The New Nutrition Facts Panel

-Dietary Fiber Rules and Strategies-

Cathy Peterson

June 5 & 6, 2017

Topics• NFP changes that impact dietary fiber

– Definition– DRV– Calories

• How to accurately report dietary fiber– Approved dietary fibers– Intact and intrinsic fibers

• Process for adding more fibers to the regulations– FDA scientific review of 26 isolated fibers– Citizen Petition or Health Claim Petition

• Where to start– Assessing existing products and determining next steps– Guidelines for new product development

• Case Study 1- Bread• Case Study 2- Crackers• Summary• Q&A

FDA Dietary Fiber Definition 2016• “Dietary fiber is defined as non-digestible soluble and insoluble

carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.

• The following isolated or synthetic non-digestible carbohydrate(s) have been determined by FDA to have physiological effects that are beneficial to human health and, therefore, shall be included in the calculation of the amount of dietary fiber: [beta]-glucan soluble fiber (as described in §101.81(c)(2)(ii)(A)), psyllium husk (as described in §101.81(c)(2)(ii)(A)(6)), cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose.“

CFR 101.9(C)(6)(i)

Fibers NOT Included in FDA Definition

gum acacia, alginate, apple fiber, bamboo fiber,

carboxymethylcellulose, corn hull fiber, cottonseed fiber, galactooligosaccharides, inulin/oligofructose/synthetic

short chain fructooligosaccharides, karaya gum, oat hull fiber, pea fiber, soluble pea fiber, polydextrose, potato

fibers, pullulan, rice bran fiber, high amylose corn/maize starch (RS 2), retrograded corn starch (RS 3), resistant wheat and maize starch (RS 4), soluble corn fiber, soy

fiber, soluble soybean polysaccharide and soy hull fiber, sugar beet fiber, sugar cane fiber, wheat

fiber, xanthan gum, xylooligosaccharides

FDA Label Changes related to FIBER• Caloric Value

– Retain 0 kcal/g for Insoluble fiber

– Change the caloric value of Soluble fiber from 4 to 2 kcal/g

• Daily Recommended Value (DRV) Fiber Intake– 14g/1,000 kcal is set as the basis for a DRV

– Using a reference calorie intake of 2,000 calories (14g/1,000 kcal x 2,000 kcal/d)

• Nutrient Content Claims* (21 CFR 101.54)"High", "Rich In", or "Excellent Source Of“

Must Contain 20% or more of the Daily Value (DRV) or 5.6g/serving vs. previous 5.0g/serving

"Good Source of", "Contains" or "Provides“

Must Contain 10%-19% of the DRV per reference amount or 2.8-5.3g/serving vs. previous 2.5-5.0g/serving

“More” 10% or more of the DRV per reference amount

* Disclaimer needed for fat if product is not also “low” in fat as defined by FDA (<3g per serving).

25g previous DRV 28g New DRV

How to Accurately Report Dietary Fiber

• If a food contains only non-digestible carbohydrates (NDC) that meet the proposed definition of dietary fiber (e.g., contains naturally occurring fiber only)– Measure using AOAC 2011.25, AOAC 2009.01 or an

equivalent AOAC method

• If a food contains a mixture of NDC that do and do not meet the proposed dietary fiber definition-manufacturers are required to make and keep records to verify the amount of soluble or insoluble NDC that do not meet the definition– NDC that do not meet the definition are subtracted from the

TDF amount as determined by analytical methods

Intact and Intrinsic Fibers

“….. by their very nature meet the definition of “dietary fiber” in the final rule. Plant-based foods that contain non-digestible carbohydrates that are intrinsic and intact and that are typically consumed as part of the U.S. diet include fruits, vegetables, whole grains, legumes, and nuts (IOM, 2001).”

“The non-digestible carbohydrates present in fiber-containing foods that are produced using mechanical processes, (e.g., milling), such that the product is still considered a food that contains other nutrients normally found in the foods are also considered to be intrinsic and intact (IOM, 2002). These intrinsic and intact fibers by their very nature also meet the definition of “dietary fiber” in the final rule.”

https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM528533.pdf

Intact and Intrinsic Fibers• Included

– Wheat and other brans– Cocoa powder– Flours– Vegetable purees or pomace– Vegetable protein extracts – Parts of a food (e.g., outer coat of peas)– Non-digestible carbohydrates (e.g., resistant starch) that are created

during the normal processing of food (e.g., flaked corn cereal)

• NOT Included– Foods or parts of foods that have been processed, resulting in a

product with an increased concentration of non-digestible carbohydrates and that no longer contain or contain lower amounts of food components, such as vitamins and minerals.

