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In today’s video, we discuss FDA enforcement against CBD product manufacturers and how to escape the jaws of the FDA.
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 understand cannabis and CBD oil products in the context of the whole regulatory framework.
Today, I’m going to talk about the kind of FDA enforcement we’ve seen so far against CBD product makers. By the end of this video, you’ll get a sense of the kinds of claims you’ll want to avoid, if you want to keep your CBD products on the market.
First, understand that the FDA regulates healthcare products in a variety of ways. For example, the FDA prohibits “adulteration,” or products from having substances in them that are likely to injure consumers. The FDA also requires current good manufacturing process (or CGMP), and honest marketing.
Products also have to have compliant “labeling.” Under FDA law, “labeling” includes not only the label itself that’s on the product bottle or box, but also all of the marketing that is associated with the product, whether that marketing is in print or online.
Improper “labeling”—taking into account the larger picture of all the marketing—makes a product “adulterated,” under FDA law. The FDA can issue a warning letter, or it can simply seize the product and tell the company to stop selling it.
Next, CBD oils can come in the form of edibles, tinctures, capsules, balms, lotions, crystals, sheets, wax, and in other forms. Here, though, we are focusing on the common thread of the claims being made for the CBD product. If the claim is for a therapeutic or medical use, the FDA considers this a drug claim, and will classify the CBD product as a drug.
Drugs cannot go to market unless approved by the FDA and safe and effective for the intended use. Most manufacturers of CBD products cannot meet this high standard, or the expense of getting this level of regulatory approval.
So, if you want to avoid FDA issues, don’t make medical or therapeutic claims for your CBD product. Among other things, this means that before taking your CBD product to market, have all of your website, social media sites, and marketing materials reviewed by FDA legal counsel, to ensure that the claims you make or approve of online, do not increase your risk of FDA enforcement.
Last, the FDA has gone after companies making products including CBD lotion, CBD pain relief patch, CBD tincture, CBD vape pen, and CBD for pets.
In its warning letters, the FDA cited company marketing including the CBD manufacturer’s Twitter and Facebook accounts.
One of the Facebook posts that the FDA flagged as making an unlawful disease claim is this one: “The top five research backed benefits of CBD include:
1) neuro[de]generative disease
2) depression and anxiety treatment
3) pain treatment
4) aids in the treatment of cancer and related symptoms to cancer . . ..”
Here are some of the other claims that the FDA cited in determining that the CBD Company was making unlawful claims:
“For chronic pain,” “for ADHD,” “for anxiety symptoms,” “effective treatment of Alzheimer’s disease,” “a natural alternative to pharmaceutical-grade treatments for depression and anxiety,” for “PTSD,” for “chronic inflammation and pain.”
These types of claims are very common in the CBD oil industry. Yet, in sending these warning letters, the FDA has signaled its seriousness that they can and will intervene when such claims are being made.
Yet another area where CBD product makers get in trouble is when they make claims that are essentially OTC (or over-the-counter) drug claims. For example: antibacterial, anti-inflammatory, and analgesic.
One of the things we do, as FDA legal counsel, is help CBD companies review their claims and decide which claims are most likely to engender FDA enforcement action. It’s all too easy to say, “everybody’s doing it” and violate the rules—until you’re the one subject to FDA enforcement action. We’re also in an environment where it isn’t possible to be totally beyond scrutiny, all the time.
A good FDA lawyer evaluates marketing claim with an eye toward compliance, yet also with a good dose of marketing savvy as well.
Thanks for watching. If you still have questions, click on the link below, 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.