Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)? This article will explain what GRAS is and how to obtain it from the U.S. Food and Drug Administration (FDA) so you can stay updated on the latest FDA regulations.  

What is GRAS Status?

GRAS stands for Generally Regarded as Safe and is status that the FDA has given to foods and ingredients, commonly known as “GRAS substances”. The FDA reviews scientific data about a substance intended for food use and can confer GRAS status based on its safety when used in accordance with their established conditions of use. Food manufacturers must comply with all applicable FDA regulations to obtain GRAS status.

Why Is it Important to achieve GRAS Status?

Obtaining GRAS status is important for food manufacturers as it allows them to add approved ingredients with specific uses and application levels to their products. This ensures that the foods are safe for consumers, as well as comply with applicable FDA regulations. It also protects food makers from potential liability in the event an ingredient or product is found to be unsafe or not correctly labeled.

What are the requirements for a product to have GRAS Status?

In order for a product to have GRAS status, it must meet the requirements set forth in the FDA’s Generally Recognized as Safe (GRAS) regulations. The criteria includes demonstrating that there is a consensus among qualified experts that the ingredient or product is safe under its intended conditions of use, has a history of safe use or has reliable scientific data to support its safety. Additionally, manufacturers must keep current records regarding any changes to the uses and applications of their products to ensure they remain in compliance with GRAS requirements.

How to get started on the FDA GRAS Application Process?

The application process to obtain GRAS status can vary significantly depending on the product. Generally, it involves an evaluation of the evidence available that indicates the product or ingredient is safe. This may include scientific data, compositions, safety assessment studies and/or published literature. After gathering the necessary information and documents, you must submit an application package to the FDA for review.

Tips on submitting a complete and accurate application:

Filing a complete and accurate application is the first step to obtaining GRAS status from the FDA. To ensure your application is thorough, here are some helpful tips. Make sure to include all necessary documents as outlined in the regulations, as omitting such documents could result in your application not being accepted by the FDA. It’s also a good idea to double-check your data and literature to make sure they are factually correct before submission. All of this can help streamline the review process and improve your chances of success!

Conclusion:

The GRAS pathway is a possible pathway for a probiotic ingredient found in the food supply and one derived from non-food sources. The GRAS pathway requires pivotal safety data to be publicly available. A conclusion of GRAS may or may not be notified to FDA.

Determining the best pathway to regulatory compliance can seem overwhelming but considering the above factors can direct you to the most appropriate path for your specific novel probiotic. RNI is also available to help you determine the best path forward based on your ingredient needs and goals and can support the development of your GRAS and NDIN dossiers for regulatory compliance.  Learn more about self-affirmed GRAS here:

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