RAC Product Labeling and Advertising 3

Question 1

A cosmetic product's label lists 'fragrance' as a single ingredient. Under current US regulations, is this compliant?

Accepted Answer

Yes, fragrance may be listed as a single ingredient under 21 CFR 701.3(a) without disclosing individual components

Answer

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'?

Accepted Answer

Information relating to each side effect, warning, precaution, and contraindication in the approved labeling

Answer

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?

Accepted Answer

Unqualified 'recyclable' claims that may be misleading if recycling facilities are not available to a substantial majority of consumers

Answer

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?

Accepted Answer

A UDI-DI in both human-readable and AIDC (barcode) format on the label and packaging

Answer

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?

Accepted Answer

At least one well-controlled clinical study demonstrating the claimed benefit

Answer

FTC interprets 'clinically proven' to imply at least one well-controlled clinical study, setting a higher substantiation bar than general efficacy claims.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Product Labeling and Advertising 3