Dismantling the Self-Affirming GRAS Model

Robert Kennedy Moves to Restructure the FDA

Every year, the Food and Drug Administration (FDA) reviews around 75 chemicals intended for our food system. The FDA plays a crucial role in both the economics of the food industry and the safety of the products brought to market. However, just because an ingredient is in a food product doesn’t mean it has earned FDA approval. In fact, an estimated 1,000 chemicals that have never undergone an FDA review are already used in food on our supermarket shelves. Even those of us operating in the realm of food and food supply chains might be surprised by that number. 

How did these 1,000 chemicals make it into our food without approval? 

The answer is by utilizing a review process called self-affirming GRAS, where a food company can put together its own panel of experts to identify if a food ingredient qualifies as “generally recognized as safe (GRAS)” and essentially bypass the FDA system. As part of his promise to bring transparency to the food system in the U.S., Robert Kennedy has moved to eliminate self-affirming GRAS, claiming the faulty model is filled with loopholes that allow unsafe chemicals into food supplies.

Health-conscious consumers fighting for this type of regulation are applauding the shift, food companies fear that eliminating the self-affirming options will have catastrophic impacts on the food industry, and the FDA is looking at an increased workload as employee numbers dwindle. To many, it seems like the choices are either to eliminate a faulty system or keep the model we have. Is it possible to update and improve the GRAS?

The Problem With Self-Affirming GRAS

Back in 1958, the ruling was meant to chart a path for food companies that were incorporating ingredients into food formulations that were generally considered safe for consumption. Most of these ingredients had been in use for 30 years or more.  Salt, pepper, and vinegar were on the original GRAS list. Submitting ingredients like these for inspection to the FDA seemed like a waste of time since they had yet to prove risky for consumers. 

From an economic standpoint, the system provided food companies with a shorter turnaround time from research and development to market and streamlined FDA efficiency. Releasing food companies from lengthy review processes spurred innovation and contributed to the development of a competitive food industry. Food companies could opt for an official FDA approval rating later, but were not hampered by excess regulatory process while getting their goods onto store shelves.

By the 1960s, the FDA realized there were some flaws in the model.  Already, new data were proving that some chemicals already in the food system were not safe for consumers. Food companies had found ways to abuse the system, and food innovations were becoming increasingly unregulated. A new ruling was issued in 1997 that kept the self-affirming option open, but made it mandatory that food companies had to share their scientific findings with the FDA. The stricter regulatory format ended up creating a buildup of data for the FDA to sift through as they worked to approve new chemicals coming under review. It proved to be an equally challenging scenario.

Many bacterial-derived ingredients, preservatives, and flavoring additives have never been brought before the FDA for approval. Instead, they are reviewed by third-party experts chosen by the individual food company. Because food companies don’t have to publicly share scientific research on ingredients or even submit findings to the FDA, there is fear that food sales are more important than food safety.

Is Eliminating Self-Affirming GRAS a Good Idea?

If the FDA has known for more than 50 years that potentially unsafe ingredients were slipping into the food system, is it time to dismantle what has been and start over?

Salts were considered safe ingredients in the late 1950s and essentially grandfathered into the safe food ingredient list. But, in 1969, cyclamate salts specifically were banned once it was discovered that they were shown to cause cancer. Under the umbrella label of salt cyclamate made its way into the food system. Over time and with more deliberate research, scientists could collectively and conclusively say that it posed a real health risk for consumers.

Self-affirming GRAS as a scientific review model might not be able to use the words collectively or conclusively. In fact, a food company only needs three experts to agree that a chemical is safe for consumption. Unlike the FDA review process, which can take more than 18 months, a self-affirming review is intended to be fast-paced. Too often, the effects of an ingredient are not monitored over a long period of time. 

Cutting corners now to stay competitive could create long-term drains on our systems. Widespread use of cancer-causing chemicals in food today could create unnecessary strain on our medical system a decade from now.  We don’t yet know the impact of many of the synthetic ingredients being used in food today. If food security involves access to nutritionally valuable food items, then we may be dropping the ball if we continue to let big food companies regulate their own ingredient safety reviews.

Can the Self-Affirming GRAS Model be Made Better?

The biggest concern with eliminating the self-affirming GRAS model is that it will create a surplus of work for the FDA, which is already undergoing downsizing. If the FDA reviews 75 chemicals per year. Adding 1,000 generally regarded as safe chemicals into the queue would mean even longer turnaround times. How would they prioritize who to review next? The companies that opted to go the route of FDA approval, even if it meant it could take longer for their food to be available to consumers, or the food items that are already on store shelves, and potentially causing health risks? It would also create a barrier for new food companies that could not afford the regulatory burden or the 18 months it would take to get to market. Limiting new products and competition in the market also negatively affects consumers.

As the review process slows due to the influx, food companies that have long adhered to FDA standards feel the overwhelmed agency will prevent valuable food items from reaching consumers. Rather than bolster good behavior, a more regulated system could slow innovation in the food sector and only encourage deceptive behavior from food companies already maximizing loopholes.

In 2015, trans fats, which were once “generally regarded as safe,” began a phaseout process. Over the course of six years, food manufacturers had to reformulate food recipes and eliminate the health risks from their products. The shift was costly, to the tune of $6.2 billion for just hydrogenated oils, and an example of what food companies fear if their products come under greater scrutiny. Even if just a handful of the 1,000 self-affirmed ingredients are deemed health risks, it could cost food companies a lot of money to resource ingredients, reformulate recipes, and recalibrate manufacturing equipment.

Is There a Middle Ground?

Like every system, perfection seems elusive. Freeing up companies to regulate themselves may have put harmful chemicals into our food system. Yet, ramping up regulatory enforcement requires FDA staffing that currently does not exist. Are there other options?

Instead of offloading more work onto the FDA, the agency could target specific ingredients it knows have the potential to cause health issues. Rather than bring systems to a halt, this option still allows for some self-governance, while letting the FDA be systematic in eliminating harmful ingredients.

Another option would be to enforce transparency. Food companies would be required to post their scientific data publicly to prove to both the FDA and consumers that ingredients were truly tested over a long period of time to ensure their safety. In this scenario, FDA scientists and the general public play a role in the collective safety ruling, and food companies can’t operate in the shadows. 

Exactly how we do away with Big Food companies abusing policy loopholes and the truly harmful chemicals in our food system while also supporting innovation and continuing to bring valuable food products to consumers is a puzzle.  And, one that is left unsolved for too long could create quite a bottleneck for the food industry.