The U.S. Food and Drug Administration (FDA) classifies potassium chloride as Generally Recognized As Safe (GRAS) for use in food products under specific regulatory standards. It is used as a flavor enhancer, nutrient supplement, pH control agent, stabilizer, and notably as a salt substitute to reduce sodium content in processed foods. In 2020, the FDA issued final guidance allowing food manufacturers to use the alternate name "potassium salt" on product labels instead of "potassium chloride," aiming to help consumers recognize it as a salt substitute and support public health goals targeting sodium reduction. The FDA emphasizes that potassium chloride can be used under good manufacturing practices at levels necessary to achieve its intended effects without safety concerns.[1][2][3][4]

WHO/JECFA Evaluations of Potassium Chloride Safety

The World Health Organization, through the Joint FAO/WHO Expert Committee on Food Additives (JECFA), assesses potassium chloride as safe for consumption without set acceptable daily intake (ADI) limits due to its low toxicity and essential role as a potassium source. WHO supports potassium chloride's incorporation in foods both to ensure adequate potassium intake and to reduce sodium consumption globally. These expert evaluations reinforce its suitability as a food additive for nutrient fortification and sodium replacement, aligning with global dietary guidelines promoting cardiovascular health.[5]

Health and Regulatory Implications

Guidelines from both FDA and WHO collectively recognize potassium chloride as a valuable ingredient to help balance sodium and potassium dietary intake, addressing hypertension risk and cardiovascular diseases. Regulatory frameworks encourage transparent labeling and compliance to ensure product safety and consumer trust. Adoption of potassium chloride supports industry efforts to formulate healthier, lower-sodium food products with beneficial nutritional profiles, advancing public health objectives worldwide.

1.https://www.hoganlovells.com/en/publications/fda-issues-final-guidance-on-use-of-potassium-salt-as-an-alternate-name-for-potassium-chloride  

2.https://www.fda.gov/media/125081/download  

3.https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-new-guidance-help-consumers-recognize-potassium-chloride-alternative-sodium  

4.https://www.fda.gov/food/hfp-constituent-updates/fda-issues-final-guidance-regarding-use-alternate-name-potassium-chloride-food-labeling  

5.https://www.cargill.com/salt-in-perspective/potassium-chloride-201-uses-in-food  

6.https://www.foodprocessing.com/ingredients-and-formulation/news/11300027/fda-allows-label-terminology-potassium-salt 

7.https://www.cargill.com/salt-in-perspective/meeting-fda-claims-with-potassium-chloride 

8.https://www.foodengineeringmag.com/articles/103006-fda-to-amend-standards-of-identity-to-include-salt-substitutes 

9.https://www.fda.gov/media/166473/download 

10.https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements