By: Thomas Bush (Summer Associate)
Having a tough time understanding blockchain? So am I, so let’s not go there.
I do think it is important, however, to address a seemingly grey area in the law today – Cannabis regulation. I am sure some of you have recently become familiar with the term “CBD”. CBD, in addition to THC, are two of the most commonly known compounds in the Cannabis plant. Their impacts on the human body are very different. THC provides “the high” often associated with marijuana, while CBD elicits a more calming, relaxing effect. Now, you are probably scratching your head thinking, “alright, Thomas, then what the heck is hemp?” Hemp is legally defined as, “the plant Cannabis sativa . . . with a [THC] concentration of not more than 0.3 percent . . .”. Simply put, if the Cannabis contains more than 0.3% THC, it is not hemp.
On December 20, 2018, the President signed the 2018 Farm Bill into law, which effectively removed hemp as a controlled substance under federal law, making it an ordinary agricultural commodity. Cannabis above 0.3% THC (i.e. marijuana) remains a Schedule 1 drug and is very much still illegal (except for you, Illinois). The purpose of these changes was to promote the farming and sale of industrial hemp. Hemp has long been manufactured into a variety of commercial items such as paper, textiles, clothing, biodegradable plastics, foods, and today, the ever-so-trendy, CBD-infused products.
How do hemp-derived CBD-infused products fit into this new law? Unfortunately, there is no clear answer (yet). CBD products must still obtain FDA approval. The FDA’s primary function is to regulate what we put into our bodies, so even though CBD-infused products may qualify as “hemp” under the 2018 Farm Bill, this does not automatically mean they are legal for human consumption. To date, the FDA has only approved one cannabis-derived drug product: Epidiolex. This drug contains a purified form of CBD used to treat seizures and requires a prescription from a licensed healthcare provider. The FDA has not yet approved CBD as a dietary supplement or food additive like they have with fish oil or sugar.
The reality of it is, however, CBD products are being sold everywhere today. I mean literally everywhere – yes, even Family Video. Is this legal? Technically, no. The Des Moines Register published an article on March 8, 2019 reporting that law enforcement officials across Iowa have been seizing and confiscating CBD products. Additionally, in signing the Iowa Hemp Act on May 13, Governor Reynolds further emphasized the continued illegality of selling and manufacturing CBD products, and that sellers must wait for the federal government to take the lead.
The FDA is moving quickly to address this. On May 17, 2019, Dr. Amy Abernethy with the FDA made a statement saying the agency is working on regulatory strategies to determine whether it is safe to include CBD in foods and other consumer products. It also held a public hearing on May 31 to discuss the short and long-term effects of CBD consumption and have established a docket for public comment to help gather more information that will close on July 16, 2019. This hearing and comment period gives CBD industry leaders an opportunity to present information and explain why the FDA should allow their products in the marketplace.
Across the U.S., the popularity of these products is showing no sign of slowing down, and the marketplace is alive and well. Conservative estimates predict CBD sales could reach $16 billion nationwide by 2025, which makes FDA intervention heavily anticipated and much-needed. A Washington D.C. lawyer, who represents a synthetic pharmaceutical-grade CBD producer, said in a recent article, “The horse is so far out of the corral here that it will be interesting to see what FDA decides to do – or can do at this point”.
Thomas is a Quad Cities native who earned his Bachelor’s Degree from the University of Notre Dame and currently attends Drake University Law School. He is involved with the James Arthur Albert Foundation and is a member of Delta Theta Phi International Law Fraternity. He also interned at the Center for the Homeless. Thomas has four younger sisters and he’s the proud uncle of two boys and enjoys stand-up comedy and cooking.