Bipartisan House members sent a letter to the FDA commissioner to complain about the agency's “completely insufficient response” to their bill, which called for hemp-derived CBD to be permitted and regulated as a food additive.
Reps. Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-MN), and Dan Crenshaw (R-TX) said the FDA “does not address provisions of our bill drafted specifically to address product safety, and is a completely insufficient response at this moment when cannabidiol (CBD) products are proliferating around the country,” reported Marijuana Moment.
What Happened: In December, the “CBD Product Safety and Standardization Act” was filed and sponsors sought technical assistance from FDA to advise on necessary provisions. The bill aims to help resolve the ongoing regulatory issue hemp stakeholders have asked the FDA to clear up.
What Did The Letter Say?
In the recent letter, lawmakers said that four months after they sent the inquiry, the FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago.”
Under the 2018 Farm Bill, FDA received regulatory authority over hemp and its derivatives. However “FDA has refused to act on that authority, allowing a marketplace where dangerous products, like those containing delta-8 THC, are often indistinguishable from products that meet strict standards for quality, dosage, packaging, and sale established by state regulators who have stepped in to fill the regulatory void,” continued the lawmakers.
“These state regulations are a direct result of FDA’s inaction, lack of clarity, and refusal to engage meaningfully on this issue,” they said in the letter. “However, we believe that FDA can and should reverse course and learn from these state governments—working with them to determine how a federal framework could be designed to eliminate the unsustainable and inefficient patchwork of state regulations.”
The U.S. Hemp Round Table, which posted the letter and expressed gratitude "for a clear, comprehensive critique of the FDA's TA on H.R. 6134! We hope it prompts the FDA to act on the establishment of a regulatory framework for hemp-derived CBD products."
What is the FDA's Position?
FDA Commissioner Robert Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply and that the situation “looks pretty much the same in terms of where we are now.”
Califf added that the FDA took steps to research the safety profile of cannabinoids to inform future rules. However, he blamed Congress, noting that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.
“We’re going to have to come up with something new. I’m very committed to doing that.”
According to the text of the legislation: FDA would be required to develop rules and hold a public comment period on the maximum amount of hemp-derived CBD that could be added to a food item or beverage per serving, labeling and packaging requirements, and the “conditions of intended use.”
Photo: Courtesy Of Robert Nelson On Unsplash
