Trans fat labeling rule took decades

By Judith Weinraub
The Washington Post

What did you have for breakfast today: A bran muffin? A piece of toast with margarine? A granola bar? A modest bowl of Wheaties?

Maybe none of those seems like a dangerous meal to you. But each of those foods was probably loaded with trans fats — those mostly man-made fatty acids we've recently learned to fear.

As obesity figures continue to rise in this country and the scientific community debates how to update dietary guidelines for Americans, trans fats are a hot topic — the latest culprits in the nation's ongoing battle against coronary heart disease and diabetes.

The issue was given nationwide attention in July, when the Food and Drug Administration ruled that trans fatty acids contribute to those diseases and that food manufacturers had until Jan. 1, 2006, to list the amount of trans fats on each product's nutrition label.

Does it sound like a straightforward decision? Well, it took a long time to get there. It's been 10 years since the dangers of trans fats were put forward to the FDA. Now that agency is allowing the industry another 2½ years to respond to the ruling. As for how long it will take Americans to pay attention to the information, that's hard to judge.

Hidden dangers of trans fats

Trans fats lurk throughout the American diet — in fast foods (especially fried ones), margarines, shortenings such as Crisco, cookies and candies, crackers, doughnuts, breads, potato chips, some cereals, packaged cake and biscuit mixes, many frozen pies and pot pies, anything with partially hydrogenated oil as an ingredient. (They also exist in very small amounts in some dairy foods and beef.)

On a gut level, perhaps without realizing it, many of us expect the government to protect us. And to a certain extent, it does. But government action on scientific findings can take a long time, and often needs prompting and assistance from people both in and out of the government. Even though concerns about trans fats started to worry scientists in the late 1970s, it wasn't until this summer that the government moved forward.

In cases where a food product may be unsafe, the first formal action is usually taken by the FDA, which can issue a ruling.

Before the FDA trans fats ruling, as always, many people had a chance to influence the agency's thinking: Lobbyists on all sides of the issue, the public (which is invited to comment on subjects before the FDA) and, of course, the relevant administration officials. In this case, that meant the commissioner of the FDA, the secretary of Health and Human Services (of which the FDA is a part) and, playing an unexpected role, the administrator of the Office of Management and Budget's information and regulatory affairs, which watches over the impact of federal regulations on the U.S. budget.

The FDA predicted that by providing more information about trans fats to consumers on nutrition labels, the costs of illness and disease for Americans could be cut by as much as $1.8 billion a year in medical fees, lost productivity and pain and suffering.


Before the July ruling, many consumers had never heard of trans fats.

Watchdog group takes note

They were first formally brought to the attention of the FDA by the Center for Science in the Public Interest (CSPI), a nutrition and health advocacy organization also known for its sometimes strident positions on health issues, such as the dangers of too much ice cream or pizza. In October 1993, the CSPI wrote to then-FDA commissioner David Kessler about the results of a study it had conducted analyzing the amount of trans fats in foods (French fries, chicken nuggets) commonly eaten by Americans.

"In the early 1990s, a number of well-designed studies had come out that showed pretty clearly that trans fats raised blood cholesterol and increased the risk of heart disease," says Margo Wootan, the director of nutrition policy for the CSPI. But that information, she says, "wasn't on anybody's radar."

One of the things that particularly worried the CSPI, as well as many scientists in the field, was the discovery that there was often just as much hidden trans fat in many of the products they had tested as there was saturated fat, making those products much more fat-laden than consumers realized.

When the law requiring nutrition labels on food products was adopted in 1993 (it didn't go into effect until 1994), saturated fats had to be acknowledged. Trans fats did not. That fall, the CSPI wrote to the FDA and asked that the amount of trans fat in a product also be required on the nutrition label.

According to Wootan, at that time the FDA told the CSPI that while it was concerned about trans fats' possible link to coronary heart disease, it would have to revisit the subject.

In February 1994, CSPI filed a more detailed petition asking that trans fats be included on the nutrition label and that the FDA set limits for amount of trans fats in foods. It pointed out that products that had no cholesterol or saturated fat and claimed to be lean and heart-healthy often had trans fats, and consumers wouldn't be aware of the danger. "If you added in trans fats, these products weren't low in heart-damaging fats," says Wootan.

At that point, however, although some scientists were alert to the dangers, few public health groups were concerned — not even the American Dietetic Association.

The food industry didn't exactly jump on the bandwagon either.

The CSPI, however, continued to press its case with the FDA as new studies came out. "Over time (the FDA) had technical questions — how (trans fats) should be measured, how good the science was," says Wootan. "They were working their way through it."

