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A new deputy commissioner at the US Food and Drug Administration (FDA) will likely be the single person with the most influence on the path to market for CBD in the US.
Amy Abernethy announced her resignation as principal deputy commissioner of food and drugs last month, only two years after taking on the highest non-political appointment at the FDA.
Abernethy led the agency’s CBD working group, the task force formed to start the FDA down the path towards regulation of CBD products by initially identifying and filling in knowledge gaps around CBD; exploring its impact on public health; and consulting on potential pathways to market if it was deemed to be safe as an ingestible consumer product.
Her replacement will be a key figure for the future of CBD regulation in the US.
It is possible the FDA might seek to add innovation by bringing in outside talent. Abernethy recently told a pharmaceutical publication that having people who could think differently and innovatively was part of the secret recipe for success at the FDA.
“It’s all about culture and having the right people. You need people who can think differently and innovatively. You cannot use old thinking to make new technology work optimally,” she said.
Inside candidates
However, two potential successors from within the FDA could be the highest-ranking officials under Abernethy: deputy commissioner for policy, legislation, and international affairs Andi Lipstein Fristedt; or deputy commissioner for food policy and response, Frank Yiannas.
Fristedt (pictured above, lower left) worked for nearly a decade in various capacities with the US Senate Committee on Health, Education, Labor, and Pensions (HELP), first as a senior advisor to chairman Tom Harkin and later to ranking member and chair Patty Murray. In addition to serving as the Senate’s top Democratic public health staffer from 2012, she was the HELP Committee’s deputy health policy director from 2017 until she joined the FDA in 2021.
Fristedt holds a bachelor’s degree from the University of Oregon and a master’s in public affairs from the Princeton School of Public and International Affairs, where she studied health and health policy.
Yiannas (pictured upper right) was not new to food safety and dietary supplements when joined the FDA in January 2018 as deputy commissioner of food policy and response.
He is, in effect, the agency’s chief ambassador to reduce food safety risks and achieve high rates of compliance with FDA food safety standards.
Food safety catchphrase
He brought to this role about a decade of experience from Walmart, the world’s largest retailer, where he was vice-president of food safety. A microbiologist, Yiannas, has a BS degree in microbiology from the University of Central Florida and a master’s in public health from the University of South Florida.
From a tenure perspective, Yiannas would seem a more likely successor to Abernethy than Fristedt, who only assumed her position this year. Yiannas has spoken about a “sea change” happening at the FDA and increased efforts on the part of the agency to drive more transparency and traceability, including on CBD.
Addressing the Dietary Supplements Regulatory Summit in Washington DC in 2019, he said: “The growth and number of adulterated and mislabelled products, including those [with ingredients] not declared on the label [as well as those making] misleading claims, create dangers to consumers that we all have to manage. At the end of the day, you’re not selling products, you’re selling trust.”
Yiannas has made the phrase “food safety culture” his personal catchphrase. He made it his fourth and final core element in the FDA’s proposed blueprint for a “New era of smarter food safety”.
While clearly an exercise in branding deriving from his considerable corporate experience, the proposal lacks specifics on how this will influence enforcement. But it does make clear that the regulatory teams will be key players and work with others to establish greater understanding.
Crackdown
“Develop procedures to further strengthen and measure the internal understanding of food safety culture, including the role of public health and regulatory partners as essential members of our food safety team,” the blueprint says.
CBD was recently the subject of a major crackdown by the Federal Trade Commission (FTC) in conjunction with the FDA, backed up by FDA warning letters covering previously unaddressed issues such as whether facilities meet Good Manufacturing Practices (GMP) certification upon inspection.
Could this continue under Yiannas’s possible leadership? A subpoint in the blueprint states: “Consider how companies’ positive food safety culture can factor into reduced inspection frequencies.”
Although Yiannas has not revealed a stance on CBD or cannabis, his vision for the FDA seems aligned with bringing transparency and his food safety culture mission across the board.
A return for Sharfstein?
If the agency decides to look beyond its current staff for Abernethy’s successor, we could see the return of Joshua Sharfstein, currently vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health.
Sharfstein (pictured upper left) was reported to be the top contender against acting commissioner Janet Woodcock to be nominated by president Joe Biden to head the FDA, having served as the agency’s principal deputy from 2009-2011 under former commissioner Peggy Hamburg. This would make an effective transition with someone already familiar with internal function, responsibilities, and politics, especially if the top FDA job is given to Woodcock, as widely expected.
Sharfstein encouraged modernising the FDA to deal with a marketplace that already has 1,500 CBD products on sale. He believes, regardless of health benefits, that CBD could have beneficial effects for the safety of all supplements and food in the US.
With co-author Pieter Cohen he wrote a paper for a medical journal in 2019 in which they wrote: “A more responsible approach would be for Congress to pass a law that both waives the prohibition created by CBD’s prior approval as a drug and creates clear, reasonable pathways for low-dose CBD and other new substances to be safely introduced into supplements and food.”
A hopeful nod?
Over the years, the FDA has established that it does not believe CBD qualifies as a dietary supplement as it is an active ingredient in a drug approved by the FDA and thus cannot be used in foods, drinks or dietary supplements. But the agency has admitted it is exploring making an exception for it through rulemaking. Such an approach would likely take years to come to fruition.
Sharfstein has called on Congress to create a new law to solve the CBD regulatory issue while simultaneously “closing long-standing gaps” in the oversight of all dietary supplements. Though he agrees with Yiannas on transparency and regulation, only Sharfstein has publicly advocated for CBD and “new substances,” which could be a hopeful nod to cannabis or at the very least other minor cannabinoids.
Abernethy said she was resigning from the FDA because she felt she could have greater impact on medical scientific data elsewhere.
In a letter to all agency employees on Abernethy’s resignation, acting commissioner Woodcock did not address CBD regulation. But she did say she was “very sorry to see the FDA lose a talented and inspiring senior leader like Amy” and complimented her as a “relentless advocate for improving the science that informs FDA decision-making”.
What This Means: Looking at the likely candidates for the role of FDA principal deputy commissioner of food and drugs, one might assume the future of CBD would be more secure in the agenda of a candidate like Joshua Sharfstein, who has at least publicly recognised its existence and discussed the creation of a pathway to legalisation as it is already on the market. Frank Yiannas is not on record as an opponent, either.
Overall it is hard to say how either would fit into the wider Biden administration vision for the FDA. Biden has not discussed CBD specifically but is known for a strong anti-drug stance, although he seemed to tone that down during his election campaign.
Support for decriminalisation of cannabis and medical legalisation has not yet translated into policy, with the issue of drugs pushed to the back of the queue by other health, social justice and economic concerns largely stemming from the Covid-19 pandemic.
Vice-president Kamala Harris recently said executive action on cannabis was some time off and the matter was not addressed in recent policy prospectuses issued by the White House. Dozens of young White House staffers have been suspended, asked to resign, or placed in a remote work program due to past cannabis use.
So what does this mean for CBD? Regardless of who is chosen to succeed Amy Abernethy, the future of CBD – and cannabis – policy is not going to be as clear as many expected after a win by the Democrats.
This places all the more emphasis on who is chosen to lead the FDA. Yiannas’s lack of comment should be taken as a comment on the matter, at least on his priorities; while Sharfstein seems more willing to include the millions of American CBD users in his policies.
– Jamie Valentino CBD-Intel contributing writer
Photos: FDA / Wikimedia Commons
