Achieving Generally Recognized as Safe (GRAS) status is a critical milestone in food and ingredient safety. This status assures consumers, regulatory authorities, and industry stakeholders that a product or ingredient is safe for its intended use. In the United States, companies have two distinct pathways to attain GRAS status: FDA-Notified GRAS and Self-Affirmed GRAS. In this blog, we’ll explore both routes, delve into the history of the GRAS program, and discuss the significance of going beyond safety to gain a competitive edge in the market.
GRAS, or Generally Recognized as Safe, is a designation by the U.S. Food and Drug Administration (FDA) that a substance is safe for its intended use in food or as an ingredient. The GRAS status assures safety to consumers and regulatory authorities.
Self-affirmed GRAS is one of the two pathways to achieving GRAS status. In this process, a company or individual affirms that their product is safe based on the conclusion of a scientific expert panel. The key feature here is that companies do not need to consult the FDA, and there’s no requirement to notify the FDA of this conclusion. However, the GRAS conclusion must satisfy the criteria set by the FDA’s Final Rule.
The FDA-Notified GRAS pathway involves petitioning the FDA to review an ingredient and grant it GRAS status through a “No Questions/Objections Letter”. This process begins with a notification that includes a detailed description of the substance, its conditions of use, and the scientific basis for the GRAS determination. The FDA then evaluates this determination, and the response can be one of three possibilities, either indicating acceptance, insufficiency, or ceasing of evaluation. While the review process is voluntary, the FDA retains the authority to de-GRAS a substance if necessary.
The FDA has been regulating food and drugs since 1906, with several milestones in the development of the GRAS program. Notable moments include the passage of the 1938 Federal Food Drug and Cosmetic Act, which marked a significant step in recognizing GRAS substances as food substances. This meant they didn’t require a formal pre-market review by the FDA to ensure safety.
In 1972, the GRAS Affirmation process began, and in 1997, the FDA proposed a notification procedure, which became the GRAS “Final Rule” in 2016. This rule formalized the voluntary notification program, modernizing key aspects and emphasizing that a group of experts must agree on the safety of a food substance and that the safety information must be common knowledge.
For a more comprehensive history, visit the FDA’s Approach to the GRAS Provision: A History of Processes
Competitive advantage takes much more than just obtaining GRAS status for your product or ingredient. Setting yourself apart from your competitors also demonstrates that your product or ingredient is effective. A product’s efficacy is demonstrated through human clinical trials necessary to substantiate health claims.
dicentra assists companies at every phase of ingredient and product development, from GRAS and New Dietary Ingredient (NDI) filing to full-service contract research operations supporting human clinical trials’ design and conduct. To succeed in the market, it’s essential to go beyond safety and prove your product’s effectiveness.
GRAS status is a crucial regulatory milestone in the food and ingredient industry. This blog has provided you with an overview of the self-affirmed and FDA-notified GRAS pathways, their requirements, and the historical context of the GRAS program. However, the specific requirements for each unique ingredient can vary significantly. For personalized guidance and to determine the best regulatory pathway for your food additive or ingredient, consult a GRAS regulatory expert at dicentra. We can help outline specific data gaps and support you in your journey to obtaining GRAS status. Reach out to us today to get started on the path to GRAS success.