While there are many questions surrounding the regulation of marijuana and related products, the FDA has made it clear where it stands on at least one issue. For the third year in a row, the FDA has issued a rash of warning letters to the makers of products containing cannabidiol (“CBD”) for marketing unapproved new drugs. CBD is a non-psychoactive compound derived from marijuana, which we’ve heard is used by many to treat symptoms including pain, anxiety, depression and insomnia. The FDA letters assert that each of the companies’ claims regarding their CBD products cause them to be considered drugs, because they purport to be intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body. Such claims are a trap for the unwary because a sloppy marketer can inadvertently cause a relatively innocuous product to be subject to strict regulation as a drug. In this case, however, even a novice would conclude that the companies’ claims were disease related:
- That’s Natural! claimed that CBD was beneficial for breast cancer, heart condition atherosclerosis, autism, and Alzheimer’s. It also claimed that several ingredients were “anti-tumor” and that “[s]cientific research by doctors have [sic] shown it actually kills cancer cells and provides a protective coating around our brain cells.”
- Stanley Brothers published testimonials attesting to efficacy in treating cancer and depression, and linked to other websites that promoted CBD to treat Alzheimer’s, diabetes, leukemia, Parkinson’s, and strokes. Its social media made claims that its CBD products could treat autism and concussions.
- Natural Alchemist claimed that its products combat tumor and cancer cells, were effective in “limiting neurological damage” following strokes and for treating neurodegenerative diseases like Alzheimer’s and Parkinson’s, and also had therapeutic benefits in treating arthritis, schizophrenia, diabetes, alcoholism, and cardiovascular disease.
- Green Roads Health claimed that CBD could inhibit certain types of cancer and that it had potential in treating asthma, Alzheimer’s, arthritis, autism, and bipolar disorder.
Based on the healing properties claimed, the FDA considers the CBD products to be “new drugs,” which may not lawfully be sold in interstate commerce without FDA approval.
The FDA also warned the CBD makers that their products were considered “misbranded” because they lack adequate directions for their intended use. A drug is deemed to have “adequate directions for use” when they enable a layperson to use the drug safely and for its intended purpose. Prescription drugs, for example, require the direction and supervision of a licensed practitioner for their safe use. In the case of the CBD products, however, the marketing claims establish that the products are intended to treat diseases that “are not amenable to self-diagnosis or treatment” without a doctor. In other words, consumers cannot typically diagnose their own cancer or heart disease, and therefore no set of directions on a drug could permit a consumer to use that drug safely without the supervision of a licensed practitioner.
Each letter warns its recipient to take “prompt action” to remedy the violations identified or risk legal action, including seizure and injunction. The CBD makers were given 15 days to notify the FDA of the steps taken to correct the violations and measures introduced to prevent recurrence.
In prior years, the FDA went further and undertook testing of the CBD products. In many cases, those tests revealed that the products contained less than the claimed amount of CBD – adding a false and deceptive advertising component to the drug regulatory issues. The responses to those letters have been mixed. Based on our recent review, some recipients appear to have closed shop (or perhaps rebranded), while others altered their marketing messages to avoid making drug claims. Several others appear not to have heeded the FDA’s warning and continue to make problematic claims, attesting to their products’ efficacy in treating cancer, depression, pain, epilepsy and seizures, autism, anxiety, nausea, insomnia, Alzheimer’s, Parkinson’s, and brain and nerve damage caused by strokes.