Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).
Unproven medical claims, unsafe manufacturing practices
The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.
The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.
The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
The main difference between CBD (cannabidiol) and THC (tetrahydrocannabinol) is that CBD does not induce a high whereas THC does.
Although a bit of a blurred line, it is smart to be cautious when purchasing or using CBD products, as their legality is still questionable. The same goes for THC, which is perhaps the more controversial compound of the two for legal use.
What Is CBD?
Despite such resistance, the continued medical data and research continues to flood in in favor of legalizing components such as CBD for widespread use.
In fact, the Drug Enforcement Administration (DEA) has attempted several times, more recently in 2016, to classify both THC and CBD as Schedule I drugs under the U.S. Controlled Substances Act, meaning they have "no currently accepted medical use and a high potential for abuse."
Its benefits have been maximized by the retail and medicinal markets, with CBD products including oils, vapes, medicines, skincare and drinks. Cannabinoid oil is a popular product created from CBD. Companies from American Eagle to Ben & Jerry's have announced plans to incorporate CBD into some of their new products.
The marijuana plant contains a wide variety of chemical compounds referred to as cannabinoids. The most commonly known cannabinoid is Delta-9 THC, typically known only as THC. This is the naturally occurring psychoactive drug found in regular cannabis that produces a “high” effect for its users.
The main difference? While Delta-8 is very similar to Delta-9 THC, Dr. Chen explains that it may be less potent — meaning you’ll need a significantly larger dose of Delta-8 to experience the same level of high. This might be a selling point for some people who are looking for an alternative in states where cannabis isn’t legal, but there are two problems with Delta-8: legality and safety.
What’s the difference between Delta-8 and regular cannabis?
“Delta-9 THC is the most widely studied cannabinoid in the cannabis plant and is believed to be primarily responsible for the intoxicating effects of cannabis,” explains Dr. Jeff Chen, who is the founder (and former direct) of the UCLA Cannabis Research Initiative, as well as the CEO and CoFounder of Radicle Science. “Delta 8-THC is an isomer of Delta-9 THC, which means they have very similar atoms and structure but are not identical.”
The second problem with Delta-8? Its questionable legal status means there isn’t as much research on the safety and efficacy of Delta-8, as well as a lack of regulation over the production and sales of Delta-8 products, so it’s hard to determine whether or not these products are safe for consumption over the long-term.
According to the U.S. Drug Enforcement Administration (DEA), Delta-8 is listed as a Schedule 1 Drug — meaning some legal experts consider Delta-8 to be a federally controlled substance — especially now that it has been banned by several states.