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CPH > Safe Food and Drugs: An Ongoing Regulatory Battle > Flashcards

Safe Food and Drugs: An Ongoing Regulatory Battle Flashcards

1
Q

Foodborne Illness

A
  • contamination of foods with bacteria, viruses, or parasites
    due to breakdowns in
    sanitation and/or proper food handling practices.
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2
Q

Foodborne illness: Bacteria

can be found where?

A

Bacteria
1) Salmonella - poultry, meat,
and eggs
- raw or not properly cooked

2) Escherichia coli 0157:H7
- ground beef, alfalfa sprouts,
unpasteurized apple juice,
raw milk, lettuce
- common in the intestinal
tracts of cows and are
excreted with their feces

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3
Q

2008, largest foodborne disease
outbreak

it is caused by?
symptoms?
sickened?
deaths? in how many states?

A

Salmonellosis

- from jalapeno and serrano 
peppers from Mexico
- symptoms: vomiting, 
diarrhea, and abdominal pain
 - sickened 1442 people, 
2 deaths in 43 states
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4
Q

2011 bacteria problem

it is because of
sickened?
deaths? in how many states?

A 
Listeria
- from cantaloupe produced
by a Colorado comp
- 148 sickened, 30 deaths in 
28 states
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5
Q

toxins -

can be destroyed through?

A

also a way that bacteria causes diseases
can be destroyed in 15 to 20
minutes boiling

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6
Q

the best known and deadlines causing bacteria that caused?

it is a?

common in?
how did it affect the people?

A 
Botulism bacteria 
- in the absence of oxygen 
- common in raw home-canned
 vegetables
- released toxins
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7
Q

Causes of foodborne disease: virus

from what?

A

1) Hepatitis A: green onions from Mexico, shellfish
- typhoid Mary
2) Norwalk virus: shellfish

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8
Q

Causes of foodborne disease: parasites

from?

A

1) Cyclospora: raspberries from Guatemala

2) Parasites in sushi, sashimi, ceviche

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9
Q

Who is responsible for meat, poultry, and processed eggs?

percentage of disease caused?
how often do they inspect?

A

US Department of Agriculture (USDA)

26%

almost everyday

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10
Q

who inspects all other food other than mean, poultry and processed eggs?

how often do they inspect? this is due to?

A

Food and Drug Administration (FDA)

every 10 years
budget constraints

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11
Q

Irrationality of system

  • Marion Nestle
  • Safe food: the politics of food safety

how much food do they regulate?
focuses on what?
budget on 2015?

A 
1) USDA has bigger budget 
and more authority.
-Regulates 20% of food.
-Has detailed laws on 
regulation of meat.
- - budget: $1014M
2) FDA has smaller budget and 
less authority.
-Regulates 80% of food.
-Regulates imported food.
- budget: $914M
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12
Q

Imported food percentage

A

seafood - 80
vegetable - 20
fruits - 50

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13
Q

Laws for better food safety

it is under?
define

A 
1) Food Safety Modernization
Law
 - under FDA
 - expanded inspections and setting standards for the safe growing, harvesting, sorting, packing, and storage 
of fresh fruits and
vegetables

2) Modernization Act of 2011
- under FDA
- has the authority to deny entry of food from a facility that refuses to permit FDA
inspection and it can detain for testing shipments of food that it has reason to believe may be harmful

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14
Q

HACCP Principles

A
  1. Conduct a hazard analysis.
  2. Determine the critical control points.
  3. Establish critical limits.
  4. Establish monitoring procedures.
  5. Establish corrective actions.
  6. Establish verification procedures.
  7. Establish record-keeping and documentation procedures.
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15
Q

Safety measures

1) Hazard analysis critical 
control point (HACCP)

implemented on?
focuses on?
purpose?
when was it implemented on seafoods?

A
  • December 1997
  • focuses on procedures,
  • purpose: identity hazard and
    how to eliminate, prevent,
    or minimize hazards
    -1999.
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16
Q

Safety measures

2) irradiation
what does it kill?
is it safe?
it reduces risk of?

A 
- Kills bacteria,
 parasites, pests
 - despite claims, it is safe as it does not leave any  residue
- reduce the Salmonella, E.
coli 0157:H7, and 
cholera bacteria
17
Q

Safety measures

3) Regulation on establishments

degrees for refrigeration?
degrees for heating?

A
  1. 1) hand washing
  2. 2) temperature regulation
    • refrigerated - 40 degrees
      - heated - 140 degrees
18
Q

Safety measures

4) Food safety programs of CDC

PulseNet
involves what?
is it considered as active or passive surveillance?
FoodNet
involves what?
is it considered as active or passive surveillance?

