FDA’s CBD Public Meeting featured a full house of manufacturers, researchers, health professionals, trade association representatives, and other stakeholders. Each speaker was given a few minutes to offer their input in response to FDA’s call for submissions relating to health and safety risks; manufacturing and product quality; and marketing, labeling, and sales. Here are key themes and highlights:
- Opening Remarks: Acting FDA Commissioner Ned Sharpless opened the meeting by acknowledging the “explosion” of consumer interest and the complexity of the task that FDA faces given hemp’s long prohibition: “When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety,” he noted. He also responded to Congressional and stakeholder pressure to explore a pathway for CBD in foods and dietary supplements by noting that the agency has a high-level working group focused on the issue.
- Regulatory Structure: Per the Natural Products Association, approximately 1500 new CBD products have been introduced over the last three years. Overwhelmingly, manufacturers and trade association representatives called on FDA to provide a predictable pathway to market, in large part by enforcing existing laws relating to product categories, such as DSHEA. Multiple speakers discussed the history of hemp in the diet as the basis for treatment of hemp extracts as a safe dietary ingredient, with some acknowledging that CBD isolate could be continued to be regulated as a drug. In addition, there were many calls to enforce quality standards such as GMPs, identity testing, product testing for contaminants, labeling requirements, and adverse event reporting.
The three to five year timeframe that FDA previously referenced for a potential new regulation was a significant concern to many stakeholders. Several speakers called on FDA to issue guidance as it explores a potential pathway for CBD in foods. One speaker, Douglas MacKay of CV Sciences, encouraged FDA to create a “lane” for different product categories, i.e., drugs, foods, dietary supplements, based on dosages and intended use, using omega-3s as an example of an ingredient that currently exists in similar “lanes.”
- Consumer Use and Understanding: Lisa Gill from Consumer Reports presented consumer survey data with several interesting findings, including the following: 26% of U.S. consumers have used CBD. Of these, edibles are the most commonly used.
Consumers are most likely to obtain CBD from a cannabis dispensary.
And – perhaps most interesting from a public health perspective – many consumers replace OTC or Rx medications with CBD and are strongly of the opinion that it is effective.
- Marketing and Labeling: Many speakers expressed concern over aggressive product claims, questionable manufacturing and testing practices, and adulteration with not just THC but other contaminants. Several speakers presented data based on product sampling and testing of CBD content, THC content, contaminants such as lead, pesticides, etc. Generally speaking, the takeaway was that CBD products feature highly variable potency and contamination levels. Two speakers who had conducted separate product surveys each found just one product that featured 100% of the amount of CBD listed on the label. Others contained no CBD and some contained multiples of the label claim. In addition, in one survey, 45% of products tested contained THC, although amounts detected were not indicated in the results presented.
- Health and Safety Risks: The World Health Organization report regarding CBD was cited by several speakers as support for the general safety and lack of evidence of addictive properties. However, key concerns noted included limited understanding of potential drug interactions between CBD and other medications and, in particular, the dose/effect relationship between such interactions. GW Pharmaceuticals and academic researchers acknowledged the potential for CBD-associated liver damage discovered during the Epidiolex trials and other studies. Other speakers encouraged FDA to review data gathered from state medical marijuana programs (some of which include CBD products) relating to adverse events and drug interactions. The effect of cumulative exposure from several product types was also cited as an area requiring further research.
- Research Restrictions: Researchers from several universities throughout the countries as well as practitioners of several specialties presented findings based on clinical studies and patient treatment with CBD and medical marijuana. While their interests varied, they universally supported more research into the safety and efficacy of CBD and expressed concern about their ability to access market-grade product for research. In particular, they cited restrictions relating to DEA scheduling, DEA’s delay in issuing cannabis permits, the inferior quality of cannabis (marijuana) that is obtainable from the U of Mississippi (the only federally-sanctioned site for cultivation), the IRB process, and related gating steps that are required for clinical studies as barriers to pursuing research.
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Throughout the day, FDA panelists asked a variety of questions such as what the speakers believed are the health benefits of CBD, what support they have for that conclusion, the number of new manufacturers who have entered the CBD market over the last few years and the degree to which they are following GMPs, and the body of evidence relating to food producing animals and pet products generally.
As expected, the meeting was largely a listening exercise and the first step in a deliberative process. Comments can be filed until July 2.