Sustainable GRAS™

To help companies stay ahead of regulatory scrutiny, Burdock Group is introducing the Sustainable GRAS™ program, designed to confirm the legitimate use of your product in interstate commerce and safeguard against future regulatory challenges. The program is structured into two levels, giving companies both a solid compliance foundation and an option for continuous, proactive oversight. Here’s how each level works:

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            Level 1 – Foundational Review

 

This entry-level review provides a baseline assessment to establish your ingredient’s legitimacy and compliance in interstate commerce.

 

Key activities include:

 

• Reviewing your documentation and safety data

• Affirming the identity of the substance

• Checking enforceable specifications (USP, CFR, etc.)

• Determining if the substance is eligible for GRAS status

• Assessing published use levels and food group limitations

• Searching FDA databases for adverse reactions or warning letters

• Confirming regulatory status in the U.S. and EU

• Reviewing claims such as “natural” or “nutritive” for accuracy and compliance

 

👉 Purpose: Build a documented foundation for compliance and risk awareness.

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            Level 2 – Comprehensive Review

 

For companies seeking deeper protection, Level 2 provides a continuous, proactive approach that goes beyond the basics.

 

Key activities include:

 

• All Level 1 tasks

• Prioritization of ingredients most likely to face FDA scrutiny

• Expanded FDA monitoring for adverse event reports

• Continuous literature reviews for new safety or toxicology data

• Benchmarking against competitor or similar ingredients

• Monitoring global regulatory developments beyond the U.S. and EU

• Assessing whether changes in manufacturing or process affect GRAS status

• Ongoing surveillance of recalls, warning letters, and regulatory shifts

   

👉 Purpose: Create an early-warning system that anticipates risks, protects your brand reputation, and ensures long-term compliance.

 

As regulatory scrutiny intensifies, legacy GRAS determinations may become the most vulnerable target for FDA oversight. For manufacturers, this creates both a risk and an opportunity.

 

By adopting a Sustainable GRAS™ strategy, companies can move from a reactive stance to a proactive one anticipating potential challenges, strengthening compliance, and safeguarding brand reputation. Whether through the foundational Level 1 review or the continuous protection offered by Level 2, the program ensures that your ingredients remain defensible, and your business stays resilient.

 

We invite you to contact Burdock Group for a complimentary 30-minute consultation to discuss the potential vulnerabilities in the industry and how the Sustainable GRAS™ program can help protect your company’s future.

 

Sustainable GRAS™ is a trademarked name by Burdock Group 2025