As a milestone CBD bill is hampered by insufficient support from the FDA, the bill sponsors are calling for more technical assistance.
Several of the cosponsors of H.R. 6134, a bipartisan bill petitioning for the FDA regulation of CBD as a food additive, have sent a letter to FDA Commissioner Dr. Robert Califf expressing their frustration with the agency’s response to the bill.
Particularly, the “technical assistance” document provided by the FDA—which is supposed to offer suggestions to guide the proper implementation of the provisions within the bill—was described by House Representatives Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-ME), and Dan Crenshaw (R-TX) as “A reformatting of a document provided to Congress over two years ago.”
It appears the older document in mention is the FDA’s response to H.R. 8179, a document entitled “FDA/HHS Technical Comments on H.R. 8179,” as reported by Natural Products Insider in late 2020.
One of the opening statements in the letter to the FDA by the cosponsors of H.R. 6134 aptly reflects their disappointment, citing the four-month period between H.R. 6134 being introduced and the FDA’s insufficient response, which “did not address provisions of our bill drafted specifically to address product safety.”
H.R. 6134, or the CBD Product Safety and Standardization Act, would require the FDA to “Regulate food containing cannabidiol (CBD) derived from hemp as a food additive,” per the official language.
This means all food items containing hemp-derived CBD would have to comply with FDA regulations relating to food additives, which includes labeling requirements.
Importantly, the bill is calling for new FDA regulations that would set a limit on the maximum amount of hemp-derived CBD allowed in a single serving, along with new packaging and labeling requirements along with guidelines for use suggestions.
Clearly, H.R. 6134 is a pointed attempt for full-blown FDA regulation of CBD, or at least the first phase of it, which explains the extra pressure from congress and supporting stakeholders to mobilize on this legislation.
As always, we will keep a close eye on this key piece of legislation and update our audience with any developments.