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FDA Regulations on Nutrition Facts Labels

Labeling food is one of the most important measures to protect consumer health. Through food labels, consumers can grasp information about the ingredients, nutritional content, quality, expiration date, and more of the product, enabling them to make choices suitable for their needs and health.

This article will provide some basic information about the FDA’s regulations on food labeling. Let’s explore the types of information with GOL that must be included on food labels, the types of allowed nutritional and health claims, as well as regulations regarding language and font size on labels.

1.What are Nutrition Facts?

Nutrition facts, also commonly referred to as the Nutrition Facts Label, encompass the meaning of nutritional labels, nutrient content labels, or nutritional information labels. Nutrition facts provide detailed information about the nutritional content of a food product, including quantities of nutrients such as fat, sugar, sodium, and fiber.

The Nutrition Facts Label is mandated by the Food and Drug Administration (FDA) on most packaged foods and beverages.

Nutrition Facts

2. FDA Regulations on Food Product Labeling

There are five fundamental elements on the packaging label of a food product, as regulated by the Food and Drug Administration (FDA):

  • Product Name
  • Net Weight
  • Manufacturer’s Address
  • Nutrition Facts
  • Ingredient List

The Nutrition Facts section is perhaps the most intricate part of a food label. It comprises three main components:

  • Serving Size
  • Nutrient Content
  • Vitamins and Minerals

Serving Size

The real challenge in creating nutrition facts labels lies in understanding the serving size requirements. Food manufacturers must determine the accurate recommended serving size for their food product by consulting the list of products on the FDA website and their Reference Amounts Customarily Consumed (RACC) values.

The nutrition facts label must also include information on five core nutrients, namely calories, total fat, sodium, total carbohydrates, and protein.

Ingredient List, Allergens

  • List the ingredients in descending order of weight, from the heaviest to the lightest component.
  • Allergens, if present in the food product, must always be listed within the ingredients.

Read more: What are the consequences of food mislabeling products?

3. Key highlights in the changes to the FDA Nutrition Facts label

The details presented in the upper section, indicated as #1-4, of the sample nutrition label (below) can differ for each food and beverage product; it encompasses product-specific details such as serving size, calories, and nutrient information. The lower section features a footnote clarifying the % Daily Value and providing the calorie count used for general nutrition advice.

In the following Nutrition Facts label, we have highlighted specific sections to facilitate a more detailed explanation. It is important to note that these highlighted sections do not appear on the actual food labels of the products you purchase.

the changes to the FDA Nutrition Facts label

3.1 Serving Information

(#1 on sample label)

Serving Information

When examining the Nutrition Facts label, begin by reviewing the number of servings per package (servings per container) and the designated serving size. Standardizing serving sizes facilitates the comparison of similar foods and is presented in familiar units like cups or pieces, accompanied by the metric quantity, such as the number of grams (g). The serving size reflects the typical amount people consume, but it does not suggest the recommended intake.

It’s crucial to understand that all the nutritional values indicated on the label, including the calorie count, pertain to the specified serving size. Pay close attention to the serving size, particularly the total servings in the food package. For instance, consider whether you are consuming half a serving, one serving, or more. In the provided label, one serving of lasagna equals 1 cup. If you consume two cups, you are having two servings, which means you should double the nutrient and calorie amounts, as well as the % Daily Values, to accurately assess what you are obtaining from two servings.

 

EXAMPLE
One Serving of Lasagna %DV Two Serving of Lasagna %DV
Serving Size 1 cup 2 cups
Calories 280 560
Total Fat 9g 12% 18g 24%
Saturated Fat 4.5g 23% 9g 46%
Trans Fat 0g 0g
Cholesterol 35mg 12% 70mg 24%
Sodium 850mg 37% 1700mg 74%
Total Carbohydrate 34g 12% 68g 24%
Dietary Fiber 4g 14% 8g 29%
Total Sugars 6g 12g
Added Sugars 0g 0% 0g 0%
Protein 15g 30g
Vitamin D 0mcg 0% 0mcg 0%
Calcium 320mg 25% 640mg 50%
Iron 1.6mg 8% 3.2mg 20%
Potassium 510mg 10% 1020mg 20%

 

3.2 Calories

(#2 on sample label)

Calories

Calories serve as an indicator of the energy derived from a serving of this food. In the given instance, a single serving of lasagna contains 280 calories. If you were to consume the entire package, equivalent to four servings, your intake would reach 1,120 calories.

