You may not see it on a food label, but “GRAS” is everywhere. It stands for “Generally Recognized as Safe,” and it’s a designation used by the U.S. Food and Drug Administration to classify substances added to our food, from sweeteners to preservatives, as safe for consumption without needing pre-approval. GRAS has made its way to headlines in recent months and it’s a designation that is often overlooked and not understood, so I broke it down in a recent Podcast episode and decided to share a summary in this week’s column.
The GRAS concept emerged from the 1958 Food Additives Amendment. This law required any new food additive to undergo a formal FDA approval process, unless it was considered GRAS. That means if experts agree that a substance is safe, based on scientific evidence or historical use, it can bypass the formal approval process and be added to food under the designation of GRAS.
For example, table sugar (sucrose), citric acid (from citrus fruits), and even vitamin C (ascorbic acid) are GRAS. Now, many GRAS ingredients can sound intimidating but are commonly used in both health and conventional foods.
The GRAS notification process is voluntary, and this is where public concern arises. Companies are highly encouraged to submit a “GRAS Notice” to the FDA explaining how and why their ingredient is safe. Once submitted, the FDA has 180 days (extendable to 90 more) to review it. The agency will either respond with: “No Questions Letter,” meaning they don’t disagree with the conclusion; or they may raise concerns or say the notice doesn’t provide enough evidence. A no questions letter is not the same as formal approval, but does allow the food to be considered GRAS.
Challenges to this system are present. A 2010 report by the U.S. Government Accountability Office criticized this voluntary system for its lack of oversight. The report revealed that companies can make GRAS determinations internally and start using ingredients in food without ever notifying the FDA. This raised red flags about the agency’s ability to track what’s in our food.
Despite the gaps in the GRAS process, there are many layers of regulation our food does go through, each requiring some government level of oversight:
• Formulation and ingredient review
• Nutrition labeling and health claims
• Shelf stability and microbial testing
• Compliance with FSMA (Food Safety Modernization Act) and GMPs (Good Manufacturing Practices)
• Tracking systems for produce and foodborne illness prevention
This system ensures that if a food safety issue occurs, like a salmonella outbreak, agencies can trace it back to the source.
So, what happens when a GRAS substance turns out to be harmful? Partially hydrogenated vegetable oil (trans fats), was once considered safe, and later it was linked to heart disease. In 2015, the FDA revoked their GRAS status, forcing the food industry to reformulate products and eliminate their use. So, oversights are in place.
GRAS remains a critical part of how the FDA manages food safety, but its voluntary nature and limited oversight have sparked debate. As the FDA considers reforms to increase transparency, it’s a good reminder to stay informed. However, I have faith that our foods are safe. And it’s important to remember when hearing fearmongering over our food additives that scary names doesn’t always mean harmful ingredients and the dose makes the poison, because even something like water can be fatal in large amounts.
If this is a concern for you and you want to learn more, I would encourage you to tune in to the Bite-by-Bite Podcast for more on GRAS and many other food and nutrition fact or fiction topics.
Monica Nagele is the Montgomery County Extension Educator and County Extension Director, Health and Human Science. She is a registered dietitian. The Extension office is at 400 Parke Ave., Crawfordsville; 765-364-6363. She may be reached by email at mwilhoit@purdue.edu.
