Shortly after publishing my last post (“FDA’s ‘New Drug’ Warning to CBD Companies”), the FDA uploaded two additional warning letters. In addition to the unsubstantiated claims that I addressed last week, the FDA is also focusing on conventional foods. I received a few questions regarding the addition of CBD to food products and wanted to address it briefly. After this post, my plan is to move away from CBD until the FDA issues their promised guidance (hopefully before the year ends). So let’s get chewing… is it legal to add CBD to food and sell it?!
Short on time? Here’s the answer…
No. Food containing CBD cannot be introduced into commerce. If you awoke suddenly last night and thought, “I’ll create CBD-infused ice cream!”… I’ll ask you to pause for two reasons. First, it’s already been done. Second, you will be going against the current law if you try and sell your new creation. Lowel Schiller recently made this point clear when making remarks at the National Hemp Council 2019 Hemp Business Summit (Aug. 13, 2019). Mr. Schiller repeated this statement: “Under current law, it’s unlawful to sell a food or a dietary supplement with CBD in interstate commerce.” If you don’t like this answer and want to sell your ice cream regardless… may I suggest the name “Miracle Moo”? “Cannabinoid Chip”? “Naturally Baked”? Ok, I’m done.
How is “food” defined?
Law school makes you ask questions like, “what does ‘the’ mean?” Don’t worry, chances are I’m not going to rewire the way you think of “food.” Here’s the full definition to get things rolling: The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. 21 U.S.C. § 321(f).
The meat of the issue…
So why is it illegal to sell a food product containing CBD? You need to focus in on 21 U.S.C. § 331 (ll). I will break up the language for you…
- It is prohibited to introduce into interstate commerce,
- any food,
- with an active ingredient of
- an approved drug OR a drug for which clinical investigations have been instituted and made public.
The final bullet deserves additional attention.
Approved Drugs and Clinical Investigations
These terms are important. I will explain them and then discuss where CBD fits into the mix. “Approved drug” comes from 21 U.S.C. § 355. For our purposes, we only need to focus on the fact that this represents a product approved as safe and effective by the FDA. An article that is an active ingredient within an approved drug may not be added to food. Similarly, an active ingredient within a drug subject to substantial clinical investigations may not be added to food. A drug subject to such investigations may or may not be approved by the FDA.
The FDA has concluded that CBD may not be added to food because it falls within the two categories mentioned above. CBD is an active ingredient in an approved drug and it was studied clinically many years prior to that approval. FYI… The FDA is speaking about Epidiolex. Since CBD is the active ingredient in Epidiolex (an FDA-approved drug), CBD cannot be added to food. Even if Epidiolex was not approved in 2018, CBD still could not be added to food since Epidiolex was studied clinically for years.
For the sake of completeness, it is important to acknowledge that there are exceptions to the two provisions detailed above. However, the FDA has concluded that these exceptions do not apply to CBD. Therefore, I won’t discuss the exceptions but encourage you to reach out if you have questions.
Remember, if you are asked whether or not CBD can be added to food and then sold, the answer is no. This is the answer because CBD is the active ingredient in an approved drug and also because CBD was subject to substantial clinical investigations prior to being added to food. I apologize if I melted your ice cream-related business plan.
I am truly enjoying the process of receiving questions, digging in, and answering them in private or on this site. Thank you for reading and for engaging. You can contact me at firstname.lastname@example.org or find me on social media.
As always, please remember that I am NOT a lawyer. If you need legal services or advice, please consult an attorney.