On December 22nd, the Food and Drug Administration (the “FDA”) issued new warning letters to five companies that were illegally selling and marketing unapproved CBD products that the companies claimed could prevent, diagnose, alleviate, treat or cure.
This final round of enforcement was triggered by specific concerns about the manner in which many of these CBD products were being administered, namely through the nasal, eye and inhalation routes.
The five recipients of these warning letters are:
- Bee Delightful, a Texas company claiming its law Bees Rescue Blend, a blend of honey and CBD, has the potential to reduce chronic pain, inflammation, depression, and anxiety, to name a few. However, what most likely led the FDA to target this company were claims that this blend of honey and CBD could help fight “the invisible enemies out there.” The FDA has repeatedly stated that it is focusing on companies selling fraudulent COVID-19 products, which it believes pose a major threat to public health.
- G&L Wellness, LLC, a Wisconsin company that sells and markets eye drops for pets and humans, both of which are marketed as a “Multi-Symptom Eye Care Solution.”
- New Leaf Pharmaceuticals, LLC, a Connecticut company that promoted CBD nasal sprays, which the FDA identified as “special from a public health perspective” because of their rapid absorption into the bloodstream. In addition, New Leaf Pharmaceuticals made tremendous medical claims about its products, including their ability to reduce the risk of arterial blockage and fight tumor and cancer cells.
- NextL3vel Service Group, LLC dba This stuff is good for you, a Nevada-based company that sells and markets CBD pet shampoo, dog treatment, and CBD tinctures, eye drops, and vapes for human consumption. As in the warning letter from New Leaf Pharmaceuticals, the FDA questioned the fact that the company was making claims targeting vulnerable populations. In this case, one of the NextL3vel Service Group’s social media outlets had a graphic showing a young child next to the message “CBD FOR CHILDREN ADD / ADHD”.
- Wellness Biosciences Rx, another Texas company that sells a CBD inhaler and CBD-themed. The FDA had a particular problem with the metered dose inhaler “because the ingredients and possible contaminants in oral inhalation sprays can induce laryngospasm and bronchospasm and be toxic to tissues in the upper or lower airways.”
This final round of warning letters was issued less than a week after the Federal Trade Commission (the “FTC”) fined six CBD companies for making similar misleading health claims. However, unlike the FTC warning letters, no fines were imposed in the FDA letters. Instead, they asked companies to fix the violations with written corrective action plans within 15 working days.
In the agency’s press release, Dr. Amy Abernethy, the FDA’s assistant chief commissioner, that the FDA will continue to issue warning letters until the agency changes its policies and the FDA “remains[s] focused on exploring possible avenues for lawfully commercializing CBD products while educating the public about these open questions about the safety of CBD. “In addition, Dr. Abernethy that the FDA “will continue to monitor companies and, if necessary, take action that unlawfully market their products – and prioritize those that pose the greatest risk to the public.”
This final round of warning letters should come as no surprise as they are exactly in line with the FDA’s enforcement actions over the past two years (read more on the subject here and here). However, these letters should remind CBD companies that making unlawful medical claims is risky as it can lead to additional and more serious headaches, including litigation and significant fines and penalties. In addition, FDA warning letters can lead to consumer protection claims under state law based on the prohibition of unfair and misleading commercial practices, claims under the Lanham Act for false and misleading advertising, consumer and shareholder actions related to CBD (think Curaleaf Inc. and CannaRegs). and even personal injury.
As we have stated repeatedly on this blog, CBD companies should not make medical claims about their products, directly or otherwise. This is the ONLY way to protect yourself from enforcement actions and other legal issues.