What is GRAS?

GRAS stands for "Generally Recognized As Safe," a designation created by Congress in 1958. It was originally created to exempt common ingredients like salt, water, and vinegar from the time-consuming FDA pre-market approval process. However, over time GRAS became a loophole for companies to push through ingredients without any objective, third party testing and introduce new additives without FDA oversight.

GRAS loophole in product safety

Under the GRAS rule, companies can independently determine the safety of new ingredients. This means, companies are essentially self-regulating. What's worse? This process is voluntary. Manufacturers are not even required to inform the FDA about these new substances. As a result, hundreds of chemicals have been introduced without federal review, leaving both the public and the FDA in the dark about their safety.

Health concerns with GRAS ingredients

Many GRAS-designated substances have known health risks. For example, EGCG (or epigallocatechin-3-gallate), often found in dietary supplements, is linked to serious health issues such as liver toxicity and heart defects. Despite these concerns, the FDA accepted its GRAS status in 2018. Similarly, other GRAS substances like propyl paraben, BHA, and BHT have been associated with potential health problems ranging from hormone disruption to cancer.

The GRAS loophole places the "burden" of product safety on manufacturers, not the FDA. This lack of oversight has significant implications for public health. According to a 2022 analysis by the Environmental Working Group, 99% of new food chemicals have bypassed FDA review since 2000, raising serious questions about the safety of our products.

Most of the public has no idea about GRAS

A survey by the Consumer Reports National Research Center found that many consumers believe GRAS ingredients have been evaluated and deemed safe by the FDA. This misconception highlights the public's expectation that ingredients sold to the public should have stricter regulation. Without mandatory FDA review, harmful chemicals have been making their way into our food and personal care products for decades.

Legislative efforts to close the GRAS loophole

Some lawmakers are pushing for reform. The Ensuring Safe and Toxic-Free Foods Act, introduced in 2023, aims to require manufacturers to notify the FDA of new GRAS designations and to eliminate conflicts of interest in safety evaluations. Another bill, the Food Chemical Reassessment Act, seeks to establish an FDA office dedicated to reassessing the safety of existing food additives in particular.

What You Can Do

Given the significant gaps in the GRAS system, it's crucial for consumers to be vigilant about the products they purchase. Just like these corporations are essentially self-regulating product safety, you can "self-regulate" the food and products you bring into your home.

Look for items with clear, transparent ingredient lists and shop on websites like Crunchy & Co which opt for brands that prioritize safety and quality. By choosing products that avoid questionable ingredients, you can help protect your health and encourage better industry practices.

In addition, consistently choosing products with better ingredients communicates to manufacturers that consumers want safer choices (vote with your dollar!).

Learn more:

https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras
https://www.fda.gov/food/generally-recognized-safe-gras/how-us-fdas-gras-notification-program-works
https://www.ewg.org/news-insights/news/2024/03/what-gras
https://www.consumerreports.org/food-safety/gras-hidden-ingredients-in-your-food/