FDA and herbal Flashcards
What is the role of the FDA in regulating OTC and herbal supplements?
Approves OTC drugs, ensures safety and efficacy, monitors dietary supplements.
What is the role of the FTC in regulating OTC and herbal supplements?
Regulates advertising of OTC drugs and supplements.
What are prescription drugs?
Drugs requiring provider approval for use.
What are OTC drugs?
Drugs available to the public and deemed safe for self-use.
What are ‘behind the counter’ (BTC) drugs?
Drugs dispensed by pharmacists without a prescription, such as pseudoephedrine.
What happens in Phase 1 of clinical testing?
Safety is tested in healthy volunteers.
What happens in Phase 2 of clinical testing?
Efficacy is evaluated in small patient groups.
What happens in Phase 3 of clinical testing?
Large-scale trials assess safety and efficacy.
What happens in Phase 4 of clinical testing?
Post-marketing surveillance for long-term safety and efficacy.
What does GRASE stand for?
Generally Recognized As Safe and Effective.
Why is it difficult to regulate dietary supplement claims?
Lack of pre-market approval and the burden is on the FDA to prove harm.
What is the purported benefit of echinacea?
Immune stimulation.
What is the purported benefit of garlic?
Cardiovascular health.
What is the purported benefit of ginkgo?
Memory improvement.
What is the purported benefit of St. John’s wort?
Depression treatment.
