The FDA regulates GRAS ingredients in animal food through the GRAS Notification Program. Food companies and manufacturers may either submit a GRAS Notice (GRN) to the FDA to get a “No Questions” letter, or independently draw the GRAS conclusion based on the opinions of the panel group.

GRAS stands for Generally Recognized As Safe. It is the FDA primary framework for managing the safety of food ingredients. To obtain GRAS status, a company must compile a complete English‑language GRAS dossier and have it reviewed independently by a qualified panel of experts, who must reach a consensus on the ingredient’s safety. The dossier is a technical compilation that systematically explains the substance’s characteristics and its safety for consumption. Under 21 CFR Part 170 Subpart E, a GRAS notice must contain seven statutory parts.

Recently, CIRS Group successfully assisted Penglai Marine in obtaining Self-GRAS Notice for its anhydrous magnesium citrate. It signifies that Penglai Marine’s anhydrous magnesium citrate may now be legally marketed and utilized as a safe food ingredient within the U.S. market, marking a significant step forward in Penglai Marine’s internationalization efforts.

Understanding the US FDA’s regulations and policies is vital for companies that intend to export their food materials to the US market. However, in recent years several companies have ceased their submitted GRAS Notice, and it's important to understand the reasons why.

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.

An ingredient intended for use in or as a dietary supplement in the United States, is called a dietary ingredient (DI). The term was introduced into U.S. law by the Dietary Supplement Health and Education Act of 1994 (DSHEA). DIs are regulated separately from ingredients intended for use in conventional foods.

“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.