By Sean Moloughney, Editor02.22.24
Following a series of food safety failures, including the infant formula crisis of 2021-22, the FDA is in process of a massive reorganization designed to streamline operations within a unified Human Foods Program (HFP).
The blueprint for the reorganization largely comes from a report by an expert panel convened by the Reagan-Udall Foundation, an independent think tank established by Congress to advance FDA’s mission.
However, even though the nearly 30-year-old Dietary Supplement Health and Education Act (DSHEA) defined and regulated supplements as a subcategory of food, FDA specifically instructed Reagan-Udall to exclude supplements from its review.
Why the agency told Reagan-Udall not to cover supplements remains an open question, according to Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA). “We’ve asked FDA. We asked the commissioner directly, but we still don’t have a satisfying answer. For whatever reason, we were not included, and that is a great shame,” he added, as FDA is pursuing many of the recommendations made by the foundation.
“Everybody ought to read the Reagan-Udall report,” Israelsen urged, “because that’s the blueprint of where this is all going.”
Jones, who also served on the panel convened by Reagan-Udall to evaluate FDA’s human foods program, met with Israelsen and delegates from four other industry trade associations in December to discuss issues related to food safety and nutrition—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA).
“He’s very direct and made it really clear that he was there to listen. He was there to learn,” said Israelsen. “But he was also bringing a deep expertise from EPA on chemical safety ... We’re going to see that reflected in how FDA addresses food safety. There’s going to be a real emphasis on chemicals, both (naturally occurring) in foods as well as added.”
In the proposed reorganization, which is now under review at the U.S. Department of Health and Human Services (HHS), the Office of Dietary Supplement Programs (ODSP) will report to a newly created “Office of Food Chemical Safety, Dietary Supplements, and Innovation,” (OFCSDSI), which FDA said “will work to modernize and strengthen oversight of food chemical safety, advance dietary supplement safety, and enable the HFP to support and effectively regulate food ingredient innovation.”
In a joint letter to Jones in January, UNPA, CHPA, and AHPA proposed the agency consider changing the name to the “Office of Food Ingredient Safety, Dietary Supplements, and Innovation.”
“We think there’s a really important distinction between ingredients and chemicals,” said Israelsen. “Chemicals have a more pejorative sense to people. We feel ingredients better describe the vision and consumer understanding of what food safety is, food not chemicals”
However, Jones’ career experience with chemical safety, including herbicides and pesticides, and FDA’s inclusion of dietary supplements in the same office as food additives, will almost certainly reflect how the agency addresses food safety from a revised perspective.
Related Reading: FDA Commissioner: Office of Dietary Supplement Programs Won’t Lose Resources in Proposed Reorganization
“This is a fundamental overhaul,” he added. “You have a number of offices within the program of human foods, and all of those have to be essentially rethought (with) staffing changes, reassignment of responsibilities, (and understanding) who reports to who. A big part of that will be the Office of Regulatory Affairs (ORA).”
In the new FDA model for ORA, certain functions will remain with the HFP while others will transition to other agency centers, but ultimately the three core functions will be inspections, investigations, and imports.
Better supporting structure and information sharing between the human foods program, focused on science and safety, with field investigators and inspectors on the ground could, at least in theory, lead to more direct guidance and focus on key priorities.
“What parts of the food supply really require attention and some priority?” said Israelsen.
A key goal, and major question mark, is Congressional appropriations for the Human Foods Program overall and the office that oversees dietary supplements.
“FDA is two parts, drugs and foods, to make it simple,” said Israelsen. “Drugs are largely funded by user fees. The majority of their budget comes from pharmaceutical companies who pay a lot of money to speed up the approval of new drugs.”
With patented drugs, it makes sense for them to fund the cost of a faster approval process. Time is profits.
Conversely, the food side of FDA relies entirely on appropriations from Congress. “Many believe, and I agree, that FDA’s underfunded on the food side,” said Israelsen. “The current Congress has not shown, I would say, a strong interest in increasing budgets of most government agencies, FDA among them. This will be a chronic problem.”
