Reasonable certainty of no harm?

The Food and Drug Administration, the agency charged with ensuring that food ingredients are safe, requires that they pose a “reasonable certainty of no harm.”  That standard recognizes that it’s not possible to prove that a chemical will be absolutely safe to every individual in every circumstance.  Instead, the FDA requires a reasonable certainty that a substance won’t harm the vast majority of consumers.

Unfortunately, the FDA has ignored that standard time and time again.  As a result, each year tens of thousands of people unnecessarily get sick or die.

The biggest problem is a category of food ingredients that the law calls “generally recognized as safe,” or GRAS.  When the law went into effect half a century ago, Congress assumed that only substances that were assuredly safe, like vinegar or citric acid, would be considered GRAS, so it didn’t even require companies to inform the FDA that they were introducing such chemicals into the food supply.  Congress mandated that other substances be regulated more tightly as “food additives,” with FDA pre-approval required before they could be used.

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Ironically, the FDA has accepted three of the most harmful ingredients in our food supply as being generally recognized as safe, even though public health officials consider them to be “generally recognized as dangerous” at the high levels consumed: partially hydrogenated oil, salt, and sugar.

Partially hydrogenated oil—used for over a century to make shortenings and margarines—is the source of artificial trans fat.  Trans fat was long thought to be harmless, but beginning in 1990, careful clinical studies demonstrated that trans fat increases the “bad” cholesterol and reduces the “good” cholesterol in blood.  Epidemiology studies then associated trans fat with upwards of 50,000 premature deaths annually. 

Following a decade-long rulemaking, in 2006 the FDA required food labels to list trans fat content.  The labeling, together with massive publicity and several lawsuits, persuaded many manufacturers and restaurants to switch to healthier vegetable oils.  But meanwhile the evidence that trans fat was the most dangerous fat in our food supply became as solid as the Ivory-soap-like shortenings in which it was abundant.  Beginning in 2003, Denmark and several other countries virtually banned partially hydrogenated oils.  But since 2006 the FDA has done nothing.  As a result, Pop Secret popcorn, Long John Silver’s fried foods, Pillsbury refrigerated biscuits and other popular products still contain the nasty fat…and thousands of people are still dying prematurely.

Salt has been a subject of controversy for well over three decades because excess consumption boosts blood pressure and the risk of heart attacks and strokes.  In 1979, the FDA’s own advisory committee said there was insufficient evidence to consider salt to be GRAS.  The FDA’s response was to ask industry to reduce sodium levels.  But in 2010, the Institute of Medicine concluded that 40 years of voluntary “action” achieved nothing and that it was time for the FDA to regulate.  The FDA’s response?  So far it’s only more appeals to industry to voluntarily cut the salt.

Sugar and high-fructose corn syrup are other biggies on the GRAS list.  The average American consumes about 80 pounds of the sweet stuff a year.  Long known to promote tooth decay, recent research has found that refined sugars, at least when consumed in beverages, promote overweight and obesity and possibly heart disease.  FDA’s response?  Don’t even bother asking.

The list of questionable GRAS substances and food additives goes on:  The artificial sweetener aspartame has caused cancer in three animal studies.  Mycoprotein, a fungus-based GRAS ingredient in Quorn-brand imitation meats, causes violent vomiting and anaphylactic reactions, including at least one recent death.  Butylated hydroxyanisole (BHA), according to the Department of Health and Human Services, is “reasonably anticipated to be a human carcinogen.”  Red 3 is a food dye that in 1984 FDA said should be (but wasn’t) banned because it caused thyroid tumors in animals.  The deceptively named “caramel coloring” long used in soft drinks has been contaminated with dangerous levels of a carcinogen. 

The FDA could easily ban unnecessary ingredients like partially hydrogenated vegetable oil, mycoprotein, Red 3, and BHA.  And it could set safe conditions of use—limits, warning labels, or other approaches—on substances like sugar and salt.  But the FDA has done nothing about, or has even defended, each of those unsavory substances.

The FDA is hardly the aggressive public-health watchdog that Americans expect and need.  What’s needed is aggressive oversight by Congress and a wholesale house-cleaning of the FDA’s division of food and color additives.

Jacobson is executive director of the Center for Science in the Public Interest.