Lawmakers want to find solution in wake of FDA CBD announcement

U.S. lawmakers’ mixed reactions to FDA’s announcement that Congress should provide a new pathway to oversee the market for cannabidiol (CBD) included criticism and affirmations of the need of Capitol Hill to intervene. 

“The current regulatory gray zone for hemp-derived CBD isn’t working,” Sen. Ron Wyden, Democrat from Oregon, said in a written statement. “Regulations are needed to protect consumer safety and to make sure the hemp producers and farmers in Oregon and across the country are on a level playing field with other legal products.”

Along with Sens. Rand Paul (R-Kentucky) and Jeff Merkley (D-Oregon), Wyden introduced a bill in 2021 (the Hemp Access and Consumer Safety Act) to exempt hemp-derived CBD from prohibition in food, beverages and dietary supplements. According to U.S. regulators, CBD is prohibited from food and supplements under the Federal Food, Drug & Cosmetic Act due to its investigation as a drug.

Wyden said he planned to reintroduce his bill “to ensure the FDA can regulate food and dietary supplements containing CBD.”

"Farmers, producers and consumers need certainty about when and how CBD is safely included in products,” a spokesperson for Merkley told Natural Products Insider. “Sen. Merkley will continue pushing, because stakeholders need action from FDA, not a plan to wait for Congress. They have the authority they need and should use it."

Related:FDA denies CBD dietary supplement petitions, looks to Congress for new pathway

Following “careful review,” FDA has determined the need for a new regulatory pathway “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” FDA Principal Deputy Commissioner Janet Woodcock, M.D., announced in a Jan. 26 news release. “The agency is prepared to work with Congress on this matter.”

FDA has safety concerns about CBD, especially its long-term use. Woodcock said the compound has demonstrated the potential for possible harm to the liver, interactions with particular medications and possible harm to the reproductive system.

“CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant,” she added.

Woodcock said consumers would benefit from a new regulatory pathway that would offer oversight and protections to abate and manage risks associated with CBD products. She referenced such potential measures as clear labels, content limits on CBD, a minimum purchase age and prevention of contaminants.

Rep. Chellie Pingree, a Democrat from Maine who introduced the Hemp Advancement Act of 2022 to resolve certain issues that were not addressed by the 2018 Farm Bill, said in a statement that FDA’s announcement Thursday “affirms the need for Congress to pass legislation and finally provide a regulatory path for CBD.”

Rep. James Griffith (R-Virginia) expressed interest in working with FDA to craft a solution. He and a former colleague, Kurt Schrader (D-Oregon), who recently departed Congress, introduced the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020.

“In the past 24 hours, I have been in contact with the FDA regarding their recent cannabidiol (CBD) market announcement and their willingness to work with Congress to create a regulatory pathway for CBD products,” Griffith said in a statement Thursday. “I look forward to working with the FDA so we may create a safe pathway for these products to come to market.”

Rep. James Comer (R-Kentucky), who oversees the House Committee on Oversight and Accountability, criticized FDA following its announcement Thursday, which included denial of three citizen petitions, requesting the agency engage in rulemaking to allow CBD to be marketed in dietary supplements.

“The FDA failed for too long to take steps to ensure the safety of hemp-derived dietary products, putting the health and safety of the American people at risk,” he said in a statement. “The Committee on Oversight and Accountability will investigate this decision to understand why exactly the FDA has decided to abdicate their regulatory responsibilities. We need to be sure that the FDA is not using this as an opportunity simply to leverage more authority and resources from Congress.”