Reading Labels for Health and Profit

1
Reading Labels for Health and Profit

• Lecture 12
• March 3, 2008
• Dr. Hirsch

2
OUTLINE Label Requirements and Claims

• Food Policy - Role of the FDA and CFSAN
• Labeling What is REQUIRED, what is ALLOWED
• Dissection the NUTRITION FACTS - Back Panel
• Defining Claims
• 1. Nutrient Content Claims
• 2. Health Claims
• Health Claims
• Qualified Health Claims
• Structure/Function Claims
• What are the current health claims?
• Making Good Food Choices
• Organic vs. Natural
• Exceptions to the Rules?

3
FDA www.fda.govFood and Drug Administration

• FDA regulates over 1 trillion worth of products,
  which account for 25 cents of every dollar spent
  annually by American consumers
• Food
• Cosmetics
• Drugs (Medicines)
• Medical devices
• Biologics
• Radiological Products
• Feed and Drugs for pets

CFSAN Center for Food Safety and Applied
Nutrition
4
FDA and CFSAN
5
CFSANs controlHow BIG is the Food Industry to
the US?

• MONEY
• Hundreds of billions of dollars
• 10-20 of the U.S. Gross National Product
• JOBS
• Employment of about 16.5 million individuals
• Provides an additional 4 million jobs in related
  industries

6
CFSAN Priorities Workplan FY2008

• (1) Food Defense
• (2) Food Safety
• (3) Nutrition and Labeling
• (4) Dietary Supplements and Cosmetics
• (5) Priority On-Going Activities

http//www.cfsan.fda.gov/lrd/fr070703.html
7
Why Read the Food Package?

• Make informed choices
• Determine nutritional value
• Compare similar products
• Increase awareness of the links between good
  nutrition and reduced risk of chronic diet
  related diseases

8
Why eat/buy Cheerios?
Tastes Great
Nice Texture/Crunchy
80s
Babies Love Them
Good as a Snack
Early 90s
Memory Ate as a Kid
Healthy
Cheerios is clinically proven to be the only
leading cold cereal to help lower cholesterol in
a low fat diet
9
Timeline of Nutrition Labeling
Nutrition Labeling Regulations, including U.S.
Recommended Daily Allowances (US RDAs) Dietary
Goals for the United States Dietary Guidelines
for Americans (First Edition) Nutrition Labeling
and Education Act (NLEA) Reference Daily Intakes
and Daily Reference Values, proposed rule to
implement NLEA Dietary Supplement Act Reference
Daily Intakes and Daily Reference Values, final
rule Dietary Supplement Health and Education
Act Dietary Supplement Labeling Regulations
Qualified Health Claims Dietary
Guidelines Addition of Trans Fats to Labels
1970s
1980s
1990s
2000s
10
Packaging/Labeling of Foods

• Allowed/Regulated
• Comparisons
• Nutrient Descriptors
• High, low, potency
• Dietary Guidance
• Relevance to Food Guide Pyramid
• Health Claims
• Health Claims
• Qualified Health Claims
• Structure Function Claims

• Required
• Front
• Product Name
• Manufacturer
• Net Weight
• Elsewhere
• Ingredients (by ? concentration)
• Nutrient Content
• Nutrition Facts Panel

11
Foods and Packaging
12
Requirement
Calories
Fat
Cholesterol
Sodium
Carbohydrate
Protein
Vitamin A Vitamin C Calcium Iron
13
FDA How to Understandand Use the Nutrition
Facts Label

• The Daily Values (DVs) are recommendations for
  key nutrients for a 2,000 calorie daily diet
• DV
• To be used as a frame of reference
• Helps you determine if a serving of food is high
  or low in a nutrient
• Note a few nutrients, like trans fat, do not
  have a DV

http//www.cfsan.fda.gov/dms/foodlab.htmltwopart
s
14
More Nutrition Facts
Can add more nutrients to the Nutrition Facts
panel if you fortify
Can highlight healthfulness by including
unsaturated fats
15
Where are the regulations? CFR - Code of Federal
Regulations

• PART 101--FOOD LABELING
• Outlines and details every required and allowable
  aspect (words, pictures, etc.) of a food label

http//a257.g.akamaitech.net/7/257/2422/12feb20041
500/edocket.access.gpo.gov/cfr_2004/aprqtr/pdf/21c
fr100.155.pdf
16
More Facts

• Gotta have the label even if theres not much to
  say!

