OTC

Question 1

What does the FDA do?

Answer 1

Drugs = safe & effective

Reviews all claims- Rx, OTC, BTC, Supplements

Question 2

Categories of non-prescription

Answer 2

OTC
Herbal Supplements

Question 3

Dietary Supplement Health & Education Act regulates?

Answer 3

Non-tobacco product; Intended to supplement diet

Must contain at least one of the following: Vitamins, minerals, herbs, botanicals, or amino acids

Intended delivery: oral

Non-nutritive (non-caloric)

Question 4

Guidelines for promotional literature

Answer 4

-Cannot include disease tx or prevention claims

3 Permissible claims : Nutrient content, structure/function (Ca builds strong bones) , Health- general health (promotes bowels/ immunity)

Evidence to support these claims must be present before marketing

Question 5

T/F: Evidence to support these claim for supplements must be present before marketing.

Answer 5

TRUE

Question 6

Echinacea: CLaim? Issue?

Answer 6

Claim- Immune function, inflamm

Issues- GI upset

Question 7

Garlic: Claim, Issue?

Answer 7

Claim: Cholesterol, coag, Ca, anti-bacterial

Issue- Odor (bad breath), coagulation

Question 8

Ginko Biloba: Claim?

Answer 8

Increased blood flow, memory, dementia

Question 9

St. John’s Wort: Claim, Issue, Other?

Answer 9

Claim: Depression

Issue- Induce CYPs

Other- w/ MAOIs = SEROTONIN SYNDROME

Question 10

Ginseng: Claim?

Answer 10

Memory, immunity, analgesia

Question 11

How does the DSHEA regulate their products?

Answer 11

“Like a food” aka “dietary supplement”