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Food safety legislation will bring about a slew of new regulations, requirements, and guidance documents. Also, increased attention and coverage of whether or not the new requirements are achieving the goals of the changes, have maintained status quo, or alternatively, are failing to address the food safety concerns both domestically and abroad (i.e., import concerns).
What are some of the key issues with food safety?
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Even more attention will be given to potential and actual food label changes. Changes to individual nutrient levels (i.e., sodium) due to the current dietary guidance, population demographics, and increasing demands from consumer advocates for “nutritious” products (keeping in mind, nutritious is defined differently by different subpopulations).
What are some of the key issues with label changes?
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Sustainable packaging to locally sourced ingredients to using the full value and function of ingredients and products. Foraging, a recent culinary trend to use ingredients found in the woods and land that are traditionally not utilized. Stories discussing food processing and packaging, as more and more companies will seek to explain and publicize where their ingredients come from and how their products are made.
What are some of the key issues with sustainability?
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Seek out ways to individualize health, nutrition, and food safety messages. Mobile devices and applications will continue to make health, nutrition, and food safety information easy to access and use, both through speedy delivery and through user-friendly descriptions. Individuals will see out mechanisms and methods to sort through the “noise” to identify which messages are relevant to them, and how those messages can be personalized to their busy lives and lifestyles.
What are some of the key issues with instant gratification and personalization?
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Obesity and CDC
- 70 million adults
- 1/3 of children
-
Food Insecurity and USDA
- About 15%
- More than 45 million
- 1 in 5 children
- More than 40 million food stamps
-
Food Borne Illness and CDC
- 48 million
- 128,000 hospitalized
- 3,000 deaths
-
From Legislation to Action
People -> Congress -> Law (acts) -> Agencies -> Regulations
-
FDA Food Safety Modernization Act
- Tracking on where foods are from
- Government can force recall
- Better monitoring of food in and out of the US
-
Healthy, Hunger Free Kids Act
- USDA can reform the school lunch plans to make more nutritious
- Provides incentives to already healthy schools
- School gardens
-
Food Security
- Access by all people at all times to enough food for an active, healthy life
- 15% of US households are food insecure
-
Female head of family
Low income
Minority
South and West
Would be worse without SNAP, WIC, or other programs
Highest Food Insecurity
-
Supplemental Nutrition Assistance Program
- Food stamps
- Over 40 million people receive them each year
-
WIC, SNAP, and other governmental programs
Help people get jobs and income
Food 2 Kids
How to help decrease food insecurity
-
Minimally Processed
Foods that require little processing or production
-
Washed vegetables and fruits
Bagged salads
Roasted and ground nuts
Coffee beans
Examples of Minimally Processed Foods
-
Canned tuna, beans, and tomatoes
Frozen fruits and vegetables
Pureed and jarred baby foods
Foods processed to help preserve and enhance nutrients and freshness of foods at their peak
-
Instant potato mix
Cake mix
Rice
Jarred tomato sauce
Spice mixes
Dressings and sauces
Gelatin
Foods that combine ingredients such as sweeteners, spices, oils, flavors, colors, and preservatives to improve safety and taste and/or add visual appeal
-
Breakfast cereals
Ice cream
Yogurt
Fruit chews
Rotisserie chicken
Fruit drinks
Carbonated beverages
Cheese spreads
"Ready to Eat" foods needing minimal to no preparation
-
Prepared deli foods and frozen meals
Entrees
Pot pies
Pizza
Foods packaged to stay fresh and save time
-
FDA
Regulates food, drugs, and supplements
-
FTC
Regulates advertising of supplements and food
-
Drug
Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or a product (other than food) intended to affect the structure or any function of the body
-
Food
Intended for use as a food or drink, i.e., consumed primarily for taste, aroma, or nutritive value
-
Supplement
Intended to supplement the diet that contains one or more of the following dietary ingredients: 1) vitamin, 2) mineral, 3) herb or botanical, 4) amino acid, 5) dietary substance for use to supplement the diet by increasing total dietary intake, 6) concentrate, metabolite, constituent, extract, or combination of any of these ingredients
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Food Additive
Any substance that is reasonably expected to become a component of food that is subject to premarket approval by FDA, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive definition
-
1958 Amendment to FD&C Act- GRAS
-
Many substances added to food don’t need a formal premarket FDA safety review:
- Safety established (long history of use in food)
- Nature of substance, customary or projected use, and scientific knowledge about ingredient
- Examples: salt, oil, flour, sugar, HFCS
-
"Everything" Added to Food in the United States (EAFUS)
- Links to GRAS, true food additives and colors
- Function and use of ingredient
- Allowable amounts for some ingredients
- More than 3000 substances
-
Nutrition Labeling and Education Act 1990
- Food labeling
- Health claims
-
Dietary Supplement Health and Education Act of 1994 - DSHEA
-
nBroadly defines dietary supplements
- nStructure-function claims
- Exempts ingredients from food additive requirements of the FD&C Act
- FDA must prove danger (not manufacturer)
- Very limited authority for FDA to regulate supplements (but still regulated!)
-
Food and Drug Modernization Act of 1997
- Food and dietary supplement industries thought DSHEA too strict
- So . . . got Congress to loosen regs for expanding permissible disease prevention claims and nutrient content claims to include authoritative statements by other federal health agencies and the NAS
-
Public Health Security and Bioterrorism Preparedness Response Act - 2002
- In response to 9/11/01
- In part requires FDA to enhance controls over various foods
- Final rule published in 2008
-
Food Labeling Guide, FDA, appendices A, B, C, D, and F
Nutrition Labeling and Education Act (NLEA) of 1990 governs food labeling
-
Serving Sizes
- Common household unit
- Metric unit
- NLEA definesDiscreet units (bars, cookies…)
-
Daily Value
- Daily Reference Values (DRV)
- - Macronutrients, Na, K
- Reference Daily Intakes (RDI)
- - Micronutrients
- - Based on 1973 “USRDA”
- Are not NAS-DRIs (RDA, EAR)
-
Reference Daily Intakes
Used for intakes of nutrients per day
-
Daily Reference Values
- Based on 2,000 calories a day
- For adults and children over 4 only
- Includes: Fats, cholesterol, protein, carbohydrates, sodium, potassium, and fiber
-
Nutrient Content Claims
- Used mainly for Na, fat, other macronutrients:
- - Free, without, no, zero
- - Low (lo), little, few, low source
-
> 20% DV
10-19% DV
25% less
25% less
50% less
10% more
- Key words:
- High or Hi
- Good source
- Reduced
- Less or fewer
- Light
- More
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Relative Claims
The amount of a nutrient in a food must be compared to an amount of nutrient in an appropriate reference food like light, or reduced and added or more or less
-
Light
(1) A food representative of the type of food bearing the claim (e.g., average value of top three brands or representative value from valid data base), and (2) Similar food (e.g., potato chips for potato chips)
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"Reduced" and "Added" (or "Extra," "Plus," "Fortified," and "Enriched")
(1) An established regular product or average representative product, and (2) Similar food
-
More and Less (Fewer)
1) An established regular product or average representative product, and (2) A dissimilar food in the same product category which may be generally substituted for the labeled food (e.g., potato chips for pretzels) or a similar food
-
More," "Fortified," "Enriched," "Added," "Extra," or "Plus"
10% or more of the DV per RACC. May only be used for vitamins, minerals, protein, dietary fiber, and potassium
-
Lean
On seafood or game meat products that contain less than 10g total fat, 4.5g or less saturated fat, and less than 95mg cholesterol per RACC and per 100g
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Extra Lean
On seafood or game meat products that contains less than 5g total fat, less than 2g saturated fat and less than 95mg cholesterol per RACC and per 100g
-
High Potency
May be used on foods to describe individual vitamins or minerals that are present at 100% or more of the RDI per RACC or on a multi-ingredient food product that contains 100% or more of the RDI for at least 2/3 of the vitamins and minerals with RDIs and that are present in the product at 2% or more of the RDI
-
Modified
May be used in statement of identity of a food that bears a relative claim (e.g., "Modified fat cheesecake, contains 35% less fat than our regular cheesecake.")
