The United States Food and Drug Administration held a public hearing on May 31, 2019, to gather information on CBD and cannabis-derived compounds. This was the very first time that the agency held a hearing on the matter.
The agency’s purpose was to gain scientific data and information regarding the functions related to cannabis-derived and CBD products, including their safety, manufacturing, marketing, labeling, quality, and sale.
There were more than 400 requests from various parties of interest to make oral presentations and to testify. And because the FDA cannot accommodate all requests for the one-day hearing, it had to create a lottery system to narrow down the list to 120, representing the academe, agriculture, consumer groups, health, manufacturing, public safety, and retail and distribution sectors.
Even that number was a lot, so they were each given only two minutes to make a case to the panel, while some were given five. The presiding panel was made up of top FDA officials, including Acting FDA Commissioner Norman E. Sharpless, MD, who gave the opening remarks.
The number of presenters was just on top of the over 500 people who attended in person and the over 800 who registered to join the hearing remotely. The overflowing auditorium was a testimony to the enormous level of interest the public holds for cannabis-related matters.
The current state of cannabis and cannabis-derived products
The agency has been skeptical of the burgeoning cannabis industry, but U.S. Congress has been putting it under increasing pressure to ease the path towards marketing cannabis-derived products. And why shouldn’t it, when CBD-related sales in the country is estimated to reach $16 billion in five to six years?
It should be noted, though, that when we talk of cannabis and cannabis-derived products, these are separate and different from medical cannabis, which is already allowed in the majority of states for the treatment of epilepsy, chronic pain, and other medical conditions and symptoms. There is a wide range of CBD and cannabis-based products – from bath salts to skincare products to beverages – being sold by various businesses both in stores and online.
Currently, the FDA is believed to have been lenient – or to have turned a blind eye. In fact, even if CBD is currently not legally allowed in food products and in dietary supplements, the FDA has overlooked these infractions. However, the agency will eventually have to decide whether to allow these companies to continue doing so.
For decades, the U.S. federal government categorized hemp and marijuana – both are plants from the cannabis family – as controlled substances. It did not matter that these plants were different in terms of their active chemical compounds. Marijuana is rich in the psychoactive chemical component tetrahydrocannabinol (THC), which is the one that creates the high and the mind-altering effects. For this reason, marijuana is more associated with recreational use. Hemp, on the other hand, has less THC or none at all, and it is more associated with industrial uses. Both plants contain cannabidiol (CBD), which is non-psychoactive and therefore brings therapeutic benefits minus the high.
In late 2018, the Farm Bill removed hemp and hemp derivatives like CBD from the federal government’s controlled substance list and approved products containing them as long as they didn’t have more than 0.3 percent THC. But, here’s the catch: the law preserved the authority of the FDA to regulate cannabis compounds.
Why doesn’t the FDA just approve CBD?
It is the FDA’s responsibility to regulate drugs, including the ones that are derived from cannabis. It can also take enforcement actions against and impose penalties on businesses or companies that are selling food items or dietary supplements containing CBD or THC – which are both considered drugs. However, the agency has taken such action only against those companies that have made excessive health claims for their cannabis products, like claiming to cure cancer and other ailments. For the rest, the FDA has rarely budged.
So, with the legalization of hemp, why doesn’t the FDA just give CBD and cannabis-derived ingredients its stamp of approval, make it official for the cannabis companies, and get it over with?
CBD and THC have specifically been studied and were approved as drugs. And the Federal Food, Drug & Cosmetic Act strictly prohibits adding drugs to human or animal food in interstate commerce. To put it simply, CBD and THC are both considered prohibited drugs and they cannot lawfully be added to food or
marketed as a dietary supplement.
And while the new law authorizes the FDA to issue regulations creating new exceptions to the statutory provisions, the agency has never issued one for any particular substance. Dr. Sharpless said that if they thought about doing that for CBD or for any other substance, that would be a new terrain for them.
Dr. Sharpless noted in his opening remarks, though, that there are already several cannabis-derived substances that have come to market through the GRAS (generally recognized as safe) pathway. In fact, the FDA announced in December that they have completed their evaluation of the GRAS notices for three hemp seed ingredients. The agency had no objection to these ingredients being marketed in human food products for certain uses without their prior approval — provided, of course, that they comply with all the other requirements.
For CBD alone, the FDA pointed out the lack of quality control in CBD products, as well as the lack of standard dosages. The agency also stressed out the absence of data that proves the compound is safe and effective.
Additionally, health agencies in the U.S. have called for more research into the medicinal potentials of CBD and other cannabis derivatives, as well as the health risks.
