1. Food In The Market Place

2. 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.

3. Functional Foods-Definition beyond ‘Foods which provide a health benefit beyond basic nutrition’.  International Food Information Council

4. Functional Foods-Definition manipulated on modified ‘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

5. 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.

6. 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.

7. 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

8. 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

9. 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

10. 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

11. Thy food shall be thy remedy Hippocrates, 2000 years ago

12. ific.org : Questions and Answers About Functional Foods Functional Component SourcePotential health benefit LuteinGreen vegiesHealthy vision Omega 3 fatty acids Salmon, fatty fish May reduce risk of cardiovascular disease and improve mental, visual functions AnthocyanidinsBerries, red grapesBolster antioxidant defenses

13. Regulation of Functional Foods Federal Food and Drug Cosmetic Act as amended - FDCA  conventional foods  food additives  dietary supplements  medical foods  foods for specialty use

14. 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 http://www.cfsan.fda.gov/~dms/qhc- sum.html

15. 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.

16. 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.

17. 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”.

19. 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”.

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

21. Health Claims Calcium and Osteoporosis Food or supplement must be ‘high’ in calcium and not contain more phosphorus than calcium.  High: 20% or more of the Daily Value for a particular nutrient in a serving Claims for products with >400 mg of calcium must state that a daily intake over 2,000 mg offer no added benefit.

22. Health Claims Dietary saturated fat & cholesterol and risk of coronary heart disease Foods must meet the criteria for ‘low fat’, ‘low saturated fat’ and ‘low cholesterol’  low fat: 3 g or less/serving  low-saturated fat: 1 g or less/serving  low cholesterol: 20 mg or less & 2 g or less of saturated per serving

23. 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.

24. Health Claims Fiber container grain products, fruits & vegetables and cancer Food must meet criteria for ‘low fat’ and be a ‘good source’ of dietary fiber Good source: one serving of food that contains 10 - 19% of Daily Value of food for a particular nutrient.

25. Health Claims Fruits, vegetables and grain products that contain fiber, particularly soluble fiber and the risk of coronary heart disease. Foods must meet criteria for ‘low fat’, ‘low saturated fat’, and ‘low cholesterol’ They must contain, without fortification, at least 0.6 g soluble fiber per reference amount and the soluble fiber content must be listed.

26. Health Claims Dietary sugar alcohol and tooth decay Food must meet criteria for ‘sugar free’ food contains no amount or only a trivial amount of fat, saturated fat, cholesterol, sodium, sugar and calories  5 calories, or 0.5 g/serving for fat and sugar

27. Health Claims Dietary soluble fiber (oats and psyllium) and coronary heart disease Foods must meet criteria for low fat, saturated fat and cholesterol Foods that contain whole oats must contain 0.75 g of soluble fiber food that contain psyllium seed husk must contain at least 1.7 g of soluble fiber

28. Health Claims Folate and neural tube birth defects Foods must meet or exceed criteria for ‘good source’ of folate  at least 40 mcg of folic acid per serving or at least 10% of the recommended daily value A serving cannot contain more than 100% of the daily value for vitamin A and D

29. Health Claim Soy and Coronary Heart Disease Foods must meet criteria for low fat, saturated fat and cholesterol Foods must contain at least 6.25 grams of soy per serving

30. Health Claim Plant Sterol or Plant Stanol in reducing risk of Coronary Heart Disease Foods that qualify include spreads, salad dressing, snack bars and dietary supplements in softgel form Foods must meet the requirement for low saturated fat and cholesterol and contain no more that 13 grams fat/serving

31. Health Claim Should also state: “should be consumed as part of a diet low in saturated fat and cholesterol” Must contain 0.65 grams of plant sterol esters per serving or 1.7 grams of plant stanol esters per serving

32. Authorized Health Claims - NLEA (1990) Well established relationship between the a food, food component, dietary ingredient or dietary supplement and risk of a disease.

33. 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

34. 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

35. Authorized Health Claims - NLEA (1990) Foods that contain fiber from Psyllium – CHD Soy Protein – CHD Plant Sterol/Stanol esters - CHD

36. Labeling Requirements ClaimNutrient 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

37. 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.

38. The Food and Drug Administration Modernization Act of 1997 (FDAMA) Potassium – blood pressure and stroke Whole grains – heart disease and cancer

39. 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.

40. 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.

41. 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.

42. 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”