Last week, the United States Food and Drug Administration (FDA), in conjunction with the Federal Trade Commission (FTC), issued a warning letter to Rooted Apothecary, LLC in Florida for unlawfully marketing products containing cannabidiol (CBD). The warning letter specifically addresses unsubstantiated claims that the company’s products treat teething pain, ear aches in infants, autism, attention deficit disorders, and Parkinson’s and Alzheimer’s disease. Despite the FDA’s promises to explore potential pathways for the lawful marketing of various CBD products, it has yet to publish any specific guidance on that issue. As the CBD industry waits for regulatory guidance from the FDA, the recent warning letter, which is not the first of its kind issued this year, serves as a cautionary reminder for CBD companies regarding their sales and marketing strategies.

The warning letter identifies four categories in which the company’s marketing tactics are in violation of the current federal regulations. Those categories include dietary supplement labeling, unapproved new drug products, misbranded drug products, and unsubstantiated advertising claims. Specifically, the FDA found that the company was unlawfully marketing products as dietary supplements. The warning letter also addresses the fact that several of the products are not generally recognized as safe for their marketed uses. Therefore, under the Food, Drug and Cosmetic Act (FD&C Act), those products are considered “new drugs” and require FDA approval. Furthermore, the products are misbranded under the FD&C Act because their labeling does not bear adequate directions for use.

With respect to the advertising claims, the letter points out that, under the FTC, it is illegal to advertise that a product can prevent, treat, or cure a human disease unless there is competent and reliable scientific evidence substantiating such claims. As such, the warning letter cites the FTC’s concerns over some of the efficacy claims about the CBD products and outlines how the company used product webpages, both in its online store and on social media websites, to make unfounded health claims. Examples of claims the federal agencies took issue with include:

  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “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 oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • “[P]ossible 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.”

The FDA and FTC granted the company 15 working days to state how it will correct the violations, and cautioned that failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. The agencies also warn that the letter is not necessarily an all-inclusive list of violations and the company has an obligation to ensure it complies with all requirements of federal law and FDA regulations.

In connection with the release of the warning letter, FDA Commissioner, Dr. Ned Sharpless, stated that the “FDA treats cannabis/cannabis-derived compounds the same as any other substance. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting & promoting public health through sound, science-based decision-making remains our top priority.” So, even though there may be hope for the lawful marketing of cannabis products, CBD companies need to remain diligent in their marketing and advertising approaches to avoid costly federal violations. As the FDA and FTC warned Rooted Apothecary, failure to correct violations can result in legal action and product seizure. However, in addition to such repercussions, simply being the subject of a public warning letter can have immediate negative credibility and publicity implications for any company. To prevent falling victim to a warning letter, CBD companies should avoid language that guarantees results or claims to cure certain ailments. The more aggressive and egregious the claim, the more likely it is going to attract the attention of the FDA. Companies should stay up to date on the most recent research regarding CBD and ensure that, even for seemingly minor health claims, they possess competent and reliable scientific evidence to back it up. When in doubt, consulting with outside counsel can help to mitigate risk and avoid many common pitfalls in this complicated regulatory arena.