Dr. Scott Gottlieb, the FDA commissioner who stepped down from his post in April, said in an interview that he doesn’t think CBD is doing anything close to that “magic quality” people are claiming. According to him, safety is the real issue and that there are risks of accumulated effects. He pointed out that CBD “is not a completely benign compound.”
Aside from the FDA, there are two other federal agencies that play a role in the oversight of cannabis. There’s the Drug Enforcement Administration, which issues registrations for the cultivation and processing of cannabis for medical research. There’s also the Department of Agriculture, which is now developing a plan for the regulation of hemp – something that state governments can do provided they meet certain criteria.
Why the need for the hearing?
Dr. Sharpless explained in his opening remarks that they have reasons to prohibit including drugs in the food supply. When they approve a drug, they carefully evaluate a specific formulation’s benefits and the risks, strength, and dosage form for a particular population. Often, they would decide that in order for a substance to be safely used, medical supervision or prescription should be required to help prevent any potential dangerous misuse. CBD and THC are not exempt from such evaluation.
According to Dr. Sharpless, there are real risks that are associated with CBD and THC. Moreover, critical questions remain regarding the safety of the widespread use of these compounds in dietary supplements and in food, as well as in other consumer products like cosmetics and pet food.
So, Dr. Sharpless said, given the immense interest in the marketing of cannabis products across a range of areas that are regulated by the FDA, they find the need to cautiously evaluate how all the pieces would fit together, especially when it comes to how consumers would access cannabis products. The same goes for CBD.
Moreover, the agency admits that while there is an explosion of interest in CBD-containing products, there is still a lot that they don’t know about the substance. Before the 2018 farm bill, population-based research would include cannabis-focused observations as a whole. But when hemp was removed as a controlled substance, the lack of research and the lack of evidence supporting the broader use of CBD in FDA-regulated products, including food and dietary supplements, resulted in unique complexities for its regulation. These complexities include many unanswered questions regarding its safety.
These questions include:
- How much CBD is safe to take in a given day?
- How will CBD interact with other drugs that a user may be taking?
- What if the user is pregnant?
- What if someone applies a topical CBD product, consumes a CBD edible or beverage and also consumes CBD oil? How much is too much?
- What if children consume CBD products like gummies? What happens when someone chronically takes CBD for prolonged periods?
These questions and many others represent important and significant gaps in everyone’s understanding.
Thus, in order to help the agency evaluate these questions, as well as see the potential pathways for CBD products, the agency formed an internal working group responsible for addressing these data gaps. This working group will provide updates as they come in the months to come.
Dr. Sharpless also made it clear that the agency is aware of some companies that are marketing products with cannabis and cannabis-derived ingredients in ways that are not in accordance with the law. The FDA, he said, has already issued warning letters to these companies.
The acting FDA commissioner also pointed out that their biggest concern is the marketing of products that place consumers’ health and safety at risk. These include products that claim to diagnose, prevent, treat, mitigate, or cure serious medical conditions like cancer without the required approvals.
Dr. Sharpless explained that selling unapproved drug products that carry unsubstantiated therapeutic claims violates the law and puts patients at risk. Consumers suffering from serious and even fatal ailments may be influenced not to use approved treatment therapies if they see a promise of cure from these unapproved products.
That being said, Dr. Sharpless clarified that the FDA does not have a policy of enforcement discretion when it comes to any CBD products. There are many questions the agency will need to answer in order to ensure that they are taking the appropriate well-informed and science-based approach to the regulation of cannabis, CBD, and other cannabis derivatives.
The FDA is hoping that the hearing and the comments submitted in their public docket will help the working group as it tries to approach the issue in a science-based manner. The hearing is an important step in their continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.
The academic researchers who presented at the hearing agreed that CBD has potential health benefits. However, many of them also argued that there is a need for more clinical trials before making any sound decision on whether or not CBD should be allowed further into the food supply.
Several speakers also cited issues pertaining to:
- adulterated or contaminated CBD products, which have been found to include pesticides, fungi, lead, or other metals
- research indicating CBD’s potential to cause liver problems and other adverse effects
- inconsistent CBD levels that lead to consumers taking too high doses and then getting sick.
You can take a look at what presenters from various sectors had to say about CBD and other cannabis-based products in this hearing transcript.
You can also check out a webcast recording of the hearing, which is available in four different segments that are based on the agenda:
Docket still open!
The FDA created to a docket on the topic to help them with more information as they consider important policy options that are related to the regulation of products that contain cannabis and cannabis-derived compounds.
All stakeholders who were not able to join in the hearing are encouraged to submit comments to the docket. This will remain open until July 16, 2019. (Yes, the FDA has decided to extend the period from the previously announced July 2 closing.)
You can access the docket here.