A Conversation with Kristi Muldoon-Jacobs
The U.S. Food and Drug Administration’s pre- and post-market programs that assist industry in meeting their responsibility to market safe food are essential to the safety of the U.S. food supply. The FDA’s role includes regulating ingredients used in food and substances that come into contact with food, such as through food packaging, storage or other handling. The agency envisions a future framework for an ongoing post-market, systematic review of the safety of ingredients and food contact substances on the market. In the fiscal year 2024 President’s Budget, the FDA is requesting new funding for its post-market review framework. The agency is committed to working with Congress to secure the necessary funding to implement this important initiative. As new, relevant data become available, we may reassess the safety of food ingredients and food contact substances.
Dr. Kristi Muldoon-Jacobs is the acting director of the Office of Food Additive Safety (OFAS). In her role, she directs the office responsible for overseeing the safety of ingredients in food and substances that come into contact with food through packaging and manufacturing. What drives Dr. Muldoon-Jacobs, a toxicologist and mother, are the safety and nutrition of food. She is equally passionate about the FDA’s mission as she is about informing consumers about food science and safety. She wants to help consumers understand that most chemicals are not harmful. Chemicals are the building blocks for everything in the world. People, animals, and plants are all made up of chemicals. Chemicals are also used in food during food production and in food packaging for useful purposes, such as preserving quality, adding nutritional value, extending shelf life, and protecting food from pathogens that can make people sick. Above all, Dr. Muldoon-Jacobs believes that the FDA’s food safety system is one of the best in the world, and U.S. consumers should have confidence in the food they eat and feed to their families.
Dr. Muldoon-Jacobs shares her insight about the FDA’s current post-market assessment of ingredients and substances that come into contact with food and how the FDA envisions enhancing its approach to support this work.
How does the FDA assess ingredients in foods and food contact substances on the market?
Kristi: Most of my team’s work is spent reviewing the safety of ingredients and food contact substances before they are brought to market. Keeping our food supply safe is a responsibility we share with industry. Ultimately, food manufacturers are responsible for ensuring the food they market is safe and meets all applicable FDA requirements. We have several pre-market programs through which the FDA reviews information to determine whether an ingredient or food contact substance is safe when used as proposed. A recent U.S. Government Accountability Office report evaluated the FDA’s review of food contact substances and noted that our food additive safety program has helped prevent and stop unsafe uses. The pre-market safety evaluation is a critical part of the food safety system, and this work will continue to be a priority for the FDA. For example, to market a new food additive a manufacturer or other sponsor must first seek the FDA’s approval by submitting a food additive petition or a food contact notification. Of course, our role doesn’t end there. We also have post-market activities to help ensure that anything added to food, either directly as ingredients or indirectly from food contact uses, continues to be safe as new data and information become available over time.
I want to discuss our work on the safety of ingredients and food contact substances already on the market, or post-market assessment. Our post-market assessments address two general scenarios:
First, we review petitions or notifications submitted by industry and other stakeholders that necessitate assessing a previously authorized use. For example, just last year, about 25 percent of the total food contact substances we reviewed were re-assessments of food contact substances previously authorized as part of our pre-market notification program. Just as with a new food additive, manufacturers also need to seek the FDA’s approval to use a previously authorized additive differently. As a result, we often receive submissions from multiple sources regarding the same ingredient or food contact substance.
The second scenario is when new scientific information is published that raises questions for our scientists. When we identify new information that could impact the safety profile of an ingredient or food contact substance, we review that information to determine if a reassessment is warranted. We focus on ingredients and food contact substances that present the most significant public health concerns.
What do you think people should understand about the science of food ingredients and food contact substances?
Kristi: Food science is advancing rapidly and is beneficial to our work. The amount of new data and information available is increasing at a staggering rate. As advancements in science occur, some laboratory studies may report new findings on ingredients or food contact substances. Some of these studies help refine or explain what is already known about the safety of these ingredients and food contact substances. These studies may also show effects that could occur when the ingredient or food contact substance is tested at exposure levels higher than what is in the food supply. For anything used in food or during food manufacturing or packaging to be considered safe, data must demonstrate it is safe when used as specified. We take action when new information demonstrates concerns for safety at expected consumption levels.
To that end, we are developing and improving internal processes to strengthen our ability to identify new information and prioritize information for our evaluation. As part of this, we incorporate modern methods and tools in computational and analytical methods and toxicology into our safety assessments. Precise methods and valid tools are most meaningful to us as we assess the safety of ingredients and food contact substances on the market.
We continue to invest in developing information technology (IT), informatics, data analytics, and other tools to support our safety assessments. The range of tools includes those that house our administrative records, a chemical, toxicological, and regulatory information knowledge base, and a platform that centralizes nutrition and ingredient data from retail and restaurant foods. We want to continue to build on these tools and help connect them, as funding allows, for more seamless processes.
Can you tell us more about the ingredients or food contact substances on the market that the FDA is currently reviewing?
Kristi: FDA scientists must stay abreast of the latest science to inform our safety assessments. We do this in a variety of ways. We participate in international scientific and standard-setting activities related to food ingredient safety, attend scientific conferences, and engage with public health and research stakeholders in other ways. These activities, as well as reviewing scientific literature and information released by other agencies, help us stay informed about the safety of ingredients and food contact substances.
This is especially important as more and new information is continually becoming available. We must prioritize our time and activities to be most protective of public health. And, to inform those decisions, we need to draw upon high-quality information as the science evolves.
At this time, we are reviewing petitions from stakeholders on red dye no. 3, titanium dioxide, and BPA, to name a few. We also maintain public inventories where any stakeholder can view information on petitions under review or notifications completed by the FDA's Office of Food Additive Safety.
