What is the FDA’s Stance on CBD?
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The federal government’s stance on cannabis has been clear: it remains federally prohibited under the Controlled Substances Act, despite a growing tide of state-level legalization measures that have been adopted.
But for cannabidiol (CBD), one of the major non-intoxicating components of cannabis, the federal position is slightly more complicated.
CBD and US law
The Controlled Substances Act (CSA) currently lists all tetrahydrocannabinols (forms of THC) and similar CB1 receptor agonists as Schedule 1 controlled substances, meaning that the federal government considers these compounds to have both a high potential for abuse and no currently accepted medical uses.
Notable in its absence from these measures, is CBD.
The passage of the 2018 Farm Bill officially removed hemp-derived CBD from the Controlled Substances Act, as well as legalizing the cultivation of hemp itself. In effect, this legislation allows for the legal production and sale of CBD products, with the US Food and Drug Administration (FDA) having the power to regulate these and other similar hemp-derived cannabinoid products.
2018 also brought with it an important milestone for cannabis-derived CBD policy, the FDA’s approval of Epidiolex, a cannabis-derived CBD oral solution for treating seizures in Lennox-Gastaut syndrome and Dravet syndrome. Its approval was the first time the FDA had condoned any cannabis-derived drug, and the first approval of any drug for Dravet syndrome.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said then-FDA Commissioner Scott Gottlieb in a news release.
Following its approval by the FDA, the Drug Enforcement Administration (DEA) moved to re-schedule the drug from a Schedule 1 controlled substance under the CSA, to a Schedule 5 controlled substance. At the time, the FDA argued that this decision didn’t go far enough, writing in a letter to the DEA that “CBD and its salts… do not have a significant potential for abuse and could be removed from the [Controlled Substances Act (CSA)],” adding, “we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA.”
In April 2020, the DEA officially removed Epidiolex from the Controlled Substances Act completely, which Epidiolex’s manufacturers said would improve patient access to the anti-epileptic medicine.
CBD as a dietary supplement
At present, one of the biggest issues concerning the FDA and CBD is the use of CBD products in foods and as dietary supplements.
As per the provisions of the Farm Bill, the FDA holds the power to regulate the usage of hemp-derived cannabinoids like CBD. Legally, the FDA maintains that it’s “unlawful under the [Federal Food, Drug and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
However, the FDA has been willing to listen to feedback on this position from industry stakeholders, act and the general public. Last May, the FDA held a public hearing on the use of CBD products which featured more than 100 speakers testifying in front of FDA officials. A subsequent public comment period drew over 4,400 submissions by the middle of July from a mixture of public organizations, industry stakeholders, and members of the general public.
While the comment period formally closed on July 16, 2019, this March the FDA announced that it would be extending the comment period “indefinitely” so that the public can continue to provide information in real-time as the research in this area evolves.
The FDA and CBD enforcement
Though the FDA does appear to be willing to consider sensible reform to its CBD policy, it remains active in enforcing its current rules. While CBD products may be legally sold in the US, the FDA upholds strict rules on how these products can be marketed and sold under the Federal Food, Drug, and Cosmetic Act.
In the past month, the FDA has sent out warning letters to two companies for making unproven claims that their CBD products were effective alternatives to opioid medications and effective at treating opioid addiction. While some studies have indicated that CBD could hold potential as a treatment for opioid use disorder, there are no CBD products approved by the FDA for this application, and clinical study is still evolving.
The FDA also recently warned one UK-based CBD manufacturer for making unproven claims on its website that implied its products could be used to prevent contracting Covid-19. Though the company is based in London, its CBD products were also listed for sale in the United States, prompting the FDA to issue its warning.
Several other companies outside of the cannabis sector have also been warned by the FDA and the Federal Trade Commission (FTC) for similar misleading claims regarding Covid-19.
FDA warning letters typically give companies a period of time to respond and retract the claims being made with regard to their products, with a failure to correct the violations leading to further legal action.
Just last week, a California-based CBD firm which ignored FDA warnings about misleading medical claims and dietary supplement labelling has been named in an FTC complaint which seeks a temporary restraining order and a preliminary injunction against the business. The full administrative case from the FTC isn’t scheduled to begin until January 2021.
In order to avoid FDA warnings, CBD companies are advised not to make any medical claims, expressed or implied, about their products. The FDA is currently in the process of exploring pathways to allow for the marketing of CBD as a dietary supplement, but until this is solidified, companies should be sure to comply with the current stipulations of the Federal Food, Drug and Cosmetic Act.