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 beyondbasic 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 diet-disease 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
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 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
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”