Overview

Download PDF Version Of This Document

This document is a compilation of all important links involving the new FDA nutrition facts labels for food vendors.  As always, if you have any questions, feel free to e-mail us at contact@menutail.com.

Proposed Rules to Watch:

Pending Questions Awaiting FDA Response:

These are a compilation of questions we have asked the FDA and their responses so far.

Compliance Dates

Label Examples:

Download Sample PDF Labels

These labels are all generated using the Menutail system.  Notice that we are keeping the FDA preferred fonts of Helvetica for the best design continuity. 

Label Type	Description	Example
Vertical	Most commonly used vertical label
Vertical Simplified	Vertical label, but line items are removed when insignificant amounts occur (DV is less than 2%)
Long Tab Label	Tabular version
Short Tab Label	A version for smaller packaging
Linear Label	Text only label for the smallest packaging
Vertical Dual Column Label	This label is triggered when your serving size ratio is >200% and <= 300%
Tabular Dual Column Label	This label is triggered when your serving size ratio is >200% and <= 300%

A lot of people have been asking if maltodextrin is an added sugar, and the FDA has sent this response:

We issued draft guidance in January of this year that address sugars created through hydrolysis, such as maltodextrin.  Please see our response to question #13 starting on p. 14 of the draft guidance: 

https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM535372.pdf

Here is the text below for your convenience:

13. Some ingredients contain mono- and disaccharides (DP1 and DP2 (one and two degrees of polymerization)) that are created through processes such as hydrolysis.   Do the mono and disaccharide portions of ingredients that are created through hydrolysis need to be declared as added sugars on the label?

In the preamble to the final Nutrition Facts label rule (81 FR 33742 at 33831), we said that, other than sugar syrup types of products where the sugars are specifically and purposely produced via hydrolysis, we do not have information suggesting that sugars produced through incidental hydrolysis of complex carbohydrates results in significant increase in the sugar content of foods. Sugars which are produced through incidental hydrolysis would be captured in the total sugars declaration, but we did not have any comments or other information suggesting that these sugars should be captured under the added sugars declaration. Therefore, they are not included in our definition of added sugars and would not be declared as added sugars on the label. We also explained our position that if a manufacturer purposely employs a hydrolysis step as part of a food manufacturing process to increase the sugar content of a food product (e.g. enzymatic hydrolysis of corn starch to make corn syrup in the same facility as part of the cookie-making process), we would consider the sugar generated from the hydrolysis step to be added sugars, since hydrolysis was purposely used by the manufacturer to increase the sugar content of the product (81 FR 337242 at 33832).

In the preamble to the Nutrition Facts label final rule (81 FR 33742 at 33835), we also said that, in determining which sugars should be included in the definition of added sugars, we have considered the presence of added sugars as a component of dietary intake and whether it is consistent with the concept of empty calories, as discussed in the 2015 DGAC Report.

Manufacturers may purposely employ methods, such as hydrolysis for a number of reasons, some of which result in an ingredient containing mono- and disaccharides with DP1 and DP2. Ingredients such as maltodextrin and corn syrup solids are hydrolyzed to achieve various degrees of dextrose equivalence (DE). The higher the DE, the lower the degree of polymerization, and the sweeter the ingredient becomes. Maltodextrins (21 CFR 184.144) are ingredients with a DE less than 20, and corn syrup solids (21 CFR 168.121) are ingredients with a DE of 20 or higher. Depending on the manufacturing process, different maltodextrin and corn syrup solids will have different DE and different amounts of monoand di-saccharides. Although maltodextrins are not used primarily for sweetening purposes, depending on the DE, some can contain 8-9% mono and disaccharides and can contribute to sweetness. We also understand that the hydrolysis process to manufacture maltodextrin and corn syrup solids are controlled so that the desired DE can be consistently achieved. This indicates that some maltodextrins and corn syrup solids are manufactured purposely to contain certain levels of mono- and disaccharides.

If a serving of a product contains less than 0.5 grams of added sugars from maltodextrins, corn syrup solids, or another ingredient made with a hydrolysis step, we would consider the presence of this low amount of mono- and disaccharides to be an insignificant amount towards the empty calorie contribution from the added sugars content of the diet. The added sugars content may be expressed as zero on the label at these low levels. When the monoand disaccharides are present in such small amounts that they do not contribute to the sweetness of a product, we would anticipate that the amount of mono- and disaccharides would be so low that they would not contribute to an added sugars declaration (e.g. there would be less than 0.5 grams of mono- and disaccharides contributed by the ingredient). Such small amounts of mono- and disaccharides would also not contribute meaningful amounts of calories to the diet.

Ingredients, such as maltodextrins, are used in many food products and may contribute more than 0.5 grams per serving in some foods. When maltodextrins are intentionally created through hydrolysis in amounts of greater than 0.5 grams per serving, their contribution to the overall diet would be consistent with the concept of empty calories, and when present, must be declared as added sugars on the label. Similarly, when mono- and disaccharides with DP1 and DP2 are created through hydrolysis and are present in other ingredients in amounts of 0.5 grams or greater, those mono- and disaccharides contribute empty calories to foods and must also be declared as added sugars on the label (21 CFR 101.9(c)(9)(iii)).

