CBD has recently changed from Schedule 4 (prescription only) to Schedule 3, which means you should be able to get low dose CBD (max.150 mg daily dose) over the counter at your local pharmacy.
However, there are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria. And that process of approval could take years.
So, what’s legally available in Australia?
So yeah, the government and researchers are well aware that a lot of people in Australia are opting to bypass the current system and spend their money offshore, buying online from places like Canada and the US. But there are signs that prices will go down, since obviously there’s an increasingly competitive market for it.
But CBD research takes money, something which scientists are notoriously short on. And ideally they’d be able to grow their own products here to research but that would take less regulation, something which governments are notoriously fond of.
So to be clear, CBD is used for medical reasons and NOT Reefer Madness. What kind of medical reasons? According to Dr Iain McGregor, Professor of Psychopharmacology, “It’s more a case of what it doesn’t do rather than what it does.”
6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
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)]).
In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.
21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
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.
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.
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.
The CBD industry is flourishing, conservatively projected to hit $16 billion in the United States by 2025. Already, the plant extract is being added to cheeseburgers, toothpicks and breath sprays. More than 60 percent of CBD users have taken it for anxiety, according to a survey of 5,000 people, conducted by the Brightfield Group, a cannabis market research firm. Chronic pain, insomnia and depression follow behind. Kim Kardashian West, for example, turned to the product when “freaking out” over the birth of her fourth baby. The professional golfer Bubba Watson drifts off to sleep with it. And Martha Stewart’s French bulldog partakes, too.
Tips for Better Sleep
But without clinical trials in humans, psychologists say CBD’s effect on depression is still a hypothesis, and not an evidence-based treatment.
Some CBD products may contain unwanted surprises. Forensic toxicologists at Virginia Commonwealth University examined nine e-liquids advertised as being 100 percent natural CBD extracts. They found one with dextromethorphan, or DXM, used in over-the counter cough medications and considered addictive when abused; and four with a synthetic cannabinoid, sometimes called Spice, that can cause anxiety, psychosis, tachycardia and death, according to a study last year in Forensic Science International.
Dr. Smita Das, chair of the American Psychiatric Association’s Council on Addiction Psychiatry’s cannabis work group, does not recommend CBD for anxiety, PTSD, sleep or depression. With patients turning to these to unproven products, she is worried that they may delay seeking appropriate mental health care: “I’m dually concerned with how exposure to CBD products can lead somebody into continuing to cannabis products.”
“Our top therapies attempt to break the association between reminders of the trauma and the fear response,” said Mallory Loflin, an assistant adjunct professor at the University of California, San Diego and the study’s principal investigator. “We think that CBD, at least in animal models, can help that process happen a lot faster.” While large clinical trials are underway, psychologists say there isn’t compelling evidence yet as to whether this is a viable treatment.