Menutail FDA2016 Changes Fact Sheet

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Percival Garrett
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1 Menutail FDA2016 Changes Fact Sheet /15/2016 Overview: On May 27, 2016 the FDA approved a new redesigned label for food manufacturers. This document is a fact sheet of all of the changes and links. Resource Notes Menutail Guidelines for Redesigned FDA Labels An overview of how to create a redesigned nutrition facts label. Even if you aren t using the Menutail platform this is a good overview of the changes. FDA: Changes to the Nutrition Facts Label FDA's fact sheet of all of the changes. Industry Resources on the Changes to the Nutrition Facts Label Detailed guidance for those creating labels. Food Labeling Guide This guide is not fully up-to-date in regards to the new labeling rules. Hopefully this will be updated next year. FDA Contact NutritionProgramStaff@fda.hhs.gov A contact where you can send questions. Turn around can be from a couple days to about 2 weeks. Food Labeling Regulation (21 CFR 101) Detailed rules of codified food labeling regulation.

2 21 CFR Nutrition labeling of food 21 CFR Reference amounts customarily consumed per eating occasion. Specific link on the nutrition labeling rules. Specific link on the new RACC rules. Includes definition of new RACC amounts. 21 CFR 101.9(c)(6)(i) Dietary Fiber Definition Dietary fiber is defined as nondigestible soluble and insoluble carbohydrates... (see regulation) Proposed Rules to Watch: Pending Rule Notes Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used To Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments This is in response for requests to amend serving size regulations and establish a RACC and product category for cupcake filling. Comments must be received on or before January 3, Pending Questions Awaiting FDA Response: These are a compilation of questions we have asked the FDA and their responses so far. Question Is maltodextrin considered an added sugar? Response We have received many inquiries about whether maltodextrin is an added sugar. We plan to address this topic in guidance that will be issued later this year or early next year.

3 Are there specific rules in declaring quantitative amounts of vitamins and minerals? Reference We plan to issue guidance later this year or early next year that provides more information to assist manufacturers in determining how they should declare the quantitative amounts of vitamins and minerals on their labels. Compliance Dates Question If your company has more than $10 million of sales annually If your company has less than $10 million of sales annually July 26, 2018 July 26, 2019 Response Is a food manufacturer allowed to have any legacy products with the old nutrition facts labels on a grocery shelf on July 27th, 2018, or do they have to pull all products on the shelf with the old label? [FDA Response] Products that are labeled in production on or after July 26, 2018 (and July 26, 2019 for manufacturers with less than $10 million in annual food sales) must affix a nutrition label that meets FDA s new nutrition labeling requirements in 21 CFR and 21 CFR Products that were labeled in production before July 26, 2018 (and July 26, 2019 for manufacturers with less than $10 million in annual food sales) may continue to be shipped in interstate commerce, which includes being able to be shipped from a warehouse. These products may also remain on store and warehouse shelves. FDA does not object to the use of a sticker for providing a revised nutrition label that meets our new requirements in 21 CFR and 21 CFR before new packaging is printed. The sticker label should not cover any other mandatory information and should adhere to the package during normal handling.

4 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 a. 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 a. 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 a. 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) a. 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. b. 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 a. If your package has less than two servings, the FDA will force the serving size to be rounded up to the entire package. b. 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. c. 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.

5 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: no=21;cc=ecfr#se _ Look up your product in the page either through the a. Category Filter

6 b. 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

7 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

workflow Scenario 2: Dual Column Label If your formulation flagged a dual column, you have two options:

8 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

9 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

10 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 flour for your ingredient statement

Allergens: Here you can mark which items

11 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

12 Step 5: Final Review You can review your final label here Step 6: PDF Download Here are samples of the new redesigned labels: Vertical:

13 Vertical Simplified: Notice that line items are removed where nutrients are allowed to be deemed insignificant. Long Tab Label Short Tab Label

14 Linear

15 Step 6: Dual Column Download If your label is dual column, you only only can download 1 of these 2 labels.

Today is the Day - Final Regulations on Nutrition and Supplement Facts Labels and Serving Sizes Officially Published in the Federal Register

Today is the Day - Final Regulations on Nutrition and Supplement Facts Labels and Serving Sizes Officially Published in the Federal Register By: Carolina M. Wirth and Alyson L. Wooten PharmD Today, Friday,