A Look Back
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“The line from industry used to be: ‘Nutrition won’t sell food. It’s price, taste and convenience,’” [Ed Scarbrough] said.34 “By the time we got into the 1980s, nutrition clearly was selling products. Industry recognized this and started making claims about the food.”
That was both good and bad, Scarbrough said. On the one hand, it gave consumers more information about nutrition. But on the other, claims got pushed to their outer limits as manufacturers scrambled to gain a competitive edge for their products.
“Consumers reacted to that,” he said. “They couldn’t believe many of the claims being made.”
At about the same time, the Surgeon General of the U.S. Public Health Service and the National Academy of Sciences’ National Research Council released two reports that lent strong support to development of a new food label. These reports—the 1988 Surgeon General’s Report on Nutrition and Health, and the 1989 National Research Council’s Diet and Health: Implications for Reducing Chronic Disease Risk—concluded that evidence substantiates an association between diet and risk of chronic disease and recommended similar dietary changes.
Those recommendations reflected what many public health experts had been saying for years: for example, that Americans should reduce their intake of fat (especially saturated fat), cholesterol, and sodium; maintain appropriate body weight; and consume adequate amounts of calcium and fiber….
It soon became apparent, however, that the [old] food label did not offer enough information to help consumers follow those guidelines. That, coupled with often questionable marketing practices, led to the first serious effort to revamp the food label….
According to John Vanderveen, Ph.D., director of FDA’s Office of Plant and Dairy Foods and Beverages, the law makes the United States the first country in the world to have mandatory nutrition labeling and to allow health claims on food labels. “We’ve been pioneers,” he said….
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Economic Impact
It is estimated that the new food label will cost FDA‐regulated food processors between $1.4 billion and $2.3 billion over the next 20 years. However, the benefits to public health—measured in monetary terms—are estimated to well exceed the costs. Potential benefits include decreased rates of coronary heart disease, cancer, osteoporosis, obesity, high blood pressure, and allergic reactions to food.
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4.4 TRANS FATS
4.4.1 Background on Trans Fat
Findings from human feeding studies and epidemiological studies show a positive association between the intake of trans fatty acids and the incidence of coronary heart disease. Walter Willett, professor of epidemiology at Harvard School of Public Health, in 1997 estimated that the use of hydrogenated oils was resulting in 30,000 heart disease deaths per year, representing “the biggest food processing disaster in U.S. history.”35
Most trans fatty acids are created in the hydrogenation of vegetable oil. Hydrogenation is the forcing of hydrogen atoms into the double bonds of unsaturated oil. This saturation of the oil is accomplished with high pressure, heat, and catalysts. Unfortunately, partially hydrogenated fats, along with trans fat, could be found in “everything you love to eat: margarine, commercial cakes and cookies, doughnuts, potato chips, crackers, popcorn, nondairy creamers, whipped toppings, gravy mixes, cake mixes, frozen French fries and pizzas, fish sticks and virtually all fried foods, unless you fry them yourself in un‐hydrogenated oils.”36
4.4.2 Petition to Ban Hydrogenated Oil
“In 2003, the National Academies’ Institute of Medicine concluded that the only safe level of trans fat in the diet is zero, and in 2004 an FDA advisory panel concluded [that] trans fat is even more harmful than saturated fat.”37 For this reason, the Center for Science in the Public Interest (CSPI) in 2004 proposed revoking GRAS status for hydrogenated oil that contains trans fatty acids.38 “Unlike fats that occur in nature, partially hydrogenated vegetable oil is totally artificial and absolutely unnecessary in the food supply,” said CSPI’s Michael Jacobson. “Food‐processing companies should worry less about the shelf life of their products and more about the shelf life of their customers. Getting rid of partially hydrogenated vegetable oil is probably the single easiest, fastest, cheapest way to save tens of thousands of lives each year.”39
The National Food Processors Association called the petition the wrong way to address the issue because “Nutrition experts—including FDA—have called for consumers to choose diets low in trans fats, not to eliminate them. Nutrition experts also have cautioned consumers, in their efforts to reduce trans fat intake, against making dietary choices that lead to a nutritionally inadequate diet or that have other unintended effects, such as replacing trans fats in their diets with saturated fats.”40
4.4.3 The Trans Fat Labeling Rule
Rather than ban trans fat in 2003, FDA took a more moderate approach. FDA promulgated a rule to require the labeling trans fat in packaged foods.41 The FDA final rule requires that the amount of trans fat in a serving be listed on a separate line under saturated fat on the Nutrition Facts panel. However, trans fat does not have to be listed if the total fat in a food is less than 1/2 gram per serving and provided that no claims are made about fat, fatty acids, or cholesterol content.
4.4.4 Partially Hydrogenated Oil De‐GRASed
However, evidence mounted on the harm of trans fat from partially hydrogenated oils (PHOs). Finally, in 2015, the FDA issued a final determination that PHOs are no longer generally recognized as safe (GRAS) for any use in human food. This determination centers on the industrially produced trans fatty acids found in PHOs. This determination was based on the available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat and also responds to the citizen petitions.42 PHOs are no longer recognized as safe under any condition of use in human food.43
4.5 NLEA AND RESTAURANTS
The Nutrition Labeling and Education Act of 1990 (NLEA) generally exempt restaurants from the NLEA Nutrition Facts labeling requirements, but the Act did not exempt restaurants from the NLEA requirements when a nutrient content claim or health claim was made for menu food. Nonetheless, the FDA decided to exempt restaurant menus from all NLEA nutrition and health claim requirements. In part, the FDA invoked the doctrine of administrative necessity and argued that the agency lacked the resources to enforce NLEA in restaurants. In the following case, the court rejected FDA’s reasoning and found that FDA must abide by the unambiguous meaning of the statute.
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