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Fiber Claims
Made and the food is not low in total fat, then the label must disclose the level of total fat per labeled serving
-
Anitoxidant
- An RDI must be established for each of the nutrients that are the subject of the claim; each nutrient must have existing scientific evidence of antioxidant activity; the level of each nutrient must be sufficient to meet the definition for "high," "good source," or "more"; Beta-carotene may be the subject of an antioxidant claim when the level of vitamin A present as beta-carotene in the food is sufficient to qualify for the claim.
- Name(s) of nutrient(s) that is (are) the subject of the claim is (are) included as part of the claim. (e.g., high in antioxident vitamins C & E)
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Low Fat
< 5 g fat /RACC & /100g
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Low Saturated Fat
< 2 g sat fat /RACC & /100g
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Sodium
≤ 480 mg /RACC and /l.s.; or /50 g, if RACC is small
-
Cholesterol
< 95 mg /RA & /100 g
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Beneficial Nutrients
Contains at least 10% of DV /RACC for vitamins A, C, calcium, iron, protein, or fiber
-
Nutrient claims for infants and children under the age 2
- Claims describing the percentage of vitamins and minerals in a food in relation to a daily value
- Claims on infant formulas
- The terms "Unsweetened" and "Unsalted" as taste claims
- "Sugar Free" and "No Added Sugar" claims on dietary supplements only
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Healthy
- Low in fat, sat. fat, limited cholesterol, Na
- 10% of at least one: A, C, Fe, Ca, protein, fiber (exemptions)
- Meals: 10% of several nutrients
- < 360 or < 480 mg Na
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Fresh
- Not mandated by NLEA
- “Suggests” food is raw or unprocessed
- Fresh frozen, frozen fresh, freshly frozen
- Blanching allowed
-
Labels for infants and small children
- Nutrition Facts labels for foods specifically for children less than 4 years do not provide % Daily Values for the macronutrients
- Foods for children less than 2 years of age must not have calories from fat and calories from saturated fat and quantitative amounts for saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol
- In both cases, % Daily Value is declared only for protein, vitamins, and minerals.
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Ingredient Labeling
- All ingredients
- 2004-05 FDA: new regs for 8 allergenic foods
- % juice in juice
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Health Claims
- Can be structure/function claims
- - “Calcium builds strong bones”
- - “Fiber maintains bowel regularity”
- - Must say: “not intended to diagnose, treat, cure, or prevent any disease” (only drugs can do this)
- - Companies inform FDA, but FDA does not have to pre-approve (but FDA/FTC can take action against company if needed)
-
2 Essential Components of Health Claims
- Substance: food, ingredient, supplement
- Disease or health-related conditions
- Example: Low saturated fat reduces risk of heart disease
- NOT: Fruits and vegetables are healthy
-
3 Types of Health Claims
- 1.NLEA authorized health claims (Act in 1990)
- 2. 1997 FDMA: authoritative statements of government or NAS (usually foods, not supps)
- 3. Qualified Health Claims (Weakest)
-
NLEA authorized health claims (Act in 1990)
- FDA reviews science to authorize claims
- Significant scientific agreement (SSA)
- Currently 12 of these (most from 1990)
-
1997 FDMA: authoritative statements of government or NAS (usually foods, nut supps)
Whole Grain Foods and Risk of Heart Disease and Certain CancersPotassium and the Risk of High Blood Pressure and Stroke
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Qualified Health Claims (Weakest)
- 2003 FDA Consumer Health Information for Better Nutrition Initiative
- Foods AND supplements
- “Grade” claims based on strength of scientific evidence (A, B, C . . . )
- If “A” grade – then unqualified
- If < A grade – then “qualified” (weak)
- Data not strong for full health claims
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qGreen tea & cancer
qSelenium & cancer
qNuts & heart disease
qOlive oil & CHD
qChromium picolinate & diabetes
- www.fda.gov/Food/
- GuidanceCompliance
- RegulatoryInformation/
- GuidanceDocuments
- /FoodLabelingNutrition/FoodLabelingGuide
- /ucm064923.htm
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6 Steps for evaluating scientific evidence needed for health claims
- 1.Define the substance/disease relationship
- 2.Identify relevant publicly available evidence
- 3.Classify the evidence by study design 4.Rate the evidence for methodological quality
- 5.Rate the strength of the body of evidence
- 6.Report a “rank”
-
Define the substance/disease relation
- Reduction in incidence of a disease, or
- Beneficial changes in surrogate endpoints for disease
-
Surrogate endpoints are biological variables (biomarkers) related to a disease
Indicator or predictor of that disease, and from which the risk of a disease can be inferred (but not a measure of the actual disease)
-
Good Surrogate Endpoints
- 1.Associated with disease
- 2.Mediates relationship between consumption of substance and development of disease
- 3.Its expression is modified by intake of a substance in healthy people
-
Disease- Colon Cancer Endpoint- Adenoma Polyps
Disease- CHD/stroke Endpoint- blood pressure, total cholesterol, LDL-cholesterol
Disease- osteoporosis Endpoint- bone density
Examples of Surrogate Endpoints
-
Intervention (type 1)
- Best, because investigator controls doses of food, ingredient, supplement etc, that is given to the person
- - Randomized controlled trial - best
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Observational Studies
- Weaker because people are just eating “whatever” and not controlled by investigator
- - Prospective cohort studies
- - Retrospective: case–control studies and cross-sectional studies
-
Methodological Quality
- Study design, participants
- Biochemical measures, dietary assessment
- Statistics
-
Rate the body of evidence and report an “evidence-based” rank (“level of comfort”)
A highest, then B, C, D (very low)
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Functional Foods
- Foods with health benefits beyond “basic nutrition”
- Legal definition? US=No. Japan=Yes.
- In US, we use the labeling regulations to help consumers identify foods with health benefits
- Perception > Science
- Example: Salt fortified with iodine
- Natural or fortified or processed . . .
