Before you reach into that jar of CBD gummies, or add some CBD oil to your bath, proceed carefully. Do you really know what’s in that “miracle cure” that you purchased online or at the health store for anxiety or your aching back?
Cannabidiol, or CBD, is a component of the cannabis plant lacking the “high” associated with marijuana, and right now products claiming to contain CBD are everywhere — from gummies to cocktails, ice cream to hand cream, and more. An estimated 64 million consumers, according to a January 2019 Consumer Reports survey, have tried products containing CBD in the past two years alone.
With widespread marketing that is largely unregulated, CBD purchased online or at stores is often promoted as a one-stop product for a range of potential health benefits, such as relieving stress, soothing aches and pains, reducing inflammation or improving sleep.
Interest in — and access to — CBD increased with the passage of the Farm Bill which removed CBD derived from hemp (a variety of cannabis that contains very low levels of tetrahydrocannabinol or THC) from the list of controlled substances. Although CBD products are now available online or in many stores, health or medical claims made by the product manufacturers are still subject to regulation by the FDA to ensure consumer safety. Through all the current interest surrounding CBD one critical question remains: Are widely available CBD products safe and effective?
Separating fact from fiction
The contents and dosage of CBD products sold in retail stores or online are often unknown and not consistently, if at all, regulated. To navigate the current environment, consumers first need to understand that not all CBD products are equal:
- FDA-approved drugs have been studied in a rigorous scientific process, including clinical trials to understand their safety profile and effectiveness for specific medical conditions. Non-FDA approved CBD products are not studied this way and there is no credible scientific evidence backing any medical claims made about these products.
- To ensure consistency and quality, FDA-approved medications are tested and manufactured to meet strict federal regulations. Testing standards for non-FDA approved CBD products vary by state, with some requiring no testing. Because of the lack of testing standards, these products may not contain what their labels say.
- Many believe that CBD is natural and therefore safe for general use — this is untrue. As demonstrated in controlled clinical trials, CBD can interact with other medicines or cause side effects. The use of CBD products should be monitored by a health care provider, such as your doctor.
- Only FDA-approved CBD medicines are dispensed by pharmacies and covered by health insurance.
So, what’s the bottom line for the millions of people currently using CBD products? As the saying goes, the smart consumer is the wise consumer. The FDA approval process is considered by many to be the gold standard in the medical field and was put in place to protect patients. Taking unregulated CBD products that lack scientific evidence can pose health risks, particularly for very sick patients who may be looking for hope in these products, in part, because of unproven health claims.
You deserve to know what you’re taking
It can be difficult to know if CBD products actually contain what they claim. A 2017 study published in the Journal of the American Medical Association found that almost 70% of all CBD products sold online did not contain the amount of CBD stated on the label — 42% contained a higher concentration of CBD than the label claimed, and 26% of the products contained less. Twenty percent included enough unlabeled THC to cause intoxication, especially in children. The FDA also evaluated some of these products and found that they did not contain the levels of CBD that they claimed. More studies and regulations are needed to ensure these products are safe for consumer use.
An important moment in the evolution of CBD occurred in June 2018 when the FDA approved Epidiolex® (cannabidiol) oral solution CV, the first prescription CBD medicine. Because it is a prescription, available in pharmacies just like any other FDA-approved medicine, it is legal throughout the entire U.S. when prescribed by a licensed health care professional. It is the only FDA-approved CBD product currently available.
“The approval of Epidiolex is historic not only for the long-awaited relief it provides patients with Lennox-Gastaut syndrome and Dravet syndrome, two very difficult-to-treat epilepsies, but also for the parameters it has put in place for how a CBD medicine should be studied to understand its safety profile and efficacy,” said Justin Gover, CEO of GW Pharmaceuticals, plc, the company responsible for Epidiolex. “We hope that this opens the door for further well-controlled clinical studies of CBD in other medical conditions to achieve FDA approval and ensure patients are getting the medicines they deserve.”