Food

Industry Resources on the Changes to the Nutrition Facts Label

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Final Rules

Final Rule: Revision of the Nutrition and Supplement Facts Labels

See submitted comments, supporting documents, and references in Docket No. FDA-2004-N-0258.

Request for Information

FDA announces request for information (RFI) to invite comments, data and other information on the appropriate reference amount customarily consumed (RACC) and product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored), as well as products that can be used to fill cupcakes and other desserts.

FDA announces request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule.

Fact Sheets, Infographics, and Other Downloads

Guidance for Industry

Meetings & Workshops

News & Press Releases

Following are the most frequently asked questions we have received to our mailbox, NutritionProgramStaff@fda.hhs.gov, and during presentations made to various stakeholder groups. Additional questions will be included in guidance documents under development. This is not an exhaustive list and new questions may be added in the future to address emerging issues and topics that require clarification.

Topics:


Locating Resources

Where can I find a copy of the final rule titled Revision of the Nutrition and Supplement Facts Labels?

The final rule can be accessed and a PDF can be downloaded from the Federal Register website at the following link: https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11867.pdf.

Where can I find a copy of the final rule titled Serving Sizes of Foods That Can Be Reasonably 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?

The final rule can be accessed and a PDF can be downloaded from the Federal Register website at the link: https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11865.pdf.

What are Daily Values and where can I find them?

Daily Values are comprised of two sets of reference values for reporting nutrients in nutrition labels—the Daily Reference Values (DRVs) and the Reference Daily Intakes (RDIs). To limit consumer confusion, the single term “Daily Value” is used to designate both the DRVs and RDIs. The DVs are used to calculate the % Daily Values that consumers see on the Nutrition and Supplement Facts labels. The % Daily Value helps consumers understand how the amount of a nutrient that is present in a serving of a food fits into their total daily diet, and allows them to compare the nutritional value of food products.

Where can I find the new Reference Amounts Customarily Consumed (RACCs)?

A table with the new RACCs can be found starting on page 34041 of the final rule titled 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. A PDF version is also available: New Reference Amounts Customarily Consumed (RACCs) (PDF: 242KB).


Format

Where can I find a quick reference with all of the format requirements for the new label (e.g. font sizes)?

We received many questions about the specifications for the different label formats that were shown in the Nutrition Facts label final rule. Therefore, we are posting graphic illustrations depicting the changes that were made to several format displays, including the standard vertical display, standard tabular display, tabular display for small packages, and the linear display for small packages. These illustrations provide information on requirements for the use of bold font and type sizes that were established in the Nutrition Facts label final rule. We are also providing illustrations on the new Nutrition Facts label depicting other format elements that have not changed, such as line thickness, font styles, and leading specifications that were previously shown in Appendix B to Part 101, Title 21 of the CFR.

Note that, except for the hairline above the Added Sugars declaration, all hairlines between nutrients extend the full width of the label so that the hairlines almost touch the left border of all label formats (with the exception of the tabular and linear displays). We acknowledge that the dual column label formats depicted in the final rule incorrectly showed the hairlines between Saturated Fat and Trans Fat as not extending to the left edge of the label. We plan to correct this error. Additionally, a type size was inadvertently left out of the rule for the “Amount Per Serving” statement CFR 101.9(d)(1)(iii), we plan to correct that in a future rulemaking.

Will FDA be providing templates of the Nutrition Facts label for industry to use?

FDA has not provided label templates in the past, nor do we plan to do so now. The use of a template would not necessarily reflect all of the factors that a company may need to consider that are unique to its product, such as the placement of information on a particular package size, the need for certain nutrition information based on label claims made elsewhere on the label, and decisions related to voluntary nutrition information that may be included or omitted. Therefore, we suggest that companies use the sample labels and graphic illustrations as visual guides when formatting their own labels.

To help industry comply with the changes described in the new regulations, we are posting graphic illustrations of several different format displays that depict the requirements and also provide examples of certain format elements that have not changed. Please see question #5 above. FDA is also aware that the private sector is equipped to provide labeling templates.

Will the agency be releasing high-resolution versions of the mockups?

See High-Resolution Examples of Different Labels in the New Format (for reference only) (PDF: 1.15MB).

What order should nutrients be listed on the Nutrition Facts label?

