Why GRAS Works

Why GRAS Works

How the FDA’s final rule helps ensure safety

In 2016, the Food and Drug Administration (FDA) published its final rule regarding substances in food that are “generally recognized as safe” or GRAS. This rule formalizes the steps food manufacturers must take to ensure GRAS substances are safe for human consumption and reaffirms a process that has worked well for many years.

GRAS is one of two methods by which a substance can be lawfully added to food in the U.S. In order for a substance to be GRAS, there must be general recognition by qualified experts that it is safe when consumed in accordance with its intended use in a food or beverage. This final rule clarifies and strengthens the FDA’s oversight of food ingredients by better explaining how general recognition of safety is demonstrated under the law and by requiring companies to provide additional information when submitting GRAS notifications for FDA review.

The GRAS concept, which is rooted in the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act, is intended to address ingredients that have a long history of use or where a general recognition of safety exists in the public domain.  While the FDA does an excellent job of policing food and food ingredients to ensure they are safe for consumers, Congress recognized that the Agency simply doesn’t have the resources to look into every ingredient and should instead focus on substances where a general recognition of safety doesn’t exist. GRAS therefore puts the onus for determining safety on the ingredient manufacturer rather than the FDA, and provides strict direction that manufacturers are legally responsible to follow to ensure the safety of the products they produce before they can be used in food.

This is why the GRAS system works so well for consumers, FDA and food manufacturers.  It allows the food industry to step in and provide the resources to review substances and help determine their safety. These expert determinations can be submitted voluntarily to the FDA for review, a common practice employed by many companies. Over the last several decades, the content of these submissions has evolved to include research and information on a particular substance, its intended use, how much is expected to be consumed in foods and other information in order to provide the FDA with enough information to determine whether they agree with the GRAS determination. Since the process has evolved over time, this ruling brings additional transparency and establishes the burden of proof to determine if a substance is GRAS.

The GRAS process represents the pinnacle of public and private sector collaboration. Because of it, FDA resources can be directed at activities that have the greatest impact on public health, such as implementing the FDA Food Safety Modernization Act, while providing a clear legal framework under which food manufacturers can produce innovative, safe ingredients. This final rule is a positive step towards the continued collaboration with groups like IFAC and food manufacturers that work with the FDA to ensure it has as much information and research as possible about the ingredients used in food.  IFAC and its members look forward to working with FDA and other stakeholders to implement this final rule and achieve our common goal of maintaining the safest food supply in the world.