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37 Cards in this Set

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What is regulated under the FFDC act?
Regulated under the FFDC Act:

• Drugs including parenteral nutrition (intravenous eg glucose)
• Medical Devices
• Cosmetics (“Glowelle”)
• Foods - 21 CFR Parts 1-199 natural, fabricated, additives, artificial colors, packaging, food contact surfaces, GMO
• Special Dietary Foods
• Medical Foods eg enteral feeding (naso-gastric vs intravenous)
• Infant formula
• Hypoallergenic
• Weight loss
• Dietary Supplements
• Functional Foods - regular foods or food ingredients with health
claims and structure function claims for other naturally present
compounds (eg antioxidants)
What is the difference between a food and a drug?
A DRUG is any article intended for the
use in the diagnosis, cure, mitigation,
treatment or prevention of any disease
in man or other animals
Define a disease or health-related condition.
A disease or health-related condition:
~Means damage to an organ, part, structure, or system of the body such that it does not function properly (e.g. cardiovascular disease)

~or a state of health leading to such dys-function (*hypertension)
~except that diseases resulting from essential nutrient
deficiencies (e.g. scurvy, pellagra) are not included in this definition
What are drug requirements?
Drug Requirements:
Drugs
--> required IND, NDA, Efficacy, GMPs, shelf life
-->Extensive clinical documentation required
-->Multi-faceted studies
-->Contraindications (including ads)
-->Safety
-->Shelf life kinetics & use by date
Name the 4 different types of drugs.
Types of Drugs:
1.) Prescription
2.) Original
3.) Generic
4.) Over The Counter (OTC)
What is food defined as?
Food:
*food and drink for man
and other animals (not meat and poultry) and chewing gum
ex: Nutrilab v Schweiker
-starch blocker case
*Food is a substance ingested in part for taste, aroma or nutritive value
What are some examples of dietary supplements?
Dietary Supplements:
-Vitamins, minerals, amino acids
-Herbs and other botanicals
-metabolites
-concentrate, constituent, extract or combination thereof
Define 'dietary supplement'.
A dietary supplement is....
-Ingested as tablet, capsule, powder, softgel, gelcap
or liquid or...
-Not represented as a conventional food or as a sole item of a meal or the diet and
-Labeled as a dietary supplement

**permits dietary supplements to “simulate,” but not be “represented as” a conventional food.
T or F:
"A product cannot simultaneously be promoted as substitute for a conventional food (e.g., “cereal”)."
True!
A product cannot simultaneously be promoted as substitute for a conventional food (e.g., “cereal”).
What are the key components of Dietary Supplement (DS) labeling?
DS Labeling:
• Principle Display Panel (PDP)
"dietary supplement"
• Supplement facts/use DRV or RDI
• List other ingredients (largest 1st)
• List source of supplement ingredients
• (eg calcium-citrate malate)
• Herbs/Botanicals declare which plant part it came from
plus Latin name descriptor
• List quantity per serving
Why do we preserve/process food, drugs, seeds, and biologics?
We dry food to....
1. Insure against microbial/chemical safety problems: growth of pathogens, reduction of natural toxicants,
minimize new toxicants

2. Extend shelf life - reduce rates of biochemical, chemical, physical and microbiological reactions to
allow for distribution and storage. Minimize quality change, dosage loss, function change or nutritional
changes during distribution

3. Create convenience with new products (easy to use)
*ie: RTE cereals, power bar, microwave meals or instant coffee
What is the function of water in foods?
Water in foods....
-Serves a nutrient
-Creates texture - eg gels, crackers, ice cream
-Serves as reaction phase for chemical and enzymatic degradation reactions
-Serves as a phase for microbial growth
*ie spoilage or pathogens (biological
reactions)
List the basic food processing principles (7)
Basic Food Processing Principles:
1.) remove water
2.) bind water
3.) affect water structure {heat, freeze, high pressure}
4.) refrigerate
5.) package
6.) ferment
7.) preservatives
How are water activity methods related to salts and humectants?
Water Activity (a_w) is decreased by using salts and humectants...
• salted meats & fish
• sugared fruit slices
• Power bars (maltitol)
• drugs - glycerol (not
diethylene glycol) - cough
medicine, tooth paste
• IMF foods Pop Tarts, jerky
List 3 different types of heat treatments that kill pathogens.
HEAT:
1.) pasteurized foods
2.) canned foods
3.) aseptic foods
How does refrigeration (with or without pasteurization) affect food?
*Refrigerate w/wo pasteurization*:
• Slows reaction rates & micro grow
• Short shelf life (microbes)
• Dairy/Substitutes
• RTE meats
• Fish
• poultry
How does freezing affect food components?
*Freezing*:
~ lowers T and reduces water
available as solvent for reaction
• Juice
• Ice cream and novelties
• Veges, fruit, meat, fish, meals,
pizza
• starter cultures
• seed plasma, bacterial DNA,
spermatozoa
How does high pressure affect food components?
*High Pressure*:
• New technology
• Semi batch
• 400-600 mPa (50,000-80,000 psi)
• Kills pathogens
• Done in package
• Geometry not important
• Affects water structure
What are the key factors in fermentation?
*Fermentation*:
• Controlled spoilage
• Produces acids
• Lactic - cheese
• Acetic- vinegar
• Produces ethanol
• Beer
• Wine
• soy
What are the 2 different types of preservatives that can be added to food?
1.)*Antimicrobial*
• benzoate
• sorbate
• etc

