By Sean Moloughney, Editor12.04.23
Part 1: FDA Restructuring and FTC Activity
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation
In January 2023 the U.S. Food and Drug Administration (FDA) proposed a unified Human Foods Program that would combine the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) under one leader.
In September, James “Jim” Jones was selected as that leader, becoming the first Deputy Commissioner for Human Foods. Now reporting directly to FDA Commissioner Robert Califf, MD, Jones is a former Environmental Protection Agency (EPA) official with more than 30 years of experience in chemical safety.
In FDA’s proposed reorganization, the Office of Dietary Supplement Programs (ODSP) would report to a new “Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI).” The agency said there are no plans to reduce ODSP’s resources or capabilities, also noting that the dietary supplement program remains “a critical priority for the agency.”
FDA explained the vision for OFCSDSI is “to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements.”
NW: What’s your assessment of FDA’s proposed restructuring of its Human Foods Program and the potential impact this might have on the dietary supplement industry?
Sibyl Swift, PhD, Chief Science Officer and VP of Regulatory Affairs, cbdMD, Inc./CBD Industries, LLC (and former associate director for research and strategy at the FDA Office of Dietary Supplement Programs): I joined the agency shortly before ODSP was elevated from a division in 2015. The agency stated in the announcement that the office was elevated from a division to raise the profile of dietary supplements within the agency, effectively providing ODSP with more resources and a stronger voice within the agency.
This recent announcement regarding the new reorganization would mean that dietary supplements are once again buried within a group of products without the necessary focus the category deserves. ODSP already competes for resources and prioritization to execute on its agenda in key areas as a stand-alone office. Lumping ODSP into a larger entity with food chemicals would certainly slow down enforcement and force resources to be split between categories within the office.
As an industry, we are still waiting for guidance documents on critical areas, responses to citizen petitions, and education initiatives. Burying the program within a group of unrelated categories would only ensure that we as an industry do not receive this critical information in a timely manner.
Furthermore, moving the dietary supplement program into a category that includes chemical safety indicates that the agency does not understand the dietary supplement category in general. Dietary supplements are food and are regulated as such. The reorganization would push dietary supplements into a group of substances that focuses on harm, which is wholly inappropriate for our category.
Loren Israelsen, President, United Natural Products Alliance (UNPA): Right now, I have many questions, and few answers. The agency has shared no details since announcing this reorganization which, it must be said, is a significant one. UNPA’s attention will be focused on the new “Office of Food Chemical Safety, Dietary Supplements, and Innovation.” I get the yips when I see “chemical food safety, dietary supplements, and food additives” in the same sentence. Absent additional briefings from FDA, we are presently left to speculate, which I won’t do here, as I have few insights on what FDA is thinking. Was industry consulted? No. Is that unusual? No.
I would note that Mr. Jim Jones, the new Deputy Commissioner of Human Foods, spent 30 years at the EPA. The one view I would offer is the likely refocus on safe food (food additives, colors, flavors, NDI (New Dietary Ingredient) process, and novel technologies such as synbio and nanotech, as opposed to food safety (Food Safety Modernization Act). As for funding, it’s always an issue, and there is never enough money.
Duffy MacKay, Senior Vice President, Dietary Supplements, Consumer Healthcare Products Association (CHPA): As the consumer healthcare category continues to grow, it’s essential that it receives appropriate attention, authority, and resources within the FDA. Following the agency’s organizational announcement this summer, CHPA requested to meet with FDA leadership to ensure the proposed structure would in no way dilute the prioritization of dietary supplements. CHPA is actively collaborating with the FDA during its reorganization process and looks forward to meeting and working with Mr. Jones. It is imperative FDA prioritize appropriate regulation of this category to ensure consumers have continued access to safe and beneficial products.
"For years, dietary supplements have been underfunded, understaffed, and under-resourced at FDA. The industry worked very hard to get an Office of Dietary Supplement Programs created in 2016, and since then we have worked to double the budget."
Steve Mister, President and CEO, Council for Responsible Nutrition (CRN): CRN has already expressed some very grave concerns about the reorganization. We understand why FDA is trying to create efficiencies, but our concern is that dietary supplements will be the loser in all of this with even less attention from the agency.
