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materials is prohibited except as expressly provided by Med-Diet, Inc. or the presenter.

Copyright 2016 Med-Diet, Inc. All rights reserved.

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The Law Behind Food LabelsNutrition Facts Updates

Objectives

• Be aware of changing regulations

• Discuss the revised food label to be able to apply to daily use

• Understand label claims and evaluate for target populations

Background

• U. S. Food and Drug Administration• Oversees items that account for $0.20 of every dollar you & I spend.

• In the beginning…• 1862 started as Dept. of Agriculture with one guy in a lab

• 1906 Food and Drug act was the start of today’s FDA

• ~15,000 employees and $4+ billion budget

http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm

Food Labels = Serious Business

Food labels cannot be misleading.

• Presence and absence of information is relevant• Words, brands, logos, pictures

• “Label” = label + website and any print material

Nutrition Facts Face Lift

• Original Nutrition Facts is 20 years old

• Products following NLEA must be manufactured with revisions before / on January 1, 2020.

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Practice Tip

Revised labels are in the market now…

you don’t have until 2020 to get ready to talk to consumers.

Emphasis on serving size

Emphasis on calories per serving; note calories from fat is gone

Serving sizes are updated to reflect what people eat/drink today.

Serving sizes are NOT about recommending amounts to consume.

Similar foods will have similar serving reference amounts

Practice Tip

Manufacturer’s don’t get to “make up” their package serving size

The FDA specifies the “RACC”

Reference amounts customarily consumed

The 2016 revised servings sizes helped with course correction for portions

No longer report calories from fat

Added sugars is new

New definitions

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Fiber Defined

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.

Fiber Defined

• Suggested “physiologic effect” for fiber to be recognized:• Total/LDL cholesterol lowering, post-prandial blood glucose lowering,

increased fecal bulk and laxation, colonic transit time, blood pressure lowering, SCFA production, modulation of colonic microflora, weight loss or maintenance and satiety.

Fiber

• Allowed:• Beta-glucan soluble fiber

• Psyllium husk

• Cellulose

• Guar gum

• Pectin

• Locust bean gum

• Hydroxypropylmenthylcellulose

• Missing from the list:• Acacia gum

• Soy fiber

• Bamboo fiber

• Oat fiber

• Pea fiber

• FOS

• Inulin

• And others

FOR NOW…..

What is an “Added Sugar”

• Sugars that have been added during processing or packaging of a food

• Examples: sugar, honey, sugar from syrups (e.g. agave, brown rice, corn), naturally occurring sugars that are isolated from a food and concentrated (e.g. fruit juice concentrate)

• Sugar alcohols – optional to declare with carbohydrates unless a sugar claim is made.

Practice Point

Be prepared to help consumers navigate sugars / added sugars

• Beware the “healthy halo”• Brown rice syrup, agave syrup, honey, maple syrup

Revised to reflect nutrients of concern

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Changes to Daily Reference Values (DV)

• 27 of 34 nutrient targets have changed• 10 increased

• 17 decreased

• 7 stayed same

• 1 new addition (added sugar)

Practice Tip

• Foods / Beverages sold into retail space must follow NLEA Food Labeling• Includes dietary supplements

• Medical Foods – optional to follow; most do not• Tube feeds, modulars, etc.

Original New 2016 Notes

Original New 2016 Notes

About those Label Claims…• Healthy

• Natural

• Organic

• GMO-Free

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Claiming ‘Healthy’

• Guidance = recommended but not required

• ‘Healthy’ = Implied nutrient content claim

• 2016 evaluation updated criteria• Prior guidance circa1993

• May/may not change from the 2016 update

• FDA has discretion to enforce their guidance

Claiming ‘Healthy’

NOTE: l.s. = labeled serving; RACC = Reference Amount Customarily Consumed per Eating

Occasion; small RACC = 30 g or less, or 2 tablespoons or less

Conditions for the Use of "Healthy"

Individual Food Seafood/Game Meat Meal/Main Dish

TOTAL FAT low fat < 5 g fat /RACC & /100g low fat

SATURATED FAT> low sat fat < 2 g sat fat /RACC & /100g low sat fat

SODIUM ≤ 480 mg /RACC and /l.s.; or /50 g, if RACC is small

≤ 480 mg /RACC and /l.s.; or /50 g, if RACC is small

≤ 600 mg /l.s.

CHOLESTEROL ≤ disclosure level < 95 mg /RACC & /100 g ≤ 90 mg /l.s.

BENEFICIAL NUTRIENTS

Contains at least 10% of DV /RACC for vitamins A, C, calcium, iron, protein, or fiber except: raw fruits and vegetables; or a single ingredient or mixture of frozen or canned single ingredient fruits and vegetables (may include ingredients whose addition does not change the nutrient profile of the fruit or vegetable); enriched cereal-grain products that conform to a standard of identity in 21 CFR 136, 137, or 139.

Contains at least 10% of DV /RACC for vitamins A, C, calcium, iron, protein, or fiber

Contains at least 10% of the DV /l.s. of two nutrients (for a main dish product) or of three nutrients (for a meal product) of vit. A, vit. C, calcium, iron, protein, or fiber.

FORTIFICATION Per 21 CFR 104.20 Per 21 CFR 104.20 Per 21 CFR 104.20

Claiming “Natural”

• Not defined

• Hard to define

• FDA stance is “natural” means nothing artificial or synthetic• No added color; no artificial flavors and no synthetic substances

• What is missing from guidance is how to categorize:• Food production methods, food processing or manufacturing

methods, use of pesticides…

Claiming “Organic”

• No FDA definition; falls under USDA

• Organic food:• Produced within environmental conditions

• Animals receive no antibiotics or growth hormones

• Plants grown without most conventional pesticides, synthetic fertilizers, bioengineering, or radiation

• Government-approved certifiers inspect farm

• Any middleman producer or processer must also be certified

CFR Regulatory Text, 7 CFR Part 205, Subpart A — Definitions. § 205.2

Practice Points

• Not safer or healthier than conventionally grown food

• Nutrient differences are negligible

• Claims of ‘better taste’ are not supported by evidence

The USDA organic seal assures product is at least 95% organic

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Claiming “NON-GMO”

• What is it?• The process of intentionally making a copy of a gene for a desired trait from

one plant/organism and using it in another

Claiming “Non-GMO”

• Currently voluntary to label “non-GMO” or “GMO food”

• GMO = bioengineered food• FDA does not use the terms “genetically modified” or “genetically modified

organism”

• USDA is “working on” regulations• ~2 years to rule “due date”

Claiming “Non-GMO”

• FDA’s suggested statement examples:• “Not bioengineered.”

• “Not genetically engineered.”

• “Not genetically modified through the use of modern biotechnology.”

• “We do not use ingredients that were produced using modern biotechnology.”

• “This oil is made from soybeans that were not genetically engineered.”

• “Our corn growers do not plant bioengineered seeds.”

Practice Points

www.GMOAnswers.com

Beware of false labels – there are some foods that cannot be GM

Closing Thoughts

• Food labels• Nutrition is geared to the healthy, average individual

• Provide factual data; should not mislead

• Offer excellent teaching moments

Thank you for participating in today’s session!

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This presentation is intended to provide general information but is not intended

to provide medical advice.

Presentation Author: Debra Zwiefelhofer, RDN, LD

Your Special Diet Partner