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In today’s video, we talk about marketing CBD oil products, and what FDA allows vs. what FDA prohibits.
In the Wild West gold rush into the CBD oil market, many healthcare companies and startups forget that FDA continues to enforce FDA laws and regulations, even in this new and booming market.
My name is Michael H. Cohen and I’m founding attorney of the Cohen Healthcare Law Group. Having advised over 1,000 healthcare industry clients on healthcare and FDA legal issues, we know cannabis industry regulation and how companies promoting CBD oil products can run afoul of the legal rules.
Today, I’m going to explain the basics of FDA law governing CBD Oil Claims.
First, understand that FDA is not anti-cannabis. On the contrary: FDA recognizes the therapeutic potential that cannabis products have. However, FDA is most interested in having cannabis products get to the market through the drug approval process.
Drug approval means that FDA has determined that the cannabis product is safe and effective for its intended use. This is great news for patients, and for cannabis government regulators. It’s bad news for companies in the cannabis industry that don’t have millions, if not tens of millions, of dollars and a half dozen or more years to get through the new drug approval process.
Second, while FDA regulates “drugs” through the drug approval process, FDA regulates dietary supplements and cosmetic primarily by regulating the claims companies make about these products. And FDA is telling us to be careful not to make claims about CBD products that promise treating medical conditions. This includes both physical conditions—such as cancer and diabetes—and also psychological conditions, such as anxiety. And FDA regarding claims about treating “pain” and “inflammation” also as prohibited, treatment claims.
Third, look to the CBD products themselves and understand that FDA’s first job is to classify the product. Besides being classified as a “drug,” a product can be a food, a food additive, dietary supplement, cosmetic, medical device, biologic, or radiation-emitting device. It’s unlikely you’ll find a CBD product in one of the latter categories, but the question is, can THC and CBD products themselves be considered “dietary supplements?”
FDA says, no: “FDA has concluded that THC and CBD products are excluded from the dietary supplement definition.”
If the THC or CDB is an active ingredient, then the substance is an investigational new drug.
If the THC or CBD is added to an existing dietary supplement, then FDA says that generally, the manufacturer must submit a notification to FDA of a “New Dietary Ingredient,” or NDI. The NDI must include information demonstrating that the dietary supplement containing the new dietary ingredient (the THC or CBD) “will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.” If the manufacturer cannot show this, then the product is considered “misbranded,” and that leads to FDA penalties.
In fact, in general, FDA says it is illegal to add THC or CBD and sell that food in interstate commerce.
Remember, there is an exception for certain hemp seed products. From here the rules get a bit more complicated, and you have to know about when substances are deemed to be GRAS—Generally Recognized as Safe—or otherwise excepted from the definition of a “food additive.”
Third, what makes the cannabis industry so fascinating from the standpoint of legal compliance, is the sheer variety of uses for cannabis-related products. For example, you have CBD pain cream, CBD-infused teas and drinks, CBD bars and gummies and capsules, and other CBD products; and then you have CBD vs. THC, hemp, and marijuana.
If you follow what we’ve talked about so far, we mentioned the FDA pathway of new drug approval; FDA’s position that CBD products are not dietary supplements; and FDA’s note that hemp and hemp seed products generally fall within an exception to these rules.
That leaves one more route for marketing CBD products, and that’s as a cosmetic. Cosmetics, like dietary supplements, do not require premarket approval by FDA.
The CBD product cannot contain any poisonous or harmful substance that would cause it to injure consumers in ordinary use. And the manufacturer cannot make therapeutic claims. With these caveats in mind, you’re likely to see a lot of CBD products marketed as or in cosmetics.
Again, we recommend that an FDA attorney evaluate the claims to ensure they aren’t red flags for FDA enforcement, or for enforcement action by FTC or lawsuits by private plaintiffs.
Thanks for watching. If you still have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment.
Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
CBD Oil Claims: The FDA Law Basics