The  U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. revealed in an FDA News Release that diet-related chronic diseases are the leading causes of death and disability in the U.S.

The majority of the people in the U.S. tend not to consume sufficient amounts of fruits, vegetables, dairy, or whole grains, while their intake of saturated fat, sodium, and added sugars remains excessive, depicting that the eating patterns in the U.S. do not align with the updated federal dietary guidelines. These poor nutrition trends significantly contribute to chronic and preventable diseases like cardiovascular disease, diabetes, and obesity. The FDA recognized that it could play a vital role in helping consumers make informed choices about the foods they eat and improve the health of millions of Americans. Hence, came forth the latest Food Labeling Draft Guidance.

Labeling statements like Dietary Guidance Statements on food packages assist consumers in making healthier choices by providing quick and decisive nutrition information. FDA released the latest food-labeling draft guidance on March 24th, 2023, outlining their up-to-date recommendations for utilizing Dietary Guidance Statements in food labeling. The objective is to ensure that these statements effectively encourage and support healthy eating habits while assisting food enterprises in their implementation.

The new draft guidance aims to promote the use of more nutrition-related labeling statements that specifically focus on foods and food groups concerning health-conscious eating plans. Let’s dive into some aspects of dietary guidance statements, principal initiatives undertaken by the FDA regarding general nutrition enhancement, and an outline of the new food-labeling draft guidance.

Comprehending Dietary Guidance Statements

Dietary guidance statements comprise written or visual content derived from authoritative consensus reports provided by health organizations, nutrition experts, or government bodies. These statements are utilized in food labeling to indicate or imply that a particular food or food group can contribute to or support the maintenance of a healthy and nourishing dietary pattern by providing individuals with evidence-based advice. Specific dietary guidance can vary across countries, organizations, and health conditions. Following are some key elements that can be seen in dietary guidance statements.

Macronutrient Balance: Guidance statements often emphasize the importance of achieving a balanced intake of macronutrients, which include carbohydrates, proteins, and fats. Recommendations may specify the recommended ranges or proportions of each macronutrient to support overall health and prevent chronic diseases.

Fruit and Vegetable Consumption: Encouraging the consumption of fruits and vegetables is a consistent element in dietary guidance. Statements often recommend several servings or portions daily to ensure an adequate intake of essential vitamins, minerals, and dietary fiber.

Whole Grains: The consumption of whole grains, such as whole wheat, oats, and brown rice, is commonly promoted. These foods are rich in fiber, vitamins, and minerals and can contribute to overall health and lower the risk of chronic diseases like heart disease and type 2 diabetes.

Lean Protein Sources: Guidance statements usually suggest choosing lean protein sources, such as poultry, fish, legumes, nuts, and seeds. These foods provide essential amino acids, vitamins, and minerals while being lower in saturated fats than other protein sources.

Healthy Fats: Recommendations often emphasize the importance of choosing healthier fats, such as those found in nuts, seeds, avocados, and vegetable oils, while limiting saturated and trans fats, which are commonly found in fried and processed foods.

Added Sugars and Sodium: Dietary guidance commonly advises limiting the consumption of added sugars and sodium. High intake of added sugars has been linked to various health issues, including obesity and dental problems. Excessive sodium intake can contribute to high blood pressure and increase the risk of heart disease.

Portion Control: Many dietary guidance statements highlight the importance of portion control and mindful eating. This includes being aware of serving sizes, listening to hunger and fullness cues, and avoiding excessive calorie intake. 

Personalized Approach: Some guidance statements emphasize the need for individualized approaches to nutrition. This may include considering age, sex, physical activity levels, and specific health conditions when implementing dietary recommendations.

Sustainable Food Choices: Recently, there has been an increased focus on promoting sustainable food choices within dietary guidance. Recommendations may encourage the consumption of locally sourced, seasonal, and environmentally friendly foods and reduce food waste.

Paving the Way for the New Draft Guidance on FDA’s Food Labeling Requirements

At the FDA Conference on Hunger, Nutrition, and Health on September 28, 2022, the White House published a National Strategy to end hunger and increase healthy eating and physical activity by 2030.

As part of the strategy, the FDA has implemented multiple initiatives to accelerate efforts in empowering consumers with information and fostering a healthier food supply. These initiatives include the development of an updated definition and a voluntary symbol for the “healthy” nutrient content claim, the introduction of front-of-package labeling, the inclusion of Dietary Guidance Statements on food labels, and gathering input for nutrition labeling on online grocery platforms. It also addresses the importance of promoting the production of healthier foods by setting targets to decrease sodium in food products and exploring further approaches to reducing added sugars in foods, complementing the existing requirement of including added sugars on the Nutrition Facts label.

