RAC Product Labeling and Advertising 3 — Questions and Answers
Question 1: A cosmetic product's label lists 'fragrance' as a single ingredient. Under current US regulations, is this compliant?
- Yes, fragrance may be listed as a single ingredient under 21 CFR 701.3(a) without disclosing individual components (Correct answer)
- No, all fragrance components must be individually listed by INCI name
- Only if the product contains fewer than five fragrance chemicals
- Only for products marketed exclusively to professional salons
Correct answer: Yes, fragrance may be listed as a single ingredient under 21 CFR 701.3(a) without disclosing individual components
Current US cosmetic regulations under 21 CFR 701.3 allow 'fragrance' as a collective term, though the Modernization of Cosmetics Regulation Act of 2022 introduced new fragrance allergen disclosure requirements.
Question 2: Under 21 CFR 202.1, a prescription drug advertisement must include which element known as the 'brief summary'?
- Information relating to each side effect, warning, precaution, and contraindication in the approved labeling (Correct answer)
- A summary of the drug's mechanism of action and pharmacokinetics
- The drug's complete Phase III clinical trial results
- A comparative analysis with competing drugs in the same therapeutic class
Correct answer: Information relating to each side effect, warning, precaution, and contraindication in the approved labeling
The brief summary requirement under 21 CFR 202.1 mandates disclosure of all risk-related information from approved labeling in print drug advertisements.
Question 3: The FTC's Green Guides (16 CFR Part 260) address which of the following environmental marketing claims?
- Unqualified 'recyclable' claims that may be misleading if recycling facilities are not available to a substantial majority of consumers (Correct answer)
- Carbon offset claims certified by third-party ISO 14064 auditors
- Biodegradable claims only for packaging materials
- Claims about reduced water usage during manufacturing processes
Correct answer: Unqualified 'recyclable' claims that may be misleading if recycling facilities are not available to a substantial majority of consumers
The FTC Green Guides specify that unqualified 'recyclable' claims are deceptive if recycling facilities are not available to at least 60% of consumers.
Question 4: Under EU Medical Device Regulation (MDR) 2017/745, what is required on the label of a Class IIa implantable device?
- A UDI-DI in both human-readable and AIDC (barcode) format on the label and packaging (Correct answer)
- The full instructions for use printed directly on the device label
- A QR code linking to the EUDAMED database entry for the device
- The name and address of the notified body that certified the device
Correct answer: A UDI-DI in both human-readable and AIDC (barcode) format on the label and packaging
EU MDR Article 27 and Annex VI require UDI-DI in both human-readable and AIDC format on labels of implantable devices.
Question 5: A company markets a product as 'clinically proven' in its advertising. According to FTC enforcement principles, what type of evidence is needed to substantiate this claim?
- At least one well-controlled clinical study demonstrating the claimed benefit (Correct answer)
- Any published study, including observational research or case reports
- Internal company testing data reviewed by company scientists
- Expert endorsement from a licensed physician affiliated with the company
Correct answer: At least one well-controlled clinical study demonstrating the claimed benefit
FTC interprets 'clinically proven' to imply at least one well-controlled clinical study, setting a higher substantiation bar than general efficacy claims.
Question 6: Under the Fair Packaging and Labeling Act (FPLA), which requirement applies to the net quantity declaration on consumer commodity labels?
- Net quantity must appear on the principal display panel in a specific minimum type size relative to the panel area (Correct answer)
- Net quantity must be expressed only in metric units for all products sold in the US
- Net quantity may appear anywhere on the label as long as it is legible
- Net quantity disclosure is required only for products sold by weight, not by count
Correct answer: Net quantity must appear on the principal display panel in a specific minimum type size relative to the panel area
FPLA and implementing regulations at 16 CFR Part 500 require net quantity on the principal display panel in a minimum type size proportional to the panel area.
Question 7: For a combination product regulated primarily as a drug with a device constituent part, which FDA center has primary jurisdiction for labeling review?
- CDER or CBER, as the drug or biologic component determines primary jurisdiction (Correct answer)
- CDRH always has jurisdiction over combination products containing a device component
- OCP (Office of Combination Products) independently reviews all combination product labeling
- Jurisdiction is split equally between CDER and CDRH regardless of the primary mode of action
Correct answer: CDER or CBER, as the drug or biologic component determines primary jurisdiction
For combination products, FDA's Office of Combination Products assigns primary jurisdiction to the center regulating the primary mode of action, typically CDER or CBER for drug-led combinations.
RAC Product Labeling and Advertising 3
A cosmetic product's label lists 'fragrance' as a single ingredient.
Under current US regulations, is this compliant?