The New Label: What Dietitians Need to Know

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Lynne Cross
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1 The New Label: What Dietitians Need to Know Brenda Jacob, RDN, LD, MPH Labeling Manager 4/20/18

2 Agenda 1 Who is Land O Lakes? 2 Overview of Labeling functions 3 Labeling Regulations Recent Regulatory Activities Rulemaking Process Nutrition label changes Product examples 4 Labeling Hot Topics FDA Strategic Policy Roadmap Menu Labeling Healthy Claims not defined by regulation SmartLabel Bioengineering

3 Who is Land O Lakes?

4 Who is Land O Lakes?

6 Labeling functions Labeling Regulatory Compliance Review/approve package: Product Name, Net Wt, Nutrition, Ingredients, Manufacturing info, vignette, typesize, romance copy, Kosher/USDA/Organic Claims Substantiation (nutrition, ingredient, other) Review/approve marketing and advertising materials with nutrition, ingredient and claim information (includes websites) Generate Nutrition Facts Panel/ Ingredient Lists including allergen information Resource for labeling regulatory information

7 Required Label Information Product name Net Wt Nutrition Facts Guarantor (Manufacturer s address) Ingredients (with allergens, as applicable) Safe handling instructions

8 Labeling Regulations

9 Nutrition Label Reform U.S. Dietary Guidelines FDA Guidance: compliance dates Menu and Vending Labeling Labeling Regulator y Activity GMO Labeling Revised Healthy definition Nutrition and Health Claims

10 Rulemaking Process Overview Congress Agency (FDA, USDA) Individuals and Groups Agency (FDA, USDA) Passes law Directs agency to create regulations Advance Notice of Proposed Rulemaking (ANPR) published in Federal Register notice/comment process begins Submit comment s Issues Proposed Rule, Interim Final Rule or Final Rule Federal Food Drug & Cosmetic Act Fair Packaging and Labeling Act Nutrition Labeling & Education Act

11 Reasons for Nutrition Label Changes Most extensive change since 1990 NLEA Reflects updated scientific information, including link between diet, chronic disease and public health Updated serving size reflects amount of food people actually consume Format draws attention to calories and serving size

14 Daily Value Changes Total Fat 65g to 78g/day (from 30% to 35% of calories) Carbohydrates 300g to 275g/day (from 60% to 55% of calories) Added Sugars established at 50g/day (10% calories) Fiber 25g to 28g/day Sodium 2,400mg to 2,300mg/day Calcium 1,000mg to 1,300mg/day Potassium 3,500mg to 4,700mg / day Vitamin A 5,000 IU to 900 RAE (mcg) (~3,000 IU)/day Vitamin C 60mg to 90mg/day Vitamin D doubled from 400 IU to 20 mcg (~800 IU)/day Unit of measure changes for vitamins A & D from IU to mcg

Old and New Nutrition in marketplace 2016 2017 2018 2019 2020 May FDA labeling regulation first announced June FDA announced deadline extension September FDA proposed extending compliance to January

15 Old and New Nutrition in marketplace May FDA labeling regulation first announced June FDA announced deadline extension September FDA proposed extending compliance to January 1, 2020 July original compliance deadline March- guidance for fiber, added sugars, serving size Finalize compliance date in Spring January Proposed compliance date extension USDA- issue bioengineering regulations? Packages with old Nutrition label Packages with new Nutrition Label

16 Vitamin D Example of old and new nutrition label difference Change in % Daily Value (% DV) from 400 IU to 20 mcg (~800 IU)/day: o Amount per serving in product = 80 IU (2 mcg) o Old Nutrition Facts Panel (NFP): 20% DV o New NFP: 10% DV If serving size for new label changes from ½ cup to 1 cup o Amount per ½ cup serving = 80 IU (2 mcg) o Amount per 1 cup serving = 160 IU (4 mcg) o New NFP per serving: 160 IU (4 mcg) = 20 % DV

17 Added Sugars New mandatory nutrient on NFP: 50g / day = 100% DV Added Sugars - either added during processing of foods, or packaged as such; includes free, mono- and disaccharides, sugars from syrups, honey, & concentrated fruit or vegetable juices. Pure lactose is Added Sugar, lactose from whey, NFDM, other dairy products, not Added Sugar Analysis cannot differentiate total sugar from added sugar Record keeping required to verify labeled added sugars.

