Source: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm513734.htm?utm_campaign=FDA%20Extends%20Nutrition%20Facts%20Label%20Compliance%20Dates&amp;utm_medium=email&amp;utm_source=Eloqua&amp;elqTrackId=26f869b37c104130a4406973d566f1f5&amp;elq=e6b92cfa33ff4220849bde9c4c96da2c&amp;elqaid=3382&amp;elqat=1&amp;elqCampaignId=2567
Timestamp: 2019-04-22 16:17:51+00:00

Document:
Provides technical amendments to the two final rules concerning Nutrition Facts and Supplement Facts labeling.
Following are resources and the most frequently asked questions we have received via our inquiry form, 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.
Where can I find the final rules, guidance, and other helpful reference information related to the Nutrition Facts and Supplement Facts labels?
Is there 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 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 and we do not 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. Refer to the previous question for links. 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: 475KB).
Does the FDA have an example of an English/Spanish bilingual Nutrition Facts label?
For an example of an English/Spanish bilingual standard vertical label, see Nutrition Facts/Datos de Nutricion – Bilingual Label (for reference only) (PDF: 115KB).
In 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 page 33982 and page 33983 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 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.
 "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.
In 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.
 Must be declared if a claim is made about the nutrient; otherwise, declaring the nutrient is voluntary.
 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.
FDA now permits the voluntary declaration of fluoride as provided for in §101.9(c)(5). Where should fluoride be placed on the Nutrition Facts label and how should it be formatted (i.e. indentation, bolding, etc.)?
Our current thinking is to place the declaration for “Fluoride” directly beneath the declaration of “Sodium” on the Nutrition Facts label, when fluoride is voluntarily declared pursuant to 21 CFR 101.9(c)(5). Our current thinking with regards to formatting fluoride is to list the nutrient in bold or extra bold type and not to indent the declaration; an approach consistent with the declaration of sodium, which would appear directly above the voluntary fluoride declaration. We plan to address this in future guidance.
Is it permissible to use the abbreviations identified for nutrients in §101.9(j)(13)(ii)(B) in the statement, “Not a significant source of ____” as required by §101.9(f)(4) when the simplified Nutrition Facts panel format is used and nutrition claims are made on the label?
The use of abbreviations for nutrients identified in 21 CFR 101.9(j)(13)(ii)(B) may be used in that statement for foods in packages that have a total surface area available to bear labeling of 40 or less square inches. The modified requirements set forth in § 101.9(j)(13)(ii)(B) do not apply to all packages that use the simplified Nutrition Facts panel, only those packages that have a total surface area available to bear labeling of 40 or less square inches.
If there is insufficient continuous vertical space (i.e., larger than 3 inches) for the Nutrition Facts panel, can the tabular format be used?
The regulation in § 101.9(d)(11)(iii) provides that if there is not enough vertical space (i.e., approximately 3 in.) to accommodate the required components of the Nutrition Facts label, up to and including the mandatory declaration of potassium, the nutrition label may be presented in a tabular display.
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.
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 pantothenic acid on the label and fluoride must be at the end of the list of nutrients, below potassium when it is declared), 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. Also, we are requiring a footnote for labels of 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 intend to 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.
On May 3, 2018, the FDA issued a final rule to extend the compliance dates for the Nutrition Facts and Supplement Facts label and Serving Size final rules from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would have an additional year to comply – until Jan. 1, 2021.
When can I start making changes to my labels?
Updated Nutrition and Supplement Facts labels may be displayed on packages now.
When must the label be displayed on food packages?
Manufacturers with $10 million or more in annual food sales are expected to update their labels by Jan. 1, 2020. Manufacturers with less than $10 million in annual food sales are expected to update their labels by Jan. 1, 2021.
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 issued the Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals, which addresses this topic.
Are the sugars in a bag of sugar added sugars? If so, what should the total and added sugars declaration look like?
Yes, the sugars in a bag of sugar are included in the definition of added sugars in the final rule. 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 the Nutrition Facts Label Final Rule for the definition of “Added Sugars.” For example the total sugars for a serving of sugar 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.
Are the sugars in a jar of honey or maple syrup added sugars? If so, what should the total and added sugars declaration look like?
FDA defined sugars from honey and maple syrup as added sugars in the final rule. The agency heard from the honey and maple syrup industries about their concerns that consumers may believe their products are adulterated if they declare “added sugars” on the label, when in fact, no sugars have been added to the products.. In response to these concerns about economic adulteration, the FDA issued Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products.
The draft guidance would allow manufacturers to use the “†” symbol immediately after the added sugars percent Daily Value information on pure honey, pure maple syrup, and certain cranberry products. The symbol would lead the reader to truthful and non-misleading statements outside the Nutrition Facts label to provide additional information regarding the added sugars.
The agency is accepting public comment on the Draft Guidance.
Why is the FDA allowing certain cranberry products to use the “†” symbol on their labeling?
Stakeholders raised concerns that cranberries are a naturally tart fruit and consumers might avoid cranberry products that are sweetened for palatability in favor of products that contain the same amount of total sugar, but list zero grams of “added sugars” on the labels because they are inherently sweet. The use of the “†” symbol would provide an opportunity to clarify that sugars were added for palatability.
