FMI Statement on FDA’s Proposed Rule on GRAS Food Safety Process

ARLINGTON, VA – The Food Industry Association Chief Public Policy Officer and General Counsel Stephanie Harris offered the following statement regarding the U.S. Food and Drug Administration’s (FDA) proposed rule that would reform the Generally Recognized as Safe (GRAS) process.

“FMI supports meaningful, science-based modernization of the GRAS framework to strengthen transparency, reinforce consumer confidence and ensure the continued safety of the U.S. food supply. We believe FDA should remain the authoritative federal body for evaluating food ingredients and making safety determinations based on rigorous science, qualified expertise and a transparent process.

“FDA’s proposal is an important step, but it underscores the limits of what the agency can accomplish under its existing statutory authority. Durable reform requires Congress to give FDA the clear mandate, tools and resources necessary to modernize the GRAS program effectively and establish a national uniform standard.

“Congress should act this year to establish a nationally uniform, science-based framework for ingredient transparency that strengthens FDA’s role, avoids a fragmented state-by-state patchwork and provides consumers and the food industry with clarity and confidence. We look forward to working with lawmakers on both sides of the aisle as well as the White House to make this a reality.”

About FMI

As the food industry association, FMI works with and on behalf of the entire industry to advance a safer, healthier and more efficient consumer food supply chain. FMI brings together a wide range of members across the value chain — from retailers that sell to consumers, to producers that supply food and other products, as well as the wide variety of companies providing critical services — to amplify the collective work of the industry.

About GRAS

GRAS is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.