Why Isn't CBD Regulated by the FDA?

Your CBD gummies and supplements may not get an OK from the Food and Drug Administration any time soon. The agency said last week that it cannot regulate CBD products with the same rules used for food additives and dietary supplements because of various safety concerns.

The FDA said it plans to work with Congress to develop a regulation strategy for CBD. However, without a clear outline of the next steps, the budding CBD industry is left in limbo.

Yasmin Hurd, PhD, director of The Addiction Institute at Mount Sanai Hospital in New York, said she agrees with the FDA’s decision because commercial CBD products are not always marketed accurately and may even be contaminated with heavy metals.

“The decision by the FDA to not rule on allowing the use of CBD in dietary supplements or conventional foods is a big wake-up call for the CBD industry,” Hurd told Verywell via an email.

“Although clinical studies have consistently reported that CBD is safe and is generally well tolerated, we do not have the same knowledge about the CBD-infused products currently on the market,” she added.

Hemp-derived CBD is not psychoactive like delta-9-tetrahydrocannabinol (THC), the compound in cannabis that produces a high. Since the passing of the 2018 Farm Bill, Congress no longer considers hemp a controlled substance, but each state gets to decide its own laws around CBD.

Chad Johnson, PhD, co-director of the Masters in Medical Cannabis Science and Therapeutics program at the University of Maryland, said he believes the FDA wants the cannabis industry to progress, but “they just want to do it cautiously.”

Most CBD Health Risks Remain Unknown

CBD has been touted to treat anxiety, depression, and chronic pain but most evidence comes from animal studies, small clinical trials, or anecdotes.

“A lot of people say it helps. But until we do a real blinded study, it’s kind of hard to say for sure,” Johnson said.

So far, the FDA has only approved one CBD drug called Epidiolex (cannabidiol), which helps treat severe, rare forms of epilepsy. Some participants in the Epidiolex trial had mild side effects like sleepiness, elevated liver enzymes, and insomnia, but these risks may not be the same for other unregulated CBD products on the market.

The FDA is unsure about the safety of long-term CBD use. Some studies have suggested a potential for these products to harm the male reproductive system or interact with certain medications. Pregnant people and children may also be at a greater risk for adverse health effects.

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” Janet Woodcock, MD, the FDA’s principal deputy commissioner, said in a press release.

CBD products may also be contaminated with bacteria, heavy metals, or pesticides. Some research has also shown that these products contain different doses of CBD than written on the label—and some even contain THC.

Scientists are also still learning how different forms of CBD, such as vaping, edibles, or patches, might impact risk.

“Without strong support of research, we will continue to jeopardize harnessing the potential benefits that CBD could provide for many while limiting its health risks,” Hurd said.

CBD Regulation Is Left in Limbo

The FDA said a new regulatory pathway could help “manage and minimize risks related to CBD products” by creating clear labels, limiting contaminants, and creating a minimum purchasing age. The agency will also continue to monitor the marketplace and send warning letters to companies making unfounded health claims for CBD products.

However, Hurd said this announcement likely won’t have an immediate impact on CBD products on the market. She recommends checking third-party analysis before purchasing any products.

“Although it is challenging, consumers should try to do their due diligence and check out the companies selling the CBD products,” Hurd said.

Johnson also does not think that the FDA announcement will lead to any immediate, drastic changes. He said the FDA may randomly test certain CBD products for safety, but for now, regulation will continue to be left to the states.