Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods

Description

This guidance is intended to provide measurable voluntary short-term (2.5-year) goals for sodium content in commercially processed, packaged, and prepared foods to reduce excess population sodium intake, while recognizing and supporting the important roles sodium plays in food technology and food safety.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Commercially processed, packaged, and prepared foods

The primary scope of the sodium reduction goals; Target products for sodium reduction goals

Ready-to-eat food

Food that is in a form that is edible without additional preparation to achieve food safety

Dietary supplements

subject to 21 CFR part 111; Foods not subject to preventive controls requirements; Specific product category with modified FSVP requirements.; Included in human food sales calculation; foods not covered under systems recognition arrangements

Stakeholders

3

Food manufacturers

Entities encouraged to reduce sodium in foods; Primary industry members encouraged to reformulate products

Restaurants

Entities involved in commercial food preparation

Small businesses

Firms that may have fewer resources for reformulation

Regulatory Context

Document Types

3

Dietary Guidelines

Recommended intakes that consumers cannot reach without overall sodium reduction in the food supply.

Food labels

Source of sodium content data for packaged foods

Menus

Source of sodium content data for restaurant foods

Attributes

6

Microbial safety

A functional role of sodium in food

Baseline level

Amount of sodium in a category representing the 2010 U.S. food supply.

Stability

A functional role of sodium in food

Nutritional quality

Property to be maintained during sodium reduction

Sales volume data

Used to weight the influence of products on category averages

2.5-year goals

Short-term timeframe for achieving sodium reduction targets

Technical Details

Substances

6

Sodium propionate

Example of a sodium-containing ingredient found in foods.

Sodium benzoate

preservative used in hummus to inhibit yeast and mold; Inhibits growth of or inactivates Listeria monocytogenes.

Sodium lactate

Example of a sodium-containing ingredient found in foods.

Sodium

The primary nutrient of concern in this guidance; Primary substance targeted for reduction; Chemical entity or electrolyte targeted for reduction; Primary substance of regulatory focus for reduction

Sodium chloride

Commonly referred to as salt, a major source of sodium in diet; Common salt, 39 percent sodium by weight

Sodium nitrite

A specific sodium-containing ingredient used in food formulation

Testing Methods

3

What We Eat in America (WWEIA) survey

Consumption data used to model sodium intake

Sales-weighted mean

Measurement of sodium content weighting individual products by volume sales.

National Health and Nutrition Examination Survey

Survey (NHANES) used to provide consumption data for risk modeling

Processes

1

Reformulation

The process of changing food composition to reduce sodium; Strategies to reduce sodium content in food products

Clinical Concepts

2

Hypertension

comorbidity associated with obesity; Common weight-related comorbidity; Weight-related comorbidity

Cardiovascular disease

Risk associated with high sodium intake; Risk reduced by lowering sodium intake

Identified Hazards

Hazards

1

Acrylamide formation

Potential risk to balance during product reformulation

Standards & References

External Standards

3

FDA Food Code (2013)

Source for the definition of food establishment.

Dietary Guidelines for Americans, 2020-2025

Federal recommendations for sodium consumption limits

Chronic Disease Risk Reduction Intake

NASEM standard for sodium intake to reduce disease risk

Specifications

9

Target mean concentration

The goal for a food category as a whole

Upper bound

Goal upper bound sodium content of an individual food product or menu item.

Target mean

Goal sodium level for a category calculated as sales-weighted mean sodium level.

Upper bound concentration

The goal for the highest sodium concentration for any product in a category

2,300 mg/day

Recommended sodium limit for individuals 14 years and older

3,000 mg/day

Short-term average sodium intake goal

Target mean concentrations

Goals for sodium levels for a food category

Upper bound sodium concentrations

Goals for the highest level of sodium for products in a category; Standard applied to every individual product in a category

Target Mean Sodium Concentrations

Desired average sodium concentration in each category weighted by sales volume

Related CFR Sections (4)

21CFR101.22§ 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.
(a)Read full regulation →
21CFR170.30§ 170.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →
21CFR182.1§ 182.1 Substances that are generally recognized as safe.
(a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use. This pRead full regulation →
21CFR101.74§ 101.74 Health claims: sodium and hypertension.
(a) Relationship between sodium and hypertension (high blood pressure).Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 402(a)(2)(C)(i)

22

Unfair or deceptive acts or practices

6

Unfair or Deceptive Marketing

5

Unapproved new drugs

4

Misbranded drugs

3

Prohibited act under section 301(ll)

3

Adulterated human foods

3

Introduction of adulterated food into interstate commerce

3

unapproved new drugs

2

Adulterated food containing an unsafe food additive

2