WASHINGTON — Stakeholders in the manufacture, distribution, use and regulation of products containing cannabis or cannabis-derived compounds, such as cannabidiol (C.B.D.), had their say before a panel of Food and Drug Administration officials during a daylong public hearing held May 31 at the agency’s White Oak Campus in Silver Spring, Md. More than 400 individuals and associations applied to address the panel; more than 100 were able to do so.
A docket set up by the F.D.A. to collect statements from individuals and stakeholders has received more than 1,211 comments by June 7. The docket will remain open until July 2.
The F.D.A. convened the hearing to inform its efforts to develop regulations to bring order, oversight and responsibility to a rapidly growing but heretofore largely unconstrained C.B.D. industry. Acting Commissioner Norman Sharpless opened the hearing on a cautionary note. Mr. Sharpless reminded hearing participants that there remained important questions that must be answered before the safety and appropriate uses of C.B.D. in foods and dietary supplements may be determined.
“There are important reasons to generally prohibit putting drugs in the food supply,” Mr. Sharpless said, adding that cannabis extracts including C.B.D. are not exceptions.
The official stance of the F.D.A. is that it is not permissible to use C.B.D. in food and dietary supplements. Nevertheless, thousands of products using or incorporating C.B.D. already are available nationwide. The F.D.A. is playing catchup. To date, it only has taken disciplinary actions in the form of warning letters dispatched to individual manufacturers who have made unapproved and unsubstantiated health claims for their C.B.D. products, claims that the F.D.A. asserted may discourage consumers from seeking critical medical assistance and treatment.
At the May 31 hearing, consumers provided testimonials on how C.B.D. helped treat various health issues, academics shared the latest research, and entrepreneurs pointed to the health and economic benefits of their products and industry.
The American Medical Association in its submission to the F.D.A. docket pointed to a 2017 report of the National Academies of Sciences, Engineering and Medicine that indicated there was conclusive or substantial evidence that cannabis or cannabinoids are effective for the treatment of chronic pain in adults (cannabis), as antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids) and for improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids). The report also pointed to moderate evidence that cannabis or cannabinoids are effective for improving short-term sleep outcomes for certain individuals. Otherwise, evidence was deemed limited or insufficient for many of the other health benefits touted by some C.B.D. advocates.
The need for additional research was viewed as compelling.
Many manufacturers of C.B.D. products have joined under the umbrella of the National Cannabis Industry Association. The N.C.I.A. in its comments to the F.D.A. panel and its submission to the comment docket said it sought to partner with the F.D.A. to “develop an appropriate regulatory framework to ensure the safety and efficacy of these important products.”
The N.C.I.A. said it was important for the F.D.A. to act quickly to clarify the regulatory environment because of consumer confusion.
“Consumers consistently ask why a federally legal substance is currently prohibited in food and wellness products under F.D.A. regulations,” the N.C.I.A. said. “These inquiries will likely remain a source of confusion, especially when so many individuals already use C.B.D. products.”
The N.C.I.A. said it appreciated the F.D.A.’s position that hemp-derived C.B.D. may not be used as ingredient in dietary supplement or food.
“At the same time, we are confident that the F.D.A. will quickly change this position in recognition of the broad use, efficacy and safety of these products,” the N.C.I.A. said. “In addition, until such time as the F.D.A. issues a new regulation, we recommend that the F.D.A. continue to exercise its enforcement discretion to allow consumers continued access to hemp-derived C.B.D. products. We support the F.D.A.’s issuing warning letters for drug claims that go beyond substantiated claims and believe that this is the best approach until the F.D.A. issues rules establishing a pathway for regulating food and supplements containing C.B.D.”
Food manufacturers and marketing associations also emphasized the importance for the F.D.A. to move quickly to address consumer confusion.
Betsy Booren, senior vice-president, science and technology, Grocery Manufacturers Association, told the F.D.A. panel, “As consumer interest for food, beverage, personal care and household products containing cannabis and cannabis derivatives continues to grow, the necessity for national uniform regulatory frameworks that protect public health is of critical importance. The potential patchwork of laws at the state and local level will promote confusion among consumers.”
Peter Matz, director, food and health policy, Food Marketing Institute, told the F.D.A. officials, “Because of the consumer interest in this emerging market, and the desire of our members to provide products their customers are seeking, we are fielding more and more questions from companies that are understandably seeking clarity about the current regulatory framework for the sale and labeling of products containing C.B.D. And, while we want to be in full compliance with all F.D.A. requirements, we also want to ensure our members have appropriate assurances that the products they are selling are both safe and being sold appropriately.
“Having said that, F.M.I. sees the regulatory challenges surrounding the legal and appropriate sale of hemp and hemp-derived products as a critically important policy issue. And, given the prevalence of these products in the marketplace, we respectfully urge F.D.A. to move swiftly to provide additional clarity and establish a pathway forward.”
Amy Abernethy, Ph.D., the F.D.A.’s deputy commissioner, who is in charge of the agency’s working group on cannabis and cannabis-derived compounds, tweeted during the hearing: “Key questions about product safety need to be addressed. Data are needed to determine the safety thresholds for C.B.D … There are both positive supporters of cannabis and cannabis-derived products including C.B.D. and also concerned citizens worried that widely available products can be harmful.”
Dr. Abernethy’s comments seem to underscore both the importance of the hearing itself and the fact that much work is yet to be done.
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