– Obtained from non-food sources, such as stems, branches, and trunks of trees, inedible hulls and husks, seaweed, and fungus.

How will more fibers be included?

• FDA can add a fiber to the CFR definition based on their review of the comments and scientific data received as of February 13, 2017

• Citizen petition process in § 10.30 – FDA issued guidance to industry on submissions to demonstrate

physiological effects that are beneficial to human health.

• Health claim petition process in § 101.70

Core Physiological Effects

• FDA Initial Scientific Review

– Attenuation of blood glucose levels• Short term based on post-prandial glucose levels

• Long term based on fasting blood glucose levels

– Attenuation of cholesterol levels

– Improved laxation

• Reduced transit time or increased rates of defecation

– Reduced energy intake (for example, due to the fiber promoting a feeling of fullness)

– Increased mineral absorption

NOT INCLUDED

• Fermentation or changes in colonic microbiota• Increased fecal bulk

Best Practices and Case Studies

Guide to Assessing Fiber Status and Next Steps

• Determine fiber level in product (grams and % DV)

• List all sources of dietary fiber– Determine which ingredients can be declared as fiber on NFP

• Intact and intrinsic fibers

• Added or isolated fibers that are included in the definition

– Determine remaining Non Digestible Carbohydrates

• Request updated nutritional sheets from suppliers– Ask for dietary fiber and non-digestible carbohydrate levels

– Double check caloric values

• Re-calculate calories as needed

• Calculate new grams of dietary fiber

• Calculate new % DRV

• Calculate the “fiber gap” per product

Guide to Assessing Fiber Status and Next Steps

• List all claims or call-outs• Look for any references to fiber or calories on packages,

web site, marketing materials• Determine any technical functions of fiber in the formula

– Moistness, resiliency

• Decision Points:1. Keep existing formula, reduce the grams of fiber on the NFP

and adjust associated fiber claims accordingly2. Reformulate to maintain existing claims and fiber and calorie

levels• Can existing fibers be increased to fill the gap?• Which approved or intrinsic fibers can be added?

