Product Labeling and Advertising Flashcards
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Read the first 7 Product Labeling and Advertising flashcards as text
A supplement company places a QR code on its label that links to a webpage making disease claims. How does FDA treat this webpage from a regulatory standpoint?
Answer: The webpage constitutes labeling if it accompanies the product, meaning disease claims could render the product an unapproved drug
FDA has consistently held that digital content (including websites) accessible via product labeling can constitute labeling under 21 USC 321(m), subjecting disease claims to drug regulatory requirements.
Under 21 CFR 101.13, which of the following is an 'implied nutrient content claim' requiring compliance with FDA definitions?
Answer: A label depicting a heart symbol next to a low-fat product implying cardiovascular benefit
Symbols and logos that characterize the nutrient level of a food constitute implied nutrient content claims under 21 CFR 101.13(b) and must comply with relevant definitions.
When a generic drug applicant submits an ANDA, how must the proposed labeling compare to the Reference Listed Drug (RLD) labeling?
Answer: It must be identical to the RLD labeling except for differences due to formulation or legal exclusivity
Under 21 CFR 314.94(a)(8), ANDA labeling must be identical to the RLD labeling except for permitted differences such as trade name, manufacturer, and situations where the RLD has proprietary information.
Under FTC Act Section 5, what makes an endorsement or testimonial in advertising potentially deceptive?
Answer: Failure to disclose a material connection between the endorser and the advertiser
FTC's Endorsement Guides (16 CFR Part 255) require disclosure of material connections — including payment, free products, or employment — that could affect how consumers view the endorsement.
A manufacturer receives an FDA Warning Letter citing misbranding because their OTC drug label omits required information. Under 21 USC 352, which scenario constitutes misbranding?
Answer: A label that fails to include adequate directions for use by laypeople in the language required by regulation
Under 21 USC 352(f), a drug is misbranded if its labeling does not contain adequate directions for use, meaning instructions a layperson can follow safely without professional guidance.
Australia's Therapeutic Goods Administration (TGA) requires medicines to have an AUST R or AUST L number on the label. What does AUST L indicate?
Answer: The product is listed on the Australian Register of Therapeutic Goods (ARTG) as a lower-risk medicine with self-assessable indications
AUST L (Listed) products are lower-risk medicines with permitted indications that do not require individual TGA efficacy assessment, unlike AUST R (Registered) products.
Under 21 CFR Part 606, blood establishment labels must include which information to ensure traceability and safe transfusion?
Answer: The donor identification number, product name, collection facility, expiration date, and ABO/Rh blood group
21 CFR 606.121 mandates specific label elements for blood products including donor ID, product name, facility, expiration, and blood type to ensure safe and traceable transfusions.