Earlier this week, FDA sent its status report regarding a potential CBD enforcement discretion policy to Congress. As we wrote here, FDA was required to issue the report per the Joint Explanatory Statement attached to the 2020 Ag Appropriations Bill. Here is our analysis and report highlights:
- Overall Status: The report is consistent with FDA’s public statements and enforcement regarding CBD. FDA acknowledges the vast proliferation of CBD but remains concerned about safety risks. These risks include mislabeling, potential contamination with THC, pesticides, and heavy metals. More data is needed. There are no surprises relative to the agency’s legal positions.
- Dietary Supplements: FDA is continuing to evaluate a potential dietary supplement pathway. The agency has been actively working to identify and review safety data. Concerns remain around continuous use, particularly in the absence of medical supervision. To help address this, FDA is asking for safety data on individual products. Given the proprietary nature of this data, the agency is working on a process to collect this information while still protecting trade secrets or confidential information.
- Foods: FDA reiterates its position that it is not lawful to add CBD to human or animal food based on currently-available safety data. In the November 2019 warning letters, the agency discussed its position that CBD is not generally recognized as safe for foods. The agency encourages interested parties to submit relevant safety data.
- Cosmetics: FDA is aware of limited safety data regarding CBD in topical form. FDA is working to address data gaps by conducting its own research. More on this below.
- Drugs: The drug pathway to market is clear. FDA reiterates the existing approval processes.
- Vape Products: FDA remains concerned about vaping and toxicity. Also, vape products that meet the definition of tobacco product will be regulated as tobacco products. CBD-containing products that are intended for use as a drug will be regulated as drugs. More safety data is needed.
FDA is taking the following steps to evaluate potential lawful pathways for CBD.
- Safety Information Collection: FDA is reopening the docket established as part of the May 2019 public meeting. This will provide a means of allowing stakeholders to submit information. The docket will remain open indefinitely.
- Engagement With Government Partners: FDA has had conversations with many federal, state, local, and international partners. Interestingly, the listed international parties did not include the UK, which recently announced a 70 mg/day threshold for CBD in novel foods.
- Full and Broad Spectrum: FDA acknowledges that “full spectrum” and “broad spectrum” are undefined. The agency is seeking information as to how these extracts are derived, their content, and how they compare to CBD isolate.
- Research: FDA is generating its own data. This includes a rat study on the effects of CBD exposure during pregnancy. The agency also initiated a research study in partnership with the University of Mississippi to evaluate CBD and THC levels in a sample of cosmetic products (about 100 products, including some positive controls), to assess sensitization of THC and CBD topically, and dermal penetration.
- Product Sampling: Congress directed FDA to perform a sampling study of the current CBD marketplace. The study is intended to test the extent to which products are mislabeled or adulterated. FDA is developing an action plan for sampling.
Stakeholders will appreciate hearing of the new steps but, overall, are likely to find the report frustrating. It fulfills the agency’s reporting obligation but doesn’t provide the clarity for which Congress and industry have been clamoring.
Nevertheless, it is vital that interested parties continue to engage with FDA. Even if Congress steps in and passes legislation that exempts CBD from the drug preclusion, FDA remains the primary regulator. As a science-based public health agency, they will need to be convinced that CBD is safe in its various forms and dosages in order to provide the clarity that the market demands.