Overview
In a March 5, 2020 update on its evaluation of cannabidiol (CBD) products, Dr. Stephen Hahn, the Food and Drug Administration's (FDA) Commissioner of Food and Drugs, announced that the agency is currently evaluating issuance of a risk-based enforcement policy that would provide "greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions." In light of FDA's continuing stance on the illegality of CBD foods and dietary supplements in particular, the industry should welcome any future policy that would provide more clarity and regulatory assurance as to FDA's decision-making. Unfortunately, FDA did not identify any timeline for issuance of this enforcement policy.
Importantly, the update reinforced that FDA will continue enforcement against CBD products that the agency considers to pose a risk of public harm because they are making unsupported claims, are marketed to vulnerable populations, or may have adverse effects due to contamination or inaccurate labeling (i.e., incorrect CBD content).
FDA also announced that it is re-opening the public docket that the agency established for its May 2019 public hearing for an indefinite comment period to provide an easy way for the public to submit new scientific information and data on CBD to the agency. The docket will also include a mechanism for the submission of confidential information or data.
FDA repeated the agency’s continuing plea for "reliable and high quality" data that addresses the following:
- The sedative effects of CBD;
- The impacts of long-term sustained or cumulative exposure to CBD;
- Transdermal penetration and pharmacokinetics of CBD;
- The effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile;
- The safety of CBD for use in pets and food-producing animals; and
- The processes by which "full spectrum" and "broad spectrum" hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.
These requests reflect the safety concerns that FDA has previously communicated regarding use and consumption of CBD-containing products, such as potential liver injury, drug interactions, and male reproductive toxicity; side effects such as drowsiness and effects of cumulative use; and the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children, and certain animal populations. FDA noted that given the new federal legal status for cannabis and cannabis derivatives with very low levels of delta-9 tetrahydrocannabinol (THC), research into these products is proliferating, including for additional pharmaceutical uses, and FDA wants to be the recipient of that data.
