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).
4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.
When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.
Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.
Cannabidiol and THC are just two of the plant’s more than 100 cannabinoids. THC is psychoactive, and CBD may or may not be, which is a matter of debate. THC can increase anxiety; it is not clear what effect CBD is having, if any, in reducing it. THC can lead to addiction and cravings; CBD is being studied to help those in recovery.
Cannabidiol, or CBD, is the lesser-known child of the cannabis sativa plant; its more famous sibling, tetrahydrocannabinol, or THC, is the active ingredient in pot that catapults users’ “high.” With roots in Central Asia, the plant is believed to have been first used medicinally — or for rituals — around 750 B.C., though there are other estimates too.
What are the claims?
But he cautions that the side effects could have been because of an interaction with other medications the children were taking to control the seizures. So far, there hasn’t been a randomized, placebo-controlled, double-blind trial (the gold standard) on sleep disorders and CBD.
Many soldiers return home haunted by war and PTSD and often avoid certain activities, places or people associated with their traumatic events. The Department of Veterans Affairs is funding its first study on CBD, pairing it with psychotherapy.
Facts about wellness.
Tempted to give your pup one of those CBD dog biscuits? "Generally we expect CBD products to be safe, and they could show some benefit for anxiety in pets," says John Faught, DVM, a veterinarian based in Austin, Texas.
Does CBD get you high? What are the actual benefits? Will it show up on a drug test? Here’s everything you need to know about the product that’s suddenly everywhere.
It should not, as long as you're buying third-party tested CBD with no added THC, says Dr. Chin. But she does point out that athletes, who often are required to take drug tests that are more sensitive, "could potentially test positive" for trace amounts of THC if they've been using CBD products.
Will CBD show up on a drug test?
That same 2018 Farm Bill means you can now travel between states with legit CBD products. "Flying with CBD should pose no issues now," Parrish says. However, if you're traveling with a tincture, be mindful of TSA limits on how much liquid you can carry on an airplane, she adds. (You can also mail CBD products, just like "companies that comply with the Bill can ship their hemp-derived CBD products anywhere in the U.S.," Parrish notes.)
When people talk about hemp oil, they're referring to oil extracted from the seeds of the hemp plant. There are no cannabinoids—CBD or THC—in hemp oil. This ingredient is packed with healthy fats and often appears in beauty products for its moisturizing benefits.
"Right now, you just have pharmacies trying to make some sort of sense out of it and say, 'Yes, it works for this,'" he says, "but that's not the way medicine is practiced—it should be based on evidence, and there's not a lot of evidence to really support these claims."
The only CBD medication that is currently FDA-approved is Epidiolex, which the agency approved last year for the treatment of certain types of epilepsy. But many people swear CBD has helped with a slew of other health conditions, including back pain, osteoarthritis, even cancer.