On Monday, the Food and Drug Administration (FDA) issued its single largest group of enforcement warning letters against 15 companies selling dietary supplements. This represents nearly one-third of the total FDA warning letters related to dietary supplements issued this year.
The Agency asserts these supplements are adulterated and misbranded because they contain cannabidiol (CBD). The warnings were accompanied by a consumer update stating CBD has uncertain safety or benefits, which is why the FDA currently considers CBD illegal for use in food and supplements.
The specific content of these warnings provides valuable lessons to companies as to how the FDA may continue to enforce and regulate CBD, especially as it relates to children, social media, and animal products and feed residue.
Children and Infants
Children and infants took prominence in several of these warnings because of unpredictable and unintended consequences in vulnerable populations. In its letter to Natural Native, LLC of Norman, Oklahoma, the Agency described its concern through the following example: “Specifically, a post to your Facebook page links to an article entitled ‘CBD for Brain-Damaged Babies?’ in which the following statement is made, ‘[t]he launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.’” While the company’s product was not described by name, this implied claim shows the strong attention the FDA gives products for vulnerable consumers like children.
Instagram, Twitter and Facebook provided ample sources of the drug claims the FDA used as the bases for certain enforcement actions. Although the FDA’s prior enforcement for dietary supplements rarely includes claims from social media, Monday’s warning letters cite several instances where drug claims made on social media also direct consumers to purchase products from linked company websites. Companies should keep in mind that over the past five years of CBD enforcement actions, the FDA has shown a shift from testing for adulteration to issues arising from label review during facility inspections to the recent actions based on website and social media reviews.
Animal Products and Feed Residue
In addition to the warning Letters, the FDA provided a news release and a consumer update that provide more information about FDA concerns regarding CBD safety, which includes the safety of the resulting human food products (e.g., meat, milk or eggs) from food-producing animals consuming feed formulated with CBD. Specifically, the news release raises concerns about whether CBD residue can be hazardous to human safety. Historically, FDA enforcement focused on pet products and not food-producing species. Addressing CBD residue questions arising from feed intended for food-producing animals will involve applying legal and regulatory principles to the scientific background about hemp and CBD products.
The breadth and scope of issues described in the warning letters confirms that the FDA has its sight on dietary supplements and food that contain CBD, even as the Agency continues to use enforcement discretion for many products. These enforcement actions suggest that all companies, not just CBD-focused companies, should understand that enforcement discretion is not a shield for illegal or ignorant practices resulting in drug claims, inappropriate use of social media and, most importantly, failure to confirm product safety.