Throughout this series, we’ve delved into the specifics of why ingredients like Red Dye No. 3 and Brominated Vegetable Oil (BVO) are being removed from our food supply. We’ve explored the health concerns and provided a guide for navigating the grocery store. But this raises a fundamental question: how does an ingredient that was considered safe for decades suddenly get reclassified as a risk? The answer lies in a crucial, often misunderstood, regulatory concept known as GRAS. This four-letter acronym is the foundation of food additive safety in the United States. Understanding how an ingredient gets—and more importantly, loses—its GRAS status pulls back the curtain on the entire food safety system. It reveals a dynamic, evolving process where science, law, and public pressure collide to define what is truly safe to eat.
What is GRAS? A Foundation of Food Safety
GRAS stands for “Generally Recognized as Safe.” The concept was established by the 1958 Food Additives Amendment [1], a landmark piece of legislation that transformed food safety in America. Before 1958, manufacturers could add substances to food with very little federal oversight. The amendment changed that, requiring that all food additives be approved by the FDA before they could be used in food. However, lawmakers recognized that requiring a full, formal review for every single common ingredient—like salt, pepper, vinegar, and baking soda—would be impossibly burdensome. They created a two-track system for legal food ingredients:
- Food Additives: Substances that must undergo a rigorous, formal pre-market review and approval process by the FDA.
- GRAS Substances: Substances that are exempt from the formal review process because they are “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.”
The key here is scientific consensus. For an ingredient to be GRAS, its safety must not be a matter of debate among the scientific community.
The Path to ‘Safe’: How an Ingredient Becomes GRAS
There have historically been two main ways for an ingredient to gain GRAS status:
- Pathway 1: Historical Use: Many substances were “grandfathered in” as GRAS simply because they were widely used in food prior to the 1958 amendment without any evidence of harm. Salt and vinegar are classic examples.
- Pathway 2: Scientific Procedures: This is the modern pathway. A company can conduct its own evaluation, gathering publicly available scientific data, toxicology reports, and other evidence. If they conclude that this body of evidence demonstrates a scientific consensus on the ingredient’s safety, they can submit a “GRAS Notification” to the FDA. The FDA then reviews the submission. If the agency agrees that the evidence is sufficient, it issues a “no questions” letter, and the ingredient can be marketed as GRAS.
The Reversal: How an Ingredient Loses Its ‘Safe’ Status
Here is where the process becomes most interesting. GRAS status is not a permanent seal of approval. It is a snapshot based on the scientific understanding at a given time. When that understanding changes, so can an ingredient’s status. There are three primary ways this happens.
Reason 1: New Scientific Evidence Emerges This is the most common and powerful driver for revoking GRAS status. Scientific knowledge is not static. A study conducted today with advanced analytical tools can uncover risks that were impossible to detect 50 years ago.
- Case Study: Partially Hydrogenated Oils (PHOs): For decades, PHOs—the primary source of artificial trans fats—were considered GRAS. They were cheap and effective for improving food texture and shelf life. However, over many years, a mountain of independent scientific research created an undeniable consensus: trans fats dramatically increased the risk of heart disease. Faced with this overwhelming new evidence, the FDA had no choice but to act. In 2015, the agency officially revoked the GRAS status of PHOs, leading to their removal from the U.S. food supply and preventing an estimated thousands of heart attacks each year [2].
Reason 2: Citizen Petitions and Public Pressure The FDA is a massive agency with limited resources. It cannot constantly re-review every one of the thousands of approved substances. Often, the push to re-evaluate an ingredient comes from outside the agency. Advocacy groups, consumer organizations, and even individuals can file a “Citizen Petition” asking the FDA to review the status of an additive based on existing or new evidence.
- Case Study: Red Dye No. 3: The FDA’s own research linked the dye to cancer in 1990. Yet, due to a regulatory loophole, it remained in our food. For over 30 years, groups like the Center for Science in the Public Interest (CSPI) filed petitions and lawsuits, demanding the FDA close this loophole. The final push came from the California Food Safety Act in 2023. This combination of relentless advocacy and state-level action finally forced the FDA to formally reconsider the dye’s status for ingestion. The FDA announced its decision to revoke the dye’s use in food in November 2023, citing safety concerns [3].
Reason 3: Changes in Use or Consumption Levels An ingredient may be safe at the consumption levels of the 1960s, but what about today? If a new manufacturing trend causes the public to consume vastly more of an ingredient than ever before, its original safety assessment may no longer be valid.
- Case Study: Brominated Vegetable Oil (BVO): While BVO was used for a long time, the rise of “super-sized” culture and massive consumption of citrus sodas and sports drinks meant that some individuals were ingesting it at levels far beyond what was originally anticipated. This led to new studies on its tendency to accumulate in body fat and disrupt thyroid function. These new understandings of the risks associated with modern consumption levels were a key factor in the FDA’s 2023 decision to declare it no longer safe [4].
The Delaney Clause: A Powerful Legal Tool
One other important factor is the Delaney Clause [5]. Part of the 1958 amendment, this clause is a zero-tolerance rule for cancer. It states that no additive can be deemed safe if it is found to “induce cancer when ingested by man or animal.” This powerful clause was the legal basis for the 1990 ban on Red Dye No. 3 in cosmetics and is the central, non-negotiable argument used by petitioners to demand its removal from food.
Conclusion: A System Designed to Evolve
The journey from “safe” to “scrutinized” can seem confusing, but it’s a sign that our food safety system—while sometimes frustratingly slow—is working as intended. It is designed to be a living process, one that can adapt to new scientific discoveries and reflect changing public health standards. The fact that ingredients like PHOs, BVO, and Red Dye No. 3 can be successfully challenged and removed from our food is a testament to the power of independent science and persistent advocacy. By understanding the GRAS process, we can see the full picture behind the headlines and appreciate the complex, ongoing effort to ensure the food on our shelves is truly safe.
References
1.U.S. Food and Drug Administration (FDA). “The Delaney Clause.” https://www.ncbi.nlm.nih.gov/books/NBK216642/
2.U.S. Food and Drug Administration (FDA). “Generally Recognized as Safe (GRAS).” https://www.consumerreports.org/food-safety/gras-hidden-ingredients-in-your-food/
3.U.S. Food and Drug Administration (FDA). “The Final Determination Regarding Partially Hydrogenated Oils.” https://www.federalregister.gov/documents/2015/06/17/2015-14883/final-determination-regarding-partially-hydrogenated-oils
4.U.S. Food and Drug Administration (FDA). “FDA Proposes to Revoke Authorization for Red No. 3 for Use in Food.” https://www.ehn.org/fda-bans-red-dye-3-in-foods-and-medicines-after-cancer-concerns-what-to-know?gad_source=1&gad_campaignid=17673658777&gbraid=0AAAAAow5yZ4YyqI0mraNhOLTVUW3lhfvn&gclid=CjwKCAjwtrXFBhBiEiwAEKen1z1dhPyKpbMnlLRWCdtx1VjrSrMVnuCvlGh-XExRX0GVr-3vvoFwKhoCfW4QAvD_BwE
5.U.S. Food and Drug Administration (FDA). “FDA Proposes to Ban Brominated Vegetable Oil (BVO).” https://www.federalregister.gov/documents/2024/07/03/2024-14300/revocation-of-authorization-for-use-of-brominated-vegetable-oil-in-food
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