Cannabis Laws 101
In today’s video, we discuss laws governing the cannabis industry.
Many healthcare companies are rushing into the cannabis and CBD oil space, and they’re looking for legal counsel on what they can lawfully market (or not).
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 are familiar with cannabis industry regulation.
Cannabis and CBD oil are on the spectrum of health and wellness products, and this is where we have deep industry expertise.
Today, I’m going to explain the basics of cannabis industry regulation as it applies to companies making claims about CBD products.
Bear in mind that the regulatory landscape is constantly changing, yet hopefully we can give you an orientation that will stand the test of time.
In a nutshell, remember these key points when branding a CBD oil product for marketing.
First, let’s get oriented through some basic definitions. Cannabis is the broadest term. As FDA itself explains to us, cannabis contains over 80 biologically active chemical compounds.
The most commonly known compounds are THC and CBD. Parts of the cannabis sativa plant are known as marijuana, which has psychoactive effects.
Then there is “hemp.” Federal law defines hemp as cannabis and its plant parts, which have a THC concentration of less than .3 percent. According to the 2018 Farm Bill, hemp is no longer a controlled substance.
Next, FDA has approved one cannabis-derived drug and three cannabis-related drug products. The cannabis-derived product is Epidiolex, which contains CBD and is approved to treat seizure disorders.
Second, understand that FDA approves drug products, but does not “approve” foods, dietary supplements, or cosmetics. This means that FDA has not approved any other claims for cannabis products, and therefore, those products are subject to general prohibitions by FDA—as well as FTC, the Federal Trade Commission—pertaining to advertising of healthcare products.
FDA has expressed concern about companies marketing CBD products for therapeutic or medical uses. Essentially, FDA prohibits therapeutic claims unless the product is approved as a drug.
So, although many people are giving testimonials that CBD oil can help with things like anxiety, chronic pain and inflammation, or even acne, ADHD, and digestive diseases such as IBS (or irritable bowel syndrome), companies marketing CBD products should beware of FDA rules prohibiting disease treatment claims.
Third, all claims must be truthful and non-misleading. This means that claims about products related to health must be substantiated, or capable of proof, by “competent and reliable scientific evidence.”
This is a high standard. It’s more than anecdotal reports. Scientific evidence has to be published in the literature, supported by scientific and medical peers capable of reviewing and vetting that evidence.
The market for cannabis and CBD oil products is booming. There are huge opportunities for cannabis and CBD oil businesses. Still, FDA has sent warning letters to companies making therapeutic claims for CBD products. And FDA enforcement can be heavy—so too can lawsuits by private plaintiffs, piggybacking off regulatory action. That’s where good legal counsel can help anticipate trouble ahead of time and create legal strategy for branding, marketing, and labeling.
Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.