When the 1958 Food Additives Amendment was enacted, Congress required that a food additive (defined as any substance intentionally added to food) undergo pre-market approval by FDA unless the food additive was Generally Recognized as Safe (GRAS) or otherwise exempted from the definition of food additive (i.e., color additive). While a significant number of food additives have already been recognized as safe for use in foods, to market new or novel food ingredients, manufacturers are required to either obtain FDA’s approval though a Food Additive Petition (FAP) or establish GRAS status for the substance.
This blog series will focus on the who, what, where, when, why, and how of the GRAS process—not necessarily in that order—and highlight essential information to help manufacturers and other responsible parties decide if pursing a GRAS determination is the right regulatory pathway for a food ingredient.
Who? From manufacturers and product developers to Expert Panels and FDA, there are a variety of people and entities involved in the GRAS evaluation process. In this blog series, the key players and their roles will be identified, as well as when they’re most likely to be involved in the process.
What? Substances intentionally added to food or that are likely to become components of food are considered food additives, and are under the purview of FDA. By law, food additives are subject to pre-market review and approval by FDA unless GRAS status has been achieved. In the coming weeks, this blog series will cover how to determine if an ingredient is eligible for a GRAS evaluation and what the minimum requirements are for a positive GRAS conclusion.
Where? The GRAS requirement for food additives is specific to the United States, per the regulatory requirements listed under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act. Ingredients manufactured both domestically and internationally are subject to the GRAS requirement for use in food. Achieving GRAS status in the US does not necessarily fulfill regulatory requirements elsewhere, nor does regulatory approval by entities other than FDA provide GRAS status in the US.
When? GRAS status must be attained prior to introducing the substance to market as an ingredient in conventional foods, and in certain cases, is required for import into the United States. The GRAS evaluation process can be time- and resource- intensive, and generally takes anywhere from six months to one year (or more) to complete. Factors such as ready access to publicly available safety data, breadth of ingredient characterization and manufacturing detail, and exercising the option to notify FDA can all impact project timing.
Why? In short, to meet regulatory requirements for food additives. Per the Federal Food, Drug, and Cosmetic Act sections 201(s) and 409, pre-market approval must be obtained for food additives unless the substance is GRAS under the conditions of its intended use. Regulations in 21 CFR 170.3 and 21 CFR 170.30 define food additives and the eligibility for a substance to be determined to be GRAS, either through scientific procedures or history of use.
How? This blog series will discuss the main steps involved in the GRAS Assessment process, including how to determine if an ingredient is eligible for GRAS status, what considerations should be made when preparing a GRAS dossier, how to select the right consultants, and what to expect from the FDA’s GRAS Notification process.
To kick things off, next week’s blog post will cover What is GRAS? A Brief History.
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📷: Gerd Altmann on Pixaby