On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction with a public hearing notice, FDA said it is aware of both Congress and the public's interest in cannabis and cannabis-derived products, and the Agency is actively considering the proper regulatory framework for the lawful marketing of these products.
In the statement, FDA notes that under current rules, it remains unlawful to market food and dietary supplements containing CBD. However, the Agency pledges to take actions to develop new regulations to enable lawful marketing of cannabis and cannabis-derived products, including food and dietary supplements containing CBD.
FDA will hold a public hearing on May 31, 2019, to hear from stakeholders and discuss information about the "safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds." The public hearing will be held at FDA's White Oak Campus, and the docket for public comments, FDA-2019-N-1482, will remain open until July 2, 2019. Companies can register to attend or present at the hearing or can submit comments in writing. The goal of the May 31 hearing is to "obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform [FDA's] regulatory oversight of these products."
FDA is interested in receiving data and information in three general categories—Health and Safety Risks, Manufacturing and Product Quality, and Marketing/Labeling/Sales. Under each category, FDA has posed specific questions including the following:
Health and Safety Risks
- Are there particular safety concerns that FDA should consider regarding its regulatory oversight and monitoring of these products? For example, what levels of cannabis and cannabis-derived compounds cause safety concerns?
- What endpoints or outcomes would define a maximal acceptable daily intake from all products?
- How does the existing commercial availability of food products containing cannabis derived compounds such as CBD (which may in some cases be lawful at the State level but not the Federal level) affect the incentives for, and the feasibility of, drug development programs involving such compounds?
- How would the incentives for, and the feasibility of, drug development be affected if food products containing cannabis-derived compounds, such as CBD, were to become widely commercially available? How would this change if FDA established thresholds on acceptable levels of cannabinoids, including CBD, in the non-drug products it regulates? What else could FDA do to support drug development from cannabinoids?
Manufacturing and Product Quality
- Are there particular standards needed to address any safety issues related to the manufacturing, processing, and holding of products containing cannabis and cannabis derived compounds (e.g., genotoxic impurities, degradation of active compounds)?
- Are there any currently used standardized definitions for the ingredients in cannabis products (e.g., "hemp oil")? If standardized definitions would be helpful, what terms should be defined and what should the definition(s) be?
- What are the functional purposes of adding cannabis-derived compounds, such as CBD, to foods (e.g., nutritive value, technical effect), both in terms of manufacturer intent and consumer perceptions and/or expectations? To the extent a compound is added to food to achieve a particular functional purpose, what evidentiary support is available to demonstrate that the addition of such compound has the intended or perceived effect?
- How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about?
- What conditions, restrictions, or other limitations on the manufacturing and distribution of these products have been put in place under state or local law, particularly with respect to food products containing cannabis-derived compounds such as CBD (which may, in some cases, be lawful at the state level but not the Federal level)?
Interagency Working Group
FDA also formally announced the formation of an internal agency working group "to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed." The working group is tasked with exploring legislative options currently available that "might lead to more efficient and appropriate pathways." The working group plans to begin sharing information and findings with the public as early as Summer 2019.
Recent Enforcement Action
FDA has made clear that it will take action against companies that make unfounded and unproven medical claims about their products. FDA recently took enforcement action against three companies making disease claims selling food, supplements, oil and salve containing CBD. FDA will continue its enforcement against companies it determines are putting the public health and safety at risk.
As we have previously discussed here and here, and as evident of FDA's Statement and the questions posed in the hearing notice, FDA is continuing the Agency's "evaluation of cannabis and cannabis-derived compounds in FDA-regulated products." We expect more to come after the public hearing.