GRAS determinations can be achieved through:
Both pathways require a robust scientific foundation, including toxicology, exposure assessment, and evidence demonstrating safe use under intended conditions.
The pathway selected—and how it is executed—can impact:
dicentra works with clients to align GRAS strategy with both regulatory expectations and commercial objectives from the outset—ensuring that your ingredient is positioned for both approval and long-term success.
Schedule a discovery call to explore how our regulatory and scientific expertise can support your GRAS program.
GRAS (Generally Recognized as Safe) is a designation that a substance is considered safe for its intended use in food based on scientific evidence and expert consensus. It is one of several regulatory pathways available for ingredients entering the U.S. market.
Self-affirmed GRAS is established through an independent expert panel without notifying the FDA. FDA-notified GRAS involves submitting a notification to the FDA and receiving a “no questions” letter following their review.
Both pathways require the same level of scientific evidence, but the choice depends on factors such as regulatory strategy, commercial goals, and stakeholder expectations.
Timelines vary depending on the complexity of the ingredient and available data. Most GRAS projects range from several months to over a year, including feasibility, data development, dossier preparation, and review.
FDA review timelines for notified GRAS submissions are typically around 180 days but may be extended.
A GRAS determination typically requires:
The extent of data required depends on the novelty and intended application of the ingredient.
Choosing the correct regulatory pathway depends on the ingredient and its intended use. GRAS is one option, but others include New Dietary Ingredient (NDI) notifications, Old Dietary Ingredient (ODI) status, or food additive petitions.
Incorrect classification can lead to regulatory non-compliance, enforcement actions, or delays in commercialization. Early regulatory assessment is critical to determine the appropriate pathway.
Yes. GRAS determinations can apply to food ingredients and, in some cases, dietary supplement ingredients. However, dietary ingredients may also fall under NDI or ODI requirements depending on their history of use and classification.
If GRAS is not appropriate, alternative pathways such as food additive petitions or NDI notifications may be required. These pathways often involve different timelines, data requirements, and regulatory considerations.
dicentra evaluates all available pathways to ensure the most appropriate and efficient route to market.