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Frequently Asked Questions on FDA Generally Recognized As Safe (GRAS) Certification, Vol. 2
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.
In the first quarter of 2024, the official website of the FDA updated the GRAS status of 27 products. Among these, approval was granted for 2 substances, 2 substances ceased to be evaluated at the notifier’s request, and 23 substances are still pending after submission. This article provides a summary of the US FDA GRAS acceptance and approval status in the first quarter of 2024, for the information and reference of businesses.
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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.
In recent years, fueled by consumers’ growing demand for low-calorie diets, sweetness-related keywords such as “low-sugar” and “zero-sugar” remain highly popular. Sugar substitutes are widely used in the downstream food and beverage industry, due to the characteristics of high-sweet, low-calorie, and not causing a rise in blood sugar levels.
Human Milk Oligosaccharides (HMOs) stands as a unique carbohydrate present exclusively in breast milk, ranking as the third-largest solid component, following lactose and fat. With diverse functions, HMOs plays a crucial role in enhancing the gut microbiota, boosting cognitive function, and alleviating symptoms of irritable bowel syndrome, among other benefits. Currently, there are over 150 known types of HMOs, each with distinct structures, functions, and applications. Several types have initiated compliance efforts globally, with commercialization taking root first in the EU and the United States.
In recent years, an increasing number of domestic and international companies have sought FDA GRAS certification for new substances added to food. The U.S. Food and Drug Administration (FDA) regularly updates the list of "Generally Recognized as Safe (GRAS)" substances on its official website, with the most recent update as of October 31, 2023. CIRS Group has made a detailed analysis and summarized the substances submitted for GRAS certification from 2021 to 2023 to provide businesses with valuable insights.
In recent years, NMN (β-Nicotinamide mononucleotide) products are quite popular among businesses and consumers for its “anti-aging” function. In May 2022, SyncoZymes (Shanghai) Co., Ltd. received the first US FDA New Dietary Ingredient (NDI) approval for its NMN ingredient. Recently, however, the FDA has changed its position and stated that NMN cannot be marketed as a dietary supplement because it has been authorized for investigation as a new drug.
In recent years, with the rapid improvement of social medical level and the living standard, Chinese consumers are paying close attention to health. Besides, the outbreak of coronavirus pandemic since the beginning of 2020 has made everyone become more aware of the importance of health and the pursuit of health has become more urgent. Therefore, health food with specific health functions and/or could regulate body functions have gradually become the focus of consumers.