99% of New Food Chemicals Added to the U.S. Food Supply Since 2000 Have Never Been FDA Reviewed, Analysis Finds

Nearly every new chemical added to American food over the past two decades has entered the market without any federal safety review. According to a 2022 analysis by the Environmental Working Group, 99 percent of new food chemicals introduced since 2000 were never evaluated by the FDA, cleared instead through a regulatory exemption that allows companies to self-certify their ingredients as safe.

That exemption is called GRAS, short for “generally recognized as safe,” and it dates back to a 1958 act of Congress. Under the rule, if a company determines its ingredient is broadly accepted as safe among qualified experts, it can bypass the FDA’s standard premarket approval process entirely. Health and Human Services Secretary Robert F. Kennedy Jr. told 60 Minutes the loophole has since been used to add “thousands upon thousands of new ingredients” into the food supply without government oversight.

Ultraprocessed foods, items engineered from refined starches, added sugars, synthetic additives, and industrial flavor compounds, now account for roughly 50 percent of daily caloric intake among American adults and approximately 60 percent of what children eat, according to CBS News’ 60 Minutes. Kennedy and former FDA Commissioner Dr. David Kessler each said the GRAS exemption enabled that shift by allowing ingredients to reach consumers without any federal safety evaluation.

A Nearly 70-Year-Old Loophole Is Shielding Thousands of Food Ingredients From Federal Review

According to Kennedy, speaking on 60 Minutes, the FDA itself cannot confirm how many ingredients are currently in American food, with estimates ranging between 4,000 and 10,000. The generally recognized as safe loophole “was hijacked by the industry,” he said, allowing companies to add ingredients without scrutiny. In Europe, he noted, there are only 400 legal ingredients permitted in the food supply.

Common GRAS-classified substances found in U.S. products include sodium benzoate, a preservative used in soft drinks; aspartame, a low-calorie sweetener; titanium dioxide, a whitening agent; and a range of corn-derived sweeteners such as maltodextrin, dextrose, and high-fructose corn syrup, according to Newsweek. Several states have taken independent action, pursuing bans on additives including aspartame, cottonseed oil, and grapeseed oil that remain on the FDA’s approved list.

Dr. David Kessler, who served as FDA Commissioner from 1990 to 1997 under Presidents George H.W. Bush and Bill Clinton, filed a formal petition with the FDA in the summer of 2025 requesting that the agency revoke GRAS status for dozens of processed refined carbohydrates, unless manufacturers can prove those ingredients are safe and not fueling obesity. Kessler, a pediatrician, zeroed in on the issue after reading ingredient labels on packaged foods, citing corn syrup, maltodextrin, dextrose, xylose, and high-fructose corn syrup as examples during his 60 Minutes interview.

“Our Biology Was Never Intended to Handle” What’s Now in the Food Supply

“Over the last 40 years, the United States has been exposed to something that our biology was never intended to handle,” Kessler told correspondent Bill Whitaker on 60 Minutes, citing ultraprocessed foods as a driver behind rising rates of type 2 diabetes, pre-diabetes, hypertension, abnormal lipids, fatty liver disease, heart attacks, stroke, and heart failure. He called it “the greatest increase in chronic disease in our history.”

Kessler compared the ultraprocessed food crisis to his earlier work exposing the tobacco industry, when he helped bring tobacco executives before Congress over allegations they had manipulated nicotine levels to hook consumers. When asked whether the two public health emergencies were comparable, he said it was “as large, if not larger,” noting that while not everyone smoked, virtually every American consumes these foods. Last December, San Francisco City Attorney David Chiu filed a landmark lawsuit against 10 food manufacturers, alleging they knowingly engineered and marketed addictive products while hiding the risks.

A 2024 review in the British Medical Journal linked heavy consumption of ultraprocessed foods to an elevated risk across 32 distinct harmful health outcomes, according to Newsweek. More than 70 percent of American adults are overweight or obese, and nearly one in three adolescents between the ages of 12 and 17 has prediabetes, according to Newsweek, which cited federal data from new HHS dietary guidelines.

Kennedy Plans to Close the GRAS Loophole, but Kessler Wants to Go Further

Kennedy told 60 Minutes, “We will act on David Kessler’s petition,” adding that the questions Kessler raises are ones the FDA “should’ve been asking a long, long time ago.” Kennedy said he plans to use what he described as “gold standard science” to review GRAS ingredients, though CBS News reported his credibility on that score has been widely called into question because of his history of vaccine skepticism.

Food author Michael Pollan, speaking with 60 Minutes, connected federal farm subsidies directly to the rise of ultraprocessed foods. The Farm Bill, he argued, primarily supports commodity corn and soybean farming, crops that in their industrial form serve as raw ingredients for processed foods rather than direct human consumption. “We are supporting both sides in the war on type 2 diabetes,” Pollan said, noting the government subsidizes high-fructose corn syrup production through farm policy while simultaneously bearing the healthcare costs tied to it.

The Consumer Brands Association, a major food industry trade group, told 60 Minutes there is no “agreed upon scientific definition of ultraprocessed foods” and that member companies follow the FDA’s science-based safety standards. Whether federal action ultimately follows remains an open question; Kennedy has not yet issued a formal response to Kessler’s petition, and no timeline has been confirmed, according to Newsweek. In his 60 Minutes interview, Kessler framed the broader goal this way: “We changed how this country views tobacco. We need to change how this country views these ultraprocessed foods.”