FDA had 60 days from December 20 to issue a report to Congress regarding the Agency's progress toward obtaining and analyzing data to help determine a policy of enforcement discretion regarding CBD products. In its overdue report, FDA reiterated its concern about the potential safety risks of using CBD and about problems related to a number of currently-marketed products, like product mislabeling; the potential for the products to be contaminated with THC, pesticides, or heavy metals; and the potential for the product to negatively interact with other drugs, cause liver injury, or cause drowsiness. Animal studies found risks, including related to male reproductive toxicity, some of which exist at even the lowest levels of exposure studied.
The Agency indicated that it is working to further understand the safety profile of CBD, especially for sustained exposure, interactions with other drugs, and for vulnerable populations. FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements and made clear that CBD products cannot currently be lawfully marketed in this category or in human or animal food.
FDA also noted that it is evaluating issuance of a risk-based enforcement policy that would provide greater transparency regarding FDA's priorities. The Agency has not yet adopted that approach and it intends to continue taking action to address violations that it feels put the public at risk including against companies (1) making therapeutic claims about their products that are unsubstantiated and/or have not gone through the drug approval process, (2) marketing products with false claims or statements, (3) marketing products for use by vulnerable populations, and (4) marketing products containing contaminants or other harmful substances.
FDA announced that it is reopening the comment database from the May 2019 public meeting and is asking researchers and other stakeholders to use this docket for reporting new data and information about CBD safety.
Essentially, FDA used this report to tell Congress and the public what we already know - that FDA is continuing to gather safety data about CBD, that the Agency will continue to enforce against products bearing egregious claims and products that put users at risk, and that FDA might adopt an enforcement-discretion policy in the future.
The Agency has been taking a variety of concerted actions to advance its continued evaluation of potential regulatory pathways for FDA-regulated consumer products containing or derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD). This report discusses actions FDA has been taking, as well as additional new steps the Agency is taking or intends to take soon.