CRAP CRAP Labeling & Advertising Regulations 2 — Questions and Answers
Question 1: What is the purpose of the 'Supplement Facts' panel required on dietary supplement labels?
- To list the manufacturer's quality certifications
- To disclose serving size, ingredient amounts, and percent daily values (Correct answer)
- To provide dosing instructions for therapeutic use
- To indicate FDA approval status
Correct 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.
Question 2: Which of the following constitutes a labeling violation under FDA regulations?
- Including a toll-free number for adverse event reporting
- Making a disease claim on a dietary supplement without FDA approval (Correct answer)
- Listing all inactive ingredients on prescription drug labels
- Including patient counseling information on drug labels
Correct 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.
Question 3: What is required in the 'Indications and Usage' section of prescription drug labeling?
- The mechanism of action of the drug
- A description of the condition(s) for which the drug is approved (Correct answer)
- The pharmacokinetic profile of the drug
- The clinical trial methodology used for approval
Correct 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.
Question 4: Which federal law requires food labels to include a standardized Nutrition Facts panel?
- Food Quality Protection Act (FQPA)
- Nutrition Labeling and Education Act (NLEA) of 1990 (Correct answer)
- Food Safety Modernization Act (FSMA) of 2011
- Federal Food, Drug, and Cosmetic Act of 1938
Correct 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.
Question 5: What is the regulatory classification of a product whose label contains false or unauthorized claims?
- The product is considered adulterated
- The product is considered misbranded (Correct answer)
- The product requires a mandatory boxed warning
- The product must be reformulated before sale
Correct 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.
Question 6: Under FDA regulations, which best describes the legal definition of 'labeling'?
- Only the physical label attached to the product container
- All written, printed, or graphic material accompanying the product (Correct answer)
- Only promotional materials pre-approved by FDA
- The package insert distributed with prescription drugs only
Correct 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.
CRAP CRAP Labeling & Advertising Regulations 2
What is the purpose of the 'Supplement Facts' panel required on dietary supplement labels?