Cannabis Nurses Respond to FDA News Release

Updated: Dec 20, 2019






The FDA news release on November 25th, 2019 states “Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

We must remember that the FDA also states that NOTHING can cure, treat or prevent a disease unless it is a pharmaceutical. To make any of these claims is breaking the law that they created. Let that SINK IN!


The original article is here https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details?fbclid=IwAR3WrVTlG5hAJWZ8EmeqnOaq4YttdD9T-KGoORaHVRyRslDFw_XWmKp-zOk


Let us not forget the Federal government has a trademark and patent on CBD. Patent number 6630507 states cannabinoids have been found to have anti-oxidant properties which makes them useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia. Non-psychoactive cannabinoids, such as cannabinol, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. (1)


We must also look at the issues the FDA has had over the years with many pharmaceuticals they approved. One third of all FDA drugs have had problems. “Patients might think the US Food and Drug Administration's stamp of approval means that a product is the last word on safety, but about a third of the drugs the FDA approved between 2001 and 2010 were involved in some kind of safety event after reaching the market, according to a study published Tuesday in the Journal of the American Medical Association. The authors found that in that time, 222 novel therapeutics were approved, and there were 123 post market safety events involving 71 products that required FDA action. Manufacturers needed to add 61 boxed warnings, also commonly called a black box warning, to call attention to serious or life-threatening risks.” (2)


In my opinion as a cannabis nurse, patient, advocate and clinician working with thousands of patients, I find CBD is Generally Recognized As Safe when used as a phyto-botanical nutrient for optimal health and wellness and for managing symptoms as other foods and nutrients do. For the FDA to say that CBD is not GRAS is an unfortunate misuse of power in attempts to continue preventing one of civilization’s most important plants from helping people. CBD and the cannabis plant is an adaptogen and works on multiple organ systems and receptor signaling systems simultaneously to bring about balance or homeostasis to the entire body. Humans had been consuming CBD for hundreds of years (via eating animals that fed on hemp) until 1937 when hemp production was banned with the passing of the Marihuana Tax Act.


As nurses, we call for CBD products to be regulated. We feel that companies need to be transparent with their testing and test for purity and potency including cannabinoid profiles, terpenes, residual solvents, contaminants, and heavy metals. In order to keep us all safe we need to have experts in the industry regulate it. Cannabis Nurses are a natural part of that regulatory process. The industry needs there to be a Cannabis Nurse Approved Program for quality control that is created by and managed by expert cannabis nurses such as those of the American Cannabis Nurses Association, The Cannabis Nurses Network and The GreenNurse Group.


In conclusion many medical professionals including nurses who have been the most trusted profession for 17 years in a row feel that this could all be remedied by

1. De-scheduling

2. Fast-track, Retro-active education for all Healthcare Professionals ASAP

3. State designated specialties of licensed Cannabis RN and Cannabis Nurse Practitioner’s.

~ Sherri Tutkus RN BSN


Other Cannabis Nurses from the American Cannabis Nurses Association Respond



"As a clinician working in cannabinoid medicine, I can tell you that the patients are way out ahead of the providers in trying new products. I believe we do indeed need strict regulation of cannabidiol. My concern is that the FDA is looking at cannabidiol completely wrong. It is only the first in what will be a long line of cannabinoids. For this reason, Cannabis nurses are calling on the FDA to expand a new department for plant medicine. It is inevitable that we will see cannabigerol in the news soon. We can stop endlessly playing catch-up if brave people make scientifically sound choices." Julie Battel CNM, MPH


“As a health care professional, I appreciate the FDA’s position in wanting to make sure products being sold are safe for human consumption. However, as a health care provider, the benefits for my patients have greatly outweighed any concerns I have for safety. Cannabis is, by far, the safest medication I have worked with, and I have seen many people improve the quality of their lives by adding into their daily regimens. If the FDA wants to oversee CBD and the safety of products, I encourage them to demand third part lab testing for purity and potency. Chemicals harm far more humans and animals than Cannabis. As a retired ED nurse, I have seen many patients in acute liver failure due to overdose of Acetaminophen, which anyone can buy over the counter.”

~ Heather Shelton BSN, RN


“What we seem to forget is that cannabis is an herb. A plant that is being used medicinally just as it has been done safely for thousands of years. The first pharmaceutical factory produced commercial products in 1859. Before that plants were used medicinally. Cannabis does not work like a single molecule pharmaceutical product. It does not fit traditional study models and harvested plants have a wide range of Biodiversity. There are thousands of published studies showing safety, How can the FDA not take these into consideration and move forward? Considering 1/3 of the “approved” pharmaceutical products have dangerous side effects I find it interesting they can’t make a decision about the safe use of an herb. FDA approved NSAIDS, I have seen overdoses, liver failure, allergic reactions resulting in death. They approved Afrin, it can be addicting. I took care of a 32-year-old who was addicted to Afrin and suffered a heart attack from its use. Tachycardia and seizures resulting from caffeine-infused energy drinks and over the counter antihistamines have landed children and adults in the hospital. I find it disturbing on many levels that they can’t take a common-sense approach and look at current data and move forward. They need to mandate testing on all cannabis products showing potency, freedom from contaminants and correct labeling. There needs to be clear consequences for products that are marketed with false claims of cure and inaccurate concentrations of cannabis products. In my opinion the inaction of the FDA brings into question the pharmaceutical company’s influence on their decision. Since the creation of the FDA people have being using cannabis products, which includes CBD. If it were as dangerous as they make it out to be we would be seeing massive health problems linked to its use. Like many over the counter products, cannabis is not for everyone, but for some, it brings life-chaging healing.” ~ Cheryl Kumberg RN, CMT


Resources

(1) http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6630507.PN.&OS=PN/6630507&RS=PN/6630507

(2) https://www.cnn.com/2017/05/09/health/fda-approval-drug-events-study/index.html



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