The U.S. Food and Drug Administration (FDA) recently issued a draft guidance to advise food manufacturers of its intent to exercise enforcement discretion for the name “potassium chloride salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.” Potassium chloride is often used as a partial substitute for sodium chloride (i.e. salt) in many foods.

FDA has determined that the draft guidance furthers the agency’s Nutrition Innovation Strategy. The strategy, which was announced on March 29, 2018, reevaluates and reformulates methods of reducing preventable death and disease related to poor nutrition. It is comprised of five key elements:

  • Modernizing Claims: FDA is considering updating the criteria for “healthy” claims, defining the term “natural,” encouraging healthy dietary patterns and food groups rather than focusing on single nutrients, and streamlining the process for reviewing health claims.
  • Modernizing Ingredient Labels: FDA is reevaluating methods to make ingredient information more consumer-friendly, including allowing the use of simpler names for certain ingredients, such as vitamins, to help consumers better understand what is in their food.
  • Modernizing Standards of Identity: In order to facilitate innovation while protecting public health, FDA is reevaluating existing standards of identity in light of marketing trends and the latest nutritional science.
  • Implementing the Nutrition Facts Label and Menu Labeling: Due to recent changes in the labeling requirements for food, FDA will continue releasing guidance to assist food companies with compliance and an education campaign for consumers to ensure they understand the new nutrition information that is being used in the marketplace.
  • Reducing Sodium: FDA is continuing efforts to advance voluntary short-term sodium targets, furthering dialogue on longer-term sodium reduction efforts, and aligning these efforts with the Dietary Reference Intake for sodium and potassium review conducted by the National Academies.

The draft guidance is consistent with FDA’s Nutrition Innovation Strategy as one method of addressing the over-consumption of sodium and under-consumption of potassium. According to FDA, addition of the term “salt” to the common or usual name “potassium chloride” may encourage manufacturers to use this sodium alternative as well as help consumers to better understand the similarities between potassium chloride and sodium chloride with respect to taste and function.
FDA is currently accepting comments on this draft guidance and how using the name “potassium chloride salt” in the ingredient statement, instead of “potassium chloride,” may improve consumer understanding of the ingredient and alternate names to “potassium chloride salt” or other methods or approaches could improve consumer understanding. FDA will accept comments on the draft guidance until July 19, 2019.

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Husch Blackwell has experience advising food manufacturers on FDA regulations, including regulations on food labeling. Our FDA lawyers have the required scientific and technical backgrounds to assist companies with compliance. Contact Seth Mailhot, Emily Lyons or your Husch Blackwell attorney.

Written with the assistance of Maya Desai, a summer associate in the Husch Blackwell LLP Washington, DC office.