What’s the deal with the FDA delaying CBD rules? (Update 2022)

The hemp industry was shaken to the core when the 2018 Farm Bill was passed. It’s not that the changes weren’t expected. In 2014, a similar law was signed, beginning the process of re-legalizing hemp.

The possibilities were suddenly overwhelming. With “industrial hemp” CBD products containing less than 0.3% THC now essentially legal in all 50 states, the hemp market has had ample room for growth.

Over the past year, however, hemp industry stakeholders have begun to feel like they’re hitting a wall of sorts. Comprehensive regulation from the FDA (the new federal regulator of CBD) has been expected since 2020 but has still not arrived, causing widespread unease.

The pandemic has slowed things down, but other factors are at play here as well. Find out why it’s already 2022 and the FDA still hasn’t regulated CBD properly.

The current status of CBD

Under the Farm Bill 2018, most hemp-extracted CBD products that contain less than 0.3% delta-9 THC are considered industrial hemp, a legal category entirely separate from the Controlled Substances Act’s definition of “marijuana”. is. As a result, CBD oil for pain and a variety of other CBD products are now widely sold online and shipped to all 50 states.

CBD isn’t exactly legal in the sense of being an over-the-counter drug, a dietary supplement, or even a prescription drug in most cases. The DEA may no longer have jurisdiction over CBD, but the FDA has largely failed to take the reins.

The position of the FDA

In June 2022, hopes briefly surfaced that the FDA might be close to issuing some definitive CBD guidelines. The federal agency announced that it would convene its Scientific Council to discuss the challenges associated with regulating cannabinoids as dietary supplements or food ingredients.

Before it even happened, however, industry insiders were already confident that this meeting would not result in any significant changes to the status quo of CBD regulation in the United States. Recent FDA statements make it clear that the agency faces significant challenges in developing a regulatory framework that adequately encompasses CBD as an easily accessible online ingredient.

The FDA has at least one legitimate reason to take its time with CBD: There’s still a serious lack of definitive safety data on the cannabinoid itself and the types of products that commonly contain it. The FDA has commissioned various studies to determine the safety of CBD, but it takes a while for this type of research to arrive.

However, the lack of safety data isn’t the only factor holding the FDA back. A decision the agency made in 2018 regarding CBD has returned to haunt the here and now.

The Epidiolex dilemma

Epidiolex is a CBD-based prescription drug developed by British cannabis giant GW Pharmaceuticals. The FDA approved Epidiolex for certain types of intractable epilepsy (including Dravet syndrome) in 2018 and has since expanded the CBD drug’s accepted uses.

Despite being referred to as a “CBD-based drug” in regulatory contexts, the only active ingredient in Epidiolex is hemp-derived CBD: the same hemp-derived CBD as you can find in hemp products sold online.

The FDA has a longstanding precedent of not approving substances as dietary supplements or over-the-counter drugs after they’ve already been approved as prescription drugs. Although additional variables, such as state cannabis legislation, may also affect the FDA’s decision on this matter, the fact that CBD in Epidiolex is available on a prescription basis makes it very difficult for the agency to approve or regulate the cannabinoid in other contexts.

Possible solutions on the horizon

In May 2022, the Democrat-controlled US House of Representatives passed a bill that would remove cannabis from the Controlled Substances Act. If the bill goes through the Senate and reaches the President’s desk, it could be the trigger the FDA needs to finally resolve the paradoxes surrounding federal CBD regulation.

However, due to significant policy failures since winning a majority in 2020, it’s possible that the House and Senate could fall back under Republican control during the midterm elections, potentially stalling cannabis reform. Over time, more research into the safety of CBD will emerge, and the FDA will eventually resolve regulatory conflicts between Epidiolex and other forms of CBD. However, the near future of the American hemp industry remains bleak.

Summary: When will the FDA take action on CBD?

In mid-2019, virtually every industry expert was predicting that sweeping federal cannabis reform — accompanied by FDA clarity on CBD — would arrive in 2020. Then the pandemic struck and non-essential federal government activities were largely halted.

Now, political ambiguity combines with regulatory entanglements that are harder than expected to resolve, making the exact path America’s CBD will take from here worryingly uncertain. What we do know for sure, however, is that leaders in the CBD industry are committed to creating a brighter future for hemp every day.

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