The terminology used to describe different products is the source of a lot of the potential confusion in the world of CBD oil. For example, while you might see labels that use the word hemp to indicate that the CBD came from a legal hemp plant rather than a marijuana plant, there is also a totally separate product called hemp seed oil.
That being said, whether CBD is extracted from hemp or marijuana, it remains identical on a molecular level.
Finally, as outlined above, hemp plants are legally defined as cannabis plants with less than 0.3% THC. Despite these very low levels of THC, these plants still produce a broad range of cannabinoids and terpenes. These plants are typically grown for industrial uses and for other legal products.
“At this point, what we know about cannabinoid therapy is that it is highly individualistic and depends to a significant extent on the symptoms being treated,” Riggle said. “The clinical data is not there yet to provide a one-size-fits-all answer to this question.”
There is an exception to this rule. Some emerging craft hemp varieties possess unusually high concentrations of CBD, such as Cherry Charlotte, Cobbler, and Berry Blossom. These cultivars contain between 12% and 20% CBD with 0.3% THC or less.
CBD comes from one of two types of cannabis plant: hemp or marijuana.
Thanks largely to legal changes introduced by the 2018 Farm Bill, cannabidiol (CBD) has become an increasingly common fixture in medicine cabinets and on the shelves of local convenience stores and major drugstores.
The defining difference between hemp and marijuana is their psychoactive component: tetrahydrocannabinol, or THC. Hemp has 0.3% or less THC, meaning hemp-derived products don’t contain enough THC to create the “high” traditionally associated with marijuana.
CBD comes in food, tinctures and oils, just to name a few. Here are some commonly used terms used to describe CBD products in the store.
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While the terms “CBD tincture” and “CBD oil” are often used interchangeably, the two are actually different. Tinctures are made by soaking cannabis in alcohol, while oils are made by suspending CBD in a carrier oil, like olive or coconut oil.
Hemp, marijuana and CBD are all related, but they differ in significant ways. Here’s what you need to know about their legality, effects and potential health benefits.
FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).
A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.
A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.
The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).