Chemicals in Food: FDA Steps Up Post-Market Review

The U.S. Food and Drug Administration (FDA), the primary federal agency committed to safe exposure to chemicals in the food supply, has recently stepped up efforts to ensure food safety, especially in the post-market assessment area. Stakeholders in commercial chemical operations and product lines involving chemicals used for or found in the food supply should be prepared for increased inspections and enforcement in this area.

 

The Federal Food, Drug, and Cosmetic Act (FFDCA) regulates substances reasonably expected to become components of food. Substances must be authorized by the FDA for use as food additives unless the use of a particular substance is generally recognized as safe (GRAS) by qualified experts or otherwise qualifies for other exclusions. For example, dietary ingredients are excluded but subject to other FDA premarket requirements.

 

Chemical stakeholders must be mindful of the markets and uses their chemical products may find their way into and any corresponding regulatory requirements. Marketing departments can be uniquely creative in locating new uses of and markets for intentionally produced chemicals or their chemical byproducts, but sometimes they’re less cognizant of the regulatory requirements these new uses and markets invite. FFDCA’s broad jurisdiction is triggered by chemical uses “reasonably expected” to become food components. If a chemical producer sells or offers for sale a chemical “reasonably expected” to be used in food, FDA regulation may well apply, even if the parties are unaware of FFDCA’s jurisdictional relevance.

 

Chemical stakeholders should also be aware of the relevance of process contaminants and/or food ingredient impurities in the food supply. If found in food, or reasonably expected to be there, these types of chemicals are also regulated by the FDA. The FDA monitors the food supply for contaminants and impurities by testing both domestic and imported food through several different programs it administers.

 

Several recent FDA developments suggest the agency’s post-market review of chemicals in the food supply is likely to be more robust, systematic and proactive. First, the FDA issued a “Constituent Update” on March 4, 2024, updating its “List of Select Chemicals in the Food Supply Under FDA Review.” The list of chemicals under review is not new; however, the updated list and the newly added information are new and noteworthy.

 

The agency states the update is intended “… to provide more insight on the status of its post-market assessments of chemicals in the food supply.” The information posted includes many chemicals the FDA has been actively engaged in reviewing for the past several years. The update also explains the process used to evaluate risk and includes for each chemical a type, a status and the location of more information. The “type” definitions are provided by the FDA in the table and list itself. 

 

The agency notes that “… post-market assessments take time …” and is a key driver in the establishment of the then-proposed Unified Human Foods Program (HFP), the purpose of which is to transform “… the agency to be more efficient, nimble and ready for the future with the ever-changing and complex industries [it] regulate[s] ….” 

 

The second significant development is the newly created FDA position, Deputy Commissioner for Human Foods, currently filled by Jim Jones as of September 2023. Jones reports directly to the FDA Commissioner and leads the charge in setting and advancing priorities for the aforementioned and now approved unified HFP, which includes food safety, chemical safety and nutrition activities.

 

Deputy Commissioner Jones was previously assistant administrator of the Toxics Office at the U.S. Environmental Protection Agency (EPA) during the Obama administration. Jones has a long and distinguished history in the areas of pesticides, toxic substances, chemical safety and pollution prevention. He has devoted much of his 30-year tenure as a federal regulator involved in leadership and decision-making related to food safety. Jones was also deeply involved in the 2016 modernization of the Toxic Substances Control Act (TSCA), when he led discussions with members of Congress, industry and environmental groups to reshape how chemical safety is managed in the United States.

 

The third development is FDA’s reorganization plan, effective May 13, 2024. The plan's approval resulted in the creation of the HFP, the adoption of a new model for its field operations, and other significant modernization efforts. The reorganization implementation is currently targeted for Oct. 1, 2024. 

 

According to the FDA, the reorganization will enable it to be more efficient, nimble and prepared for evolving technologies and the ever-changing industries it regulates, including new food and medical product technologies and the impacts of globalization, climate change and other factors that require rapid response. The new organization will better position the agency to uphold the safety of the nation’s food supply and respond to food-related emergencies, such as the 2022 infant formula shortages.

 

The HFP realigns functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response, and key functions from the Office of Regulatory Affairs (ORA) under one program. 

 

Importantly, the restructuring of ORA “will enable our field operations unit to focus on inspections, investigations and imports as its core mission. The FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real-time insights and science-based evidence necessary to ensure the safety and quality of products Americans depend on,” said the agency.

 

What exactly does all this mean? To FDA watchers, it means buckle up, as all the tea leaves point to a ramped-up, more institutionally organized and focused post-market FDA monitoring and enforcement capacity. The FDA will almost certainly define more precisely the contours of its mission later this year. Based on what’s publicly available now, the inescapable conclusion is that the FDA has reorganized, updated its select list of chemicals under FDA review and installed as its first deputy commissioner a seasoned regulator who knows how to assess risk and build a durable government program capable of producing results.

 

What should stakeholders do now? First, review the list of chemicals under FDA review. Consider reaching out to the FDA to understand better what the next steps might include after assessing how the FDA’s interest in your chemicals might impact your operations. For example, if the FDA conducts a post-market food safety assessment, how might your use of the chemicals align with the assessment?

 

Second, assess more broadly compliance with FDA food additive regulations. As noted above, companies can be subject to FDA jurisdiction whether they intend to be or not. Instances of “accidental jurisdiction” can invite huge business disruption consequences and unflattering brand attention.

 

Finally, carefully monitor FDA announcements. Communications are often posted only on the agency website and not published in the Federal Register, so the FDA’s regular updates could go unnoticed if monitoring is not routine.

 

Stay tuned, as this is a fast-changing area that is expected to be quite consequential for commercial stakeholders.