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 doesn’t work anymore,

Here, eat this root.

Functional Foods-Definition

‘Foods which provide a health benefit beyondbeyond basic nutrition’. International Food Information Council

Functional Foods-Definition

‘Those foods in which concentrations of one or more ingredients have been manipulated on modifiedmanipulated 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 populationself-efficacy or autonomy in health careincreased healthcare costsadvancing evidence (research) that diet

can regulate disease progressionchanges 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 diet-disease

relationship is not conclusiveExamples:

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

Source Potential health benefit

Lutein Green vegies Healthy vision

Omega 3 fatty acids

Salmon, fatty fish May reduce risk of cardiovascular disease and improve mental, visual functions

Anthocyanidins 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/qhc-sum.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 FTCMore 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 – OsteoporosisSodium – HypertensionDietary fat – cancerSaturated 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 – cancerFolate – neural tube birth defectsSugar alcohols – dental cariesFoods that contain fiber from whole

grains - CHD

Authorized Health Claims - NLEA (1990)

Foods that contain fiber from Psyllium – CHD

Soy Protein – CHDPlant Sterol/Stanol esters - CHD

Labeling Requirements

Claim Nutrient amount allowed

Low Fat ≤ 3 gms

Low Saturated Fat

≤1 gm

Reduced Calorie ≤25% of Cal of original

Cholesterol Free <2 mg

Lean meat <10g fat, 4.5g SF 95 mg Chol

Extra Lean Meat <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 strokeWhole 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”