For years, dietary supplements have been underfunded, understaffed, and under-resourced at FDA. The industry worked very hard to get an Office of Dietary Supplement Programs created in 2016, and since then we have worked to double the budget. We have received assurances from the FDA commissioner that, under the reorganization, the funding and staffing will not diminish in any way; but we have concerns about whether that will actually happen in practice.
The effect for the dietary supplement industry is that we lack enforcement of existing regulations. We need to be reassured that FDA will increase enforcement rather than what we perceive could be decreased enforcement and attention to supplements.
Michael McGuffin, President, American Herbal Products Association (AHPA): AHPA has been assured ODSP will retain the same staffing, scope, and responsibilities under this reorganization. However, our main concern is transparency. AHPA and the responsible industry has made great efforts to increase ODSP’s budget and to be able to readily obtain details about ODSP’s budget size, number of full-time equivalent employees, etc. It is not apparent that this same budgetary information would be as accessible under the new structure, though we have received some assurances from FDA that the agency will exhibit great transparency.
"In 2016, the commissioner said that the supplement program needed to be elevated to an office. What has changed in 7 years that would now need to result in putting a stovepipe over the program?"
Daniel Fabricant, PhD, President and CEO, Natural Products Association (NPA), and former Director of the Division of Dietary Supplement Programs at FDA: We have serious concerns with the restructuring. First and foremost, there’s a firewall in the statute regarding treating dietary supplements like food additives. The history there is that the agency tried to use the food additive provisions to remove dietary supplements—a bad and storied history by the FDA that led to DSHEA (the Dietary Supplement Health and Education Act). DSHEA very surgically was structured to keep that from happening again.
A combination of the offices will at least operationally make it very difficult to retain that structure without some clear guardrails, which begs the question: why do it at all? Why not just keep it as two separate offices? We can talk synergies all we want but I don’t think anyone looks to the government/FDA for synergies and efficiencies.
In 2016, the commissioner said that the supplement program needed to be elevated to an office. What has changed in 7 years that would now need to result in putting a stovepipe over the program? That part makes no sense, and the fact that supplements were left out of the Reagan-Udall review, which is the stimulus for the restructure, also seems like the fix is in for no apparent reason. Why not take the time to conduct a real review of the supplement program before moving it around like a board-game piece? That sentiment gives no one peace of mind.
Additionally, the proposed rolling up of ORA (Office of Regulatory Affairs) is also a problem and will cut the legs out from a dedicated supplement inspectorate, which all should be in favor of. We want FDA inspectors to be dedicated to learning the specifics—which can be very detailed—of 21 CFR part 111 inspections. ORA is incredibly important to any industry. The best thing FDA does is inspect and test; why would the agency, through rolling up ORA, reduce the autonomy of the inspectorate versus move it into a structure that favors paperwork above all else?
Karen Howard, CEO, Executive Director, Organic & Natural Health Association: FDA seems more interested in “over-slight” vs. oversight of the supplement industry. Perhaps there is a desire to reduce consumer confidence in the rapidly growing industry, which could be compromised by a restructuring that would encourage fly-by-night companies to move into our space. And, there are ample reasons for FDA to redirect funds to other, more lucrative sectors that migrate their employees in and out of the federal government. That said, consumer confidence in supplements and a desire to manage the entirety of their healthcare needs will not go away easily.
" ... any attempt by FTC to enforce a notice that has distributed vague, unclear, and contrary regulatory guidance would violate due process, since it fails to provide any company with fair notice of what is prohibited."
Carolyn Herrmann, Deputy General Counsel, CHPA: While CHPA is not going to speculate, we will note that any attempt by FTC to enforce a notice that has distributed vague, unclear, and contrary regulatory guidance would violate due process, since it fails to provide any company with fair notice of what is prohibited.
We also note that companies may choose to have internal discussions with their legal and regulatory teams to review their claims and substantiation procedures. However, because the notices have no legal effect, they are merely threatening companies for engaging in permissible and truthful promotion of products.
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation
In January 2023 the U.S. Food and Drug Administration (FDA) proposed a unified Human Foods Program that would combine the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) under one leader.
