FDA Suggests Labeling Changes to Attack the Obesity Issue

Date: Apr 01, 2004

The tobacco industry just got some good news: The Food and Drug Administration (FDA) may soon no longer consider tobacco to be the leading preventable cause of death in the U.S.; instead, that honor may go to obesity.

It is pretty obvious that America has a weight problem. With the recent release of FDA's Obesity Working Group (OWG) report and recommendations, that diagnosis has now become official, and the government has decided to do something about it. Mostly, what the government intends to do is to encourage modifications to nutrition fact panels and other parts of food labels to help inform and educate Americans on the caloric intake associated with the foods they eat. However, the agency may also take some other steps as well, including enforcement actions both for inaccurate labeling for food products and false or misleading claims for dietary supplements.

First, The Facts

The Center for Disease Control and Prevention (CDC), a sister agency of FDA in the Department of Health and Human Services, recently estimated that 64% of all Americans are overweight, including more than 30% who are considered obese. About 15% of children and adolescents, aged 6 to 19, are overweight; this is almost double the rate of two decades ago.

According to both CDC and FDA, this increase in weight is taking its toll on American health. Overweight and obesity increase the risk for coronary heart disease, type II diabetes and certain cancers. FDA's work group also cites some estimates which indicate that at least 400,000 deaths each year may be attributed to health problems related to obesity. The costs are also quite staggering, estimated at about $117 billion per year, including more than $50 billion in avoidable medical costs.

Often missing in the equation, however, are the people who deserve the most blame, that is, the "victims" themselves who can't seem to push away from the table.

FDA recognizes that "the problem of obesity has no single cause," and that there will be no single solution. According to the Agency, obesity will be brought under control through numerous coordinated, complementary efforts from a variety of sectors of society.

That being said, the OWG recommendations are centered on the "scientific fact that weight control is primarily a function of caloric balance" and focus on "calorie counting." Thus, FDA intends to encourage food manufacturers and restaurateurs to give consumers the information that they need to maintain a healthy diet.

Second, The Advice

In its report, FDA has several recommendations on how this can be done:

  • FDA is seeking significant modifications to the nutrition fact panel on most food products. The Agency intends to initiate rulemaking on how to give more prominence to calories on food labels. Further, FDA wants manufacturers to start labeling food products as a single serving if the entire content of the package can reasonably be consumed in a single eating occasion. For example, a 20 ounce bottle of soda currently lists 110 calories per serving and 21/2 servings per bottle (see illustration). FDA says this serving size should be changed.
  • FDA also is considering authorizing health claims for food products that meet FDA's definition of "reduced" or "low" calorie food. Such a health claim for reduced or low calorie food might be: "Diets low in calories may reduce the risk of obesity, which is associated with Type II diabetes, heart disease, and certain cancers."
  • The Agency is considering a proposal that will provide for nutrient content claims related to the carbohydrate contents of foods, including guidance for use of the term "net" carbohydrates.
  • FDA is encouraging food companies to use comparative labeling and dietary guidance statements that would help consumers make healthy substitutions and pay attention to caloric balance. An example of the former would be, "Instead of cherry pie, try our delicious low fat cherry yogurt." An example of the latter, " To manage your weight, balance the calories you eat with your physical activity."
  • If this encouragement doesn't work, it appears that FDA will ratchet up the stakes by bringing enforcement actions for what it considers to be inaccurate or misleading labels, especially regarding serving sizes.
  • And, never wishing to leave its animus against the dietary supplement industry far behind, the Agency will continue to work with the Federal Trade Commission to target dietary supplement products that make false or misleading weight loss claims. FDA is even exploring the concept of third party certification of weight loss diet plans and related products.

In a crude paraphrase of the words of William Shakespeare, the problem lies not so much in our food, but in the amount of it that we eat - and no amount of laying blame, or filing lawsuits, is going to resolve that problem. FDA hopes that the steps it outlines in this report will provide the basic framework for changing the way that Americans think about diet and weight.

Changes to the Nutrition Facts box will focus on calories, serving size and "net" carbohydrate content.

Used with permission. Copyright FOOD & DRUG PACKAGING, May, 2004.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.