Cannabis Legal Highs & Lows: FDA on CBD
In today’s video, we discuss CBD oil claims that are very common on the shelves, yet which the FDA has specifically warned will lead to FDA enforcement action.
Today, we’ll discuss several common prohibited CBD claims and ways to mitigate the risk the FDA jaws will snap shut.
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 understand cannabis and CBD oil products as part of the legal framework governing the multi-trillion-dollar market for health and wellness.
By the end of this video, you’ll understand prohibited vs. allowable CBD claims.
Take a look at the following CBD claims:
CBD for Alzheimer’s: “Science also shows that CBD has anti-emetic, anti-convulsive, anti-inflammatory and analgesic properties. Because all of these come into play with Alzheimer’s, particularly brain inflammation, CBD is a viable option for minimizing these effects within the brain.”
CBD for Anxiety: There is “evidence that the therapeutic efficacy of CBD in the treatment of anxiety-related disorders was pronounced, particularly in the areas of conditioned fear responses, stress, generalized anxiety disorder, social phobia, panic disorder, PTSD, and OCD.”
CBD for Depression: “For many, CBD holds the answers to treating depression.”
CBD for Fibromyalgia: “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
CBD for Skin Conditions: “The compounds present in CBD are found to have anti-inflammatory effects . . . Psoriasis is an inflammatory disease.”
These are all good claims, because they are supported by science?
Whether or not the science in fact supports these claims, what the FDA cares about is the fact these are claims about medical or therapeutic use of the CBD products. That makes each and every one of these, what the FDA calls a “disease claim,” or a “drug claim.”
Simply put, if you make a disease claim for a CBD product, the FDA will classify your product as a drug.
As the FDA puts it—and the FDA uses this same paragraph in one warning letter after another: “The claims on your websites establish that the products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body.”
So, if you’re looking to avoid a tango with the FDA, don’t make disease claims. Even though you might see these same kinds of claims on many other websites, if you make these claims, you’re setting yourself up for FDA enforcement.
All of the above claims were ones flagged by the FDA in an FDA warning letter to Nutra Pure LLC in 2019.
The FDA also raised as a second issue that the claims lacked substantiation, or proof. And federal law prohibits false and misleading advertising.
So what were the consequences?
The FDA directed the company to notify the FTC, the Federal Trade Commission, as well as the FDA, within fifteen working days of receipt of the warning letter, of “specific actions” the company will have taken to address these concerns.
The FDA told the company: “Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.”
In other words, once you get the warning letter, you have 15 working days to correct the violations. All of them. And the violations that the FDA flags on the warning letter are not an all-inclusive list.
Some time ago we helped a company respond to an FDA warning letter. In that letter, the FDA flagged 9 different violations in the claims made for various products. When we did our audit of the company’s marketing materials, we found over 150 different claims.
Any one of which could have raised FDA or FTC enforcement.
And once the FDA sends a warning letter, the next time enforcement could be much more severe.
As for the FTC, they can require a company to “disgorge the unlawful gains.” The penalties can be in the millions, or even tens of millions. One company came to us with a 50-million-dollar demand from the FTC.
Consumer lawsuits can follow. As well, warning letters get out to the media, which can decimate a company’s clientele by broadcasting the FDA violations.
So, it would be wise to take enforcement seriously, and not to dismiss the possibility of an FDA warning letter as a slap on the wrist. In fact, even an FDA warning letter can be the beginning of the end.
This is where an ounce of prevention is worth a pound of cure. We review marketing materials so clients get a sense from legal counsel of potential violations, and make wise business judgments ahead of time. If you can stave off FDA or FTC enforcement, you just might stay ahead on the market without regulatory jeopardy or litigation costs.
Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
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