- From biotechnology OK
- Animal and plant foods
-
Functional Foods- IFIC
- Demand is high
- Scientific proof needed
- Many types of health-related claims
- Nutrigenomics or “personalized nutrition”
- –Tailor diet recommendations to person’s genetics
- –Requires more research (physiological, behavioral)
-
Carotenoids
- Beta-Carotene
- Lutein, zeaxanthin
- Lycopene
-
Beta-Carotene
- Sources- carrots, pumpkins, sweet potatoes, cantaloupe
- Potential Benefits- neutralizes free radicals, which may damage cells; bolsters cellular antioxidant defenses; can be made into vitamin A in the body
-
Lutein, Zeaxanthin
- Sources- kale, collards, spinach, corn, eggs, citrus
- Potential Benefits- may contribute to maintenance of healthy vision
-
Lycopene
- Sources- tomatoes and processed tomato products, watermelon, red/pink grapefruit
- Potential Benefits- may contribute to maintenance of prostate health
-
Dietary Fiber
- Insoluble fiber
- Beta glucan
- Soluble fiber
- Whole grains
-
Insoluble Fiber
- Sources- wheat bran, corn bran, fruit skins
- Potential Benefits- may contribute to maintenance of a healthy digestive tract; may reduce the risks of some types of cancer
-
Beta Glucan
- Sources- oat bran, oatmeal, oat flour, barley, rye
- Potential Benefits- may reduce risk of coronary heart disease
-
Soluble Fiber
- Sources- psyllium seed husk, peas, beans, apples, citrus fruit
- Potential Benefits- may reduce risk of coronary heart disease and some types of cancer
-
Whole Grains
- Sources- cereal grains, whole wheat bread, oatmeal, brown rice
- Potential Benefits- may reduce risk of coronary heart disease and some types of cancer; may contribute to maintance of healthy blood glucose levels
-
Fatty Acids
- Monounsaturated fatty acids
- Polyunsaturated fatty acids-omega 3-ALA
- Polyunsaturated fatty acids-omega 3-DHA/EPA
- Conjugated linoleic acids
-
Monounsaturated Fatty Acids
- Sources- tree nuts, olive oil, canola oil
- Potential Benefits- may reduce risk of coronary heart disease
-
Polyunsaturated Fatty Acids-Omega 3-ALA
- Sources- walnuts, flax
- Potential Benefits- may contribute to maintenance of heart health; may contribute to maintenance of mental and visual function
-
Polyunsaturated Fatty Acids-Omega 3-DHA/EPA
- Sources- salmon, tuna, marine, and other fish oils
- Potential Benefits- may reduce risk of coronary heart disease; may contribute to maintenance of mental and visual function
-
Conjugated Linoleic Acids
- Sources- beef and lamb, some cheese
- Potential Benefits- may contribute to maintenance of desirable body composition and healthy immune function
-
Flavonoids
- Anthocyanins-cyanidin, delphinidin, malvidiin
- Flavanols-catechins, epicatechins, epigallocatechins
- Flavanones-hesperetin, naringenin
- Flavanols-quercetin, kaempferol, isorhamnetin, myricetin
- Proanthocyanidins
-
Anthocyanins-Cyanidin, Delphinidin, Malvidiin
- Sources- berries, cherries, red grapes
- Potential Benefits- bolsters cellular antioxidant defenses; may contribute to maintenance of brain function
-
Flavanols-Catechins, Epicatechins, Epigallocatechins
- Sources- tea, cocoa, chocolate, apples, grapes
- Potential Benefits- may contribute to maintenance of heart health
-
Flavanones-Hesperetin, Naringenin
- Sources- citrus foods
- Potential Benefits- neutralize free radicals, which may damage cells; bolsters cellular antioxidant defenses
-
Flavanols-Quercetin, Kaempferol, Isorhamnetin, Myricetin
- Sources- onions, apples, tea, broccoli
- Potential Benefits- neutralize free radicals, which may damage cells; bolsters cellular antioxidant defenses
-
Proanthocyanidins
- Sources- cranberries, cocoa, apples, strawberries, grapes, wine, peanuts, cinnamon
- Potential Benefits- may contribute to maintenace of urinary tract health and heart health
-
Isothicyanates
Sulforaphane
-
Sulforaphane
- Sources- cauliflower, broccoli, broccoli sprouts, cabbage, kale, horseradish
- Potential Benefits- may enhance detoxification of undesirable compounds; bolster cellular antioxidant defenses
-
Minerals
- Calcium
- Magnesium
- Potassium
- Selenium
-
Calcium
- Sources- sardines, spinach, yogurt, low-fat dairy products, fortified foods and beverages
- Potential Benefits- may reduce the risk of osteoporosis
-
Magnesium
- Sources- spinach, pumpkin seeds, whole grain breads and cereals, halibut, brazil nuts
- Potential Benefits- may contribute to maintenace of normal muscle and nerve function, healthy immune function, and bone health
-
Potassium
- Sources- potatoes, low-fat dairy products, whole grain breads and cereals, citrus juices, beans bananas
- Potential Benefits- may reduce the risk of high blood pressure and stroke, in combination with a low-sodium diet
-
Selenium
- Sources- fish, red meat, grains, garlic, liver, eggs
- Potential Benefits- neutralizes free radicals, which may damage cells; may contribute to healthy immune function
-
Phenolic Acids
Caffeic acid, ferulic acid
-
Caffeic Acid, Ferulic Acid
- Sources- apples, pears, citrus fruits, some vegetables, coffee
- Potential Benefits- may bolster cellular anitoxidant defenses; may contribute to maintenance of healthy vision and heart health
-
Vitamins
- A
- B1 (Thiamin)
- B2 (Riboflavin)
- B3 (Niacin)
- B5 (Pantothenic Acid)
- B6 (Pyridoxine)
- B9 (Folate)
- B12 (Cobalamin)
- Biotin
- C
- D
- E
-
Vitamin A
- Sources- organ meats, milk, eggs, carrots, sweet potato, spinach
- Potential Benefits- may contribute to maintenance of healthy vision, immune function, and bone health; may contribute to cell integrity
-
Vitamin B1 (Thiamin)
- Sources- lentils, peas, long-grain brown rice, brazil nuts
- Potential Benefits- may contribute to maintenance of mental function; helps regulate metabolism
-
Vitamin B2 (Riboflavin)
- Sources- lean meats, eggs, green leafy vegetables
- Potential Benefits- helps support cell growth; helps regulate metabolism
-
Vitamin B3 (Niacin)
- Sources- dairy products, poultry, fish, nuts, eggs
- Potential Benefits- helps support cell growth; helps regulate metabolism
-
Vitamin B5 (Pantothenic Acid)
- Sources- organ meats, lobster, soy beans, lentils
- Potential Benefits- helps regulate metabolism and hormone synthesis
-
Vitamin B6 (Pyridoxine)
- Sources- beans, nuts, legumes, fish, meat, whole grains
- Potential Benefits- may contribute to maintenance of healthy immune function' helps regulate metabolism
-
Vitamin B9 (Folate)
- Sources- beans, legumes, citrus fruit, green leafy vegetables, fortified breads and cereals
- Potential Benefits- may reduce a woman's risk of having a child with a brain or spinal cord defect
-
Vitamin B12 (Cobalamin)
- Sources- eggs, meat, poultry, milk
- Potential Benefits- may contribute to maintenance of mental function; helps regulate metabolism and supports blood cell formation
-
Biotin
- Sources- liver, salmon, dairy, eggs, oysters
- Potential Benefits- helps regulate metabolism and hormone synthesis
-
Vitamin C
- Sources- guava, sweet red/green peppers, kiwi, citrus fruit, strawberries
- Potential Benefits- neutralizes free radicals, which may damage cells; may contribute to maintenace of bone health and immune function
-
Vitamin D
- Sources- sunlight, fish, fortified foods and beverages such as milk, juices, and cereals
- Potential Benefits- helps regulate calcium and phosphorus; helps contribute to bone health; may contribute to healthy immune function; helps support cell growth
-
Vitamin E
- Sources- sunflower seeds, almonds, hazelnuts, turnip greens
- Potential Benefits- neutralizes free radical, which may damage cells; may contribute to healthy immune function and maintenance of heart health
-
Functional Foods and ADA
- Have “physiologically active components”
- Focus on whole foods, fortified, enriched, or enhanced foods, as part of a varied diet
- Need more research to define health benefits
- Health claims should be based on the SCIENCE
-
•Consumers want to control their health
More aged, ethnic
High health care costs
Competitive food market, small profit margins
Advances in technology
Changes in regulations
Evidence-based science about food and health
Why are Function Foods becoming more popular?
-
ADA definition of Functional Foods
- Provide “additional” health benefits, prefers that they refer to foods and not supplements
- US- no government, yes industry
- Canada- yes (and defines “nutraceuticals”)
- Europe- beyond adequate nutritional effects
- Japan- yes, “Foods for Specified Health Use”
-
Research and Functional Foods
- Many types of research studies:
- –In vitro, cells, animals, laboratory studies
- –Epidemiologic studies
- –Clinical trials
- Size = small, medium, large
- Design = poor, OK, excellent quality
- With or without control groups
- Best is RCT, randomized control trial
- -Need consistent reporting standards (pg 743 – what does this encompass?
