The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.
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.
You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.
Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices
Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.
Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.
The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.
The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.
Margaret Rajnic, a doctor of nursing practice experienced in medical cannabis and CBD, emphasizes the importance of using therapy in tandem with any type of cannabis or CBD for PTSD. “There is an amount of therapy that is needed for PTSD,” she says. “But CBD will give you that little bit of decreased anxiety.”
In one such study, researchers administered CBD to people with heroin use disorder. Over the course of a week, CBD significantly reduced heroin users’ cue-induced cravings, withdrawal anxiety, resting heart rate and salivary cortisol levels. No serious adverse effects were found.
4. Treat Opioid Addiction
In 2018, in a study of more localized treatment, researchers administered a synthetic CBD gel in either 250-milligram or 500-milligram doses daily or a placebo to patients with knee pain due to osteoarthritis. Patients also stopped taking any other anti-inflammatory medications or painkillers, with the exception of acetaminophen, before and during the study period.
CBD research is growing, too. Here are nine ways studies suggest CBD oil could benefit your health.
Arthritis involves the deterioration of the tissues in and around your joints. There are several types of arthritis, and symptoms include pain, stiffness and loss of motion. Arthritis treatment usually targets pain relief and improved joint function.
More than 60 percent of CBD users were taking it for anxiety, according to a survey of 5,000 people. Does it help?
But without clinical trials in humans, psychologists say CBD’s effect on depression is still a hypothesis, and not an evidence-based treatment.
What is CBD?
“If you take pure CBD, it’s pretty safe,” said Marcel Bonn-Miller, an adjunct assistant professor at the University of Pennsylvania’s Perelman School of Medicine. Side effects in the Epidiolex trial included diarrhea, sleepiness, fatigue, weakness, rash, decreased appetite and elevated liver enzymes. Also, the safe amount to consume in a day, or at all during pregnancy, is still not known.
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.
Up in the wee hours of the night, stuck watching videos of puppies? CBD may be promising as a sleep aid; one of the side effects of the Epidiolex trials for epilepsy was drowsiness, according to Mr. MacKillop, a co-author of a review on cannabinoids and sleep. “If you are looking for new treatments for sleep, that may be a clue,” he said.