4_1CAMRegulation Flashcards

1
Q

What did the Proxmire Amendment on 1976 do?

A

prohibited standards to limit vitamin potency and regulate as drugs

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2
Q

What did the Nutrition Labeling and Education Act of 1990 do?

A

1) required nutritional labeling on food and dietary supplements; 2) proposed medication standards being applied to vitamins

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3
Q

What are the 3 categories of claims allowed on food and supplement labels?

A

1) health claims; 2) structure/function claims; 3) nutrient content claims

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4
Q

What did the Dietary Supplement Health and Education Act of 1994 do?

A

1) disallowed disease-related claims; 2) allowed either health, structure/function, or nutrient content claims

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5
Q

What is a health claim?

A

citing a study that states effect on health

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6
Q

What is a structure/function claim?

A

statement that a product promotes wellness related to a structure/function of body

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7
Q

What are the requirements for structure/function claims?

A

must have disclaimer according to DSHEA “this statement has not been evaluated”

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8
Q

What are structure/function claims prohibited from doing?

A

claiming ability to 1) cure, 2) treat 3) mitigate 4) prevent or 5) diagnose

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9
Q

When were label requirements for dietary supplements passed?

A

1999

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10
Q

What are the label requirements for a dietary supplement?

A

1) statement of identity; 2) net quantity of contents; 3) disclaimer if structure/function; 4) directions; 5) supplement facts; 6) other ingredients in descending order; 7) name/place of manufacturer

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11
Q

What did the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 do?

A

required supplement/OTC manufacturers to notify FDA of serious ADRs

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12
Q

When did DSNDCPA reporting begin?

A

2007

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13
Q

What is a seal of approval program?

A

a voluntary-participation program provided by non-government organizations to 1) measure proper manufacturing, 2) evaluate the presence of listed ingredients, 3) confirm lack of harmful contaminants

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14
Q

What organizations put on seal of approval programs?

A

Consumerlab, NSF, USP

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15
Q

Which organization that puts on Seal of Approval program is not credible?

A

Council for Responsible Nutrition (put on by manufacturers)

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16
Q

What are the causes of Class I recalls for supplements?

A

mainly undeclared ingredients; also contamination, ADR, tampering, mislabeling

17
Q

What is a class I recall?

A

a recall in which people have been harmed

18
Q

What percentage of class I recalls are from supplements?

A

50%

19
Q

What is adulteration?

A

changing the content of a drug; tampering

20
Q

What supplements are the most commonly adulterated?

A

1) male enhancement, 2) weight loss, 3) anabolic steroids

21
Q

What is the FDA’s role in supplement regulation?

A

enforcing claims and issuing recalls

22
Q

What claims may the FDA enforce regarding supplements?

A

1) adulteration, 2) illegal claims, 3) unsafe ingredients

23
Q

What committee moved to give the FDA oversight of supplements?

A

senate special committee on aging

24
Q

What drove the FDA receiving oversight of the supplement market?

A

the US GAO report that found 37/40 products contained unsafe levels of contaminants

25
Q

What drove the passing of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006?

A

difficulty removing ephedra from the market

26
Q

What was ephedra?

A

a drug with stimulant properties that was popular for weight-loss and performance enhancement in the 80s and 90s

27
Q

When did the FDA propose the ban on ephedra > 8 mg?

A

1997

28
Q

When did the FDA officially ban ephedra?

A

2004

29
Q

What state overturned the FDA’s ephedra ban on products > 10mg?

A

UT

30
Q

When did the FDA determine that no dose of ephedra was safe?

A

2007

31
Q

What substance has replaced ephedra on the market?

A

synephrine

32
Q

What things are listed in the Supplement Facts section of the label?

A

serving size, amount, and active ingredient

33
Q

What drove the passing of the Proxmire Amendment?

A

manufacturer lobbying

34
Q

What was the Tryptophan Tragedy of 89?

A

menstrual and sleep problem warning from the FDA; 1510 cases of eosinophilia and 38 deaths; recall led to discovery of manufacturing problem

35
Q

How were supplements regulated prior to 1973?

A

by the FDA; MDR was given but no restrictions; manufacturers claimed megadose benefits; FDA attempted to limit to 150% of RDA and require disclaimer

36
Q

What was the MDR?

A

minimum daily requirement

37
Q

List the legislation passed regarding supplement regulation.

A

1) Proxmire Amendment in 1976; 2) NLEA of 90; 3) DSHEA ‘94; 4) DSNDCPA ‘06