hand writing a letter on a desk from the FDA issuing warnings to CBD Companies for making unsubstantiated health claims

Why the FDA is Sending Warning Letters to CBD Companies

Despite the fact that hemp became federally legalized by the 2018 Farm Bill, the popular compound derived from hemp, CBD, still has a complicated relationship with the Food and Drug Administration (FDA). 

These days CBD products can be found almost anywhere. Consumers can buy a CBD tincture from their local pharmacy, CBD pills and gel capsules are widely available. There’s even dog CBD for your canine companion. Despite CBD’s newfound ubiquity, almost 99% of CBD products have not been approved by the FDA. But if that’s true, why are they lining mainstream retailer’s shelves?

Is Hemp Now Legal? 

The Farm Bill legalized hemp on the federal level, but ultimately it’s up to each individual state to set their own laws regarding the cultivation, sale, and regulation of hemp. So is CBD legal in the US? The answer will depend on where you live. If you’re in a hemp legal state, then it’s safe to assume that CBD is legal as well. 

Hemp Legal In The United States, But CBD  Still Not Approved By The FDA

With the exception of Epidiolex, a pharmaceutical-grade CBD oil prescribed for the treatment of seizures, the FDA has not approved any cannabis product for therapeutic or medicinal use to date. From the FDA’s website:

“There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses, and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.” 

Why The FDA Is Sending Warning Letters To CBD Companies

Companies that market CBD medicinally are technically in violation of the FD & C act. While the FDA hasn’t taken any significant action to prevent these companies from continuing to participate in commerce, they have sent dozens of warning letters. These warning letters are sent in part due to some of the CBD manufacturers’ less-than-honest marketing strategies.

Certain CBD companies have jumped the gun by claiming that their products have been proven to relieve pain or treat anxiety.

While there has been a mountain of anecdotal evidence and some significant scientific research into the medicinal benefits of CBD, including the use of CBD oil for anxiety and CBD oil for pain, there needs to be even more research conducted to confirm these preliminary findings. Historically, due to cannabis being listed as a schedule 1 drug (substances with no currently accepted medical use and a high potential for abuse), efforts to research these potential therapeutic applications have been hamstrung by the government. With hemp’s updated legal status, hopefully, more scientific studies will continue to be conducted.

In the American tradition of snake oil salesmen, some companies are going so far as to market CBD as a cure-all for almost every type of ailment. Warning letters have also been sent to companies attempting to exploit the country’s pandemic fears by claiming CBD can cure/prevent coronavirus.

The FDA lab tests these products before sending warning letters. Not so surprisingly, several of these companies peddling unsubstantiated health claims also mislabel their product’s cannabinoid contents. 

In general, the CBD industry supports the FDA’s targeting of these bad actors that misrepresent CBD to consumers. However, there are concerns regarding the agency’s alarmist tone in press releases as well as its slow response in performing necessary evaluations that would allow for CBD to receive FDA approval.