William asked
I recently read to news that the FDA is approving a CBD product, called Epidiolex. How is this different from over the counter CBD?
Answer
Epidiolex is described by its manufacturer, GW Pharmaceuticals, as, "...a proprietary oral solution of pure plant-derived cannabidiol, or CBD." Basically, this is a preparation of purified cannabidiol in a solution that can be taken by mouth.
CBD In Epidiolex Vs. OTC CBD
The CBD (cannabidiol) in Epidiolex is no different from CBD present in "over-the-counter" CBD preparations; however, with Epidiolex, the manufacturer must adhere to the same strict standards for pharmaceutical production that any other pharma company has to. Those standards help ensure the product contains what it says it contains, and in the correct amounts.
It is important to note that many news sources are reporting Epidiolex as a "medicine made from marijuana", which is true, but remember that it only contains CBD, not THC which is most often associated with marijuana due to the euphoria it can cause. CBD is not thought to cause a "high" or euphoria, even at high doses.
While both over the counter CBD and Epidiolex contain cannabidiol, there are some major differences, discussed below.
Legal Status Of Epidolex And CBD
Epidiolex, just recently approved by the FDA on June 25, 2018, will be available as a prescription drug only. Given that all CBD products are technically Schedule I drugs, with, "no currently accepted medical use" according to the DEA, it may be subject to a special access program, or need to be reclassified by the DEA to allow legal prescribing. In fact, according to various news sources, the DEA is expected to reclassify CBD products within 90 days.
Once approved, Epidiolex will be subject to the FDA's regulatory authority, which makes sure it continues to adhere to those manufacturing standards. This product has also undergone clinical trials and can legally claim to treat or cure certain diseases or conditions it is approved for.
Unregulated CBD products, meaning anything you might buy online, at a health food store, smoke shop, etc, have absolutely no quality or other standards to meet. In other words, the products can contain whatever the manufacturer decides to put in there, and no one will really know for sure unless they test the stuff.
Popular over the counter CBD products include:
- Charlotte's Web
- Plus CBD Oil
- Green Gorilla CBD
- Canna Trading Co.
Interestingly, the FDA has done quite a bit of this kind of testing, and has sent out warning letters to a few dozen firms with mixed results. See Warning Letters and Test Results for Cannabidiol-Related Products.
While there doesn't appear to be a concerted effort (or really any effort, frankly) to stop sales of CBD products, if you are going to purchase these products, please be aware that there is no guarantee of their quality, effectiveness, potency, safety, or legality, and you will have little recourse if you are injured or otherwise harmed as a result of purchasing or using them. At the very least, stick with reputable companies. Be smart, be safe.
Per the FDA in their announcement of the approval of Epidiolex:
"Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval [of Epidiolex], prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. ...But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
Other Differences Between CBD And Epidiolex
Aside from the legal status and testing standards, one of the main differences between Epidiolex and OTC CBD oil is the fact that Epidiolex is far more concentrated (100mg/ml) than all over the counter CBD products.
Most over the counter CBD Oil products contain CBD concentrations (remember to look for CBD content, not hemp extract content) ranging from 3mg/ml to 10mg/ml. At least one company, CW Hemp, manufactures products with CBD concentrations up to around 50mg per mL (although this is not stated on the label). Epidiolex will be available in a concentration of 100mg/mL which will require smaller dosage volumes.
Other differences include:
- Epidiolex will have specific dosing instructions for patients.
- The recommended starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day). Based on individual clinical response and tolerability, Epidiolex can be increased up to a maximum recommended maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day).
- Epidiolex has a strawberry flavor, and sucralose as the sweetener.
- Epidiolex will be made with no ingredients made from a gluten-containing grain (wheat, barley, or rye).
Summary
- Epidiolex is an FDA approved medication containing CBD and has to adhere to strict quality standards. Over the counter CBD products do not have to adhere to strict standards and are not routinely tested for quality and purity.
- Epidiolex is more concentrated than over the counter CBD products. It will be available as a 100mg/ml solution.
- Epidiolex has approved dosing recommendations based on clinical trials for the drug.
