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On March 5, 2020, the Food and Drug Administration (FDA) issued a report to Congress on how the agency intends to regulate hemp-derived CBD (Hemp CBD). The report was accompanied by a press release from the FDA. The report states that the FDA will continue to work on a regulatory framework for Hemp CBD but in the meantime will provide enforcement priorities that will provide transparency to the industry.
The report focuses on safety, human and animal drugs, dietary supplements, human and animal food, cosmetics, products outside the FDA’s jurisdiction, and enforcement. If you’re unfamiliar with the FDA’s overall operation, this report provides good insight into how the agency works. However, I think most Hemp CBD stakeholders were hoping this report would do more to alleviate the tension between the FDA and the Hemp CBD industry. That tension stems from the FDA’s treatment of Hemp CBD up to this point.
No conversation about the FDA and Hemp CBD can get very far without mentioning Epidiolex, a prescription drug containing CBD. It is the only FDA-approved CBD drug. However, there are many Hemp CBD products available without a prescription. The FDA considers many of these Hemp CBD products “drugs” based on their intended use. If a Hemp CBD manufacturer or distributor makes medical or human structure claims about a Hemp CBD product, then the FDA considers that product a drug, and unless that product is Epidiolex, the product is deemed an unapproved drug.
The FDA’s main focus appears to be on Hemp CBD products classified as unapproved drugs. The FDA has sent numerous warning letters to companies selling Hemp CBD products. In every letter, the FDA identified some marketing material that indicated the product was a drug. This usually means that the seller made a health claim about the product (e.g., CBD reduces anxiety) or otherwise marketed the product in a way that indicated it had some medical value (e.g., naming a product “CBD Pain Balm” or allowing customer testimonials on its website or social media page). The FDA’s enforcement usually does not go beyond this letter writing, but the letters can have very serious consequences, aside from causing the Hemp CBD industry to operate in a legal grey area.
In addition, the FDA holds the position that Epidiolex was investigated before Hemp CBD was marketed in food or dietary supplements. That’s relevant because under the Food, Drug and Cosmetics Act (FDCA), any article that is investigated or approved as a drug, cannot be used as a food ingredient or dietary supplement unless it was marketed as such before being investigated as a drug. Non-ingestible products, such as cosmetics, are treated differently under the FDCA and the approval of Epidiolex does not automatically prohibit Hemp CBD from being used in cosmetics.
The report provides insight into what Hemp CBD will look like in the future. Eventually, the FDA will likely enact regulations that address Hemp CBD products. The FDA has reopened the comment period for Hemp CBD, which is good because it gives stakeholders the opportunity to weigh in again, but it also means that we are still far from the FDA putting “pen to paper” and writing up regulations (which would then be subject to another round of input from the public during a “notice and comment” period).
In the report, the FDA indicated that it wants to regulate Hemp CBD in a way that encourages the development of additional FDA approved drugs like Epidiolex:
As FDA considers additional non-drug products containing CBD that are products regulated by FDA, the Agency is also focused on encouraging further CBD-drug development and ensuring that there remain adequate incentives for clinical research. If the widespread availability of consumer CBD products were to significantly discourage clinical research, our knowledge of CBD’s potential medical uses could be stunted.
This means that the FDA is likely going to enact regulations that protect Hemp CBD pharmaceuticals.
The FDA has been working on regulations for quite some time, during which it has consistently postured against Hemp CBD foods and dietary supplements and occasionally sent warning letters based on medical claims.
According to the report, that could change:
Under current law, CBD products cannot lawfully be sold as dietary supplements, but FDA has the authority to remove this exclusion through rulemaking. We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements. In the coming months, as we further evaluate such rulemaking, we are also evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rulemaking.
These enforcement priorities are not laid out in the report but the FDA does provide a few more details:
FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway. As we move forward, FDA intends to continue taking action to address violations we identify that put the public at risk.
A clear, risk-based enforcement policy would be a welcome change. Currently, the FDA sends warning letters to a very small number of actors. The priority seems to be solely focused on medical claims, which means that it’s hard to predict when the FDA will send a letter. That attenuated risk is tolerated by both responsible and irresponsible Hemp CBD sellers. If the FDA were to change its enforcement priorities and make that information public, it could address these irresponsible sellers while working on regulations that responsible sellers would eventually follow.
The report includes a section on enforcement. It appears that the FDA will continue to monitor for therapeutic claims, especially if those claims relate to “serious diseases and conditions like cancer, Alzheimer’s disease, and opioid use disorder.” The FDA may also start to look at risks to public health beyond just that of unsubstantiated medical claims:
We also have serious concerns about products that put the public at risk in other ways. For example, we are acutely aware of the risks posed by product contaminants (e.g., heavy metals, high levels of THC, or other potentially harmful substances). We also have significant concerns about products marketed with false claims or statements (e.g., omitted ingredients, incorrect statements about the amount of CBD), products marketed for use by vulnerable populations (e.g., children or infants), and products that otherwise put the public health at risk.
One could imagine the FDA’s enforcement priorities are going to be similar to the Cole Memo, the two-page memorandum from the Obama-era Department of Justice that listed what the federal prosecutors should look for in deciding whether or not to prosecute marijuana crimes in states that had legalized. The Cole Memo outlined priorities relating to public safety, including sales to minors, the involvement of gangs and cartels, and the use of firearms. The Cole Memo was nonbinding and has since been rescinded. And although it was never a legally binding document, it did allow states to regulate marijuana with guardrails.
If the FDA were to adopt a policy on Hemp CBD it would have a similar effect. States could have more leeway in regulating Hemp CBD products. The FDA could also focus resources in a more effective manner. Like the Cole Memo, it wouldn’t be a perfect solution but it could be a stopgap that allows an industry to develop within a semi-regulated framework while the FDA lands on something more permanent– some day.
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