- –Meta analyses combine results of many studies
- Ultimately, should study in people in several RCT and then meta-analyses
-
How Functional Foods are Regulated
- Conventional food, additive, supplement, drug, medical food, or food for special dietary use
- 3 health claim categories:
- –Nutrient content claims
- –Structure/function claims
- –Health claims – most active area and science-based
-
Stay informed
MNT client education
Consumer education
Corporate consulting
Research
Government policy
What is most important in Functional Foods?
-
Phytochemicals
- Biologically active, naturally existing plant chemicals that act as natural defense systems in plants and show potential for reducing risk of human diseases
- Provide color, aroma, and flavor
-
Phytochemical Content
Depends on plant species and cultivar, ripeness, light, temperature, moisture, soil, stress, processing, storage time and conditions, preparation method
-
Phytochemical Bioavailability
What chemical form is absorbed, how much, target organs
-
Antioxidants
Protects many molecules from reactive chemicals
-
Phytochemicals and Keeping Us Healthy
- Antioxidants
- Cell cycles, enzymes, genes
-
Oxygen Radical Absorbance Capacity Assay
- Compares food, mixture, or phytochemical’s ability to quench the “peroxyl” radical
- Comparison moleculre is Trolox (water soluble vitamin E analog)
- –Other radicals, phytochemicals’ changed with food processing or metabolism in the body
-
Polyphenols
- ~2,000 to 5,000 types
- May act synergistically
- Might chelate iron (+ or – benefits)
- Not easily absorbed; modified by gut microflora and enzymes; various sugars:
- –Aglycone (without the sugar)
- –Glycosylated (with the sugar molecule)
- Intake ~ 200 mg to 1 gram daily
-
Synergy Hypothesis
- Different antioxidants work
- together to regenerate
- one another; if only “one”
- then may be imbalanced
- Other compounds in foods
- may be responsible for their
- beneficial health effects
-
Pomegranate
- Native to the Middle East, now also grown in CA and AZ
- Popular additive and juice
- –POM Wonderful
- May lower susceptibility of LDL to oxidation
-
Acai
- Freeze dried powder of acai berries:
- –Highest ORAC of any food tested
- –High activity against some oxidants in vitro
-
Goji Berry
- “Wolfberries”
- Used in Traditional Chinese Medicine
- Zeaxathin
-
Noni Berry
- May modulate immune function
- Palu 2008
- May be an ergogenic aid
- –Reduced fatigue in mice
-
Mangosteen
- Anti-inflammatory properties
- Cardioprotective
-
Nuts & Spices
- Pecans
- Walnuts
- Cinnamon
- Tumeric (curry)
- Cloves
-
Chocolate
- Dark chocolate is high in antioxidants
- Must be processed correctly
- High fat food
-
Mission of NIH Office of Dietary Supplements (ODS)
- Strengthen knowledge
- ¨Evaluate scientific information, research, disseminate research results, and educate public
- Evaluate total intake:
- ¨Foods, beverages, fortified products, dietary supplements, and medications
-
Bioavailability of Dietary Supplements
- Source in diet (e.g., plant, animal, synthesized)
- Dietary and supplement composition
- Physiological state and age
- Other unknown factors
-
Information about Supplements
- Health benefits, safety and efficacy very by age, sex, and physiological state
- Higher use in older vs younger adults
- Analytical standards and reference materials
- ¨Correct identity of plant sources
- ¨Allergen or other unsafe substances
- ¨Improve analytical methods
- ODS/FDA/AOAC Partnership
- ¨Validate analytical methods using AOAC's Official Methods Program
- ¨Offer training programs
-
ODS/NHLBI/ARS Collaboration
-
ODS provides funding to NHLBI/ARS to develop analytical methods
- Update nutrient values for USDA nutrient data base
- Develop analytical methods for phytochemicals (e.g., isoflavonoids, lutein, and zeaxanthine)
-
ODS/NIST Efforts
- Provide Standard Reference Materials for analytical methods performance evaluation
- NIST can only provide 1–2 standard reference materials/year (> 3000 plants used in dietary supplements)
-
Adequacy of Dietary Supplement Databases
- Incomplete databases
- ¨Not analytically substantiated
- ¨Unknown active constituents for many herbs
- Label-based dietary supplement database
- ¨Provide information on users of supplements
-
Filling Research Gaps About Supplements
- Form botanical research centers, stimulate investigator-initiated research, and provide educational support
- Investigator-initiated research
-
ASHP Position on Supplements
- Include clinical studies of interactions between dietary supplements and medications
- Avoid use of supplements with drug therapy
- Urges pharmacists and others to integrate awareness of supplement use into practice
- Encourage more effort to prevent interactions between dietary supplements and drugs
- Supports education of pharmacists and others in taxonomy, formulation, pharmacology, and pharmacokinetics of supplements
-
DSHEA and FDA and Supplements
-
Not required for FDA to do pre-market review evidence of efficacy or safety of supplements
- To remove product from market, FDA must prove product is unsafe
- > 40% Americans use dietary supplementsSpend $18 billion annually
-
5 Dangers to Public Health of Supplements
-
1.Naturally unsafe to eat (e.g., chaparral, ephedra, comfrey, tiractricol, aristolochic acid, pennyroyal)
- 2.Lax regulation of manufacturing:
- Risk of contamination with harmful substances (e.g., carcinogens)
- Dangerous variability in amount of active ingredients among products
- 3.May compromise, delay, or supplant treatment with therapies of proven efficacy
- 4.Possible dangers to: children, pregnant women, surgery patients, poor organ or immune function
- 5.Spending is enormous health expenditure of unsubstantiated value
-
Recommendations for Regulation of Supplements
- Undergo FDA approval for safety and efficacy
- Mandate FDA-approved supplement labeling describing safe use in a clear, standardized format
- ¨Potential for interaction with medications
- ¨Cautions for special populations
- Require FDA to make and enforce GMPs
- Meet FDA-established standards for identity, strength, purity, and quality
- Empower FDA to establish and maintain an adverse-event-reporting system for dietary supplement manufactures
-
Recommends Pharmicists know this about Supplements
- Typical uses; efficacy and safety
- Potential interactions between dietary supplements and all types of medications
- Signs and symptoms of adverse effects and toxicities
- Potential effects of certain disease states on supplement absorption, distribution, and elimination
- Safety before and after surgery
-
Conclusions by ASHP about Supplements
- Inclusion criteria in health-system formularies for dietary supplements should be rigorous
- Current laws and regulations should be revised to ensure safety and effectiveness of supplements
-
Facts about Supplements
- 20% of US adults take herbal products
- 20,000 products available in US
- Natural does not mean safe
- Many not standardized, so highly variable composition
- Recommendations (Bent 2008)
- ¨Register with FDA
- ¨Testing similar to drugs
- ¨Claims should have scientific proof
- ¨Labels accurately list ingredients
-
Complexity of Herbal Products
- Any form of a plant or plant product
- Contain a single herb or combinations of several with complementary effects
- Raw plants or extracts
- Difficult to determine which chemical(s) has biological activity
- Processing alters pharmacological activity
- Environmental factors affect levels of components in an herb (e.g., growth, processing)
- Standardization: Make consistent product
- ¨Herbal markers
- ¨Final product may not contain original balance of ingredients
-
Efficacy
- Systematic review
- ¨A summary of healthcare literature
- ¨Precise, exhaustive literature search and critical review of each study
- ¨Combine the valid and applicable studies
-
Echinacea
- Common use- upper respiratory tract infection
- Efficacy- inconclusive
- Side effects- simple placebo
-
Ginseng
- Common use- physical, cognitive performance
- Efficacy- inconclusive
- Side effects- case representative hyperactive
-
Ginkgo biloba
- Common use- dementia
- Efficacy- likely effective
- Side effects- case representative bleeding
-
Garlic
- Common use- claudication, high cholesterol
- Efficacy- likely effective
- Side effects- GI
-
St. John's Wort
- Common use- moderate/mild depression
- Efficacy- likely effective
- Side effects- drug interference
-
Peppermint
- Common use- GI issues
- Efficacy- inconclusive
- Side effects- mild
-
Ginger
- Common use- nausea
- Efficacy- inconclusive
- Side effects- none
-
Soy
- Common use- menopausal symptoms, high cholesterol
- Efficacy- not effective, effective
- Side effects- concern
-
Chamomille
- Common use- insomnia, GI
- Efficacy- no high Q studies
- Side effects- rare allergy
-
Kava Kava
- Common use- anxiety
- Efficacy- likely effective
- Side effects- liver
-
Why are changes needed in supplements?
