Understanding FDA’s GRAS Final Rule
October 3, 2016
By: Manojit Basu, Ph.D., Technical Lead, Consumer Product Safety & Regulatory Affairs and René Viñas, MS, Ph.D., Toxicologist, Consumer Product Safety
Ensuring the safety of food products and maintaining the confidence of consumers–is the single most important goal of our industry. The long history of producing safe, quality and affordable food has been supported by the industry’s use of ingredients added during production. These substances are used for functions such as taste, texture, flavor, color, consistency, and shelf life preservation and are commonly referred to as food–additives.
The U.S. Food & Drug Administration (FDA) has defined food additives as any substance that is directly or indirectly added to food and is reasonably expected to be a part of the food or affect the characteristics of the food. Food additives are subject to premarket review and approval by FDA before they can be used in a food product, unless the additive has been determined to be generally recognized as safe or GRAS.
GRAS came into existence in 1958, when Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic (FD&C Act). Under this amendment, a substance that is GRAS for an intended use may be added to food without an approval from FDA (e.g., garlic, garlic oil, sucrose, etc). If a manufacturer establishes the GRAS status of sucrose as a sweetener, then sucrose can be used in sweetened products without requiring FDA’s approval. This amendment to FD&C reflected Congress’s determination that certain substances intentionally added to food do not need premarket review to ensure their safety either because the safety has been established by a long history of use in food or because safety has been established by information about the ingredients that is generally available and recognized as safe by qualified scientific experts.
Recently, FDA issued the final rule detailing the criteria for determining whether or not the use of a substance in human or animal food is GRAS. The final rule brings increased transparency to the process and greater information sharing by industry. Manufacturers submitting a GRAS notification to FDA must include in the notice, the applicable conditions of use of the notified substance, including the foods in which the substance is to be used, levels of use, and the purposes for which the substance is used. The manufacturer must also provide (when appropriate) a description of the population expected to consume the substance. The notice must also include a signed statement indicating that the assessment of the ingredient provided is balanced and includes all available data, both positive and negative, related to the substance.
In addition to FDA’s GRAS final rule, GMA has embarked on a GRAS Modernization Initiative, which will further enhance the transparency of this process. This five-part initiative will further improve the process for making GRAS determinations of food ingredients and will include ongoing education and training; development of a publically available specification; establishment of a database listing self-determined GRAS substances and a code of practice; and informing stakeholders and consumers.
The GRAS process has helped ensure the safety of food ingredients in the U.S. for 55 years and is globally recognized. FDA’s GRAS final rule and GMA’s GRAS Modernization Initiative together will only improve this process and further strengthen the safety of our food supply.