What is CBD oil? CBD oil is a form of cannabidiol, a phytocannabinoid (derived from a plant) discovered in 1940. It is one of some 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant’s extract. In 2018, clinical research studies on cannabidiol included anxiety, cognition, movement disorders and pain. Results are inconclusive.
How is cannabidiol classified? The 2018 U.S. Agriculture Improvement Act (“Farm Act”) classifies hemp-derived products as food or supplements. Cannabidiol was recently classified by the Food and Drug Administration as a prescription drug.
The trade name is Epidiolex, a controlled substance approved for the treatment of subsets of seizures for pediatric patients with Lennox-Gastaut syndrome or Dravet syndrome. It has no other approved uses.
The FDA considers any other product containing CBD oil to be illegal to use even though the medical literature has reported that many individuals are using non prescription CBD oil obtained via the internet.
Internet promotion: CBD oil is being promoted for indications such as anxiety, arthritis, insomnia and pain on the internet. Clinical evidence for the effectiveness and safety of these indications is absent or incomplete. Not recommended by the FDA.
Is CBD oil safe? Results of a recent study evaluating 84 products sold by 31 different companies showed that 31% of the products were accurately labeled concerning their CBD content. Of the 84 products tested, 18 tested positive for tetrahydrocannabinol, a contaminate not disclosed on the label. These 18 products are considered mislabeled and should not be sold.
Another study evaluated CBD products containing liquids intended for vaporization and found to contain cannabimimetic (SF-ADB), a known schedule 1 “spice” drug plus dextromethorphan, both contaminants. According to the FDA website, 22 suppliers of CBD products have received letters from the FDA since the year 2015 due to marketing of misbranded products.www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm
Regulation of CBD oil: CBD oil available without a prescription is not well regulated as far as safety and effectiveness by the FDA or any other government regulatory agency. Consequently consumers often do not know what they are buying. These products are being highly promoted and widely marketed by their manufacturers for a variety of uses. Consumers must be cautious and beware when purchasing CBD products from any source.
Any questions you may have about using CBD oil and products containing CBD should be directed to your health care provider or pharmacist before purchasing to determine safety and to determine if the product is right for you.
Keith Miller, Pharm.D.