We have provided a sample label (Standard Vertical label with voluntary nutrients) on page 33986 of the final rule showing the order in which the mandatory nutrients and some commonly listed voluntary nutrients are declared on food product labels. Following the “Calories” declaration located near the top of the label, the general order for listing nutrients is: macronutrients (and sodium), mandatory public health nutrients (i.e., vitamin D, calcium, iron, and potassium), voluntary vitamins, and voluntary minerals. As stated in 21 CFR 101.9(c)(8)(ii)(B), voluntary vitamins and minerals must be listed on the Nutrition Facts label in the order established in the table in 21 CFR 101.9(c)(8)(iv) (see the table on page 33982 of the final rule). It should be noted that this table also includes the mandatory vitamins and minerals (i.e., vitamin D, calcium, iron, and potassium) and protein, which should not be considered when determining the order of the voluntary nutrients. In addition, this table lists the unit of measure and RDI for each nutrient. Nutrients having a DRV are shown in the table on pages 33982-83 of the final rule (21 CFR 101.9(c)(9)), but these nutrients are not listed in the exact order they appear on the Nutrition Facts label. 

The following table summarizes the order that mandatory and voluntary nutrients are generally declared on the Nutrition Facts label: 

Calories

Calories from Saturated Fat

Total Fat

Saturated Fat

TransFat

Polyunsaturated Fat

Monounsaturated Fat

Cholesterol

Sodium

Fluoride

Total Carbohydrate

Dietary Fiber

Soluble Fiber

Insoluble Fiber

Total Sugars

Added Sugars

Sugar Alcohol [1]

Protein

Vitamin D

Calcium

Iron

Potassium

[1] The specific name of the sugar alcohol (e.g., “Xylitol”) may be declared on the label if only one sugar alcohol is present in the food.

Vitamin A

Vitamin C

Vitamin E

Vitamin K

Thiamin

Riboflavin

Niacin

Vitamin B6

Folate [2]

Vitamin B12

Biotin

Pantothenic Acid

Phosphorus

Iodine

Magnesium

Zinc

Selenium

Copper

Manganese

Chromium

Molybdenum

Chloride

Choline

[2] "Folate" and "Folic Acid" must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.

What order should nutrients be listed on the Supplement Facts label?

The order in which nutrients are listed on the Supplement Facts label is described in 21 CFR 101.36(b)(2)(i)(B) on page 33994 of the final rule. Our final rule requires that choline be declared after pantothenic acid on the Supplement Facts label and that fluoride be declared at the end of the list of nutrients (i.e., after potassium). The sample label on page 33999 of the final rule shows the order in which commonly listed vitamins and minerals are declared on dietary supplement labels. However, this label contains an error, as choline should be declared after pantothenic acid, rather than after potassium as it now appears. FDA plans to correct this error in a technical amendment.

The general order in which macronutrients and micronutrients in a dietary supplement product are listed on the Supplement Facts label is summarized in the following table:

Calories

Calories from Saturated Fat [1]

Total Fat

Saturated Fat

Trans Fat

Polyunsaturated Fat [1]

Monounsaturated Fat [1]

Cholesterol

Total Carbohydrate

Dietary Fiber

Soluble Fiber [1]

Insoluble Fiber [1]

Total Sugars

Added Sugars

Sugar Alcohol [1, 2]

Protein

Vitamin A

Vitamin C

Vitamin D

Vitamin E

Vitamin K

Thiamin

Riboflavin

Niacin

Vitamin B6

Folate [3]

Vitamin B12

Biotin

Pantothenic Acid

Choline

[1] Must be declared if a claim is made about the nutrient; otherwise, declaring the nutrient is voluntary.

[2] The specific name of the sugar alcohol (e.g., “Xylitol”) may be declared on the label if only one sugar alcohol is present in the dietary supplement.

[3] "Folate" and "Folic Acid" must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.

Calcium

Iron

Phosphorus

Iodine

Magnesium

Zinc

Selenium

Copper

Manganese

Chromium

Molybdenum

Chloride

Sodium

Potassium

Fluoride


Food Labeling Guide

Is FDA planning to update the labeling guide posted on your website?

We are working on updating our current Food Labeling Guide to incorporate the changes to the Nutrition and Supplement Facts labels, but this will take some time. Parts of the labeling guide are up to date including the net quantity statements, ingredient lists, and claims information. While the Nutrition Labeling section of Food Labeling guide is being updated, the nutrition labeling changes are addressed in our final rules that updated the Nutrition Facts label and we are also providing this Question and Answer document to highlight the areas of change to the format.


Supplement Facts Label

Is the format changing for the Supplement Facts Label? How big should the calorie declaration be for the Supplement Facts label?

The format of the Supplement Facts label is not changing substantially. Similar to the Nutrition Facts label, we will no longer require vitamin A, vitamin C, or calories from fat to be declared as (b)(2) dietary ingredients, and instead we will require vitamin D, potassium, and added sugars to be declared. In addition, we have replaced “sugars” with “total sugars” in the list of (b)(2) dietary ingredients, and we have made several changes in the order in which vitamins and minerals are listed (for example, when declared, choline must follow potassium on the label and fluoride must be at the end of the list of nutrients), as described on page 33933 of the final rule (§ 101.36(b)(2)(i)(B)). Furthermore, we have updated the Daily Values based on recent science, and we are updating the units of measures. We also are requiring a footnote for labels for certain products represented or purported to be for use by children 1 through 3 years of age as shown in § 101.36(e)(11)(ii) (Please see Section P beginning on page 33932 of the final rule).