What does that mean for the dietary supplement industry? Self-regulation must continue to be a collective priority, said Israelsen. “Doing the job better ourselves, ultimately, is what it means. If we’re serving the consumer, the buck stops with us.”
As of this writing, Congress has only been able to pass stopgap federal funding bills. What might the implications be for FDA or other agencies if there’s a partial or full government shutdown?
“That would be exceptionally unfortunate if there were a shutdown, or an unwillingness to fund the agency at this moment in time, when they’ve said we need to take some urgent action to address the needs of today’s marketplace,” said Israelsen. “I truly hope Congress will appropriate the money needed to protect human health in this country.”
“What the agency is most profoundly concerned about is a loss of trust among the public, and the commissioner has spoken very openly about this. The states have all jumped in to do FDA’s job, along with judges that override FDA scientific opinions, and this deeply disturbs FDA ... I think we can look at the changes at the food program as a clear reflection of the agency’s resolve to regain the public’s trust.”
“Some of their programs are pretty ambitious, and they’re going to require substantial additional funding,” said Israelsen. “It will come down to what is the perceived greatest return on investment. Where are the greatest problems to be solved? What is the best case that FDA can make to Congress to say, ‘we need more money to do this.’”
Israelsen expects FDA to prioritize safety of infant and children foods “for the obvious reasons that they’re the most susceptible to chemical injury, whether it’s herbicides, pesticides, or heavy metals. There was a really ugly event recently with imported applesauce that was heavily loaded with lead and cadmium. That was an eye-opener.”
Additionally, FDA may seek more resources for foreign inspections of food ingredients and excipients, Israelsen noted, to try to “get ahead of this problem that we saw with applesauce that came from South America.”
Given Jones’ background with chemical safety, Israelsen said he expects a closer relationship between FDA and EPA, which could lead to deeper collaboration.
“We should all take a look at EPA’s Chemical Safety Assessment Program. That would be the analogous program that I believe we would see elements coming over to FDA. That is all authorized under the Toxic Substance Control Act passed by Congress. We need to understand chemical safety as EPA sees it.”
Israelsen also said he senses a shift in focus regarding the Food Safety Modernization Act (FSMA). “There was a lot to be done in terms of food safety plans, assessing critical control points, PCQI (Preventive Controls Qualified Individual) training. So that process is now largely in place. Whether companies are fully compliant, we’ll see ... The new focus will be on what is in food and on food that raises safety issues.”
FDA’s task is massive, he added. “There are thousands of approved herbicides and pesticides. There’s a lot of heavy metals on this planet, some of which get into our foods, and there’s a lot of other undesirables that people are rightly concerned about.”
Speaking of concern, states have been taking up initiatives to ban certain food additives. Through the California Food Safety Act, the golden state banned the use of brominated vegetable oil, potassium bromate, propylparaben, and red dye no. 3. A previous version of the bill also included titanium dioxide. While that was stripped out of the final bill, Illinois has a similar bill pending that also includes titanium dioxide.
A patchwork of state bills that ban select groups of additives would create headaches for industry and FDA.
“Jones said he wants FDA to be doing enough on food chemical safety that states no longer feel they need to jump into the space,” Israelsen noted. “FDA deeply believes they’re the arbiter of food safety for the nation.”
About a month after California passed its Food Safety Act, FDA proposed its own ban on brominated vegetable oil and it is currently reviewing safety for red dye no. 3.
While critics suggest the FDA isn’t moving fast enough, Jones has stated his intention to develop “a faster and more nimble process for evaluating chemicals in the food supply,” through the proposed Office of Food Chemical Safety, Dietary Supplements, and Innovation.
Jones will need to deliver “clear direction,” Israelsen said, “tying that to timelines and deadlines and metrics of what success looks like. For our industry, there are real implications here.”
In the meantime, Israelsen suggested industry stakeholders on the analytical side, “take a deeper look at fundamental food safety as FDA is now defining it,” which means “chemical safety.”