-
1.Safety testing not always extensive
- 2.No incentives for industry to conduct extensive testing
- 3.Very challenging to characterize supplements for clinical trials
- 4.No repository or coding system for supplements sold in the US
-
Big Themes-Supplements
- Food/supplement industry LOVES antioxidants
- Food antioxidants usually studied by observational epidemiology (not RCT)
- Supplement antioxidants more easily studied by RCT (randomized control trial)
- All antioxidants are different
- Benefits depend on type, source and “disease” or other outcome
- Antioxidants (AX) help make oxygen metabolism less “toxic”
- BUT, true benefit (or harm) could be any other metabolic pathway (2nd messengers, hormone, endocrine, genetic, etc)
-
Antioxidants and Cancer
- Rationale: oxidants attack cells, DNA, causing damage that could lead to cancer
- Methods:
- –Technical experts in 16 areas (no nutrition)
- –Searched 13 databases of scientific articles
- –Limited to 3 AX, RCT, clinical controlled trials, meta-analyses, and systematic reviews, any language
-
Antioxidants and Cancer
- No evidence to review for coenzyme Q10
- 3 trials examined vitamins C + E:
- –No benefit to cancer deaths
- –Part of 1 trial: decrease in prostate cancer
- 7 trials of vitamin C on advanced cancer and found NO mortality benefit
- 6 trials studied C+E (+/- BC): no benefit on colonic polyps
- 1 trial of vitamin E + omega-3 showed increased survival with severe malignancies
- 1 trial of vitamin C + TB-vaccine showed reduction in new bladder tumors
-
Antioxidants and CVD
- Rationale: Antioxidants decrease blood platelet aggregation and reduce risk of developing CVD
- Methods:
- –Comprehensive search
- –Any languages; 15 databases; systematic review
- –Placebo-controlled randomized trials; 60+ patients
-
Vitamin E and CVD
- This alone and in combination with other antioxidants
- –Not prevent all-cause death or CVD death
- –Evidence mixed and generally no consistent benefit on fatal and nonfatal MI
-
Coenzyme Q10 and cardiac function and CVD
- Mixed findings
- Not enough evidence; need more studies
-
Antioxidant Supplements for Cancer and CVD
- USPSTF could NOT determine the balance of benefits and harms of routine use of supplements for the prevention of cancer or CVD
- –Vitamins A, C, or E
- –Multivitamins with folic acid
- –Antioxidant combinations
-
Beta-Carotene and Cancer and CVD
- USPSTF advises against use of these supplements, either alone or combination for cancer or CVD prevention (grade D recommendation=fair evidence of harm).
- In heavy smokers, this supplementation was associated with higher incidence of lung cancer and higher all-cause mortality.
- These supplements are unlikely to provide important benefits and might cause harm in some groups.
-
Methods for Echenacea
- RCT
- Pediatrician from 7 private practices and 1 inner-city clinic
- 2 to 11 years old, without sig. health problems, no autoimmune disease, no history of allergy
- Advertised in many media
- Informed consent, questionnaires
- 4 month enrollment
- Data from up to 3 URIs per patient
-
Conclusions for Echinacea
- Among the largest studies (in any age) Participants had sought traditional care Parents couldn’t tell what they were taking
- 707 URI reported
- Multiple outcome measures
- Limitations
- –Was it started soon enough? Was dose optimal?
- –Hard to assess these outcomes
-
Methods of a Study
- Setting
- Control of variables
- Sample size
- Number of study groups
- Treatment or variables being observed
- Length of study
- How data collected
- Statistics
-
Results of a Study
- The “answers” or data
- Statistics
- –Descriptive
- –Relationships among variables
- Correlations
- Regression
- –P-value < 0.05 usually “significant”
-
Discussion of a Study
- Points out new, novel, key findings
- Puts results in context with other data
- Draws conclusions
- See if authors’ conclusions supported by the data
- Who do results apply to? Young, old, men, women, very high intakes of a nutrient or very very low intakes of a food, etc.
-
Communicating "Risk"
- Absolute risk - how many people get this disease or have this problem
- Relative risk - increased or decreased risk of getting disease
- –Smoking causes 10x increase in lung cancer
- –High F&V intakes cuts risk of some cancers by 30 to 50%
- Diet x health relationship usually in range of 0.5 to 2 X risk range
-
Basic Research
- “Test tube”
- Cell culture
- Animals
- Finding out “why”
- How does vitamin E prevent oxidation of LDL; how is vitamin E absorbed and where does it go in the body
- “In vitro” = in test tube or cell culture
-
Applied Research
- Food composition
- Human
- – Observational
- – Experimental (animals, too)
-
Observational Research-Examples
- Observe how intakes of certain foods are related to health or illness
- Cross-sectional
- –Correlate at one time point
- Retrospective
- –Look at what was eaten in the past and what health is now
- Prospective
- –Look at current eating patterns and health, then see what happens in the future
-
Experimental Research-Examples
- Manipulate something in human or animal (e.g., modify diet, give a supplement)
- Random assignment to a treatment or intervention (low-fat diet vs. normal fat diet). Researcher and subject should be “blind” to the treatment.
- Can still have problems:
- –People won’t eat the diet or take the supplement
- –People can tell what diet they are on (e.g., low vege) or what supplement they are taking (e.g., taste)
- –Not generalizable (e.g., study of safety of low fat diets in 20 year olds, but not be relevant for people aged 2 or 70)
-
Clinical Trials
- Are done in humans
- –Can have few or many people, depending on how big of an effect is expected
- Need few people to show that eating more vitamin C markedly increases vitamin C in blood (few people, few days)
- Need lots of people to show that smokers who are counseled to eat more vegetables and fruits are less likely to get lung cancer (many years and many people)
- Done as a randomized control trial (RCT) is considered strongest for proving diet and health relationships
- But, can’t or not always done
- -RCT were not done for smoking
-
Experimental Research- RCT
- Sodium and Blood Pressure
- –Used to set the Adequate Intake and Upper Levels for sodium
- Control Diet represents typical American diet.
- DASH diet emphasizes fruits, vegetables, and low-fat dairy foods, includes whole grains, poultry, fish, and nuts, and is reduced in fats, red meat, sweets, and sugar-containing beverages.
- 3 sodium levels are higher (3,450 mg/d), intermediate (2,300 mg/d) and lower (1,150 mg/d).
-
Meta-Analysis
Combines results from separate studies, such as RCT or observational studies
-
2010 Dietary Guidelines for Americans
- Used for everyone over the age of 2
- –Includes those at risk of chronic disease
-
Key Concepts of DGA
- Balancing calories to manage weight
- Foods to reduce intake
- Foods to increase intake
- Elements of food safety
- Includes calorie levels
- Serving sizes
- Meal Patterns for different diets
-
Additions to DGA
- SOFaS
- Red vegetable category
- Emphasis on Na
- Seafood
-
DGA is used for..
