In the US, safety is the core of the regulation compliance for food ingredients. Currently, there are four main pathways for food ingredient compliance in the US as follows: Food Additive Petition (FAP), Color Additive Petition (CAP), independent conclusion of Generally Recognized As Safe (GRAS) status, and the Dietary Ingredient (DI) pathway. The first three pathways apply to conventional food ingredients, while the DI pathway applies to a separate category of food ingredients that have their own unique regulatory framework, in which DIs are defined and categorized as new DIs (NDI) or pre-DSHEA DIs. CIRS Group has conducted a brief analysis of the key points of these four pathways, aiming to enable entrepreneurs to select their optimal compliance pathway based on the characteristics of products.

“GRAS” is an acronym for Generally Recognized As Safe, which stands as an important food regulatory category in the United States. Simply speaking, if a substance is GRAS under the conditions of its intended use among qualified experts, it is excluded from the definition of a food additive and is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act.

“GRAS” is an acronym for Generally Recognized As Safe, which stands as an important food regulatory category in the United States. Simply speaking, if a substance is GRAS under the conditions of its intended use among qualified experts, it is excluded from the definition of a food additive and is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act.

Recently, Fushine successfully obtained the self-GRAS notification for its FuNext protein, with the support of CIRS food expert team. This achievement not only highlights the company's robust research and development capabilities, but also serves as further proof of CIRS’s professional service expertise.

Recently, Guilin Layn Natural Ingredients Corp. (hereinafter referred to as "Layn"), with the support of CIRS, received a "no questions" letter from the FDA for its enzymatically converted rebaudioside M2 (hereinafter referred to as RebM2). This indicates that RebM2 has been successfully notified under the FDA GRAS (Generally Recognized as Safe) notification program. The official FDA GRAS notification, unlike a self-affirmed GRAS, carries greater authority and market recognition.

Recently, CIRS supported Zhuhai Long Health Biotechnology (hereinafter “Long Health”) in achieving Self-GRAS notification for its 2’-Fucosyllactose (2’-FL), a key component of its HMOs product line. It not only underscores Long Health's strong R&D capabilities and outstanding product quality, but also marks a significant advancement for the company in its expansion into the global nutrition and health market. Additionally, it serves as a powerful testament to CIRS's professional service capabilities.

In the wave of globalization in the food industry, innovation and safety are inseparable. An increasing number of companies are actively pursuing the FDA GRAS notifications for new food ingredients. Unlike self-GRAS, the FDA GRAS require the formation of GRAS evaluation materials, and when GRAS materials are submitted to the FDA, the FDA issue the inventory notices on its official website and updates information periodically. The latest update to this inventory was on January 7, 2025.

On October 29, 2024, we hosted a free webinar on the key points and considerations in health food development. Many questions were raised during the webinar. We have collected the questions and made a Q&A summary

In the second quarter of 2024, the US FDA's official website updated the GRAS status of 19 products. Among these, one substance was approved, while 18 are still under review.

Frequently Asked Questions on FDA Generally Recognized As Safe (GRAS) Notice, Vol. 2