On March 5, 2020, the Commissioner of the U.S. Food and Drug Administration (FDA) released a statement describing the agency’s continued evaluation of cannabidiol (CBD) products and signaling issuance of an enforcement policy against sellers and marketers of CBD products.
Forthcoming Enforcement Policy. To date, FDA largely has enforced only against companies making egregious health claims, such as treatment for cancer or Alzheimer’s Disease. While FDA will continue to take actions against companies marketing products with aggressive therapeutic claims, FDA Commissioner Hahn reported that the agency will be taking a harder look at products that contain heavy metals, THC (greater than 0.3% on a dry weight basis), or other contaminants. FDA also expressed concerns over products with inaccurate statements regarding CBD content, and those containing undeclared ingredients—an issue that has plagued the dietary supplement industry for years. This is one reason why companies should be carefully vetting their supply chain, including raw material suppliers, contract manufacturers, and contract laboratories.
Moving forward, FDA is evaluating issuing a risk-based enforcement policy that would provide greater clarity on the factors it considers when making enforcement decisions. While the industry would indeed benefit from such clarity, it is unlikely that the policy would differ in material respects from FDA’s current implicit policy, which is demonstrated in its published Warning Letters. The statements from the Commissioner signal increased interest in product ingredients (or omitted ingredients) and marketing specifically geared towards children.
Closing the Gap in Safety Data. In light of the insufficient information FDA has received thus far, FDA also reported that it is re-opening its public docket that it established for its May 2019 public hearing and extending the comment period indefinitely. The docket will have a mechanism for stakeholders to submit information that they consider confidential, increasing the likelihood that companies would actually submit data. Without this safeguard in place, any data that stakeholders submit becomes publicly available upon submitting to the docket. Companies that submit information to the revised docket should be very clear when identifying which information should be kept confidential.
FDA specifically is seeking high-quality data on topics such as:
- The sedative effects of CBD;
- The impacts of long-term or cumulative exposure to CBD;
- Transdermal penetration and pharmacokinetics of CBD;
- The effects of various routes of administration (g., oral, topical); and
- The safety of CBD for use in pets and food-producing animals.
This is not to say that the FDA believes that CBD is unsafe; it just cannot, at this time, conclude that unapproved CBD products are safe for use.
While the statement does not provide any clarity on a regulatory path forward for CBD products, it does indicate the agency’s continued concerns over the safety of CBD products and the accuracy of their labeling.