IDFAs Labeling Workshop Making the Change

1
IDFAs Labeling WorkshopMaking the Change
International Dairy Foods Association January
26, 2005
2
IDFAs Labeling WorkshopMaking the Change

• FDA Perspective on Label Changes
• Trans Fat
• Allergens
• Using you Label to Sell the Benefits of Dairy
• Healthy Weight with Dairy
• Nutrient Content and Health Claims
• Future Labeling Changes
• FDAs Anti-obesity Initiative
• Dietary Guidelines

3
Declaration of Trans Fatty Acids

• Cary Frye
• Vice President, Regulatory Affairs
• International Dairy Foods Association

4
Declaration of Trans Fatty Acids

• Definition and source of trans fat
• Health implications
• Labeling Regulations for declaration of trans
  fatty acids
• Level of trans fat in milkfat
• Format
• Compliance

5
Types of Fatty Acids
Saturated Fatty Acid
Unsaturated Fatty Acid
Trans Fatty Acid
H
H
H
H
H
C
C
C
C
C
C
Carbon-CarbonDouble Bond
H
H
H
Carbon-CarbonSingle Bond
Hydrogen atoms are on opposite sides of the
chain of carbon atoms at the carbon-carbon
double bond.
6
Trans Fatty Acids

• Trans fat are predominately found in hydrogenated
  oils and oils used for high temperature frying
• Baked goods, fried foods, snacks
• Dairy foods and meat have small amounts of
  naturally occurring trans fat
• Cows produce small amounts of trans fat in
  digestion
• Milk contains both conjugated and non conjugated
  forms

7
Health Implications

• Saturated and trans fats have been shown to raise
  LDL (bad cholesterol) and lower HDL (good
  cholesterol)
• Scientific evidence indicates a positive
  association between cholesterol intake and
  LDL-cholesterol levels and increased risk of
  Cardio-vascular heart disease
• IOM Recommended that consumption of all types of
  trans fats be limited as much as possible
• Diary products have much lower trans fat than
  margarine, shortening and other hydrogenated oils
• Milk fat contains a type of trans fat (conjugated
  linoleic acid (CLA))
• Research with animals suggests that CLA has a
  positive effect including inhibiting cancer and
  reducing deposits in arteries
• New Dietary Guidelines suggest limiting trans fat
  to 1 of calories
• 2 grams per day for a 2000 Kcal diet.

8
Trans Fat Labeling Regulation

• Consumers (CSPI) petitioned FDA to label trans
  fatty acids in reaction to affect on heart
  disease -1994
• FDA final rule completed 7/11/2003 for mandatory
  declaration in the nutrition fact panel the level
  of trans fat per serving
• DV not established due to lack of scientific
  consensus on recommended amounts
• Nutrient content claims for trans fat remain
  undefined
• trans fat free, reduced trans fat or low in
  trans fat are prohibited
• Trans fat defined as unsaturated fatty acids
  that contain one of more isolated (i.e., non
  conjugated) double bonds in a trans
  configuration.
• Conjugated forms of fatty acids (i.e., conjugated
  linoleic acids (CLA)) are excluded

9
Trans Fat Labeling Regulation

• All food labels must be changed by Jan 1, 2006 to
  declare level of trans fat per serving
• Less than 0.5 g trans fat may be declared as 0
• Rounding .049g 0, .0510.5g

10
Trans Fat Labeling Regulation

• Less than 0.5 g TOTAL FAT can use a footnote
  not a significant source of trans fat at bottom
  of Nutrition Facts panel
• Juice, drinks, ice pops
• Food that make a claim about fat, fatty acids or
  cholesterol -fat free low fat etc. Must
  declare amount as 0 in NFP
• Most dairy products
• Simplified format - water

Not a significant source of trans fat
11
Trans Fat Labeling Regulation

• To date no nutrient content claims for trans fat
  are allowed i.e. trans fat free or low in
  trans fat
• Most milk and dairy foods can make truthful
  statements 0 gram of trans fat per serving
• FDA has not established a Daily Value
• FDA is reviewing claims and DV, but may tie
  claims to combined levels of trans fat plus
  saturated fat