“We would be advised to revisit adulterants and contaminants that would appear in natural products in particular, and to be vigilant about holding tight standards around those products,” he added. “Certainly as you’re working with third-party analytical labs, have an agreement or understanding of what the budgets should look like for enhanced chemical testing.”
Science has changed dramatically from when food additives were originally approved 50-60 years ago. “Detection levels were much, much, lower,” said Israelsen. “We’re entering a new world called ‘the race to zero.’ You can find anything if you look hard enough with the right detection tools.”
Related Reading: FDA Leadership Discuss Rationale for Reorganization, Hope for Better Collaboration and Agility
“What the agency is most profoundly concerned about is a loss of trust among the public, and the commissioner has spoken very openly about this,” said Israelsen. “The states have all jumped in to do FDA’s job, along with judges that override FDA scientific opinions, and this deeply disturbs FDA ... I think we can look at the changes at the food program as a clear reflection of the agency’s resolve to regain the public’s trust.”
As it pursues its reorganization and operational priorities this year, FDA is at a critical point in its history. Jones and his team have their work cut out for them, and they’ll need support to demonstrate the agency will lead on food safety, Israelsen said.
Jones has had an open door policy with industry to date, he noted. Following the joint trade-association meeting with Jones and his senior staff in December, the parties agreed to regular meetings, likely at a cadence of four times per year, and ongoing updates provided by both sides.
“We’ll be sharing our perspectives to help them better understand how we see various parts of the evolution of the Human Foods Program,” said Israelsen.
For his part, Jones has made a point of saying transparency, openness, and listening will be hallmarks of his time at FDA. “So far he’s doing that,” Israelsen said.
The blueprint for the reorganization largely comes from a report by an expert panel convened by the Reagan-Udall Foundation, an independent think tank established by Congress to advance FDA’s mission.
However, even though the nearly 30-year-old Dietary Supplement Health and Education Act (DSHEA) defined and regulated supplements as a subcategory of food, FDA specifically instructed Reagan-Udall to exclude supplements from its review.
Why the agency told Reagan-Udall not to cover supplements remains an open question, according to Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA). “We’ve asked FDA. We asked the commissioner directly, but we still don’t have a satisfying answer. For whatever reason, we were not included, and that is a great shame,” he added, as FDA is pursuing many of the recommendations made by the foundation.
“Everybody ought to read the Reagan-Udall report,” Israelsen urged, “because that’s the blueprint of where this is all going.”
Deputy Commissioner and Office Structure
As the agency’s first Deputy Commissioner of Human Foods, Jim Jones, a 30-year veteran of the Environmental Protection Agency (EPA), reports directly to FDA Commissioner Robert Califf, MD.Jones, who also served on the panel convened by Reagan-Udall to evaluate FDA’s human foods program, met with Israelsen and delegates from four other industry trade associations in December to discuss issues related to food safety and nutrition—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA).
“He’s very direct and made it really clear that he was there to listen. He was there to learn,” said Israelsen. “But he was also bringing a deep expertise from EPA on chemical safety ... We’re going to see that reflected in how FDA addresses food safety. There’s going to be a real emphasis on chemicals, both (naturally occurring) in foods as well as added.”
In the proposed reorganization, which is now under review at the U.S. Department of Health and Human Services (HHS), the Office of Dietary Supplement Programs (ODSP) will report to a newly created “Office of Food Chemical Safety, Dietary Supplements, and Innovation,” (OFCSDSI), which FDA said “will work to modernize and strengthen oversight of food chemical safety, advance dietary supplement safety, and enable the HFP to support and effectively regulate food ingredient innovation.”
In a joint letter to Jones in January, UNPA, CHPA, and AHPA proposed the agency consider changing the name to the “Office of Food Ingredient Safety, Dietary Supplements, and Innovation.”