In September, James “Jim” Jones was selected as that leader, becoming the first Deputy Commissioner for Human Foods. Now reporting directly to FDA Commissioner Robert Califf, MD, Jones is a former Environmental Protection Agency (EPA) official with more than 30 years of experience in chemical safety.
In FDA’s proposed reorganization, the Office of Dietary Supplement Programs (ODSP) would report to a new “Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI).” The agency said there are no plans to reduce ODSP’s resources or capabilities, also noting that the dietary supplement program remains “a critical priority for the agency.”
FDA explained the vision for OFCSDSI is “to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements.”
NW: What’s your assessment of FDA’s proposed restructuring of its Human Foods Program and the potential impact this might have on the dietary supplement industry?
Sibyl Swift, PhD, Chief Science Officer and VP of Regulatory Affairs, cbdMD, Inc./CBD Industries, LLC (and former associate director for research and strategy at the FDA Office of Dietary Supplement Programs): I joined the agency shortly before ODSP was elevated from a division in 2015. The agency stated in the announcement that the office was elevated from a division to raise the profile of dietary supplements within the agency, effectively providing ODSP with more resources and a stronger voice within the agency.
This recent announcement regarding the new reorganization would mean that dietary supplements are once again buried within a group of products without the necessary focus the category deserves. ODSP already competes for resources and prioritization to execute on its agenda in key areas as a stand-alone office. Lumping ODSP into a larger entity with food chemicals would certainly slow down enforcement and force resources to be split between categories within the office.
As an industry, we are still waiting for guidance documents on critical areas, responses to citizen petitions, and education initiatives. Burying the program within a group of unrelated categories would only ensure that we as an industry do not receive this critical information in a timely manner.
Furthermore, moving the dietary supplement program into a category that includes chemical safety indicates that the agency does not understand the dietary supplement category in general. Dietary supplements are food and are regulated as such. The reorganization would push dietary supplements into a group of substances that focuses on harm, which is wholly inappropriate for our category.
Loren Israelsen, President, United Natural Products Alliance (UNPA): Right now, I have many questions, and few answers. The agency has shared no details since announcing this reorganization which, it must be said, is a significant one. UNPA’s attention will be focused on the new “Office of Food Chemical Safety, Dietary Supplements, and Innovation.” I get the yips when I see “chemical food safety, dietary supplements, and food additives” in the same sentence. Absent additional briefings from FDA, we are presently left to speculate, which I won’t do here, as I have few insights on what FDA is thinking. Was industry consulted? No. Is that unusual? No.
I would note that Mr. Jim Jones, the new Deputy Commissioner of Human Foods, spent 30 years at the EPA. The one view I would offer is the likely refocus on safe food (food additives, colors, flavors, NDI (New Dietary Ingredient) process, and novel technologies such as synbio and nanotech, as opposed to food safety (Food Safety Modernization Act). As for funding, it’s always an issue, and there is never enough money.
Duffy MacKay, Senior Vice President, Dietary Supplements, Consumer Healthcare Products Association (CHPA): As the consumer healthcare category continues to grow, it’s essential that it receives appropriate attention, authority, and resources within the FDA. Following the agency’s organizational announcement this summer, CHPA requested to meet with FDA leadership to ensure the proposed structure would in no way dilute the prioritization of dietary supplements. CHPA is actively collaborating with the FDA during its reorganization process and looks forward to meeting and working with Mr. Jones. It is imperative FDA prioritize appropriate regulation of this category to ensure consumers have continued access to safe and beneficial products.
"For years, dietary supplements have been underfunded, understaffed, and under-resourced at FDA. The industry worked very hard to get an Office of Dietary Supplement Programs created in 2016, and since then we have worked to double the budget."
— Steve Mister, Council for Responsible Nutrition
Steve Mister, President and CEO, Council for Responsible Nutrition (CRN): CRN has already expressed some very grave concerns about the reorganization. We understand why FDA is trying to create efficiencies, but our concern is that dietary supplements will be the loser in all of this with even less attention from the agency.
For years, dietary supplements have been underfunded, understaffed, and under-resourced at FDA. The industry worked very hard to get an Office of Dietary Supplement Programs created in 2016, and since then we have worked to double the budget. We have received assurances from the FDA commissioner that, under the reorganization, the funding and staffing will not diminish in any way; but we have concerns about whether that will actually happen in practice.
