FDA Won’t Regulate CBD – Cannabis | weed | marijuana

The U.S. Food and Drug Administration (FDA) will not regulate CBD after a “careful review” of the issue.

Instead, the FDA is asking Congress to create a regulatory regime that balances “risk” with access to CBD products.

This announcement did not change the status of CBD products, which are legal but not regulated as foods or dietary supplements.

Some companies were disappointed to hear the FDA won’t regulate CBD. Many people associate the federal bureaucracy with consumer-friendly standards and practices.

Agriculture Act 2018

CBD or cannabidiol is one of the main cannabinoids found in the cannabis plant. Although technically psychoactive, you can take CBD and keep your head clear. Consumers like CBD for its anti-inflammatory effects as well as its neuroprotective properties.

CBD is also popular among cannabis connoisseurs for its ability to mitigate the effects of THC. Some say cannabinoids work better when they’re all present, a process called the entourage effect.

CBD’s popularity in the United States grew after President Donald Trump signed the 2018 Farm Bill, which legalized cannabis production as long as the plants contained less than 0.3% THC.

According to a report by CannIntelligence, the US CBD market is expected to reach $1.9 billion this year, with a projected value of well over $3 billion by the end of the decade.

However, many of these predictions depend on how the FDA and Congress decide to regulate CBD.

The FDA only approves patented CBD

Epidiolex. Photo courtesy of CNN.

The announcement that the FDA will not regulate CBD as a dietary supplement or food product has many wondering: What’s next?

So far, the FDA has only approved one CBD-based product: Epidiolex.

Epidiolex was approved in 2018 for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, and received the thumbs-up for patients as young as two years old.

The FDA approved Epidiolex based on clinical studies they claimed showed its effectiveness and safety in treating these forms of epilepsy. Of course, other studies show the effectiveness of CBD for epilepsy. You don’t need Epidiolex per se.

But of course Epidiolex is patented. It was developed and marketed by GW Pharmaceuticals. This justifies the high cost of the drug.

(There have also been issues with the misrepresentation of their clinical trial data on Epidiolex and long-term side effects such as liver problems. Note that none of these cost, safety, or side effect issues are present in the raw form of cannabis).

FDA on CBD: Passing the Buck to Congress

The FDA has expressed concern about “CBD exposure” from “vulnerable populations” such as pregnant women and children.

Ergo, they passed the buck to Congress. Nothing has changed at the moment. And if Congress’s reputation holds up, nothing is likely to change. At least not in the short term.

There is talk of listing CBD as a dietary supplement in the 2023 Farm Bill, but nothing has materialized so far.

However, the states of Colorado, Oregon, Washington, Maryland, and Virginia already have regulations on CBD products.