The calorie declaration on the Supplement Facts label does not need to be as prominent as on the Nutrition Facts label because many dietary supplements do not contribute a significant amount of calories to the diet. Therefore, as we state on page 33939 of the final rule, we are not requiring that information about calories be displayed in a larger type size or be highlighted in bold type or extra bold on any Supplement Facts label. In a future technical amendment, we will correct the error in the codified section of the final rule (§ 101.36(e)), which states that a font size at least two points greater [than 8 point] shall be used for “Calories” and the heading “Calories” and the actual number of calories per serving shall be highlighted in bold or extra bold type.


Guidance

Will you be issuing guidance on the Nutrition Facts labeling requirements? If so what is the timing?

Yes. FDA plans to issue two guidance documents later this year or early next year – one related to helping the industry comply with the new requirements (e.g., the compliance date and added sugars) and the other on the scientific evaluation of the evidence on the physiological benefits of dietary fiber. Additional guidance documents are being planned related to RACC tables and units of measure.


Compliance

When can I start making changes to my labels?

Updated Nutrition and Supplement Facts labels may be displayed on packages now but must be on packages by July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).

When must the label be displayed on food packages?

Our current thinking is that food products that are initially introduced into interstate commerce on or after July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales) would need to include the new version of the Nutrition Facts and Supplement Facts labels.

This approach is consistent with that used for the regularly scheduled labeling for the Uniform Compliance Date, where we base enforcement on whether the food products are initially introduced into interstate commerce on or after the scheduled compliance date.

We plan to address this further in guidance.

When determining whether my labels need to be in compliance with the new requirements, 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?

We have received a number of inquiries on this topic, and intend to provide more guidance to industry on the compliance dates as soon as possible.


Rounding

How should the quantitative amounts of vitamins and minerals be rounded when declared on the label since manufacturers are now required to declare both the quantitative amount as well as the % Daily Value for calcium, vitamin D, iron, and potassium on the Nutrition Facts label?

Manufacturers may also voluntarily declare the quantitative amounts of other vitamins and minerals that are declared on the label.

Manufacturers should look at the units of measurement and the number of decimal places that are used in the table for Daily Values for the vitamins and minerals when calculating the amount of vitamins and minerals in one serving of a product. Please see 21 CFR 101.9(c)(8)(iv) and question # 9 (the table of Daily Values for many of the vitamins and minerals). Zeros following decimal points may be dropped and additional decimal places may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole milligrams, but the quantitative amount may be declared in tenths of a milligram). See 21 CFR 101.9(c)(8)(iii) on p. 33981 of the Nutrition Facts Label Final Rule.

Should the %DV declaration be determined based on the amount of the nutrient before or after rounding?

In order to calculate the %DV, determine the ratio between the amount of the nutrient in a serving of food and the DV for the nutrient. That is, divide either the actual (unrounded) quantitative amount or the declared (rounded) amount by the appropriate DV. When deciding whether to use the unrounded or rounded value, consider the amount that will provide the greatest consistency on the food label and prevent unnecessary consumer confusion. (See Appendix F: Calculate the Percent Daily Value for the Appropriate Nutrients in the FDA Food Labeling Guide).


Added Sugars

Are the sugars in a jar of honey or a bag of sugar added sugars? If so, what should the total and added sugars declaration look like?

Yes, the sugar in a jar of honey and the sugar in a bag of sugar are added sugars. The definition of added sugars includes sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type. The definition excludes fruit or vegetable juice concentrated from 100 percent fruit juice that is sold to consumers (e.g. frozen 100 percent fruit juice concentrate) as well as some sugars found in fruit and vegetable juices, jellies, jams, preserves, and fruit spreads. Please see 21 CFR 101.9(c)(6)(iii) on page 33980 of the Nutrition Facts Label Final Rule for the definition of “Added Sugars.” For example the total sugars for a serving of honey would be 17 grams (g) and the added sugars declaration would also be 17g.

FDA defined sugars from honey as added sugars in the final rule. The agency has heard concerns from the honey industry about declaring the sugars in a jar of honey as added sugars, including that the sugar in honey is not added to the product. FDA plans to invite further comment in the near future.

Do sugars found in concentrated fruit or vegetable purees and pastes need to be declared as added sugars on the label?

We have received a number of inquiries related to this topic since publication of the final rule.  We intend to issue guidance to further clarify this issue.

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