The joke’s on us: FDA fails to police food additives

Since 1958, the U.S. Food and Drug Administration has considered the ingredients that companies add to food as either approved “food additives” or substances considered “generally recognized as safe” — GRAS in agency parlance — under the conditions of their intended use. 

GRAS ingredients were envisioned to be substances that everyone knew were safe, like vinegar, baking powder, and spices, while food additives were more suspicious substances that could only be used after a careful review by the FDA.


In 1997, the FDA provisionally relaxed the review process for GRAS ingredients. Since then, companies have largely bypassed government scrutiny by determining on their own that almost all new chemicals used in food were GRAS. Sometimes companies never even told the FDA what they were adding to the food supply and in what quantity, prompting former FDA commissioner David Kessler to call the agency’s scheme a “joke.”

Ironically, the three most dangerous ingredients — considering their effects on the body and the amounts used in the food supply — have all been considered GRAS:

  • Salt has been known for half a century to increase blood pressure, which increases the risks of heart attacks and strokes.  Americans are consuming about twice as much sodium (including from ingredients other than salt) as we should, and that is causing as many as 100,000 deaths a year. (Our organization, the Center for Science in the Public Interest (CSPI), has urged FDA since 1978 to revoke the GRAS status of salt and set limits on the amounts in various categories of food.  Last month the FDA proposed voluntary sodium-reduction targets.) 
  • Sugar is perfectly fine in small amounts. But the average person consumes 20 or so teaspoons per day, an amount that promotes tooth decay, weight gain and obesity, diabetes, and heart disease — and roughly 25,000 premature deaths per year. 
  • Partially hydrogenated oil — the basic ingredient used in Crisco for a century and most margarines for half a century — is the major source of artificial trans fat. About 25 years ago that type of fat was found to boost the “bad” cholesterol and lower the “good” cholesterol in our blood, thereby promoting heart disease. Harvard epidemiologists estimated that trans fat was causing upwards of 50,000 deaths per year. (CSPI called on FDA in 2004 to ban the discredited oil, which the FDA did in 2015.)

That was roughly 175,000 premature deaths per year from substances that the FDA considered safe! Some other GRAS substances don’t cause anywhere near that level of harm, but are problematic. One is mycoprotein, the processed fungus that serves as the basis of Quorn-brand meat substitutes. The ingredient is a potent allergen, causing a sizable percentage of consumers to suffer severe diarrhea, vomiting, and anaphylactic reactions, with apparent occasional deaths. 

Before those deaths occurred, senior FDA officials told CSPI that it agreed that mycoprotein caused severe symptoms, but that the agency still considered the ingredient to be generally recognized as safe because it didn’t cause “permanent, life-threatening harm.” So much for tough oversight by America’s food-safety watchdog.

The Natural Resources Defense Council estimates that companies have declared perhaps a thousand chemicals to be GRAS without informing the FDA — meaning there’s no way for consumers to know whether the foods they buy contain ingredients that only the food or chemical manufacturers themselves have determined were “safe.” The additives may well be harmless. But it means we’re eating ingredients that have never been vetted by independent experts.

While we believe that the FDA could correct the GRAS problems on its own, it clearly has not. Hence, Congress needs to do some major statutory surgery to ensure that all of the chemicals being pumped into our heavily processed food supply are safe.

Congress should require companies to submit for FDA review all their toxicology data regarding un-vetted GRAS substances and estimates of how much of these chemicals they are using. Those submissions need to be made public so that independent scientists can review and comment on the research. Congress also should order the FDA to periodically review the safety of all types of food additives and give the agency the authority to quickly get dangerous ones off the market. 

Americans rely on the FDA to keep foods safe. We should not have to depend on self-interested, back-room industry determinations to protect us from the partially hydrogenated oils or mycoproteins of the future.

Jessica Almy is deputy director of nutrition policy, and Michael F. Jacobson is executive director of the Center for Science in the Public Interest.