In 1996 the CSPI had more products — fast food French fries, chicken and fish dishes from stores and restaurants, margarines, baked goods, crackers, snacks and microwave popcorn — tested for their fatty acid profiles. "It became pretty clear," says Wootan. "There was as much trans fat hidden as there was saturated fat listed on the food label."

Movement gains steam

By this time, the FDA began to express concerns about trans fats. But it wasn't until November 1999 that it issued its original proposal regarding trans fats, which amended the nutrition labeling regulations so that trans fatty acids were included in saturated fat calculations with a footnote indicating the amount of trans fats. It received more than 1,650 letters from industry, trade associations, consumers, consumer advocacy organizations, academia, health care professionals, professional societies, city and state governments, other federal agencies and other countries commenting on the proposal.

(The following year, the U.S. Department of Agriculture's 2000 Dietary Guidelines for Americans, on which the food pyramid is based, mentioned trans fats in the 39-page booklet version of the guidelines — rather than the previous one-page handout. The booklet said foods high in trans fatty acids tend to raise blood cholesterol and identified them as foods high in partially hydrogenated vegetable oils, such as hard margarines and shortenings and some commercially fried foods and bakery goods.)

In 2001, as with any change in presidential administration, a new cast of characters came into play. One of them, John Graham, the new administrator of the Office of Information and Regulatory Affairs at OMB, would become an unlikely agent of change on the trans fats issue. Graham was founding director of the Harvard Center for Risk Analysis at Harvard's School of Public Health. He and his colleagues at the center assessed and compared medical and health measures in terms of their costs, per life saved and per life-year saved or per quality-adjusted life-year saved.

While at Harvard he'd come into contact with scientists and doctors who were concerned about trans fats, in particular Walter Willett, chairman of the department of nutrition at the Harvard School of Public Health, an expert on diet's impact on coronary heart disease.

But Graham was also exposed to the viewpoints of the scientists at the food companies that were supporters of his center, as well as to scientists affiliated with the International Life Sciences Institute (ILSI), which is supported by major food companies. "As of 1995, as I recall, there remained considerable skepticism among some industry scientists about Willett's trans fats theory," Graham says.

Pressing for change

When Graham got to OMB he asked his staff to provide him with "promising examples of pro-health regulations that had never been adopted." One idea was the completion of the FDA's trans fat labeling regulation. Graham's staff, in particular John Morrall, an economist and longtime health and safety expert, told him that adopting it could save thousands of lives each year at modest cost to the food industry and consumers.

To learn more about the science linking trans fats and heart disease, Graham and his staff then contacted both Willett and the scientists at ILSI. Willett told them what they expected to hear, given his years of research. And the ILSI scientists told them they had funded a series of experiments to test the trans fats theory, largely because they hadn't been persuaded by Willett. "The results of this ILSI-supported work actually confirmed important aspects of Willett's trans fats theory," Graham recalls.

Graham became convinced.

In September 2001, a delegation from the CSPI visited Graham to discuss the trans fats rule and their frustration at trying to persuade the FDA (which at that point was without a commissioner) to allow trans fats information on nutritional labels.

That same month, Graham initiated a series of "prompt letters" — devices indicating administration priorities. The very first one, urged a quick finalization of proposed rules for trans fats labeling. Using the FDA's own estimates, Graham noted that a change in labeling that warned consumers about trans fats would prevent from 7,600 to 17,100 cases of coronary heart disease and avert 2,500 to 5,600 deaths per year within 10 years after the rule became effective. And the United States would save billions in health costs. In other words, trans fats labeling could be one of the most cost-effective things the government could do in terms of health.

A rule 10 years in the making

In November 2002, Mark McClellan became commissioner of the FDA. By the time he became commissioner, the trans fats issue had been a priority for some time. The language of the proposed trans fat regulation had been updated twice (based on further scientific findings), and the comment period had been reopened each time. His senior professional staff was on board, too. Graham's letter had made clear OMB's concern with the health implications of trans fats. And the science regarding the issue was more secure.

Almost a decade after the trans fats issue was brought to the FDA, it was time to move forward.

"This one is a case where everything was lined up," McClellan says. "We were helped along not only by solid science but also solid administration support — the president, (Health and Human Services) Secretary (Tommy) Thompson, OMB, as well as the agency."

Willett, among those who pushed the concerns along, is philosophical about how long the whole process has taken.

"Sometimes the scientific weight of opinion shifts slowly.

The evidence was clear six or seven years ago, including a big study by the USDA. But everybody had to do (his) own study to believe it," he says.

How the food industry and the public will respond is another story.