Ask the Experts: Was the FDA’s Latest CBD Warning Too Harsh?

Expert insight into the FDA's recent CBD warning

While more research is needed to fully understand CBD, many experts believe it to have a positive safety profile, especially compared with conventional medications. Image Credit: By Tinnakorn jorruang on shutterstock.

A few days before Thanksgiving, the Food and Drug Administration (FDA) made an announcement about CBD that inspired ominous headlines around the country:

FDA Warns Consumers:‘CBD Has the Potential to Harm You’

The FDA’s letter emphasized the many things we still don’t know about CBD, including its potential for interacting with other medications and the effects of taking it for extended periods of time. It also pointed out — correctly — that many CBD brands are guilty of making low-quality products and marketing them with inflated health claims. At best, this is a deceptive and unscrupulous practice. At worst, it’s downright dangerous to public health.

Yet to many people, the FDA’s CBD-related skepticism seemed a bit over the top. Curiously, it cited few specific examples for many of its more provocative claims, like “CBD can cause male reproductive toxicity.” And while the FDA is absolutely right that more studies are needed to give the public a clearer picture of CBD’s potential risks and benefits, the agency made no mention of the fact that many researchers and doctors have found the non-intoxicating cannabinoid has a positive safety profile, especially compared with conventional medications. In fact, a report from the World Health Organization (WHO) stated that CBD is “generally well tolerated with a good safety profile” and “there is no evidence of … any public health-related problems associated with the use of pure CBD.” 

What Medical Experts Think About the FDA’s Latest CBD Warning

To help our readers make sense of the FDA’s announcement, we asked four cannabisMD medical experts to share their thoughts on what it means for the future of CBD. Here’s what they had to say:

Dr. Joseph J. Morgan: In my opinion, the FDA’s warning was justified and long overdue. Unscrupulous and/or insufficiently educated folks have been pushing mislabeled CBD products, and there are problems at every step of the supply chain: sourcing, harvesting, extracting, manufacturing, distributing, and so on. Worst of all, many of these products come with health claims that are not supported by appropriate data. 

Right now, there’s only one rigorously tested, FDA-approved CBD medication: Epidiolex, which is made by GW Pharma. The company is only allowed to make two specific claims about its uses (for treating rare forms of childhood epilepsy), and it has a rigorous clinical research program to determine other potential uses. Other companies shouldn’t be allowed to skip this step. It’s not a free speech issue, but rather one of non-deceptive claims. Back in 1906, the government passed the Pure Food and Drug Act to safeguard the public against being misled by corporations, and that’s still important today. Like any substance, CBD is not innocuous — even vitamin C can cause adverse effects like diarrhea when taken in excess. 

The fact is brands have been misleading consumers since the CBD boom started, and it’s up to the FDA to protect people. Every product should have its THC and CBD content carefully tested by independent third-party labs — and the real amount should be within 10 percent of what’s on the label (as is standard practice for dietary supplements). This means if a product claims to contain 500 mg of CBD, it should have no less than 450 mg and no more than 550 mg. That’s just ethics. We need to put more emphasis on quality control, too. No products should contain unsafe levels of contaminants, and if they use any solvents these should be prominently disclosed. On top of that, every batch of products should be labeled with a unique number and labs should retain a sample from each batch for future reference. 

Dr. Elizabeth Mironchik-Frankenberg: I believe last week’s ‘consumer update’ from the FDA about CBD was a disappointment. Since the public hearings conducted last May, interested parties from all areas of this industry have been eagerly awaiting a progress report on the agency’s task to develop a regulatory framework surrounding CBD products. Instead, the statement was simply a stronger reiteration of the FDA’s previously stated concerns about CBD — and another example of the government using scare tactics to sway Americans’ views.

From the veterinary perspective, I agree that use of any CBD products should always be discussed with a pet’s healthcare provider, and that further testing and evaluation are needed to better understand the potential risks and long-term effects. This is generally accepted by the veterinary professional community. However, I object to the over-stating of potential harm, without the corresponding information on the potential benefits that have recently been elucidated. This one-sided perspective is doing an injustice to the public.