We also publish in multiple places the work and research on ingredients and substances on the market conducted by our scientists. For example, information on how we test food for dietary exposure to PFAS and our assessments of the safety of aspartame over time are available on our website.
We want to do more to provide more insight into the FDA’s work on post-market assessments. You can learn about some examples of our current assessments on our new List of Select Chemicals Under FDA Review page. Though not a complete list of all our current post-market assessments, it illustrates our ongoing work to safeguard our food supply.
What is important for people to know about some ingredients or food contact substances they are hearing more about in the news?
Kristi: To help keep the public and industry informed, we have just released a new public inventory of examples where we have determined certain food ingredients to be unsafe for their intended use in food.
You may hear about ingredients or substances added to food in social and news media, perhaps in ways that might seem concerning. Some news may accelerate the spread of chemophobia (fear of chemicals) regarding chemical ingredients in the food supply. It’s important to remember that the world around us is made up of chemical substances, including our food. The FDA helps safeguard the food supply by evaluating the safety of food ingredients and food contact substances, such as food packaging, to ensure these uses are safe. We continually monitor the science to look out for new information that could change our understanding of their safety. While this monitoring might lead the FDA to take some kind of follow-up action, that is not always the case. Some information may not raise concerns when considering it in the context of all the available data. Other information may prompt the agency to conduct research to fill data gaps. Our work in collaboration with the National Institute of Environmental Health Sciences on brominated vegetable oil is an example of this.
Monitoring helps inform us about food technologies and industry trends. One example of that is potassium bromate – an ingredient used since 1916 in some commercially produced baked goods. We worked with the American Bakers Association to help industry improve baking technology and testing so that the ingredient is used in a way that minimizes residual bromate levels to ensure safety. Normal control measures can ensure that bromate residues when present in final products are at safe levels. When food manufacturers use potassium bromate properly, it converts to harmless potassium bromide, similar to salt, in the finished food.
How is the FDA working to enhance its approach to post-market assessment?
Kristi: It’s clear that rapid advancement in data and information on ingredients and substances on the market calls for a more proactive approach to post-market assessment. We are working on plans for an updated framework for systematically monitoring and reviewing the safety of food ingredients and food contact substances. A systematic, proactive post-market assessment approach should be based on scientific principles for identifying and prioritizing ingredients and food contact substances for safety reviews based on potential for public health risk, with opportunity for stakeholder engagement and input. In the President’s fiscal year 2024 Budget, the FDA has proposed funding to enhance its post-market assessment capabilities. We believe that a systematic, post-market assessment framework will help to identify and prioritize food ingredients and food contact substances that pose a potential public health risk. This, in turn, will allow the agency to take timely action to protect consumers. Implementation of a systematic post-market assessment framework will take increased resources, new knowledge management and monitoring tools, and scientists to conduct updated safety assessments.
Could you describe how the framework would operate?
Kristi: Through our envisioned framework, we would detect signals that could trigger the Agency’s assessment through routine surveillance of information, then verify and prioritize those signals based on an initial evaluation of potential risks. We would use new tools and data in toxicology, exposure assessment and modeling, prioritization, and assessment, some of which the Agency has developed. Some tools we would like to use for safety testing are New Approach Methods (NAMs) - new biological and exposure methods that are intended to reduce, refine, or replace animals in the evaluation of the safety of a chemical, including ingredients added to food. This information will contribute to updated risk assessments. As part of the new framework, we expect to publish information or propose regulatory action, incorporate processes to seek public comment, and conduct additional outreach to garner stakeholder feedback.
I’ve already talked about some of our in-house safety assessment tools but looking forward we propose integrating existing and new data analytics and other tools to inform our risk prioritization and assessment that support the framework. We are in the early stages of developing new criteria for our risk prioritization. For example, these criteria would inform how we manage information suggesting a possible new safety issue (we call that a signal) based on the initial review of its risks, including whether to take immediate action, monitor for additional information, or add to a list of substances that would be systematically reassessed for safety. Through this risk prioritization framework, we could triage ingredients and food contact substances more efficiently once we are aware of new and relevant science. This would enable the FDA to preserve its resources by not expending them on ingredients still supported by science as safe, regardless of how long they have been on the market.
What do you see as the challenges ahead?
Kristi: We need adequate resources to do more and to make the enhanced framework a reality. Our pre-market programs are already stretched thin. These programs are critical as they help prevent unsafe ingredients and food contact substances from coming onto the market and help ensure that innovative approaches in manufacturing food ingredients and packaging result in safe food products. The teams working on these programs are small; for example, we have only six full-time staff dedicated to reviewing plant biotechnology and conducting consultations regarding human food made from cultured animal cells. We are committed to enhancing our approach to post-market assessment, and we believe that a systematic post-market assessment program will help to achieve this goal. Our recent budget request goes into more detail about the additional resources needed to sustain our pre-market programs and develop this new work.
Having access to all data relevant to determine the safety of an ingredient or food contact substance is critical for our assessments. A key piece of data we need in food chemical safety assessments is the exposure or dose. We have the authority to assess the safety of ingredients in foods on the market. However, manufacturers are generally not required to submit post-market use information under our current authorities, so we generally have to rely on less accurate publicly available information or data submitted voluntarily to estimate exposure. We are exploring how to obtain better information on the post-market use of food ingredients from industry and other stakeholders. This information is critical to evaluating the safety of ingredient or food contact substances on the market.
What can stakeholders expect from the FDA moving forward?
Kristi: You will be hearing more about stakeholder engagement opportunities in the coming months, including opportunities for public comment and engagement through public meetings, webinars, and other events. Our stakeholders can learn more about our work on food chemical safety by visiting our Food Chemical Safety page.
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