WASHINGTON — The US Food and Drug Administration will exercise enforcement discretion for companies using the name “potassium salt” in the ingredient statement of food labels as an alternative to “potassium chloride,” according to final guidance issued by the agency on Dec. 17.
The ruling differs from FDA draft guidance found in the May 20, 2019, issue of the Federal Register in which the agency said it would exercise enforcement discretion on the name potassium chloride salt but not on the name potassium salt. In its final guidance, the FDA said allowing the name potassium salt may result in food and beverage manufacturers using potassium chloride as a substitute ingredient for some sodium chloride and may lead to reduced sodium intake.
The alternate name potassium salt may help consumers understand the identity of potassium chloride and its use as a salt substitute, according to the final guidance. The FDA added it is unlikely the name potassium salt would confuse consumers and that the name should indicate that potassium salt is distinct from regular salt (sodium chloride).
The FDA pointed out Americans on average consume 3,400 mg of sodium per person per day, which is above the maximum intake of 2,300 mg recommended by the Dietary Guidelines for Americans. Excess sodium intake increases risk for hypertension, a leading cause of heart disease and stroke, according to the FDA.
NuTek Food Science, LLC (now known as NuTek Natural Ingredients) in a citizen petition dated June 27, 2016, initially requested that the FDA recognize potassium salt as an additional or common name for potassium chloride. After the FDA issued its draft guidance, it received more than 70 comments, many saying the name potassium chloride salt would be confusing or would not achieve the goal of reduced sodium consumption. The FDA, after reviewing the comments, decided to exercise enforcement discretion for the name potassium salt.
The final guidance was scheduled to appear in the Dec. 18 issue of the Federal Register. The FDA will accept comments on the final guidance at www.regulations.gov. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. All comments must include the Docket No. FDA-2019-D-0892 for “The Use of an Alternate Name for Potassium Chloride in Food Labeling.”