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FDA label rule lacks scientific basis
January 25, 2000 BY STEVEN J. MILLOY SPECIAL TO THE SUN-TIMES
Federal agencies are notorious for their "ready-fire-aim" regulations:
* The Occupational Safety and Health Administration backtracked amid enormous public pressure on regulating home offices for workers who telecommute.
* The Environmental Protection Agency is being pilloried for promoting the gasoline additive MTBE, contaminating groundwater across the country.
* And most recently, the Food and Drug Administration, following up its fiascos involving silicone breast implants and the fen-phen diet pills, is preparing to scare consumers about crackers--really.
Crackers, margarine, cookies, cereals and many other foods contain "trans fatty acids," called "partially hydrogenated vegetable oils" on ingredient labels. Trans fats keep margarine stiff at room temperature and extend the shelf life and flavor of foods.
The FDA recently proposed to require information on trans fats be included on Nutrition Facts labels. The FDA says labeling will cost food processors--including Illinois-based Kraft Foods, ConAgra and Quaker Oats--about $900 million to implement. But the FDA estimates the labels will produce up to $59 billion in benefits by preventing up to 17,100 cases of coronary heart disease and 5,600 deaths annually.
Sounds like a bargain? Labeling seems harmless enough: who could oppose knowing what's in their food?
Likewise, businesses and consumers should know about the junk science going into regulations they pay for and live with.
The FDA based its proposal on studies statistically associating consumption of trans fats with increased blood LDL-cholesterol--so-called "bad" cholesterol--which, in turn, is statistically associated with increased coronary heart disease.
But the FDA admits not knowing whether trans fats actually increase bad cholesterol. The studies the FDA relies on replaced dietary fatty acids, which also affect cholesterol levels, with trans fats. Worse, the reported effect of trans fats was artificially magnified in some studies because it was compared to that of olive oil, known to reduce cholesterol levels.
Most important, there are no epidemiologic studies--those involving human populations--credibly linking trans fats with increased coronary heart disease.
The FDA acknowledges existing studies are flawed because of imprecise data collection, difficulty in eliminating the effects of other heart disease risk factors and because higher consumption of trans fats is not associated with more coronary heart disease. These flaws are typically fatal to the validity of epidemiologic studies.
But the FDA says, "despite these . . . deficiencies . . . the repeated and consistent findings . . . suggest that consumption of trans fatty acids is associated with adverse effects on [coronary heart disease] risk in humans."
What the FDA omits is the reason there are "repeated and consistent findings" in these studies. There is essentially one activist-researcher behind them, Harvard University's Walter Willett.
Willett operates with the notorious Center for Science in the Public Interest, an activist group doing its best to scare Americans about food. CSPI calls fettuccine Alfredo "heart attack on a plate," and tried to demonize movie popcorn and Chinese food. CSPI pushed for trans fat labeling, filing a petition with the FDA in 1994.
Willett recently editorialized in the New England Journal of Medicine that epidemiologic studies indicate trans fats have an adverse effect on the risk of coronary heart disease. Of the six studies he cites, four reported trans fats increase heart disease risk.
But guess what? Willett co-authored all four studies! Reliance only on Willett's research contravenes the scientific method, the standard process guiding scientific research that calls for independent replication of scientific findings.
My favorite Willett study is a 1997 study of 90,000 women that reports a statistical association between trans fats and coronary heart disease. But it reports no association between intake of saturated fat, total dietary fat or cholesterol and heart disease. The results contradict what the public health establishment has been telling us for the last 25 years about the dangers of fat.
Either Willett's study or conventional wisdom is wrong. If Willett's study is bad, the trans fat result should be doubted. If Willett's study is sound, and the public health bureaucracy has been so wrong for so long, why should we now believe the worst about trans fats?
Ultimately, the problem is not Walter Willett. It's the FDA. Despite the FDA's admission the science isn't adequate to support a $900 million regulation and accompanying food scare, it has decided, "Damn the scientific torpedos, full regulatory speed ahead."
* Steven J. Milloy is a biostatistcian and lawyer. He publishes Junkscience.com and is an adjunct scholar at the Cato Institute in Washington D.C.
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