Nutrition and Regulatory Update

Michelle Albee Matto, MPH, RDN Principal

AM Food & Nutrition

Cary Frye V.P. Regulatory & Scientific Affairs IDFA

Nutrition Labeling

Final rule out this year

5

• Updated Daily Values

• Updated Serving Size

• Emphasis on Calories

• New added sugars – Total Sugars

– Added Sugars DV 50g

• Change in nutrients required – Actual amounts

• New footnote

Single serving requirements change • Foods with less than 200% of

RACC are single servings • Food with 200% - up to and

including 400% of RACC will require dual column labeling serving and whole container nutrition information

• Ice cream:

– Containers up to (but not including) 1 pint would need to be labeled as 1 serving

– Containers from 1 pint up to 1 quart would need to label per 1 cup serving and per whole container

Dual Column Nutrition Information

New declaration for “added sugars” and DV of 50 grams (aligns with 2015 DGA)

• New definition: Sugars that are either added during the processing of foods, or are packaged as such and included sugars (free, mono-and disaccharides), syrups, naturally occurring sugars that are isolated from a whole food and concentrated (e.g., fruit juice concentrates) and other caloric sweeteners.

• Ice creams and frozen desserts containing both natural (lactose) and added sugars from sweeteners or flavorings, would need to provide records access to FDA to prove accuracy of labeling

Nutrition Labeling Proposed Rule

• FDA changing Recommended Amount Customarily Consumed (RACC) for ice cream

• RACC for bulk ice cream would double to 1 cup (from ½ cup)

–Common serving of ice cream is 0.875 cups

–No change for novelties – individual size pieces

Serving Size/RACC Proposed Rule

Implications for ice cream

• Doubling of serving size and change in Daily Values will affect ability to make claims

–Comparative claims such as “Light” and “Reduced Fat” “Reduced Sugar” would not change since they are compared on same 1 cup serving size

–But inherent claims “fat free” or “low fat” will now be based on the larger 1 cup RACC and will require reformulation or loss of claim

Nutrition Labeling Proposed Rule

Nutrition Facts Size Concerns

IDFA Comments on Proposed Rule

• Nutrition Facts Changes – Generally supported updated DVs for nutrients, except:

• Opposed added sugars labeling and %DV – Definition would need significant revision – Lactose and milk ingredients containing lactose, dried milk,

conc. milk, whey, should not be included – Opposed record keeping requirements

• Opposed ice cream RACC change to 1 cup – Suggested ½ is common and appropriate serving – If food intake data are combined for ice cream and novelties

the result is ½ cup serving. – Reanalysis of food intake data with proper density conversion

from volume to weight =3/4 cup

• Supported Yogurt RACC change to 6 oz.

• Asked for a four-year implementation time period

• Final Rule is expected out in 2016

Dietary Guidelines for Americans

Focus on Healthy Eating Patterns • Healthy eating patterns -

Mediterranean, the U.S.-Style and the Vegetarian-Style:

– Fat-free or low-fat dairy – A variety of vegetables – dark green,

red, oranges, legumes (beans and peas), starchy and others

– Fruits, especially whole fruits – Grains, at least half should be whole

grains – A variety of protein foods, including

seafood, lean meats, poultry eggs, legumes, nuts, seeds and soy products

– Oils

15

Dairy group includes milk, lactose-reduced milk, yogurt, frozen yogurt, dairy desserts, and cheeses. Cream, sour cream and cream cheese are not included due to their low calcium content

• Nutrients of Concern (i.e. underconsumed) – Calcium, Potassium, Vitamin D, Fiber

• Added Sugars – Defined as “syrups and other caloric sweeteners

used as a sweetener in other food products” – Less than 10 percent of calories

• 2000 calories diet - 50 grams of added sugars daily. • Ice cream, yogurt, and flavored milk only account for

4% of the added sugars in our diet – (47% of added sugars are from sugar sweetened beverages)

• Sodium/Salt – Limit of 2300 mg for the general population – 1500 mg for specific populations, such as those

with high blood pressure

• Saturated Fat – Less than 10 percent of calories

• 2000 calorie diet – 22 grams daily • Full-fat dairy, butter and cheese sources of saturated fat

Dairy Remains an Underconsumed Food Group

17

My Plate, My Wins

• Suggestion to make healthier choices still can accommodate dairy foods people like

– Order cheese with your egg sandwich

– Grab chocolate milk

– Treat yourself to a scoop of frozen yogurt

• Need to take into account the sodium, saturated fat or added sugar – not exceed the recommended limits.

18

Dietary Guidelines Impact

• Basis for USDA’s nutrition programs – School Meals

– Competitive Foods

– WIC/CACFP

• Basis of government’s nutrition education efforts

• Resource for regulations, legislation, private nutrition recommendations, etc.

GMO Labeling

Where is GE used in animal agriculture?

• GE products are used in animal feed, vaccines (chickens, pigs, horses, dogs, cats), pharmaceuticals, food processing aids, and food

21

FDA GE Labeling Guidance • November 2015, FDA finalized guidance for voluntarily

indicating whether or not a food has been derived from GE plants

– GE labeling could be required if the GE production is a material fact (e.g., the food has significantly different nutritional properties or includes an allergen the consumer might not expect)

– Voluntary, truthful labeling statements can be used for a food that is not bioengineered or does not contain bioengineered ingredients, but the statements should not mislead a consumer to think the food is safer

• Rejected citizen petition requesting mandatory GE labeling

• FDA counseled against using the terms “GMO free,” “GE free,” “does not contain GMOs” and similar claims

• Guidance only considers the food itself and does not address agricultural inputs like feed or hormones used in the production of food

22

What do consumers want?

