Redefining Healthy Sodium Levels

On Sept. 29, 2005, FDA amended its regulation concerning the maximum sodium levels permitted in foods that can carry the nutrient-content claim “healthy.” The agency decided to retain the currently effective, less-restrictive, “first-tier” sodium-level requirements for all food categories, including individual foods (480 mg per serving) and meals and main dishes (600 mg per serving), and is eliminating the more-restrictive “second-tier” sodium-level requirements for all food categories (360 mg sodium per serving in individual foods and 480 mg sodium per serving for meals and main dishes).

The initial ruling was implemented on May 10, 1994 and defined criteria for use of the nutrient-content claim “healthy” and its derivatives (i.e., “health” and “healthful”) on individual foods, including raw, single-ingredient seafood and game meat, and on processed meal and main-dish products. It also established two separate criteria for sodium content in foods bearing a “healthy” claim.

The intent of the two-tiered sodium- level requirements was to encourage industry innovation and to further reduce sodium levels in foods bearing the term “healthy.” However, since this regulation, food manufacturers have urged FDA to eliminate the more-restrictive second- tier sodium requirements until food technology catches up with FDA’s goal of reducing the sodium content in foods. This rule has made it difficult for food manufacturers to develop new products and threatened existing “healthy” products because of stricter nutrient requirements and lack of demand. Over the past decade, manufacturers have found it difficult to find suitable alternatives for sodium and the lack of consumer acceptance of certain “healthy” products made with salt substitutes and/or lower sodium, due to undesirable flavor profiles, which often led to poor sales of products that met the second-tier sodium level requirements.

Manufacturers also faced reformulating and marketing costs to keep the “healthy” claim on an existing product. Because the health claim was so restrictive and reformulation costs so high, some manufacturers chose to rebrand or relabel their products out of the “healthy” category, which meant they were not subject to any sodium limit. For example, the Campbell Soup Company, Camden, NJ, makes structure/function claims for its soup and juice products that contain more sodium than that required amount to evade an FDA-approved sodium health claim.

For this reason, FDA reevaluated its position on this rule and realized that enforcing the second-tier sodium level requirements for the “healthy’’ claim by Jan. 1, 2006 might, in fact, result in a smaller selection of nutritionally desirable foods on the market. Having more-restrictive sodium levels inhibits the development of new “healthy” food products in the marketplace due to the lack of technology and sodium alternatives. By retaining the higher first-tier sodium level requirements for all food products bearing the term “healthy,” FDA hopes to encourage manufacturers to continue making healthy products consistent with dietary guidelines.

Even though FDA has amended its original ruling, “we think it ought to be eliminated entirely. There is no scientific evidence that a reduced-sodium diet is beneficial in health outcomes,” says Richard L. Hanneman, president, Salt Institute, Alexandria, VA. “We’re hopeful to see the FDA drop its requirement for sodium entirely.”

But Michael F. Jacobson, executive director, Center for Science in the Public Interest, Washington, D.C., is concerned by this news because sodium levels in food already “range from high to extremely high.” With FDA removing the more-restrictive second-tier sodium requirement, “it is virtually impossible for people to follow health authorities’ advice to cut way back on sodium,” especially when packaged and restaurant foods make up such a big part of Americans’ diets, he adds. He further comments that this ruling does not encourage food companies to use less salt, especially in products that have the highest sodium levels.

Furthermore, FDA has revised the term “healthy” as an implied nutrient content claim. The agency decided to redefine the regulatory text for the definition of “healthy” to clarify the term and the nutrient-content requirements for “healthy” so more consumers and manufacturers can understand the scope and meaning of the regulation and the requirements for using the “healthy” claim in food labeling.