300%+ Increase in CBD Warning Letters This Year
Companies marketing CBD products should avoid making disease claims
This year there have been 26 CBD-related warning letters. This is up from just seven in all of 2021. That is over a 300% increase, and we are only in August!
This shows the FDA's growing intolerance for CBD products that make marketing disease claims. It is important to note all the CBD warning letters included high-risk disease claims such as Alzheimer's, depression, cancer, and PTSD. You may be saying, "of course, companies shouldn't make these claims," which I agree with. However, some of the 26 companies may not have known they were making disease claims, as forgotten several-year-old social media and blogs may have disease claims lurking in them.
Here is a post about several-year-old social media posts being called out in a warning letter.
CBD for animal products is mentioned in 30% of these 2022 warning letters. It is important to note that the FDA seems to have a lower "tolerance" for claims made about animal products. For example, mentions of "anxiety" and "inflammation" may be enough to attract an animal product warning letter. Still, some higher-risk words such as "depression" are usually present in the human letters.
Some of the letters also include bizarre mentions, such as this example of a wrist band that was labeled as a supplement. The issue with this, of course, is that supplements must be ingested. Marketing products like this clearly show the FDA that the company does not understand the basics of dietary supplement regulations. From warning letter: "your website shows Supplement Facts panels for the "Tanka T-FLEX Band ….. your products' labeling states that the products are intended to be worn on the wrist. For example, your website describes how the "patented macromolecular technology works through direct contact with the skin to provide timed controlled-release of up to 30 days."
45% of the warning letters include the disease claim one-two punch "anxiety" and "depression." It should come as no surprise these two disease words continue to be called out in letters. Here is a video about this. Other Common high-risk words are "insomnia," “fibromyalgia,” and “Alzheimer's.” See this post and video for a deeper discussion.
From warning letter “post on Instagram states, “What can #CBD do for #animals and our #furbabies ~ #anxiety #inflammation #arthritis #pain #seizures #cancer #cbdoil #health #dogs #cats #horses #cows #freestateoils ->> freestateoils.com/hemp-cbdpellets-for-farm-animals.” The post includes a graphic with photographs of several farm animals and pets, and includes statements such as, “Anti-ANXIETY || Anti - INFLAMMATORY || Anti – ARTHRITIC”
The learning target here is the authorities look at the totality of the advertisement. This post is on a social media site that links back to a shopping cart; this is the material connection. The disease hashtags are claims and when a company adds its name in a hashtag, it further elevates the risk. The image with the animals and therapeutic claims such as "anti-anxiety" further demonstrate the intended use of animal disease prevention.
Several of the warning letters include study citations. Even mentioning CBD studies on a commercial site is enough to attract a warning letter.
Here is an example from one FDA warning letter. "Israeli researchers have launched three clinical trials that utilize CBD's anti-inflammatory properties as potential COVID-19."
Here is a post about several CBD companies that received warning letters for similar infractions.
More than half of these warning letters include claims made on social media. Here is a post about this.
47% of the warning letters include claims made in blogs. This is a continued enforcement trend, and several letters this year include claims made in old blogs that contained disease words. It is possible the companies didn't realize their several-year-old blogs contained high-risk words. A good reminder for a compliance "tune-up." Here is a post about this.
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.