On April 2, 2019, the Federal Food and Drug Administration (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:
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.
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.
Companies interested in participating in the FDA's regulatory process or who have questions, should feel free to contact us.
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