2.) *Antioxidants*
• BHA/BHT
• Carotenoids
• Vitamin E
• Vitamin A
What are the 3 Main Food Stability Problems?
3 Main Food Stability Problems:
1.) microbial spoilage & pathogens
2.) chemical stability
3.) textural change
What is the "front label net weight"?
Net weight = total food
weight in package in grams

Weight of a serving = Net
weight divided by # of servings
On the nutrition label, does the amount of carbohydrate account for soluble and insoluble fiber?
Yes --
CHO includes fiber
What are some LOW moisture foods?

LOW = 1-8%
LOW Moisture (1-8%):
-Chips
-RTE cereals
-Powders (infant formula, non-dairy creamers, spray dried coffee)
-Crisp bars
-Crackers
-Dry pasta
-Chocolate
-Hard candy
-Peanut butter ~ 5% recent recall for salmonellae
-Any above with functional ingredient
What are some LOW moisture food issues?
LOW moisture foods...
• Loss of crispness as pick up moisture
• Caking and/or stickiness as pick up moisture
• Non-enzymatic browning (NEB)
• Production of brown color
• Loss of protein nutritional value
• Produces toxic substances eg HMF (bee deaths)
• Lipid oxidation (LO)
• Oxidative rancidity
• Free radicals damage DNA
• Loss of some nutrients e.g. Vit A and Vit C
• Degradation of functional ingredient
• Loss of color
• No microbial growth but can hibernate
What are some MEDIUM moisture foods?

MEDIUM = 9-30%
MEDIUM moisture (9-30%):
-Raisins and other dried fruits IMF pet food
-soft candies (eg caramel, gummy bears)
-Chewing gum
-Soft energy/protein bars
-most nuts
-Parmesan cheese
-Any above with functional ingredient
What are some MEDIUM moisture food issues?
MEDIUM moisture foods...
• Mold growth
• NEB - Maillard Browning
• Lipid oxidation
• Color changes
• Nutrient loss
• Loss of sweetness
• Loss of flavors in gums
• Degradation of functional ingredient
• Production of toxicants (aflatoxin)
What is the Maillard reaction?
Maillard reaction:
-Condensation reaction between an amino group (lysine) and the carbonyl of a reducing sugar
ex:
High rate of Maillard browning observed for whey protein based nutritional bars with fructose/glucose
-Leads to decrease in protein quality, undesirable color, functionality changes
What are some HIGH moisture foods?

HIGH > 30%
HIGH moisture (>30%):
• Jams and jellies
• Many cheeses
• Canned foods
• Fresh meats
• Fresh produce
• Fresh fish
• CAP/MAP pasta meals
• Any above with functional ingredient
• Ice cream - amount frozen depends on temperature
What are some HIGH moisture food issues?
HIGH moisture foods...
-Spoilage microbes
-Pathogen growth (food poisoning)
-Enzymatic degradation
• browning, lipid oxidation, nutrients
NEB
-Degradation of functional ingredient
What are some examples of FUNCTIONAL INGREDIENTS?
Some ex's of functional ingredients:
• Antioxidants eg reservatrol
• Hypertension lowering whey peptides
• Omega 3 fatty acids - brain food
• Isoflavones - menopause symptoms
• Margarine with stanol esters
• Brocolli sprouts - anti cancer
Describe the structure of liquid water~
Water:
• two hydrogen and one oxygen atom
• liquid angle = 104.5° vs tetrahedral angle @ 109° 28" - so more dense
•O---H energy 110 kcal/ mole (46 Kj/mole)
•O---H bond nuclear distance
~ 0.96 Å
Describe the structure of ice~
Ice:
•O---O distance 2.76 Å while liquid is 3.1 Å
•So closer O distance but is less dense because..........
•Bond angle is 109 ° vs104.5 for liquid
What are the interacting bonds in the water molecule?
• Hydrogen bond (Linus Pauling)
• Each oxygen
• 2 covalent bonds to H from oxygen
• 2 H bonds per oxygen to H of another water @ ~ 4 Kcal/mole
• One H bond from each H to another water @ ~ 4 Kcal/mole
• Net ~ 16 Kcal/mole - Creates three dimensional structure
• Oxygen at center of tetrahedron
What are the two main solution interactions?
Two main solution interactions:
1.)mu_m = dipole moment of molecule
*vector for charge gradient
2.)E_o = dielectric
*bulk property of solvent based on dipole moment and inter-molecular interactions
*ability to disperse charge therefore solvency of solution for solutes
*so water easily dissolves ionic solutes but poor for many organics
What is the Zeroth Law of Thermodynamics in relation to food?
Zeroth Law of Thermodynamics-
*intensive properties equal in all phases at equilibrium
*(P and T but not amount ie: moisture content)
What is the 1st law of Thermodynamics in relation to food?
1st Law of Thermodynamics-
*driving force for equilibrium is difference in energy per mole of component in each system domain (eg: interstitial water vs water in starch granule)