12
Trans Fat Labeling Regulation

• FDA requires declared nutrient content in a
  composite sample not to exceed 20 if the label
  declaration allows for natural variation of
  nutrients 21 CFR 101.9 (g)(5)
• Levels of trans fat can be tested or calculated
  from ingredient values
• Test methods defined by AOAC Gas Chromatography
  (GC) method for fatty acid profile
• To account for seasonal variation in nutrient
  composition FDA proposed alternative method for
  labeling using a calculated one-sided 95
  prediction interval value
• FDA stated the source of the data used to
  calculate nutrition labeling values is the
  manufactures prerogative.
• Either the mean nutrient value or 95 predictive
  value may be used

13
Trans Fat Labeling Regulation

• IDFA Database
• Can be used to calculate amount of trans fat in
  milk fat
• Samples (37) from all regions across country in
  order to determine regional differences, if any.
  
• Weighted by regions milk production
• Results showed weighed national average of 3.56
  trans fat in milk fat
• Range of 4.47 3.2
• One-sided 95 prediction value for trans fat in
  milk fat is 4.74
• Data using mean weighted value of trans fat in
  milkfat is published in IDFA Milk and Ice Cream
  Labeling Manuals for nutrition facts calculations
  of milk fat

14
Level of trans fat in milkfat
Comparison of Label Declaration Using Weighted
Mean and 95 Prediction Interval Values for the
Level of Trans Fat in Milkfat
Rounded labeling values
15
Calculating the trans fat label

• Most dairy products will be able to declare level
  of TFA as 0 (14 g milk fat/serving 0 trans fat,
  15 g milk fat .5 g trans fat)
• Milkfat value can be used for milk, cream,
  butter, AMF if milk source is typical of US milk
  supply
• Special testing may be needed for small milk
  supplies, sole breed farms, organic milk or
  special feeding practices
• Remember other ingredients may have TFA ice
  cream coatings, inclusions, cookies, emulsifiers

16
Calculating the trans fat

• IDFA is undertaking work on level of trans fat in
  cheese
• Samples of milk and cheese (cheddar, mozzarella,
  Swiss) have been tested to determine if the level
  of trans fat changes when milk is made into
  cheese
• Preliminary data show no significant difference
• Working is underway to verify data and conduct
  statistical analysis
• Project will be completed by February 2005

17
Making the Change

• Determine if you will test final products or use
  a component calculation for trans fat based on
  milk and dairy ingredient supply
• Calculations
• Choose either weighted mean or predictive value
  for calculating the level of trans fat in milkfat
• Review formulations for each product to determine
  source and amount of fats
• Contact suppliers of ingredients that may contain
  trans fat to verify amount (baked goods, oils,
  fats, coatings, variegates inclusions, nuts etc.)
• Calculate weight (in grams) per labeled serving
• Calculate the unrounded amount of total fat per
  serving contributed from milk fat only
• Using the unrounded amount of total fat per
  serving, calculate the grams of trans per serving
  (multiply the total fat time IDFA value of 3.56
  (.0356)
• Add any trans fat contribution from other sources
  calculated on a per serving basis
• Round trans fat value for label declaration using
  FDA labeling rules

18
Example
Example Whole milk containing 3.25
milkfat. The labeled serving size is one cup
(240 mL). The product's weight is 244
grams "Total fat" "Amount per serving" (in
grams) is determined by multiplying the milkfat
(MF) by the weight, in grams, of a one cup
serving Calculation 0.0325 ( MF) x 244
g/serving 7.93 g MF/serving Round for labeling
purposes Total Fat 8 g "Trans fat" "Amount
per serving" (in grams) is determined by
multiplying the number of grams of MF per serving
by a factor of ".0356" (i.e., the number of grams
of trans fat per gram of milkfat). Calculation
7.93 g MF/serving x 0.0356 g trans fat/g MF
0.282 g trans fat/serving Round for labeling
purposes. (values less than 0.5 (up to 0.499) can
be declared as 0) Trans fat 0 g
19
Compliance

• All packages entering into interstate commerce on
  January 1, 2006 must bear trans fat declaration
• IICA petitioned for a stay of action
• Two year extension (Jan. 1, 2008)
• Ice cream and frozen dessert less than 500
  employees
• Request pending
• IDFA joined 13 food trade associations requesting
  FDA align labeling with allergen to packages
  labeled on January 1, 2006
• Request pending