- Food
- –Whole food vs. nutrient guidelines
- Education
- Information
-
Food Allergy
- Any adverse reaction to an otherwise harmless food or food component that involves body’s immune system (food hypersensitivity)
- Food allergen: usually protein, not a carbohydrate or fat
- Immediate hypersensitivity
-
Immunological (hypersensitivities)
- IgE mediated
- non-IgE mediated
-
Non-immunological (intolerances)
- Toxicological- Scombroid Poisoning (Tuna, Mahi Mahi, histamine reaction)
- Metalbolic- Lactose intolerance
-
Microbial
- Infections- Salmonellosis
- Toxins- Staphylococcal enterotoxins
-
Big 8 Food Allergies
- Represent 90%
- Milk, eggs, fish, soy, shellfish (crustacea, mollusks), wheat, peanuts, tree nuts (e.g., walnuts)
-
Symptoms of Allergies
- IgE mediated symptoms begin minutes to a few hours after exposure
- Involve/include:
- –Swelling/itching of lips, mouth, throat –Nausea, vomiting, cramping, diarrhea
- –Itching, hives, eczema, redness of skin
- Highly individual
- –Severity, time to onset, location of symptoms, amount of food
- Anaphylaxis
- –rare, potentially fatal, rapid progress
- –Severe itching, hives, sweating, swelling of throat, breathing difficulty, lowered bp, unconsciousness, death
-
Asthma and Allergies
- When triggered by food allergy, increased risk of life-threatening reaction
- Common food triggers
- –8 common food allergens
- –Sulfites and sulfiting agents
- Occur naturally
- Used in food processing
- Listed on food label
-
Prevalence IgE-mediated Food Allergies
- Up to 6% of children, up to 4% of total population
- 30,000 ER visits/yr, 2000 hospitalizations/yr, 150 deaths/yr
-
Prevalence and Food Allergies
- Many childhood allergies resolve on their own
- 20% population alter diet because of “perceived” food reaction (self-diagnosing)
- Reactions to fruits and vegetables are less common
- Genetic risk factors include
- –a family history of atopic (“allergic”) disorders
- –environmental factors modulate the expression of food allergy (e.g., recent doubling in childhood peanut allergy)
-
Diagnosis of Allergies
- Thorough medical history, physical examination
- Food diary
- Elimination diets - for diagnosis and treatment
- Skin tests - with diluted extract of suspected food
- Laboratory tests - RAST (radioallergosorbent test), ELISA (enzyme-linked immunosorbent assay)
- Food challenge (best)
- –Double-blind
- –Placebo-controlled
-
Skin Prick Test (SPT)
- For IgE-mediated disorders
- –SPT alone is not diagnostic
- Positive SPT + clear food-induced allergic reaction = diagnosis
- Increasing SPT wheal size is roughly correlated with an increasing likelihood of clinical allergy.
-
Allergy and Diet
- Carefully planned diet
- Adept reading of labels
- Check every time food is consumed
- –Formulations change
- Contact manufacturer with questions
- What about immunotherapy?
- Not proven effective for food allergies*
-
Allergies and Babies
- In high-risk infants, there is evidence that exclusive breastfeeding for at least 4 months, and delaying of complementary foods until 4-6 months, prevent the development of allergy
- Some evidence that supplementing hydrolyzed formulas in high-risk infants may delay or prevent allergic disease No convincing evidence that maternal manipulation of diet during pregnancy or lactation, use of soy products, or infant dietary restrictions beyond 4-6 months has any effect on the development of atopic disease
-
Allergy Emergencies
- Fatal food-induced anaphylaxis: peanut or tree nuts
- Victims are teenagers or young adults
- –usually with a known food allergy and asthma
- –there is a failure to promptly administer epinephrine
-
Asthma and Obesity
- Childhood obesity significantly affects health of children with asthma
- Obese children recover more slowly, even after adjustment for baseline asthma severity and admission severity of illness
-
Food Allergan Labeling
- U.S. Food Allergen Labeling & Consumer Protection Act (FALCPA), Jan. 2006
- Recognizes “big 8” as most allergenic foods
- Requires “plain English language” to identify sources of ingredients
- –Casein and whey from milk
- –Semolina from wheat
- –If no source identified, presumably not a common allergen
- Collective declaration of certain ingredients allowed
- Exception is highly refined oil
-
Concerns with FALCPA
- Labeling all ingredients from commonly allergenic sources could lead to avoidance of many foods that contain very low amounts of protein or allergen –Lack evidence of allergenicity of ingredients in many cases
- –Very restrictive diets for allergic consumers
- Congress did not define “highly refined oil”
- Did not identify commonly allergenic tree nuts
- –Include kola nut and nutmeg?
- Reg’s apply only to intentionally added ingredients
- –Residues of allergenic foods can occur –Result from food-industry practices (shared equipment)
- –Can/does present a greater risk than posed by some intentional ingredients from allergenic sources
- FDA may clarify this aspect of the reg’s
- –Regulatory interpretation
-
Climate
- Average/Expected ‘Weather’
- The temperature & precipitation range
- Distribution of all possible weather
- Record of Extreme events
- The statistical properties of the atmospheric variables like temperature, precipitation, and wind
-
Climate Change
Any change in some statistical property like mean temperature
-
Changes Since Industrial Revolution
- Increase in CO2
- Increase in CH4
- Increase in N20
-
Melting of the Greenland Ice Sheet
This would commit the world to a 20 foot increase in sea level.
-
Thawing of the Permafrost
This could lead to an increase in atmospheric burden of global warming pollutants 10 times present amount (mostly potent methane)
-
Global Climate Change and Health
- Climate change affects fundamental requirements for health
- Areas with weak health infrastructure, will be least able to cope
- Through better transport, food and energy-use choices can result in improved health.
-
Global Environmental Changes and Health
- Emergence of larger-scale environmental hazards to human health
- -Stratospheric ozone depletion
- -Stresses on terrestrial and ocean food-producing systems
- -Global dissemination of organic pollutants
-
Food Habits and Climate Change
- Agriculture accounts for 60% of N2O and 50% of CH4methane
- Energy consumption
- -Pesticide & chemical fertilizer application
- -Waste generation
-
Where do GHG's come from?