17
Want to Lose Weight?

• Calories
• Fat
• Carbs?

18
1. Content ClaimsNutrient Descriptors

• A claim that expressly or implicitly
  characterizes the level of a nutrient
• low in saturated fat
• no sodium
• high in vitamin C
• fat free

19
1. Content Claims
In General MUST have more than 10 of nutrient

• Phrase DRI
• Excellent source 20 or more
• Good source 10
• Free Depends on nutrient

20
Relative Claims

• Calories
• Sugar
• Sodium
• Fat
• Cholesterol

• Light, Lite, Reduced, Less, More, Fewer
• Need reference food
• Must be same type for comparison
• Must state reference food and difference
• Must be prominent on label
• Cannot use if reference already meets claim
• Note strict regulations as to when and how you
  can say what you want to say

21
Look for FLAGS
Content
Comparison
22
2. Types of HEALTH Claims allowed
LEAST Scientific Evidence

• Health Claims
• Qualified Health Claims
• Structure/Function Claims

MOST Scientific Evidence
23
2A. Health Claims (Unqualified)

• Characterize The Relationship Of A Food To A
  Disease Or Health-Related Condition
• MUST be FDA approved
• All about PREVENTION reducing RISK
• may help to reduce the risk (of a disease)

24
When/How do Health Claims get APPROVED?

• Submit petition
• Show proof from publicly available scientific
  evidence of the effects
• Need Significant Scientific Agreement among
  experts (SSA)

There is a very high standard of scientific proof
required before FDA can be expected to issue
such a regulation
25
Allowable Food Health Claims Nutrient and Health
Condition

• Calcium and Osteoporosis
• Sodium and Hypertension
• Dietary Fat (Lipids) and Cancer
• Folate and Neural Tube Defects
• Dietary Sugar Alcohol and Dental Caries

http//www.cfsan.fda.gov/dms/flg-6c.html
26
A. Allowable Food Health Claims Nutrient and
Reducing Risk of
Nutrient
Reducing Risk of

• Dietary Saturated Fat and Cholesterol
• Soluble Fiber
• from Certain Foods
• Soy Protein
• Plant Sterol/Stanol esters
• Potassium

Coronary Heart Disease
High Blood Pressure and Stroke
http//www.cfsan.fda.gov/dms/flg-6c.html
27
A. Allowable Food Health Claims Whole Foods and
Reducing Risk
Whole Food
Reducing Risk of

• Fiber-Containing Grain Products, Fruits, and
  Vegetables
• Fruits and Vegetables
• Fruits, Vegetables and Grain Products
• that contain Fiber, particularly Soluble Fiber
• Whole Grain Foods

Cancer
Coronary Heart Disease
Heart Disease Certain Cancers
http//www.cfsan.fda.gov/dms/flg-6c.html
28
Health claims on labels
Website regulation different FTC not FDA
29
2B. Health Claims Qualified Health Claim

• If FDA concludes that it cannot approve a
  proposed health claim
• because the claim is not supported by
  significant scientific agreement
• the agency may instead approve a
• qualified health claim

30
ALL Qualified Health Claims Allowed by FDA

• Cancer Risk
• Tomatoes and/or Tomato Sauce Prostate, Ovarian,
  Gastric, and Pancreatic Cancers (F)
• Calcium and Colon/Rectal Cancer Calcium and
  Recurrent Colon/Rectal Polyps (S)
• Green Tea Cancer
• Selenium Cancer (S)
• Antioxidant Vitamins Cancer (S)
• Cardiovascular Disease Risk
• Nuts Heart Disease
• Walnuts Heart Disease
• Omega-3 Fatty Acids Coronary Heart Disease
  (F/S)
• B Vitamins Vascular Disease (S)
• Monounsaturated Fatty Acids From Olive Oil and
  Coronary Heart Disease (F)
• Unsaturated Fatty Acids from Canola Oil
  Coronary Heart Disease (F)
• Corn Oil Heart Disease (F)
• Cognitive Function
• Phosphatidylserine (soy derived) Cognitive
  Dysfunction and Dementia (S)
• Diabetes
• Chromium Picolinate Diabetes (S)
• Hypertension