“We think there’s a really important distinction between ingredients and chemicals,” said Israelsen. “Chemicals have a more pejorative sense to people. We feel ingredients better describe the vision and consumer understanding of what food safety is, food not chemicals”
However, Jones’ career experience with chemical safety, including herbicides and pesticides, and FDA’s inclusion of dietary supplements in the same office as food additives, will almost certainly reflect how the agency addresses food safety from a revised perspective.
Related Reading: FDA Commissioner: Office of Dietary Supplement Programs Won’t Lose Resources in Proposed Reorganization
Process and Cost
How long will this fundamental overhaul take? It will likely be through 2024 “to really feel like the dust has settled and the furniture’s in the right place,” said Israelsen.“This is a fundamental overhaul,” he added. “You have a number of offices within the program of human foods, and all of those have to be essentially rethought (with) staffing changes, reassignment of responsibilities, (and understanding) who reports to who. A big part of that will be the Office of Regulatory Affairs (ORA).”
In the new FDA model for ORA, certain functions will remain with the HFP while others will transition to other agency centers, but ultimately the three core functions will be inspections, investigations, and imports.
Better supporting structure and information sharing between the human foods program, focused on science and safety, with field investigators and inspectors on the ground could, at least in theory, lead to more direct guidance and focus on key priorities.
“What parts of the food supply really require attention and some priority?” said Israelsen.
A key goal, and major question mark, is Congressional appropriations for the Human Foods Program overall and the office that oversees dietary supplements.
“FDA is two parts, drugs and foods, to make it simple,” said Israelsen. “Drugs are largely funded by user fees. The majority of their budget comes from pharmaceutical companies who pay a lot of money to speed up the approval of new drugs.”
With patented drugs, it makes sense for them to fund the cost of a faster approval process. Time is profits.
Conversely, the food side of FDA relies entirely on appropriations from Congress. “Many believe, and I agree, that FDA’s underfunded on the food side,” said Israelsen. “The current Congress has not shown, I would say, a strong interest in increasing budgets of most government agencies, FDA among them. This will be a chronic problem.”
What does that mean for the dietary supplement industry? Self-regulation must continue to be a collective priority, said Israelsen. “Doing the job better ourselves, ultimately, is what it means. If we’re serving the consumer, the buck stops with us.”
As of this writing, Congress has only been able to pass stopgap federal funding bills. What might the implications be for FDA or other agencies if there’s a partial or full government shutdown?
“That would be exceptionally unfortunate if there were a shutdown, or an unwillingness to fund the agency at this moment in time, when they’ve said we need to take some urgent action to address the needs of today’s marketplace,” said Israelsen. “I truly hope Congress will appropriate the money needed to protect human health in this country.”
“What the agency is most profoundly concerned about is a loss of trust among the public, and the commissioner has spoken very openly about this. The states have all jumped in to do FDA’s job, along with judges that override FDA scientific opinions, and this deeply disturbs FDA ... I think we can look at the changes at the food program as a clear reflection of the agency’s resolve to regain the public’s trust.”
— Loren Israelsen, United Natural Products Alliance (UNPA)
Priorities
Unless Congress gives FDA more funding, Jones will be in a tough position as his team considers a range of important priorities.“Some of their programs are pretty ambitious, and they’re going to require substantial additional funding,” said Israelsen. “It will come down to what is the perceived greatest return on investment. Where are the greatest problems to be solved? What is the best case that FDA can make to Congress to say, ‘we need more money to do this.’”
Israelsen expects FDA to prioritize safety of infant and children foods “for the obvious reasons that they’re the most susceptible to chemical injury, whether it’s herbicides, pesticides, or heavy metals. There was a really ugly event recently with imported applesauce that was heavily loaded with lead and cadmium. That was an eye-opener.”
Additionally, FDA may seek more resources for foreign inspections of food ingredients and excipients, Israelsen noted, to try to “get ahead of this problem that we saw with applesauce that came from South America.”
Given Jones’ background with chemical safety, Israelsen said he expects a closer relationship between FDA and EPA, which could lead to deeper collaboration.
