January 27, 2023

NASC Lauds FDA Message that a “New Way Forward” is Needed for Cannabidiol Assessment

The FDA this week announced that existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol and would work to find a new way forward, and the statement was welcome news for advocates of animal wellness including the National Animal Supplement Council.

“Over our 21-year history, we have always worked very successfully with the FDA to define, develop and implement regulatory pathways that provide responsible outcomes for all stakeholders while maintaining regulatory oversight,” NASC President Bill Bookout said in a statement. “We view this announcement and indications we have received from the FDA-CVM as positive progress, and we welcome the opportunity to continue to help shape a viable path forward. Doing the right things right always pays dividends in the long run.”

Dr. Janet Woodcock, FDA Principal Deputy Commissioner, said, “The FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

Woodcock’s statement cautions the agency is still prioritizing safety in its new pathway. “The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” she said. However, existing regulations are limiting. “The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.”

NASC has helped shape thinking around how that new pathway might materialize. “On behalf of our members, NASC has been on the forefront of this issue since 2015,” said Bookout. “Following our testimony at the FDA’s Public Meeting in 2019, we provided the agency with our program for what we believe are components of a responsible path forward. Our program includes virtually all general requirements mentioned in the announcement and in addition, we are in the final stages of completing our long-term safety study for CBD, CBD/CBA and CBD/CBG in dogs. The results of our study have shown very favorable results within the administration ranges we identified.”

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