Maintaining a healthy body weight involves striking a balance between the calories you consume and those your body expends. While 2,000 calories a day serves as a general nutritional guideline, your specific calorie requirements can be higher or lower, varying based on factors such as age, gender, height, weight, and physical activity level.

It’s important to recognize that the quantity of servings you consume directly influences the calories you ingest. Consuming an excessive number of calories per day is associated with the risk of being overweight and obesity.

3.3 Nutrients

(#3 on sample label)

Nutrients

Refer to section 3 on the sample label to discover crucial nutrients impacting your well-being. Utilize the label to tailor your dietary choices according to your individual needs – seek out foods rich in desired nutrients and minimize those containing nutrients you aim to restrict.

Nutrients to limit include Saturated Fat, Sodium, and Added Sugars. These are components associated with potential health risks, and their excessive consumption is a common issue among Americans. Overindulgence in saturated fat and sodium, for instance, is linked to increased risks of health conditions like cardiovascular disease and high blood pressure. Additionally, an excess of added sugars can hinder meeting essential nutrient requirements while adhering to calorie constraints.

Understanding Added Sugars and distinguishing them from Total Sugars is important.

Total Sugars on the Nutrition Facts label encompasses sugars naturally occurring in nutritious foods and beverages, such as those in milk and fruit, along with any added sugars in the product. No Daily Reference Value is set for total sugars as there is no established recommendation for their daily intake.

Added Sugars on the Nutrition Facts label comprise sugars incorporated during food processing (e.g., sucrose or dextrose), sweeteners packaged with foods (e.g., table sugar), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices. Diets high in added sugars can complicate meeting daily recommended nutrient levels while staying within calorie limits.

The inclusion of the term “includes” before Added Sugars on the label indicates that these sugars are accounted for in the total grams of sugars in the product.

For example, a container of yogurt with added sweeteners, might list:

This indicates that the product contains 7 grams of Added Sugars and 8 grams of sugars naturally present – totaling 15 grams of sugar.

Nutrients to increase intake include Dietary Fiber, Vitamin D, Calcium, Iron, and Potassium. These nutrients, highlighted on the label, are typically consumed below the recommended amounts by Americans and are emphasized as nutrients to prioritize. A diet rich in dietary fiber can enhance bowel movement frequency, lower blood glucose and cholesterol levels, and decrease calorie intake. Diets with higher levels of vitamin D, calcium, iron, and potassium can diminish the risk of osteoporosis, anemia, and high blood pressure.

Keep in mind: Utilize the label to align with your specific dietary requirements—select foods with higher levels of the nutrients you aim to increase and lower levels of the nutrients you wish to restrict.

3.4 The Percent Daily Value (%DV)

(#4 on sample label)

The Percent Daily Value (%DV)

The % Daily Value (%DV) represents the proportion of the Daily Value for each nutrient contained in a serving of the food. Daily Values serve as benchmarks, expressed in grams, milligrams, or micrograms, indicating the recommended or maximum amounts of nutrients to be consumed daily.

The %DV illustrates the contribution of a nutrient in a serving of food to the overall daily diet.

It aids in discerning whether a serving of food is rich or deficient in a particular nutrient.

Calculating percentages is unnecessary to utilize the %DV, as the label (the %DV) performs the calculations for you. It facilitates the interpretation of nutrient quantities (in grams, milligrams, or micrograms) by standardizing them on a uniform scale for the day (0-100%DV). The %DV column doesn’t accumulate vertically to 100%. Instead, it represents the percentage of the Daily Value for each nutrient in a serving, indicating whether the food contributes significantly or minimally to your daily intake of each nutrient.

Note: Certain nutrients on the Nutrition Facts label, such as total sugars and trans fat, lack a %DV and will be addressed later.

Guidelines for % Daily Value (%DV):

  • 5% DV or less of a nutrient per serving is considered low.
  • 20% DV or more of a nutrient per serving is considered high.

