FDA Is Not Protecting Consumers From Unsafe Food Additives

The bottom line is that FDA officials just don't act as if they are the protectors of health that the public expects them to be. Instead, time and time again, they have shoved problems under the carpet, perhaps hoping the problems will be forgotten or solved through voluntary action.
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It was in 1970, the year after Richard Nixon became president, that I came to Washington to be a new Nader's Raider. On my first day at work, Ralph Nader asked me to research and write a book about food additives. I had no idea what food additives were, let alone how to write a book, but I dove in.

It didn't take me long to see why some people considered the three letters F-D-A to stand not only for Food and Drug Administration, but also for Foot Dragging Artists. For the next four decades I've seen countless examples of failure to act, which have resulted in countless illnesses and deaths.

One glaring example of FDA's plodding pace concerned sulfites, which had long been used as preservatives in wine, raisins, and other foods and were thought to be safe. In 1982 the FDA proposed that sulfites formally be declared "generally recognized as safe," or GRAS, a legal category of substances added to food, even though several years before California researchers found that sulfites could trigger asthma attacks. The problem arose because restaurants had begun soaking iceberg lettuce and peeled, raw potatoes in a sulfite solution. The sulfites prevented browning but resulted in high levels in the foods.

The Center for Science in the Public Interest (CSPI) publicized the sulfite problem and then, even in those pre-Internet days, heard from many people who suffered asthma attacks after eating a restaurant salad or drinking a glass of wine. Then we heard from more than a dozen people whose family members died after eating sulfite-laced foods. That made me realize that sulfites had probably caused hundreds or thousands of deaths.

With people dying, CSPI petitioned FDA to ban sulfites, but the agency did nothing. 60 Minutes ran, and then re-ran, a story, but still the FDA did nothing. It took a 1985 congressional hearing led by Rep. John Dingell to move the FDA. The parents of a young girl told the committee how she died minutes after eating a salad with sulfite-treated ingredients. FDA commissioner Frank Young then acknowledged that the agency published its GRAS proposal without updating its literature review. But it took five years, and who knows how many unnecessary deaths, before the FDA finally banned sulfites from fresh vegetables and limited the amounts permitted in other foods.

Numerous more recent examples demonstrate that the FDA still needs a major transfusion of spine stiffener to take on the food industry and protect consumers:

  • Until 1990, artificial trans fat, which forms when partially hydrogenated vegetable oil is manufactured, was generally thought to be innocuous. But then researchers did a study that showed that trans fat promoted heart disease by raising "bad" LDL cholesterol. In 1993 CSPI called on the FDA to require trans fat to be listed on the new Nutrition Facts labels. It took the FDA 13 years to do that. Meanwhile, new research showed that trans fat was the single most harmful fat in our diet.

Walter Willett, chairman of the nutrition department at the Harvard School of Public Health, estimated that trans fat was causing tens of thousands of fatal heart attacks annually. So in 2004, CSPI petitioned the FDA to ban partially hydrogenated oil, which is still officially GRAS. Eight years later, the FDA still has not done so, and some foods -- like Marie Callender's Lattice Apple Pie, Pillsbury Grands! Buttermilk Biscuits, Pop Secret popcorn, and White Castle Chocolate Frosted Donuts -- still contain copious amounts of the deadly fat. (Denmark, Austria, Switzerland, and Iceland have all essentially banned the use of partially hydrogenated oil.)

  • In the 1990s, FDA scientists developed new analytical methods that found worrisome amounts of the carcinogen benzidine in Yellow 5 and Yellow 6 food dyes. The FDA's response to its own discovery of a carcinogen in the second and third most-widely-used dyes? It hasn't done any tests since, let alone warn the public, ban the dyes, or restrict benzidine to safe levels. The FDA also is ignoring the fact that synthetic dyes can trigger hyperactivity and other behavior problems in susceptible children. In contrast, the European Union passed a law requiring warning labels on the few remaining foods that still contain some of the most questionable dyes.
  • The most harmful ingredient in our diet is, surprisingly, salt. Salt and other sodium-containing additives have been known for more than half a century to boost blood pressure and the risk of dying from a heart attack or stroke. In 1979, FDA's own advisory committee said that salt should no longer be considered GRAS, but the FDA has done almost nothing, and Americans' consumption of sodium actually has increased. In 2004 Steve Havas, then of the University of Maryland School of Medicine, Claude Lenfant, then director of the National Heart, Lung, and Blood Institute, and another NHLBI employee estimated that cutting sodium consumption in half would save 150,000 lives a year. In 2010 the authoritative Institute of Medicine concluded that for more than 40 years industry had ignored calls to reduce sodium levels and that the FDA should set gradually-declining limits. The FDA has been studying the matter for the past two years while foods are still awash with salt -- and people are dying unnecessarily due to high blood pressure.
  • Far less harmful than salt, but a cause of great misery, is mycoprotein, the euphemism for the processed mold used to make Quorn-brand meat substitutes. However, Quorn products can cause horrible gastrointestinal problems (including vomiting so severe that blood vessels in the throat and eyes burst), hives, and life-threatening anaphylactic reactions. Such ingredients obviously do not have a "reasonable certainty of no harm," the FDA's safety standard, and do not belong in the food supply. The FDA has ignored CSPI's call for a ban of this dangerous ingredient, while the complaints (now more than 1,800) pile up.
  • Last March the FDA actually defended the presence of a cancer-causing contaminant (4-methylimidazole) in the caramel coloring used in Coke, Pepsi, and other soft drinks. In stark contrast, the state of California adopted a regulation requiring colas to sport a cancer-warning notice unless their levels of 4-MI were under 30 micrograms (most brands had about five times as much). After failing to fend off the requirement, companies quickly began marketing colas made with less-contaminated caramel colorings. But only in California.
  • The bottom line is that FDA officials just don't act as if they are the protectors of health that the public expects them to be. Instead, time and time again, they have shoved problems under the carpet, perhaps hoping the problems will be forgotten or solved through voluntary action.

    The FDA appears to suffer from two problems. First, its own staff requires virtually absolute proof -- as in dead bodies with toe tags identifying the chemical cause of death -- that a substance is deadly before it dares reverse a previous approval. Second, agency officials fear that companies would run to their friends in Congress to stop the agency from acting. And with the current pro-business House of Representatives, that is not an idle concern. But whatever the underlying cause, the public expects -- and deserves -- greater protection from the agency that was established to keep harmful substances out of their daily diet.

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