“We should all take a look at EPA’s Chemical Safety Assessment Program. That would be the analogous program that I believe we would see elements coming over to FDA. That is all authorized under the Toxic Substance Control Act passed by Congress. We need to understand chemical safety as EPA sees it.”
Israelsen also said he senses a shift in focus regarding the Food Safety Modernization Act (FSMA). “There was a lot to be done in terms of food safety plans, assessing critical control points, PCQI (Preventive Controls Qualified Individual) training. So that process is now largely in place. Whether companies are fully compliant, we’ll see ... The new focus will be on what is in food and on food that raises safety issues.”
FDA’s task is massive, he added. “There are thousands of approved herbicides and pesticides. There’s a lot of heavy metals on this planet, some of which get into our foods, and there’s a lot of other undesirables that people are rightly concerned about.”
Speaking of concern, states have been taking up initiatives to ban certain food additives. Through the California Food Safety Act, the golden state banned the use of brominated vegetable oil, potassium bromate, propylparaben, and red dye no. 3. A previous version of the bill also included titanium dioxide. While that was stripped out of the final bill, Illinois has a similar bill pending that also includes titanium dioxide.
A patchwork of state bills that ban select groups of additives would create headaches for industry and FDA.
“Jones said he wants FDA to be doing enough on food chemical safety that states no longer feel they need to jump into the space,” Israelsen noted. “FDA deeply believes they’re the arbiter of food safety for the nation.”
About a month after California passed its Food Safety Act, FDA proposed its own ban on brominated vegetable oil and it is currently reviewing safety for red dye no. 3.
While critics suggest the FDA isn’t moving fast enough, Jones has stated his intention to develop “a faster and more nimble process for evaluating chemicals in the food supply,” through the proposed Office of Food Chemical Safety, Dietary Supplements, and Innovation.
Jones will need to deliver “clear direction,” Israelsen said, “tying that to timelines and deadlines and metrics of what success looks like. For our industry, there are real implications here.”
In the meantime, Israelsen suggested industry stakeholders on the analytical side, “take a deeper look at fundamental food safety as FDA is now defining it,” which means “chemical safety.”
“We would be advised to revisit adulterants and contaminants that would appear in natural products in particular, and to be vigilant about holding tight standards around those products,” he added. “Certainly as you’re working with third-party analytical labs, have an agreement or understanding of what the budgets should look like for enhanced chemical testing.”
Science has changed dramatically from when food additives were originally approved 50-60 years ago. “Detection levels were much, much, lower,” said Israelsen. “We’re entering a new world called ‘the race to zero.’ You can find anything if you look hard enough with the right detection tools.”
Related Reading: FDA Leadership Discuss Rationale for Reorganization, Hope for Better Collaboration and Agility
Trust Issues
Establishing acceptable limits for certain chemicals based on scientific data becomes a bigger challenge if the public doesn’t trust the agency’s authority or judgment.“What the agency is most profoundly concerned about is a loss of trust among the public, and the commissioner has spoken very openly about this,” said Israelsen. “The states have all jumped in to do FDA’s job, along with judges that override FDA scientific opinions, and this deeply disturbs FDA ... I think we can look at the changes at the food program as a clear reflection of the agency’s resolve to regain the public’s trust.”
As it pursues its reorganization and operational priorities this year, FDA is at a critical point in its history. Jones and his team have their work cut out for them, and they’ll need support to demonstrate the agency will lead on food safety, Israelsen said.
Jones has had an open door policy with industry to date, he noted. Following the joint trade-association meeting with Jones and his senior staff in December, the parties agreed to regular meetings, likely at a cadence of four times per year, and ongoing updates provided by both sides.
“We’ll be sharing our perspectives to help them better understand how we see various parts of the evolution of the Human Foods Program,” said Israelsen.
For his part, Jones has made a point of saying transparency, openness, and listening will be hallmarks of his time at FDA. “So far he’s doing that,” Israelsen said.
