What GRAS means
GRAS stands for “Generally Recognized as Safe.” It was originally designed for common ingredients with a long history of safe use, such as salt and vinegar.
Over time, the pathway has also been used for newer substances through expert-panel review, often conducted by the companies themselves.
This system allows thousands of additives to be added to the food supply without a formal FDA safety review or public disclosure.
The "Self-Affirmation" process
Under current rules, a company can hire their own experts to determine that an ingredient is safe for its intended use.
The company is not legally required to notify the FDA of this determination, though a voluntary notification program does exist.
This "self-affirmation" loophole has been a point of significant debate among public health advocates and regulatory watchdogs.
Why it matters
When safety is determined before FDA review, public visibility can be limited.
This creates a different burden of proof compared to systems that require pre-market approval from a government body.
Understanding the GRAS pathway helps explain why some additives might be widespread in the US despite limited long-term independent testing.
Frequently Asked Questions
Many GRAS substances are perfectly safe, but the process has been criticized for a lack of transparency and potential conflicts of interest when companies hire their own safety experts.
Yes, if new evidence emerges that a substance is no longer "generally recognized" as safe, the FDA can take action, as they did with trans fats (PHOs).
Sources
- PRūF Red Team Validation report — Internal synthesis provided by PRūF Labs (2025).
Summaries are educational and may be updated as regulations change.