Opinion: It’s time for Congress to modernize, not dismantle, the FDA’s food safety framework

Having spent the better part of my career in food safety regulation, I have seen the inner workings of the American food supply chain from a perspective few get to witness. With a doctorate in microbiology and over a decade of experience leading teams at the Food and Drug Administration that reviewed food and color additive petitions, GRAS notices and plant biotechnology consultations, I have navigated the complex process that defines how the government protects what sits on dining tables across the nation. One thing is clear today: uniform national standards for our food are critical to deliver on promises to fix America’s health. 

Experts agree that the Generally Recognized as Safe, or GRAS, framework is a vital, science-based pillar of FDA’s regulatory architecture. As with many regulatory bodies, it is overdue for modernization to ensure the highest levels of safety and increase consumer awareness. What separates GRAS from other regulatory work is the phrase “generally recognized.” Those words carry enormous legal and scientific weight and are rarely sufficiently explained in public debates about food safety. Under the framework codified in 21 CFR 170.30(b), general recognition of safety based on scientific procedures requires the same quantity and quality of scientific evidence as required for a food additive regulation, but with the additional requirement that this evidence be generally available and reflect a consensus among qualified experts in the relevant fields. 

It also means that a food manufacturer cannot rely on a single favorable study that is not available for evaluation by independent scientists nor can a GRAS conclusion rest solely upon the opinion of consultants retained by the food manufacturer. 

Some critics believe we should eliminate the GRAS provision at the federal level and pull GRAS substances under an additive framework while simultaneously continuing to allow states to implement their own food ingredient regulatory frameworks. As someone who knows firsthand the technical implications of such ideas and the difficulties assembling well-resourced and unbiased bodies of experts with appropriate technical knowledge, this trend is troubling. 

A patchwork of state-specific GRAS frameworks applying differing sets of scientific standards to the same national food supply creates regulatory inconsistency, undermines scientific coherence, and further erodes public confidence in the integrity of the nation’s food safety system.

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Further, advocating for the “nuclear option,” while not appreciating the consequences for our food system, is rash and irresponsible. Permitting states to take on these additional responsibilities will create a web of conflicting regulations, simultaneously throwing every single food substance into the time-consuming and cost-intensive food additive petition process that would place an unnecessary burden upon FDA and slow innovation. Ultimately, lack of innovation disadvantages consumers who increasingly seek products tailored to diverse health objectives, allergen sensitivities, cultural preferences and convenience expectations. These aspects depend upon a regulatory environment capable of supporting timely, science-based evaluation of new ingredients and technologies. Congress acted on labeling of food from bioengineered sources to implement a uniform system rather than allow a slew of potentially conflicting state standards; similarly, it should use its authority to ensure a uniform national solution.

Congress is currently exploring GRAS reform to strengthen the process and provide further national oversight by granting FDA expanded authority. Rep. Kat Cammack recently released draft legislation, the FRESH and Affordable Foods Act, to establish a uniform, national and science-based standard. By making GRAS registration for pre-enactment substances and notification for post-enactment substances mandatory, the FRESH and Affordable Foods Act ensures that the FDA has a complete, real-time inventory of every substance in the interstate commerce food supply and preserves the scientific foundation of food safety while adding a robust layer of accountability for consumers. This allows the agency to act as the central authority rather than having a patchwork of potentially conflicting and duplicative state-level mandates. 

In my years at the FDA, we conducted robust GRAS reviews, but the voluntary nature of the program and its implementation created a misperception of a transparency gap. Backlogs are often due to staffing and funding limits, rather than FDA scientists' ability to assess science. The FRESH and Affordable Foods Act would address this by adequately funding FDA enforcement, authorizing a biennial registration fee for food facilities.

Strengthening the safety and scientific rigor of the American food supply calls for modernization, not demolition. The pillars of that foundation are robust scientific evidence, evaluation by unbiased and qualified experts, and a uniform yet agile regulatory process capable of supporting continued innovation while maintaining public confidence in the safety of the food supply.