Dietary Supplement: Regulation and Quality

Question 1

What are the categories of dietary supplements

Answer 1

Big Box (Walmart/Costco), Multi-level, Retail Brands (specific brands/branded products), Professional lines (only used by healthcare providers)

Question 2

What was signed into law in 1994, what happened before

Answer 2

Dietary Supplements Health and Education (DSHEA), dietary supplements were unregulated

Question 3

When was the final rule on structure function claims

Answer 3

2000

Question 4

When was mandatory reporting of adverse effects made

Answer 4

2006

Question 5

What government entitiy regulates health claims and marketting of dietary supplements, manufacturing

Answer 5

Federal Trade Commision (FTC), FDA

Question 6

What is a dietary supplement

Answer 6

A product intended to supplement the diet that is a vitamin, mineral, herb/botanical, amino acid that must be ingested orally (swallowed) that must be labeled as a dietary supplement and is not a food/meal

Question 7

What is a new dietary ingredient

Answer 7

A dietary ingredient that was not marketed in the US in a dietary supplement before October 15, 1994

Question 8

T/F: The FDA will always need to respond for NDI before manufacturing can occur

Answer 8

False: The FDA NOT responding means that manufacturing can move forward

Question 9

How many days must the FDA be notified in advance prior to marketing product

Answer 9

75 days

Question 10

What are requirments that Dietary Supplements DO NOT have

Answer 10

Pre-approval of human studies, proof of safety, proof of efficacy

Question 11

What requirement is needed for medications and dietary supplements

Answer 11

Compliance with GMP

Question 12

T/F: Dietary supplements do not generally have notification required for adverse effects

Answer 12

True

Question 13

T/F: Dietary supplements cannot claim to affect a disease state (health claims)

Answer 13

True

Question 14

What is a structure/function claim

Answer 14

Describes the role of a substance intended to maintain the structure or function of the body (Do not require preapporval by FDA)

Question 15

What are DSHEA label requirements

Answer 15

Name of product, latin name of plant, part of the plant, amount, statement of nutritional support, FDA disclaimer

Question 16

What did the dietary supplement and nonprescription drug consumer protection act do

Answer 16

Establishes a mandatory reporting system of serious adverse events for non-prescription (OTCs) drugs and dietary supplements sold and consumed in the United States

Question 17

What are the provisions of 3546

Answer 17

Manufacturers and distributors must report all serious adverse events to FDA, reports of death and life-threatening experience and hospitalization including incapcity and birth defect, prohibits false reporting, 15 days to submit serious reports

Question 18

When were there new GMPs for dietary supplements

Answer 18

2007

Question 19

T/F:Dietary supplements always have the exact amount or more inside of them

Answer 19

True