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FDA Greenlights Use of “Potassium Chloride Salt” as an Alternative Name for “Potassium Chloride” in Food Labeling

  • Under section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the label of food fabricated from two or more ingredients must bear the common or usual name of each ingredient.  As we have reported, however, a number of health advocacy groups, food manufacturers, and food retailers argued to the Food and Drug Administration (FDA) that use of the name “potassium chloride salt” instead of the common or usual name for this ingredient on food labeling would lead to increased consumer understanding of the use of potassium chloride as a replacement for sodium chloride (i.e., salt).  The group found that in this era of clean labeling, consumers are suspicious of “chemical-sounding” ingredients and may mistakenly believe potassium chloride to be an “undesirable chemical substance” that should be avoided.

  • FDA’s May 17, 2019 Constituent Update announces a new draft guidance for Use of an Alternate Name for Potassium Chloride in Food Labeling (May 2019 Draft Guidance).  Specifically, FDA has advised food manufacturers of the Agency’s intent to exercise enforcement discretion for declaration of the name “potassium chloride salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.”  FDA hopes that allowing the declaration of potassium chloride salt on food labels may encourage manufacturers to use potassium chloride as an alternative to sodium chloride because it may correct the consumer misconception that is associated with the common name of the ingredient.  This policy aligns with FDA’s previous activities to encourage manufacturers to reduce the sodium levels in food products in the interest of public health and with FDA’s Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States.

  • Comments on the draft guidance for the use of potassium chloride salt in food labeling should be submitted to FDA by July 16, 2019 to ensure that they are considered before FDA plans to begin work on the final guidance.

  • We will continue to monitor developments regarding the common or usual name of potassium chloride in Canada where our readers may remember a request was submitted to Health Canada and the Canadian Food Inspection Agency (CFIA) to allow “potassium salt” to be used as a permitted synonym for potassium chloride on food labels.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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