Responding to the Food and Drug Administration's move to banish trans fats from the nation's diet, some public health advocates grumped Thursday that the agency was playing catch-up to a trend already well underway nationwide. Still, many of the same experts expressed hope that the FDA's move will open the way to a new era in the agency's regulation of food additives.
By setting several new precedents, the FDA's decision on trans fats may bring some of our most beloved ingredients -- salt and sugar -- under new scrutiny by the agency, they predicted.
"Sodium is next," said Dr. Dariush Mozaffarian, a Harvard University epidemiologist and cardiologist at Boston's Brigham and Women's Hospital. In this case, said Mozaffarian, the FDA has acknowledged a scientific consensus on trans fats: that they are hazardous to the public's health. The role of excess dietary sodium in eroding public health has drawn a similar scientific consensus, he added. That should be an equally powerful prod to FDA action, said Mozaffarian.
Tom Neltner, an analyst with the Natural Resources Defense Council in Washington, D.C., said that sugar, too, may become a target in the wake of Thursday's FDA decision. In regulating food additives, the FDA has historically focused on removing chemicals that cause death and acute injury, Neltner said. With Thursday's trans fat decision, the agency showed that it is willing to step in when a food additive contributes to chronic diseases that kill many people slowly.
"I hope this presages a new willingness to regulate with an eye to these chronic illnesses," Neltner said.
Even compared with saturated fat -- a frequent fellow traveler -- trans fatty acid is a bad actor, knocking the blood's lipid levels into dangerous territory on two fronts. Not only does it raise levels of LDL cholesterol, the bad kind. Trans fat consumption depresses levels of HDL cholesterol, which is considered protective against heart disease.
Harvard University public health professor Walter Willett and colleagues estimated in 1994 that consumption of trans fatty acids caused 30,000 Americans to die prematurely of coronary heart disease, and other estimates have soared as high as 100,000 premature deaths per year.
In a more recent update of trans fat's toll, the Centers for Disease Control and Prevention reckoned that eliminating remaining trans fat from American diets would prevent the premature cardiovascular deaths of 7,000 Americans and head off three times as many nonfatal heart attacks.
In an interview Thursday, Willett cautioned that regulating sodium and sugar as additives would hardly be as easy as making a decision to ban trans fats. While trans fats have no nutritional value, salt is an essential nutrient. And sugar, when consumed at reasonable levels, is not harmful, he said. If it is to act on mounting scientific concern about dietary sodium and sugar, the FDA will have to rethink the assumption that an additive it considers as safe "is safe in any amount," Willett said.
The FDA's regulation of food additives has come under growing criticism in recent years, and again on Thursday with the release of a three-year assessment of the FDA's program by the Pew Charitable Trusts.
As the number and variety of substances added to food in the United States has exploded, the agency's resources -- as well as its regulatory powers under the 1958 Food Additives Amendment -- have been overwhelmed, the Pew report concludes.
The FDA has the legal authority to scrutinize any new chemicals before they are added to food and are introduced to the market, and to approve or deny their use. But in 1997, the agency acknowledged it was sitting on an overwhelming backlog of requests, and announced that it would accept voluntary notifications of planned additive use from food manufacturers.
That policy would allow a food company pondering use of a new chemical in its product to make the case that the proposed additive was "generally recognized as safe." Unless the FDA challenged the company's argument, the company would then be free to use the additive as it saw fit.
The review by Pew's experts found that many manufacturers of foods and food additives have bypassed the voluntary notification process altogether. The result, the report estimates: About 1,000 new chemicals have been introduced into the U.S. food supply as additives without any FDA oversight at all.
And it's not often that the FDA kicks a food additive off the list of edibles it calls "generally recognized as safe" (or GRAS) as it did Thursday with trans fats. The agency last did so three years ago, when it warned three makers of alcoholic beverages that it considered caffeine an "unsafe food additive" when mixed with alcohol and ordered their products off the market.