Ranking Member Cassidy, Colleagues Demand More Information on FDA's Foods Reorganization
Letter
Dear Commissioner Califf:
Thank you for your March 10, 2023 response to our joint letter outlining additional details on
how the Food and Drug Administration (FDA) intends to reorganize the Human Foods Program
(HFP).1 Ensuring that the reorganized HFP has a clear vision to protect public health is a priority
for all stakeholders. However, you have yet to provide sufficient detail on how the HFP will
accomplish this mission, instead pointing to the forthcoming reorganization plan that FDA plans
to publish later this Fall.2 FDA should not use the forthcoming plan to dodge congressional
oversight over FDA's progress in improving food safety, and we will continue to press for
answers to questions about how FDA will better protect American families from food safety
events.
In light of the recent infant formula crisis, Congress needs more information to be able to assess
FDA's planned reorganization. Nearly all of FDA's answers to our February letter provided little
detail, punting to forthcoming announcements. Accordingly, when you release the reorganization
plan this fall, we ask that you provide updated answers to the questions from our February letter
on a question-by-question basis and that the reorganization announcement provide clear and
comprehensive answers addressing these questions.3 We would also request a staff briefing with
the new deputy commissioner to better understand the changes made in the reorganization and
the deputy commissioner's vision for implementing such changes. We expect that this plan will
address the following points to ensure that American families have access to safe, nutritious
food:
1 Ranking Member Cassidy, Colleagues Seek Clarity on FDA's Foods Reorganization, Senate Committee on Health, Education, Labor & Pensions (February 28, 2023), https://www.help.senate.gov/ranking/newsroom/press/rankingmember-cassidy-colleagues-seek-clarity-on-fdas-foods-reorganization.
2 FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring, Food and Drug Administration (February 28, 2023), https://www.fda.gov/news-events/press-announcements/fdaprovides-update-proposed-human-foods-program-and-office-regulatory-affairs-restructuring.
3 That letter, dated February 28, 2023, is attached as Exhibit 1.
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An Empowered Deputy Commissioner for Foods is Essential to Improve Food Oversight
One of the greatest challenges FDA's human foods program faces is the lack of a single voice to
oversee the many functions FDA plays in ensuring food safety. Creating a new deputy
commissioner for foods is a positive step, but the lack of clarity thus far leaves many unanswered
questions about how this role will be able to successfully manage the HFP.
FDA had a similar deputy commissioner position from 2010-2019, but this role lacked the power
needed to effectively manage food oversight.4 While FDA has stated that this new role will
oversee some of the responsibilities previously within the Office of Regulatory Affairs (ORA),
the reorganization will still maintain ORA as a separate office.5 Numerous stakeholders have
raised concerns that failing to fully integrate ORA's food oversight within the HFP will deprive
the new deputy commissioner of the ability to serve as an effective leader.6 An empowered
deputy commissioner is essential to properly manage the HFP. Consequently, FDA must provide
greater detail about the authorities and responsibilities of the deputy commissioner and how
regulatory duties will be divided between the HFP and ORA. This should include a specific
accounting of the steps taken to ensure seamless coordination between HFP and ORA on foodrelated oversight activities. We look forward to hearing from the recently announced deputy
commissioner on how he intends to fulfill this new role and effectively implement the planned
reorganization.7
Clear Performance Metrics Are Needed to Measure the Success of FDA's Reorganization
Congress, FDA, and other stakeholders cannot evaluate whether the HFP reorganization is
improving food safety without a framework to define goals and assess progress. Unfortunately,
FDA has yet to provide such a framework or any details on how it will assess the HFP. FDA
commonly releases strategic plans for other programs that measure progress across different
metrics and issues quantitative status updates via FDA-TRACK. FDA must establish a similar
framework to measure the reorganization and evaluate what more may need to be done to
effectively regulate foods.
When the panel convened by the Reagan-Udall Foundation released its report evaluating FDA's
foods program, it emphasized that cultural change is needed to improve food safety oversight.8
4 Megan Poinski, FDA food safety chief Frank Yiannas resigns, FoodDive (January 26, 2023),
https://www.fooddive.com/news/fda-frank-yiannas-resigns/641300/.
5 FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs, Food and Drug Administration (June 27, 2023), https://www.fda.gov/news-events/pressannouncements/fda-provides-update-proposal-unified-human-foods-program-including-new-model-officeregulatory.
6 See, e.g., Deidre McPhillips, FDA update on redesigned foods program sets final proposal for fall, draws disappointment from industry stakeholders, CNN (February 28, 2023), https://www.cnn.com/2023/02/28/health/fdafood-program-update/index.html.
7 FDA Names First Deputy Commissioner for Proposed United Foods Program, Food and Drug Administration (August 23, 2023), https://www.fda.gov/news-events/press-announcements/fda-names-first-deputy-commissionerproposed-unified-human-foods-program.
