Food labeling; nutrient content claims, definition of sodium levels for the term "healthy." Final rule

Fed Regist. 2005 Sep 29;70(188):56828-49.


The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim "healthy." The agency is retaining the currently effective, less restrictive, "first-tier" sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the "second-tier" (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new "healthy" food products and risk substantially eliminating existing "healthy" products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term "healthy" will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the "healthy" regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for "healthy" into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.

MeSH terms

  • Consumer Behavior
  • Diet, Sodium-Restricted / standards
  • Food / classification*
  • Food Labeling / legislation & jurisprudence*
  • Government Regulation
  • Humans
  • Hypertension / etiology
  • Maximum Allowable Concentration
  • National Institutes of Health (U.S.)
  • Nutritional Physiological Phenomena
  • Public Health / legislation & jurisprudence
  • Sodium* / adverse effects
  • Sodium* / classification
  • United States
  • United States Department of Agriculture
  • United States Food and Drug Administration


  • Sodium