attributed to any one neurological deficiency, research has been done on the potential of CBD as an alternative treatment option.

4)      Insomnia and sleep disorders

Insomnia is another condition where it is difficult for doctors define an exact physiological cause. However, studies have shown results that CBD’s interaction with the body’s endocannabinoid system may play an important role in maintaining a healthy sleep-wake cycle. As noted in the Journal of Psychopharmacology in 2013: “The acute administration of CBD appears to increase total sleep time in addition to increase sleep during the day of administration.”

5)      Pain and inflammation

One of CBD’s most popular uses is as an analgesic (pain relieving) treatment. There has been a great deal of research conducted on the compound in this regard. The U.S. National Institute of Health has stated that,” CBD is a cannabinoid with analgesic, anti-inflammatory, antineoplastic and chemo-preventative activities”.

6)      Diabetes and Diabetic Nerve Pain

One of the main side effects of diabetes is extremity nerve pain brought on by obesity and poor blood sugar regulation. Many studies have shown CBD helps to effectively improve blood glucose stability and reduce nerve and neuropathy in diabetic patients. Studies have also been done that confirm that CBD lowers the incidence of diabetes and suppresses inflammation in non-obese diabetic mice.

7)      Cardiovascular Disease

As odd as it may sound, when talking about the effects of cannabis, more specifically CBD, on cardiovascular and heart disease there have been several important research publications highlighting the positive effects on blood pressure and general heart health. As noted in the Journal of Thoracic Disorders in 2017: “Beneficial effects have been demonstrated in studies showing that cannabis or marijuana use attenuates (reduces) common cardiovascular disease risk factors”.

8)      Arthritis

Behind pain and anxiety, arthritis pain relief may be the third most popular reason why individuals use CBD. Users claim that effective joint pain relief has been experienced in oral CBD oils as well as topical CBD creams and topical lotions. In 2016 The European Journal of Pain noted that “the transdermal use of CBD reduces inflammation and pain related behaviors in rat models of arthritis.”

9)      Muscle Spasms

There can be many conditions that can cause muscle spasms and muscular disorders. Some of which may be attributed to diabetes, kidney disorders, spinal cord injuries, hormone issues and nervous system disorders like ALS and MS. Though not often occurring, a great deal of scientific research has been done on the effects of CBD in regards to muscle spasms. As noted at The 2014 Spinal Cord Injury and Wellness Summit: “The use of medical cannabis relieves muscle spasms and can also enhance the effects of other anti-spasticity medications like baclofen.”

10)   Multiple Sclerosis

MS is a neurodegenerative autoimmune disorder wherein the body’s immune system attacks and deteriorates its own nerve cells which can, in some cases, lead to paralyzation. Studies have shown the use of cannabis extracts have been known for decades to offer relief for those affected with MS. This was highlighted in a meeting in 2008 of The Neuropsychiatric Disorders and Treatments which stated that: “Several studies suggest that cannabinoids and endocannabinoids may have a key role in pathogenesis and therapy of Multiple Sclerosis.

11)   PTSD

Post Traumatic Stress Disorder (PTSD) is defined as the “result of poor adaption to a traumatic experience”.  This may be attributed to several underlying causes. PTSD often includes such symptoms as severe anxiety, depression and sudden mood swings. Studies have shown positive results in regards to the therapeutic benefits of CBD. As noted in 2018 by The Frontiers of Neuroscience: “The effects of CBD on the different stages of aversive memory processing make this compound a candidate for supplementary PTSD therapy.”

12)   Stress Relief

The term “stress relief” can have a wide variety of implications both clinical and non-clinical. But, the fact remains that one of the primary uses of CBD oil has been the day-to-day reduction of stress. This is attributed to the belief that Cannabidiol has many calming, sedative effects. Therefore, it is becoming preferable to dangerous, addictive prescription medications at a fraction of the cost. It has long been thought that chronic stress can lead to depression like symptoms. Investigation into the endocannabinoid system may give insight into possible therapeutic manipulations for the treatment of stress related conditions.

In closing, CBD and Hemp Oil products have gained a great deal of notoriety in the world of clinical research.

Some of the drawbacks are related to the reluctance of the FDA to allow accredited research into the potential benefits of these products as they relate to some of the conditions we have mentioned. Sadly, due to this, the market has been flooded with inferior products that lay claim to alleviating a number of maladies with little or no medical proof. Because of this, those desperate to find relief are often led to purchase products that are not properly developed, fully lab tested and laboratory controlled. What then occurs is, due to their lack of positive results, they cease to seek alternative cures and revert back to prescription only pain relief and addictive opioids. We can only hope that this situation improves for the future health of those suffering needlessly.

That’s it for today…Once again, thanks for taking time to read our blog…CBD Doc.