3. Reformulate to remove fiber and adjust calorie and fiber values and associated claims

Sources of “Intrinsic” Fiber% TotalDietary

Fiber

Mostly Insoluble

Mostly Soluble

Whole oats/oat flour 14 X

Oat Bran 16-32 X

Whole wheat flour 12 X

Wheat bran 38-46 X

Wheat germ 20 X

Barley flour 10 X

Barley bran 20-43 X

Rye (whole rye flour) 15-17 X

Flax seed 26 X

Corn bran 89 X

Psyllium 80 X

Pea Hull Fiber 85 X

Sources of “Isolated” Fiber

% TotalDietary

Fiber

Mostly Insoluble

Mostly Soluble

Oat Fiber 85-95 X

Soy Fiber (from hull) 90 X

Soy Fiber (from bean) 60 X

Cellulose 96 X

Sugarcane 95 X

Inulin (chicory) 83-90 X

Cottonseed 80-90 X

Bamboo 80-90 X

Pea (inner pea fiber) 80-90 X

Sources of “Isolated” Fiber

% TotalDietary

Fiber

Mostly Insoluble

Mostly Soluble

Sugarbeet 73 X

Potato 72 X

Citrus 40-55 X

Polydextrose (derived from corn) 95 X

Resistant Starches (derived from

corn, wheat or potato) Type 2, 3, 440-60 X

Resistant Maltodextrins (derived

from wheat or corn)70 X

Partially Hydrolyzed Guar Gum 75 X

Nutritional Composition of Various Fiber Types

Powdered Cellulose Oat Fiber

Sugar Cane Fiber

Total Dietary Fiber* %(g/100g) 96 0 0Total Insoluble Fiber %(g/100g) 95.9 0 0Total Soluble Fiber, %(g/100g) 0.1 0 0Other Dietary Fiber %(g/100g) 0 94 96.2Other Insoluble Fiber %(g/100g) 0 93.1 95.64Other Soluble Fiber, %(g/100g) 0 0.9 0.56Carbohydrates, Total, %(g/100g) 96 94 96.2Total Sugar %(g/100g) 0 0 0Calories (Insoluble Fiber Subtracted/100g) 1 1 387Ash %(g/100g) 0.30 1.78 0.31Moisture %(g/100g) 3.59 4.02 3.07Total Fat %(g/100g) 0.01 0.10 0.02Trans Fat, %(g/100g) 0.00 0.00 0.00Cholesterol (mg/100g) 0.00 0.00 0.00Protein (6.25), %(g/100g), by Dumas 0.10 0.10 0.40Calcium (mg/100g) 38.10 52.40 35.20Iron (mg/100g) 3.94 1.63 5.16Sodium (mg/100g) 35.50 125.00 16.90Potassium (mg/100g) <3.0 <3 <3.0Vitamin C (mg/100g) <1.0 <1.0 2.87Total 100.0000 100.0000 100.0000

* For the definition of dietary fiber and list of fibers that can be declared on the Nutrition Facts Label see 21 CFR 101.9(6)(i)

High Fiber Bread Example

1 source of dietary fiber: Meets FDA Definition

Approximately 3% additional fiber required to maintain “Excellent Source” of fiber

claim

Increase fiber from 5g to 5.6g(6g using rounding rules)

Label Comparison for a High Fiber Bread with Oat Fiber

INGREDIENTS: WATER, UNBLEACHED ENRICHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, REDUCED IRON, NIACIN, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), OAT FIBER, WHEAT GLUTEN, SUGAR, CONTAINS 2% OR LESS OF EACH OF THE FOLLOWING: YEAST, SALT, NONFAT MILK, SODIUM STEAROYL LACTYLATE, ETHOXYLATED MONO- AND DIGLYCERIDE, XANTHAN GUM, CALCIUM PROPIONATE, ASCORBIC ACID, ENZYMES.

Current with Fiber New with Fiber

1 source of dietary fiber: Does not meet FDA definition

-Total Carbohydrate DRV% IncreasesDRV 8% up to 9%

-Dietary Fiber grams decrease5g down to <1g

-Total Dietary Fiber DRV% DecreasesDRV 20% down to only 3%

Current with Fiber New with Fiber New without Fiber

Label Comparison if Oat Fiber was Removed

-Calories per serving Increase110 up to 140

--Total Sodium DRV% and grams IncreaseDRV 11% up to 12%250mg up to 270mg

-Total CHO DRV% and grams IncreaseDRV 9% up to 10%24g up to 28g

INGREDIENTS: WATER, UNBLEACHED ENRICHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, REDUCED IRON, NIACIN, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), OAT FIBER, WHEAT GLUTEN, SUGAR, CONTAINS 2% OR LESS OF EACH OF THE FOLLOWING: YEAST, SALT, NONFAT MILK, SODIUM STEAROYL LACTYLATE, ETHOXYLATED MONO- AND DIGLYCERIDE, XANTHAN GUM, CALCIUM PROPIONATE, ASCORBIC ACID, ENZYMES.

Reformulation: Oat Fiber to Cellulose

• Select cellulose based on particle size and water holding capacity

• Factors to consider

– Water (absorption and hydration dynamics)

– Dough mixing (speed, time)

– Gluten development (bread vs cookie or cracker)

– Sensory properties (color, flavor, aroma, texture)

– Functional properties (shelf life, dough yield, strength and flexibility)

Ingredients:Made from: Whole Wheat Flour, Water, Modified Wheat Starch, Chicory Root Fiber, Sugarcane Fiber, Wheat Gluten, Sugar, Yeast, Contains 2 Percent or Less of: Soybean Oil, Unsulphured Molasses, Wheat Bran, Nonfat Milk (Adds a Trivial Amount of Cholesterol), Lower Sodium Natural Sea Salt, Salt, Calcium Propionate and Sorbic Acid to Retard Spoilage, Distilled Monoglycerides, DATEM (Dough Conditioner), Soy Lecithin.

Meets FDA Fiber Definition Pending FDA Approval

Pepperidge FarmWhole Grain Double Fiber Bread

Calories: 100 per sliceDietary Fiber: 6g (23% DV)

6 Ingredients contribute to total dietary fiber

Ingredients:Whole Wheat Flour, Water, Unbleached Enriched Wheat Flour (Flour, Malted Barley Flour, Reduced Iron, Niacin, Thiamin Mononitrate [Vitamin B1], Riboflavin [Vitamin B2], Folic Acid), Cellulose Fiber, Yeast, Sugar, Wheat Gluten, Cracked Wheat, Polydextrose, Rye, Corn Grits, Oats, Salt, Soybean and/or Canola Oil, Preservatives (Calcium Propionate, Sorbic Acid), Grain Vinegar, Monoglycerides, Barley, Brown Rice, Flaxseed, Millet, Triticale, Citric Acid, Cellulose Gum, Xanthan Gum, Reb A (Natural Stevia Leaf Sweetener), Cornstarch, Soy Lecithin, Soy Flour.

