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, right? Wrong! 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. 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 cannabis
venture, we look forward to working with you soon.

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