- Agricultural productions (Rice cultivation) Livestock enteric fermentation
- Livestock manure management
-
GHG Effect During the Life-Cycle of Certain Foods
- Carrots, tomatoes, potatoes, pork, rice and dry peas consumed in Sweden
- -Characteristics of foods with low emissions
-
Greenhouse Effect During the Life-Cycle of Certain Foods
- Life-cycle approach was used in the study
- Energy consumption during production chain
- GHG emissions
-
Greenhouse Gases
- Emissions of greenhouse gases and energy consumption varied for different food items
- -Lowest for the vegetable products (carrots, potatoes and dry peas)
- -Emissions of greenhouse gases highest for rice and pork
-
Distribution of GHG emission during life-cycle of vegetables
- Emissions during farming dominant for tomatoes, rice and dry peas
- Emissions during storage highest for carrot
-
Distribution of GHG emission during the life-cycle of pork
- Maximum emission during rearing and crop farming for animal-feed
- N2O and methane major gases released
- Slaughtering, transportation and storage contributed minimal emission
-
GHG emission from foods
- Analysis of GHG emission of 22 food items in Sweden
- Fresh vegetables, cereals and legumes had lowest emission
- Meats and exotic fruits showed maximum emission
-
GHG emissions and protein content in foods
Beef is the least efficient way to produce protein as compared to cereals
-
Food Mile
- Measure of how far a food travels between production and final consumer Freight t-km from production to retail in US (1997): 1.2 × 1012 t-km
- ◦~ 12 000 t-km/household/yr
- 25% of t-km from “direct” tier of the food supply chain
- Varies by food groups
- Increased due to increased international trade
-
Solutions to Greenhouse Gases
- Carbon labeling policies
- Local productions
- Organic farming
- Biochar cooking
-
Food Additives
- Direct
- Indirect
- True food additive
- GRAS
- Colors
- –Certified
- –Uncertified
-
Food Additves Regulations
- FD&C Act 1938
- Amendment 1958:
- –FDA approves before use
- –Manufacturer must prove safety
- –Exemptions (based on before 1958):
- Group I: Prior sanctioned, e.g., nitrite
- Group II: GRAS - history of safety: salt, sugar, spice, MSG
- –If later found to be unsafe, FDA can remove
-
Food Additives and Colors
-
•Color Additives Amendment 1960
- All colors had to undergo further testing
- Of 200:
- –~ 90 listed as safe
- –Rest removed by FDA or withdrawn by industry
- –Can’t use if found to cause cancer
-
How to Approve Food Additives
- Company 1st petitions FDA (~100/yr)
- –Submits to FDA animal & human studies
- FDA reviews composition, properties, probable intake, other safety factors
- If approved, FDA specifies foods,
- maximum amounts, and labeling
- ARMS (Adverse reaction
- monitoring system)
-
Preservatives
- Job- prevent food spoilage from bacteria, molds, fungi, or yeast (antimicrobials); slow or prevent changes in color, flavor, or texture and delay rancidity (antioxidants); maintain freshness
- Types of food- fruit sauces and jellies, beverages, baked goods, cured meats, oils and margarines, cereals, dressings, snack foods, fruits and vegetables
- Labeling- ascorbic acid, citric acid, sodium benzoate, calcium propionate, sodium erythorbate, sodium nitrite, calcium sorbate, potassium sorbate, BHA, BHT, EDTA, tocopherols (Vitamin E)
-
Sweetners
- Job- add sweetness with or without the extra calories
- Types of food- beverages, baked goods, confections, table-top sugar, substitutes, many processed foods
- Labeling- sucrose (sugar), glucose, fructose, sorbitol, mannitol, corn syrup, high fructose corn syrup, saccharin, aspartame, sucralose, acesulfame potassium (acesulfame-K), neotame
-
Color Additives
- Job- offset color loss due to exposure to light, air, temperature extremes, moisture and storage conditions; correct natural variations in color; enhance colors that occur naturally; provide color to colorless and "fun" foods
- Types of food- many processed foods, (candies, snack foods margarine, cheese, soft drinks, jams/jellies, gelatins, pudding and pie fillings)
- Labeling- FD&C Blue Nos. 1 and 2, FD&C Green No. 3, FD&C Red Nos. 3 and 40, FD&C Yellow Nos. 5 and 6, Orange B, Citrus Red No. 2, annatto extract, beta-carotene, grape skin extract, cochineal extract or carmine, paprika oleoresin, caramel color, fruit and vegetable juices, saffron
-
Flavors and Spices
- Job- add specific flavors (natural and synthetic)
- Types of food- pudding and pie fillings, gelatin dessert mixes, cake mixes, salad dressings, candies, soft drinks, ice cream, BBQ sauce
- Labeling- natural flavoring, artificial flavor, and spices
-
Flavor Enhancers
- Job- enhance flavors already present in foods (without providing their own separate flavor)
- Types of food- many processed foods
- Labeling- monosodium glutamate (MSG), hydrolyzed soy protein, autolyzed yeast extract, disodium guanylate or inosinate
-
Fat Replacers
- Job- provide expected texture and a creamy "mouth-feel" in reduced-fat foods
- Types of foods- baked goods, dressings, frozen desserts, confections, cake and dessert mixes, dairy products
- Labeling- olestra, cellulose gel, carrageenan, polydextrose, modified food starch, microparticulated egg white protein, guar gum, xanthan gum, whey protein concentrate
-
Nutrients
- Job- replace vitamins and minerals lost in processing (enrichment), add nutrients that may be lacking in the diet (fortification)
- Types of food- flour, breads, cereals, rice, macaroni, margarine, salt, milk, fruit beverages, energy bars, instant breakfast drinks
- Labeling- thiamine hydrochloride, riboflavin (Vitamin B2), niacin, niacinamide, folate or folic acid, beta carotene, potassium iodide, iron or ferrous sulfate, alpha tocopherols, ascorbic acid, Vitamin D, amino acids (L-tryptophan, L-lysine, L-leucine, L-methionine)
-
Emulsifiers
- Job- allow smooth mixing of ingredients, prevent separation
- Keep emulsified products stable, reduce stickiness, control crystallization, keep ingredients dispersed, and to help products dissolve more easily
- Types of Food- salad dressings, peanut butter, chocolate, margarine, frozen desserts
- Labeling- soy lecithin, mono- and diglycerides, egg yolks, polysorbates, sorbitan monostearate
-
Stabilizers and Thickeners, Binders, Texturizers
- Job- produce uniform texture, improve "mouth-feel"
- Types of food- frozen desserts, dairy products, cakes, pudding and gelatin mixes, dressings, jams and jellies, sauces
- Labeling- gelatin, pectin, guar gum, carrageenan, xanthan gum, whey
-
pH Control Agents and acidulants
- Job- control acidity and alkalinity, prevent spoilage
- Types of food- beverages, frozen desserts, chocolate, low acid canned foods, baking powder
- Labeling- lactic acid, citric acid, ammonium hydroxide, sodium carbonate
-
Leavening Agents
- Job- promote rising of baked goods
- Types of food- breads and other baked goods
- Labeling- baking soda, monocalcium phosphate, calcium carbonate
-
Anti-caking agents
- Job- keep powdered foods free-flowing, prevent moisture absorption
- Types of food- salt, baking powder, confectioner's sugar
- Labeling- calcium silicate, iron ammonium citrate, silicon dioxide
-
Humectants
- Job- retain moisture
- Types of food- shredded coconut, marshmallows, soft candies, confections
- Labeling- glycerin, sorbitol
-
Yeast Nutrients
- Job- promote growth of yeast
- Types of food- breads and other baked goods
- Labeling- calcium sulfate, ammonium phosphate
-
Dough Strengtheners and Conditioners
- Job- produce more stable dough
- Types of food- breads and other baked goods
- Labeling- ammonium sulfate, azodicarbonamide, L-cysteine
-
Firming Agents
- Job- maintain crispness and firmness
- Types of food- processed fruits and vegetables
- Labeling- calcium chloride, calcium lactate
-
Enzyme Preparations
- Job- modify proteins, polysaccharides and fats
- Types of food- cheese, dairy products, meat
- Labeling- enzymes, lactase, papain, rennet, chymosin
-
Gases
- Job- serve as propellant, aerate, or create carbonation
- Types of food- oil cooking spray, whipped cream, carbonated beverages
- Labeling- carbon dioxide, nitrous oxide
-
Consistency
Emulsifiers, stabilizers, thickeners
-
Nutrition
Vitamins, minerals, phytochemicals
-
Wholesomeness
Antimicrobials, antioxidants
-
-
Flavor, Color
Spices, natural/artificial colors
-
Chemical Composition
Enzymes
-
Preservatives and Food Additives
