Do you have feelings about how the federal government is handling the regulation of CBD products? Now you can share those thoughts—along with studies, data and other important information—with the Food and Drug Administration (FDA).
On Wednesday, the agency published an official notice announcing a public hearing for next month on its approach to regulating products, including dietary supplements and foods, that contain cannabidiol.
But you don’t have to participate in the meeting itself to make your voice heard. In conjunction with the May 31 event, regulators have also opened up an official docket to take feedback on the issue. The public comment period is open through July 2.
Specifically, FDA is requesting information related to health and safety risks, manufacturing and product quality and the way in which products containing cannabis or cannabis-derived compounds are marketed and sold.
As the agency writes in its notice: “While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.”
Broadly, the FDA wants to see information concerning the notion that hemp-derived CBD is safe to consume in food, what kind of standards need to be put into place to ensure product quality and consistency and what information needs to be included on labels to ensure consumers know exactly what risks they’re taking, if any.
Other questions include:
- What levels of cannabis and cannabis-derived compounds cause safety concerns?
- How do cannabis and cannabis-derived compounds interact with other substances (e.g., drug ingredients)?
- What validated analytical testing is needed to support the manufacturing of safe and consistent products?
David Mangone is the director of government affairs at Americans for Safe Access (ASA). He told Marijuana Moment that submitting comments to the FDA is an opportunity for the general public to help shape policy—and that every comment is read.
“The federal government is anywhere from 10 to 15 years behind the American public and the state-level politics on this issue,” he said in a phone interview. “It’s important for people to be able to use their voice,” and this is one way to do that.
If you’re planning to submit a public comment on the issue, here are a few things to keep in mind:
Be thoughtful about your comment.
“When you see comments particularly on this issue from the general public, you see a lot of brief comments that are very opinionated,” Mangone said.
Last month, another cannabis-related docket was opened to gauge public interest in how the United States should vote on World Health Organization recommendations to reschedule cannabis and its compounds. Nearly 2,000 comments were filed, and an overwhelming number of them support marijuana reclassification.
But, Mangone pointed out, many of those comments were brief, boiling down to “Legalize it” or offering stories about how medical cannabis helps people who are struggling with debilitating conditions.
“That’s not really what the FDA is ever looking for,” he said. “I wish we could sway federal policy with patient stories—and, to a degree, we can on Capitol Hill—but with a regulatory body like the FDA, they’re looking for very specific answers to very specific questions.”
As such, Mangone suggested picking one question from the public notice document on CBD and focusing on it.
Include scientifically sound research.
“This is not a popularity contest. It’s not like an up/down vote on how many comments in favor and how many comments against [CBD products],” he explained. “It’s based off the quality and content of the comments.”
That’s why including studies and data in your submissions is so important. Start by looking for scientific studies that include a large number of people in the sample. Pay attention to who it was conducted by (a university or international body is ideal) and whether or not the authors have a financial interest in the outcome of the study, Mangone said.
Remember who your audience is.
“You’re writing to a government regulatory body that for the past 40 to 50 years has worked actively against allowing CBD—and cannabis largely—as a medicine,” Mangone said. “You have to be respectful in your comments, but you also can’t leave anything on the table.”
Photo courtesy of Rick Proctor.