FDA’s Nutrition Guidelines

The FDA’s Nutrition Initiatives aim to enhance access to healthier foods and provide easily accessible nutrition information to help individuals in the United States identify healthier choices, thus improving everyone’s health and wellness. In this way, FDA works towards improving dietary patterns within a broader, whole-of-government approach to reduce the burden of nutrition-related chronic diseases, advance health equity, and usher in healthier future generations.

A primary aspect of their work concentrates on claims and nutrition-related statements on food labeling, as they can be a powerful tool for change. They can act as conclusive signals to help consumers, particularly those with lower nutrition literacy, understand nutrition information and make healthier picks. They also encourage the food industry to reformulate products by offering food manufacturers guidance on using Dietary Guidance Statements on food labels to meet consumer demand for healthier options.

FDA’s Dietary Guidelines

Dietary Guidance Statements remain voluntary labeling statements that do not directly characterize the nutrient content of food but instead communicate its role in a nutritious dietary pattern. The FDA seeks input from various stakeholders through public meetings and comments to develop these guidance statements. They consider consensus reports, such as the Dietary Guidelines for Americans, 2020-2025 (Dietary Guidelines), as the basis for labeling comments representing or suggesting how a food or food group contributes to a nourishing diet system.

On July 26, 2018, the FDA organized a public meeting where they asked a variety of stakeholders, including industry, consumers, trade associations, and consumer groups, for their thoughts on essential elements of the Nutrition Innovation Strategy. This included: 

(1) Which types of claims or labels related to nutrition would be most helpful in creating healthier food options?

(2) Which types of claims and labels would be most helpful for consumers to choose foods that align with the Dietary Guidelines for Americans?

The feedback and comments from the event demonstrated a strong interest in having labels, symbols, and statements that help consumers understand how foods and food groups can contribute to a healthy diet. 

The Dietary Guidelines, published every five years by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), are devised with the input of science-based recommendations of a panel of experts called the Dietary Guidelines Advisory Committee. They are built upon existing scientific and medical knowledge and serve as the foundation for federal nutrition policy. Despite being updated every five years, the mainstream objectives of most recommendations in the Dietary Guidelines, such as limiting the intake of saturated fat, sodium, and sugars, and consuming foods with adequate amounts of fiber, have remained constant since its initial release in 1980. They recommend amounts for particular food from different food groups found in healthy dietary patterns: the Healthy U.S.-Style Dietary Pattern, the Healthy Mediterranean-Style Dietary Pattern, and the Healthy Vegetarian Dietary Pattern. These patterns provide intake recommendations for vegetables, fruits, grains, dairy, protein foods, and oils. The FDA’s recommendations for Dietary Guidance Statements are based on the Healthy U.S.-Style Dietary Pattern. 

The FDA has regulatory requirements for certain nutrient content claims, such as the term “healthy.” Traditionally, labeling claims have revolved around specific nutrients and their relationship to diseases. However, as scientific knowledge in nutrition has advanced, recommendations have shifted towards considering the overall dietary pattern and how foods work together to affect health. 

Core Elements of the Draft Guidance

The FDA Dietary Guidance Statements provide manufacturers with an additional set of comments that can be used on-pack, beyond nutrient content claims or “healthy” claims, which will be instrumental in advocating better, and nutrition-conscious purchase decisions. The main highlights of the draft guidance are given below:

Definition of Dietary Guidance Statements

The Dietary Guidance Statements are defined in the draft guidance as words or vignettes that represent how the consumption of a certain food contributes to an overall healthy diet.  They may also include the use of USDA’s “MyPlate” symbol on food packaging. Some examples of these claims are:

1. The Dietary Guidelines for Americans recommends eating fruits and vegetables as part of a nutritious dietary pattern. This food has ½ cup of broccoli per serving. 
2. Choose fat-free or low-fat dairy products instead of full-fat dairy options.
3. Eat leafy green vegetables as part of a nutritious dietary pattern.

Validity for the Source of Dietary Guidance Statements

A “consensus report” is defined in the draft guidance as a “report that represents the consensus produced by a group of qualified experts whose bias and conflicts of interest have been minimized and that are convened to study a specific issue.”  This ensures that the information presented in a consensus report about nutrition conveys an objective view of evidence-based scientific research on dietary patterns, which has been thoroughly reviewed for scientific rigor and stays consistent with sound nutrition science. To further the FDA’s public health agenda, they mandate that the Dietary Guidance Statements be substantiated through these consensus reports. The FDA advises food manufacturers to incorporate the key or principal recommendations from consensus reports into their Dietary Guidance Statements. These recommendations, often highlighted in a box or executive summary, represent the critical conclusions of the reports. However, it is not necessary for a food manufacturer’s statement to mirror the exact wording of the consensus report’s main recommendation.

