Functional Foods 1

drug

A substance recognized by an official pharmacopoeia or formulary; substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Nutrition Labeling and Education Act

Act of Congress to amend FD&C nutrition labeling; new regulations governing nutrition labeling, nutrient descriptors, disease prevention claims for food; ALLOWS labeling claims that "characterize the relationship of any substance to a disease or health-related condition" with the approval of the FDA

Federal Food Drug and Cosmetic Act

Amended; Principal food and drug law which defines foods, drugs, adulteration, labeling, standards of identity, many other purposes

in vitro

In a test tube, glass, or artificial environment; method used to identify the relationship between food components and health benefits

Common uses of soy

Livestock feed, seed, miso, tofu, tempeh, soy sauce

observational

Observing and measuring specific characteristics without modifying the subjects

dietary supplement

Product, other than tobacco, intended to supplement the diet that contains at least one or more of...vitamin, mineral, herb, amino acid, metabolite, constituent or extract of any of these ingredients; usually in the form of pills, powder, or capsules

dietary supplements

Products (other than tobacco) taken by mouth that contains a "dietary ingredient" intended to supplement the diet; comes in various forms including extracts, concentrates, tablets, capsules, gel caps, liquids, and powders

Dietary Supplement and Health Education Act

Response to FDA's imposition on dietary supplements; imposed limitations on FDA authority over supplements; Broadly defined dietary supplements, authorized structure-fx claims, exempted dietary supplement products from food additive requirements of FD&C; impose burden on FDA to demonstrate lack of safety

epidemiological studies

Study of patterns, causes, control of diseases in groups of people; aids in linking between observations and and outcomes in groups of people

Generally Recognized as Safe

Substances for which use in food has a proven track record of safety based either on history of use before 1958 or on published scientific evidence, and that need not be approved by FDA prior to being used.

bioavailability

Sum of impacts that may suppress or improve utilization of a fx food component

epidemiological

_______ observations of soy include lowered incidence of cardiovascular disease certain types of cancer, bone fractures, menopausal symptoms

Adulteration

a food prepared in a way where it may be rendered injurious to health

25

a health claim involving soy and reduced risk of heart disease claims a daily intake of _____ grams a day will be effective

health related claims

allowed under NLEA; disease-risk-reduction claims

neutraceutical

anything consumed primarily for health reasons

Food Additives Amendment

authorized FDA to evaluate safety of all new ingredients including dietary supplements; ignores GRAS

functional foods

food that provide a health benefit beyond basic nutrition; includes conventional foods, fortified, enriched, enhanced foods and dietary supplements; provides more nutrients necessary than needed for normal growth; provide other biologically active components that impart health benefits

functional foods

foods that provide health benefits beyond their nutrient contributions; Include conventional foods; fortified, enriched, enhanced foods; dietary supplements

bioactive

having a capacity to interact with a living tissue or system; components can be naturally existent or artificially added; metabolized to reap health benefits; used in Demonstrating efficacy and determining intake level necessary to achieve desired effect

interventional

having experimental and control groups

case controlled clinical trials

human lab setting with human subjects; method used to identify the relationship between food components and health benefits

first

identifying the relationship between food components and health benefits is the _____ step of bringing functional foods to market

in vivo

in the living organism; method used to identify the relationship between food components and health benefits

reasons for interest in functional foods

increased health care costs, aging of the populations, increased interest of health and exercise, recent legislation, scientific discoveries

health care

increased interest in functional foods is due to Increased cost of ________ _________, Aging of the population, Increased interest in health and exercise, Recent legislation, Scientific discoveries

goiter

iodine deficiency

anemia

iron deficiency

osteoporosis

isoflavones are known to have a positive effect on _______, menstrual symptoms, and cancer.

emulsifier

lecithin's most common use is as a(n) _______

FDA Modernization Act

legislation that expanded methods by which a health claim could be approved (ie NIH, CDC, National Academy of Sciences)

Dietary Supplement and Non Prescription Drug Consumer Protection Act

makes serious adverse event reporting mandatory for dietary supplements and nonprescription drugs

pellagra

niacin deficiency

Orphan Drug Act Amendment

piece of legislation that defines medical foods

Kwashiorkor

protein deficiency

FDA

regulatory agency involved in regulating labels and safety issues

FTC

regulatory agency that regulates advertising

vitamins

some of the required nutrients for basic nutrition are _______, minerals, essential fatty acids, essential amino acids, and sufficient calories

35

soy is made up of ______ percent carbohydrates

20

soy is made up of ______ percent oil

40

soy is made up of ______ percent protein

CFSAN

subdivision of the FDA that particularly deals with regulating labels and safety issues

beriberi

thiamin deficiency

lecithin

three major bioactive components in soy are isoflavones, vitamin K, and ________

Structure Function Claim

type of claim that describes role of nutrient or ingredient intended to affect normal structure or function in humans, may characterize means by which nutrient or ingredient affects structure or function, may describe benefit related to a deficiency, must be accompanied by disclaimer that FDA has not reviewed claim and that product is not intended to "diagnose, treat, cure, or prevent any disease." ex: protein helps build strong and healthy muscles

Nutrient Content Claim

type of claim that describes the amounts of certain nutrients; food must provide at least 20% of recommended daily intake

Qualified Health Claim

type of claim that is similar to an authorized health claim but evidence is not yet strong enough for the FDA to approve

genistein

type of isoflavone known to have an important role in lowering severity and frequency of menopausal heat flashes

scurvy

vitamin C deficiency

rickets

vitamin D deficiency

thinning blood

vitamin K is most effective at ______ ________

second

Demonstrating efficacy and determining intake level necessary to achieve desired effect is the _____ step of bringing functional foods to the market

Jelly Bean Rule

Foods bearing a health claim must contain 10% or more of RDI or DRV for vit A, vit C, iron, calcium, protein or fiber per reference amt normally consumed prior to any nutrient addition; prevents misleading labeling (ex: vitamin water)

nutraceutical

Bio-active compound (nutrient and non-nutrient) that has health benefits