GoldbergChapter 14Over-the-Counter DrugsChapter 3Performance-Enhancing Drugs

Chapter 14 Goldberg

A. Sure, vitaminsB. Herbal supplementsC. Amino acids to bulk

upD. No way!

Sure, v

itam

ins

Herbal s

upplem

ents

Amin

o acids t

o bulk

up

No way!

57%

0%

30%

13%

Food, Drug & Cosmetic Act

Food = safe, pure, NOT required to show they are effective or have benefit

Drug = intended for use in diagnosis, cure, mitigation, treatment or prevention of disease

Dietary Supplement Health and Education Act 1994

Defined supplements and set regulation for safety and labeling

Same as food labeling

▪ Includes: vitamins, minerals, herbs (and concentrates), amino acids

Category I: generally recognized as safe

(GRAS) generally recognized as effective

(GRAE) generally recognized as honestly

labeled (GRAHL)

Category II: Not generally recognized as safe or effective or is improperly labeled

Category III: Cannot be sold

A. My mom.

B. Advertisements.

C. Friends.

D. Used it in the past.

E. Nothing.

My m

om.

Advertise

ments

.

Frie

nds.

Used it

in th

e past

.

Nothin

g.

42%

15%12%12%

18%

1962 Kefauver-Harris amendment required all drugs be evaluated for safety and efficacy

FDA can only declare a product adulterated if it presents a significant or unreasonable risk of illness or injury

Health claims

Structure/function claims

Carries disclaimer

What are the pros and cons of current supplement regulations?

What are some supplements you’ve heard of?

FILM http://digital.films.com/PortalViewVideo.aspx?xtid=32926#

Definitely hazardous Aristolochic acid

Ephedra

Very likely hazardous Comfrey

Androstenedione

Chaparral

Germander

Kava

Cesium

Colloidial Siver

Graviola

Likely hazardousBitter orangeOrgan/glandular extractsLobeliaPennyroyal oilScullcapYohimbe

Commonly used

St. John’s WortGingko BilobaEchinaceaGoldensealAloe VeraFlax Seed Oil

Green TeaPrimroseGinsengSaw Palmetto

A. 2

B. 4

C. 10

2 4 10

0% 0%0%Response

A. It doesn’t; they are the same.

B. OTC drugs are safer than prescription drugs.

C. Supplements are safer than prescription drugs.

It doesn

’t; th

ey are

the ..

.

OTC dru

gs are

safe

r than...

Supplem

ents are

safe

r t...

0% 0%0%

Response

A. Yes, thoroughlyB. Well, I skim itC. Nope, never looked

Yes, th

oroughly

Well,

I skim

it

Nope, never l

ooked

0% 0%0%

A. 1 in 20B. 1 in 50C. 1 in 100

1 in 2

0

1 in 5

0

1 in 1

00

0% 0%0%

A. TrueB. False

True

False

0%0%

1938 Food, Drug & Cosmetic Act established class of prescription drugs

DIFFERENCES:

Dosage

Active ingredient

FDA reviews products, may switch to OTC

Stimulants

Only caffeine

Weight-control products

Only Orlistat/Alli

Sedatives/sleep aids

No approved sedatives, sleep aids contain antihistamine

Analgesics

Acetylsalicylic Acid, Acetaminophen, Ibuprofen (NSAIDs)

Cold/Allergy remedies

Antihistamines

Nasal decongestants

Analgesic-antipyretics

A. TrueB. False

True

False

0%0%

A. TrueB. False

True

False

0%0%

A. Seizures

B. Cancer

C. Infections

D. Mental illnesses

Seizure

s

Cancer

Infe

ctio

ns

Menta

l illn

esses

0% 0%0%0%Response

Goldberg Chapter 3

http://digital.films.com/PortalViewVideo.aspx?xtid=43517

A. Mood stabilizer

B. Testosterone

C. Enzyme

D. Protein

Mood st

abilize

r

Testost

erone

Enzym

e

Prote

in

0% 0%0%0%Response

A. Deepening voice

B. Growth of facial and chest hair

C. Decrease depression

D. Increase muscle mass

Deepening v

oice

Growth

of f

acia

l and ch

es...

Decreas

e depre

ssio

n

Incr

ease m

uscle

mass

0% 0%0%0%

Response

A. Changing metabolism

B. Increasing protein synthesis

C. Affecting neurotransmitters

D. Increasing growth hormone

Changing m

etabolis

m

Incr

easing p

rote

in sy

nthesis

Affect

ing n

eurotr

ansm

itters

Incr

easing gro

wth

horm

one

0% 0%0%0%

Response

A. Depression

B. Growth deficiencies

C. AIDS

D. Cancer

Depress

ion

Growth

defic

iencie

sAID

S

Cancer

0% 0%0%0%

Response

A. Using steroids to get bigger and stronger

B. Using steroids to ward off depression

C. Using steroids to improve looks

D. Using steroids to combat side effects from chemotherapy

Using st

eroid

s to get b

igg..

Using st

eroid

s to w

ard o

f...

Using st

eroid

s to im

prove...

Using st

eroid

s to co

mbat .

..

0% 0%0%0%

Response

A. Respiratory distress

B. High blood pressure

C. High cholesterol

D. Liver damage

Respira

tory

dist

ress

High b

lood p

ress

ure

High ch

olest

erol

Liver d

amage

0% 0%0%0%Response

A. Abnormal growth of muscles

B. Having an unrealistic perception of your body

C. A symptom of eating disorders

D. Caused by a hormone imbalance

Abnormal g

row

th o

f mus..

.

Having an u

nrealis

tic p

er...

A sym

ptom

of e

ating d

is...

Caused b

y a horm

one im...

0% 0%0%0%

Response

Stimulants

Steroids

Human growth hormone

Creatine

A. Yes

B. No

C. Depends

YesNo

Depends

0% 0%0% Response

A. Yes

B. No

YesNo

0%0%Response

In your group, talk about use of performance-enhancing drugs:1. Under what circumstances is it acceptable?

Why?2. Under what circumstances is it unacceptable?

Why?3. When should testing for PEDs be implemented?

Under what situations or conditions? Why? For what groups?

High school, college, professional athletes?

Cheerleading?

Academic competitors?