- Speech by
Norman E. "Ned" Sharpless,
White Oak, MD
(Remarks as prepared for delivery)
Thank you for joining FDA today for this public hearing titled “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds”.
I am pleased to see that there is such interest in this topic. We have over 500 people registered to attend in person, over 800 people registered to join us remotely, and over 100 speakers on today’s agenda presenting on this topic.
We encourage all stakeholders – presenters, attendees, and those unable to participate in today’s hearing – to submit comments to our docket on this topic, which is open until July 2, 2019.
Docket comments will help inform FDA as we consider the important policy options related to the regulation of products containing cannabis or cannabis-derived compounds.
It is important to note that the FDA’s role in the regulation of products containing cannabis or cannabis-derived compounds is not new.
Cannabis contains more than 80 biologically active chemical compounds, including the two best known compounds, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
If one of these compounds, or the plant itself, is added to a food or cosmetic, marketed as a drug, or otherwise added to an FDA-regulated product in interstate commerce, then it falls within FDA’s jurisdiction. As I said, this is nothing new for FDA.
At the same time, some relevant laws have changed. First, some states have changed their laws to allow for “medical” use of marijuana or CBD, and others have begun allowing for recreational marijuana use, or decriminalized recreational marijuana possession.
Second, certain federal laws have changed as well. Parts of the Cannabis sativa plant have been controlled under the Federal Controlled Substances Act, or CSA, since 1970 under the drug class “Marihuana.”
Marihuana is included in Schedule I of the CSA – the most restrictive schedule – due to its potential for abuse, largely attributable to the psychoactive effects of THC, and the absence of a currently accepted medical use in the United States.
Late last year, the federal scheduling of cannabis changed. The Agriculture Improvement Act of 2018, or the Farm Bill, removed hemp – meaning cannabis or derivatives of cannabis with a very low THC content (below 0.3% by dry weight) – from the CSA’s definition of marijuana. As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law.
As these laws have changed, FDA’s authorities have become more relevant.
The 2018 Farm Bill explicitly preserved FDA's authority to regulate products containing cannabis or cannabis-derived compounds. In doing so, Congress recognized FDA's important public health role with respect to all the products it regulates – including when those products are or contain cannabis ingredients.
FDA treats substances derived from cannabis just like we do any other substances, and they are subject to the same authorities as any other substance.
Under FDA’s authorities, the relevant legal requirements vary depending on which type of product we’re talking about.
For example, if a product is being marketed as a drug – meaning, for example, that it’s intended to have a therapeutic effect such as treating a disease or affecting the body’s structure or function – then it’s regulated as a drug, and it generally cannot be sold without FDA approval.
FDA has approved several drug products that contain compounds found in cannabis.
These include EPIDIOLEX, which contains CBD, for the treatment of specific types of seizures in certain pediatric patients, and MARINOL and SYNDROS, which contains dronabinol, a synthetic THC, for uses including the treatment of anorexia in patients with AIDS.
These drugs have important therapeutic value, and it is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis.
Food, including dietary supplements, is regulated differently, but with the same overarching goal of protecting consumers.
We know that American consumers depend on FDA to help make sure that the food they eat, and that they serve to their families, is safe. We do this through a number of requirements.
For example, while we don’t generally require foods to be approved by FDA before coming to market, we do require that a new food additive be approved as safe by FDA before being put in the food supply, unless the substance is generally recognized as safe, or GRAS.
This requirement applies to cannabis-derived ingredients, just as it does to any other substance. Americans deserve to know that substances being added to their foods are safe, regardless of the source.
I will note that several cannabis-derived substances have already come to market through the GRAS pathway.
In December, FDA announced that we completed our evaluation of GRAS notices for three hemp seed ingredients and had no objection to their being marketed in human foods for certain uses without approval, provided they comply with all other requirements.
As I mentioned earlier, however, some compounds found in cannabis – specifically, CBD and THC – have been studied and even approved as drugs. It’s important to note that the Federal Food, Drug & Cosmetic Act prohibits adding drugs to human or animal food in interstate commerce.
That includes both substances that have been approved as drugs, as well as compounds for which substantial clinical investigations have been instituted. Similarly, the law excludes these products from the statutory definition of a dietary supplement.
Based on the information available to FDA, we have concluded that these provisions apply to CBD and THC. And while there is an exception when the substance was marketed as a food or dietary supplement before it was studied as a drug, we have concluded that that is not the case for CBD or THC.
What that means is that, under current law, CBD and THC cannot lawfully be added to a food or marketed as a dietary supplement.
Although the law says that FDA can issue regulations to create new exceptions to these statutory provisions, FDA has never issued a regulation like that for any substance.
So, if we were thinking about doing that for a substance like CBD, it would be new terrain for the FDA.
There are important reasons to generally prohibit putting drugs in the food supply. When FDA approves a drug, we carefully evaluate the risks and benefits of a specific formulation, dosage form, and strength for a particular population.
Often, we conclude that to be safely used, it requires a prescription or other medical supervision to help protect against potentially dangerous misuse.
THC and CBD are no exception.
There are real risks associated with both those substances and critical questions remain about the safety of their widespread use in foods and dietary supplements, as well as other consumer products – including cosmetics, which are subject to a separate regulatory framework.
And 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.
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.
Prior to the 2018 Farm Bill, population-based research mostly included cannabis-focused observations in aggregate, rather than specific to CBD.
When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety.
For example, how much CBD is safe to consume in a day? What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil? How much is too much? How will it interact with other drugs the person might be taking? What if she’s pregnant? What if children access CBD products like gummy edibles? What happens when someone chronically uses CBD for prolonged periods?
These and many other questions represent important and significant gaps in our knowledge.
To help us evaluate these questions, as well as potential pathways for CBD products, FDA has formed an internal working group to address these data gaps specifically. You’ll be hearing more from this group in the months to come.
FDA is aware that some companies appear to be marketing products containing cannabis and cannabis-derived compounds in ways that violate the law.
FDA has issued warning letters to companies selling unapproved CBD products.
Our biggest concern is the marketing of products that put the health and safety of consumers at risk, such as those claiming to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, in the absence of requisite approvals.
Selling unapproved drug products with unsubstantiated therapeutic claims is a violation of the law, and puts patients at risk.
Patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
That being said, the agency does not have a policy of enforcement discretion with respect to any CBD products.
There are lots of questions we will need to answer to ensure that FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.
We hope that this meeting, and the comments submitted to our public docket, will help us as we try to approach this issue in an informed way. This hearing is an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.
I thank you all for taking the time to join us today and your contributions toward this important topic. We have a full agenda….