In the past months, there has been some shuffling of executive positions within the Food and Drug Administration (FDA). First, the FDA Deputy Commissioner for Foods and Veterinary Medicine and two-times acting commissioner of the FDA, Stephen Ostroff, M.D. announced on October 18th, 2018 that he would retire by January 2019. He was replaced by Frank Yiannas, the former vice president of food safety for Walmart.
Then, on March 5th, 2019, the FDA Commissioner, Scott Gottlieb, M.D., to whom both Ostroff and Yiannas were reporting to, announced that he would resign within a month. Gottlieb's departure leaves an enormous hole, and many important initiatives remain up in the air, such as the ban on youth vaping. Nothing has been announced in terms of who will replace him or what this means for the FDA's long-term strategy.
While it will be interesting to see what transpires over the coming weeks in terms of Gottlieb's succession, it is worth taking a closer look at the impact Yiannas' entry will have on the food industry, especially in regards to the future of food safety.
A New Role & The Office of Food Policy and Response
When Stephen Ostroff retired and Frank Yiannas arrived, the FDA was in the throes of a reorganization effort. This explains why Mr. Yiannas' title as the new Deputy Commissioner for Food Policy and Response (including a newly created office called the Office of Food Policy and Response to go with it) varies significantly from its predecessor's, Deputy Commissioner for Foods and Veterinary Medicine.
In that role, he will head up the progressing implementation of the Food Safety Modernization Act (FSMA) in addition to serving as a senior scientific advisor to the commissioner on various food safety and supply chain issues.
In a statement letter, the former commissioner, Dr. Gottlieb, said about Frank Yiannas: “Additionally, he’ll help lead and coordinate certain cross-cutting policy activities and associated external engagement activities related to food safety and animal health. We’ll also leverage his experience and leadership across the agency, and all product areas, on the issues of supply chain security and the use of new tracking technology, recall effectiveness, and traceback investigation processes.”
A Proponent Of Blockchain
Just before leaving the retail giant after a 10-year tenure, Yiannas caused excitement by announcing on September 24th, 2018 that Walmart and Sam’s Club had informed their fresh, leafy greens suppliers that they needed to "trace their products all the way back to the farm using blockchain technology" starting "by this time next year."
Known in the industry as an outspoken proponent of blockchain and renowned food safety expert, he was a large driver of this initiative.
Traceability Pilot Programs Across The FDA
Since taking office in December 2018, the new Deputy Commissioner has not only released findings from the agency’s investigation of the 2018 outbreak of E. coli O157:H7 in romaine lettuce — he has also laid out a new strategy to drive the FDA’s food safety mission and modernize oversight of imported food, and has provided input and guidance to agency-wide efforts to increase traceability.
"When it comes to food safety, it's not a competitive issue. We all win or lose together."
— Frank Yiannas
For example, in an announcement of the Drug Supply Chain Security Act Pilot Program, a program to increase the pharmaceutical industry's ability to track and trace products in order to quickly detect and remove potentially dangerous drugs from the drug supply chain, the former commissioner, Dr. Gottlieb, said:
"We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain. To advance these efforts, the FDA recently recruited Frank Yiannas, an expert on the use of traceability technologies in global food supply chains. He’ll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply. Under his leadership, we’ll continue to leverage all tools available to ensure greater accountability."
The FDA currently faces a lot of pressure from all sides, e.g., some EU states not wanting to import US beef over food safety concerns, outbreaks of E. coli, Salmonella, and other food-borne illnesses, and the increase of counterfeit drugs in circulation. With the FDA commissioner resigned and most likely not being replaced until 2020, this could potentially destabilize the organization — but it also opens a window of opportunity for change.
It has been only just over three months since the new Deputy Commissioner for Food Policy and Response took office — and much has changed in those first 100 days. There is no doubt in my mind that Frank Yiannas, with his microbiology background paired with extensive corporate experience, will bring modernization and a stronger emphasis on traceability, visibility, and transparency.
With several pilots underway, it is only a matter of time until blockchain becomes a required standard within the food (and pharma) supply chains. Now is the time to start evaluating and piloting to be in the best possible competitive position when the time comes!
(Image Credit: Walmart, 2018)