The FDA’s Warning Letters for CBD-Related Products

Every year, the U.S. Food & Drug Administration (FDA) publishes its warning letters to companies that market unapproved drugs. To quote:

“Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.”

The companies that reach 2017’s list and have been issued warning letters include That’s Natural!, the Stanley Brothers, Natural Alchemist and Green Roads Health. 2015’s and 2016’s lists are even bigger, with Cali Stores, Dose of Nature, Green Garden Gold, Healthy Hemp Oil, Michigan Herbal Remedies, LLC, Morgue Juice, Pain Bomb, LLC, Sana Te Premium Oils, Canna Companion, Canna-Pet, LLC, CBD Life Holdings, LLC, Hemp Oil Care, Natural Organic Solutions, and Twin Falls Biotech, LLC making their way onto them.

Molecular Structure - CBD
CBD molecular structure.

Is there a reason why the FDA issues these letters? From our reading, there are three main reasons why the FDA decided that these companies merited a warning letter, including:

1. One or more products not containing the levels of CBD they claimed they had, or are misbranded in another way (e.g. by not giving directions for usage and dosage, or have inappropriately called one or more of their products “dietary supplements” when CBD-based products are outside the definition of “dietary-based supplement”).
2. Claiming that the use of CBD can cure, mitigate, treat or prevent any disease, or be used in any way to diagnose an illness, injury or disease.
3. An Investigational New Drug (IND) application is needed for all clinical investigations of products. Claims about CBD’s efficacy for certain conditions may get the FDA writing to a company, saying that this means that “some of the claims on your websites that provide evidence that your products are intended for use as drugs”.

There may be an additional two reasons why certain CBD-based products may get a warning letter, including:

4. They contain other cannabinoids – in particular tetrahydrocannabinol (THC) – and the levels found may make them illegal.

5. They contain high amounts of pesticides, pollutants, pathogens etc.

So, what does this mean for medical cannabis patients? Essentially, that they ought to keep a critical eye on CBD-based products, even ones that are legal and derived from hemp. Extraordinary claims require extraordinary evidence, and the FDA is correct in saying “We just don’t have the evidence to prove one way or the other whether CBD or any other cannabinoid-terpenoid-based product works for specific conditions.”There is little regulation in this area, and companies should definitely be held to account when tests show they are unsafe and/or are mislabelled in any way. We here are often critical of non-tested, hemp-derived, CBD-only products, and sometimes lists like these seem to vindicate our stance. Whilst European hemp-based products seem to be better regulated, they are by no means perfect, either.

This is of particular concern to patients, who may be being sold essentially snake oil. There is perhaps little worse than giving people false hope. Another concern is whether patients are getting the results they desire by going down the “CBD-only” route, as there could be huge benefits in taking a broad range of cannabinoids and terpenoids, and/or a particular dosage and specific cannabinoid-terpenoid profile that they need. As there are no studies on how much and what particular cannabinoid-terpenoid profiles a patient may need for their condition, we cannot make claims that CBD will help in any way.

Tincture Made at Home
Homemade Tincture

Now, there are perhaps a couple of areas where some sympathy can be granted. Sure, there are a lack of clinical trials showing CBD’s efficacy for humans, but we do have lots of in vitro, in vivo and animal studies, as well as many case studies. We know that CBD and various other cannabinoids and terpenoids may help for a whole variety of conditions, and it is perfectly understandable for people to ask, “How can we talk about the potential medical benefits if we can’t make any statements about it and look at the evidence wherever it may arise?”

There are also very promising results from GW Pharmaceuticals regarding CBD and THC for the treatment of cancer (specifically glioblastoma multiforme, an aggressive brain tumor), epilepsy (CBD-only, specifically Dravet Syndrome and Lennox-Gastaut Syndrome) and multiple sclerosis (MS). Can we not reference these and other studies when looking at the medical benefits cannabinoids can potentially provide? Surely patient testimonials and the huge numbers of other studies add to the strength of evidence such clinical trials provide? Does it not become progressively more and more difficult to say “There is no definitive evidence as of yet”, when there is a huge body of evidence showing that, though it may not be definitive, at least merits some consideration and further study?

Whilst we understand and mostly agree with the FDA’s assessments, there are some arguments that we can sympathise with. When the hurdles that many scientists and doctors have to overcome with regards to clinical trials for the medical potential of cannabinoids of all kinds are so high, it comes as no surprise that they become so exasperated when it comes to the claims they can or can’t make. Slipping up and making some sort of scientific claim becomes quite easy to do, especially when there are so many studies showing that cannabinoids and terpenoids seem to have numerous medical applications. Something will have to give at some point, and at the moment it looks like both the government’s stance on cannabis and those who make bad products will be the ones who will be the ones giving in.


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