20
Format Examples
Full vertical format
Full horizontal format
Full vertical format with foot note to the side
Packages 40sq. Inches available labeling space
21
Format Examples
Tabular format
Linear format
Packages 22
Milk Example
Example Eggnog containing 8 milkfat and 2 egg
yolk solids (.5 fat 0 trans) The labeled
serving size is one cup (240 mL). The product's
weight is 244 grams "Total fat" "Amount per
serving" (in grams) is determined by multiplying
the milkfat (MF) by the weight, in grams, of a
one cup serving Calculation 0.08 ( MF) x 244
g/serving 19.52 g MF/serving 0.01 ( egg
yolk fat) x 244g/serving 2.44 egg fat/
serving total fat 21.96 g per serving Round
for labeling purposes - Total Fat 22 g "Trans
fat" "Amount per serving" (in grams) is
determined by multiplying the number of grams of
MF per serving by a factor of ".0356" (i.e., the
number of grams of trans fat per gram of
milkfat). Calculation 19.52g MF/serving x
0.0356 g trans fat/g MF 0.55 g trans
fat/serving Round for labeling purposes Trans
fat 1 g (0.5 - .0549 0.5, .0549 1.49 1 g)
23
Yogurt Example
Example Lowfat yogurt flavored with strawberries
- 1 milkfat base is blended with 20
strawberries ( 0 trans) The labeled serving
size is 6 ounces - (170 grams). "Total fat"
"Amount per serving" (in grams) is determined by
multiplying the milkfat (MF) by the (80)
weight, in grams, of a 6 oz. serving
Calculation 0.01 ( MF) x 136 g/serving 1.36
g MF/serving Round for labeling purposes - Total
Fat 1.5 g "Trans fat" "Amount per serving" (in
grams) is determined by multiplying the number of
grams of MF per serving by a factor of ".0356"
(i.e., the number of grams of trans fat per gram
of milkfat). Calculation 1.36 MF/serving x
0.0356 g trans fat/g MF 0.048 g trans
fat/serving Round for labeling purposes Trans
fat 0 g
24
Cheese Example
Example Pasteurized processed cheese made with
50 cheddar cheese (32 MF), and 5 anhydrous
milk fat (99 MF) The labeled serving size is 1
ounce - (28 grams) "Total fat" "Amount per
serving" (in grams) is determined by multiplying
the milkfat (MF) by the weight, in grams, of a
1 oz. serving (50x.32) 16 (5X.99) .495
16.495 Calculation .16495 ( MF) x 28
g/serving 4.618 g MF/serving Round for labeling
purposes - Total Fat 5 g "Trans fat" "Amount
per serving" (in grams) is determined by
multiplying the number of grams of MF per serving
by a factor of ".0356" (i.e., the number of grams
of trans fat per gram of milkfat). Calculation
4.618MF/serving x 0.0356 g trans fat/g MF 0.164
g trans fat/serving Round for labeling purposes
Trans fat 0 g
25
Ice Cream Example
Example cookies and cream premium ice cream
made with ice cream mix 14 milkfat (100
overrun) and 10 chocolate sandwich cookies
(hypothetical 25 fat and 6 trans fat) "Total
fat" "Amount per serving" (in grams) is
determined by multiplying the milkfat (MF) by
the weight, in grams, of a ½ cup serving (120
g) Calculation ice cream 0.07 ( MF) x 108
g/serving 7.56 g MF/serving cookies .25 x
12g 3 g fat, total per serving 10.56 Round for
labeling purposes - Total Fat 11 g "Trans fat"
"Amount per serving" (in grams) is determined by
multiplying the number of grams of MF per serving
by a factor of ".0356" (i.e., the number of grams
of trans fat per gram of milkfat). Calculation
7.56 MF/serving x 0.0356 g trans fat/g MF
0.269g trans fat/serving plus the amount of trans
in cookies (12 x .06 0.72 g trans) 0.989g
trans fat Round for labeling purposes Trans
fat 1 g
26
Questions?