Is CBD Safe? - Regulations, Research, Use Data & Beyond

On May 31st, 2019, the FDA held a public hearing to collect scientific data and information about the safety, manufacturing, quality, marketing, labeling, and sale of products containing CBD. After the hearing, the FDA opened a docket for public comments which closed on July 16th, 2019.

Among the 4,000+ comments submitted, the US Hemp Roundtable submitted an extensive report including feedback from dozens of member companies. This 29-page document appeared in their news article titled: Roundtable to FDA: “CBD is Safe. Here’s the Data.” The document provides a high-level look at the wealth of safety-related information on the use of hemp-derived products as well as some important use data.

The circulation of this information offers us a chance to highlight the complete scope of currently available information on the safety profile of CBD use. Below we dive into current research, data from the above-mentioned report, and more supporting details to provide a complete picture of the current status of this important topic.

CBD is Currently Unregulated

Before we dive in, it's important to discuss why these public comments are being submitted. The CBD industry is currently unregulated, and the industry at large is looking to the FDA to establish fair governing rules. Within the currently unregulated market, product consistency, quality, and ingredients can vary wildly and this creates unnecessary negative safety concerns.

Luckily the growth of the industry over the last 10 years has seen top companies in manufacturing and direct to consumer sales shine. Today there are leading organizations like the Hemp Roundtable that are working to educate and promote quality practices to ensure product quality and purity. Education has helped inform consumers what to look out for as they shop, but regulation is needed.

If everything goes well, the FDA will take the wisdom and data provided by the public comments, hearings, and their internal expertise to establish regulations which will enforce good manufacturing and marketing practices to ultimately protect consumers. This will help establish official positions on the safety profile of CBD products and help consumers access products which meet quality standards that enable this safety profile to exist.

At the time of writing, the FDA has intended to respond in late summer/early fall 2019. Until official regulations are released, let's take a look at the current safety-related information available.

CBD is Widely Shown to Be Safe & Well Tolerated

While the industry waits for regulatory guidance, there is a wealth of information already out there from highly reputable sources pointing to the safety of CBD use. Below we've compiled some notable published research and documentation on the safety profile of cannabidiol. Note that these data points are not advice or clearance, and should be taken as informational only:

The World Health Organization published a critical review of cannabidiol in June 2018 which included the following statements in the summary:

In humans, CBD exhibits no effects indicative of any abuse or dependence potential.

CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.

To date, there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.

As a part of the process to get Epidiolex approved by the FDA, the Department of Health & Human Services (HHS) submitted a letter to the Drug Enforcement Agency (DEA) in May 2018. This letter suggested that CBD be re-scheduled to Schedule V from its then classification as a Schedule I substance. Though hemp and it's CBD-rich derivatives were later de-scheduled in the 2018 Farm Bill, these comments are still valid:

The HHS stated: "CBD also does not appear to produce physical dependence." The letter also goes on in to provide a wealth of supporting research. In this data, they state "there is little indication that CBD has abuse potential or presents a significant risk to the public health."

Food Standards Australia New Zealand (FSANZ) found in their review of cannabidiol's hazard profile that: "CBD administered by the oral route has been investigated in clinical trials in healthy subjects and in patients with various medical conditions. CBD has been shown to be well tolerated at doses greater than 1000 mg per day. No reports of adverse effects attributable to oral CBD were located in the published literature."

A 2017 review of clinical data on the safety and side effects of cannabidiol by Iffland and Grotenhermen concluded that "In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight."

Real-World Data Supports CBD's Safety Profile

While the above reports are encouraging, the recent letter by the Hemp Roundtable provides notable real-world evidence to help support these conclusions.

Several companies in the Roundtable group provided data on reported adverse reactions. The paper includes data from the sale of millions of products - with striking real-world results showcasing CBD's safety profile. The US Hemp Roundtable states in their blog post:

"In fact, in a test including millions of products sold, less than 0.1% reported ‘adverse events’ related to human ingestion or topical application of CBD products. This data clearly showed that CBD does not appear to pose unreasonable safety risks to consumers and therefore can be regulated by the FDA like any other botanical ingredients used in these products."

In these reports, non-serious adverse events ranged from "lack of effect" to "headache" and "abdominal discomfort". Here is a summary of the data from the four companies who submitted data to the organization:

Approximately 580,000 products sold resulted in zero serious adverse events and 308 non-serious adverse events.

Approximately 1,400,000 products sold resulted in zero serious adverse events and 623 non-serious adverse events.

Hundreds of thousands of products sold resulted in an average of less than 0.1% complaints per product sold.

Over 2,000,000 products sold resulted in zero serious adverse events and 220 non-serious adverse events.

This encouraging data provides large-scale statistically relevant anecdotal support for the research indicated safety profile.

What About Safety for Animals?

While the data for humans is growing, what about animals? The National Animal Supplement Council (NASC) also submitted comments to FDA that included the data points from their database regarding hemp and hemp-derived compounds used in pet products.

There are 209 NASC registered products with hemp & hemp-derived compounds.

These ingredients have been on the market for 10 years.

There is well-documented use in Dogs, Cats, and Horses.

In total there have been zero serious adverse events and 10 non-serious adverse events reported in nearly 34 million administrations across the 3 species.

The NASC does note that it agrees additional research is needed but that “the data at this time suggests these compounds, provided by responsible companies, does not pose risk to dogs, cats, and horses.”

Potential Risks: Side Effects & Drug Interactions

While the studies and anecdotal evidence support a safe profile for CBD use, the compound is also not without some risks.

Though it's often well-tolerated, CBD has been studied to carry some non-serious side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. The compound has also been shown to carry the potential for liver issues if used extremely high doses that are very, very far above standard dosages.

Perhaps the most important topic though is CBD's potential for drug interactions. The compound is processed by the same bodily systems that process a wide range of other drugs. For more on the topic, see our post outlining CBD's potential for interaction with other drugs. More research is needed in these areas looking at specific populations, applications, and ingredients.

Future Outlook: Promoting Good Safety Practices

From a broad perspective, the industry, consumers, and FDA all want guidance and standards in place. The mission to reduce bad actors while creating safe products for consumers is a universal goal. While top brands are setting an example, fair top-down guidance from the FDA would align the entire industry and allow it to grow and improve safety-related knowledge and research.

Some of the ways that this might be accomplished are by creating manufacturing, quality, and testing standards. Creating standardized definitions for ingredients and marketing and labeling processes, consumers can clearly know what is in, and what to expect from the products they purchase.

Here at Big Sky Botanicals, we are committed to providing top quality products that adhere to industry best practices and future regulations. We accomplish this today by sourcing the best quality products available, providing transparent information around our product creation processes, and publishing a wealth of supporting information. We look forward to continued improvement and safe use across the CBD industry.