A

4.1) PulseNet
- Epidemiologic
surveillance (passive
surveillance)
- DNA “fingerprinting” on
foodborne bacteria
- has timely comparisons
on outbreaks

  1. 2)FoodNet
    - active surveillance
    - asking around
19
Q

Additives and contaminants
1) Hormones

1.1
banned on?
increases risks of?
1.2
allowed for? why?
on?
A 
1.1) Diethylstilbestrol 
Estrogen is banned in 
chickens 
- increases breast cancer risks
1.2) Bovine growth hormone 
is allowed for cows: BGH 
does not get into milk.
- allowed in 1994
20
Q

Additives and contaminants

2) Antibiotics
why is it not allowed?

A
  • They cause antibiotic

resistance

21
Q

Additives and contaminants

3) Organic foods
- USDA set standards on?
- what is not allowed?

A

2004

1) meat, poultry, eggs, and dairy products: no antibiotics and hormones
2) organic products: without pesticides, synthetic fertilizers, sewage sludge, and GMO, and radiation

22
Q

Additives and contaminants

4) Additives
what is it used for?
it can be approved if?

A 
- They are used to prevent 
deficiency diseases, 
- Preservatives
- improve color, flavor, or texture. 
- FDA or GRAS ( "generally regarded as safe" ) list must 
approve them.
23
Q

Process for drug approval by FDA

it can be revoked when?

A

FDA must approve after studies by the pharmaceutical company.
1) Company files a new drug application (NDA).

2) If NDA is approved, there are three phases of trial:
1. Use a small number of subjects; measure absorption, distribution, metabolism, and excretion; look for side effects and toxicities.
2. Test a larger number of patients for signs that the new drug is effective.
3. Conduct a clinical trial.

FDA can revoke approval through post-marketing surveillance.

24
Q

FDA rules on cosmetics

what is required?

A
  • Cosmetics are loosely
    regulated by the FDA.
  • No requirements exist for safety testing of cosmetics,
    BUT a warning label must be attached to any product not
    tested.
25
Q

Food and Drug Labeling and Advertising

A
  • FDA regulates labeling of
    foods with information on nutrients and recommended
    daily intakes.
26
Q

T or F
Labeling was one of the important provisions of the original Pure Food and Drugs Act in 1906.
-Recommended daily
allowances for nutrients became required on labels
in 1994.

A

T

27
Q

When was trans fat labels required? why was it okay?

when was it banned?

A

in 2006, foods has been
required to add trans fat labels as they were least harmful

2015

28
Q

Advertising of over-the-counter drugs is by ?

A

Federal Trade

Commission

29
Q

Dietary Supplement Health and Education Act

passed on?

A
  • Passed in 1994.
    Forbids FDA from regulating herbs and food supplements.
    -FDA can remove a substance from the market only if proven harmful
30
Q

drugs revoked licenses on Dietary Supplement Health and Education Act

what was in the ad?
what did it cause?

A
  1. 1996, Ephedra - Ultimate Xphoria
    ad: energy booster, aids weight loss,
    caused: heart attacks, seizures, and psychoses
  2. 1 2003, used by Baltimore Orioles
  3. melatonin
    ad: sleep aid and treatment for jet lag
    caused: affect the brain, and reproductive and immune systems
  4. 2013, OxyElite Pro
    ad: weight loss and building muscles
    caused: acute liver failure and hepatitis
31
Q

T or F

A law passed in 2007 requiring supplement manufacturers to report serious adverse effects to the FDA.

A

T

32
Q

2007 legislation on addressing

criticism on FDA reauthorizes

A
  • It reauthorized the use of
    user fees for the
    drug-approval process
33
Q

In 2014, the FDA banned the importation of products from three Indian pharmaceutical companies, after several recalls and import bans

A
  1. Ranbaxy Laboratories
    - doses got mixed up
  2. Sun Pharmaceuticals
    - had an epilepsy drug
  3. Another Indian company
    - heartburn drug due to microbial contamination
34
Q

most widely advertised
drug in the world
how much did it earn?

A

Vioxx

2.5B
heart attacks and strokes

35
Q

a diet drug that caused severed heart valve problems

A

Fenphen

36
Q

diabetes drug Rezulin:
allergy drug Seldane:
cholesterol-lowering drug Baycol:

A

liver problems

cardiac arrhythmias

injury to muscle tissue

CPH (6 decks)

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