Former FDA Chief Warns GRAS ‘Loophole’ Lets 99% of New Food Chemicals Skip Review As 70% of Americans Battle Obesity

A lot of Americans say they are trying to eat better, yet the food landscape keeps getting more complicated. Ingredient lists are longer. New additives appear with names most shoppers cannot pronounce. At the same time, obesity and related health problems keep rising, even as more people pay attention to diet and exercise.

This tension sits at the center of a warning from Dr. David Kessler, a former commissioner of the U.S. Food and Drug Administration. Kessler says a regulatory pathway called GRAS, short for “generally recognized as safe,” has grown far beyond its original purpose and now allows many new substances to enter the food supply without FDA review. He has urged the agency to revoke GRAS status for categories of processed refined carbohydrates and related additives used widely in ultra-processed foods.

The warning has landed at a moment when new research suggests nearly 70% of U.S. adults could be classified as having obesity under an updated definition that looks beyond BMI alone. The debate now is not only about personal choices, but also about how the rules shaping the food system have changed over time.

What GRAS Means and Why Kessler Says It Became a Loophole

GRAS was created in 1958 as an exemption meant for familiar ingredients, like vinegar and baking soda, that were already common in kitchens. Over time, critics say, the system shifted in a way that lets companies decide for themselves when a new substance is safe, and under current rules, companies do not always have to notify the FDA when they make that determination.

In August 2025, CNN reported that Kessler filed a citizen petition arguing that the FDA has the authority to declare certain sweeteners, refined flours, and other additives not GRAS. If the FDA removed that designation, manufacturers would have to reformulate products or prove safety through a more formal process. Kessler told CNN that his goal is to shift the burden of proof back to industry, using GRAS as the legal hook to force a safety conversation.

Kessler has also made the case that ultra-processed foods have become so widespread and engineered that they drive overeating and metabolic harm. In a February 2026 interview with CBS News, he said Americans have been exposed to “energy-dense, highly palatable, rapidly absorbable” foods that “our biology was never intended to handle,” and he linked that shift to rising rates of chronic disease.

The 99% Figure and What It Suggests About Oversight

The claim that “99% of new food chemicals” can bypass government review comes from analyses of how GRAS works in practice. CNN cited a 2022 Environmental Working Group analysis that found nearly 99% of new chemicals used in food or food packaging since 2000 were approved not by the FDA, but through industry determinations. The same reporting noted that during that period, manufacturers asked the FDA’s permission to introduce a new substance only a small number of times.

The EWG analysis describes what it calls “secret GRAS,” where companies determine substances are generally recognized as safe without notifying the FDA. The report identified at least 111 food chemicals that were “rubber-stamped” for use, and it found that 49 of those substances appear as ingredients across thousands of branded food products. The report emphasizes that being on the list does not prove a substance is harmful, but it argues that the lack of public review and transparency makes it difficult for consumers to know what has been evaluated.

Critics of GRAS say the problem is not only the number of substances but the structure of the system. The Consumer Federation of America notes that under current rules, companies do not have to notify the FDA when they make a new GRAS determination, and that this process has drawn criticism for lacking transparency and safeguards. Supporters of reform also point to past FDA action as a precedent, such as the agency’s 2015 move to remove trans fats from the food supply by revoking GRAS status for partially hydrogenated oils.

Why Obesity Numbers Are Changing and How Food Policy Fits In

Kessler’s warning has gained traction partly because of new research on obesity prevalence. In October 2025, Mass General Brigham researchers reported that applying a new definition of obesity that includes body fat distribution measures could raise U.S. adult obesity prevalence from about 43% to about 69%. The study, based on more than 300,000 participants in the NIH All of Us cohort, found particularly high prevalence among older adults, approaching 80% for those over 70.

The study explains how the updated framework moves beyond BMI alone by incorporating waist measures and distinguishing between clinical obesity and preclinical obesity. Researchers also found that people newly classified under the expanded definition had higher risks of diabetes, cardiovascular disease, and mortality compared with those without obesity, which is part of why proponents argue it offers better risk detection.

Still, linking obesity trends directly to GRAS is more complicated. The policy debate has two layers. One focuses on whether ultra-processed foods and their ingredient profiles make it harder for people to maintain healthy weight and metabolic health. The other asks whether the current safety and transparency system for food additives matches the reality of modern industrial food. Kessler and some advocates argue that changing GRAS could push reformulation and reduce exposure to certain processed refined carbohydrates and additives, while industry groups argue current safety checks are robust and necessary to meet demand and keep costs down.