Question

FDA requirements for efficacy need to be established based upon randomized controlled trials for all of the following types of products except:

a) Prescription drugs.
b) Over-the-counter medications.
c) Medical devices.
d) Herbal supplements.

Answer 1

Herbal supplements do not need to establish efficacy through randomized controlled trials like prescription drugs, over-the-counter medications, and medical devices do. They are regulated more like foods, with less stringent requirements.

Step-by-step explanation:

The FDA requirements for efficacy based on randomized controlled trials do not apply to all of the listed product types. Specifically, herbal supplements are the products not required to meet the same stringent efficacy standards as prescription drugs, over-the-counter medications, and medical devices. Instead, herbal supplements are regulated more like foods and must meet the FDA's Good Manufacturing Standards. However, they are not held to the same clinical trial standards for proving efficacy. Manufacturers can make certain health-related claims, but they must include disclaimers stating that the products are not intended “to diagnose, treat, cure, or prevent any disease.” Additionally, supplements can only be removed from the market if the FDA proves they are hazardous.

The answer to the student's question is that herbal supplements are the type of products that do not need to establish efficacy based on randomized controlled trials.