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News from CRIS: Trending - GRAS Loophole?

April 7, 2025

Top Takeaways:

  • GRAS stands for Generally Recognized As Safe — a legal category for food ingredients used by the U.S. Food and Drug Administration (FDA).
  • Companies can self-approve GRAS status without telling the FDA, sparking debate over safety transparency.
  • Conversations on GRAS aim to boost oversight and close what critics call the “GRAS loophole.”

What is GRAS?

GRAS stands for Generally Recognized As Safe. Under U.S. law, ingredients added to food and beverages must either:

  • Go through formal FDA approval, or
  • Be recognized as GRAS.

An ingredient can be considered GRAS if:

  • It has a history of safe use before 1958, or
  • It has been evaluated by qualified experts and found to be safe for its intended use based on publicly available scientific information.

GRAS status allows manufacturers to use approved ingredients in food without undergoing repeated evaluations, which can support innovation and help streamline product development.

How does an ingredient get GRAS status?

There are two main ways manufacturers confirm an ingredient’s safety and GRAS status.

  • Scientific process (modern): used for new or novel food ingredients
  • Experience-based process (historical): used for ingredients in our diets prior to 1958.

Let’s take a closer look.

What is the scientific process for an ingredient to meet GRAS status?

To be considered Generally Recognized As Safe (GRAS) through modern scientific procedures, an ingredient goes through the following steps:

  • Gathering evidence: The company collects scientific data showing that the ingredient is safe when used as intended. This includes toxicology studies, exposure estimates, and other safety research.
  • Expert review: A panel of qualified experts (often external scientists or researchers) reviews the evidence. If they agree the ingredient is safe for its intended use, they consider it “generally recognized as safe.”
  • Company decision: Based on the expert consensus, the company can either:
    • Self-affirm the GRAS status (decide internally it meets the criteria), or
    • Voluntarily notify the FDA by submitting a GRAS notice.

If a company chooses to notify the FDA, the FDA reviews the submission and issues a response. A “no questions” letter means the FDA has no objections to the GRAS determination. If there are issues, the FDA may respond with a letter identifying concerns or indicating that the basis for GRAS status is insufficient.

Important note: Submitting a GRAS notice to the FDA is voluntary. A company can legally market the ingredient based on its own GRAS determination without FDA review, a process known as the self-affirmation process.

What is the historical process for an ingredient to meet GRAS status?

The historical process only applies to ingredients commonly used before January 1, 1958. To qualify, the substance must have been consumed by a significant number of people, in substantial quantities, and without known harmful effects.

Additionally, the ingredient must have been used for the same intended purpose, such as a preservative in food, NOT in drugs or cosmetics.

Common examples of ingredients that meet these criteria include salt, vinegar, and baking soda.

What Is GRASE? Will that process change?

GRASE, short for Generally Recognized As Safe and Effective, applies to over-the-counter (OTC) drugs and therapeutic personal care products, such as salicylic acid in OTC acne creams.

The current proposed changes do not involve GRASE ingredients/

What’s the GRAS loophole?

The term GRAS loophole typically describes the self-affirmation pathway within the GRAS framework.

If the company believes there is general recognition of safety among experts, it is not required to notify the FDA.

It’s important to note that a company would be acting illegally if:

  • The ingredient doesn’t meet GRAS standards (e.g., lacks sufficient evidence of safety under intended use)
  • They misrepresent data or hide known risks
  • The ingredient is used outside the conditions of the GRAS determination (wrong dose, wrong population, etc.)

Are GRAS ingredients FDA-approved?

No, the GRAS status doesn’t mean the FDA has approved the ingredient. This means that the ingredient is legally permitted in the food system based on the currently available legislation and guidance.

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To continue reading the entire blog post, visit: https://cris.msu.edu/news/generally-recognized-as-safe-gras/gras-loophole/.