The GRAS System Works: “Generally Recognized as Safe” Conflict of Interest Claims Not Supported

By: Jeremy Morris, Associate Editor, USDR

Recent claims that the U.S. Food and Drug Administration’s (FDA) food additive review process is inadequate or fosters conflicts of interest are not supported by evidence according to the International Food Additives Council (IFAC).  These accusations illustrate fundamental misunderstandings and mischaracterizations of a complex, science-based system that ensures the safety of our food supply and functions to the benefit of consumers, food manufacturers and regulators.

“Consumers can be assured that foods containing additives and GRAS substances used as food ingredients are safe,” says Dr. Haley Stevens, Executive Director of the International Food Additives Council. “The current U.S. food additive approval process, including the ‘Generally Recognized As Safe’ program, functions to ensure the safety of the food ingredients we eat.”

“GRAS” is an acronym for the phrase “Generally Recognized As Safe.” To be considered GRAS, a substance must be shown to be safe for its intended use based on a review of publicly available scientific and toxicological data by qualified, independent scientific experts.  A general recognition of safety through GRAS requires the same quantity and quality of scientific and toxicological evidence as is required by the FDA’s Food Additive Petition Process. If there is no scientific data showing the safety of a substance, that substance cannot be considered GRAS.

According to Dr. Stevens, “by definition, the GRAS system relies on scientific experts to review published research on a substance and validate the safety of the substance for its intended use in food.  Claims that the GRAS process creates a ‘loophole’ or offers financial incentives to approve a substance are unfounded.”

A GRAS panel is often composed of three to four independent scientific experts who rely on their area of expertise by training and their detailed analysis of available evidence to make a GRAS determination.  Dr. Stevens adds, “although these scientists are compensated for the time they spend thoroughly reviewing scientific research, their determinations are completely independent of any compensation.  Because FDA expects supporting documentation demonstrating safety to be available upon request, the process fosters innovation and efficiency without sacrificing safety.”

Furthermore, the GRAS process places the burden and cost of locating and retaining independent scientific experts on the manufacturer, rather than the FDA, eliminating the use of Agency resources required for rulemaking in the food additive petition process.  At a time when FDA resources are limited and in great demand for implementation of transformative regulations like the Food Safety Modernization Act, the GRAS process allows the Agency to focus resources on urgent priorities while ensuring that substances added to foods are safe.

All opinions expressed on USDR are those of the author and not necessarily those of US Daily Review.

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