Everything business owners should Know about GRAS Ingredients

Introduction to GRAS:

Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have to be. This comprehensive guide gives you a detailed overview of GRAS ingredients and the regulations governing their use in food products, so you can get up to speed quickly. Your food scientists and our regulatory experts can work together to ensure there are no harmful components in your goods.

According to the Federal Food, Drug, and Cosmetic Act’s sections 201(s) and 409, which are referred to as the “Generally Recognized as Safe” (GRAS) standards, any ingredient added to food must be evaluated for clearance by the U.S. FDA unless it is a GRAS ingredient.

What are GRAS Ingredients?

GRAS stands for “generally recognized as safe,” and it refers to food ingredients that have been deemed safe by a qualified expert panel. Under the Federal Food, Drug, and Cosmetic Act, the FDA recognizes certain ingredients as GRAS if the scientific data and information in the form of published studies demonstrate that there is a general recognition of safety among qualified experts. A GRAS substance has passed expert safety analyses and has been proven safe when used as intended. Once experts concur that it is safe to use as planned, it is added to the list of GRAS ingredients, allowing producers to utilize it in their products. Alternatively, it could be a component widely used before 1958, in large quantities, by a large population, and for an extended period without any documented adverse effects. Ingredients in that category are considered safe and need no further safety testing.

What’s required with the labeling of GRAS Ingredients?

GRAS-related labeling requirements depend on the GRAS ingredient, its intended use, and FDA regulations. Generally, product labels and advertisements must accurately reflect the nature of the GRAS ingredients used in food products. GRAS substances must be listed alphabetically, identified with their common or usual name on a product’s label, and include a description of the substance’s functional use in the food. Additionally, important safety information about potential hazards associated with certain GRAS ingredients must be included on product labels.

What are the safety risks with GRAS Ingredients?

It’s important to consider potential food safety risks associated with the use of GRAS substances in the manufacturing of food products. Some common risks may include contamination, spoilage, or overuse of GRAS ingredients, which can result in an adulterated product and pose health hazards. To mitigate these risks, manufacturers must adhere to current Good Manufacturing Practices (GMPs) for ensuring each ingredient is safe for human consumption.

What are the considerations before making a GRAS determination?

Before you make a GRAS determination, there are several factors you should consider. For example, self-GRAS determinations require extensive research regarding the safety of your ingredient, including toxicological data and evidence that it is likely to be safe for its intended use. Companies must also keep records of their assessments and be able to provide manufacturers with an up-to-date list of safe food additives. In addition, after a product has been manufactured with a GRAS-determined ingredient, companies must ensure they adhere to current label regulations.

What are the reporting requirements for GRAS substances?

Companies making GRAS determinations must comply with the reporting requirements outlined in the Generally Recognized as Safe (GRAS) regulations. Under these rules, companies are required to annually report the amount of GRAS substances used, as well as any safety studies or other relevant information used in making their assessments. Companies must also provide manufacturers with a list of current ingredients they have determined to be GRAS and must keep records of their assessments. In addition, after a product has been manufactured using an ingredient that has been generally considered safe for its intended use, companies must adhere to the correct labeling regulations established by the Food and Drug Administration (FDA).

How does an ingredient become a GRAS ingredient?

To notify the U.S. FDA that an ingredient satisfies GRAS criteria:

1. An industry seeking to use a new ingredient must conduct rigorous scientific safety assessments, win consensus on safety from a non-biased panel of food safety experts, and prepare and submit a final report. After reviewing the report, the U.S. FDA notifies the company if any concerns indicate the ingredient should not be regarded as safe. The item is added to the GRAS list if there are no noticeable problems.

2. It is automatically a GRAS component and has been used safely before 1958.

Why do we need GRAS ingredients?

GRAS ingredients enable food producers to quickly and safely develop foods and food products. The U.S. FDA would be overworked and may be forced to impede innovation if required to reevaluate an ingredient for each new product containing the chemical.

Food manufacturers can continue to develop and respond to the market by including these approved GRAS components in their new formulations without needing additional FDA clearances by compiling an approved list of GRAS ingredients.

Are there concerns over GRAS ingredients?

Yes, there are worries regarding the GRAS clearance process from numerous organizations and advocacy groups. The food industry may classify ingredients as GRAS through the report and notification process or if they have proof that an ingredient has been utilized since 1958 under the present procedure, which was put into place in 1997.

The process of reporting and notifying has drawn the most critical attention. Ingredients have been added to the GRAS list, despite the FDA’s ability to assess notice reports, some of which need more peer review. Organizations are attempting to change this procedure and mandate more FDA additive regulation.

Can the status of a GRAS ingredient change?

Yes, the U.S. FDA will withdraw an ingredient’s GRAS designation and forbid it from being used in foods if researchers find it poses safety issues. This has happened multiple times over the years and involves components like trans fats, partially hydrogenated oils, and particular synthetic flavorings.

Conclusion:

The GRAS pathway is a possible pathway for a new 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. Suppose a probiotic is GRAS and placed into the food supply. In that case, the probiotic may be used in a dietary supplement as a new dietary ingredient without the required NDI notification, provided the dietary supplement does not contain significantly higher levels of the NDI than is used in already established conventional foods or does not exceed the levels established as safe in a GRAS conclusion.

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:

Additional Reading about GRAS: