Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry. Provided by the United States Food and Drug Administration.
Table of Contents
III. Questions and Answers on Compliance Issues
IV. Questions and Answers on Added Sugars
V. Question and Answer on Format Issues
VI. Question and Answer on the Declaration of Quantitative Amounts of Vitamins and Minerals
This guidance is intended for conventional food and dietary supplement manufacturers. It provides questions and answers on topics related to compliance with our final rules issued on May 27, 2016, entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742; the “Nutrition Facts label final rule”) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000; the “serving size final rule”) (codified at title 21 of the Code of Federal Regulations, part 101 (21 CFR part 101)). This guidance also discusses labeling of added sugars, as well as formatting for lines (e.g. thickness of lines) and leading (e.g. space between lines) in the examples of graphics used by FDA on the Nutrition Facts label.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. In this guidance, “you” (or “I”) refers to a manufacturer of conventional food or dietary supplements.
On May 27, 2016, we published the Nutrition Facts label and the serving size final rules related to the Nutrition and Supplement Facts labels, which amended our labeling regulations for foods to provide updated nutrition information to assist consumers in maintaining healthy dietary practices. Below is a summary of the combined major provisions of the Nutrition Facts label final rule and serving size final rule.
The final rules revise the Nutrition Facts and Supplement Facts labels by:
• Removing the declaration of “Calories from fat”;
• Requiring the declaration of the gram (g) amount of “added sugars” in a serving of a product, establishing a Daily Reference Value (DRV) for added sugars, and requiring the percent Daily Value (DV) declaration for added sugars;
• Changing “Sugars” to “Total Sugars” and requiring that “Includes ‘X’ g Added Sugars” be indented and declared directly below “Total Sugars”;
• Updating the list of vitamins and minerals of public health significance;
• Updating certain reference values used in the declaration of percent DVs of nutrients on the Nutrition Facts and Supplement Facts labels;
• Revising the format of the Nutrition Facts labels to increase the prominence of the declaration of ‘‘Calories”;
• Removing the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets;
• Requiring the maintenance of records to support the declarations of certain nutrients under specified circumstances;
• Amending the definition of a single-serving container;
• Requiring dual-column labeling for certain packages;
• Amending several reference amounts customarily consumed that are used by manufacturers to determine their label serving size; and
• Establishing an effective date of July 26, 2016, and a compliance date of January 1, 2020, for manufacturers with more than $10 million in food sales (originally scheduled to be July 26, 2018) and January 1, 2021, for manufacturers with less than $10 million in annual food sales (originally scheduled to be July 26, 2019).
III. Questions and Answers on Compliance Issues
1. Must the updated Nutrition or Supplement Facts label appear on all foods sold by the applicable compliance date?
After publication of the final rule, we included a frequently asked question on our website asking “When must the label be displayed on food packages?” In our response, we stated that the revised labels were to be displayed on food products that are initially introduced into interstate commerce on or after the compliance date, and said we would address the issue further in guidance. We received a number of questions about products at various points in the distribution chain and whether the product would need to bear the new version of the Nutrition or Supplement Facts label. After further consideration, we are providing the following guidance.
Products that are labeled (i.e., when the label is placed on the product) on or after the applicable compliance date must bear a nutrition label that meets our new nutrition labeling requirements in 21 CFR 101.9 and 21 CFR 101.36. Products that are labeled before the applicable compliance date do not need to be in compliance with the new labeling requirements, and therefore, do not need to bear the new nutrition label.
We consider the date the food product was labeled for purposes of determining whether the product must bear a nutrition label that meets the new requirements. We would not consider the location of the food in the distribution chain to determine whether a food product must bear a nutrition label that meets our new nutrition labeling requirements. For example, the food product, whether labeled before or after the compliance date, may be at the manufacturing facility awaiting distribution, at a warehouse awaiting further distribution, in transit to the United States to be offered for import, or on the store shelf of a U.S. retail establishment.
We do not object to the use of a sticker for providing a revised nutrition label that meets our new requirements in 21 CFR 101.9 and 21 CFR 101.36 before new packaging is printed.
The sticker label should not cover any other mandatory information and should adhere to the package during normal handling.
2. When determining whether labels need to be in compliance with the newrequirements, should the determination as to whether my company has $10 million or more in annual food sales be based on domestic food sales or total food sales, including international sales, and how many years of sales should I consider?
To determine whether a company has $10 million or more in annual food sales, a firm can either take the smallest sales volume from the previous three years (e.g., 2013, 2014, and 2015), or alternately the firm can take the average of the previous three years sales volume. A firm’s total (domestic plus international) food sales best reflects the firm’s resources and, thus, ability to comply with the final rules by the applicable compliance date.
3. Are there certain approved companies or nutrition databases that manufacturers can use to get the nutrition values for their products?
FDA does not approve nutrition databases. However, the United States Department of Agriculture provides nutrition information for a number of foods, and there are also several commercially available nutrition databases you can use to determine nutrition values for your products.
4. Who is responsible for the accuracy of the Nutrition Facts label on a food product’s label? Who is responsible for maintaining the records needed to verify the accuracy of certain nutrient declarations, including where a firm may perform operations that include those of an ingredient supplier, a manufacturer of a finished food sold under their own brand name, and/or a labeler that labels the product under the firm’s or another firm’s brand name?
The Federal Food, Drug, and Cosmetic Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a misbranded food (21 U.S.C. 331(a)). For example, a supplier has responsibility to ensure that the information about the amount of a nutrient in an ingredient it sells to a manufacturer is accurate, where there is no suitable analytical method available that the manufacturer can use to measure the nutrient’s quantity. The manufacturer has responsibility for the accuracy of the nutrient declarations on the label of its food and a manufacturer generally would receive information from its supplier about the amount of the nutrient in the ingredient to ensure the accuracy of the nutrient declaration on the finished food. A distributor that purchases a finished food and then labels the product under its own brand name has responsibility for the accuracy of its food label. Such a distributor also generally would receive information from its supplier (the manufacturer) about the amount of the nutrient in the finished food product to ensure the accuracy of the nutrient declaration on the finished food.
Food manufacturers must make and keep records to support certain nutrient declarations on their product labels (21 CFR 101.9(g)(10)). The recordkeeping requirements specified in 21 CFR 101.9(g), are only for foods for which Association of Official Analytical Chemists (AOAC) International or other reliable and appropriate analytical methods are not available (81 FR 33742 at 33775). The manufacturer of a finished food must make and keep records to support nutrient declarations, as required by 21 CFR 101.9(g)(10) and to make the records available during an inspection. The manufacturer would be expected to have information from its ingredient supplier if an ingredient contains a nutrient added by the supplier for which there is no suitable analytical method available that the manufacturer can use to measure the nutrient’s quantity. In such a case, the amount of the nutrient added may be known only to the supplier. In situations where we inspect a distributor that distributes a product labeled under its own brand name, and that product includes a nutrient for which there is no suitable analytical method available to measure the nutrient’s quantity, we intend to ask the distributor to provide information from the manufacturer that supports the nutrient declaration on the distributor’s label for product the distributor introduced, or delivered for introduction, into interstate commerce. Without such information, it is not clear how a distributor could ensure its labeled nutrient declarations do not misbrand its product.
5. How does FDA intend to exercise enforcement discretion with respect to mandatory nutrition labeling for bottled water products and coffee beans (whole or ground), tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that would have been exempt under § 101.9(j)(4) prior to the effective date of the Nutrition Facts label final rule?
FDA intends to exercise enforcement discretion (i.e., we intend to refrain from taking regulatory or compliance actions) against bottled water products and coffee beans (whole or ground), tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that would have been exempt under § 101.9(j)(4) with respect to mandatory labeling prior to the effective date of the Nutrition Facts label final rule if these products do not meet the new requirements. We intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these products.
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