18 Dietary Fiber FDA new fiber definition to match IOM definition Intrinsic and intact in plants - non-digestible soluble and insoluble carbohydrates with 3 or more units, and lignin Isolated fibers to be included in the calculation of the amount of dietary fiber have known health benefits beta-glucan soluble fiber Psyllium husk cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose. Analytical Methods Different methods for food, inulin, other fibers Record Keeping Required

19 Isolated/Synthetic Fiber Source Approval Status Approved in FDA's Dietary Fiber Definition Beta-glucan soluble fiber Psyllium husk Cellulose Guar gum Pectin Locust bean gum Hydroxypropylmethylcellulose Currently Under FDA Review Gum Acacia Alginate Apple Fiber Bamboo Fiber Carboxymethyl Cellulose (Cellulose Gum) Corn Hull Fiber (Corn fiber, Insoluble Corn fiber, Corn Bran Fiber) Cottonseed Fiber Galactooligosaccharides (GOS) Inulin/Oligofructose/Synthetic Short Chain Fructooligosaccharides Karaya Gum Oat Hull (Insoluble Oat) Fiber Insoluble Pea Fiber, Pea Hull Fiber and Soluble Pea Fiber Polydextrose Potato Fibers Pullulan Rice Bran Fiber High Amylose Corn/Maize Starch (Resistant Starch 2) Retrograded Corn Starch (Resistant Starch 3) Resistant Wheat and Maize Starch (Resistant Starch 4) Soluble Corn Fiber Soy Fiber (Soy Polysaccharide), Soluble Soybean Polysaccharide and Soy Hull Fiber Sugar Beet Fiber Sugar Cane Fiber Wheat Fiber Xanthan Gum

20 Calcium Calcium DV increased from 1,000 to 1,300 mg per day 10% DV now 130mg/serving - minimum for Good Source claim 20% DV now 260mg/serving minimum for Excellent Source claim Many Excellent Source claims (20% DV) downgraded to Good Source; some Good Source no longer able to make a claim

21 Potassium Now required Why? Adequate potassium intake is beneficial in lowering blood pressure, and intakes of this nutrient are also low among some population groups. Increased from 3500 to 4700mg /day DV

22 Vitamin D Vitamin D now required Why? Vitamin D is important for its role in bone development and general health, and intakes among some population groups are inadequate Previous Vitamin D amount was based on 1970 s science recommendations

Impact to Land O Lakes Review impact to claims/product Supplier outreach for raw material nutrition data 500+ ingredients, 130+ suppliers Update all Product specifications 2000+ specs: Purchased

23 Impact to Land O Lakes Review impact to claims/product Supplier outreach for raw material nutrition data 500+ ingredients, 130+ suppliers Update all Product specifications specs: Purchased Material, Formulated Material, Nutrient Profile & Graphical Package Ensure all packages are updated 400+ SKUs (packages) Update nutrition information wherever published SmartLabel, LOL websites, Product Bulletins, Technical Data Sheets

24 Example: 25% RF Cheddar Snack Cubes Changes % DV fat decreases Vitamin A % DV increased Remove Vitamin C Calcium % DV decreased (from excellent source to good source) Potassium now required Old New

25 Labeling Hot Topics

26 FDA 2018 Strategic Policy Roadmap Menu labeling Nutrition label guidance healthy Health claims Standards of Identity Ingredient information Sodium reduction guidance

27 Menu Labeling Compliance date remains at May 7, 2018 FDA to issue clarifying guidance Covered establishments include chains with 20 or more locations doing business under same name (e.g., restaurants, bakeries, coffee shops, pizza and take out, grocery store, convenience stores, etc.) Must provide calories on menu board, other nutrition upon request Based on NLEA label regulations ( old nutrition label)

28 Previous claim requirement Low fat and saturated fat 480 mg sodium, 60 mg cholesterol Contains at least 10% DV key nutrient of one of following Vitamin A Vitamin C Calcium Iron Protein Fiber Healthy New claim guidance Fat profile of predominantly mono and polyunsaturated fats 480 mg sodium, 60 mg cholesterol Contains at least 10% DV key nutrient of one of the following Vitamin A Vitamin C Calcium Iron Protein Fiber Potassium Vitamin D

29 Claims and other important changes Claims not defined by regulation: Natural Clean Label Transparency Non-GMO Allergen-free Vegan, Vegetarian

30 GMO Labeling (Bioengineering) 7/7/16: Senate passed the GMO Disclosure Bill Winter 2017 ANPR and public meeting s Comment Period 7/29/16: Obama signed the bill into law including state preemption. VT law is no longer valid. USDA has 2 years to develop the standard. USDA to Issue Proposed Rule? July 2018 statutory deadline for final rule

31 Modernization of Standards of Identity 300 identity standards 20 categories of food Provide definitions for processing, ingredients, composition Many haven t been updated for decades

Dietary Guidelines for Americans Published every 5 years since 1980 by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA).

32 Dietary Guidelines for Americans Published every 5 years since 1980 by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA). Serves as the foundation for several nutrition education and promotion programs, food assistance programs, nutrition labeling rules and the school meals program. In process of selecting committee members for 2020 Dietary Guidelines for Americans

33 SmartLabel

34 What is SmartLabelTM?

35 SmartLabel.org landing page

36 Nutrition

37 Ingredients and Allergen information Please refer to the label on your product for the most accurate nutrition, ingredient and allergen information

38 Other information: Claims and Health/Safety

39 Nutrition Label Reform U.S. Dietary Guidelines FDA Guidance: compliance dates Menu and Vending Labeling Labeling Regulator y Activity GMO Labeling Revised Healthy definition Nutrition and Health Claims

40 Thank you

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