Generally Recognized as Safe (GRAS): Ensuring Ingredient Safety with Confidence

If you're introducing a new food ingredient or substance into the U.S. market, obtaining GRAS (Generally Recognized as Safe) status can be a strategic advantage—saving time, cost, and regulatory burden.
The U.S. Food and Drug Administration (FDA) designates certain substances as GRAS when they are proven safe for use in food, either through extensive scientific evidence or a long history of common use.

What is GRAS?

Under the Federal Food, Drug, and Cosmetic Act, food additives typically require FDA pre-market approval. However, if an ingredient is “generally recognized as safe” by qualified experts, it can bypass this process through the GRAS pathway.
This means your ingredient can enter the market faster and with fewer regulatory hurdles—provided safety is well-documented.

Pathways to GRAS Status

GRAS status can be determined in two ways:

1. Scientific Procedures
   Based on robust, peer-reviewed scientific data, reviewed by experts in toxicology, food safety, and nutrition.
2. Common Use in Food (Pre-1958)
   If the substance has been safely consumed in food before 1958, and this use is well-documented, it may qualify under the common use criteria.

Voluntary Notification to the FDA

While not mandatory, manufacturers can voluntarily notify the FDA of their GRAS determination. The FDA may:

• Issue a "no questions" letter (a positive outcome),
• Request additional information,
• Or cease review at the notifier’s request.

Even with GRAS status, the responsibility for ensuring ongoing safety and compliance rests with the manufacturer.

Transparency & Trust

All GRAS notices submitted to the FDA are included in a public database, giving your stakeholders, investors, and customers added assurance about your product’s safety.

Why GRAS Status Matters for Your Business

• Faster Market Entry – Avoid lengthy food additive petitions.
• Cost-Efficient – Streamline regulatory pathways.
• Build Consumer Trust – Demonstrate commitment to food safety.
• Innovate with Confidence – Use novel ingredients backed by science.

Need Help Navigating GRAS?

We specialize in helping food and ingredient companies achieve GRAS status efficiently and effectively—from scientific evaluations to FDA notification support. Whether you’re looking to validate a new compound or leverage historical use, we can guide you every step of the way.