Someone Needs To Do Their Job

 

In this week’s blog, we are going to try to shed some light of the current FDA position regarding cannabis and hemp related products. We are not in any way making a statement as to the effectiveness of these compounds but are merely attempting to call attention to what we feel is the need for a more comprehensive study and controls in hopes that the products that are being released to the public are consistent and safe for use.

In December 2018, the 2018 Farm Bill was signed into law under President Donald J. Trump. In essence what this did was to legalize the growing and processing of hemp related crops by licensed farmers provided the plant contained less than 0.3% THC. This bill also preserved the FDA’s authority over hemp products in the Agricultural Improvement act of 2018 (2018 Farm Bill, PL 115-334). Before a meeting of the Committee on Agriculture, Nutrition and Forestry, D. Amy Abernethy, Principal Deputy Commissioner of the Food and Drug Administration stated “we recognize the substantial potential that hemp has for our nation’s farmers and agriculture sector.  FDA’s approach to cannabis and cannabis derived products just like we do any other. FDA is committed to advancing hemp products through the Agency’s existing regulatory pathway’s  and we are further exploring whether it would be appropriate to make additional pathways available to hemp products such as those containing cannabidiol (CBD). FDA believes this approach protects patients and the public health, fosters innovation for safe and appropriate products and promotes consumer confidence.”

Some of you may remember that in June of 2018, the FDA approved the drug Epidiolex for the treatment of two sever forms of childhood seizures Lennox-Gastrault syndrome and Dravit syndrome in patients two years of age and older. While this was certainly groundbreaking, it clearly shows the need to further develop programs to properly evaluate the active ingredients in marijuana and hemp related products to determine their effectiveness in treating a variety of maladies from anxiety, to sleep and stress disorders, opioid addiction and the list goes on. 

Unfortunately, the FDA’s role in moving forward with additional study has become somewhat bogged down by special interests and remains the same as it was originally, which was to protect and promote public health. So far, it appears, the FDA’s biggest concern has been to halt the marketing of products that make unsubstantiated claims to prevent, mitigate, treat or cure diseases without the support of FDA analysis. In addition, the FDA recognized other concerns such as review of some products showed they did not contain the amount of CBD noted on the products label and in fact contained materials not mentioned on the label such as THC, heavy metals and other contaminants. While this is certainly concerning, part of this could be very well attributed to the lack of a qualified drug approval process that would establish consistent policies and guidelines that would help halt the production of inferior products and ensure public safety. How is it then that the FDA can hold manufacturers accountable for not meeting the guidelines that they are responsible for developing?

While the FDA agrees that there has been an explosion of interest in products that contain CBD, there is still much they do not know about it. That seems a little odd since they are claiming to have little knowledge about a compound that has been in existence for close to 5000 years.

The first documented use of a cannabis derived medicine dates back to 2737 B.C. when the Chinese Emperor, Sheng Nung used cannabis infused tea to aid with a variety of reported ailments including memory loss, malaria, rheumatism and gout.

In 1839, Irish physician and researcher William B. O’Shaughnessey published a study which investigated the plants therapeutic effects and started to consider it for possible medical applications. In his study, which was then considered quite controversial, O’Shaughnessey explored the effects of cannabis and described its potential as an anesthetic. This also opened the door to an unknown compound that would later be known as cannabinoids which were discovered almost a hundred years later in 1940 by British Chemist Robert S. Cahn.

In 1992, at the Hebrew University in Jerusalem, Dr. Lumir Hanus along with American researcher Dr. William Devane discovered the endocannabinoid anandamide. The same team later discovered a second major endocannabinoid 2-anachidonoyglycerol (2-AG) and in addition a less known one known as endocannabinoids, homo-gamma-lineleoul ethanolamide, docosatetraenoul ethanolamide (DEA) and noladen ether (2-AGE). These are a handful of endocannabinoids that have been identified along with G-coupled protein receptors that interact with these cannabinoids in the creation of metabolic pathways of phyto-cannabinoids and endocannabinoids which are a molecular signaling system within the body that regulates a variety of biological functions. The “system” was named the endocannabinoid system and is responsible for maintaining a stable environment, in spite of the external environment, thereby maintaining the body’s homeostasis or balance. The thought being that, by stimulating and supporting your endocannabinoid system, one can experience relief from a variety of illnesses and conditions.

So now, you have a little better idea as to how long these compounds have been in use and tested by a broad range of scientists and researchers throughout the world. By that it begs to question why the FDA would say they are reluctant to recognize CBD’s healing properties because there has still been very little formal testing conducted. How do they consider 5000 years of study a little?

What we are asking is the FDA to do is to accelerate the development of a serious program to help manage the CBD “craze” by establishing the testing guidelines and minimum criteria to which all manufacturers must adhere. You have a flood of CBD products being released into the marketplace and all sorts of claims being made by those trying to sell them. Simply issuing warning letters and expecting banks and social media to act as the “gate keepers” does little to solve the problem and may in fact be hindering the progression of drugs and supplements which could not only improve people’s quality of life but may be a solution to the ever worsening opioid crisis in our country. The thing is how will we ever know if the governing body, tasked with the authority of setting the guidelines, appears to be under the control of those that are in a position to benefit most by their inaction?

These are some of the questions that need to be asked and answered by those responsible for moving this potential “miracle” from the wild-west to the future. Please, get the word out to your representatives in congress and implore them to put pressure on the FDA to do their job.

With that, thanks for reading this week’s blog and stay healthy…CBD Doc.