“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.
An At-Home Face-Lift
“It’s promising in a lot of different therapeutic avenues because it’s relatively safe,” said James MacKillop, co-director of McMaster University’s Michael G. DeGroote Center for Medicinal Cannabis Research in Hamilton, Ontario.
This year, 1,090 people have contacted poison control centers about CBD, according to the American Association of Poison Control Centers. Over a third are estimated to have received medical attention, and 46 were admitted into a critical care unit, possibly because of exposure to other products, or drug interactions. In addition, concern over 318 animals poured into the American Society for the Prevention of Cruelty to Animals’ Animal Poison Control Center.
Does CBD help sleep and depression?
CBD is advertised as providing relief for anxiety, depression and post-traumatic stress disorder. It is also marketed to promote sleep. Part of CBD’s popularity is that it purports to be “nonpsychoactive,” and that consumers can reap health benefits from the plant without the high (or the midnight pizza munchies).
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.
But without clinical trials in humans, psychologists say CBD’s effect on depression is still a hypothesis, and not an evidence-based treatment.
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Cannabis containing 0.3 percent or less of THC is hemp. Although last year’s Farm Bill legalized hemp under federal law, it also preserved the Food and Drug Administration’s oversight of products derived from cannabis.
20. Does the FDA have concerns about administering a cannabis product to children?
9. Can THC or CBD products be sold as dietary supplements?
Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).
The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).
Research and Expanded Access
13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”
As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.
A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
A. The 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 the FDA has concluded that this particular drug product is safe and effective for its intended use. 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 cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, 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.