8 Operational Evaluation of the FDA Human Food Program, Reagan-Udall Foundation for the Food and Drug Administration (December 6, 2022), https://reaganudall.org/sites/default/files/2022-
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Specifically, the report highlighted FDA's inability to make policy decisions, inhibiting
successful regulatory actions.9 While we appreciate FDA's recognition that a reorganization of
its human foods program is necessary, we are concerned that FDA has not provided specific
details about how it will foster an improved culture within the HFP.
FDA is responsible for protecting the public health and keeping the American food supply safe.
As such, we look forward to FDA providing a clear vision for the HFP and outlining the
program's strategic goals. Beyond the need for radical cultural change within this program, FDA
must provide concrete, granular details in the upcoming reorganization plan specifying which
metrics the agency will use to measure the HFP's performance over time. Each discrete part of
the reorganized HFP should have its own metrics, tailored to the mission and functions of that
organizational unit. These should include metrics both on activities and outcomes, such as:
* Activities
o Number of State and FDA inspectors trained or re-trained on food safety and the
consideration of company and facility food safety culture in prevention-oriented
inspections;
o Number of preventive control inspections and allocation of inspection time to
prevention-oriented activities, including review of company food safety
principles, food safety plans and programs, review of environmental monitoring
records and actions taken in response to adulteration of product and/or
contamination of environment, and assessments of what companies did to address
process or product failures in the system;
o Number of inspections, including number per type of product facility, and
allocation of inspection time to educational activities, such as providing guidance
documents and other activities to foster regulatory compliance and prevent food
safety risks;
o Number of prevention action plans developed and implemented to address the
highest-priority risks, such as risks related to produce and non-produce foods, as
well as chemical contaminants;
o Number of follow-up inspections conducted within FDA's goal timeframe;
o Number of guidance documents published and how those guidance documents
relate to the overall strategic goals and priorities of the HFP;
o Number of submissions reviewed (e.g., infant formula notifications, food additive
petitions, food contact substance notifications, consultations on food from new
plant varieties, etc.), and associated timelines.
* Outcomes
o Number of food safety incidents (e.g., foodborne illness outbreaks);
o Number of product recalls;
o Number of product recall notices released within one day of initiation;
12/Human%20Foods%20Program%20Independent%20Expert%20Panel%20Final%20Report%20120622.pdf#page12.
9Id. at 11-12.
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o Number of remedial actions, by type, to bring facilities into compliance
successfully completed, and the timelines for implementing such actions.
The Office of Critical Foods Must Address Food Safety Issues
Congress established the Office of Critical Foods (OCF) in 2022 in response to the infant
formula crisis to ensure accountability and oversight over the safety of infant formula and
medical foods. FDA, however, intends to place OCF within its new Center of Excellence in
Nutrition. Your response expanded on this decision, emphasizing that FDA considers critical
foods to be a subset of nutrition work, pointing to these foods as "a sole source of nutrition for
vulnerable populations."10
We remain concerned that placing the OCF within the new nutrition-focused Center of
Excellence will detract from its intended mission to oversee the safety and supply of critical
foods. It is essential that FDA provide greater detail in the upcoming reorganization plan on how
it intends to structure the OCF within the Center of Excellence and prioritize its mandate to
oversee the safety and availability of critical foods.
FDA Must Work with Other Agencies to Improve Food Oversight
As FDA implements the HFP reorganization, it should also consider how to improve its
partnerships with other federal agencies involved with food safety. Both the Centers for Disease
Control and Prevention (CDC) and the Department of Agriculture (USDA) play a role in
monitoring foodborne illnesses and supporting the development of innovative foods.
It is unclear how well the food safety agencies are working together to carry out their respective
responsibilities. For example, CDC has failed to regularly update its data on foodborne illness
incidence, last publishing a report on foodborne disease surveillance reflecting events in 2017.11
Additionally, CDC continues to use outdated information to estimate foodborne illness
incidence, relying on data from 2006.12 FDA, however, collects extensive and up-to-date
information related to recall events and preventive controls to ensure food safety.13 FDA should
be working with CDC and USDA to maximize interagency activities to protect public health,
including sharing updated data between agencies to inform cross-agency priorities. We ask that
FDA provide additional detail in the upcoming reorganization plan on how it intends to improve
its engagement with other federal stakeholders and leverage updated information to inform
HFP's activities.
10 See Letter to Senator Bill Cassidy et al., Food and Drug Administration (March 10, 2023), at 5.
11 Annual Summaries of Foodborne Outbreaks, Centers for Disease Control and Prevention (September 12, 2019), https://www.cdc.gov/fdoss/annual-reports/index.html.
12 Estimated Annual Number of Illnesses Caused by 31 Pathogens, Centers for Disease Control and Prevention (November 8, 2018), https://www.cdc.gov/foodborneburden/index.html.
13 FDA-TRACK: Preventive Controls and Current Good Manufacturing Practice Measures, Food and Drug Administration (May 19, 2023), https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fdatrack-preventive-controls-and-current-good-manufacturing-practice-measures#4.
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We look forward to reviewing the final reorganization plan this fall and working with you and
other stakeholders to ensure FDA's foods program is best equipped to protect food safety.
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