Regulatory Impact of 2005 Dietary Guidelines

The guidelines certainly provide some additional momentum toward revisions in the Nutrition Facts box.

By David Joy, Contributing Editor

The federal government recently issued its most current dietary advice, the 2005 Dietary Guidelines for Americans. The National Nutrition Monitoring and Related Research Act of 1990 requires USDA and the Dept. of Health and Human Services to publish these guidelines at least every five years.

The primary purpose of the guidelines is to influence the way Americans eat. The 2005 edition also seeks to influence the way we exercise. Many have rightly questioned whether Americans are likely to follow these new recommendations. For example, many adults do not get close to 60 or 90 minutes of exercise per day, and the closest many adults get to three glasses of milk per day is the dairy product or dairy analog added to our coffee.

Apart from the question of influencing our eating habits - or not - it’s worth asking what impact the guidelines have on federal regulatory policy. Will the new recommendations affect FDA’s food labeling regulations?

FDA has already been considering changes in the Nutrition Facts box required on food labels. The agency intends to publish an advance notice of proposed rulemaking in 2005 to solicit comments on:
* Giving more prominence to the calorie content by, for example, increasing the font size or including a percent daily value.

* Requiring packaged foods that can reasonably be consumed at one time to be treated as a single serving in the Nutrition Facts box.
* Updating the established serving sizes generally.
* Updating daily values (for example, the expected amounts of total fat, saturated fat, carbohydrates, etc., based on a 2000-calorie diet).

These possible changes are generally geared toward combating obesity, which is a major focus of the 2005 guidelines. The guidelines certainly provide some additional momentum toward these kinds of revisions in the Nutrition Facts box.

One subject addressed briefly in the guidelines is the manner in which sugars are reported in the Nutrition Facts box. Currently, there is a declaration for total sugars, but there are not separate listings for added sugars and naturally occurring sugars. Some argue that consumers should limit their consumption of foods containing added sugars for the purpose of limiting total calorie intake; and a separate line for added sugars in the Nutrition Facts box would encourage this. Perhaps more sensibly, consumers should be expected to check the ingredient declaration for added sugars if they are interested in this information, and it is not necessary to communicate the presence of added sugars in two different ways on food labels.

The guidelines normally might be considered a resource for food manufacturers interested in making health claims under the notification procedure established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). Under FDAMA, authoritative statements made by federal scientific bodies can be the basis for a health claim on a food label. Unfortunately, however, the guidelines specify that only statements included in the “executive summary” and the portions headed “key recommendations” can be used for identification of authoritative statements supporting health claims.

The rationale behind this limitation is that statements found elsewhere in the guidelines may not be supported by a preponderance of scientific evidence. Other portions of the guidelines seem at times to be very carefully worded to emphasize this point, as in “limited evidence suggests an association between consumption of fatty acids in fish and reduced risk of mortality from cardiovascular disease.”

The guidelines are not nearly so circumspect when it comes to statements about nutrients to avoid, such as saturated fat, trans fat, cholesterol and added sugar.

The new recommendations often are criticized as being too influenced by the food industry and for not going far enough to discourage consumption of less nutritious foods. It is difficult to take this criticism seriously, considering that the Center for Science in the Public Interest has praised the guidelines and considering that the guidelines seek to circumvent FDAMA’s provision for health claims based on authoritative statements. Furthermore, the guidelines cannot be realistically expected to bring about a radical change in American eating habits. A nudge in the right direction seems to be what these rules are sensibly aiming for.

In terms of direct regulatory impact, the guidelines will not bring about significant changes. What the food industry does from a marketing standpoint is a separate question. Many manufacturers are already working on new recipes that can be promoted as containing whole grains and other ingredients that receive favorable treatment in the guidelines.

David Joy is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. He specializes in food and drug law, is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's website at

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