Before a manufacturer can distribute a product that contains a ...

[Garrulous]

Before a manufacturer can distribute a product that contains a new dietary ingredient, it must provide data that demonstrate
 
  a. the safety and efficacy of the product.
  b. that the product is distinct from other available products.
  c. that the quality of the product can be maintained consistently.
  d. that the product has been safely used by study subjects for at least 2 years.

Question 2

Interactions that affect drug or nutrient metabolism and occur after the digestive and absorptive processes are complete are classified as:
 
  1. Alteration in excretion.
   2. Alteration in bioavailability.
   3. Alteration in metabolism.
   4. Alteration in inhibition.

[Bsand8]

Answer to Question 1

A
Before manufacturers distribute products that contain new dietary ingredients, they must provide data to the FDA that demonstrates the safety and efficacy of the product. The product does not need to be distinct from other available products. The FDA is concerned with safety rather than quality. Safety does not need to be demonstrated over a specific length of time.

Answer to Question 2

3
Rationale: Interactions that affect drug or nutrient metabolism occurring after digestion and absorption are complete and the substances are in the circulation en route to tissues are referred to as alterations in metabolism. Alterations in excretion refer to the elimination of metabolic byproducts. Alterations in bioavailability are the result of a change in absorption of drugs or nutrients. Inhibition results from alteration in the use of enzymes during metabolism and results in increased drug absorption.