- Antioxidants
- Antimicrobials
- Use must not deceive consumer (e.g., can’t mask spoilage)
- GMP - use only as much as needed
-
Food Additives and Antioxidants
- Prevent oxidation of fats, vitamins, proteins, carbohydrates
- – Free radical terminators (BHA, BHT, PG, TBHQ, vitamin E)
- – Metal chelators (EDTA, citric acid, polyphosphates)
- – Packaging prevents light exposure
- Natural chemicals that ¯ oxidation:
- - Proteins
- - Spices (phenols):
- Rosemary, sage, thyme, cloves, allspice, mace
- - Amino acids
- - Phospholipids
- - Flavonoids
-
Ascorbic Acids
- Chelating
- Donate hydrogen to phenols
- Ascorbyl palmitate - fat soluble
- Synergistic with phenolic antioxidants
-
Inhibitors produced by processing:
- Maillard reaction products
- Fermentation products
- Protein hydrosylates
- Wood smoke
-
Food Additives - BHA & BHT
- GRAS
- Max 0.02% or 200 ppm in fat
- Max cereals 0.005% or 50 ppm cereal
- – Tumors in forestomach of rats, livers of fish
- – Low intake with no observed effects (called a NOEL)
- – Protects against some cancers
- Minimal risk (FASEB report)
-
Antimicrobials
- Decrease growth of bacteria, yeast, molds
- Spices
- Sulfites, nitrites
- Organic acids (acetic, benzoic, citric, propionic, sorbic, p-hydroxybenzoic or “parabens”)
- – decrease in pH
- – Most effective as the acid (rather than the “salt”)
- – P-hydroxybenzoic acid and sorbic acid work best in the higher pH foods (5.5-5.8)
- Killers: ethylene and propylene oxides (gases)
-
Emulsifiers
- Prevent separation of: fat/water Solubilize other food ingredients
- Examples:
- - Peanut butter
- - Baked goods
- - Margarine
- - Proc. meats
- - Salad dressings
- - Desserts
-
Sulfites
- Antioxidant
- Anti-browning
- Antibacterial
- Bleaching
- Dough conditioner
- Lowers rust & scaling in processing
- Prohibited on increase B1
- 1,000 adverse reactions since 1985
- Also, used in some medications
- Banned on fresh fruit and vegetables
- Still allowed in many foods
- 1/100 people are sensitive
- 1/20 asthmatics - especially steroid users (prednisone or methylprednisolone)
- Sulfite beverages or fumes (after spraying)
- Sensitivity can develop at any time
- Hives
- Bronchial constriction
- Anaphylactic shockMost reactions occur from food - sulfite
-
Sulfite Examples
- Sulfur dioxide
- Na sulfite
- Na & K bisulfite
- Na & K metabisulfite
-
Sulfites and GRAS 1985
Safe for most people, but unpredictable in asthmatics
-
Sulfites and GRAS 1986
- Prohibit use on fresh fruits and vegetables
- Must list on food ingredient labels
- State reason why in food
- Bulk foods: managers must post signs
- Allowed on potatoes (canned, dehydrated, frozen), such as French fries
- Not allowed on fresh potatoes
-
Sulfites are found in
- Baked goods
- Condiments
- Dried fruits, jam
- Gravy
- Dehydrated or pre-cut potatoes
- Molasses
- Shrimp
- Soup mix
- Beer, wine, hard cider
- Fruit, vege juice, tea
-
Components working together for health
- Fat
- Soy protein
- Isoflavones & phytoestrogens
- Saponins, globulins, phytates, etc.
-
Soy Protein
- 38% protein
- A complete protein!
- Equal to meat, milk, eggs and fish for human nutrition.
- 100% of amino acids.
- Recommendations based on the amount of soy protein.
-
Soy Protein and Children
- Healthy option, meets vegetarian needs
- Allowed in school lunch programs
- Interest may increase with recent recalls of beef
-
Soy Formula-Infants
- Preference: breast milk, cow milk, lastly soy milk
- Use soy in place of cow milk-based formula:
- –Galactosemia, hereditary lactase deficiency (rare)
- –When vegetarian diet preferred
- Should not be used:
- –To prevent/manage colic (doesn’t help)
- –To prevent/manage allergy/atopic disorders (doesn’t help)
- –Known allergy to cow milk (use hydrolyzed protein)
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Soy Allergy-Protein
- Some people have soy allergy (to protein).
- Read labels to prevent eating soy protein.
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Soy Isoflavones (Phytoestrogens)
- Soybeans higher concentration than other foods
- Non-processed highest (genistein, daidzein, glycetein)
- Can act like weak estrogens
- Non-estrogenic effects
- Antioxidant effects (polyphenols)
- May be anti-carcinogenic
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Health Claim on Soy Foods
- 1.FDA: “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of the food) provides (blank) grams of soy protein.”
- 2.Other researchers: only 10 grams /day (isoflavone-rich foods) for health benefits – but no health claim
- –Typical Asian intake
- –~15 % of total U.S. protein intake
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Soy Isoflavone & FDA
- FDA rejected an original petition:
- –At least 2 mg isoflavone/ gram of soy protein
- USDA database for food isoflavones
- Listed on some nutrition labels
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Soy Products - AHRQ
- Soy supplements used ¾ trials (146 treatment arms)
- –57% soy protein with isoflavones
- –36% isoflavones alone
- –6% soy protein without isoflavones
- Soy foods used in rest (68 treatment arms)
- 0 to 154 grams soy protein/day
- Median dose 36 grams soy protein/day
- –Over one pound of tofu or ~3 soy protein shakes!!
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Cardiovascular Endpoints
- Small to moderate effects on lipids
- –Wide range of net effects for total cholesterol, LDL and triglycerides
- No discernible effect on blood pressure No conclusions drawn on benefit/harm of soy protein on CVD risk factors
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Overall, effects of soy protein and/or its isoflavones inconsistent across studies
- High withdrawal and dropout rates
- Every trial found decrease in hot flash frequency in both treatment and control groups
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Endocrine Function
- No significant changes seen in any area analyzed, including:
- –Testosterone levels
- –FSH levels (related to male, female infertility)
- –Estradiol levels
- –TSH (thyroid function)
- –Menstrual cycle length
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Cancer and Tumor-Related Biomarkers
- Evaluated subjects without history of cancer for effects of soy on tumor-related biomarkers
- No study reported development of cancer as outcome
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Bone Endpoints
- Few long-term randomized trials
- No consistent effect on BMD seen in five studies of 1-year minimum duration
- Other effects not consistent across studies
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Kidney Function, Neurocognitive Function and Glucose Metabolism
- No statistically significant changes reported for each of the following:
- –Glomerular filtration rate after 8 weeks
- –Neurocognitive function
- Verbal episodic memory
- –Fasting blood glucose
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Adverse Events
- Greater rates of adverse events in soy treatment vs. control
- –Generally minor
- Most reported events
- –Gastrointestinal in nature
- –Menstrual complaints
- –Musculoskeletal complaints, headache, dizziness, rashes
- More withdraw from soy treatment due to bad taste
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Conclusions on Soy
- Soy has small effect on blood lipids
- Duration of studies generally short
- Evidence does not support effect of soy products on endocrine function, menstrual cycle length, or bone health
- Greater likelihood of adverse events with soy consumption – but mostly these are minor
- Few studies of 1 year or longer
- –Uncertain of long-term
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Future Research for Soy
- Better quality, well-reported, larger, and longer duration studies are needed Future studies need to
- –Fully report components of soy products used
- –Compare different doses, soy products, and populations
- –More closely evaluate different soy components (non-protein, non-isoflavone)
- –Fully consider types of foods being replaced by soy products and the controls being used
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Bioavailability and Soy
- Important factor in determining beneficial effect
- –Helps reveal dose-response relationship
- Affected by:
- –Absorption rate
- –Incorporation rate into the blood stream
- –Metabolism of intestinal bacteria
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