The Food and Drug Administration (FDA) announced earlier this month that it was accepting public comments on CBD regulations, and more than 400 people have already made their voices heard.
Comments published on Regulations.gov range widely in subject matter, but the main theme running through them is that regulations should be light and companies should be able to lawfully market products containing cannabidiol. Many added that marijuana in general should be legalized, even though the agency did not request that people weigh in on that broader issue.
The comment period was designed to help inform an upcoming public hearing on CBD regulations that the FDA is holding on May 31. Amy Abernethy, principal deputy commission of the FDA, tweeted a link for stakeholders to register for the hearing on Wednesday.
Are there particular safety concerns re: products with cannabis/cannabis-derived compounds? How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety & exposure? Comments/data on important issues like these can help inform FDA reg. oversight.
— Dr. Amy Abernethy (@DrAbernethyFDA) April 17, 2019
We’re seeking input re: FDA’s reg. strategy for existing products, lawful pathways by which appropriate products containing cannabis/cannabis-derived compounds can be marketed & how to make them more predictable/efficient. Register or submit to the docket: https://t.co/xISRzDgN1S pic.twitter.com/maBllYjr3O
— Dr. Amy Abernethy (@DrAbernethyFDA) April 17, 2019
The FDA listed out several questions mostly concerning the safety of cannabis-derived products, how to enact quality control measures and what “validated analytical testing is needed” to ensure that CBD is manufactured in a consistent manner.
David Mangone, director of government affairs at Americans for Safe Access, offered some tips on how to submit effective comments in an earlier interview with Marijuana Moment, and one of the takeaways was that the FDA is primarily interested in receiving scientific evidence that addresses the agency’s specific questions—as opposed to personal anecdotes about CBD use.
Some, like Matthew Lubeck, followed that advice. He commented that CBD should be allowed into the food supply because “the bioavailability and reactiveness within the human body and the cannabinoid system” isn’t ideal when the compound is isolated.
Brent King offered an assessment examining the potential use of CBD as an exit drug from addictive substances such as opioids. He cited a study that showed reduced opioid overdoses in states that have loosened marijuana laws as an example.
“The gateway theory falls victim to the mistaken assumption that correlation alone implies causation,” King said. “Using the same logic, one could argue that drinking milk is a gateway to illicit drug use since most people who use illicit drugs also drank milk as young people.”
Others raised questions about the CBD market as it exists today—unregulated by the FDA as the agency continues to weigh possible options to allow hemp-derived CBD into the food supply or as dietary supplements. An anonymous comment expressed concerns about product consistency across companies that are already selling CBD, arguing that “variance from product to product is confusing” and makes it difficult to “make an informed decisions” about what products to use.
“The public needs protection from unscrupulous companies goals to get rich,” the person wrote.
All that said, most comments did not adhere to Mangone’s or the FDA’s guidelines. The vast majority of comments were anecdotal and individualized. People suffering from conditions such as anxiety, pain, post-traumatic stress disorder and insomnia urged the FDA to loosen restrictions on CBD, describing their own life-changing experience with the product. Several others talked about the health benefits of CBD that they observed in pets.
While that might not be what the agency asked for, that doesn’t change the fact that there is a broad consensus among those who took the time to comment: CBD is safe and has proven medical value, and people should be allowed to freely access it.
It’s not that simple from the FDA’s perspective, however. Former Commissioner Scott Gottlieb has repeatedly stressed that because CBD exists as an FDA-approved drug (Epidiolex) and hasn’t previously been introduced to the food supply, there’s no clear regulatory framework to put it through, even if that was the intention of the 2018 Farm Bill that legalized hemp and its derivatives.
Gottlieb has told members of Congress that additional legislation may be required to provide for the marketing of CBD, or else it may take years before the FDA can identify an alternative regulatory pathway. In the meantime, the FDA is taking a “risk-based” approach to enforcing laws governing CBD marketing that involves cracking down on companies making unsanctioned claims about the health benefits of their CBD products.
Federal requests for public input on cannabis-related policies are nothing new. Thousands offered their perspective on marijuana scheduling under international treaties when the FDA requested feedback on that issue last year. More recently, another federal agency solicited studies from the public on how cannabis can treat symptoms of Alzheimer’s disease.
Photo courtesy of Rick Proctor.