May 19, 2014

Food Labeling: Revision of the Nutrition and Supplement Facts Labels

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Pursuant to the Nutrition Labeling and Education Act (NLEA) of 19901 and the Dietary Supplement Health and Education Act (DSHEA) of 1994,2 the Food and Drug Administration (FDA) issued regulations requiring food and dietary supplement products to display labels declaring their nutrient content. The regulations specified the format for nutrition labeling as well as the reference values to use in declaring the nutrient content.

The FDA now proposes to revise its food labeling regulations in order to improve the nutrition label’s accuracy and usability.3 In particular, the proposed Food Labeling rule aims to do the following:

  1. Update the nutrition label content based on the latest scientific evidence on health and nutrition captured in the Institute of Medicine (IOM) reports and Dietary Guidelines for Americans (DGA).
  2. Update the nutrition label design to improve its use and readability.
  3. Prompt manufacturers to reduce added sugars or to reformulate their products in order to maintain health claims under the updated Daily Value (DV) amounts.

The FDA makes an important effort to update its nutrition label content to reflect the best available science. The proposed rule will provide the public with more accurate nutritional information and will help consumers make healthier food choices and ultimately improve their health. With this rule, the FDA follows the principle set out in Executive Order 13563, which requires each agency to “ensure the objectivity of any scientific and technological information and processes used to support the agency’s regulatory actions.” 4

Unfortunately, the FDA fails to apply this principle consistently. While the FDA makes a strong case that updating DV amounts would help consumers ensure adequate intake of vital nutrients, the agency provides little evidence that the proposed additional mandatory declarations and label format changes will result in consumers making healthier choices. On the contrary, the study commissioned by the FDA shows that a major proposed label change to increase the prominence and font size of calorie information has little impact on consumers’ choices. The FDA failed to test the effectiveness of other proposed label changes as well.

In addition, the FDA uses flawed assumptions to derive the rule’s benefit estimates and bases its calculations on a single unpublished study, casting doubt on its estimates’ validity. Even taking its flawed benefit estimates at face value, the FDA fails to maximize net benefits. The FDA opts for a two-year compliance period, even though the four-year compliance period offers higher net benefits and a fourfold reduction in regulatory burdens, which would translate into lower food prices for consumers.

Before issuing the final regulation, the FDA should take the following steps:

  1. Obtain empirical evidence about whether its proposed label changes will have the expected beneficial health impact.
  2. Reexamine its benefit estimates using peer-reviewed studies. In estimating benefits, the FDA should rely on the empirical studies clearly demonstrating the health impacts of proposed label changes. It should not simply assume that the proposed rule would produce the same type of benefits as the NLEA rule.
  3. Separately estimate the marginal benefits of each proposed change and focus only on changes shown to have a positive impact.
  4. Consider a broader range of regulatory alternatives.
  5. Opt for a longer compliance period in order to maximize net benefits and to considerably reduce compliance costs.
  6. Establish measures to monitor the rule’s health impacts.