Generally Recognized as Safe (GRAS) Services

Intertek understands the intricacies of the GRAS regulations and has successfully completed hundreds of GRAS evaluations for our clients. Our team of experts can help your company navigate the scientific and regulatory requirements for supporting the GRAS status of your ingredients.

In the United States (U.S.), food ingredients must either be approved as food additives or qualify as Generally Recognized as Safe (GRAS) based on scientific evidence and expert consensus. To obtain GRAS status, companies may either conduct an independent safety evaluation supported by scientific evidence, often strengthened through review by an expert panel, or voluntarily submit a GRAS notice to the U.S. Food and Drug Administration (FDA). In both cases, the level of scientific rigor is expected to be comparable to that required for food additive approval; however, GRAS conclusions must additionally meet the threshold of general recognition through publicly available data and expert consensus. When a GRAS notice is submitted, the FDA evaluates the information provided and may respond with a “no questions” letter, indicating that the Agency has no questions regarding the notifier’s conclusion that the substance is GRAS under the intended conditions of use. Alternatively, the FDA may raise concerns that could lead the notifier to withdraw the submission, or, if not addressed, result in a “no basis for GRAS” response. Although GRAS notification is not legally required, it is widely recognized as a best practice, as many food manufacturers expect some level of FDA engagement before incorporating new ingredients into their products, and a “no questions” letter can provide additional confidence in the marketplace.

The regulatory landscape is also evolving, with proposed changes that could require mandatory GRAS notifications and increased transparency around ingredient use. This shift reflects growing momentum toward greater FDA oversight and underscores the importance of a proactive regulatory strategy. Companies introducing new ingredients to the U.S. market are therefore encouraged to engage early with the FDA, ensuring compliance, reducing risk, and strengthening their position in an increasingly competitive and scrutinized environment. At Intertek Health Sciences, Inc., we help food ingredient manufacturers navigate the evolving regulatory framework with confidence. Our offerings include:

Regulatory Strategy & Consultation: Provide strategic guidance on GRAS pathways, FDA engagement, labeling considerations, and risk communication to support compliant and market-ready solutions.
GRAS Determination & Expert Panels: Conduct scientifically robust GRAS evaluations, including coordination of independent expert panel reviews to strengthen credibility and support general recognition of safety.
Preparation of GRAS Notification: Develop and compile comprehensive GRAS dossiers, supporting effective FDA submission and facilitating successful “no questions” outcomes.

We have extensive experience preparing GRAS notifications for a wide variety of food ingredients, including:

Human milk oligosaccharides (HMOs)
Food enzymes
Fermentation-derived ingredients
Live microbial ingredients
Plant extracts and botanical ingredients
Plant-based proteins
Other specialty nutritional ingredients

With over 100 of GRAS notifications prepared and successfully evaluated by the FDA, our team combines regulatory expertise, scientific rigor, and industry experience to support your product’s safe market entry.