The effect for the dietary supplement industry is that we lack enforcement of existing regulations. We need to be reassured that FDA will increase enforcement rather than what we perceive could be decreased enforcement and attention to supplements.
Michael McGuffin, President, American Herbal Products Association (AHPA): AHPA has been assured ODSP will retain the same staffing, scope, and responsibilities under this reorganization. However, our main concern is transparency. AHPA and the responsible industry has made great efforts to increase ODSP’s budget and to be able to readily obtain details about ODSP’s budget size, number of full-time equivalent employees, etc. It is not apparent that this same budgetary information would be as accessible under the new structure, though we have received some assurances from FDA that the agency will exhibit great transparency.
"In 2016, the commissioner said that the supplement program needed to be elevated to an office. What has changed in 7 years that would now need to result in putting a stovepipe over the program?"
— Daniel Fabricant, Natural Products Association
Daniel Fabricant, PhD, President and CEO, Natural Products Association (NPA), and former Director of the Division of Dietary Supplement Programs at FDA: We have serious concerns with the restructuring. First and foremost, there’s a firewall in the statute regarding treating dietary supplements like food additives. The history there is that the agency tried to use the food additive provisions to remove dietary supplements—a bad and storied history by the FDA that led to DSHEA (the Dietary Supplement Health and Education Act). DSHEA very surgically was structured to keep that from happening again.
A combination of the offices will at least operationally make it very difficult to retain that structure without some clear guardrails, which begs the question: why do it at all? Why not just keep it as two separate offices? We can talk synergies all we want but I don’t think anyone looks to the government/FDA for synergies and efficiencies.
In 2016, the commissioner said that the supplement program needed to be elevated to an office. What has changed in 7 years that would now need to result in putting a stovepipe over the program? That part makes no sense, and the fact that supplements were left out of the Reagan-Udall review, which is the stimulus for the restructure, also seems like the fix is in for no apparent reason. Why not take the time to conduct a real review of the supplement program before moving it around like a board-game piece? That sentiment gives no one peace of mind.
Additionally, the proposed rolling up of ORA (Office of Regulatory Affairs) is also a problem and will cut the legs out from a dedicated supplement inspectorate, which all should be in favor of. We want FDA inspectors to be dedicated to learning the specifics—which can be very detailed—of 21 CFR part 111 inspections. ORA is incredibly important to any industry. The best thing FDA does is inspect and test; why would the agency, through rolling up ORA, reduce the autonomy of the inspectorate versus move it into a structure that favors paperwork above all else?
Karen Howard, CEO, Executive Director, Organic & Natural Health Association: FDA seems more interested in “over-slight” vs. oversight of the supplement industry. Perhaps there is a desire to reduce consumer confidence in the rapidly growing industry, which could be compromised by a restructuring that would encourage fly-by-night companies to move into our space. And, there are ample reasons for FDA to redirect funds to other, more lucrative sectors that migrate their employees in and out of the federal government. That said, consumer confidence in supplements and a desire to manage the entirety of their healthcare needs will not go away easily.
" ... any attempt by FTC to enforce a notice that has distributed vague, unclear, and contrary regulatory guidance would violate due process, since it fails to provide any company with fair notice of what is prohibited."
— Carolyn Herrmann, Consumer Healthcare Products Association
FTC Activity
NW: FTC has been very active over the past year, updating its Health Products Compliance Guidance and, controversially, issuing Notices of Penalty Offense to hundreds of companies, for which CHPA filed a citizen petition. What should companies expect from FTC moving forward? How do you recommend they prepare?Carolyn Herrmann, Deputy General Counsel, CHPA: While CHPA is not going to speculate, we will note that any attempt by FTC to enforce a notice that has distributed vague, unclear, and contrary regulatory guidance would violate due process, since it fails to provide any company with fair notice of what is prohibited.
We also note that companies may choose to have internal discussions with their legal and regulatory teams to review their claims and substantiation procedures. However, because the notices have no legal effect, they are merely threatening companies for engaging in permissible and truthful promotion of products.