KEY(F) Food also in blue (S) Supplements ONLY
http//www.cfsan.fda.gov/dms/qhc-sum.html
31
Qualified Claims Language
http//www.ift.org/pdfs/expert/ff/FinalReport.pdf
32
2C. Health Claims Structure Function Claims

• Role of a nutrient or dietary ingredient intended
  to affect the structure or function in humans
• Cannot talk about disease
• General reference
• Examples
• Builds strong bones
• Does not cause tooth decay
• For a healthy heart

33
2C. Structure Function Claims

• Unlimited options

34
Structure/Function Regulations
http//www.ift.org/pdfs/expert/ff/FinalReport.pdf
35
Making Good Food Choices
http//www.cfsan.fda.gov/lrd/advlabel.html
36
New Food Labeling System (?) - ONQI

• The Overall Nutritional Quality Index (ONQI) is a
  new labeling system that is being formed to help
  consumers choose healthy products
• http//www.griffinhealth.org/Research/ONQI.aspx
• Consists of a 1 to 100 scale for healthy food
• 100 being the healthiest
• Example Strawberries 100, Soda 1
• Supposedly a consistent way of labeling foods
• Still being worked on and reviewed by FDA

37
Organic Labeling
Organic Foods Production Act and the National
Organic Program (NOP) ensure consistent
standards. On food labels"organic" must meet the
following guidelines

• 100 organic must contain (excluding water and
  salt) ONLY organically produced ingredients
• ORGANIC must consist of at least 95 organically
  produced ingredients (excluding water and salt)
• Made with organic ingredients Processed products
  that contain at least 70 organic ingredients

The USDA makes no claims that organically
produced food is safer or more nutritious than
conventionally produced food.  Organic food
differs from conventionally produced food in the
way it is grown, handled, and processed.
http//www.ams.usda.gov/nop/FactSheets/LabelingE.h
tml
38
Natural vs. Organic Labeling

• Natural and organic are not interchangeable.
• Only food labeled "organic" has been certified
  as meeting USDA organic standards
• USDA has policy for meat and poultry products.
• This states that products can only carry a
  'natural' claim if they contain no artificial or
  synthetic ingredients, and if they are minimally
  processed
• No FDA definition of natural in NLEA
  (Nutrition Labeling Education Act)

• Market Data
• 63 of consumers have a preference for natural
  foods and beverages (NMI, 2004)
• In 2003, food sales in natural product stores
  11.4 billion

39
7-Up Natural

• May 2006, Cadbury Schweppes Launches Now Natural
  Campaign for 7-Up
• By removing calcium disodium EDTA (a flavor
  preservative), the new lemon-lime 7-Up is
  replaced with "natural flavors"

40
Jelly Bean Rule

• A regulation that protects consumers by
  preventing manufacturers from marketing junk food
  as health food
• Under the "Jelly Bean Rule," health claims are
  prohibited on products containing "disqualifying
  nutrient levels."
• That is, products cannot carry health claims if
  they contain "excessive levels of fat, saturated
  fat, cholesterol, or sodium" or contain virtually
  no nutritive value at all
• No food may bear a disease prevention claim
  unless it contains 10 or more of the DRV for
  vitamin A, vitamin C, iron, calcium, protein or
  fiber before supplementing

Getting around legislation
41
7-Up Plus 2004
42
Diet Coke Plus Spring 2007

• Sparkling Beverage
• 1st nutrient-enhanced soda
• 15 DV of Niacin, B6 and B12
• 10 DV for zinc and magnesium

Great taste has its benefits
43
Tava February 2008

• Pepsi Vitamin enhanced beverage
• with Vitamins E, B6, Niacin Chromium
• free of calories and caffeine
• Beneficial ingredients with sophisticated flavor
  blends and helps with weight management
• Intriguing Flavors
• Mediterranean Fiesta
• Tahitian Tamure
• Brazilian Samba

44
Jelly Belly Sport Beans

• formulated to fuel and replenish your body during
  intense activity with carbohydrates, electrolytes
  and vitamins C and E