Search results for: salt

  • As we have previously blogged, last month FDA indicated that it would publish a proposed rule amending the standards of identity (SOIs) of foods in which salt (i.e., sodium chloride) is a mandatory or optional ingredient to allow for the use of salt substitutes. Yesterday, FDA published the proposed rule in the Federal Register with comments due by August 8, 2023 (120 days from publication).
  • The proposal allows for the use of salt substitutes in standardized foods and rather than specifically list salt substitutes, it defines “salt substitute” broadly to include any safe and suitable ingredient or combination of ingredients which is used to replace salt and which does not alter the essential characteristics of the food. This approach is intended to cover both ingredients that are currently used as salt substitutes (e.g., potassium chloride), as well as ingredients that in future will be used as salt substitutes (without the need for additional rulemaking). We note that the rule does not propose to amend the SOI for oysters in 21 CFR 161.130 since FDA’s understanding is that industry uses readily available seawater during the shucking process and does not add salt. FDA is requesting comment on its understanding of this process.
  • Currently, the only option for most manufacturers who would like to lower the salt content of standardized foods which reference salt is to make a nutrient content claim, but this requires a very significant reduction in salt content which is often difficult to achieve (e.g., a “reduced sodium” claim requires a 25% reduction). We note that there are a few SOIs for low sodium foods which already allow for the use salt substitutes (e.g., 21 CFR 133.116 (“low sodium cheddar cheese”)).
  • The proposed rule is part of FDA’s continuing efforts to improve nutrition and reduce intake of sodium, which increases risk of high blood pressure, a leading cause of heart disease and stroke. Americans consume an average of 3,400 mg of sodium per day, which is almost 50% more than the 2,300 mg/day recommendation adopted by the Dietary Guidelines for Americans, 2020-2025. 70% of this consumption comes from sodium added during manufacturing and commercial food preparation.
  • We will continue to monitor and report on FDA’s efforts to modernize SOIs and improve nutrition.
  • On March 24, the U.S. Food and Drug Administration (FDA) proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes.  The proposed rule, “Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods,” is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health and complements the goals of the FDA’s voluntary sodium reduction targets for processed, packaged, and prepared foods.
  • Most SOIs that feature salt as a required or optional ingredient would preclude the use of salt substitutes.  The proposed rule uses a “horizontal” approach to updating the SOIs.  Specifically, it would amend the 80 relevant SOIs.  Because these 80 SOIs are referenced in other SOIs, 140 of the 250 SOIs currently established would be affected.
  • The proposed rules does not list permitted salt substitutes, but defines them as safe and suitable ingredients used to replace some or all of the salt in a standardized food.  The extent to which salt can be replaced depends on the ability of salt substitutes to replace the functions of salt without compromising the food safety or essential characteristics of the food.  Salt substitutes are subject to the same labeling requirements as other ingredients.
  • FDA will be accepting comments to the proposed rule 120 days after it is published in the Federal Register.  Specifically, FDA requests comments on potential salt substitutes that may be used as a result of the new flexibility provided by the proposed rule.  Keller and Heckman will continue to monitor this area and relay any developments.
  • On November 19, a proposed class of consumers sued Del Monte Foods Inc. in Illinois federal court over a “no preservatives” claim on its canned Farmhouse Cut Green Beans. The proposed class alleged that the salt added to the green beans causes the “no preservatives” claim to be false and misleading.
  • The complaint, filed by named plaintiff Jaymee Fleming, alleges that consumers are increasingly looking for foods produced without preservatives, and that Del Monte charges a premium for its green beans by claiming that they have no preservatives. Fleming further alleges that the green beans packaging advertises that they are “with natural sea salt,” noting that salt can be added for taste as well as preservative effect. Fleming argues that Del Monte uses the salt as a preservative because it prevents deterioration of the green beans, makes it harder for bacteria to survive in the can, prevents and slows discoloration, and helps the green beans maintain texture and flavor. Thus, Fleming argues that the claim “no preservatives” is misleading to consumers who do not want to consume any type of preservatives in their food.
  • Fleming alleges that by using the salt, Del Monte gains an advantage over other companies and is able to charge more for its products by claiming that they are made without preservatives. Fleming seeks to represent two classes of consumers who purchased green beans: one for buyers in Illinois and another for buyers in North Dakota, Rhode Island, Michigan, Virginia, Wyoming, and Delaware. Keller and Heckman will continue to monitor and report on any developments.