“Food Group Equivalents” Concept

For a food item to be labeled with Dietary Guidance Statement, it must contain a “meaningful amount” of the mentioned food or food groups, quantified by the FDA’s “food group equivalents” standard. The FDA’s “food group equivalents” standard is a proposed framework to redefine the concept of “healthy” food products. The standard focuses on ensuring that nutrient-dense foods that help consumers build a diet consistent with current dietary recommendations qualify for the “healthy” claim. It establishes criteria for the required quantity of food from specific food groups and sets particular limits for three essential nutrients (sodium, saturated fat, and added sugars). These criteria and limits vary depending on whether the product is an individual food item, a mixed product, a main dish, or a complete meal and are determined based on the Reference Amount Customarily Consumed (RACC).

Recommendations for Nutrient Levels for a Product with Dietary Guidance Statements

The draft guidance emphasizes that food products carrying a Dietary Guidance Statement should adhere to specific limits regarding certain nutrients. These limits pertain to saturated fat, sodium, and added sugars and are designed to ensure that these nutrients are not present in excessive amounts. The recommendations for the maximum amounts of sodium, saturated fat, and added sugars in products with a Dietary Guidance Statement depend on key recommendations from the Dietary Guidelines. The recommended nutrient levels differ based on the food item category, with main dishes and meals having more flexibility compared to other products. It is crucial for food manufacturers to thoroughly examine the proposed guidance to ascertain its application in specific situations.

Applicability of Dietary Guidance Statements

While the Dietary Guidelines and other sources offer recommendations for infants and children below the age of 2 years, the draft guidance solely provides recommendations for individuals aged two and older through Dietary Guidance Statements. Infants and young children have distinct nutritional requirements crucial to their developmental stages. Additionally, the recommendations for food quantities and nutrient limits differ tremendously between children under two and the general U.S. population aged two and above, as stated in the current consensus reports. The FDA intends to carefully consider how Dietary Guidance Statements could or should be used on food items intended for the youngest population groups.

How Can Smart Food Safe Help to Comply With the Emerging Food Labeling Requirements?

Food manufacturers often face the tedious task of navigating and maintaining compliance with complex labeling requirements, all while ensuring appropriate representation of dietary guidance statements on their product labels to guarantee the safety of food products and enable consumers to make informed decisions about the foods they purchase. This is where SmartFoodSafe’s Smart Specification, Smart Compliance, and Smart Label can equip food industries to maneuver the complex landscape of food labeling requirements efficiently and effectively, saving time and resources while ensuring regulatory compliance.

Smart Specification empowers businesses to create and manage material specification data, encompassing ingredients, allergens, nutritional values, packaging, recipe, and manufacturing processes, with the power and convenience of digital specifications.

Smart Label simplifies the creation and management of accurate and compliant food labels based on product specifications, incorporating mandatory information such as nutritional facts, allergen warnings, ingredient lists, and relevant dietary guidance statements to ensure consistency across product lines and facilitate efficient label updates in response to evolving regulations. 

With Smart Compliance, businesses can effectively bring optimized product compliance in real-time, reduce product hold time with the automated product release, uphold regulatory documentation, monitor supplier and materials adherence, and protect their brand reputation through automated verification of specifications. 

The three modules can be integrated to smoothen the process of handling specifications, automate compliance monitoring, and facilitate accurate and up-to-date labeling, ultimately ensuring consumer safety and minimizing risks of non-compliance. Our digital tools can assist your food enterprise in staying compliant with FDA’s latest draft guidance on food labeling to ensure that your products meet the requirements, provide consumers with accurate and useful information about the nutritional content of their products, and aid them in making informed decisions for healthier food choices.

FAQ

What is an FDA draft guidance?

An FDA draft guidance is a document issued by the U.S. Food and Drug Administration (FDA) that provides recommendations and suggestions on various topics related to FDA-regulated products. It is a preliminary guidance document that is not legally binding but serves as a way for the FDA to communicate its current thinking on a particular subject. The purpose of a draft guidance is to seek public input and feedback before finalizing the recommendations into an official FDA guidance document.

What are the requirements for nutritional information labeling?

The requirements for nutritional information labeling typically include displaying the serving size and number of servings per container, along with the number of calories and various nutrients per serving. The label should also provide information on key nutrients such as fat, cholesterol, sodium, carbohydrates, fiber, sugars, and protein. Additionally, the labeling may require disclosure of certain vitamins, minerals, or other specific nutrients if they are present in significant amounts.

Are there specific guidelines for allergen labeling?

Yes, there are specific guidelines for allergen labeling. The FDA requires that food labels clearly identify the presence of major food allergens, such as peanuts, tree nuts, milk, eggs, fish, shellfish, soy, and wheat. The allergens must be listed in the ingredient statement or in a separate “Contains” statement to alert consumers of potential allergenic ingredients.