Ask the Experts: Predictions on the FDA's CBD Hearing | cannabisMD

Ask the Experts: What to Expect From the FDA’s CBD Hearing

Testing tubes to test CBD.

The FDA is holding its first public hearing to decide if CBD should be approved as a “dietary supplement.” Image Credit: By Anton Prado PHOTO on shutterstock.

Today, the Food and Drug Administration (FDA) will hold a public hearing on products containing cannabis and its derivatives. The long-awaited move is expected to clarify the murky legal status of cannabidiol (CBD), the non-psychoactive compound that has emerged as a popular health and wellness trend.

While CBD has become a staple of many industries, including beauty and fitness, it’s currently prohibited for use in food and beverages under the Food, Drug, and Cosmetic Act of 1938, which states that all additives — such as CBD — used in such products must be approved by the agency. The FDA recently cracked down on businesses selling CBD-infused food and drinks without government authorization.

Greater regulation of CBD products has long been a priority of the cannabis industry. Small business owners across the country have expressed frustration at the unclear rules and slow pace of regulation. Meanwhile, multinational brands such as Pepsi, Coca-Cola, and Mondelez (the makers of Oreos and other popular snack foods) that are considering their own CBD-infused products have been reluctant to make commitments without a clear picture of the supplement’s legal status.

According to a statement from outgoing FDA commissioner Scott Gottlieb, “It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products — especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods.”

To gain insight into the potential implications of the FDA’s decision, cannabisMD spoke with a group of industry and medical professionals — including people on our team. Here’s what they had to say:

cMD Expert Roundtable: The FDA Hearing on CBD Regulation

On May 31, the FDA will hold its first public hearing on cannabidiol (CBD) to determine whether it should be approved as a “dietary supplement.” The implications could be huge for the future of the cannabis space — what resolution are you hoping to see? Are there any potential outcomes that worry you? How might this affect the lives of ordinary people around the country?

Dr. Matt Montee, primary care physician: This moment in medical history has been much anticipated. We knew there would come a time when the government would see that, “what is from the earth is of the greatest worth.” That time is now and I’m hoping to see that the government resolves any issues it has with cannabis as a medicine. Nature knows best.

Cannabis has the potential to shift entire communities into a more conscious state. Think about how you feel when cannabis is sensed in any form. From the aromatic therapy of terpenes to the anti-carcinogenic effects of CBD, cannabis is in its infancy as a game-changing medicine.

It would be an absolute tragedy if the government turned its back on a medicine that comes from a plant, is highly therapeutic, and is, in some cases, curative for a multitude of diseases.

Andrea Drummer, cannabis chef: As an industry professional, I would love to see CBD certified as a dietary supplement as a starting point of standard regulation. I believe that it’s important for anyone operating in the cannabis space that we maintain strong standards of quality. More importantly, it’s vital to the general populace. The average person should be able to trust the efficacy of the product that they are purchasing, whether it’s direct resale or an additive.

My concern is that CBD could be regulated the same as THC, which would offer limited access to those who may need it most. Recently, we’ve witnessed the unfortunate arrests of average Americans who are simply trying to manage their health and wellness the best way that they see fit. I want to see greater access to CBD for all Americans, and hopefully funding for additional medical research with fewer restrictions.

I also hope that regulation will be inclusive of the CBD industry as a whole. That is to say, we have to consider the future of the product and not just the confines of the immediate argument. We need to figure out a plan for regulating the future of cannabis, and that means considering how we’ll approach things like topicals, edibles, and commercial uses. If we don’t figure that out now, we’ll be back in the same position sooner rather than later.

Dr. Elizabeth Mironchik-Frankenburg, veterinarian: As a veterinarian and a cannabis educator, I am hoping to see the FDA move towards reasonably regulating hemp products and hemp-derived CBD products to ensure safety and quality. Currently, due to the lack of regulation, the public is exposed to products of varying quality and questionable safety. In addition, consumers have no reliable source of information, or resources at their disposal with which to compare products and measure quality. To promote consistency and quality in the hemp product marketplace, I believe in developing standards of product development and manufacturing that ensure accuracy in ingredient labeling, product purity, and safety profiles. To this end, having standard testing requirements and making test results readily available in the form of a Certificate of Analysis, would ensure products meet basic safety standards and would offer a fair measure of consumer protection.