The Daily Intake is taking a break for the Thanksgiving holiday and will return on November 29. We wish you a wonderful Thanksgiving holiday!

  • Our readers may recall a 2016 citizen’s petition filed by NuTek Food Science that requested FDA to permit “potassium salt” as a common or usual name for potassium chloride because of consumers’ negative associations with the word “chloride.”  While NuTek withdrew the petition following FDA’s release of a 2019 draft guidance authorizing the term “potassium chloride salt,” which FDA framed as a compromise, the case was made in numerous food industry comments, as discussed here, for removal of the word “chloride” as requested in NuTek’s petition.  Several health advocacy groups also supported this position.  Morton Salt, the manufacturer of salt (the common name for sodium chloride), was alone in urging FDA to permit only “potassium chloride” as a common name.
  • With a December 18, 2020 notice, FDA released its final guidance to advise food manufacturers of the Agency’s intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.”  In support of this change from the draft guidance, FDA cited consistency with activities to encourage manufacturers to reduce the sodium levels in food products and FDA’s Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering consumers with information, and supporting and fostering industry innovation in developing and promoting healthfulness of food options.
  • Keller and Heckman will continue to follow a request, discussed here, for Health Canada to likewise allow “potassium salt” as an alternate name for “potassium chloride” in food labeling in Canada.
  • Food manufacturers, including Nestle USA and Kraft Heinz, have submitted public comments on FDA’s draft guidance regarding the use of “potassium chloride salt” as an alternative common or usual name for potassium chloride. The comments opposed the use of “potassium chloride salt” and urged the agency to choose “potassium salt,” asserting that the term meets the common or usual name requirements at 21 CFR 102.5 and is better received by consumers.
  • As our readers may remember, the issue of potassium chloride labeling arose in a 2016 citizen’s petition filed by NuTek Food Science. NuTek’s petition had requested that FDA permit “potassium salt” as a common or usual name for potassium chloride because of consumers negative associations with the word “chloride.”  FDA has acknowledged that wider use of potassium chloride as a salt replacement could help reduce sodium intake and increase potassium intake and therefore, in May 2019, responded to NuTek’s petition with draft guidance proposing the term “potassium chloride salt” as a compromise.
  • Many of the public comments noted consumer suspicion of the term “chloride.” Indeed, one consumer survey conducted by the International Food Information Council (IFIC) Foundation found that shoppers rated “potassium salt” as safer, healthier, and tastier than “potassium chloride salt.” Similarly, the survey found that names of ingredients that contained both potassium and chloride were perceived as least safe, with 47% of consumers ranking “potassium chloride” and 38% ranking “potassium chloride salt” as least safe.
  • At least one comment urged FDA to revise their guidance and require potassium chloride to be labeled as such. Morton Salt stated that “salt is the common or usual name for sodium chloride, and potassium chloride is the common or usual name for potassium chloride that consumers recognize on our food nutritional labels and that is accepted by industry.” The comment period closed on September 17, 2019. Keller and Heckman will continue to monitor this issue.
  • NuTek Food Science—the company that filed a 2016 citizen petition to obtain FDA permission to label potassium chloride as “potassium salt”—has withdrawn its citizen petition.  The company made its decision based on FDA’s recent issuance of draft guidance authorizing the term “potassium chloride salt” as an alternative name for “potassium chloride” on food labels.
  • NuTek’s petition had requested that FDA permit “potassium salt” as a common or usual name for potassium chloride because consumers have negative associations with the word “chloride.”  In a press release, NuTek’s Chief Strategy Officer, Brian Boor, stated, “Although the FDA’s initial draft guidance fails to address the problematic use of the word ‘chloride,’ we are confident that the food industry and the health community can make a compelling argument for its removal during the 60-day comment period.”
  • NuTek’s citizen petition received support from members of the food industry and seems to have started a dialogue in other countries, such as Canada, that also may consider allowing potassium chloride to be declared as “potassium salt” on food labels.

 

  • 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.

