By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition
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 to preserve quality, add nutritional value, extend shelf life, and protect food from pathogens that can contaminate it and make people sick. Some chemical ingredients in food are declared on the label by a common or usual name that is different from their chemical name, like salt for sodium chloride and Vitamin C for ascorbic acid.
Importantly, it is the responsibility of the food industry to ensure the safety and regulatory status of chemicals added to food either directly as ingredients or indirectly from food contact uses. In general, chemicals added to food must be authorized for use as a food or color additive before they may be used in food although some are excepted either because they are generally recognized as safe by qualified experts or have a prior sanction from USDA or the FDA. Through its pre-market review programs, the FDA reviews the safety of substances added to food to help industry meet its responsibilities and to ensure that the uses are safe.
In addition, reassessing the safety of food ingredients and substances as new, relevant data become available, is a key part of our food safety mission in the post-market context. Over time, scientific and technological advances can provide more information about chemical effects, industry practices and changes in consumer patterns of intake, which may impact our safety evaluation.
Post-market Review of Chemicals Added to Food
In light of this need to continue to assess the safety of food ingredients and food contact substances as new information becomes available, the FDA is embarking on a more modernized, systematic reassessment of chemicals with a focus on post-market review. Currently, there are two ways the FDA reviews chemicals used as food ingredients or substances that come in contact with food after they are on the market.
The first one is through data and information submitted through petitions or notifications, which is a way for stakeholders to ask the FDA to establish or change a regulation or to take other administrative action. For example, the FDA is currently reviewing petitions asking us to revoke regulations on titanium dioxide and Red No. 3 uses in food and drugs.
The agency also evaluates chemicals on our own initiative as part of our ongoing commitment to oversee the safety of the food supply. When FDA scientists identify new research that calls into question the safety of a chemical, we reassess and take action as needed. Take per- and polyfluoroalkyl substances (PFAS) for example. New information became available that demonstrated that the uses of certain types of PFAS in certain types of food packaging raised concerns. The FDA took steps to revoke these authorizations or to work with manufacturers to phase out the use of these PFAS. Another example is our ongoing work conducting studies and publishing the results to inform our reassessment of the safety of brominated vegetable oil.
Developing New Approaches to Mine Data and Prioritize Substances Based on Risk – An Enhanced Approach and New Framework
But we want to do more. At present, most chemical reassessment activity is through our pre-market programs as uses and industry changes warrant resubmission, or in response to stakeholder petitions. Submissions to the agency through established channels have mandated deadlines and typically take priority over agency-initiated activities except those related to public health emergencies. However, we are working to develop new approaches to mine existing data more efficiently and prioritize substances for in-depth review based on risk.
Greater funding would allow us to establish a framework for routine systematic review of chemicals through ongoing monitoring after they are on the market. This, combined with additional authorities to require industry to share new data and information, would allow the FDA to prioritize based on risk and better target our resources toward chemicals that we think warrant in-depth post-market review. We have outlined an enhanced approach to regulating food chemical safety and as part of this approach we envision a new framework to systematically reassess chemicals post-market.
This new proposed framework aligns with the agency’s work to create a stronger, unified Human Foods Program, and a more robust and effective risk-management framework to underpin the future of the organization. Under this proposed framework, we could detect potential emerging safety information that would trigger the agency’s assessment early, through routine surveillance of information, and prioritize based on an initial evaluation of the risks. For this to be successful, we need to enhance our tools and establish processes to identify and receive accurate and reliable new information on toxicity and use and conduct risk assessments.
To fully build this framework we need resources, including new staff, expanded regulatory authority, and support from consumer advocacy groups, regulated industry, and Congress to achieve our vision. We are also looking to enhance transparency by publishing information and engaging stakeholders, including opportunities for public comment and other stakeholder feedback about the framework through public meetings, webinars, and other engagements. We will share more about our plans in the coming months.