CRAP Labeling & Advertising Regulations Flashcards
6 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRAP Labeling & Advertising Regulations flashcards as text
What is the purpose of the 'Supplement Facts' panel required on dietary supplement labels?
Answer: To disclose serving size, ingredient amounts, and percent daily values
The Supplement Facts panel, required under DSHEA, discloses serving size, ingredient amounts, and percent daily values for dietary supplements.
Which of the following constitutes a labeling violation under FDA regulations?
Answer: Making a disease claim on a dietary supplement without FDA approval
Dietary supplements cannot legally claim to diagnose, cure, treat, or prevent diseases without FDA approval, as such claims would classify them as drugs.
What is required in the 'Indications and Usage' section of prescription drug labeling?
Answer: A description of the condition(s) for which the drug is approved
The Indications and Usage section describes the specific disease, condition, or patient population for which FDA has approved the drug.
Which federal law requires food labels to include a standardized Nutrition Facts panel?
Answer: Nutrition Labeling and Education Act (NLEA) of 1990
The Nutrition Labeling and Education Act (NLEA) of 1990 mandated standardized Nutrition Facts panels on most packaged food products sold in the US.
What is the regulatory classification of a product whose label contains false or unauthorized claims?
Answer: The product is considered misbranded
A product with false, misleading, or unauthorized labeling claims is considered misbranded under the FD&C Act and is subject to regulatory action.
Under FDA regulations, which best describes the legal definition of 'labeling'?
Answer: All written, printed, or graphic material accompanying the product
Under 21 USC 321(m), 'labeling' broadly includes all written, printed, or graphic matter on or accompanying a product, not just the physical label affixed to the container.