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. Additional information is available in our Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.
We intend to respond to questions we received on the draft guidance about concentrated fruit or vegetable purees and pastes when we issue the final guidance.
FDA has standardized Brix data for a variety of juices (§ 101.30(h)) but this table does not include all of the common fruit/vegetable juices used to formulate products today (e.g., coconut water, acai juice). Does FDA plan to update the Brix table in § 101.30(h)?
We are not planning to update the Brix table in 21 CFR 101.30(h) at this time. The mechanism for requesting the addition to the table of a Brix level for a single strength juice is the submission of a Citizen Petition (CP) (21 CFR 10.30). The addition to the table in § 101.30(h)(1) of a Brix level for a new single strength juice would require FDA to amend the regulation to update the table.
We intend to respond to questions relation to the calculation of added sugars in juices in the final guidance on Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.
Some products have a RACC of 30 grams, which needs to be converted to a household measure for the serving size. A RACC of 30 grams is approximately equal to a household measure of 1 ounce, but 1 ounce technically weighs 28.35 grams. If the household serving size is 1 ounce, should the gram weight equivalent of the label serving size be 30 grams or rounded to 28 grams?
For nutrition labeling purposes, if the household serving size is 1 ounce, manufacturers should use 28 grams as the rounded metric weight equivalent, as explained in 21 CFR 101.9(b)(5)(viii).
How do I know to which RACC product category my product belongs?
In February 2018, we issued Final Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category to help industry identify the product category to which specific products belong by providing a non-exhaustive list of product examples that belong in each of the product categories included in the RACC tables established in 21 CFR 101.12(b).
Are product labels that voluntarily provide an additional column of nutrition information per unit when the serving size of a product in discrete units in a multi-serving container is more than 1 unit exempt from dual-column labeling requirements, when dual-column labeling would otherwise be required?
There is no specific exemption from dual-column labeling requirements for product labels that voluntarily provide an additional column of nutrition information per unit.
The first column shall provide nutrition information per serving size, which shall be the amount that approximates the reference amount (e.g., ½ piece).
The second column shall provide the quantitative amounts and percent Daily Values per individual unit.
Note that the exemptions in paragraphs (A), (B), and (C) of § 101.9(b)(12)(i) apply to labels subject to the requirements of § 101.9(b)(2)(i)(D).
Is a manufacturer permitted to voluntarily provide an additional column of nutrition information on the serving size as determined by the RACC for products that meet the criteria for the single-serving container definition as described in §101.9(b)(6)? The product label described in this scenario would have two columns of nutrition information: (1) serving size as determined by the RACC and (2) serving size based on the entire contents of the container.
For products that meet the definition of a single-serving container, the serving size is the container, not the amount most closely approximating the RACC. Including nutrition information based on the serving size (in this scenario, the full container) is not voluntary. However, under § 101.9(b)(6), in addition to providing a column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values per serving, for a product that is packaged and sold individually that contains more than 150 percent and less than 200 percent of the applicable reference amount, the Nutrition Facts label may voluntarily provide, to the left of the column that provides nutrition information per container (i.e., per serving), an additional column that lists the quantitative amounts and percent Daily Values per common household measure that most closely approximates the reference amount.
For product that meets the criteria for the single-serving container definition and the label voluntarily discloses nutrition information on a “per unit” basis in addition to a “per serving” basis and bears a nutrient content claim, should the nutrient content claim be based on the serving (i.e., the entire contents of the container) or the unit?
As explained in the Serving Size Final Rule, nutrient content claims typically must be based on the RACC, but in some cases they must be based on both the RACC and a per-label serving size (81 FR 34000, 34010, May 27, 2016). Nothing in the Serving Size Final Rule changed the preexisting requirements for nutrient content claims for those who choose to voluntarily provide a second column of nutrition information. However, under the Serving Size Final Rule, when a nutrient content claim is made on the label of a product that uses a dual column as required in § 101.9(b)(2)(i)(D) or (b)(12)(i), the claim must be followed by a statement that sets forth the basis on which the claim is made, except that the statement is not required for products when the nutrient that is the subject of the claim meets the criteria for the claim based on both the RACC and the entire container or unit amount. All information included on a product label must be truthful and not misleading.
If a manufacturer chooses to voluntarily include an additional column of RACC-based nutrition information for a product that is packaged and sold individually, that contains more than 150% and less than 200% of the applicable RACC, how should the serving size and servings per container be based?
Voluntarily choosing to provide an additional column of information does not change the serving size of the product. Under § 101.9(b)(6), a product that is packaged and sold individually that contains less than 200 percent of the applicable reference amount must be considered to be a single-serving container, and the entire content of the product must be labeled as one serving.
For variety packs where there is more than one of each product, what is the appropriate presentation for the servings per container to indicate the number of servings of each product?
Aggregate displays shall comply with the format requirements of § 101.9(d) to the maximum extent possible, except that the identity of each food shall be specified immediately to the right of the “Nutrition Facts” heading, and both the quantitative amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food.
For an example of the correct format for the aggregate display, see page 33987 of the final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Label” (81 FR 33742 at 33987).

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