Responsible Use of Dietary Supplements Flashcards
Common motivations: • Lose weight • Stay healthy • Avoid use of \_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_ • Replace healthy diet
prescription drugs
Clinical Challenges
Many supplements lack evidence of efficacy
1–Lack quality randomized, controlled trials
2–Lack long term studies
Lack of _________ doesn’t automatically mean
lack of efficacy
• Often a lack of financial incentive for manufacturers
to fund large studies
e.g. unable to patent a herb to recoup costs
evidence
Supplements that LACK evidence of efficacy and
safety are still readily available to consumers
KNOW THIS
Dietary Supplement Health and Education Act
(DSHEA) of 1994
“The ____ ______________ is responsible for
ensuring that a dietary supplement is safe
before it is marketed.”
DS manufacturer
“Although dietary supplement manufacturers
must register their facilities with FDA
Manufacturers DO NOT need to register their
products with FDA nor get FDA approval
_________ producing OR selling dietary
supplements”
BEFORE
“Unlike drugs that must be proven safe and
effective for their intended use BEFORE marketing,
there are NO provisions in the law for FDA to
“___________” dietary supplements for safety or
effectiveness before they reach the consumer.”
approve
“Once the product is marketed, FDA has the
responsibility for showing that a dietary
supplement is “________,” before it can take action
to restrict the product’s use or removal from the
marketplace.”
unsafe
“___________&___________ of DS must
record, investigate and forward to FDA any
reports they receive of serious adverse events
associated with the use of their products that
are reported to them directly.”
Manufacturers and distributors
DS Contamination or Adulteration
Issue: Poor quality DS may contain hidden or
deceptively labeled ingredients, such as the active
ingredients in drugs or other compounds that don’t
qualify as DS ingredients
• Most commonly, tainted products are marketed as DS are for __________,____________ OR __________.
weight loss, sexual enhancement, or body building
________ for companies to claim a supplement can “treat, prevent, cure” a disease except some nutrient-deficiency conditions
In general, FDA must find credible evidence to support
the claim to permit its use
Illegal
______ & __________ of nutrients can have profound
implications on the safety and effectiveness of
supplements
EX..Potency and purity of plants can differ depending on
how and where they’re grown, stored, and ________.
Quality verified by independent 3rd Party
Form, and dose
processed
Just because something is “_________” does not automatically mean it is safe
Consider:
Natural herbs for example, are not natural to the human body
natural
Any substance that can cause a beneficial effect on health, may also produce a detrimental one
• Detrimental effect known as the _______ ______ or adverse reactions
side effect
Adverse Effects
May occur because of:
- ___________ Reaction: Related to dosing
- _______ ________: When combining 2 or more substances results in an unexpected outcome that would not occur if they were used alone
- ___________: Allergic reaction not explained by the
pharmacology of the substance
Pharmacological
Drug Interaction
Hypersensitivity
Adverse Effects
May occur because of:
- _________: Overreaction to an unusually small dose
- _________: Usually does not occur, not explained by the pharmacology of the substance - other individuals would react differently, or not at all – often individual, unique immune mediated toxicity - occur rarely, unpredictably
Intolerance
Idiosyncratic
