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GRAS: What Is It and Why Should You Care

Helen Timothy
September 12, 2019

On-Demand Webinar: Food Regulations 101

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On-Demand Webinar: Food Regulations 101

FDA attorney Marc Sanchez discusses the primary regulatory agencies in the United States, what’s regulated and why, sources of law, and practical suggestions to put that regulatory knowledge into practice.

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Is the GRAS always greener on the other side? It can be if manufacturers use specific additives to make it that way. GRAS, the acronym for "Generally Recognized as Safe," is a hot topic right now, but many don’t quite understand the basics.

What is GRAS?

GRAS is the acronym used in food manufacturing and regulatory circles for the phrase “Generally Recognized as Safe.” What does this mean? It’s an FDA designation for individual chemicals or substances added to food products that experts deem safe. If a food manufacturing company uses a GRAS ingredient or additive, it can avoid the time-consuming process of getting it approved by the FDA as a safe ingredient. Using GRAS ingredients, companies take a shortcut around the approval process and push their products to market faster with ingredients exempt from the food additive tolerance requirements. One can conclude that many foods are available in local grocery stores containing ingredients that the FDA has neither evaluated nor approved.

Why is GRAS Getting So Much Attention?

Activist groups have generated recent media attention, arguing against the “broken” GRAS system. They question the judgment of food scientists hired by the industry to make safety determinations claiming they have an inherent conflict of interest. Industry groups like the Flavor & Extract Manufacturers Association (FEMA) highlight that their industry’s GRAS program is well-regarded by the FDA and other international regulatory bodies. According to FEMA, more than 100 countries accept FEMA’s GRAS determinations, demonstrating the global food regulatory community’s confidence in the program. FEMA says their expert panel has several built-in safeguards to avoid conflict of interest, and the panel’s findings are peer-reviewed. Observers point to the FDA’s proposal to de-GRAS partially hydrogenated oils (PHOs) as evidence that the process does protect the public. Still, others criticize the FDA for the slow-motion progress.

When companies create new food additives to improve texture, taste, appearance, or give products longer shelf life, manufacturers can take two different paths to add a new additive to the GRAS list:

  • Self-affirmed: Companies can determine on their own—performing their research—that what they’re adding to their food product is safe. These companies then have no legal obligation to report their findings to the FDA, but can do so if they chose to.

  • FDA GRAS Notification: The manufacturer has performed its due diligence and submitted a GRAS notification to inform the FDA of a determination that the use of a substance is GRAS. The FDA can then not question the basis for the decision, determine that the notification does not provide a sufficient basis for GRAS, or cease to evaluate the GRAS notice at the manufacturer’s request.

The History of GRAS

The GRAS loophole was introduced in 1958 as Americans grew more concerned about the mounting number of additives in food products. Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA). This act stated that GRAS ingredients were excluded from the food additive definition if they were common in food use before 1958, or if they were “generally recognized among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures” to be safe for their intended purpose.

At the time, Congress meant this act to apply to common food ingredients like sugar, vinegar, and baking soda — regular cooking ingredients regarded as safe due to their longstanding historical use.

Initially, the FDA created and maintained a list of GRAS substances. However, the FDA stated the list was incomplete, and with the sheer volume of GRAS determinations made by manufacturers, it would be impossible to list all GRAS substances.

In the 1970s, President Nixon directed the FDA to “reexamine the safety of substances considered to be GRAS.” The FDA announced it would evaluate the information regarding these GRAS substances. If the “revaluation of current data confirmed that use was GRAS, FDA would promulgate a new GRAS regulation, affirming that finding.”

An individual could also petition the FDA to review the GRAS status of substances.

But in 1997, the FDA published a proposed rule for voluntary notification, citing it could no longer devote resources to the affirmation petition process.

In 2010, the U.S. Government Accountability Office (GAO) issued a report on the GRAS process, noting several shortcomings and suggested that the FDA update the process. Since the GAO report, the FDA has reopened comments on the 1997 proposed rule, which outlines the GRAS program currently used by manufacturers. And as circular, as this process seems, that’s where we remain today.

Our on-demand webinar, “Food Regulations 101,” breaks down further need-to-know regulatory details. Watch it here

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