The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process” for chemicals already on the market. Under this program, FDA will proactively reevaluate existing ingredients, including ingredients generally recognized as safe (GRAS), food contact substances, additives, and contaminants.
The May 15 announcement follows related FDA actions to enhance chemical safety (on which we previously wrote), signaling a broad effort to boost the safety and transparency of the food supply.
Key Components of the Post-Market Chemical Review Program
Evidence-Based Prioritization of Chemicals
The agency will use a modernized, science-based system to rank existing food chemicals by risk and priority. FDA stated that a draft version of this prioritization scheme will be released for public comment in the coming months.
Systematic Review Process with Stakeholder Input
Rather than reviewing substances on an ad hoc basis, FDA will establish a final, systematic post-market review process informed by scientific evidence and shaped by stakeholder input. Food companies, scientists, and consumers will have opportunities to participate as the program is finalized.
Updated Watchlist of Chemicals Under Review
FDA provided an updated list of priority chemicals that are now under review. Notably, the list includes common additives such as BHT (butylated hydroxytoluene), BHA (butylated hydroxyanisole), and ADA (azodicarbonamide). The agency also plans to expedite review of other ingredients currently being examined, such as certain phthalates, propylparaben, and titanium dioxide, and will routinely publish the status of these reviews.
Implications for the Food Industry and on Public Health
Anticipate Agency Action
Suppliers of approved food additives will likely see increased demand for safety data. Ingredients explicitly named, such as BHT, BHA and ADA or those similar in function, may be scrutinized and manufacturers using these additives should begin assessing their formulations by verifying safety data on file, considering alternative ingredients, or planning for reformulation if needed.
Further, because FDA is expediting some reviews, companies should be prepared for potential regulatory actions in the near term, including rulemaking for synthetic dyes and GRAS ingredients.
Proactively Engage with FDA to Minimize Surprises
Food companies and their trade associations should prepare to engage with FDA throughout development of the review process. Engaging early could help shape the program’s priorities, decisions, and timeline.
Restoring Public Confidence
This initiative is explicitly tied to building public confidence in food safety. FDA stated that consumers have been demanding “more transparency and accountability around food safety” and this program is the agency’s response.
By addressing chemicals that are of high public concern and making the process open, FDA aims to reassure the public that the agency is vigilantly protecting public health. The Health and Human Services Secretary underscored this goal by saying that “no parent should ever worry about what’s in their child’s food,” highlighting the administration’s message of consumer protection.
Key Takeaways
FDA’s new post-market chemical review program represents a new level of oversight of food ingredients.
The food industry will need to create libraries of documentation of food testing and safety for possible submission to FDA as well as create teams of food scientists, operations and manufacturing authorities, and marketing experts to understand the impact of the program on products and manufacturing processes, participate in the oversight process, and manage the overall disruption that will accompany this heightened level of oversight.
The food ingredient industry for decades has been off FDA’s radar but will now be squarely in focus, and consumers and influencers will notice.