FDA Increases Warning Letter Campaign Against CBD Companies

In November the Food and Drug Administration (FDA) issued warning letters to various companies selling foods containing cannabidiol (CBD), citing concerns that such products could improperly appeal to children. The identified foods infused with CBD include gummies, hard candies, and cookies which the FDA claims have the potential to be “attractive” to children. The FDA’s warnings stated that consumers could confuse the CBD 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 it found to be in violation of agency regulations, the increasing 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 compliant hemp and CBD products, the FDA maintains certain enforcement authority under the Federal Food Drug and Cosmetic Act. Although 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. In practice however, FDA enforcement action through warning letters has mainly focused on eliminating unsubstantiated claims regarding hemp and CBD products' ability to prevent, treat, or cure certain diseases or ailments.

A warning letter from the FDA triggers a fifteen-day response deadline for an offending company to provide a response detailing how it intends to address the issues identified in the warning letters or support why the targeted products are not in violation of the law. Failure to take action in response to a warning letter or adequately address the violations can lead to legal consequences, including product seizure and/or injunction. To the extent that there is a violation of a state or federal controlled substances act, criminal investigation or prosecution could also occur.

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

Increased Issuance of FDA Warning 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. Food ingredients must be shown to be safe to be lawfully added to food and the FDA’s current position is that there is not “sufficient information showing how much CBD can be consumed, and for how long, before causing the various types of harm we’re concerned about.” The FDA added that they are holding CBD to the same high standard that they would any other substance that is intentionally added to food.

However, the prevalence and availability of these products has led to the FDA targeting the most obvious violators making unsubstantiated medical claims and, more recently, manufacturing products attractive to children and or even unsuspecting adult consumers that could unknowingly ingest a food containing CBD. Increased attention from the FDA and the absence of clear regulatory guideposts has potentially already had a chilling effect on the industry including a recent decision by a Molson Coors to abandon a hemp beverage venture citing the uncertainty about federal regulations.

Key Takeaways for CBD Companies

These letters can be a valuable tool for CBD companies which provide an opportunity to adjust marketing practices to reduce the risk of enforcement action by the FDA. Hemp and CBD companies are encouraged to work with an experienced attorney and read each warning letter carefully to better understand FDA enforcement trends.

Review of letters from years past indicate that medical claims were typically the sole trigger for warning letters. That is no longer the case. More recently, the following issues have been identified within FDA warning letters which could be the basis for enforcement action:

The FDA seeks to eliminate CBD infused foods that appeal to children. The potential for confusing conventional foods with CBD-infused foods and candies appears to be a growing concern for the FDA. Ensuring that marketing and product labeling do not intentionally or unintentionally appeal to children is an important step to address the FDA’s fear that consumers could mistakenly consume CBD.
The FDA expects companies to list CBD as an ingredient. While the sale of CBD containing food products is still impermissible under FDA rules until new regulations are implemented, the agency still expects companies to comply with existing regulations such as listing all product ingredients on the label. The FDA has shown that it will collect and analyze samples of products to test for CBD content which they have used as the basis for recent warning letters citing noncompliance.
The FDA has not approved the sale and marketing of CBD containing pet products. A rising trend in 2022 has been the issuance of warning letters to companies producing CBD-infused pet products. Although the FDA appears to have some tolerance for this growing market, companies should carefully craft materials and labels to avoid unsubstantiated medical or health claims for pets and animals.