CBD and the FDA: The State of CBD Regulation

The CBD industry has been abuzz in recent months after long-awaited statements released by the U.S. Food and Drug Administration (FDA) suggested the “potential harm” CBD could cause. As you might expect, the warning sowed worry and confusion in many consumers, and some stakeholders even pulled their shares. But for many of us within the industry, as well as medical professionals knowledgeable about CBD and consumers who’ve been taking CBD for years, the FDA’s statements caused more facepalms and eye-rolls than anything else. ICYMI, we’ll catch you up to speed.

What the FDA said about CBD

Last November, the FDA issued warning letters to 15 different CBD companies that it said were in violation of the Federal Food, Drug and Cosmetic Act for certain language on those companies’ product labels. The labels in question were claiming categorical health benefits, stating that the CBD products could do things like prevent arthritis and treat opioid addiction, as well as offer curative benefits for people with Alzheimer’s, PTSD, schizophrenia and other more severe conditions. The FDA’s warning made clear that it is illegal to market products in this way, without the data and endorsement of a regulatory body (a.k.a. the FDA) to back it up. The only drug that currently has the stamp of approval is Epidiolex, the CBD prescription drug to help treat symptoms for those with two rare forms of epilepsy.

The FDA paired the warning letters with an update to their earlier guidelines, released in June, that expanded its safety concerns and primarily targeted CBD in food and dietary supplements, citing the lack of scientific data supporting its safety in those domains. The update went further, though, pushing the notion that CBD may cause liver injury, react negatively with other medications or herbs, and even damage male reproductive organs and fertility. (Yes, you read that correctly.)

The Administration assured, “We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety, and quality of many of these products.” It said that moving forward, they were specifically focusing on the effects of “cumulative exposure” to CBD, as well as its effect on “special populations,” like the elderly, children, pregnant women and animals. “The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation may be appropriate.”

Where they’re right

Considering how long the industry has been waiting for regulations from the FDA, some of what came out of the warning letters and updated guidelines is great:

• Companies should not advertise their CBD products as miracle cures or magic bullets for specific conditions, as there is simply not enough data from clinical trials for any assertion of that sort right now.
• It’s important that the FDA reiterated the distinct need for consumers to consult with their doctors before taking CBD for a medicinal benefit to discuss proper dosage and make sure the CBD product won’t interact poorly with other medications they may be taking.
• The warning also underscores something we continuously repeat here on CBD Products: how important it is for consumers to buy CBD products from companies that employ safe production and extraction processes—those that have third-party lab testing and always supply certificates of analysis for every product. In an industry flooded with overeager businesses trying to make it big and quick, too many companies don’t take the proper steps to ensure no metals are extracted from their soils and no contaminants get into their CBD products.

Essentially, the generous perspective is that the warning letters and guideline updates were the FDA’s way of saying, “Hey, just because we approved Epidiolex doesn’t mean we think all CBD you find anywhere is good to go.” It’s highly valuable for people to take a second look at the CBD products they’re buying and make sure they’re buying from reputable brands with safe practices and strong relationships with their consumers.

Where they’re not so right

On the other hand—and this is a big other hand—the FDA’s statements made broad claims and sweeping generalizations about the nature of CBD and its safety on the whole, without specifying exactly which data they were using to back up their concerns and how various forms, isolates, and dosages of CBD might influence their data and instruction differently. For instance…

• One of the biggest concerns the FDA laid out is that CBD could cause liver damage and other potential negative side effects. Well, as we wrote about in an earlier post, much of the still-limited data pointing to liver damage is from a study conducted on mice where the mice were given doses of CBD that were effectively 30x greater than a normal, recreational dose would be. Additional data comes from clinical trials for Epidiolex. But the thing is, Epidiolex is very different from most commercial CBD—it is a highly concentrated isolate, whereas most commercial products are comprised of a web of cannabinoid compounds that interact differently with the body than highly concentrated forms.
• The FDA indicated their concern over CBD’s potential to react with other herbs and botanicals, but with typical commercial dosages, there is no evidence to show that CBD would interact with herbs and botanicals any differently than typical foods and supplements would.

How the FDA compares to other regulatory bodies on CBD

What’s interesting is that two other major regulatory bodies, the World Health Organization (WHO) and the National Institute on Drug Abuse (NIDA), have supported CBD in their past statements. The WHO released an extensive report in 2017 in which they stated there is “no evidence . . . of any public health-related problems associated with the use of pure CBD” and it showed no potential for abuse or dependence. This report came after a 2016 article and senate testimony by the director of NIDA that said: “preliminary data suggests that [CBD] may have therapeutic value for several medical conditions.”

So where the WHO and NIDA reported on specific data and opted to highlight CBD’s limited negative effects and vast potential, the FDA instead made blanket statements, opted for fear and doubt, and still didn’t provide the regulation the industry craves. The CBD industry and the companies in the industry are passionate about their products and the benefits they see for consumers. They truly want to comply with appropriate regulations, if they were given any. But instead of providing more extensive standards for safe CBD production and ushering more studies to the fore, the FDA is sitting back to watch and deem things “illegal” as they come up.

What to take away

Despite the FDA’s warnings of peril, there is no actual need to worry. The biggest thing to take away from the Administration’s statement is that, if you don’t already, you should always buy from companies with clean, safe production standards and reputable public relationships. You should definitely consult with a medical professional if you’re looking to take CBD for potential therapeutic benefits and symptom relief for predetermined conditions. And you should opt for lowest doses first, and only scale up if and to the point that you experience no negative effects.

Thankfully, we know that the companies and brands we partner with are already taking all the regulatory measures possible to ensure the safety of their products. Our mission is to keep consumers informed, safe and healthy, and we will always work to keep you up-to-date on the latest CBD research and companies doing great work.