CRAP CRAP Labeling & Advertising Regulations 2

Question 1

What is the purpose of the 'Supplement Facts' panel required on dietary supplement labels?

Accepted Answer

To disclose serving size, ingredient amounts, and percent daily values

Answer

The Supplement Facts panel, required under DSHEA, discloses serving size, ingredient amounts, and percent daily values for dietary supplements.

Question 2

Which of the following constitutes a labeling violation under FDA regulations?

Accepted Answer

Making a disease claim on a dietary supplement without FDA approval

Answer

Dietary supplements cannot legally claim to diagnose, cure, treat, or prevent diseases without FDA approval, as such claims would classify them as drugs.

Question 3

What is required in the 'Indications and Usage' section of prescription drug labeling?

Accepted Answer

A description of the condition(s) for which the drug is approved

Answer

The Indications and Usage section describes the specific disease, condition, or patient population for which FDA has approved the drug.

Question 4

Which federal law requires food labels to include a standardized Nutrition Facts panel?

Accepted Answer

Nutrition Labeling and Education Act (NLEA) of 1990

Answer

The Nutrition Labeling and Education Act (NLEA) of 1990 mandated standardized Nutrition Facts panels on most packaged food products sold in the US.

Question 5

What is the regulatory classification of a product whose label contains false or unauthorized claims?

Accepted Answer

The product is considered misbranded

Answer

A product with false, misleading, or unauthorized labeling claims is considered misbranded under the FD&C Act and is subject to regulatory action.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP CRAP Labeling & Advertising Regulations 2