The U.S. is an expansive market for new food ingredients but accessing it takes knowledge about its regulatory requirements. Generally Recognized as Safe (GRAS) substantiation is one common regulatory pathway businesses can choose to ensure their ingredient complies with U.S. standards. We will cover important points that are unique to the U.S. GRAS process and that need to be considered for long-term business success.

With the development of the food industry, there has been a growing emergence of new technologies and substances in recent years. Meanwhile, there is an increasing demand from food companies to seek new food ingredient compliance, including the GRAS certification in the United States. This article aims to address common questions about the food substance classification under the FDA GRAS, covering topics such as whether the use of a certain substance in human or animal food shall be classified as GRAS, and GRAS application compliance, among others.