Download PDF Ebook

Below is a a zip file containing all of the sample labels from a cookie recipe.
Download Sample PDF Labels

Video Overview:


On May 27, 2016 the FDA approved a new redesigned label for food manufacturers.  You can read more in the link below

FDA Regulatory Link

When do I need to have the new labels by?

If you have less than $10 million in sales, the deadline for new labels is July 26, 2019

If you have more than $10 million in sales, the deadline for new labels is July 26, 2018

Special Note

Menutail is currently the only nutrition analysis tool on the Internet that is supporting the new redesigned nutrition facts labels in the FDA preferred font of Helvetica as well as the dual column labels.

What are the major regulation changes?

1)      Serving Size Update

• The FDA has defined new Reference Amount Customarily Consumed (RACC) amounts. For example a serving of ice cream is now considered 2/3 of a cup.

2)      Added Sugars

• You are now required to disclose added sugars on your food formulation.  Things like raw sugar, brown sugar,honey, corn syrup, and sugars from syrup would be considered an added sugar

3)      Nutrient Disclosures

• Vitamin D and Potassium are now required. Also, you are now required to disclose the the actual amounts of micronutrients.  Menutail will take care of this.

4)      Dual Column Labels (see example of label at end of document)

• FDA Regulations states that if your serving size weighs at least 200% and up to 300% of your package, a dual column label is required.  Menutail will alert you if this is the case.
• Example:

Single Serving Weight 15.0g
Total Food Weight: 45.0g
Serving Size Ratio: 300% (45.0/15.0)*100

The Serving Size Ratio is between >200% and <= 300% which flags this FDA regulation and requires a dual column label. 

5)      Round Up Rule

• If your package has less than two servings, the FDA will force the serving size to be rounded up to the entire package.
• FDA Regulations states that 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.  Menutail will alert you when this happens.

Example:
Single Serving Weight 15.0g
Total Food Weight: 28.0g
Serving Size Ratio: 187% (28.0/15.0)*100
The Serving Size Ratio is between <= 200% which flags this FDA regulation

The new serving size is now 28.0g instead of 15.0g

Example:
Single Serving Weight 15.0g
Total Food Weight: 28.0g
Serving Size Ratio: 187% (28.0/15.0)*100
The Serving Size Ratio is between <= 200% which flags this FDA regulation

The new serving size is now 28.0g instead of 15.0g

New FDA 2016 Nutrition Facts Workflow

Step 0: Racc Check

The FDA has changed the definition of Reference Amount Customarily Consumed (RACC) amounts.  We have created a new page to help you find your new values.

On the left side bar click ‘Racc Helper’

This page is the same text as this regulation:

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr;sid=6daba5014ee305c0ce964e445538a128;rgn=div5;view=text;node=21%3A2.0.1.1.2;idno=21;cc=ecfr#se21.2.101_112

1. Look up your product in the page either through the
   1. Category Filter
   2. Search
2. Write down the reference amount and label statement

For example in this ice cream example
a. Serving Size – 2/3 cup

***Potential Impact to your food product packaging
Note that the new serving sizes may require you to reformulate your food packaging.  We advise that you do some test runs of creation a nutrition facts labels to assess any impacts early on.

 

Step 1: Label Name and Serving Sizes

When creating a recipe, these two new values are now required:

• Single serving weight
• Total food weight

For example, if you had

• 1 cookie – 30 grams
• 12 cookies in a package

You would write:

• Single serving weight – 30
• Total food weight 360 (30*12)

The reason we need this values up front is because have to do perform a

• Dual column label check
• Potential serving size rounding check

Step 2: Regulation Check

In this page, there are 3 scenarios you can run into

Scenario 1: All rules pass

In this scenario, your serving sizes didn’t trigger any rules, and you will go through the normal workflow

Scenario 2: Dual Column Label

If your formulation flagged a dual column, you have two options:

• Click back and reformulate your recipe so you no longer are under a dual column regulation
• Click next and continue

Scenario 3: Label Serving’s Size Rounded Up

If your formulation flagged for rounding, it means your serving size gets rounded up, increasing the value of your nutrition label.  You have two options:

• Click back and reformulate your recipe so you no longer are under this regulation
• Click next and continue

Step 3: Add Ingredients

In this step you can add ingredients with the autocomplete as usual. 

You also can rename long text like

• ‘Wheat flour, white, all-purpose, enriched, bleached’  to à ‘flour’ for your ingredient statement

Step 4: Allergens, Added Sugars, Ingredient Statement, Serving Sizes

Allergens: Here you can mark which items have allergens

Added Sugars: For the new regulation, mark which items are classified as an added sugar

Ingredient Statement: You can clean up your ingredient list before the final label

Specify your serving sizes from the RACC page

Step 5: Final Review

You can review your final label here

Vertical:

Vertical Simplified:

Long Tab Label:

Short Tab Label

Linear

Step 6: Dual Column Download

If your label is dual column, you only only can download 1 of these 2 labels.

Questions?  You can e-mail contact@menutail.com