The US Food and Drug Administration (FDA) announced it will not regulate the use of CBD as a dietary supplement.
In its review of the cannabis extract, the FDA said that CBD poses safety concerns for consumers but that Congress should take the lead on establishing regulations that would allow people to access CBD while mitigating risks. The FDA added, however, that it is prepared to work alongside Congress on developing CBD regulations.
CBD has become extremely popular among consumers in the US in recent years since the 2018 Farm Bill legalized hemp containing less than 0.3 percent of THC, the main psychoactive cannabinoid in cannabis. However, under the Federal Food, Drug, and Cosmetic Act, CBD remains illegal.
While the FDA’s announcement does not change CBD’s legal status, it comes as a disappointment to CBD businesses and stakeholders that have been lobbying the FDA for industry-wide regulations for the past four years.
CBD (cannabidiol) is one of the most abundant cannabinoids found in the cannabis plant. It is non-intoxicating and purported to have a range of therapeutic benefits, including for the treatment of chronic pain and insomnia.
According to the marketing firm CannIntelligence, the US CBD industry will reach a market value of nearly $2 billion in 2023 and is expected to grow to $3 billion by 2027.
So far though, the FDA has only approved one CBD-based product – Epidiolex – which is used to treat severe forms of epilepsy in young children.
The FDA’s hesitancy is largely due to safety concerns over the long-term use of CBD as well as its impact on young children and pregnant women.
“Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant,” the FDA’s announcement states.
Several lawmakers have already tried to pass legislation through Congress that would regulate CBD as a dietary supplement. While those efforts failed, Sen. Ron Wyden recently announced that he will reintroduce his Hemp Access and Consumer Safety Act.
Another potential legislative option is to include CBD amendments in the forthcoming 2023 Farm Bill, although this would likely be much less comprehensive than a standalone bill.
In the midst of the federal government’s impasse over CBD regulations, many states have pushed on and established their own CBD regulations, including in Colorado, Oregon, Maryland and Virginia. Nonetheless, the absence of federal regulations continues to hamper the CBD industry as businesses must comply with a patchwork of state regulations concerning packaging, labeling, and manufacturing requirements, among others.