RAC Product Labeling and Advertising 2

Question 1

Under 21 CFR Part 101, which statement about the Nutrition Facts panel serving size is correct?

Accepted Answer

Serving size must reflect the amount typically consumed in one sitting based on Reference Amounts Customarily Consumed (RACC)

Answer

FDA requires serving sizes to reflect RACC values so consumers can make realistic comparisons between similar products.

Question 2

A medical device manufacturer wants to promote an off-label use of their FDA-cleared device to physicians. Under current FDA policy, which activity is generally permissible?

Accepted Answer

Distributing peer-reviewed journal articles about off-label use upon unsolicited physician request

Answer

FDA's 2023 guidance allows firms to respond to unsolicited requests for off-label information by providing unbiased scientific information such as reprints.

Question 3

Which FTC standard applies when an advertiser claims a product produces a specific quantified outcome (e.g., 'Lose 10 lbs in 2 weeks')?

Accepted Answer

Competent and reliable scientific evidence that the specific result is typical for users

Answer

FTC requires substantiation through competent and reliable scientific evidence, and specific performance claims imply typical results unless clearly disclaimed.

Question 4

Under FDA regulations, what distinguishes 'labeling' from 'label' for a drug product?

Accepted Answer

Labeling encompasses all written, printed, or graphic matter accompanying the article, while the label is only the immediate container

Answer

Under 21 USC 321(m), 'labeling' is broader than 'label' and includes all written material accompanying the product, including brochures and websites.

Question 5

A dietary supplement label claims 'Supports healthy cholesterol levels already within normal range.' How is this claim classified under DSHEA?

Accepted Answer

Structure/function claim requiring a disclaimer that FDA has not evaluated the statement

Answer

Qualifying a benefit claim by stating 'already within normal range' typically converts a potential disease claim to a permissible structure/function claim under DSHEA.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Product Labeling and Advertising 2