Please allow me to introduce my self. My name is Mark Harrison. I am a board-certified radiation oncologist with over 30 years of clinical practice treating cancer and its related symptoms and side effects of treatment.
I has had several medical devices approved by the FDA and often asked to consult for other medical companies requuiring assistance with the regulatory process for FDA new drug or medical device approval.
The FDA basically cares about two items. Human Safety and Efficacy.
At the FDA industry meeting last tear, there was minimal significant CBD Human Safety or Efficacy data presented. My friends at the FDA told me that they were very concerned about the state of CBD. At present, the industry is basically unregulated akin to the early Wild Wild West.
Hopefully, all manufactures strive provide the highest quality CBD products, The CBD community must work together to develop the data to demonstrate the Human science concerning Safety and Efficacy of CBD. The FDA has approved one CBD based drug, Epidiolex for the treatment of two rare genetic seizure disorders in children. I encourage all of you to read the product information sheet for Epidiolex. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
I will devote the next post to the FDA white paper- What You should know about CBD.