Former FDA Chief Raises Red Flags About ‘Generally Recognized as Safe’ Ingredients
A former commissioner of the U.S. Food and Drug Administration has sounded serious warnings about how the federal “generally recognized as safe” system, commonly called GRAS, has been used to approve ingredients in the American food supply without rigorous review. In a recent national interview, Dr. David Kessler, who led the FDA in the 1990s, raised pressing concerns that many substances added to foods, especially in ultra-processed products, may not be as harmless as their GRAS status suggests and could be contributing to widespread health problems.
According to Kessler, the GRAS framework was originally intended for simple, familiar substances with long histories of safe use, but over the decades it has expanded to include dozens of additives in highly processed foods. Because companies often determine their own ingredients are GRAS without mandatory premarket FDA oversight, there is little independent verification that these additives are truly safe under modern consumption patterns, Dr. Kessler argues. His remarks have drawn attention from health experts and policymakers alike as they spotlight potential gaps in food safety oversight.
The discussion comes amid broader debates over the impact of ultra-processed foods on public health. These products, which now make up a large share of the American diet, often rely on refined sweeteners, starches and industrial additives that critics say may promote obesity, metabolic disease and other chronic conditions when consumed frequently over time. Kessler’s comments emphasize that GRAS status should not be mistaken for comprehensive FDA approval and that more scrutiny may be necessary given current health trends.
How the GRAS System Works and Why It Matters
GRAS stands for “generally recognized as safe,” a regulatory designation under U.S. law that exempts certain food additives from the usual premarket approval process if they are widely accepted by experts as safe for their intended use. This mechanism was created in 1958 to allow common, historically used substances, such as salt or vinegar, to enter the food supply without additional testing when they have a long record of safe consumption.
However, because companies can self-affirm that an ingredient is GRAS and choose not to notify the FDA, many modern additives enter the market without the agency ever reviewing safety data. Critics describe this as a loophole that lets food manufacturers determine whether their own substances are safe, potentially sidestepping independent scientific review. This situation has raised concerns because ingredients used in ultra-processed foods, like certain refined carbohydrates and flavor enhancers, may affect metabolism in ways not fully evaluated under GRAS criteria.
The distinction between GRAS and full FDA approval matters because it determines the level of scientific scrutiny required before a substance can be widely used. If an ingredient is GRAS, companies can sell products containing it without formal FDA clearance, a policy that critics say may leave gaps in safety assessment, particularly as food science evolves and new health evidence emerges. Reform advocates argue t
What the Former FDA Chief Is Calling For
In recent remarks on national television, Dr. Kessler has called attention to what he believes is a public health threat posed by the widespread use of additives that are classified as GRAS without comprehensive federal review. He specifically has urged regulators to reconsider the GRAS status of common additives, including refined carbohydrates and industrial ingredients used in many processed foods, arguing that their effects on human biology may be more harmful than previously understood.
Kessler’s concern aligns with a petition he filed urging the FDA to revoke GRAS classifications for certain substances that are prevalent in food products, claiming that these ingredients are linked to obesity, metabolic disease and other major chronic conditions. He has compared the public health impact of ultra-processed foods to other major health challenges, noting that these foods are not “empty calories” but are actively contributing to damaging metabolic effects in the body when consumed in large quantities.
Supporters of reform say that updating the GRAS process could lead to more transparency about which ingredients are in the food supply and how they are evaluated. Some health advocates have also called for improved post-market monitoring of GRAS ingredients so that any emerging safety concerns can be identified and addressed more rapidly, rather than relying solely on initial determinations made decades ago.
The Broader Debate Over Food Safety and Processed Foods
Kessler’s warnings have reignited a broader national conversation about the role of ultra-processed foods in American diets and what federal regulators should do to protect public health. Some policymakers and health leaders argue that the current GRAS framework is outdated and does not reflect contemporary scientific understanding of how diet affects long-term health, especially in light of rising rates of obesity, diabetes and other diet-related conditions.
Opponents of dramatic regulatory changes, including some industry groups, contend that the GRAS system plays an important role in allowing innovation and new food ingredients while maintaining safety standards, and that reforms should focus on improving transparency rather than eliminating the designation entirely. They argue that stronger oversight does not have to hinder food innovation or consumer choices.
Regardless of where people stand, the national focus on GRAS ingredients underscores growing public interest in food safety, ingredient transparency and the connection between diet and chronic disease. As officials and experts continue to debate potential changes, consumers may see increased attention to how food additives are regulated and whether the food supply should be held to higher safety standards in the years ahead.