When selecting foods, prioritize those that are:

  • Higher in %DV for Dietary Fiber, Vitamin D, Calcium, Iron, and Potassium.
  • Lower in %DV for Saturated Fat, Sodium, and Added Sugars.

For example, examine the sodium content in one serving as indicated on the sample nutrition label. A %DV of 37% implies a significant contribution to your diet. Referring to the General Guide to %DV, this product is classified as high in sodium (exceeding 20% DV for sodium). If you were to consume 2 servings, it would provide 74% of the DV for sodium—almost three-quarters of the recommended daily intake for sodium.

Compare Foods: Utilize %DV to compare food products, ensuring the serving size is consistent. Opt for products higher in nutrients you want to increase and lower in nutrients you aim to limit.

Understand Nutrient Content Claims: Leverage %DV to differentiate claims like “light,” “low,” and “reduced.” Simply compare %DVs in each food product to determine the relative amounts of specific nutrients. No need to memorize definitions.

Dietary Trade-Offs: Employ %DV to make dietary trade-offs throughout the day. You don’t have to eliminate favorite foods; instead, balance higher saturated fat items with lower-fat options at other times. Monitor your daily intake to keep the total amount of nutrients you wish to limit below 100%DV.

How the Daily Values Relate to the %DVs:

Examine the example below for another perspective on how Daily Values (DVs) connect to %DVs and dietary guidance. Each nutrient in the table includes a DV, a %DV, and dietary advice or a goal. Following this advice ensures adherence to recommended upper or lower limits set by public health experts for the listed nutrients, based on a 2,000-calorie daily diet.

Examples of DVs versus %DVs

Based on a 2,000 Calorie Diet

 

Nutrient DV %DV Goal
Saturated Fat 20g 100% DV Less than
Sodium 2,300mg 100% DV Less than
Dietary Fiber 28g 100% DV At least
Added Sugars 50g 100% DV Less than
Vitamin D 20mcg 100% DV At least
Calcium 1,300mg 100% DV At least
Iron 18mg 100% DV At least
Potassium 4,700mg 100% DV At least

 

Upper Limit – Consume “Less than”…

The upper limit suggests that it is advisable to stay below or consume “less than” the Daily Value nutrient amounts listed per day. For instance, the Daily Value (DV) for saturated fat is 20g, constituting 100% DV for this nutrient. The recommended goal or dietary advice is to ingest “less than” 20g or 100% DV each day.

Lower Limit – Consume “At least”…

The DV for dietary fiber is 28g, equating to 100% DV. This implies the recommendation to consume “at least” this amount of dietary fiber on most days.

Nutrients Without a %DV: Trans Fats, Protein, and Total Sugars:

Note that Trans fat and Total Sugars lack a %DV on the Nutrition Facts label. Protein only indicates a %DV in specific situations outlined below.

Trans Fat: No reference value for trans fat has been provided by experts or any other information deemed sufficient by the FDA to establish a Daily Value. Diets higher in trans fat are associated with elevated blood levels of low-density lipoprotein (LDL or “bad”) cholesterol, linked to an increased risk of cardiovascular disease. Most uses of artificial trans fat in the U.S. food supply have been phased out as of 2018.

Protein: A %DV is mandatory if a protein claim is made, such as “high in protein.” The %DV for protein is also required on the label if the product is intended for infants and children under 4 years of age. However, if the product is intended for the general population aged 4 and older without a protein claim on the label, the %DV for protein is not obligatory. Current scientific evidence indicates that protein intake is not a public health concern for adults and children over 4 years of age in the United States.

Total Sugars: No Daily Reference Value has been established for Total Sugars because no recommendations have been made for the total amount to consume in a day. It’s important to note that Total Sugars on the Nutrition Facts label encompass naturally occurring sugars (such as those in fruit and milk) as well as Added Sugars.

4. Nutrition Facts Label Variations

Numerous Nutrition Facts labels found in the market will follow a similar structure to the lasagna label illustrated throughout this page. However, food manufacturers are allowed to employ alternative formats. The concluding section will introduce two alternative label formats: the dual-column label and the single-ingredient sugar label.

