The US Food and Drug Administration issued letters to 15 companies for illegally selling CBD products, and released information on the possible risks from using CBD.
THE U.S. FOOD AND DRUG Administration on Monday updated its guidance on CBD, warning consumers that the compound “has the potential to harm you.”
The update is the strongest stance the agency has taken on the compound and notes serious concerns with the widespread use of the substance.[
The agency also announced that it sent warning letters to 15 companies for illegally selling products with CBD in ways that violate current law.
CBD, a non-psychoactive compound that can be extracted from cannabis plants, has exploded in popularity across the U.S. since Congress legalized hemp, a type of cannabis that contains low levels of the psychoactive compound THC, late last year.
Gummies, drinks, tinctures, oils, skin creams and a multitude of other products containing CBD have proliferated across the consumer landscape and the compound is purported by many enthusiasts to be an effective remedy to insomnia, stress, anxiety, aches and pains, and other ailments. While there is some evidence to back a few of the claims, research is limited, in part because of the challenges in studying a plant that, until last year, was illegal.
The FDA has struggled to regulate CBD and is currently reviewing whether or not it will allow the compound to be treated like a dietary supplement, akin to Vitamin C or fish oil.
It is currently illegal under federal rules to add CBD to food or drink, though the agency has not strictly enforced that law. The agency has, however, sent warning letters to companies that make outlandish health claims while marketing CBD products, including claims that the substance can treat cancer, dementia or other serious diseases.
Purified CBD is the active ingredient in one FDA-approved prescription drug to treat two rare forms of epilepsy – a fact that has complicated the regulation of non-prescription CBD products.
“The FDA is concerned that people may mistakenly believe that trying CBD ‘can’t hurt,'” the agency says in its guidance statement. “The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered.”
The guidance lists several concerns, including evidence that CBD can cause liver injury. During the marketing application for Epidiolex, the seizure medication, the agency identified a risk of liver injury. The risk “can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling,” according to the agency.
Testing of Epidiolex also showed a risk of CBD causing adverse drug interactions and affecting male fertility.
But the form of CBD used in Epidiolex is purified and taken in high concentrations – different from the CBD how most casual consumers take.
“There are many important aspects about CBD that we just don’t know,” the FDA says in its guidance, listing several concerns, including the unknown effects of CBD on the developing brain and what happens if someone takes CBD for a sustained period of time.