On June 26, 2016, NuTek Food Science, LLC (NuTek) petitioned FDA to recognize “potassium salt” as an optional name for potassium chloride. Petitioner claimed (and presented evidence) that consumer acceptance of potassium chloride (as alternative to salt or sodium chloride) is hindered by consumers’ association of chloride in the word “potassium chloride” with chlorine or other chemicals. To improve the acceptance of potassium chloride, Petitioner requested that “the commissioner . . . issue guidance recognizing ‘potassium salt’ as an additional common or usual name for potassium chloride as that ingredient is defined in 21 C.F.R. § 184.1622.” As discussed in the Petition, potassium has several health benefits; it helps lower blood pressure, reduces the adverse effects of sodium chloride intake on blood pressure, and reduces the risk of recurrent kidney stones. In fact, as recognized by FDA, potassium is an essential and widely under-consumed nutrient; potassium chloride (or potassium salt) could be used to enhance the amount of potassium in food. The requirement to identify the ingredient as potassium chloride, however, stands in the way of broader acceptance of the ingredient.
As evidenced by the number of supportive comments, NuTek’s Petition was supported by many in the industry and public interest organizations, such as CSPI.
In FDA’s May 17, 2019 Constituent Update FDA announced the availability of a draft guidance titled “Use of an Alternate Name for Potassium Chloride in Food Labeling.” In the draft guidance, FDA advises the industry that the Agency has decided to exercise enforcement discretion for declaration of the name “potassium chloride salt” in the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.” In the federal register notice, FDA explains that it has concluded that potassium salt (rather than potassium chloride) would be inappropriate because the Agency has no evidence that potassium salt is recognized as the common or usual name for potassium chloride. FDA also mentions concerns that consumers would confuse the term potassium salt with salt (sodium chloride) or other potassium (non-chloride) salts. FDA speculates that allowing the addition of the word salt after “potassium chloride” may help consumers better understand the similarities between potassium chloride and sodium chloride (usually identified as “salt”) with respect to taste and function. The Agency reasons that, because “potassium chloride salt” includes the entire common or usual name of the ingredient, it is unlikely that consumers would confuse it with other potassium-containing salts. Of course, the term still includes the word “chloride.” FDA has not addressed NuTek’s claim that consumers shy away from potassium chloride because of the term “chloride.” However, it requests input whether the term potassium chloride salt has benefits over potassium chloride. Specifically, FDA requests input on two issues:
- How the name “potassium chloride salt” in the ingredient statement as an alternative to “potassium chloride” will improve consumer understanding and suggestions for other methods to improve consumer understanding. Respondents are asked to provide data or information to support answers.
- Suggestions and support for names other than “potassium chloride salt.”
To be considered by FDA in finalizing the guidance, comments should be submitted to FDA by July 16, 2019.