Food In The Market Place

Evolution of Health Care

2000 BC-Here, eat this root 1000 AD- That root is heathen. Here, say this prayer 1850 AD-That prayer is superstition. Here drink this potion. 1940 AD That potion is snake oil. Here swallow this pill 1985 AD-That pill is ineffective. Here, take this antibiotic. 2000 Ad That antibiotic doesnt work anymore, Here, eat this root.

Functional Foods-Definition

Foods which provide a health benefit beyond basic nutrition.

International Food Information Council

Functional Foods-Definition
Those foods in which concentrations of one or more ingredients have been manipulated on modified to enhance their contribution to a healthful diet.
Institute of Medicine of the National Academy of Sciences

Functional Foods
Unmodified whole foods like fruits and vegetables Modified foods including fortified foods including those that have been fortified with nutrients or enhanced with phytochemicals or botanicals.

Functional Foods
The functional food industry in the U.S. was valued at $20.2 billion in 2002 or 4% of the total food industry. The market is expected to increase at an AAGR (average annual growth rate) of 13.3%, bringing the market value to $37.7 billion by 2007.

Functional Foods
Factors affecting growth of functional foods: an aging population self-efficacy or autonomy in health care increased healthcare costs advancing evidence (research) that diet can regulate disease progression changes in food regulation

Scientific Research
Strong Evidence
Substantial scientific agreement relationship of a diet-disease relationship Supported by Clinical Trials

Examples:
Fortified Margarines Sterols and Stanols Psyllum soluble fiber Soy Whole oat products Fatty Fish, n-3 fatty acids

Scientific Research
Moderate Evidence
Scientific evidence supporting dietdisease relationship is not conclusive

Examples:
Catechins in green tea reduce risks of certain types of cancers Lycopene in tomato products reduce prostate cancer Probiotics in dairy products support GI health

Scientific Research
Low Evidence
Some scientific evidence suggest a relations ship but is limited or not conclusive

Examples
Garlic reduction of total and LDL cholesterol Lutein in spinach, kale, collard greens reduction of macular degeneration

Thy food shall be thy remedy

Hippocrates, 2000 years ago

ific.org : Questions and Answers About Functional Foods

Functional Component Lutein Omega 3 fatty acids Anthocyanidins Source Potential health benefit Healthy vision
May reduce risk of cardiovascular disease and improve mental, visual functions

Green vegies Salmon, fatty fish

Berries, red grapes Bolster antioxidant defenses

Qualified Health Claims

Qualifying language is included as part of the claim to indicate that evidence supporting the claim is limited. http://www.cfsan.fda.gov/~dms/qhcsum.html

Dietary Supplements
The Dietary Supplement Health Education Act (DSHEA - 1994) exempts dietary supplements from the strict approval required for food additives. Permits dietary structure/function claims with out FDA approval.

Structure Function Claim

Statements which claim a benefit related to a nutrient deficiency disease (like vitamin C and scurvy) as long as the claim tells you how widespread the disease is in the US. Manufacturers of dietary supplements which make structure/function claims on the label must notify FDA no later than 30 days after marketing the supplement.

Structure Function Claim

May also describe the role of a nutrient or dietary ingredient affecting a structure or function in humans, such as calcium builds bones or fiber maintains bowel regularity.

Dietary Supplements
Label must contain disclaimer This statement has not been evaluated by FDA. This product is not intended to diagnose, treat, cure or prevent any disease.

Advertising
Advertising is regulated by FTC More lenient standards for advertising claims about diet-disease relationship than FDA for food labeling

Health Claims
Fish and meats must meet criteria for extra lean Extra lean: less than 5 g fat, 2 g saturated fat and 95 mg cholesterol per 100 grams.

Authorized Health Claims - NLEA (1990)

Well established relationship between the a food, food component, dietary ingredient or dietary supplement and risk of a disease.

Authorized Health Claims - NLEA (1990)

Calcium Osteoporosis Sodium Hypertension Dietary fat cancer Saturated fat & cholesterol Coronary Heart Disease (CHD) Fiber containing grain products, fruits & vegetables cancers

Authorized Health Claims - NLEA (1990)

Fruits, vegetables and grains products which contain fiber, particular soluble fiber - CHD Fruits and vegetables cancer Folate neural tube birth defects Sugar alcohols dental caries Foods that contain fiber from whole grains - CHD

Authorized Health Claims - NLEA (1990)

Foods that contain fiber from Psyllium CHD Soy Protein CHD Plant Sterol/Stanol esters - CHD

Labeling Requirements
Claim Low Fat Low Saturated Fat Reduced Calorie Cholesterol Free Nutrient amount allowed 3 gms 1 gm

25% of Cal of original

<2 mg

Lean meat
Extra Lean Meat

<10g fat, 4.5g SF 95 mg Chol

<5g fat, 2 gSF 95mg Chol

The Food and Drug Administration Modernization Act of 1997 (FDAMA)

Allows manufactures to use claims if those claims are based on current, published, and scientific statements make by authoritative government agencies such as NIH, CDC or NAS. Manufacturers must notify FDA 120 days prior to using the claim.

The Food and Drug Administration Modernization Act of 1997 (FDAMA)

Potassium blood pressure and stroke Whole grains heart disease and cancer

Qualified Health Claims - 2002

Provides for the use of qualified health claims when there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk for a disease or health related condition. Manufactures can petition for a claim, which the FDA publicly files within 45 days.

Qualified Health Claims

Petitioners need to demonstrate that the weight of scientific evidence supports the claim. Qualifying language is included as part of the claim to indicate that evidence supporting the claim is limited.

Folic acid, B6, B12 Vascular disease

As part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, Vitamin B6 and B12 may reduce the risk of vascular disease FDA evaluated this claim and found that diets low in saturated fat and cholesterol reduce the risk of heart disease, the evidence to support this claim in inconclusive.

Walnuts and Heart Disease

Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease