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cbd oil information

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:

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.

Unproven medical claims, unsafe manufacturing practices

The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:

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.

CBD products are also being marketed for pets and other animals. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. The FDA recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.

In June 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex, a CBD oral solution used for the treatment of certain rare forms of epilepsy in children under 2—Dravet syndrome and Lennox-Gastaut syndrome. Both are exceptionally rare genetic disorders causing lifelong catastrophic seizures that begin during the first year of life.

CBD oil is an extract of Cannabis indica or Cannabis sativa—the same plants that, when dried, make marijuana. CBD oil is believed by some to treat pain, reduce anxiety, and stimulate appetite in the same way that marijuana does, but without its psychoactive effects. CBD has also shown promise in treating certain types of seizures.

The tricky part is calculating the exact amount of CBD per milliliter of oil. Some tinctures have concentrations of 1,500 mg per 30 mL, while others have 3,000 mg per mL (or more).

Seizures

CBD oil can interact with certain medications, including some drugs used to treat epilepsy. CBD inhibits an enzyme called cytochrome P450 (CYP450), which metabolizes certain drugs. By interfering with CYP450, CBD may either increase the toxicity or decrease the effectiveness of these drugs.

There is currently no known “correct” dose of CBD oil. Depending on individual needs and what is being treated, the daily dose may range between 5 and 25 mg.

According to the investigators, men provided 300 mg of CBD exhibited less anxiety than those given a placebo. Interestingly, those provided 100 mg or 600 mg of CBD oil did not.

Meredith Bull, ND, is a licensed naturopathic doctor with a private practice in Los Angeles. She helped co-author the first integrative geriatrics textbook, "Integrative Geriatric Medicine."

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).

“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.

What are the claims?

A recent chart review of 72 psychiatric patients treated with CBD found that anxiety improved, but not sleep. “Over all, we did not find that it panned out as a useful treatment for sleep,” said Dr. Scott Shannon, assistant clinical professor of psychiatry at the University of Colorado, Denver and the lead author of the review in The Permanente Journal.

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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.