In November the Food and Drug Administration (FDA) issued letters to various companies selling products contained cannabidiol (CBD), citing concerns that certain products may appeal to children. These CBD infused foods include gummies, hard candies, and cookies which the FDA had the potential to be “attractive” to children. The FDA’s warning claimed that consumers could confuse the targeted products as traditional foods or beverages, “which may result in unintentional consumption of overconsumption of CBD.” While the FDA has previously issued warning letters to hemp and CBD companies in violation of agency regulations, the increased level of scrutiny throughout 2022 should have growers, processors, and retailers taking note to ensure compliance and avoid enforcement action.

FDA Enforcement Authority Over CBD Products

While state and federal law allows for the regulated growth, processing, transport, and sale of hemp and CBD products, the FDA maintains certain enforcement authority under the Federal Food Drug and Cosmetic Act. Although the CBD containing food products have become commonplace, current FDA policy prohibits the addition of CBD to food and dietary supplement products and enforcement action can be taken against violators. However, in practice FDA enforcement action in the form of warning letters have focused on eliminating unsubstantiated claims regarding hemp and CBD products’ ability to prevent, treat, or cure certain diseases or ailments.

The FDA has faced growing criticism over its failure to adopt and implement clear regulations regarding hemp and CBD. Stakeholders from all sides have acknowledged that a clear regulatory framework and compliance rules would benefit the industry which currently operates without many enforcement parameters. Without action by the FDA to develop a regulatory pathway, many have speculated that regulations and compliance guidelines may be included in the forthcoming 2023 Farm Bill.

What Caused The FDA to Send These Letters?

The increasing number of warning letters from the FDA to CBD companies should signal that the agency is not ignoring the growing number of hemp and cannabinoid containing food products on the market. However, the prevalence and availability of these products has likely forced the FDA to target the most obvious violators making unsubstantiated medical claims and, most recently, products where the FDA believes that children and even adult consumers could unknowingly ingest a food containing CBD.

Increased attention from the FDA and The FDA’s recent interest in regulating this long-ignored industry is already having a chilling effect. A joint venture between Molson Coors and HEXO Corp. ended earlier this year citing lack of certainty about federal regulations.

The FDA’s current position is that the addition of CBD to food and dietary supplement products is not permissible and enforcement action may be taken against violators. In their recent letter, they singled out American Shaman citing its biggest concern is, “CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.” Food ingredients must be shown to be safe to be lawfully added to food and the FDA has not yet “found sufficient information showing how much CBD can be consumed, and for how long, before causing the various types of harm we’re concerned about.” They added that they are holding CBD to the same high standard that they would any other substance that is intentionally added to food. This recent action by the FDA indicates a lack of urgency and reluctance to regulate CBD products, making it clearer that Congress will likely be the one having to act on behalf of the Hemp industry.

Further, the letter mentioned that they tested Shaman’s “Grandma’s Raisin & Pecan Hermit Cookies” and found them to contain 19.3 milligrams of CBD per serving, while the packaging mentions just 10 milligrams per serving, furthering the increased risk of overconsumption. American Shaman was not the only company they flagged for “illegally selling” products containing cannabidiol, as letters were also sent out to 11-11-11 Brands, Naturally Infused, CBDFX, and Infusionz. Additionally, the warning letters outlined the illegal selling of unapproved CBD products that claim to cure, mitigate, treat, or prevent various diseases.

How These Letters Can Benefit You

These letters can be a valuable tool for all CBD companies. You can learn what exactly makes the FDA tick, which offers your business the opportunity to adjust your marketing practices to reduce the risk of enforcement actions from the FDA. Every CBD company should keep up with the FDA enforcement treats and read each warning letter to help navigate this very strenuous regulatory landscape.

Previous letters showed us that medical claims were the sole trigger for warning letters – that is now not the case. The main takeaways from these letters are outlined below:

The FDA has a strong issue with CBD infused foods that appeal to children. The potential confusion of infusing conventional foods with CBD is a great concern for the FDA as it fears children are at risk to unintentionally consume CBD resulting in serious health issues.

The FDA expects companies to list CBD as an ingredient. Even when the Agency deems the sale of these products unlawful, it still expects companies to comply with existing regulations such as listing all product ingredients on the label. The Agency has collected and analyzed samples of products to test for CBD content numerous times. This has resulted in warning letters being sent out to those not complying.

The FDA strongly opposes the sale and marketing of CBD pet products. About 40% of CBD warning letters, including these most recent ones, issued this year involved CBD-infused pet products. The Agency does have some tolerance for these products when marketed as cures for pets joint and anxiety pain. Companies selling products like these should carefully craft their marketing materials to comply.