FDA Hearing on CBD: Creating a Path for Regulation

Buyer Beware: The efficacy of these products have not been confirmed by FDA-approved research. Image Credit: By mark reinstein on shutterstock.

On May 31, 2019, the US Food and Drug Administration held its first public hearing on cannabidiol, or CBD, gathering information from CBD producers, hemp growers, pharmaceutical companies, state regulators, and individuals personally affected by CBD. After ten hours of testimony and more than 100 people speaking, the clearest takeaway from the hearing might be that there is no clarity yet. In fact, the hearing technically is not finished. The FDA will continue to accept public comments on the hearing until July 2.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” said Dr. Ned Sharpless, acting commissioner of the FDA, as the hearing opened.

CBD has exploded in popularity and products, but there is no regulatory system in place to make sure that consumers are getting the CBD they paid for and nothing else. Even as major chains such as Bed Bath & Beyond, Kroger, Walgreens, and CVS roll out CBD products in many states, state regulatory arms and the FDA say it is absolutely still illegal to introduce CBD into the food supply or sell it as a dietary supplement. However, hundreds of new CBD products continue to flood the marketplace each month.

CBD Products: Legal or Illegal?

While the 2018 Farm Bill made the production and interstate transport of hemp-based products legal (those containing 0.3% of the psychoactive THC or less) by removing it from being classified as a controlled substance (an illegal drug), it clearly left room for states and the FDA to regulate those products, especially if they are introduced into foods, beverages, or supplements. The FDA so far has not created those regulations. Individual states are also scrambling to come up with their own guidelines for growing and harvesting hemp, as well as regulating hemp-based CBD products.

Sharpless said at the hearing the FDA’s big concern is for people’s safety. He said there are many vital pieces of information that are yet to be uncovered about CBD. The FDA’s stance is that regulations and safety standards are critical to ensure consumers do not purchase CBD products that actually contain little to no CBD. Also, products need to be regulated to make sure they are not tainted by unwanted substances and to be sure that the THC really has been removed or was not in the strain of hemp from which the CBD is being extracted.

Until more research and clinical trials exist and there is a regulatory standard in place, CBD products, especially those that appear to be supplements or foods or beverages that make any claims of healing, remain illegal in the United States.

How Can CBD Products Be Illegal and Still Be for Sale Everywhere?

The legality of CBD products remains “clear as mud,” many say, but products remain on store shelves because companies include a clear disclaimer on the labels that they are making no claim the product will benefit your body. It usually reads something like this:

“The statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease.”

This phrase is probably familiar, as many popular dietary supplements on the shelves at your favorite drug store also wear this on their labels. The warning tells the buyer: “You can use this, but we’re not saying it will help you.” It all comes down to, “Buyer beware.”

CBD products also remain on the shelves because, as one speaker put it, “the genie is already out of the bottle.” The consumer demand for CBD products is by far outpacing the government’s ability to regulate it. The CBD market is predicted to reach $15 to $20 billion in the next few years. Some statistics show one-fourth of Americans use or have tried CBD already. The marketplace is pushing CBD forward at a fast and furious pace. That’s good for those who believe CBD truly helps their health, but it’s also a cautionary tale because without regulations and industry standards in place, it is tough to know which companies to trust and how to be sure you are getting the same CBD every time you buy.

CBD Research and Trials Much Needed

The one major fact most at the hearing agreed upon was the need for more scientific study, research, and evidence beyond the anecdotal that CBD is beneficial to the health of humans and animals. Research and clinical trials in the US have been few and far between until recently because of hemp’s former classification as a controlled substance. It was tough to study it if even possessing it broke the law.

As of now, Epidiolex is the only FDA-approved drug formulated from CBD. It has been approved to treat seizures associated with rare types of severe epilepsy in children – Lennox-Gastaut syndrome and Dravet Syndrome. It launched on November 1, 2018.

Still, the FDA seems to understand the need for CBD clarity and the urgency consumers feel for using CBD products legally.

“Drugs have important therapeutic value, and it is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis,” Sharpless said. A recent tweet by Dr. Amy Abernathy, the FDA’s acting CIO and principal deputy commissioner and acting CIO, also seemed to support the need for the FDA to move quickly on the subject f CBD, as she wrote: “given the rapid expansion of the market, timely clarification of the path forward is critical.”

What CBD’s Murky Legality Might Mean for Christians

For those who follow Christ and want optimal health in their bodies, the fact that CBD is a natural substance derived straight from plants created by God is a plus. Those who use it firmly believe that what God designed trumps what man manufactures. The Bible instructs us to treat our bodies well, as they house the Spirit of God. What we put into our bodies matters, CBD included.

Our best advice: Do your research. If you want to use CBD, choose your products carefully by educating yourself on the company you’re buying from, the hemp they source their products from, and the claims they make. Are they growing and harvesting legally? What kind of testing are they doing to make sure their CBD products actually contain the amounts of CBD they purport to have? What kind of testing are they doing to make sure other unwanted substances are not getting into their CBD products?

Ask trusted friends, your medical providers, and church leadership to learn about CBD with you. Let your pastorate know you’re looking for solid, thoughtful advice from the pulpit. Christians need to become informed, not accept a knee-jerk reaction that all CBD is bad because it is even remotely related to the marijuana plant family. Or a flat acceptance that all CBD as good because God made it. God created us with brains that have the capacity for logic, reasoning, and analysis. Let’s use them to have informed conversations and make informed decisions about CBD.

Natalie Gillespie

Natalie Gillespie

Natalie Gillespie is an author, journalist and editor who has published more than 2,000 articles in the last 20 years in magazines and websites such as HomeLife, Guideposts.com, and Publishers Weekly.

You can reach Natalie with article ideas, personal testimonies, theological thoughts, or just to say “hello” at [email protected]
Natalie Gillespie

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Natalie Gillespie
Natalie Gillespie
Natalie Gillespie is an author, journalist and editor who has published more than 2,000 articles in the last 20 years in magazines and websites such as HomeLife, Guideposts.com, and Publishers Weekly. You can reach Natalie with article ideas, personal testimonies, theological thoughts, or just to say “hello” at [email protected]

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