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Providers, Patients Wary to Navigate ‘Confused System’ of CBD Laws, Labels
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ORLANDO — Physicians, nurses and patients must be vigilant when attempting to navigate the often contradictory, seemingly “confused system” of laws and labels associated with medical cannabis and cannabidiol – more widely known as CBD – according to a presenter at the 2019 Rheumatology Nurses Society Annual Meeting.
“Our system is very confused, and broken in some ways,” Nancy Delnay, APRN, MSN, RN, of Akron Children’s Hospital in Ohio, told attendees. “We have state rules, we have federal rules, we have the FDA, we have the DEA and we have the Department of Agriculture all doing different things. The FDA’s mission is to protect public health and ensure the safety, efficacy and security of our human and veterinary drugs, yet they are not regulating these products because it is a plant, and so it falls under the U.S. Department of Agriculture, which doesn’t need to regulate and do quality analysis on this.”
In June 2018, the FDA approved the first – and so far only – CBD drug, Epidiolex (GW Research), for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy. Epidiolex is classified as a Schedule V drug. However, at the time it was approved, the federal government and the DEA still considered all cannabis extracts to be Schedule I drugs and illegal.
This changed in December of that year, with the passage of the Agriculture Improvement Act of 2018, which included lines in the legislation that descheduled and legalized hemp – defined as cannabis sativa including no more than 0.3% of THC – while reclassifying it as an agricultural product.
“So now it is controlled by the Department of Agriculture, and no longer under the DEA,” Delnay said.
However, CBD derived from cannabis products containing more than 0.3% THC remain Schedule I drugs and illegal. In addition, as of April 2019, the FDA maintains that CBD products cannot be sold as an ingredient in food, dietary supplements or animal food, nor is it permitted as interstate commerce.
After issuing warning letters to multiple American manufacturers of CBD products for false advertising and illegal interstate marketing, the FDA in July 2019 stated, “Selling unapproved products with unsubstantiated therapeutic claims – such as claims that CBD products can treat serious diseases and conditions – can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.”
Still, CBD hemp oil continues to be sold across the country as a supplement in a variety of forms, including oil drops, chewing gum, oil extract, oil capsules, suppositories and vaping liquids.
Although some anecdotal evidence has suggested that CBD could be beneficial for a variety of conditions, Delnay said the medical community still lacks a “clear understanding” of its effects.
“There is no control over any amount of drug that is in those containers you get in the store,” she said. “It’s not subject to testing, and there are no quality measurements for it. So, what you buy at one store is not going to be the same as what you buy in another.”
“Know that you have to read the labels, and we have to educate our patients and families to read the labels,” she added. “Cannabis sativa has THC in it, so without accurate labeling, and without knowing whether it is an isolate or not, we don’t know if a particular product is strictly CBD, or if there is THC involved.”
Concerning medical cannabis, while the drug continues to be flatly illegal at the federal level, nearly every state has its own laws and regulations governing its use for a wide variety of qualifying diagnoses.
According to Delnay, these qualifying diagnoses can differ greatly between states, with Massachusetts being the only state to include arthritis in its list, while Connecticut allows patients with severe rheumatoid arthritis to receive the drug. In Hawaii, lupus is a qualifying diagnosis, while Illinois includes complex regional pain syndrome, but only Type 2. Meanwhile, any form of Ehlers-Danlos syndrome is considered a qualifying diagnosis in New Hampshire.
“I cannot encourage you enough to go to your state board and nursing board websites,” Delnay said. “We all should know what the laws and rules are for our states and practices. It is our responsibility, and we need to safeguard ourselves.”
In addition, Delany noted that physicians and practices need to be sure they are providing the correct diagnosis for each patient, as certain conditions, which may appear to the patient as a form of arthritis may be some other disease that is not appropriately treated with medical cannabis as a secondary therapy.
“We need to be very vigilant,” she said. “We need to be sure, as we are diagnosing, that we are giving them the right diagnosis, and not a diagnosis of convenience. Chronic pain, PTSD, fibromyalgia, IBD and neuropathies all fall under the category of qualifying diagnoses in multiple states, but we want to be sure we have the appropriate treatment for them.” – by Jason Laday
Reference:
Delnay N. Medical marijuana and CBD oils in rheumatology. Presented at: Rheumatology Nurses Society Annual Conference; Aug. 7-10, 2019; Orlando, Florida.
Disclosure: Delnay reports no relevant financial disclosures.