Ground swell of activists who

want foods and food

ingredients derived from

genetic engineering labeled

-Consumer Choice

-Right to Know

Unprompted polls on

additional food labeling–less

than 1% replied they want

mandatory GE labeling

(IFIC 2012)

23

Vermont’s Response to Consumer Desires • In May 2014, Vermont passed first

mandatory GE disclosure law (Act 120) for foods

– Maine and Connecticut also have laws on the books, but those laws are not yet effective

• Law goes into effect July 1, 2016

• Would require labeling of processed foods with statements such as

– “Produced with genetic engineering”

– “Partially produced with genetic engineering,” or

– “May be produced with genetic engineering”

• Prohibits the using the term “natural” and similar terms on foods containing GE ingredients 24

Vermont Regulations would include: • Exemptions:

– Foods that are 100% animal or animal derived, regardless of whether the animal was fed GE feed or received a GE drug, vaccine, or hormone

– Milk products made from milk from cows treated with rbST (with no other GE ingredients used)

– Food/cheese that use recombinant enzymes, but contain no other GMO ingredient

– Genetically engineered materials represent less than 0.9% of the total weight of the processed food.

25

Exemption: Foods for Sold Immediate Consumption • Processed foods purchased

as a taxable meal under Vermont tax law

– Includes sales at schools, prisons, summer camps, and elderly/handicap facilities

• Unpackaged foods sold in a restaurant

• Unpackaged foods sold in an establishment where more than 50% of sales are taxable meals

• Example – Ice cream sold at a roadside

stand or scoop shop

26

Exemption: Food Certified or Verified as Non-GE • Sworn statement from supplier

must declare that the food – Was made or grown from food or

seed that has not been knowingly or intentionally produced with GE; AND

– Has been segregated and not knowingly commingled with GE food

• Foods certified as organic under USDA’s National Organic Program

• Foods verified by an organization approved by VT Attorney General’s office

– The NonGMO Project – NSF International’s Non-GMO

True North Standard 27

GE Declarations • Produced with genetic engineering

• Partially produced with genetic engineering – Foods that contain less than 75% GE material

by weight

– Excludes added water and salt when doing calculation

• Include water that is an “integral part of the food”

• Water added to reconstitute dried and concentrate milk ingredient or juice ingredients is not excluded

• Water which is not part of the food is excluded – water in brine for fresh mozzarella

• May be produced with genetic engineering – Requires reasonable inquiry (i.e. active

attempt)

– Suggested use for variable ingredient base

28

Labeling Requirements • The law requires GE

declaration be easily found and read on product label

– I.e. placed in a location that is easily identifiable and readable by consumers viewing the outside of package

• Label can carry other disclosures about food

– “FDA does not consider food produced with GE to be materially different from other foods”

• Can use stickers

29

The Declaration • Must be in any contrasting

color and bolded font

• No smaller than the words “Serving Size” on Nutrition Facts Panel nor the ingredient declaration

– Font: 8 pt. or 1/16 of an inch

• If placed near Nutrition Facts Panel or ingredient declaration, presumptively easily found

30

Natural Ban • Bans the use of following

terms if food bears GE declaration

– On the label or in advertising at point of sale

– “natural,” “all natural,” “naturally grown,” “naturally made,” “nature,” or “naturally”

• Does not apply to – Food’s trade, brand or

product name – Any information required by

FDA

31

Natural Ban & “Natural Flavor” • FDA Flavor Labeling (21 CFR § 101.22)

uses a 6 Category System for all foods,

including non-standard frozen dessert –

(Frozen Yogurt, Sorbet, Gelato) and food

components of novelties (sandwich

cookies, cones)

– Artificial Flavor / Artificial Flavoring

– Natural Flavor / Natural Flavoring

– With Other Natural Flavors (WONF)

• FDA labeling requirements for “other

natural flavors” would not be exempt

from ban

32

WITH OTHER NATURAL FLAVORS

WITH OTHER NATURAL FLAVORS

Natural Ban & “Natural Flavor” • Ice Cream, Sherbet, and

water ices are subject to different 3 category flavor labeling regulations

• Does not require labeling “with other natural flavors”

• Some ice creams use terms like “natural vanilla ice cream” on the primary display if product contains only natural flavors

– Not allowed if ice cream must bear a GE declaration

– Can use term “natural flavors” in ingredient statement because common and usual name

33

Product Evaluations • Determine the source of all ingredients

– Look for major GE sources such as corn, soy, or sugar from sugar beets

• Calculate the food’s GE content by weight – Exclude salt and added water

• Can include water that is an “integral part of the food”

– Determine if any ingredients are exempt

• Calculate weight of non-exempt GE-ingredients

• Determine which label declaration, if any, is appropriate for the food

34

Supporting Records

• Proper Label – Show how product was labeled and any point of sale

advertising – “Show your math” on how determined appropriate label for

product

• Exemptions – Retain documents establishing where, when and by whom

the product was purchased, manufactured or grown, and the quantity and purpose of the specific ingredient in question

• Food not knowingly or intentionally produced with GE – Retain documents that demonstrate that there is no

commercially available GE variety of food and food not knowingly or intentionally comingled with GE food

– May rely on labeling on ingredient offered for retail sale

35

Natural Labeling Claims

Surprise Request for Comments on “Natural” Labeling Claims

• No federal regulations for “natural,” “all natural,” “100% natural”

• FDA policy: prohibits labeling “natural” if there are synthetic or artificial ingredients or an added color that a consumer would not expect in a product

• Class action lawsuits alleging consumers are mislead by “natural” claims when ingredients are derived synthetically or from biotechnology

• FDA announced a request for comments on “Natural” labeling claims • What the definition should include or exclude • How the claim should be allowed to be used on

labels? • Should it be tie to production method, minimal

processing, healthy?

37