US Food and Drug Administration (FDA) commissioner Stephen Hahn told a Congressional subcommittee that more research and data are needed before the FDA is ready to issue a formal policy on cannabidiol (CBD) products. Meanwhile, the FDA has created an online portal to collect scientific data and studies from the public regarding the safety and efficacy of CBD.
“We have a knowledge gap…that makes it difficult for us to know how to proceed in several areas,” Hahn said. “The critical need here–besides getting the enforcement policy forward and providing regulatory clarity–is conducting the research and gathering the data.”[1]
One area in particular that Hahn said needs more research before a rule can be firmly established is whether an upper limit to the amount of CBD that a product contains should be set.
“It would be very difficult and [there is] not a lot of science and data behind being able to establish that upper limit at this point,” Hahn told the subcommittee. “I don’t see that happening right now until we gather additional information.”[1]
Hahn was fielding questions about the FDA’s ongoing efforts to regulate CBD products during testimony before a House Committee on Appropriations subcommittee, after the agency submitted a report providing an update. The FDA acknowledged in that report, “We have made progress but there are still areas where timely attention is needed.”[2]
Two other central themes emerged in the subcommittee hearing.
First was that the FDA has and will continue to enforce existing laws against companies making unsubstantiated health claims on CBD products.
In November 2019, the agency issued warnings to 15 companies accused of marketing CBD products with misleading labeling.[3] “We have taken action against companies who have made false claims about CBD products curing cancer, treating Alzheimer’s, and those are the highest risk areas. We will continue to enforce that,” Hahn said during his testimony to the subcommittee.[1,4]
Second, the FDA is exploring allowing CBD as a dietary supplement.
According to Hahn’s report to Congress, “Under current law, CBD products cannot lawfully be sold as dietary supplements, but FDA has the authority to remove this exclusion through rulemaking. We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements.”[1,2]
The FDA was slightly late in updating the subcommittee, which it was supposed to have done within 60 days of the passage of an appropriations bill in December providing $2 million for data collection and enforcement measures. When it came, at least one subcommittee member felt the update was inadequate.
“Many of us were disappointed that the report didn’t provide more clarity and concrete steps forward,” said Maine Democrat Chellie Pingree. “You haven’t taken any robust action to issue regulatory guidance that would clear the market.”
Up to now, the FDA has been slow in delivering tangible progress in instituting regulations on CBD products.
The agency’s approach appears to be to take action against clearly unsupported health claims and turn a blind eye to other products until it can produce a formal policy.
One might reasonably believe the FDA’s efforts to release comprehensive CBD regulations will be slowed further as it rightly focuses much of its efforts and resources towards fighting the COVID-19 pandemic.
Image Credit: Erin Hinterland
Image Source: https://pixabay.com/photos/cbd-oil-cannabidiol-cannabinoid-5358407/
Original Article: https://www.cbd-intel.com/fda-needs-more-data-before-making-cbd-rules-hahn-tells-us-hearing/
References
- Marijuana Moment. “FDA Chief Faces CBD Questions at Congressional Hearing.” Available at: https://www.marijuanamoment.net/fda-chief-faces-cbd-questions-at-congressional-hearing/ Accessed June 29, 2020.
- Council for Responsible Nutrition. “Report to the US House Committee on Appropriations and the US Senate Committee on Appropriations: Cannabidiol (CBD).” Available at: https://crnusa.org/sites/default/files/RAC%20attachments/CBD/CBD%20RTC%20Final.pdf Accessed June 29, 2020.
- US FDA. “FDA Warns 15 Companies for Illegally Selling Various Products Containing Cannabidiol as Agency Details Safety Concerns.” Available at: https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details Accessed June 29, 2020.
- US FDA. “FDA Warns Company Marketing Unapproved Cannabidiol Products with Unsubstantiated Claims to Treat Cancer, Alzheimer’s Disease, Opioid Withdrawal, Pain and Pet Anxiety.” Available at: https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer Accessed June 29, 2020.
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