Meets FDA Fiber Definition Pending FDA Approval

Brownberry Sandwich ThinsMultigrain

Calories: 100 per rollDietary Fiber: 5g (20% DV)

17 Ingredients contribute to total dietary fiber

Good Source of Fiber Cracker

Approximately 1.5-2% additional fiber required

to maintain “Good Source” of fiber claim

Increase fiber from 2.5g to 2.8gMight not impact label due to rounding rules

New Product Development• Establish fiber and calorie goals• Determine

– Baseline fiber level– Fiber “gap”– Check for new fiber approvals– New FDA Guidance and 21 CFR 101.9(6)(i)

– Updates from ingredient suppliers– Decide which fibers can be used based on type of finished

product and target fiber level• Beverage (mostly “invisible” soluble fibers)• Cookies, bread etc (insoluble or combination of insoluble and soluble

fibers)

• Start development or revise goals

Multi-Functional Benefits of Fiber

• Extends Shelf-Life & Yield

• Increases Structure & Strength

• Improves Taste & Texture

• Enhances Gluten-Free

• Helps Reduce Fat, Sugar, & Calories

• Improves Freeze/Thaw Stability

• Replaces or Reduces Eggs

• And Many More…

Complexity of These Changes

• More time and resources now required to track approved dietary fibers and non-digestible carbohydrates (similar to added sugars)

• More calculations are required to ensure accuracy of reported fiber values and caloric content

• Most foods with nutrient content claims or specific fiber DRV goals will need to be re-formulated ➢ Some brands at risk of discontinuing due to lack of approved fibers

➢ Difficult to meet Nutrient Content Fiber claims with the restricted list

How will we reallyknow how much FIBERwe are consuming?

Challenges for Industry• Ingredient manufacturers

– Cost to prove physiological benefits (per fiber type)• Laxation >$300,000

• Blood Glucose Response $20-80,000

– Time needed to conduct trials

• Consumer product manufacturers

– Time and resources needed to track sources of fiber• 1 to 10+ sources of fiber in some cases

– Extra cost for dietary fiber analysis

– Calorie calculations will be more complex

• Nutritional database updates

• How long to wait for additional guidance and approvals

Compliance Dates and Timing Issues

July 26, 2018 > 10 million $/year

July 26, 2019 < 10 million $/year

FDA has committed to working with industry on timing issues*: “If the Agency is unable to update the list of dietary fibers in time for companies to either relabel or reformulate in advance of the first compliance date, we are committed to exploring options to address the timing issue.”

Industry groups such as ABA, GMA, AACC and many others have requested an extension of the compliance date (Comments submitted to FDA February 2017)

ABA has requested, through a Citizen Petition, that the FDA revert back to a chemical definition of fiber, adopt a less burdensome definition or immediately stay the definition until guidance is finalized.

* https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm528582.htm

Summary• The Daily Recommended Value for fiber has increased and Americans are

only consuming, on average, half of the recommended amount of fiber.

• Development of high fiber foods needs to be easier, not more difficult, to meet fiber goals.

• Many unintended consequences of the new definition and de-listing of MOST of the isolated fibers have been brought to FDA’s attention.

• FDA approval process needs to be timely to keep options available to food formulators to enable new product development and keep current products on the market.

• Adding more fibers to the current definition is FDA’s goal but timing is unknown.

Your JRS partner for USA + Canada

J. Rettenmaier USA LP

16369 US 131 Highway

Schoolcraft, MI 49087

Cathy Peterson

Regulatory and

Commercialization Manager

Phone: 617-513-3587

Email: cpeterson@jrsusa.com

Thank you for your attention!

Cathy PetersonCathy Peterson is a dedicated Food Science professional with over 25 years of experience in increasingly responsible and technically challenging positions in product development, applications and technical services, business development, management and regulatory affairs . In her role as Regulatory and Commercialization Manager for J. Rettenmaier shemaintains current knowledge of FDA and USDA regulations, including proposed and final rules. Determines the impact of new regulations on existing ingredient portfolio and provides input and direction for new ingredient development to ensure regulatory compliance.