FDA Issues CBD Warning Letter to Curaleaf

In yet another instance of the Food and Drug Administration (FDA) demonstrating its intent to enforce its prohibition on the marketing of cannabidiol (CBD) as a drug, the FDA issued a warning letter to Massachusetts based Curaleaf yesterday (July 22, 2019). You can read the letter by clicking here. The FDA also issued a “News Release” about its warning letter to Curaleaf this morning. You can read the news release by clicking here. I encourage everyone in the CBD industry to take ten minutes and read the letter and release.

I’m not encouraging people to read the letter or news release because they contain any new information. (Or, at least the information should not be new to anyone in the CBD industry.) Nor do I recommend reading them because I want to pick on Curaleaf. Many reputable companies have received similar letters over the years. The reason it is important to read the letters is to understand the FDA’s current priorities, the most important of which include warning companies about making medical/disease claims about CBD products or marketing them as dietary supplements.

The FDA has taken the firm position that CBD cannot be used as a food ingredient in interstate commerce or marketed as a dietary supplement, and that no medical/disease claims can be made about it. Despite this position the FDA has taken little no enforcement action regarding the use of CBD in consumer products. Rather, it has primarily focused its efforts on warning companies against making medical/disease claims, mislabeling their products, and marketing their products as dietary supplements.

Although the Curaleaf letter was focused on the company’s CBD animal products, the FDA’s position is the same for any CBD consumer product. Even if you do not call your CBD product a “drug”, the FDA will treat it as a drug if you make claims that your product can mitigate, treat, or prevent a disease. Based on Curaleaf’s marketing materials, the FDA contends that Curaleaf is selling an unapproved drug. Here are some of the improper claims made by Curaleaf that were identified by the FDA:

• “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
• “CBD was effective in killing human breast cancer cells.” • “CBD has also been shown to be effective in treating Parkinson’s disease.”
• “CBD has been linked to the effective treatment of Alzheimer’s disease ….”
•  “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
• “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”
• “What are the benefits of CBD oil? …. Some of the most researched and well-supported hemp oil uses include …. Anxiety, depression, post-traumatic stress disorders, and even schizophrenia …. Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
• “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”
• “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.”

Is your company making any similar claims?

The FDA also warned Curaleaf against marketing its products as dietary supplements, stating: “FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii).” Some of Curaleaf’s marketing claimed that CBD is a dietary supplement. For instance, the FDA noted this statement: “Cannabidiol (CBD) is a natural constituent of industrial hemp and is a dietary supplement.”

In an unusual twist, the FDA warned Curaleaf that some of its topical products were in violation of the Food, Drug & Cosmetic Act (FD&C Act) because they were marketed as dietary supplements. The takeaway, which I and my colleagues have been saying for a while, is that topical products that do not make medical/disease claims are not prohibited unless they are marketed as dietary supplements. To this point, the FDA states:

“The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Because these products are not intended for ingestion, this is an additional reason why your “CBD Lotion,” “CBD Pain-Relief Patch,” and “CBD Disposable Vape Pen” products do not meet the definition of a dietary supplement under the FD&C Act. Furthermore, with respect to your “CBD Tincture” products, the “Suggested Use” section of these products’ labeling includes both “edible” uses and topical uses. To the extent that your “CBD Tincture” products are intended for a delivery method other than ingestion, as evidenced by the labeling describing topical uses, this is an additional reason why these products also do not meet the definition of a dietary supplement under the FD&C Act.”

The legal status of CBD products remains grey, though we anticipate (hope) that the FDA will clarify matters soon. (For additional reading on the FDA/CBD issue, click here, click here, click here, and click here.) However, and regardless of how the FDA will eventually regulate CBD, it is abundantly clear that CBD companies should not make medical/disease claims nor market their products as dietary supplements. Doing so at this point is simply foolish.

Thanks to LVT for forwarding me a copy of the FDA letter.

July 23, 2019

Rod Kight is an attorney who represents hemp farmers and hemp businesses.  He speaks at cannabis conferences across the country, drafts and presents cannabis legislation to foreign governments, is regularly quoted on cannabis matters in the media, and maintains the Kight on Cannabis legal blog, where he discusses legal issues affecting the cannabis industry. You can contact him here.