**Exam 1 Study Guide** Flashcards
(165 cards)
define homeopathy
the idea that a disease can be cured by a substance that produces similar symptoms in healthy people
believes the lower the dose of med, the greater its effectiveness
define naturopathy, who is it practiced by? (type of physician)
based on a combo of traditional practices and health care approaches and is practiced by naturopathic physicians
what is ayervedic medicine?
ancient Indian medical system which relies on natural holistic approaches to physical and mental health
examples of traditional Chinese medicine
acupuncture
tai chi
herbal products
dietary supplements health and education act (DSHEA)
what did it do?
who is responsible for the supplements safety?
when must a supplement label be given to the FDA? (how many days)
excludes dietary supplements from being defined as “food additives”
safety of supplements is up to manufacturers, but proof is determined by FDA
supplement label must be given to FDA within 30 days of marketing
8 steps in developing safe and effective botanical dietary supps
- search scientific literature
- acquire and authenticate plant material
- determine mechanisms of action and identify active compounds
- prep for preclinical and clinical studies
- investigate metabolism of active compounds
- test drug metabolizing enzymes and transporters
- develop formulation
- conduct phase 1 & 2 clinical trials
what does cGMP stand for and what is it?
current Good Manufacturing Processes
An FDA requirement on producers of botanical dietary supplements
what types of claims are permitted for dietary supplements?
is supporting data required by manufacturer for any claims?
What must every claim be accompanied with? (Hint: FDA)
health claims
structure/function claims
nutrient content claims
Yes
This statement has not been evaluated by the U.S. Food and Drug Administration (FDA). This product is not intended to diagnose,
treat, cure, or prevent any disease
what dietary supplements are not allowed by DSHEA?
any supplement not already on U.S. market or commonly used
if it contains a drug approved by FDA
anything toxic or harmful
Any dietary supplement containing synthetic constituent(s)
who regulates accurate labeling of dietary supplements?
The U.S. Federal Trade Commission (FTC)
define complementary medicine
an uncommon practice (herb,drug,meditation,etc) used together with conventional medicine
Which state banned yoga in 1993?
Alabama
When was the ban on yoga lifted?
May 2021
Who is more likely to see a chiropractor, men or women?
Women
What did DSHEA define a dietary supplement as?
A product intended to supplement the diet that contains one or more of (a) Vitamin, (b) Mineral, (c) Herb/Botanical, (d) Amino acid (e) Supplement that increases total dietary intake
what is the mission of the Office of Dietary Supplements (ODS)?
strengthen knowledge of supplements by educating the public through scientific research in order to enhance the quality of life and health for the U.S.
T/F Aristolochia species is commonly in weight loss supplements in many countries?
False: It is toxic to humans and is banned
How Can Accidental Contamination of Botanical
Dietary Supplements be Prevented? (2 Main practices)
Implement Good Agricultural Practices (GAP)
Implement Good Manufacturing Practices (GMP)
What are mycotoxins?
How does it affect humans?
toxic compounds naturally produced by certain types of fungus
causes disease and death in humans
What does cGMP not do?
Limit consumers’ access to products
Evaluate the safety of dietary supplement ingredients
Evaluate product efficacy
Define a structure/function claim
describes the role of a nutrient or dietary ingredient intended to affect normal structure or function of the human body
if a product treats/prevents a disease, can it be regulated as a dietary supplement?
Does this type of product violate DSHEA?
No
Yes
If a supplement is not produced using cGMP, who has the right to remove it from the market?
The FDA
Who can prosecute offenders of making a false label or advertising claim?
The federal trade commission (FTC)