 

  • In a letter to Health Canada and the Canadian Food Inspection Agency (CFIA), a number of health advocacy groups, food manufacturers, and food retailers have urged regulators to allow “potassium salt” to be used as a permitted synonym for potassium chloride on food labels.  As reported by FoodNavigator, the group argued that the addition of “potassium salt” to the Permitted Synonyms for Food Additives Table would reduce sodium intake in Canada because “a friendlier name would demystify the ingredient and help the industry achieve the dual goals of lowering sodium and increasing potassium intakes.”
  • The group argued that Health Canada’s current requirement for potassium salt to be labeled as “potassium chloride” on food labels is “inconsistent with growing consumer demands for clean label food ingredients and it could inhibit consumer acceptance of this salt substitute.” Indeed, the group found that in this era of clean labeling, consumers are becoming increasingly suspicious of “chemical-sounding” ingredients.  Relying on consumer research, the group maintained that some consumers mistakenly believe potassium chloride to be an “undesirable chemical substance” and one that should be avoided. Thus, food manufacturers are often hesitant to use potassium salt as a substitute when it must be declared as “potassium chloride.”
  • There is clear precedent for allowing the use of permitted synonyms on food labels.  The CFIA has previously established synonyms for a variety of other ingredients, such as “baking soda” for sodium bicarbonate and “lye” for sodium hydroxide.
  • As our readers may remember, the FDA received a similar request in 2016. NuTek Food Science filed a citizen petition requesting that the agency recognize “potassium salt” as a common or usual name for potassium chloride, and to permit the ingredient to be labeled as such on US food labels. FDA has yet to respond to NuTek’s petition, although former Commissioner Gottlieb hinted at support for the petition in March 2018 when he announced the Nutrition Innovation Strategy. FDA has publicly stated in multiple forums that they will continue to pursue the goals set forth in the Nutrition Innovation Strategy. As such, we will continue to monitor for any developments regarding the common or usual name of potassium chloride in the US and Canada.
  • As reported on this blog previously, comments on a citizen petition from NuTek Food Science, LLC requesting that FDA recognize “potassium salt” as an alternate name for potassium chloride were due last month. Campbell Soup Company and more than 15 other companies and organizations submitted comments supporting the petition. Among the reasons provided by the commenters to allow the use of “potassium salt” on ingredient labels were: (1) consumers want clean labels, and (2) potassium chloride is used as a replacement for sodium chloride, is naturally occurring, and offers health benefits.
  • Campbell Soup’s comments summarized the results of a consumer research study that it conducted, reportedly finding that:
    • Significantly more consumers were concerned about having an ingredient called “potassium chloride” in their soups compared to “potassium salt”
    • Consumers said they were significantly more likely to purchase a soup that contained “potassium salt” over “potassium chloride”
  • As a result of the research, Campbell Soup concluded, “… permitting this alternative name would support companies in their efforts to decrease the sodium content of foods, while also encouraging consumers to increase their intake of potassium, an underconsumed nutrient of public health concern, which also has a beneficial impact on blood pressure.”
  • Only the Salt Institute and an anonymous source submitted comments urging FDA to reject NuTek’s petition. (The comments submitted in response to this citizen petition can be found in Docket No. FDA-2016-P-1826 at regulations.gov.)
  • FDA’s approval of the petition could encourage other ingredient manufacturers to request the use of less “chemical-sounding” name for additional ingredients.

FDA’s approval of a “potassium salt” citizen petition could represent a potential windfall for potassium chloride manufacturers while assisting food companies in complying with FDA’s goal of reducing sodium consumption.  

  • On June 26, 2016, NuTek Food Science, LLC petitioned FDA to recognize “potassium salt” as an alternate name for potassium chloride, noting that although potassium chloride has been an ingredient in food for years, consumers often conflate potassium chloride with chlorine or other chemicals.  The petition specifically requests “the commissioner to 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”.
  • The Salt Institute, which represents salt producers, has urged FDA to reject NuTek’s petition, arguing that granting the petitioner’s request would represent a fundamental shift in FDA’s position regarding the common or usual name for potassium chloride and, as such, should be subject to notice and comment rulemaking.  At odds with the Salt Institute, the Center for Science in the Public Interest (CSPI) supports the petition, arguing that the petition promotes truthful and accurate labeling and could potentially help reduce sodium intake.
  • FDA’s approval of this petition could represent a potential windfall for potassium chloride manufacturers while assisting food companies in complying with FDA’s recently enumerated goal of reducing sodium consumption.  At the same time, FDA’s approval of the petition could also encourage other ingredient manufacturers to request name changes for ingredients with “chemical-sounding” names.  Comments are due to FDA by December 26, 2016