In a joint warning letter, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) cautioned Rooted Apothecary LLC about the claims it made for its cannabidiol (CBD) products.
The Florida-based company touted its products—including “CBD Body Butter” and “CBD Oil”—using potentially unsubstantiated claims, the agencies said.
For example, the company’s website and social media pages featured claims such as the following: “Increasing evidence suggests that CBD oil is a powerful option for pain…anxiety…and autism…It seems like an attractive and safe option for children,” “CBD may reduce the risk of diabetes” and “possible uses for CBD include helping with skin problems such as acne, autism, ADHD and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
These statements potentially violated both the Federal Food, Drug and Cosmetic Act (FDCA) and the FTC Act, according to the letter.
Under the FTC Act, it is unlawful to advertise that a product can prevent, treat or cure human disease unless the seller has “competent and reliable scientific evidence” substantiating that the claims were true when made. As Rooted Apothecary’s claims lacked FDA approval as to their products’ efficacy, they violated the FDCA, the agencies said.
“There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” the FDA and FTC wrote. “Without this information, we are unable to ensure that these products will not cause harm to the people who use them. [With exceptions for four specific products], no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population.”
The agencies expressed “particular concern” that Rooted Apothecary marketed its products for use by infants and children, as the “use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations.”
The FDA and FTC requested a response from the company within 15 days that specified the steps taken to correct the violations alleged in the letter.
To read the warning letter, click here.
Why it matters: Given the proliferation of CBD products, it comes as no surprise that regulators have responded in kind with warning letters—including the FTC, which sent similar letters in September to three companies, and the FDA, which cautioned a major CBD retailer in July over claims that its product could be used to treat chronic pain and cancer, among other health problems. The marketers of CBD products should exercise caution when formulating their advertising claims, or they could face similar missives from the agencies.