CBD is everywhere! Gummies, oils, vape, dog treats, lollipops, brownies… you name it, someone sells it. Frankly, I find it fascinating to witness the chaos. Market participants (manufacturers, distributors, consumers, etc.) are paving a path that weaves through a landscape of regulations and research concerns. The FDA is not “anti-CBD”, but the administration is certainly trying to regain control of the reins that are flopping in the wind.
The FDA has issued four warning letters to firms marketing CBD products in 2019 (as of Oct. 1, 2019). These letters will enable us to get a general grasp of the areas where FDA is applying pressure. In this article, I will focus specifically on FDA’s warning against sales of unapproved new drugs. This is one small piece of a very large CBD pie (watch out for 21 U.S.C. 331(ll) if you are selling such pie). Therefore, I will likely cover additional warnings in subsequent articles. Let’s begin with a general review of FDA’s unapproved new drug warnings to CBD companies.
Unapproved New Drugs
If we are going to begin to understand this first violation that FDA is slapping companies with, we must understand how a “drug” and “new drug” are defined. My pharmacy friends may be thinking, “I know what a drug is!” But we need to understand how FDA defines it. You will want to look to 21 U.S.C. 321(g)(1) and 21 U.S.C. 321(p) for the definition of “drug” and “new drug”, respectively. Don’t worry! I will provide the important parts.
Let’s do drugs first. Let’s start with “drug.”
Based on the definition, a drug is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease . . . and/or intended to affect the structure or any function of the body.” If you are looking at the definition, this is one of those cases where “and” could mean “or” (law joke, but seriously).
What claims does FDA consider to constitute a drug?
Here’s where it gets fun! You likely see various ads all over the place for CBD products. CBD can cure cancer, prevent the flu, and put an end to male pattern baldness (kidding, but I’m sure some company has made similar claims). So, what type of claims contain the necessary intent for a CBD product to be a drug? Here are a few that FDA listed in their recent letter to Curaleaf, Inc.:
- “[F]or chronic pain.”
- “CBD oil can be used in a variety of ways to help with chronic anxiety.”
- “CBD has been shown to be effective in treating Parkinson’s disease.”
- “CBD has been linked to the effective treatment of Alzheimer’s disease.”
- “Some of the most common reasons to use CBD oil include . . . Chronic pain . . . mental conditions like anxiety, depression, and PTSD . . ..”
As you read through these claims, think back to the definition. Is the company advertising its CBD product with the intent of “diagnosing, curing, mitigating, treating, or preventing disease?” Does the claim appear to indicate an effect that the CBD product will have on the structure/function of the body? When reviewing a claim, if the answer to either question is “yes” then the chances are higher that FDA would consider the given CBD product a “drug.”
Now, let’s transition to what it means for a product to be a “new drug” and why it matters. Under 21 U.S.C. 321(p), “new drug” means that “such drug is not generally recognized . . . as safe and effective for use under the conditions prescribed.” In other words, the FDA has not approved the product as safe and effective for the claim listed. For example, if a CBD product is for sale online and the distributor states that it is meant to treat chronic pain. But the FDA has not approved said CBD product as safe/effective for treating chronic pain, then the product may be considered a new drug.
Drug/New Drug Summary
If you see a CBD product advertised online or in-person, you first want to consider whether or not it meets the definition of a “drug.” Focus on the claims being made and keep FDA’s definition from 21 U.S.C. 321(g)(1) in mind. Then, consider whether FDA has approved the product as safe and effective for the indication in the claim (e.g. pain). At this point, the answer will almost always be “no.” This will indicate that the product may be a “new drug.” The introduction of “new drugs” into interstate commerce is illegal without FDA approval.
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