Determining whether a new ingredient meets federal safety standards sits at the heart of compliant product development. While pre-approved additives with explicit FDA approval offer certainty, brands often leverage ingredients lacking formal federal sign-off. In these cases, adequately demonstrating recognition of safety through scientific procedures is essential for avoiding regulatory scrutiny.
This article examines the GRAS framework governing new ingredients added to foods and supplements marketed in the United States. We outline basic steps for food brands when navigating safety data, gathering qualified expert opinions, and how to determine if your ingredients require a GRAS assessment.
The Basic Regulatory Requirement
Ingredients used in foods must fit within one of four defined categories: FDA-approved food additives, FDA-approved color additives, Generally Recognized as Safe (GRAS) substances, or Prior-sactioned ingredients.
What is GRAS and who is responsible?
Ingredients that aren’t expressly pre-approved by FDA must be “generally recognized as safe” (GRAS). This requires common knowledge among qualified experts that the ingredient is safe under its intended conditions of use.
Who is responsible for determining the safety of an ingredient?
The brand or manufacturer is responsible for determining that an ingredient is GRAS, which involves preparing a dossier of evidence to support the Company's position. This exercise typically also involves convening a panel of qualified experts to review the material and attest to its safety.
GRAS in Practice
Take the example of a beverage brand looking to use a botanical extract that has never been added to food or drink in the U.S. market. The company has identified safety data from decades of traditional medicinal use globally, but there’s no existing FDA opinion or previous GRAS assessment for this application. The company has options:
Self-Affirmed GRAS Determination
After validating that global safety exposures and estimating intended use-levels fall under historic benchmarks, the company convenes an independent panel of scientific experts in toxicology, pharmacology and food science to critique the data. If these experts unanimously conclude proposed use meets GRAS standards, the company may distribute products containing the ingredient without notifying FDA. However, if FDA later wants to evaluate or challenge the self-determination, the company must be prepared to defend its conclusion.
GRAS Notification
Alternatively, the company could pursue a GRAS notification submission. This means sending FDA detailed documentation on the safety narrative and data used to conclude GRAS status, including an opinion from the expert panel affirming the review outcomes. If FDA responds with a letter of “no questions” about the ingredient, then the ingredient can be used under the conditions and limits specified in the notification. While the GRAS-notification process can be lengthy, often requiring significant back-and-forth and lengthy review periods, a “no questions” letter can enhance marketplace credibility and regulatory flexibility.
Whichever path a brand chooses, the foundational requirement is a robust scientific dossier assessing the safety of the ingredient for its intended use.
How do I know if I should pursue a GRAS assessment?
If the ingredients in your product are not explicitly listed as a pre-approved food additive, color or prior-sanctioned ingredient, then it's likely your company should explore if it's been evaluated for safety through a GRAS assessment. This could start by requesting from your raw material supplier what safety substantiation exists.
In the case the ingredient has not had a prior GRAS assessment conducted, keep reading to learn about what to expect during a GRAS substantiation exercise.
What should I expect during a GRAS substantiation exercise?
