New Food Policy Reforms Are a Step Forward for Consumers

By Nancy Glick, Director of Food and Nutrition Policy

In casual speech, geologic time is a way of describing an excessively long, painfully slow process of change. It is appropriate to describe how long it has taken the Food and Drug Administration (FDA) to issue a proposed rule to strengthen the agency’s oversight of food ingredients determined to be “Generally Recognized as Safe” (GRAS).

Going back to the Food Additives Amendment of 1958, Congress established a mandatory pre-market approval process under which manufacturers must submit safety data to the FDA before a new additive may be used in food production. At the same time, Congress recognized the need for a statutory carve-out for common, time-tested ingredients like salt, vinegar, baking soda, and flour and created the “Generally Recognized as Safe” provision for substances widely understood by qualified experts to be safe under their conditions of use. Thus, in December 1958, the FDA published the first GRAS list in the Federal Register, and soon hundreds of traditional ingredients received GRAS status.

Yet there were problems with the GRAS carve-out from the start. The 1958 statute did not lay out exactly how “general recognition” should be proven; the FDA was flooded with manufacturers’ requests for opinion letters on whether their conclusions of GRAS status were justified; and food chemical manufacturers started hiring their own experts to review proprietary safety data and declare a new chemical “GRAS.”

Then, in 1969, the FDA removed cyclamate salts from the GRAS list due to safety concerns, prompting a “comprehensive review” of presumed GRAS substances conducted over many years by an outside scientific body known as the Select Committee on GRAS Substances (SCOGS). By 1982, SCOGS submitted opinions to the FDA on the health aspects of more than 400 substances. At the same time, the FDA established rulemaking procedures for a GRAS affirmation petition process, which allowed companies to assert the GRAS status of a particular use of a substance. Under this framework, the FDA signed off on the GRAS status of numerous ingredients, including canola oil, whey, and cocoa butter substitutes.

However, because the GRAS affirmation petition process was resource-intensive, the FDA sought an alternative pathway and, in 1997, shifted to a voluntary GRAS notification system. In doing so, the FDA unintentionally created the GRAS loophole. This regulatory gap allows food companies to introduce new chemical additives into the food supply without getting approval from, or even notifying, the FDA. For consumers, this means a wide range of food products may contain undisclosed chemicals and alternative proteins that the FDA never reviewed for safety.

How serious is the problem? Reports from independent bodies and consumer and environmental organizations find that the GRAS loophole is overwhelming the food safety system. Specifically:

A February 2010 report to Congress from the Government Accountability Office (GAO), entitled FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS), concluded that the FDA did not know to what extent, or even whether, companies tracked evolving scientific information about their GRAS substances. Ten years later, a separate review published in the journal Critical Reviews in Food Science and Nutrition concluded that the FDA remained uninformed of potentially harmful GRAS substances in food.
A 2013 study published in JAMA Internal Medicine by researchers from the Pew Charitable Trusts found that between 1997 and 2012, almost all the new chemicals added to food were deemed GRAS by manufacturers. At the time, with more than 10,000 additives allowed in food, Pew’s research showed that companies added more than 1,000 chemicals as GRAS ingredients without notifying the agency.
A 2020 investigation by the Environmental Defense Fund (EDF) revealed that the FDA and food manufacturers routinely fail to evaluate the cumulative exposure to and health effects of food chemical additives linked to rising rates of chronic conditions such as obesity, diabetes, and kidney disease. Reviewing nearly 900 safety determinations, EDF’s analysis found that only one evaluation meaningfully addressed cumulative dietary exposure as required by law.
A March 2025 analysis by the Environmental Working Group (EWG) identified at least 111 novel or processed ingredients added to meals, snacks, candy, drinks, and other food products that are “secret GRAS,” meaning companies kept their safety assessments entirely in-house. They did not notify the FDA of their use. Of these substances, 49 are ingredients in thousands of food products.

For decades, the National Consumers League has been advocating for closing the GRAS loophole through reforms that will increase FDA oversight, so food companies can no longer add ingredients without the FDA’s knowledge. And we are far from being alone. In May 2017, the Center for Science in the Public Interest (CSPI) and other public-interest groups filed a lawsuit challenging the FDA’s voluntary GRAS notification rule, first proposed in 1997 and finalized in 2016, as unlawful and undermining the integrity of the nation’s food system. (Sadly, the court sided with the FDA).

Then, in 2025, former FDA Commissioner Dr. David Kessler filed a citizen petition urging the FDA to revoke the GRAS status of refined carbohydrates used in industrial food processing, such as corn syrup, corn solids, glucose syrups, wheat, and corn flour. Dr. Kessler’s petition argues that processed refined carbohydrates can no longer be considered GRAS now that scientific evidence links their consumption to metabolic harm, leading to obesity, diabetes, and cardiovascular disease.

Now, 68 years after the FDA published the first GRAS list, there is potential for meaningful change. On August 10, 2026, the agency issued a proposed rule that would end the voluntary notification system for most GRAS substances by requiring companies to notify the agency and provide details on how the manufacturer deemed the additive “generally recognized as safe.” Manufacturers with GRAS substances already on the market would also need to let the FDA know how the additive is used, information that would be made public in a database of GRAS notices. According to FDA officials, these actions will modernize the GRAS framework, increase transparency, and give the FDA greater visibility into substances entering the food supply.

NCL considers the proposed rule a good start, but along with other advocacy groups, believes that improving the GRAS framework requires more than mandatory notification. For this reason, public health and consumer advocacy organizations will be pressing for guardrails to strengthen the proposed rule, such as a requirement that companies provide the underlying data supporting their independent GRAS conclusion and a premarket approval requirement, so companies cannot sell products with GRAS ingredients before completing the notification process. Other reforms include penalties or sanctions for noncompliance and the requirement that companies conduct post-market reviews of GRAS ingredients.

Complementing these reforms, organizations like NCL are also working to pass the Food Chemical Reassessment Act of 2025 (H.R. 4306), proposed federal legislation introduced by Representatives Jan Schakowsky (D-IL) and Rosa DeLauro (D-CT) that will require the FDA to systematically reevaluate the safety of chemicals added to food and packaging every three years, targeting aging approvals and the “Generally Recognized as Safe” loophole.

After decades of debate, there is broad consensus that the GRAS loophole must be closed for good. Now it is up to those speaking on behalf of consumers to ensure that the FDA’s final rule not only ends the loophole, but adds the regulatory guardrails needed to enhance the safety of the food supply.