In a surprise move last week, the U.S. Food and Drug Administration issued 15 warning letters to companies selling CBD products. The agency claims that these companies violated the Federal Food, Drug and Cosmetic Act. There is specific concern for how these products are being marketed and the unsubstantiated health claims being made.
The agency also released a Consumer Update warning the public about the potential dangers of CBD, especially when it comes to infused food and beverages.
The FDA’s Warning
The FDA’s Consumer Update reiterated that, with the exception of Epidiolex (a CBD drug for rare forms of epilepsy), the FDA hasn’t approved any other forms of CBD. The report also warns about CBD manufacturers marketing products with “unproven medical claims” and unsafe or questionable manufacturing practices. This includes cases in which CBD products were tested and found to have less Cannabidiol than claimed.
Many of the safety issues in the report involve the use of CBD without the guidance of a health care professional. The agency cited public safety threats in the following areas:
- Liver Injury: The potential for liver injury when using CBD was originally uncovered during the FDA’s review of Epidiolex. The agency is particularly concerned about this aspect of CBD, since liver damage is something that can go unnoticed for quite a bit of time if not monitored by a physician.
- Adverse Interaction With Other Drugs: Another area of concern is the effect that CBD can have when taken in conjunction with other drugs or supplements. While more studies are needed, some of the literature published has shown that it can have an impact on these substances. This includes the potential for reducing their effectiveness.
- Male Reproductive Health: Some animal studies have shown “male reproductive toxicity”. This includes decreased testosterone and sperm inhibition. The FDA was quick to point out that animal studies don’t always apply to humans.
The FDA also cited “cumulative exposure”, an area not well studied in the literature, as well as effects on “special populations” (pregnant women, the elderly, etc), and on animals. CBD products for pets have become particularly popular.
One of the key takeaways from all of this is that, despite what many people think, the FDA does not regard CBD to be “generally recognized as safe” (GRAS) when used in human or animal food. This is mainly due to a lack of data. GRAS is important because products with this designation are allowed to be added to foods (an example of this would be pesticides being applied to commercially grown fruits).
Reaction From The Industry
In the wake of the very public warning by the FDA, many within the burgeoning CBD industry have fired back. They claim that the agency has been unclear in providing guidance. Companies also argue that the industry has been willing to comply and work with the FDA, but have been met with silence when it comes to how to proceed.
Brad Ridenour, CEO of Koi CBD expressed his frustration, saying that “they keep telling us they’re going to come out with guidance, and they don’t. They just tell us what not to do. We’re ready to comply with anything they throw at us.” Koi CBD was one of the 15 companies singled out by the warning, despite the fact that there are now countless CBD companies with similar products and marketing.
Some have also challenged the scientific claims made by the FDA. Dr. Stuart Titus, CEO of Medical Marijuana, believes that the FDA is making a mistake by conflating the adverse effects of Epidiolex (a refined form of CBD) with the CBD commonly found in these food products. “There is no evidence to show that botanical forms of CBD have much more “drug interaction” than normal foods or that the natural botanical form of CBD confers the “toxic liver effects” that the FDA mentions in its statement” he said.
Potential Impact On The CBD Industry
There’s no question that CBD represents a massive and growing market. According to one report, the CBD market in 2018 was estimated to be worth USD 1.34 billion, and is expected to grow dramatically by 2025. Another estimated that the global market will have grown 40% from last year by the time 2019 comes to a close.
One of the reasons for its growth potential is its pharmaceutical application in products such as Epidiolex. Another major factor (and the one that seems to be of concern to the FDA) is its application in food and beverages.
The bottom line is that cannabis-infused products (both THC and CBD) are big business. There has been a huge surge in everything from CBD-infused gummies to pet food.
It’s not just startups getting in on the action. In a statement on their website, Ben and Jerry’s announced their plans to launch CBD products once they become legal. The company expressed their support for legalization and encouraged customers to contact the FDA to do the same. Walgreens issued a similar statement on their website announcing their intention to carry certain topicals.
A number of small-scale companies are already selling large amounts of product. Many of them make use of their online stores, as well as local dispensaries in states allowing recreational cannabis. Until now, they’ve been able to do so without any major repercussions.
All of this despite the fact that these infused food products are technically illegal.
Part of the reason for the confusion comes down to technicalities in the law. The 2018 Farm Bill created a situation where CBD derived from hemp with under 0.3% THC is now in a legal gray zone. Many companies choose not to expand out of state, continuing to operate locally. Each state is currently in the process of clarifying its own rules regarding CBD and food.
So far the industry been able to successfully navigate this gray zone. However, this latest move by the FDA could change all of that. The agency originally published a document in June of this year, cautioning against marketing CBD as a dietary supplement. Now that they’ve strengthened their stance and officially issued warning letters to individual companies, the crackdown on this burgeoning industry may very well be on its way.