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Food Law > Exam > Flashcards

Exam Flashcards

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1
Q

Food Laws/Regulations can be broken down to what two areas?

A

Adulteration?
Misbranding?

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2
Q

Nature of food laws before Pure Food Act of 1906

A

Primarily state and local

Common law prevented sale of diseased meat

Limited activity at congressional level

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3
Q

Trigger points leading to passing of 1906 Act

A
  • Reports of food fraud/danger
  • The Jungle
  • Embalmed Beef scandal
  • Roosevelt investigates meat packing houses
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4
Q

Key changes to food laws due to 1906 act

A
  • Add reg fx to bureau of chemistry
  • USDA to inspect cattle, sheep, goats, horses when slaughtered and processed
  • prevent adultered livestock from entering into food supply
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5
Q

Limits to 1906 acts

A
  • No prohibition of false therapeutic claims
  • No pre-market testing
  • Misleading and false statements regarding ingredients banned
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6
Q

Trigger point of FD&C 1938

A
  • Diethylene glycol deaths
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7
Q

Lessons learned from previous acts that FD&C helped manage

A
  • Public not capable of self-protection
  • Protect public from physical and economic harm
  • Courts must ensure public is protected
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8
Q

USDA enforcement

A

Control
Withholding
Suspension

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9
Q

CFR

A

General and permanent rules published in the federal registrar by the agencies of the fed gov

Set of rules and regulations issued by federal agencies in the United States

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10
Q

CFR important chapters

A

FDA: title 21
USDA: title 7, 9

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11
Q

Food defintion

A
  • Articles used for food or drink for man/other animals
  • Chewing gum
  • Articles used for components of the others articles
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12
Q

Food def refinement
Nutrilab vs. Shweiker

A

Starch blockers are a drug, not a food

Guidance:
- Common sense food?
- Consumed from taste/aroma/nutrition?
- No to either —> not a food

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13
Q

Intended use

A

An article can be either a food, drug, or a supplement, but not more than 1

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14
Q

USDA regulatory model

A

Continuous inspection authority

Pre-market approval

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15
Q

USDA/FSIS responsibility

A

All domestic meat intended for human consumption

FSIS personnel inspect all meat and poultry at slaughter

Min 1 federal inspector per line during operation

Responsibility begins when the animal enters and ends when products leave

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16
Q

FDA Form 482

A

Credentials and written notice of inspection

Factory inspection act of 1953

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17
Q

FDA Form 483

A

Notice of potential violations identified during inspection

Observations that are significant and correlate to processes/product being inspected

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18
Q

FDA warning letter

A

Recommendations on the steps need to meet compliance

Created by FDA policy

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19
Q

Label

A

Written, printed, or graphic matter upon the immediate container

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20
Q

Labeling

A

Labeling, on the other hand, includes the label, as well as any printed or written material that accompanies the product

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21
Q

5 Label requirements

A
  1. Identity
  2. Quantity
  3. Ingredients
  4. Nutrition labeling
  5. Responsible party
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22
Q

PDP

A

Front label of product most likely to be displayed to the consumer

Common name of food
Net quantity

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23
Q

Info panel

A

To the right of the PDP

Ingredient list
Name and location of manufacturer/packer/distributor
Nutrition panel

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24
Q

Rules about ingredient lists

A

Common name
Decreasing order by weight
Ingredients of multi-component foods

25
Q

Incidental additives

A

Present at insignificant levels and have no technical or functional effect in that food.

26
Q

Processing aids

A

Substances that are…

Added to a food during the processing of such food but are removed

Present in the finished food at insignificant levels and do not have any technical or functional effect in that food

Converted into constituents normally present in the food

27
Q

Product Dates

A

No federal rules on sell by or use by dates

Except infant formula

28
Q

Adulteration

A

Food that contains any added poisonous or other added deleterious ingredient, which may render such and article injurious to health

29
Q

Misbranding

A

What is said about a product vs. composition of the product

FDA is not required to present evidence consumers were
misled

30
Q

Adulteration types

A

Aesthetic
- Intentional
- Indirect

Economic

31
Q

NLEA

A

Established nutrient content labeling requirements and directed FDA to establish procedures for health and nutrient claims

Mandatory nutrient info

32
Q

DSHEA

A

Requires that a manufacturer or distributor notify FDA in advance and submit safety information if it intends to market a dietary supplement in the United States that contains a “new dietary ingredient,”

Defined dietary supplement and developed a statutory framework for dietary claims.

33
Q

Supplements vs food

A

GMP’s for supplements
Must be consumed orally

34
Q

NDI - new dietary ingredient

A

Anything introduced after 1994 needs an NDI notification to FDA

35
Q

Dietary ingredient

A

A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet

36
Q

Prior to food additive amendment

A

FDA only had post-market surveillance

Burden of proving safety on the FDA

37
Q

Pressures that led to additive amendment

A

Congress under pressure to ensure food safety

FDA overwhelmed and unable to keep up with changing industry

Industry wary of negative press and consequences of unsafe food

38
Q

Food additive

A

Any substance the intended use of which results in its becoming a component or otherwise affecting the characteristic of any food

39
Q

Direct additive

A

A substance added to a food for a specific purpose

40
Q

Indirect additive

A

Those that become part of the food in trace amounts due to its packaging, storage or other handling

41
Q

GRAS list

A

A status label assigned by the FDA to a listing of substances not known to be hazardous to health and thus approved for use in foods

42
Q

Color additives

A

No GRAS exemption

The only natural color is a color that naturally occurs in the food item

Any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body

43
Q

Delaney clause

A

Requires the FDA to ban food additives that are found to cause or induce cancer in humans or animals

44
Q

FSIS Enforcement

A

control action
withholding action
suspension

45
Q

Control action

A

Retention of product
Rejection of equipment
Slowing/stopping of lines
Refuse processing

46
Q

Withholding action

A

Refusal to allow marks of inspection to be applied to products

47
Q

Suspension action

A

Interruption of assignment of employees

48
Q

FDA authority

A

Warrantless inspection of premises of regulated industries

cause or surveillance

Post market

49
Q

FDA enforcement

A

Seizures and administrative detentions

Recalls

Import refusals and alerts

Restraining orders and injunctions

Suspension of facility registration

50
Q

Seizure

A

Only if safety is in question
Requires warrant from distinct court
US marshals seize the product

51
Q

Detention

A

No warrant necessary
FDA can hold product
Need reason to believe the food is adulterated

52
Q

Economic adulteration

A

Marketing a product as containing ingredients it does not possess, or are not of the marketed standard

53
Q

Aesthetic adulteration

A

Food that may be contaminated with filth.

Food may be held in insanitary conditions and may be
contaminated

54
Q

Indirect adulteration

A

Health hazards
Indicators of insanitation
Natural or unavoidable defects

55
Q

US v. Lexington Mill and Elevator Co

A

FDA must show a significant possibility of harm to consumers, including vulnerable
populations

56
Q

US v. 1232 Cases of American Beauty Brand Oysters

A

FDA must show that a naturally occurring substance could cause injury under normal use but
also comply that removing the substance not create an effective ban of the food

57
Q

Misleading

A

FDA must present some evidence

Demonstrating that consumers were actually misled is not a requirement

58
Q

Labeling claims

A

Nutrient
Health
Structure function

59
Q

Allergens

A

Wheat
Soy
Milk
Eggs
Sesame
Fish
Shellfish
Peanuts
Tree nuts

Food Law (7 decks)

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