While the FDA is working on answering the myriad of questions about the science and safety of CBD products and their long-term impact, the fact remains that the answers to some of these questions are years away. Meanwhile, people are using these products now. American consumers need practical help, not conjecture and a ‘wait and see’ approach. What would be preferable, is an actual update as to the progress the FDA is making in their task to move this industry forward. From the consumer safety aspect, there is an urgent need for regulation to ensure that product companies provide safe, accurately labeled CBD products to the American people and their pets.

Jordan Person, LMT, LPN: When it comes to CBD regulation, the FDA’s number one goal should be harm reduction. The hard part is figuring out how to do that: the industry has grown so fast, and it’s undeniable that a lot of substandard products are flooding the market. Still, I think the blanket statement that “CBD is potentially harmful” goes a step too far.

There’s a significant amount of scientific evidence that CBD could be helpful for treating seizures, various types of pain, and anxiety, among other things. In my view, the biggest risk of CBD is its potential to interact with certain pharmaceutical drugs. We need to research drug interactions in greater detail, and if a CBD product is found to interfere with a given drug, that needs to be described in a clear and prominent way on its label. 

While I believe the FDA’s warning could have been phrased better, it was also both overdue and necessary. Companies shouldn’t be allowed to make false or inflated claims without consequences. CBD has become such a phenomenon because high-quality products do have the potential to help people. We just need to ensure any CBD that makes it to market is safe and effective (which includes testing for potency, heavy metals, pesticides, and more). I’m looking forward to the day when we have a strong regulatory framework, which will be great for both the CBD industry and the public at large. 

Dr. Ron Schefdore: The FDA poses several valid points within their statement. Chief among those arguments is the tragic deficit of credible clinical studies performed on cannabis products (including hemp-derived CBD) for practitioners to reference when treating their patients. As a result, we don’t know all of the health benefits of medical cannabis, nor do we have a clear understanding of the long-term effects of regular CBD consumption. What we do know, is that the removal of hemp-based CBD from the definition of marijuana (as stated in the Controlled Substances Act of 1970) has attracted a veritable tidal wave of entrepreneurs, desperate to offer products that are largely untested and – in the case of hemp-derived CBD – unregulated. It’s clear their sole motivation is simply to “make a buck.”  

Of course, the products that are sold in licensed medical marijuana dispensaries are very closely monitored, and constantly inspected for quality and purity. But the hemp-derived CBD that you can order online and have delivered right to your door does not have to undergo such stringent checks and balances. In my opinion, this opens the door to rampant medical quackery from a group of people who are much more concerned with their bank accounts, rather than the health and safety of their customers. That is why – by and large – I am quite skeptical of most “over-the-counter” CBD products.

However, I think that the FDA should be spending more time recommending the government drop cannabis from a Schedule I narcotic classification to Schedule III (which would actually allow them to conduct the research they need) rather than releasing articles like they did last week. Statements such as these seem to serve little other purpose than gaslighting a number of people who could possibly benefit from The Plant, but are now too afraid to try it.

Dr. Mary Clifton: It’s important that regulatory agencies approach new drugs conservatively. Look at the opioid epidemic — we are witnessing the results of setting aside age-old wisdom and prematurely embracing new products. However, cannabis and CBD aren’t new drugs by any measure. Medical use was commonplace until Prohibition took effect in the 1920’s. 

In 2018, the FDA approved CBD in the form of Epidiolex, a purified CBD derived from cannabis, for management of complex seizure disorders based on sound scientific data on safety and efficacy. CBD and other cannabinoids are generally harmless, and may function to protect the liver and other vital organs, such as the heart and nervous system, when individuals are exposed to toxic chemotherapy during cancer treatment. 

Given the situation of modern day pain management, it’s unwise to approach CBD formulations with the same conservative approach that has been applied to new pharmaceuticals in the past.

Nick Slater
Nick Slater
Nick Slater is the executive editor of cannabisMD. His work can be found in Slate, National Geographic, The Daily Beast, and many other outlets. He’s also a professional scuba diver.

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