1962 Kefauver Harris Amendment Ans✓✓✓ representative from
arkansas
response to thalidomide tragedy
drugs must be safe and effective
a botanical product approved by NDA can have marketing exclusivity
for Ans✓✓✓ 3-5 years in absence of patent
absorption of cigarette nicotine Ans✓✓✓ rapidaly dried over
smokeless heat= acidic smoke (5.8)
little absorbed in oral mucosa, pulmonary absorption is complete
cigars (6.2-8.) absorbed in oral mucosa
according to DSHEA what statements must dietary supplement labels
be marketed with Ans✓✓✓ - claims benefit related to nutrient
deficiency disease
- describes how the product affects body
- characterizes MOA
- describes well being from consumption
- *may not claims to diagnose, mitigate, treat, cure, or prevent disease*
adaptogens Ans✓✓✓ coined in 1947 by N.V. Lazarev
,used to describe effects of chemicals to increase the resistance of
organisms to stress experimental studies
normalizing effects
negative effects on sleep, addiction, abuse, tolerance
advantages of developing botanical drugs Ans✓✓✓ -substantial history
of human use
-published or historical safety/ efficacy
adverse event Ans✓✓✓ any health event associated with the use of a
dietary supplement that is adverse
based on reasonable medical judgement
alkaloid salts Ans✓✓✓ most present form
usually more stable
water soluble
given IV
alkaloids Ans✓✓✓ Karl Friederish Wilhem Meissner coined term to
describe alkaline substances
nitrogenous organic molecule with pharmacological effects
most are basic
morphine, vincristine, caffeine, atropine
,alternative medicine Ans✓✓✓ used in place of conventional medicine
alternative response to GRAS notification Ans✓✓✓ at notifier's
request, FDA ceased to evaluate notice
FDA not required to review and approve food ingredients that are for a
particular use
GRAS is unique to USA
american ginseng Ans✓✓✓ Panax quinquefolius
used in higher doses in western medicine
anthocynaidins Ans✓✓✓ w/ 1 or more sugars= anthocyanins
scavenge superoxide radicals
collagen stabilizing activity
red, purple or blue depending on pH
i.e. cyandin
content in foods 1mg/100g or 100mL
anthraquinone gycosides Ans✓✓✓ aromatic compounds with one
hexane ring and two opposite carbonyl groups
can be attached to one or more benzene rings
can have O or C
, are plant derived medicines useful therapeutic options Ans✓✓✓ yes
have been proven clinically effective in some cases
ashwagandha Ans✓✓✓ Withania Somniferum
sedative, adaptogen, and tonic
may cause GI irritation
avoid in autoimmune dz
asian ginseng Ans✓✓✓ Panax ginseng
calming and sedative
can cause allergic rxn
can lower alcohol levels
basic structure of flavonoids Ans✓✓✓ two benzene rings connected by
a 3 carbon chain
C6-C3-C6
link chain undergoes cyclization and oxidation to produce various
flavanoids
benzoquinone
napthoquinone
anthroquinone Ans✓✓✓ 1