House Oversight chair to FDA: Enough is enough

17-Jan-2023 - Last updated on 17-Jan-2023 at 17:46 GMT

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FDA’s failure to act on CBD created a space for bad actors and poor products to thrive, now the chairman—and the industry—want answers.

Rep. James Comer (R-KY), Chairman of the US House Oversight Committee, recently announced that he plans to investigate the US Food and Drug Administration (FDA) for its inaction on critical issues falling within the agency’s regulatory jurisdiction such as hemp-derived CBD.

Last week, the US Hemp Roundtable posted a video on its YouTube channel featuring its General Counsel, Jonathan Miller, speaking with Comer. The Chairman told Miller that he intends to bring FDA Commissioner, Robert Califf, before his committee for questioning regarding the Agency’s passivity.

Miller expressed gratitude for Comer, saying a US hemp industry may not exist if it weren't for the Chairman’s actions as Kentucky’s agriculture commissioner and his continued advocacy for the nation’s farmers in his current role.

Industry on board with inquest

A number of industry players are also encouraged that someone is stepping up to the plate, including Sibyl Swift, PhD, VP, Scientific & Regulatory Affairs at cbdMD, who hopes the new push will lead to answers.

"Since I joined cbdMD in 2020, the company has been pushing the FDA for clarity, including a face to face meeting where we offered them our comprehensive OECD safety studies, and subsequently filing a 136 page Citizen’s Petition demanding the FDA apply the existing framework for new dietary ingredients. Despite these efforts, the FDA has been consistently derelict in their duty to protect public health. We are therefore encouraged by the fact that Congress is seeking to hold the FDA accountable for their unwillingness to provide clarity on CBD,” said Swift.

As a former FDA official, Swift said she is absolutely baffled as to why the Agency would approach this outside of the decades-old established framework.

“The Agency is approaching this as an overall safety analysis as if they are considering the safety of CBD in all food sources and for all populations, rather than following the well-established rules for a new dietary ingredient," she said. "We aren’t asking for a blanket approval. We want the FDA to uphold the regulations applicable to a specific new dietary ingredient and require companies to submit data on their own specific ingredient. Pursuant to the existing regulation, the FDA is required to evaluate safety data on a case-by-case basis, taking into account the indications for use and any warnings or restrictions on use by any sensitive populations.”

She added that if Comer does see through to his plan to investigate the FDA, she wants the opportunity to testify and present data. “Hopefully, the Oversight Committee will see the merits in hearing from an industry leader with extensive safety data on how the FDA’s inactivity is impacting the safety of consumers who have already made a choice that they want CBD in their health and wellness routine."

Cautiously optimistic

Asa Waldstein, principal of the Supplement Advisory Group, said the lack of a clear pathway for hemp cannabinoids has resulted in numerous low-efficacy, inexpensive, poor-quality products with potential safety concerns and overshadowing the reputable players. Not to mention the flourishing market for Delta-8 and isomer-type products, which Waldstein said could have serious safety issues from residual solvents or lack of proper child-proof packaging.

“I am cautiously optimistic about the upcoming FDA comments, but I am eager for any conversation that gets us closer to a regulated world where hemp cannabinoids can exist in supplements,” said Waldstein.

Douglas Gansler, Partner at Cadwalader, Wickersham & Taft LLP, said a regulatory framework should be introduced, including an educational component that would ensure consumer safety by ferreting out any bad actors. “Hemp-derived CBD products are legal and there is a vibrant market for them, so hopefully the hearings will focus on the benefits of the products with an eye toward consumer education,” Gansler said.

“Industry deserves more”

Scott Mazza, COO and Co-Founder of Vitality CBD, said from day one the industry and consumers deserved more clarity. “Time and again, producers have been hamstrung by a lack of leadership by the FDA. Many of us were left in the dark regarding crucial policy elements about CBD like food supplements and Delta-8. As a result, bad actors and poor products thrived.”

Mazza said the Agency owes everyone answers.

“The industry deserves to know why this process has taken so long. And it will be good to hear directly from the agency head in a formal setting. But, of course, the timing is interesting given that the FDA appeared to be on the cusp of revealing its long-awaited CBD oversight plan,” he said .

Indeed, the timing is curious. Earlier this month, the FDA announced it plans to put CBD framework out in the coming months. A spokesperson for the FDA provided NutraIngredients-USA with a statement by FDA Principal Deputy Commissioner Janet Woodcock, MD, that was also given to the Wall Street Journal: "Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance. FDA is currently reviewing three Citizen petitions related to this, and we plan to respond to them soon."

“Whatever happens, it does feel like we will finally get the answers and regulatory decisions we deserve,” Mazza said.