4_1CAMRegulation

Question 1

What did the Proxmire Amendment on 1976 do?

Answer 1

prohibited standards to limit vitamin potency and regulate as drugs

Question 2

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

Answer 2

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

Question 3

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

Answer 3

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

Question 4

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

Answer 4

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

Question 5

What is a health claim?

Answer 5

citing a study that states effect on health

Question 6

What is a structure/function claim?

Answer 6

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

Question 7

What are the requirements for structure/function claims?

Answer 7

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

Question 8

What are structure/function claims prohibited from doing?

Answer 8

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

Question 9

When were label requirements for dietary supplements passed?

Answer 9

1999

Question 10

What are the label requirements for a dietary supplement?

Answer 10

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

Question 11

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

Answer 11

required supplement/OTC manufacturers to notify FDA of serious ADRs

Question 12

When did DSNDCPA reporting begin?

Answer 12

2007

Question 13

What is a seal of approval program?

Answer 13

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

Question 14

What organizations put on seal of approval programs?

Answer 14

Consumerlab, NSF, USP

Question 15

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

Answer 15

Council for Responsible Nutrition (put on by manufacturers)

Question 16

What are the causes of Class I recalls for supplements?

Answer 16

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

Question 17

What is a class I recall?

Answer 17

a recall in which people have been harmed

Question 18

What percentage of class I recalls are from supplements?

Answer 18

50%

Question 19

What is adulteration?

Answer 19

changing the content of a drug; tampering

Question 20

What supplements are the most commonly adulterated?

Answer 20

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

Question 21

What is the FDA’s role in supplement regulation?

Answer 21

enforcing claims and issuing recalls

Question 22

What claims may the FDA enforce regarding supplements?

Answer 22

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

Question 23

What committee moved to give the FDA oversight of supplements?

Answer 23

senate special committee on aging

Question 24

What drove the FDA receiving oversight of the supplement market?

Answer 24

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

Question 25

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

Answer 25

difficulty removing ephedra from the market

Question 26

What was ephedra?

Answer 26

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

Question 27

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

Answer 27

1997

Question 28

When did the FDA officially ban ephedra?

Answer 28

2004

Question 29

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

Answer 29

UT

Question 30

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

Answer 30

2007

Question 31

What substance has replaced ephedra on the market?

Answer 31

synephrine

Question 32

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

Answer 32

serving size, amount, and active ingredient

Question 33

What drove the passing of the Proxmire Amendment?

Answer 33

manufacturer lobbying

Question 34

What was the Tryptophan Tragedy of 89?

Answer 34

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

Question 35

How were supplements regulated prior to 1973?

Answer 35

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

Question 36

What was the MDR?

Answer 36

minimum daily requirement

Question 37

List the legislation passed regarding supplement regulation.

Answer 37

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