What are GRAS and NDI Notifications?
GRAS stands for “Generally Recognized As Safe.” It is a term used by the US Food and Drug Administration (FDA) to describe food ingredients that are considered safe for human consumption, based on a long history of common use in food or on the results of extensive scientific research. The GRAS designation is a way to identify ingredients that are exempt from the pre-market approval process required by the FDA. The GRAS designation was first introduced in the 1950s, and it has since been updated several times to reflect the latest scientific research on food safety. Under the current regulations, a substance can be designated as GRAS either through a scientific evaluation by a panel of experts or through a long history of common use in food.
A GRAS Notification is a way for food and ingredient manufacturers to inform the U.S. Food and Drug Administration (FDA) about their determination that a food ingredient is Generally Recognized as Safe (GRAS). The purpose of a GRAS Notification is to provide the FDA with information about the safety of the ingredient so that the FDA can make its own independent determination of GRAS status. GRAS status is an important designation for food ingredients, as it means that the ingredient can be used in food without the need for pre-market approval from the FDA. This can save time and resources for food manufacturers, who would otherwise need to go through a more lengthy approval process. To make a GRAS Notification, a company must provide the FDA with information about the ingredient, including its identity, history of use in food, scientific evidence supporting its safety, and details about the company’s GRAS determination process. The FDA reviews the information and makes its own determination of GRAS status. It is important to note that the GRAS Notification process is voluntary, and not all food and ingredient manufacturers choose to go through it. However, for those that do, it provides a level of transparency and helps to ensure the safety of food ingredients for consumers.
New dietary ingredients, or NDIs, are defined by the U.S. Food and Drug Administration (FDA) as ingredients that were not marketed in the United States before October 15, 1994. This definition applies to any substance that is intended for use in a dietary supplement, including vitamins, minerals, herbs, or other botanicals, amino acids, and other substances such as enzymes and metabolites. The FDA regulates NDIs to ensure the safety of consumers. The use of new dietary ingredients in supplements can potentially lead to harmful effects on human health, and as such, it is necessary to establish safety standards and protocols for their use.
A New Dietary Ingredient Notification, commonly known as an NDI notification, is a process that companies use to notify the U.S. Food and Drug Administration (FDA) about new dietary ingredients they intend to use in their dietary supplements. The goal of the NDI notification is to ensure the safety of new dietary ingredients before they are marketed to consumers. The dietary supplement industry is constantly evolving and introducing new ingredients to the market. The FDA requires companies to submit an NDI notification for any dietary ingredient that was not marketed in the United States before October 15, 1994. This includes new forms or new mixtures of existing ingredients. The NDI notification must include a description of the ingredient, its intended use, the manufacturing process, and any available data on the ingredient’s safety. Per the FDA, a manufacturer or supplier who intends to “market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce.” The FDA then reviews the information and determines whether the ingredient is considered safe for use in dietary supplements. It is important for companies to comply with the NDI notification process to ensure the safety of their products for consumers. Failure to comply with NDI notification requirements can result in the FDA taking regulatory action against the company, including warning letters and product seizures.