Strengthening the GRAS Process

MONOJIT BASU, GMA VP Consumer Product Safety & Regulatory Affairs
KERRY BELTON, GMA Toxicologist
NICHOLE MITCHELL, GMA Ingredient Safety Analyst

Consumers demand a food supply that tastes fresh and flavorful and is healthy, safe, expedient, vibrant, and inexpensive. To meet these demands, the industry has approximately 3,000 different ingredients available to produce a variety of products. These ingredients are listed in FDA’s Everything Added to Food in the United States (EAFUS) database.

Some of the ingredients in the database have been used for centuries and have served useful functions in a variety of foods. For example, additives such as salt can preserve meats and fish; herbs and spices add flavors or preservatives; and sugar or vinegar solutions are used in fruit and vegetable canning. Additionally, many of these additives are used in our homes on a daily basis (e.g., sugar, baking soda, salt, vanilla, yeast, herbs, spices, and food dyes).

In the U.S., FDA has the primary legal responsibility for determining the safety of additives used in food. For the food industry to market products using a new or approved additive for a different purpose, the manufacturer or a sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used.

Manufacturers also can use certain ingredients without going through the petition process, if the ingredient is generally recognized as safe (GRAS) for the intended use by experts, based on the extensive history of use in food before 1958 or on published scientific evidence. Among the several hundred GRAS substances are salt, sugar, spices, vitamins, and preservatives.

Even though food additives are evaluated for safety and the safe use is determined by FDA, some consumers express concerns about additives used in food because of long, unfamiliar names sounding like complex chemical compounds. In fact, every food we eat — whether a banana or homemade cookie — is made up of chemical compounds that determine flavor, color, texture, and nutrient value.

Over the last decade, FDA has received expressions of concerns from policymakers and other stakeholders about the GRAS process. To proactively address these concerns, the Grocery Manufacturers Association (GMA) initiated a five-part GRAS modernization program in 2014. The initiative seeks to help modernize the process of making GRAS assessments of food ingredients to further enhance transparency and consumer trust. The five parts include:

• An industry standard that will provide clear guidance on how to conduct transparent state-of-the-art ingredient safety assessments, known as the Publicly Available Standard (PAS) for GRAS determinations. The PAS is a science-based framework that specifies a rigorous and transparent ingredient safety assessment process.
• Member commitment to driving improvement in the GRAS assessment process. A Board Resolution adopted in September 2017 outlines these commitments as: conducting assessments according to the procedures defined in the PAS; maintaining the database with up-to-date information; and ensuring that employees are fully trained on GRAS procedures.
• Launch of a program that ensures FDA has increased visibility to the ingredients and a database that will list information on all GRAS assessments conducted by the food industry after September 1, 2016. All this information will be made available to FDA and other stakeholders as well as consumers to provide increased visibility of ingredients used in the food supply.
• Establishment of a curriculum of GRAS education and training programs to further increase the capability of scientists who assess the GRAS status of ingredients used by the consumer packaged goods industry.
• Implementation of a communications outreach program to inform stakeholders and consumers of the steps being taken by the industry to increase the integrity of procedures used to assess ingredient safety.

GMA’s food, beverage, and consumer products companies have committed to adopting a transparent approach when making GRAS assessments so that policymakers and consumers receive information that is not confusing and is useful for making informed choices. Food ingredients are strictly studied, regulated, and monitored. Federal regulations require evidence that each substance is safe at its intended level of use before it may be added to foods. All additives are subject to ongoing safety review as scientific understanding and methods of testing continue to improve. All of this is intended to help consumers feel safe about the foods they eat.