FDA Proposed Rule to Allow Salt Substitutes in Standards of Identity

FDA is proposing a new rule that would allow salt substitutes in a products Standards of Identity.  "The amendments would permit the use of safe and suitable salt substitutes to replace some or all of the salt used in the manufacture of standardized foods. The proposed rule would not list specific salt substitutes; instead, the proposed rule would cover ingredients or combinations of ingredients used as salt substitutes by food manufacturers currently or in the future. If finalized, the proposed rule would support efforts to reduce sodium content in standardized foods and may help to improve consumer dietary patterns by reducing sodium consumption."

"The FDA began establishing Standards of Identity (SOI) in 1939, and since then, the agency has established more than 250 SOIs. Products like milk, milk chocolate, various breads, peanut butter, and ketchup have a SOI. SOIs often describe in detail what a food must contain and what is optional and sometimes describe the amount or proportion of ingredients or components. Many SOIs also prescribe a method of production or formulation."

Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods

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

A. Purpose of the Proposed Rule This proposed rule, if finalized, would amend FDA’s definitions and standards of identity (SOI; the acronym is used to refer to both the singular “standard of identity” and the plural  “standards of identity”) that specify salt (sodium chloride) as a required or optional ingredient. Foods for which FDA has established a SOI are referred to as “standardized” foods. The amendments would permit the use of safe and suitable salt substitutes to replace some or all of the salt used in the manufacture of standardized foods. The proposed rule would not list specific salt substitutes; instead, the proposed rule would cover ingredients or combinations of ingredients used as salt substitutes by food manufacturers currently or in the future. If finalized, the proposed rule would support efforts to reduce sodium content in standardized foods and may help to improve consumer dietary patterns by reducing sodium consumption. On average Americans consume 50% more sodium than the recommended limit for those aged 14 and older  (Ref. 1). Reducing sodium consumption may help reduce the risk of hypertension, a leading  cause of heart disease and stroke. The proposed rule would allow food manufacturers the  flexibility to use salt substitutes and allow for innovation in producing healthier standardized  foods. The proposed rule would promote honesty and fair dealing in the interest of consumers by accommodating their preferences for lower sodium varieties of foods. This, in turn, would make lower-sodium options available to them

B. Summary of the Major Provisions of the Proposed Rule

FDA is proposing to amend its SOI that specify salt as a required or optional ingredient to permit the use of safe and suitable salt substitutes in standardized foods, to reduce the sodium content. We propose to amend our regulation entitled “Food Standards: General” (21 CFR part 130) to create a new subpart C entitled “Flexibility in Standardized Foods” and add a new section entitled “Ingredient Flexibility in Standardized Foods” to define salt substitute. We also propose to amend 80 SOI to permit salt substitutes.

We also propose to update the incorporation by reference (IBR) information of several SOI to refer to the most recent versions of the IBR materials and to provide up-to-date contact information for obtaining the IBR materials. For example, the proposed rule would update the referenced methods of analysis to those in the “Official Methods of Analysis of AOAC INTERNATIONAL,” 21st Ed. 2019. We also propose to make technical amendments to correct inconsistencies and typographical errors in some SOI regulations.

We tentatively conclude that the proposed amendments are necessary to modernize SOI to provide flexibility and facilitate innovation in the production of standardized foods with less sodium, and to promote honesty and fair dealing in the interest of consumer.