4.1 Dual-Column Labels

For certain products larger than a single serving but suitable for consumption either in one sitting or across multiple instances, manufacturers are required to incorporate “dual-column” labels. These labels present information on the amounts of calories and nutrients both “per serving” and “per package” or “per unit.” The purpose of this dual-column labeling is to facilitate individuals in easily determining the caloric and nutrient content if they choose to consume the entire package or unit in one instance. For instance, a bag of pretzels containing 3 servings per container might feature a label indicating the calories and other nutrients per serving as well as for the entire package (3 servings).

Nutrition Facts Label Variations

4.2 Single-Ingredient Sugar Labels

Packages and containers of products like pure honey, pure maple syrup, or packages of pure sugar are not obligated to provide information on the grams of Added Sugars in a serving, but they must include the percent Daily Value for Added Sugars. While manufacturers are encouraged (though not obligated) to use the “†” symbol alongside the Added Sugars percent Daily Value on single-ingredient sugars, this would be accompanied by a footnote explaining the quantity of added sugars in one serving and the contribution of that serving toward the percent Daily Value for Added Sugars. The labeling approach for single-ingredient sugars and syrups is designed to avoid creating the impression that additional sugars have been introduced to the product. It also ensures consumers have information on how a serving of these products contributes to the Daily Value for added sugars and their overall diet.

An illustrative example of a label on a single-ingredient sugar, such as honey, is provided below.

Single-Ingredient Sugar Labels

5. The Importance of Proper Labeling Compliance

5.1 For business

When it comes to the production/importation of food in the United States, the responsibilities of food manufacturers extend beyond the production process. Before being distributed in the market, food products must be properly labeled.

Labeling is mandatory for most processed food items, such as bread, cereals, canned and frozen foods, snacks, desserts, beverages, and more. While labeling for raw products (fruits, vegetables, etc.) is voluntary, it is highly recommended.

Errors in product labeling can lead to goods being held back and may hinder customs clearance into the U.S. market. Therefore, adhering to FDA labeling regulations is of utmost importance, impacting the entire export process for food businesses.

5.2 For consumer

Adhering to labeling regulations facilitates informed choices for consumers, enabling them to plan healthier diets, especially those with specific health conditions requiring adherence to a particular dietary regimen.

Warnings about allergens on labels also help consumers avoid regrettable situations arising from the consumption of food containing allergenic ingredients.

6. Challenges in Food Labeling According to FDA Regulations

Complex FDA Regulations on Food Labeling: Challenges for Food Manufacturers Exporting to the U.S.

The intricate regulations imposed by the FDA on food labeling can pose significant challenges for food manufacturers seeking to export their products to the United States. Some of the difficulties encountered include:

  • Time-Consuming Information Retrieval: Finding specific information about product labeling on the vast FDA website can be a time-consuming process for manufacturers.
  • Incomplete Product Listings: Not all food product categories are included on the website. For products not listed, manufacturers must either contact the FDA for guidance or submit their pending products for inclusion in new listings.
  • Numerous Exceptions: There are numerous exceptions to the rules, making it challenging to decipher which labels are mandatory and which are voluntary.
  • Limited Information and Ambiguous Regulations: The primary challenges arise from the scarcity of information and the difficulty in obtaining accurate and comprehensive details. Searching for precise and complete regulatory information is not a straightforward task.

These challenges underscore the importance for food manufacturers to seek professional assistance and inspection services to navigate the complex landscape of FDA regulations, ensuring compliance and smooth export processes to the U.S. market.

To tackle these difficulties, food manufacturers have turned to professional label inspection services, where experts provide guidance on labeling and ensure compliance with FDA regulations. This approach helps food manufacturers and businesses save time and effort, ensuring that the export of goods is executed on schedule and smoothly to the U.S. market.

GOL, with years of experience in label inspection and FDA registration consulting, stands as a reputable company in this field. With a team of highly experienced experts, GOL can assist food manufacturers in:

  • Understanding and comprehending FDA labeling regulations.
  • Providing guidance on proper labeling in accordance with regulations.
  • Conducting label inspections before export.
  • Guiding through FDA registration procedures related to food, cosmetics, medical equipment, and more.

Utilizing GOL’s label inspection services allows food manufacturers to save time, reduce effort, and ensure that product exports to the U.S. adhere to regulations seamlessly and efficiently.

Reference:

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – The Nutrition Facts Label

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