Jordan Person, LMT, LPN: CBD is a buzzword these days, and for good reason. Cannabis is a special plant, and this is a special compound — it holds a lot of potential to help people around the world.

As a nurse, I have high hopes for the future of CBD because of my understanding of the medical possibilities of the plant. Put simply, its potential in natural, symptom-soothing drugs is immense.

I’d like to see CBD integrated into many aspects of medical treatments. For example, when a patient enters an emergency room or is admitted to the hospital, generally the first thing they’re given is an IV (intravenous fluids). These IV bags contain a solution of 0.9 percent sodium chloride, which is a salt water solution that begins to hydrate the body and help it return to its natural state of homeostasis, or balance. That’s also a key function of our endocannabinoid systems, which can be activated by CBD — it’s just waiting for the signal, especially in emergency situations. That’s why it’s my hope that, in the near future, IV bags will also contain small amounts of CBD. Homeostasis is always the body’s goal, so why not give it a helping hand?

On the other hand, as a small business owner I also understand how important this decision is for businesses like mine. The hearing on May 31 has the ability to change the CBD market forever. Currently the market is wide open and anyone can make CBD products, which I think is positive in many ways. You shouldn’t have to be a huge corporation to sell CBD. However, due to the lack of regulations, some consumers are purchasing bad or ineffective medicines, and that’s not OK. Everyone deserves access to clean and potent CBD.

Joshua Neilly, entrepreneur: The U.S. has missed out on a massive opportunity with medical cannabis, and I hope they won’t make the same mistake with cannabidiol (CBD). Interest in CBD is growing every year, and when the 2018 Farm Bill was passed last December, it was a sign that the country was in line with global trends.

Corporations knew that if they did not keep innovating and introducing CBD products, they were going to miss their window of opportunity to gain some of the market. So far, I think many companies have done a good job: there are countless shops selling CBD products now, and CBD-infused food products especially seem to be a big hit.

But this popularity has raised some valid concerns, too. First, there’s a real risk that CBD could become so integrated into society in an unregulated way that the proper research would not get done into its actual benefits (to some extent, we’re seeing this already). There’s also the danger of unseen, long-term “side effects” — poor control of the substance today could have severe future consequences that we can’t predict at the moment. With both facts in mind, I believe shortly we will see the FDA bring in some regulation, particularly around the amount of CBD being allowed in food products, to encourage research and responsible use.

I believe we’re more likely to see limits on the amount of CBD that can be infused or added, rather than an all-out ban. I also think there will be a strong crackdown on companies making false claims about the health benefits of CBD — all publicity isn’t necessarily good publicity, especially when it can damage consumer trust.

Jennifer Romolini, cannabisMD editor-in-chief: I think the FDA’s regulations, in whatever form they ultimately take, need to do two things:

First, they need to protect people (and their pets!) from dangerous or mislabeled products. Could you imagine if 70 percent of cough syrups didn’t contain the ingredients that were on the label? Would anyone feel comfortable buying them for their family? If we want CBD to be taken seriously as a natural health remedy, people need to be able to trust that they’re getting a safe, consistent product.

But secondly, these regulations also need to keep the CBD industry open to small businesses and entrepreneurs. Part of the reason CBD has become so popular is because it offers an alternative to obscenely expensive pharmaceuticals. If huge corporations are allowed to dominate the market, then I think we’ll see CBD lose a lot of its appeal.

There’s a change coming, that much is inevitable. And this is a good thing, because the status quo isn’t working that great for anyone. For me, what it comes down to is: do we want CBD to be something that legitimately improves the lives of as many people as possible, whether that’s by restoring their health or helping them earn a living? Or are we comfortable with it becoming a luxury only the rich can afford?

Editorial Staff
Editorial Staff
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