FDA finally holds its first all-day hearing on CBD oils, gummies, lattes and more amid concerns over exaggerated health claims
- CBD has become a booming business in the US, expected to be worth $ 16 billion by 2025
- The Food and Drug Administration has approved several drugs that contain cannabis derivatives or synthetics
- But it has not established regulations for unapproved CBD products being sold across the country
- An all-day meeting Friday is the agency’s first foray into the many ‘unanswered questions’ swirling around CBD
The US Food and Drug Administration (FDA) has finally agreed to review CBD and other cannabis-derived products in a Friday hearing.
Coffee shops claim that their CBD lattes will wake you up and calm you down simultaneously, others peddle oils that they say will do everything from relieve pain to alleviate autism symptoms.
Some say CBD is the antidote to the opioid epidemic, while others say it’s snake oil.
After years of the industry running more or less wild as marijuana has been legalize in many US states the FDA has at last decided to take up the issue and discuss how to classify and regulate the substance.
Supplements, oils, and baked goods are just a few of the products that the FDA will discuss in its first hearing on CBD, which will serve as a starting point for regulating the host of products
CBD is about as poorly understood as it is broadly used.
Last week, the FDA’s principal deputy commissioner, Dr Amy Abernathy started a twitter thread, listing some of the unknowns surrounding CBD.
‘There are many open questions about CBD, [including] safety questions,’ she said.
‘In particular, we’re working to learn more about the potential risks of CBD, such as toxicity to the liver, when someone ingests it regularly over a long period of time, perhaps from several types of CBD products.
‘For example, what happens if you eat food with CBD in it, use CBD-infused skin cream, and use other CBD-based products on the same day? What if you use these products daily for a week or a month, or longer? What if someone taking CBD is also taking medications?’
The FDA has approved a handful of cannabis derived or synthetic cannabis drugs – including a seizure medication for children that contains CBD and drugs to improve appetite and treat nausea, which contain THC.
But many CBD products have been marketed as safe, harmless and useful for far more conditions, without the FDA ever deeming them so, though a few have in fact traveled the FDA’s ‘generally recognized as safe’ pathway to market.
As for the rest, part of the difficulty in regulating them is that they come in so many different forms.
THE DIFFERENCES BETWEEN THC AND CBD
Tetrahydrocannabinol (THC) and cannabidiol (CBD) are both derived from the cannabis plant.
Together, they are part of the cannabinoid group of compounds found in hashish, hash oil, and most strains of marijuana.
THC is the psychoactive compound responsible for the euphoric, ‘high’ feeling often associated with marijuana.
THC interacts with CB1 receptors in the central nervous system and brain and creates the sensations of euphoria and anxiety.
CBD does not fit these receptors well, and actually decreases the effects of THC, and is not psychoactive.
CBD is thought to help reduce anxiety and inflammation.
You can ingest CBD oil directly, cook it into food or baked goods, drink it in your kombucha or – if the claims made by such products are true – absorb it through your skin when you use CBD lotions.
The trouble is that even if the exact same CBD was used in all of those goods, they would still each need to be assessed and regulated in entirely different ways by the FDA.
What’s more, as Dr Ned Sharpless, acting commissioner of the FDA notes, because there are approved drugs that contain CBD and THC, it’s actually illegal for cosmetics and ingestible products to contain either compound without going through the FDA approval process.
As for the rest of the 80 estimated ‘biologically active chemical compounds’ in cannabis, they have not been thoroughly studied, much less approved by the FDA.
Currently, the most comprehensive regulation of parts of the cannabis plant is under the Federal Controlled Substances Act (CSA) which has remained largely the same since 1970 (and refers to the drug as ‘marihuana’).
And it’s still a schedule I drug, meaning it’s highly illegal and has no medical use, with the exception very low THC-content hemp which was rescheduled last year under the Farm Bill.
In other words, cannabis and its various forms, compounds and uses are treated very differently in the US.
None of that has stopped cannabis – and specifically CBD – from become an explosive business, projected to become a $ 16 billion market by 2025.
‘Given the new interest in marketing cannabis products across the range of areas FDA regulates, we will need to carefully evaluate how all these pieces fit together in terms of how consumers might access cannabis products,’ said Dr Sharpless.
‘Nowhere is this truer than with CBD. While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know.’
Friday’s all-day hearing is the first step in what will undoubtedly be a long process of trying address those unknowns and establish regulations accordingly.
It will be followed by an open comment period, which will stretch until July.
But in the meantime, the FDA says that it is sending out warning letter to anyone selling unapproved cannabis products.