Manufacturers have a ton of choices to make when it comes to picking the high-quality ingredients for their food formulations. With increasingly educated consumers, manufacturers are in turn increasingly tasked with scrutinizing each potential ingredient looking at everything from its source, to its efficacy, to what processing aids are used or not used, to GMO status, allergenicity and more. Among all of these however, one key point of distinction and telltale sign of a quality ingredient for both manufacturers and consumers is GRAS status. In fact, this is why many large F&B manufacturers require GRAS ingredients for their products.
What is GRAS?
GRAS is the acronym for Generally Recognized as Safe. Under the FDA and Federal Food, Drug and Cosmetic Act, GRAS is a regulatory classification term used to identify a food additive that is “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.”
What is the difference between a food additive and a food GRAS?
A food additive or non-GRAS ingredient can be added to a food, however it is subject to premarket review and approval by the FDA, whereas companies can use GRAS ingredients without FDA approval. Also, food additives typically have limitations for use. For example, a food additive may be safe at very low levels but harmful at high levels.
FDA GRAS vs. Self-Affirmed GRAS
There are two ways to obtain GRAS approval of an ingredient. One way is to petition the FDA to affirm that the use of a substance is GRAS. This is then recognized as FDA GRAS. The alternative, called Self Affirmed GRAS is when a person or company has convened a panel of experts to assess the safety of a particular ingredient and then informed the FDA (via a “GRAS Notification”) of their determination that the use of a substance is GRAS. With Self Affirmation, the FDA must then evaluate the information provided in the GRAS Notification and respond to the company about whether or not it agrees with the basis of the GRAS determination.
Nonetheless, both pathways to GRAS involve a rigorous process and criteria for concluding that the use of a substance in food is GRAS.
Per the FDA, “Under sections 201(s) and 409 of the Act, and FDA’s implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.”
Benefit of Using GRAS Ingredients
First and foremost, GRAS ingredients ensure the safety of our food supply, and in the same manner, the safety of consumers. Additionally, it is more burdensome on manufacturers to use food additives versus food GRAS. This is because the use of food additives (non-GRAS approved) requires the manufacturer to notify the FDA at least 75 days before the food or supplement is introduced into the marketplace. The notification requires the manufacturer to disclose a plethora of information including the dose, the conditions for use, the history of the use of the ingredient, published articles/citations and/or other evidence that leads the manufacturer to conclude that the product containing the non-GRAS ingredient is reasonably expected to be safe to use. Because GRAS ingredients have already been deemed safe, it is one less thing to worry about for both manufacturers and consumers and a surefire way to ensure quality.