April 02, 2019

More CBD Guidance – and a Public Hearing Date – from the FDA

More CBD Guidance – and a Public Hearing Date – from the FDA

As we have been sharing in this space, the FDA has been slowly charting a path toward the full legal recognition of hemp-derived CBD as a food additive and dietary supplement. Today, marks another landmark. After teasing such an announcement for weeks, the FDA published in the Federal Register this morning that it will be holding a public hearing on products containing cannabis or cannabis-derived products on May 31, 2019, from 8 a.m. to 6 p.m. Read the notice here.

The Roundtable will be fully represented at that hearing. Perhaps more significantly, FDA’s outgoing Commissioner, Scott Gottlieb, issued a statement concerning the hearing and other developments on the issue. The statement (which can be read in full here), includes the following key excerpts:

  • The public hearing will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.
  • As part of the public hearing and related public comment period, the agency is interested in whether there are particular safety concerns that we should be aware of as we consider the FDA’s regulatory oversight and monitoring of these products.
  • We’re forming a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. Given the importance of this issue, I’ve asked Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. and Principal Associate Commissioner for Policy Lowell Schiller, to co-chair the group and charged them with considering what options might be appropriate under our current authorities, in view of all the evidence before us and our agency’s fundamental public health mission. I’m also asking the group to consider whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law – again, with the same science-based, public health focus that the FDA endeavors to bring to all matters before it…The working group plans to begin sharing information and/or findings with the public as early as Summer 2019.
  • Today, the FDA is announcing that it has issued warning letters, in collaboration with the Federal Trade Commission, to three companies – Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. – in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.
  • Ultimately, we remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.The actions we’re announcing today will allow us to continue to clarify our regulatory authority over these products and seek input from a broad range of stakeholders and examine a variety of approaches and considerations in the marketing and regulation of cannabis or cannabis-derived products, while continuing to protect the public’s health and safety.

The Roundtable applauds the FDA’s efforts to crack down on companies that make unsubstantiated medical claims about hemp products like CBD – these bad actors do more harm to the industry and its reputation than any misguided law enforcement action. We also are excited to hear again that the agency is committed to a regulatory framework that will ensure that hemp-derived CBD products can be marketed widely to the American public. We look forward to working with the FDA and congressional leaders to reach a result that ensures the full development of the hemp industry, while promoting the health and safety of all Americans.