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Overhauling the GRAS Process: What Are Realistic Goals?

Whether the GRAS process needs to be overhauled is a major question, not a minor one, as it drives to the issue of how much regulation we want in our country and whether we trust companies to have consumer safety top-of-mind as they develop new products and ingredients.
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In 1958, Congress passed a law requiring companies that developed a new food additive to prove it was safe for human consumption before it could be introduced into the marketplace. Some foods -- think vinegar, oil, salt, sugar -- had been in the food supply and consumed by humans for so long that they were assumed to be safe. These products were coined "generally recognized as safe," or GRAS, as it's frequently referred to today.

Fast forward more than 50 years, where the process for GRAS status is being hotly debated. Technology has led to advances in food development, and we now exist in a global food economy with ingredients sourced from around the world. Grocery stores carry 40,000 food items with flavor profiles, textures, and nutritional properties never imagined in 1958. The time is ripe for an assessment of the effectiveness of the GRAS process.


The Food, Drug and Cosmetic Act (FDCA) regulates food additives, which are required to be approved by the Food and Drug Administration (FDA) before used in products and sold to consumers. However, some ingredients aren't formally approved as food additives and are considered GRAS if qualified experts indicate there is adequate science to show the ingredient is safe for human consumption under conditions of its intended use. As a part of the GRAS process, the foods the ingredient will be used in, projections of the total consumption of the ingredient by an individual and safety of the ingredient are all considered. Estimates suggest 43 percent of the 10,000 additives used in the food supply are considered GRAS. Colors are excluded from the GRAS process and are always considered food additives. In 1997, the FDA proposed but never finalized a rule that food companies could, at their own discretion, notify the regulatory agency when a new additive was GRAS. In practice, nearly all the major companies voluntarily submit their GRAS analysis and data to the FDA. The agency follows-up with a "letter of non-objection," indicating they agree with the GRAS report, or rejects the report.

The GRAS process gets interesting as it relates to who leads the process, defines the expert panel, and finalizes a decision that an ingredient is generally recognized as safe for human consumption. All this is done by the company that manufacturers said ingredient. An article in the August 2013 issue of JAMA Internal Medicine sites a review of 451 GRAS applications (based on criteria established by an Institute of Medicine committee in 2009) submitted to the FDA between 1997 and 2012. Of these, 22 percent were written by an employee of the company that makes and sells the food ingredient, and 13 percent by a consultant hired by the additive company. More than 60 percent of the decisions made on the GRAS status of a food ingredient were by expert panels hired by the additive company or a consulting company working for the additive company. This GRAS review was completed as a part of a Food Additives Project, which is run by the Pew Charitable Trusts, a public policy organization. One goal of this project is to analyze the GRAS process, assessing if it is thorough enough and ensures consumer protection.


As with many topics about our food supply (think GMO and fortification), there are multiple points of view embedded in debate on the GRAS process, including:

• Companies vs. the FDA: Who Decides? The role of the FDA is to ensure consumer protection. Some believe the only way to accomplish this is for the FDA to be the study coordinator, scientific reviewer and decision-maker on all issues related to food. U.S. processes in food -- think HACCP, food labeling -- establish a process where the FDA defines the rules and companies are bound to comply with them. While this isn't a perfect system (one doesn't exist anywhere in the world), it is highly effective. If U.S. consumers want this to change, we need to be prepared to pay the price. The FDA is not staffed nor funded to conduct this level of work on food. A colleague recently suggested an option for establishment of a new division of the FDA that owns the GRAS process. Food companies would then pay to have new ingredients reviewed and approved as GRAS.

• Food Companies: Friend or Foe? A major criticism of the GRAS process is that food companies, through staff or payment to experts, are driving the final decision of ingredient safety. Because money is exchanged, the assumption is that bias exists in this process. It suggests all these employees and experts are driven by money and not by their own professional integrity. This argument is inherently flawed for a variety of reasons. First, there are a limited number of experts who have enough knowledge of new ingredients (think stevia) and areas of food science, nutrition, and toxicology to review the science. Whether the FDA or the company hires them, there are select few experts who can address any given area. Second, companies want to develop and sell ingredients that are safe for human consumption and solve a problem in consumers' lives. The risk to them of an ingredient not being safe is significant, and one misstep could destroy their brand and their company. They're taking the greatest risk in determining GRAS status of ingredients. Finally, rarely addressed is the number of potential new ingredients which are explored and researched, but never go to market because they aren't safe for human consumption. Companies spend millions of dollars on exploratory research and development which doesn't result in a finished, saleable product.

• New Uses of GRAS Ingredients. Earlier this year, the Center for Science in the Public Interest (CSPI) submitted a citizens' petition to the FDA recommending the GRAS status of sugar be updated to establish safe levels of its use in food. Caffeine is another example of a food component that has had GRAS status for many years but is now being scrutinized. As it's added to products like energy drinks, alcohol and gum, concern is being raised about the effects a combination of caffeine with amino acids or alcohol might have in the human body. Also, adults and kids alike are consuming higher levels of caffeine on a daily basis, as more food categories contain this stimulant. It's fair to assume that with new uses, GRAS status of ingredients needs to be reassessed.

Whether the GRAS process needs to be overhauled is a major question, not a minor one, as it drives to the issue of how much regulation we want in our country and whether we trust companies to have consumer safety top-of-mind as they develop new products and ingredients. But it's also a question of priority. We have major economic issues in our country, ranging from debt ceilings to health care. Heart disease and obesity are crippling our economy, but we don't legislate saturated and trans fat consumption or food portions at a level equivalent to their negative impact on health. The economic and social benefits of lowering obesity and heart disease rates are much greater in scale and scope than an overhaul of the GRAS process. When all is said and done, what macro problems would an overhaul of the GRAS process really solve?