GRAS: Generally Recognized as Safe, or Cause for General Concern?

GRAS: Generally Recognized as Safe, or Cause for General Concern?

By: Blake Jackson

Many food ingredients and food additives have not been reviewed by the FDA for food safety. This is currently allowed because of a 1958 provision added to the Food Drug and Cosmetic Act excluding substances generally recognized as safe from classification as a food additive. Technological advances and an ingredients list that has expanded exponentially since 1958 calls into question the usefulness of this means of regulation or lack thereof.

There are many recent trends and gaps in communication that undermine consumer confidence in the U.S. food regulatory system. Foodborne illness remains a problem, as evidenced from the recent (and repeated) romaine lettuce outbreaks and the feeble attempts to prevent future outbreaks. Simultaneously, the debate surrounding what will be considered a genetically modified food has become even murkier (especially now GMO has been replaced by BE or “bioengineered” foods by the USDA rules on disclosure). Secretary Perdue has issued a statement indicating that even if a food has been bioengineered using new precision gene-editing techniques, it will not be considered bioengineered if it could have hypothetically been created through conventional breeding. 

However, one persistent problem in our food system, the classification of food ingredients as “generally recognized as safe or GRAS” has long-flown under the radar. Many scientists probably aren’t even aware of it, though the legal framework regulating our food system presumes their “general recognition.” Because of this loophole, substances can be added to food if they are “Generally Recognized as Safe,” allowing industry to bypass the process of classifying the substance as a “food additive” and to circumvent a pre-market review by the Food and Drug Administration (FDA), the regulatory body charged with regulating food additives.  

What is the GRAS loophole and how does it fit into the food regulatory framework?

The Food, Drug, and Cosmetic Act (FDCA) classifies a food as adulterated “if it is or if it bears or contains . . . any food additive” unless, among other things, there is a regulation classifying that food additive as “safe” and the use of the additive conforms with such regulatory criteria. By definition, a “food additive” is “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” One exclusion from this definition is when a substance is “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 under the conditions of its intended use.” Thus, a substance classified as “generally recognized as safe,” or “GRAS,” is exempt from the pre-market regulatory review that would otherwise be required under 21 U.S.C. 348 (Section 409 of the FDCA) because it does not fall within the definition of a “food additive.”

Different classifications of GRAS

The underlying basis for a GRAS claim can stem from either “scientific procedures” or “common use in food.” A GRAS conclusion rooted in scientific procedures must be based on “the same quantity and quality of scientific evidence as is required to obtain approval of a food additive.” This includes “generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.” Hence, a GRAS determination may not be based solely on private, trade secret information, though such information can be used to corroborate a GRAS claim. Furthermore, a GRAS determination predicated on “common use” must be based “solely on food use of the substance prior to January 1, 1958 and shall ordinarily be based upon generally available data and information.” In either case, GRAS “requires common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the conditions of its intended use.”

Lack of Industry Accountability, Data, and Disclosure

An industry stakeholder may apprise FDA of its GRAS conclusion under the GRAS Notification Procedure specified in 21 C.F.R. Part 170, Subpart E. In response to such a notice, the FDA may issue a response letter indicating that it has “no questions” as to the GRAS conclusion reached by the stakeholder. Similarly, the FDA may respond by stating its view that the conclusion reached by the stakeholder in the GRAS Notice is supported by an “insufficient basis.” Yet, submitting a GRAS notice to the FDA is entirely voluntary on the part of the industry stakeholder wishing to use a substance as GRAS.

Extensive Use of Outdated Provision Causes Concern

In 1958, Congress enacted the GRAS provision of the FDCA in order for common ingredients in processed foods (such as salt and vinegar) to circumvent a lengthy federal approval process.  Rampant overutilization of the GRAS process through the years has caused worry for consumer safety advocates and health professionals alike. This is because the voluntary GRAS notification provisions in 21 C.F.R. § 170, Subpart E have translated into companies adding “thousands of ingredients to foods” without FDA oversight or notification. This has become the “biggest concern” of critics because such ingredients “are not reviewed at all by regulators for immediate dangers or long-term health effects.” A 2010 GAO Report found that the FDA “has not taken certain steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified.” The lack of oversight is problematic because it stymies the ability to research the safety of current GRAS substances as science evolves.

Possible Solutions for a Path Forward?

To solve this ever-prevalent problem, a multifaceted approach is needed to alter how the U.S. regulates food additive regulation and disclosure.  One approach would require Congress changing the definition of “food additive” under the FDCA to remove this over-utilized exception currently swallowing the rule.  Similarly, the FDA could introduce a new regulatory requirement whereby all GRAS substances (including those based on industry conclusions) to be registered and effectively evaluated.   Furthermore, a less drastic reform could be as simple as the FDA becoming more proactive in obtaining documentation of past GRAS determinations from industry professionals, although Congress would still likely need to increase FDA appropriations to the aid these increase administrative efforts.   Regardless of the approach, comprehensive action is needed to increase consumer transparency surrounding food additives because, despite your best efforts to eat healthy, the lack of knowledge made available to you may be inadvertently impacting your health.